case 1:03-cv-22120-pas document 1 entered on flsd...

Case 1:03-cv-22120-PAS Document 1 Entered on FLSD Docket 08/11/2003 of 37

03- 22120 UNITED STATES DISTRICT COUR(Jy j0 SOUTHERN DISTRICT OF FLORID

MIAMI DIVISION

MILLER DONOVAN, On Behalf of Himself and All Others Similarly Situated,

Plaintiff,

vs.

k1ck,, a - 4V %10*44)0*

NOVEN PHARMACEUTICALS, INC.,

KUIitK1 U. STRAUSS,JAMLS B. M1SS1KY) and JUAN A. MANTELLE,

Defendants. ) C

S CLASS ACTION •1 :

COMPLAINT FOR VIOLATION OF THE FEDERAL SECURITIES LAWS - '.

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No copyright is claimed in the text of statutes, regulations. and any excerpts from analysts' reports quoted within this

work.

Copyright © 2003 by William S. Lerach and Milberg Weiss Bershad Hynes & Lerach LLP. William S. Lerach and

Milberg Weiss Bershad Hynes & Lerach LLP will vigorously defend all of their rights to this writing/publication.

All rights reserved - including the right to reproduce in whole or in part in any form. Any reproduction in any form by

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Lerach LLP is prohibited.


SUMMARY AND OVERVIEW

This is a securities class action on behalf of purchasers of Noven Pharmaceuticals,

Inc. ("Noven" or the "Company") common stock between October 29, 2001 and April 28, 2003 (the

"Class Period"). Noven develops, manufactures and markets transdermal drug delivery systems.

The Company's products include the first two-drug transdermal patch (CombiPatch®) and the

world's smallest estrogen patch (Vivelle-Dot®). Noven continues to focus on developing products

for hormone replacement therapy, central nervous system conditions and other therapeutic

categories. The Company is currently developing a methylphenidate transdermal drug delivery

system for attention-deficit/hyperactivity disorder ("ADI-ID") called MethyPatch®.

2. ADHD is the most common neurobehavioral disorder of childhood. Children are

diagnosed with ADHD based on complex methodology of assessment of diagnostic criteria. When

behavioral therapy is unable to achieve treatment outcomes, clinical intervention with stimulant

medication is often required. Stimulant medications have been shown to be efficacious in reducing

the symptoms of ADHD. Methyiphenidate drugs are indicated for the treatment of childhood

ADHD.

3. During the Class Period, Noven was engaged in the development and testing of

MethyPatch ®. Noven began screening and enrollment for a repetition of a Phase III clinical study

of the drug on October 29, 2001. The active ingredient in MethyPatch ® is methyiphenidate, a DEA

Schedule 11 controlled substance, also legitimately used as a stimulant medication in the treatment

of ADHD. Noven filed a New Drug Application ("NDA") with the U.S. Food and Drug

Administration ("FDA") on June 27, 2002. Subject to FDA approval, this drug was set to launch

during the second half of 2003. Defendants' false and misleading statements regarding the rationale

and marketing strategies for approval of MethyPatch® permitted Noven to artificially inflate the

value of its technology to shareholders and thereby minimize the impact of financial uncertainties

relating to serious marketed product issues during the Class Period. Moreover, it allowed defendants

to reap bonuses and insider trading proceeds.

4. Specifically, Noven represented MethyPatch® as an in-house development program,

with intentions to develop its own sales force to market the product once FDA approval was

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obtained. On February 27, 2003, Noven announced that it had signed an agreement to license -

MethyPatch® to Shire Pharmaceuticals Group plc ("Shire") for payments of up to $150 million and

ongoing manufacturing revenue. Shire agreed to pay $25 million upon closing of the transaction,

$50 million upon receipt of final FDA approval of MethyPatch®, and payments of up to $75 million

upon achievement of certain MethyPatch® sales milestones.

5. In its February 27, 2003 report of financial results for the fourth quarter and 2002

fiscal year, Noven explained the continued importance of MethyPatch® approval to the overall

business goals. Noven then reviewed the serious negative impact of the early termination of the

Women's Health Initiative ("Will") studies, corresponding disruption in the hormone therapy market

and erosion of Noven's hormone replacement therapy ("HRT") business in 2002. In attempting to

put MethyPatch® in perspective for shareholders, Robert C. Strauss, Noven's President, CEO and

Chairman stated, "We believe that the expected launch of MethyPatch® in the second half of 2003,

a stabilizing U.S. hormone business, and the advancement of new development projects, together

will position Noven for growth in the years ahead."

6. The true facts, which were known by each of the defendants but concealed from the

investing public during the Class Period, were as follows:

(a) MethyPatch® did not possess the safety and efficacy of immediate release oral

methyiphenidate products;

(b) The utility and advantages for MethyPatch® had been misrepresented by

pointing to unmet needs and product advantages that did not and would not exist by the time Noven

expected NDA approval;

(c) The FDA was aware of the reasons why MethyPatch® would not be

considered as safe or efficacious as Noven had claimed;

(d) Transdermal drug delivery systems have been the source of serious medication

errors that would complicate the product's contemplated use; and

(e) For one or more reasons related to the safety or efficacy of the product, the

MethyPatch® NDA submitted on June 27, 2002 would not be "approvable" as submitted.

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7. As a result of the defendants' false and misleading statements, Noven's stock traded -

at inflated prices during the Class Period, increasing to as high as $27.45 on June 17, 2002, whereby

the Company's top officers and directors reaped bonuses and insider trading proceeds, selling more

than $500,000 worth of their own shares.

JURISDICTION AND VENUE

8. Jurisdiction is conferred by §27 of the Securities Exchange Act of 1934 ("1934 Act").

The claims asserted herein arise under §10(b) and 20(a) of the 1934 Act and Rule lOb-S.

9. (a) Venue is proper in this District pursuant to §27 of the 1934 Act. Many of the

false and misleading statements were made in or issued from this District.

(b) The Company's principal executive offices are in Miami, Florida, where the

day-to-day operations of the Company are directed and managed.

THE PARTIES

10. Plaintiff Miller Donovan purchased Noven publicly traded securities as described in

the attached certification and was damaged thereby.

11. Defendant Noven develops and commercializes transdermal and transmucosal drug

delivery systems, including transdermal estrogen delivery systems.

12. Defendant Robert C. Strauss ("Strauss") was, at all times relevant hereto, the

President, Chairman and Chief Executive Officer of Noven. For fiscal year 2002, Strauss received

a performance-based bonus of $379,604, awarded in large part for his role in the filing of Noven's

NDA for the MethyPatch® transdermal methylphenidate delivery system.

13. Defendant James B. Messiry ("Messiry") was, at all times relevant hereto, Chief

Financial Officer of Noven. For fiscal year 2002, Messiry also received a performance-based bonus

of $116,437.

14. Defendant Juan A. Mantelle ("Mantelle") was Chief Technical Officer and chief

architect of Noven's patented drug delivery technology. During the Class Period, Mantelle sold

25,500 shares or $520,715 worth of his Noven stock.

15. The individuals named as defendants in ¶1J12-14 are referred to herein as the

"Individual Defendants." The Individual Defendants, because of their positions with the Company,

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possessed the power and authority to control the contents ofNoven's quarterly reports, press releases -

and presentations to securities analysts, money and portfolio managers and institutional investors,

i.e., the market. Each defendant was provided with copies of the Company's reports and press

releases alleged herein to be misleading prior to or shortly after their issuance and had the ability and

opportunity to prevent their issuance or cause them to be corrected. Because of their positions and

access to material non-public information available to them but not to the public, each of these

defendants knew that the adverse facts specified herein had not been disclosed to and were being

concealed from the public and that the positive representations which were being made were then

materially false and misleading. The Individual Defendants are liable for the false statements

pleaded herein at ¶J38-39, 41, 45, 47-48 and 53, as those statements were each "group-published"

information, the result of the collective actions of the Individual Defendants.

16. Each of the defendants is liable as a participant in a fraudulent scheme and course of

business that operated as a fraud or deceit on purchasers of Noven common stock, by disseminating

materially false and misleading statements and/or concealing material adverse facts. The scheme:

(i) deceived the investing public regarding Noven's business, its finances and the intrinsic value of

Noven common stock; (ii) caused plaintiff and other members of the Class to purchase Noven

common stock at artificially inflated prices; and (iii) allowed defendants to reap bonuses and insider

trading proceeds.

SCIENTER

17. In addition to the above-described involvement, each Individual Defendant has

knowledge of Noven's problems and was motivated to conceal such problems. Messiry, as CFO,

was responsible for financial reporting and communications to the market. Many of the internal

reports showing Noven's forecasted and actual growth were prepared by the finance department

under Messiry's direction. Mantelle, as CTO, was responsible for key inventions, scientific and

technical direction and communications. Defendants Messiry as CFO and Strauss as President,

Chairman of the Board and CEO, were responsible for the financial results and press releases issued

by the Company. Each Individual Defendant sought to demonstrate that he could lead the Company

successfully and generate the growth expected by the market.

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18. Strauss, Messiry and Mantelle were top executives of Noven. They ran Noven as -

"hands-on" managers, dealing with important issues facing Noven's business, i.e., its partnership and

licensing arrangements with Shire and Novartis Pharma, and the success of MethyPatch®.

19. The stated mission of Noven is to become the world's premier developer,

manufacturer and marketer of transdermal drug delivery systems. To fund this endeavor, Noven

leveraged its Vivelle-Dot® and Estradot® transdermal technologies, through partnership or direct

licensing with Novartis Pharma. Through the partnership arrangement, structured as an individual

enterprise known as Novogyne Pharmaceuticals ("Novogyne," a.k.a. Vivelle Ventures LLC), Noven

obtained its primary source of income, totaling over 66% of 2002 income before taxes. Noven relied

upon this revenue stream to fund the MethyPatch® research and development ("R&D") program.

The MethyPatch® program was represented by Noven as key for: (i) the validation of Noven's

leadership role as a developer of patented transdermal drug delivery technologies; (ii) the

demonstration ofNoven's ability to expand the application of transdermal technologies beyond HRT

and women's health into transdermal alternatives to oral and other traditional dosage forms; and (iii)

the development of creditable, full-service regulatory, sales and marketing capabilities necessary to

translate successful R&D programs into successful commercial products.

20. Inability to gain FDA approval for MethyPatch® would signal limitations with the

range of applications for certain patented transdermal drug delivery technologies, affecting revenue

streams forecasted for a number of new Noven products, including MethyPatch®. From the very

beginning of the Class Period, defendants were aware of these serious concerns and knew that:



(b) Noven had misrepresented the utility and advantages for MethyPatch® by



(c) Noven knew or should have known that the FDA was aware of the reasons

why MethyPatch® would not be considered as safe or efficacious as Noven had claimed;

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(d) Transdermal drug delivery systems have been the source of serious medication -




21. Since Noven reported that results of the Phase Ill clinical trial program were generally

positive and announced on February 27, 2003 that MethyPatch® was to be licensed to Shire, a strong

marketer in this area, investors anticipated that the FDA would issue, at least, an approvable letter

for this product. As defendants awaited an NDA decision letter from FDA, they continued to

conceal the true facts regarding product rationale and marketing strategies, resulting in a seriously

flawed and defective NDA for MethyPatch® and an anticipated downward correction in the price

of the stock. At all times during the Class Period, defendants knew that:

(a) Receipt of an "approvable letter" from the FDA signals that a drug product

can ultimately be approved. Minor correctable deficiencies and, perhaps, a commitment to do post-

approval studies are sometimes indicated in such a letter;

(b) Noven's receipt of a non-approvable letter for the MethyPatch® NDA would

signal to investors the serious scientific issues and other deficiencies inherent in the MethyPatch®

application and underlying technology;

(c) By indicating that the information included in an NDA is merely

insufficient to justify an approval action at the time of issuance as reason for a non-approval letter

misrepresents the definition for and the potentially serious implications of a non-approvable letter

received from the FDA;

(d) Citation of "clinical and other issues" in an NDA decision letter would convey

that the FDA has serious concerns about the safety or efficacy of the drug, arising in part from flaws

in the design or intended use of the product;

(e) A non-approvable letter for MethyPatch® would address one or more of the

safety and efficacy issues known to and misrepresented by Noven from the very beginning of the

Class Period; and

S


(f) Failure to release the contents of the MethyPatch® non-approvable letter -

would prevent investors from learning the extent of the misrepresentations made to them during the

Class Period.

MOTIVE AND OPPORTUNITY

22. In addition to having actual knowledge of the falsity of their statements, each of the

defendants had the motive and opportunity to perpetrate the fraudulent scheme and course of

business described herein. Noven's financial success during the Class Period was largely due to its

equity in earnings from Novogyne, a joint venture limited liability company formed in 1998 with

Novartis, which was engaged in the marketing of women's prescription healthcare products.

Novogyne's business had continued to grow rapidly and disproportionately to the Noven business,

until it reached a high of 66% of Noven's 2002 pre-tax income. Noven management was under

severe performance pressure, since the key justification for Noven management and operations

teams, separate and distinct from those at Novogyne, rested with successful execution of Noven

R&D activities. During the Class Period, the majority of Noven's R&D efforts were focused on

MethyPatch®.

23. Despite the recognition of the special problems for the use of transdermal drug

delivery systems in children, owing to variations in skin thickness and blood flow variance with age

and the reliance on skin or mucosa to control the MethyPatch® drug input rate, Noven initiated

Phase III studies of MethyPatch® in the second half of 2000. On April 2, 2001, Noven suffered a

major Phase III clinical study failure, in that the study failed to achieve statistical significance on its

primary endpoint. The study failure resulted in a loss of a third of the value of the stock. Faced with

the erosion of investor confidence in Noven resulting from the failure of the initial Phase III study

program, and severe R&D performance pressures, the management team continued in its fraudulent

rationale, marketing strategy and R&D activities for MethyPatch®.

FRAUDULENT SCHEME AND COURSE OF BUSINESS

24. Each defendant is liable for (i) making false statements, or (ii) failing to disclose

adverse facts known to him about Noven. Defendants' fraudulent scheme and course of business that

operated as a fraud or deceit on purchasers of Noven publicly traded securities was a success, as it

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(i) deceived the investing public regarding Noven's prospects and business; (ii) artificially inflated -

the prices of Noven's common stock; (iii) allowed defendants to achieve artificially inflated

executive incentive compensation, determined in large part by successful performance in

communication of false and misleading statements to investors regarding the expected launch of

MethyPatch® in the second half of 2003; (iv) allowed defendants to arrange to sell and actually sell

in excess of $500,000 worth of Noven shares at artificially inflated prices; and (v) caused plaintiff

and other members of the Class to purchase Noven common stock at inflated prices.

BACKGROUND

Methyiphenidate and Formulations

25. Methyiphenidate is an amphetamine-like molecule with effects upon the central

nervous system ("CNS"). It is a mild CNS stimulant with more prominent effects on mental rather

than motor activities. Methyiphenidate is a DEA Schedule II controlled substance and it has

potential for abuse. Methyiphenidate is effective in the treatment of narcolepsy and ADHD.

26. The standard preparation ofmethylphenidate is usually as a hydrochloride (HCI) salt

mixture of two of the four possible stereoisomers of the drug, as d,l-threo-isomers of the d,l-

erythro/erythro enantiomeric pair. This mixture is sometimes referred to as "threo" methyiphenidate.

The empirical formula of methylphenidate HC1 is C 14 1-1 19NO2'HCI. Its molecular weight is 269.77.

Many modem formulations of the drug utilize the d,l-threo isomeric mixture. At least one modern

formulation makes use of the "pure" d-threo isomer. The structural formula for methyiphenidate UCI

is:

CO 2 OH

ØCH \jHCI

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27. The formulation for the MethyPatch® transdermal drug delivery system uses the d,l-

threo isomeric mixture of methyiphenidate "free base" ("threo" methyiphenidate, not in salt form)

in a transdermal drug delivery system (the "patch"). The Noven formulation can be distinguished

from others in that it is a transdermal formulation designed in patch form, intended to deliver a

constant input/sustained release of drug through the skin. Noven was issued U.S. Patent No.

6,210,705 for "Compositions and methods of treatment of attention deficit disorder and attention

deficit/hyperactivity disorder with methyiphenidate."

28. The other available methylphenidate dosage forms are oral medications. Short-acting

immediate release tablets are the most typical oral dosage form. While a transdermal system may

not be directly compared to other dosage forms, other sustained release formulations exist in oral

form, including Ritalin SR (Novartis) and Methylin ER (Mallinckrodt). Finally, sustained release

dosage forms capable of mimicking the efficacy of immediate release dosage forms taken two or

three times daily are also available, marketed as Ritalin LA (Novartis) or Concerta (Aiza). All of

these oral formulations use the "threo" methylphenidate HCl salt form. Only one oral medication

makes use of dexmethylphenidate HC1, in an immediate release formulation known as Focalin

(Novartis).

Transdermal Drug Administration

29. Methylphenidate medications are usually provided in the oral dosage form. The

dosage form represented by MethyPatch® is transdermal, requiring that a transdermal drug delivery

system or "patch" be placed on the skin. An adhesive would hold the patch to the skin and a

formulation of the drug contained within the patch would be topically applied continuously for a

period of hours. The delivery system technology described in Noven U.S. Patent No. 6,210,705 (the

"705 patent"), issued on April 3, 2001 and intended for the delivery of basic drugs with pKa of 8.0

or greater is used for MethyPatch®. MethyPatch® was designed to be a topical application system

"which relies primarily on skin or mucosa permeability to control the drug input rate." The

technology delivers "zero order" drug kinetics, that is, "delivery of methyiphenidate at a constant

rate through the skin or mucosa at a rate which is approximately constant once steady state is

attained." Taken together, the MethyPatch® product design contemplates a drug delivery that


achieves a constant drug input rate across the skin, independent of most factors. except the

characteristics of the skin or mucosa to which the patch is attached.

30. In July of 1997, the American Academy of Pediatrics ("AAP") issued a Policy entitled

"Alternative Routes of Drug Administration - Advantages and Disadvantages." This policy

reviewed the mechanisms of drug absorption and associated problems for transdermal drug delivery

in the pediatric population. The Policy noted, in part:

The potential for toxic effects of the drug and difficulty in limiting drug uptake are major considerations for nearly all transdermal delivery systems, especially in children because skin thickness and bloodflow in the skin vary with age. The relatively rich blood supply in the skin combined with thinner skin have significant effects on the pharmacokinetics of transdermal delivery systems for children. In some situations this may be an advantage, while in others systemic toxicity may result. Central nervous system toxicity occurred in neonates washed with hexachlorophene because their very thin skin and large body surface area allowed toxic levels to develop from systemic drug absorption. The practitioner must understand the clinical implications ofthesefactors when prescribing a drug to be administered by the transdermal route.

With respect to Fentanyl, another Schedule II controlled substance, the Policy also noted:

Although it is tempting to provide patients with the latest in technology, the frntanyl patch presents a potential threat to children. Fatal toxic effects have occurred after accidental ingestion of new or "used" patches, which have been inadequately stored or discarded, and secondary to inappropriate application, ie, applied to children who have not received narcotics chronically.

Marketing Advantages

31. On March 2, 2000, defendant Strauss announced completion of MethyPatch® Phase

II studies. The announcement contained the Noven rationale and marketing strategy for the product.

The press release indicated:

Phase III Studies for MethyPatchTM to Begin in Summer 2000 New Patch May Eliminate Broad Social Issues Presented by AD/HD Pill Therapies

Noven Pharmaceuticals, Inc. today announced that it successfully completed Phase II clinical trials evaluating MethyPatchTM, Noven's once-a-day transdermal methyiphenidate patch. Methyiphenidate, the active ingredient in Novartis Pharmaceuticals Corporation's Ritalin® tablets, is the most commonly prescribed medication for Attention Deficit Hyperactivity Disorder (AD/HD). Presently, all AD/HD medications approved in the U.S. are delivered orally, and the majority of patients require more than one dose per day. Noven expects that the small patch, worn discreetly under clothing, would eliminate the stigma that many children suffer when receiving oral methylphenidate during the school day, and would substantially reduce the drug diversion and abuse issues that plague pill formulations.

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"Every day, millions of children, their parents, the school system and law enforcement agencies struggle with the issues presented by oral formulations of methylphenidate. We believe that, if approved, our MethyPatchTM transdermal methyiphenidate system will alleviate and perhaps eliminate many of these social concerns. Consider the following:

Today, parents must deliver a supply of their child's methyiphenidate pills to his or her school, and the school itself must devote considerable time and resources to delivering the medication during the school day. In contrast, MethyPatchTM is placed on the child at home by the parent before school, eliminating deliveries by the parent and relieving schools from the costly, time-consuming and undesired role of medication administrator.

• Daily visits to the school nurse to receive oral medication can stigmatize children and embarrass them in front of their peers. MethyPatchTM, applied before school and worn discreetly under clothing, assures that a child's privacy and dignity are maintained.

• A pill cannot be "unswallowed" - once ingested, it medicates a childfor thefixed duration ofdosing, which is not always desirable. MethyPatchTM, however, can be removed immediately if discontinuation of dosing is appropriate.

• Delivered through the skin and directly into the bloodstream, MethyPatchTM puts a minimal amount of drug into a child's system to induce a full therapeutic effect. Pills generally require that substantially more drug be introduced into the system in order to overcome the first pass through the liver and gastrointestinal tract.

• Across the country, methylphenidate pills are crushed and snorted by those who would abuse them. The medication in MethyPatchTM cannot be readily extracted, and you simply cannot snort a patch."

Mr. Strauss concluded: "For these and other reasons, we believe MethyPatchTM will be much more than just a long-acting methylphenidate product. We are confident that it will alleviate several broad-reaching social issues that cannot be addressed as effectively by any oral methylphenidate product on the market or in development. MethyPatchTM is expected to deliver all the benefits of methyiphenidate - the benchmark therapyforAD/HD - while eliminating a host of serious concerns."

32. These initial claims regarding the product made prior to the Class Period can be

summarized as follows: the product will eliminate the need for supervision regarding administration

of the drug during the school day; the child will be relieved of any stigma associated with use of the

drug since the transdermal system is worn discretely under the child's clothing; the patch can be

removed at any time (and presumably by anyone) during the school day; a full therapeutic effect

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results from the use of the transdermal system; and, finally, since the patch cannot be snorted or

readily extracted, it cannot be abused.

33. On April 2, 2001, Noven issued a press release, calculated to reiterate the safety and

effectiveness of the drug as the company announced that one aspect of the MethyPatch® Phase III

trial failed and would not support the anticipated submission of a New Drug Application (NDA):

NOVEN DELAYS FILING OF NEW DRUG APPLICATION FOR TRANSDERMAL METHYLPHENIDATE SYSTEM

Noven Pharmaceuticals, Inc. announced today that a preliminary analysis of Phase III clinical study data for its transdermal methyiphenidate system suggests that a supplemental clinical study will be required to support the filing of a New Drug Application (NDA). As a result, Noven expects that the NDA filing will be delayed. Results of the Phase III study remained blinded and sealed until March 28, and Noven is in the process of analyzing the results in preparation for a meeting with the Food and Drug Administration (FDA) in the latter half of April to discuss the study and Noven's NDA strategy.

"We have great confidence in the safety and effectiveness of our methyiphenidate patch, " saidAnthony de Padova, M.D., Noven 's Vice President, Clinical Research and Regulatory Affairs. "The preponderance of our Phase III data, and all of our prior clinical data, were highly successful, One aspect of the Phase III study, however, was unsuccessfuL Our analysis of the information suggests that one additional study may be necessary, and we will be discussing this with the FDA later this month."

Robert C. Strauss, Noven's President, CEO and Co-Chairman, added: "We had planned to file our NDA late in the second quarter of 2001. Based on our early analysis and subject to our discussions with the FDA, that filing will be delayed by six to twelve months. Going forward, we expect to complete our analysis of the data, discuss our findings and strategy with the FDA, and undertake an additional study and/or data re-analysis for incorporation into our NDA. We remain highly confident in this important new therapy."

In separate news released concurrently, Noven announced that Novogyne Pharmaceuticals, Noven's women's health joint venture with Novartis, has acquired the U.S. rights to Noven's CombiPatchTM, the only combination estrogen/progestin patch approved in the U.S. The Novogyne sales force now sells both the smallest estrogen patch in the world, and the only combination hormone replacement patch in the country.

Mr. Strauss added: "We had hoped to add both CombiPatch and our methyiphenidate patch to our existing base of growth drivers. As it stands, growth in 2002 will continue to be driven by increasing CombiPatch and Vivelle-Dot sales by Novogyne in the U.S., and international launches of Estalis and Estradot by Novartis. The methyiphenidate patch would not likely be launched until 2003."

Noven 's once-daily methyiphenidate patch is indicatedfor the treatment of ADHD. The patch is expected to offer the safety and efficacy of immediate release oral methylphenidate products, while eliminating in-school dosing, minimizing

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drug abuse potential, and providing physicians and parents with the ultimate in dosing flexibility and control.

34. On April 28, 2003, David Steinberg of Deutsche Bank Securities clarified Dr. de

Padova's explanation, and specifically the reason for the failure of Noven's initial Phase III clinical

trial:

Noven 's initial Phase Ill trial had failed to achieve statistical significance on its primary endpoint.

ConcertaTM Enters the Market

35. On May 5, 2001, the FDA published on its Web site the medical review for

ConcertaTM extended release tablets, approved by the FDA on August 1, 2000. As previously

indicated, extended release tablets are designed to mimic the use of immediate release tablets taken

two or three times daily. ConcertaTM is an ingenious phased-delivery capsule that releases rising

doses of methyiphenidate during the day. The impetus to design such a dosage form was explained

by Dr. Andrew Mosholder, Medical Officer, within the FDA psychiatric drug products group:

With respect to sustained release Ritalin, this was approved without efficacy trials, and some have suggested that its efficacy is not as robust as immediate release Ritalin, possibly due to insufficient Cmax values, or to tachyphylaxis of the stimulant effect (see Swanson et al. Cli,, Pharmacol Ther 1999, 66: 295-305).

36. The FDA cites the Swanson paper for the following reasons. First, Swanson observed

that the use of a sustained release form of methyiphenidate is limited by "pharmacodynamic

tolerance." This phenomenon is sometimes referred to as tachyphylaxis, a process whereby a

diminishing CNS response to the drug occurs over time. Second, the FDA understood that this

tachyphylaxis effect could be overcome by administration of drug given on a divided schedule or by

an increasing dosage of drug over time. An extended release dosage form devised to do this would

eliminate the need to administer an immediate release dosage form given on a divided schedule. To

respond to this perceived need, Aiza created the ConcertaTM, an extended release tablet formulation

to offer the safety and efficacy of immediate release oral methyiphenidate tablets taken three times

daily.

37. On October 3, 2001, Noven organized a symposium to explain the rationale and

marketing strategy for the MethyPatch® product:

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ADI-ID Experts to Present Clinical Data on Once-Daily Transdermal Methyiphenidate Patch

Noven Pharmaceuticals, Inc. today announced that MethyPatch®, Noven's once-daily transdermal methyiphenidate system for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), will be the subject of a symposium to beheld at the American Academy of Child & Adolescent Psychiatry (AACAP) Annual Meeting.

The symposium, entitled "Can a Once-Daily Methyiphenidate Patch Help Children with ADHDT', is scheduled for 10:30 a.m. (Hawaii-Aleutian Time) on October 27, 2001, at the Hilton Hawaiian Village in Honolulu, Hawaii. The symposium will review the results of MethyPatch® clinical trials completed to date. Scheduled presenters are Laurence L. Greenhill, M.D., Clinical Professor of Child Psychology, Columbia University; William E. Pelham, Ph.D., Professor of Psychology, Center of Children and Families, State University of New York at Buffalo; Donald R. Jasinski, M.D., Chief, Center for Chemical Dependents, John Hopkins Bayview Medical Center; and Mario A. Gonzalez, Ph.D., President & CEO, GloboMax Americas LLC.

Noven 's once-daily MethyPatch® is designed to offer the safety and efficacy of immediate release oral methyiphenidate products, while eliminating in-school dosing and providing physicians and parents with the ability to discontinue dosing as needed by removing the patch. Noven expects to begin a supplemental Phase III clinical study of MethyPatch® in the fall of 2001 at centers throughout the U.S.

ADHD affects 3% to 5% of school-age children, and an estimated 1.5 million children are currently on medication to treat this disorder. All presently approved ADHD medications are delivered orally. AACAP, established in 1953, is the leading national professional medical association dedicated to treating and improving the quality of life for children, adolescents, and families affected by these disorders. It is a membership based organization comprised of over 6,500 child and adolescent psychiatrists and other interested physicians. For more information about AACAP and the Annual Meeting, visit www.aacap.org .

FALSE AND MISLEADING STATEMENTS DURING THE CLASS PERIOD

38. On October 29, 2001, Noven issued a press release entitled "PHASE III TRIAL FOR

NOVEN'S METHYPATCH® UNDERWAY; METHYPATCH® CLINICAL DATA PRESENTED

AT AACAP MEETING." The press release stated in part:

New Trial Underway

"With the Food and Drug Administration's review of our new Phase III protocol completed, and with our pre-trial clinical investigators meetings behind us, we are pleased to have begun patient screening and enrollment for our MethyPatch pivotal study," said Robert C. Strauss, Noven's President, CEO and Chairman. "Target enrollment for this double-blind, placebo-controlled, multi-center study is about 200 patients, and we expect to conclude the study in the first quarter of 2002."

Noven 's once-daily MethyPatch is designed to offer the safety and efficacy of immediate release oral methyiphenidate products, while eliminating in-school dosing and providing physicians and parents the ability to discontinue dosing as

-14-


needed by removing the patch. The product combines methyiphenidate. which is an established ADI-ID therapy, with Noven's patented DOT MatrixTM patch technology, which is the delivery platform behind the commercial success of VivelleDotTM and CombiPatch® hormone replacement patches. DOT Matrix technology permits Noven to deliver therapeutic doses of a range of prescription therapies through discreet, comfortable and highly adherent patches that are well suited to active lifestyles.

* * *

The Phase III study compared MethyPatch applied once daily in the morning to placebo transdermal systems in over 200 children with ADHD between the ages of 6 and 12. The primary outcome measure was teacher ratings of patient behavior using the IOWA Conners Rating Scale (JO Scale). Secondary outcome measures were parent ratings using the 10 Scale and clinician ratings using the Clinical Global Index.

As measured by teachers, the study demonstrated improved behavior on MethyPatch as compared to placebo, but the improvement was not statistically significant. As measured by both parents and clinicians, the study demonstrated highly statistically significant improvement in ADHD symptoms on MethyPatch versus placebo. The study also demonstrated that MethyPatch was a well-tolerated delivery platformfor methyiphenidate, with an adverse event profile similar to that seen in oral methyiphenidate studies. Additional presentations at the symposium considered the pharmacokinetics, abuse potential and other aspects of MethyPatch.

39. On February 7, 2002, Noven issued a press release entitled "NOVEN COMPLETES

PATIENT ENROLLMENT FOR METHYPATCH PHASE III CLINICAL TRIAL." The press

release stated in part:

Noven Pharmaceuticals, Inc. today announced that it has completed patient enrollment for a Phase III clinical trial of MethyPatch®, Noven's once-daily transdermal methylphenidate system for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Noven completed enrollment of over 200 patients between the ages of 6 and 12 in its double-blind, placebo-controlled, multi-center MethyPatch clinical trial. Patient screening and enrollment began in October 2001.

Noven 's once-daily MethyPatch is designed to offer the safety and efficacy of immediate release oral methylphenidate products, while giving physicians and parents uniqueflexibility in managing ADHD, eliminating in-school dosing, and providing the ability to discontinue dosing as needed by removing the patch. The product combines methyiphenidate - an established ADHD therapy - with Noven's patented DOT MatrixTM patch technology, which is the delivery platform behind the commercial success of Vivelle-Dot® and CombiPatch® hormone replacement patches. DOT Matrix technology permits Noven to deliver therapeutic doses of a range of prescription therapies through discreet, comfortable and highly adherent patches that are well suited to active lifestyles.

- 15-


40. During the first half of March 2002, defendant Mantelle sold 25.500 shares. or

$520,715 worth, of his Noven stock.

41. On April 1, 2002, Noven issued the following press release, entitled "Study Results

Demonstrate Efficacy of Once-Daily Methyiphenidate Patch for ADHD; MethyPatch New Drug

Application Expected to be Filed with FDA Mid-Year 2002."

Noven Pharmaceuticals, Inc. today announced that it has completed an initial review of the primary efficacy data from its recently completed Phase III clinical trial for once-daily MethyPatch® (transdermal methyiphenidate system). The data indicate that MethyPatch, which incorporates Noven's patented DOT MatrixTM patch technology, is highly effective in the treatment of the symptoms of Attention Deficit Hyperactivity Disorder (ADHD). With the results from this pivotal trial, Noven expects to file aNew Drug Application for MethyPatch with the U.S. Food and Drug Administration (FDA) in mid-2002.

The double-blind, placebo-controlled, multi-center trial, which ended in March 2002, involved over 200 patients between the ages of 6 and 12. The primary outcome measure was teacher ratings of patient attention and behavior using the IOWA Conners Rating Scale, a standard rating scale used for this condition in classroom and other settings. By this measure, MethyPatch offered highly statistically significant improvement (p less than .001) in patient attention and behavior compared to placebo.

MethyPatch is designed to offer a safe and effective method of delivering methyiphenidate, while eliminating in-school or midday dosing and providing physicians and parents with unique flexibility in managing ADHD for the individual child. The recent Phase III study was part of a MethyPatch clinical trial program sponsored by Noven that spanned several years and included over 700 subjects in centers across the country.

42. On or about the first week of April 2002, defendants learned of a report authored by

staff of the FDA Office of Drug Safety, entitled " Transdermalpatches: High riskfor error." Noven

staff are experts in the area of transdermal drug delivery and understood the materiality of the

conclusions in this report. FDA staff advised defendants of safety issues they knew or should have

known from the very beginning of the Class Period, regarding the safety of transdermal patches,

including pediatric patch issues:

Although transdermal patches provide a useful alternative to oral medications, patch administration can be complicated. Transdermal patches are a common route of administration for hormonal therapy, narcotic analgesia, and nicotine. There are patches available for over-the-counter and prescription only use.

Medication errors with patches occur in every healthcare practice setting—patients 'homes, physician offices, intensive care units, cardiac step-down

-16-


units, day care facilities, inpatient institutional settings, emergency departments, etc. Outcomes have been associated with patient harm, including death. The highest risk is with the narcotic analgesic patches because of the potential for respiratory depression associated with this class of medications.

Not All Patches Are Equal

Like all medication errors, mistakes associated with transdermal patches are multifactorial. One common cause of error seems to be related to the patch designs, which have confused patients, caregivers, and practitioners.

The transdermal patch products available in this country vary in units of dosage-strength expression, frequency of administration, shape, size, color, and site of administration. Given all these factors and the complex healthcare environment, opportunities for errors abound.

Application, Removal of Patches

• What is an overlay? The overlay is the portion of the two-piece patch that secures the medicated patch to the skin of the patient. In the institutional setting, the overlay is sometimes returned to the pharmacy in the patient drawers when the medication cassettes are exchanged. This can be a clue to the pharmacy staff that the patches are not being applied appropriately.

• Why can 'tyou tape it on? The technology of most patches is designed to use the occlusive dressing to facilitate the absorption of the drug through the skin. Some patients do not realize that the patch must be applied directly to the skin. There was a report of a patient who applied his new patch directly on top of the old one. This continued until he hadfour patches stuck to one another instead of to his skin. In one case, a practitioner applied the overlay to the patient's skin and taped the medicated patch on top of the overlay patch.

Additionally, some patients do not realize they must remove the protective liner (usually a plastic/paper lining such as you see on an adhesive bandage) in order to expose the adhesive and medication to the skin for absorption. One report describes only partial removal of the backing, whereby a patient does not receive the proper amount of drug because the protective lining blocks the absorption.

Many patches have different instructions for where the patch is to be placed. Most patch directions suggest rotating the area of application to avoid skin irritation. For example, there are patches that are applied to the torso or trunk of the body between the neck and waistline; to the scrotal tissue; on the skin behind the ear or upper arm.

In the case of Testoderm patches, one type is to be applied to the scrotal tissue, while the other is not. Since both patches have the name Testoderm, there is potential for confusion, which may result in the patches being applied to the wrong area.

Errors have been reported wherein patients receive or apply multiple patches at once. One man did not survive after his wife applied six fentanyl patches to his skin at one time. Another common problem is that the old patch is not removed when the new patch is applied.

- 17 -


Clear patches have become popular because you cannot see them on the skin: however, this feature has also made them error-prone. Nitroglycerin and nicotine patches are available as clear patch formulations. These patches become problematic for practitioners and patients because they are difficult to find on the patient's skin when it is time to remove or replace them.

The risk for errors is increased when there are multiple caregivers, for example, when nurses change shifts or if multiple family members take turns helping patients with their medications. This arrangement can result in miscommunication, or lack of communication, about where and when the last patch was placed and the next one is due. It is also possible for a patient's transdermal patch therapy to go unnoticed by the staff as they transition between djfferent levels of care in the healthcare environment.

Nomenclature Issues

Various units of measure are used to express the dosage strength of transdermal patches. Some are expressed as mg/hour, mg/day, mcglhr, or simply as milligrams. For patches that are changed weekly, you may see the dosage strength expressed as mg/day/week.

Another source of confusion is the use of obscure abbreviations as modifiers. What does TTS mean? TTS stands for Transdermal Therapeutic System, and some patches include this in the name of the product (for example, Catapres-TTS and Testoderm-TTS). TTS has been read as an abbreviation for Tuesday, Thursday, Saturday, resulting in patch application on three days instead of once weekly.

Dosing Intervals for Patches

When do 1 change my patch? Patches are changed daily, every three days, twice weekly, weekly, every three weeks, and so on. Confusion surrounding the frequency of patch administration presents another opportunity for error. And it seems that the longer the time between patch changes, the greater the risk for forgetting where the patch was placed or forgetting to remove the old patch.

Appropriate Prescribing of Patches

It is possible for prescribers to confuse the dosing interval, dosage strengths, and instructions for use among various patch formulations. An order for Catapres TTS was written in error as once daily instead of once weekly. Ironically, even after clarification of the dosing interval took place, an error still occurred because the practitioner applied only the overlay patch and not the medicated patch portion.

Many products are available in multiple dosage formulations, including a transdermal patch and oral or injectable forms. There is a potential for error when a patient is being switched from one form to another. Additionally, there is potential for patients to receive duplicate therapy with the same or similar medications. For example, it is possible for a patient to receive a nitroglycerin transdermal patch and oral isosorbide mononitrate, in error.

Pediatric Patch Issues

For the pediatric patient population, only small portions of transdermal patches may be needed. Although some patches can be cut for partial patch administration, cutting others destroys the release of the medication. It is

- 18-


recommended that pharmacists dispense all patches to nurses intact, with instructions as appropriate.

Safe Patch Storage and Disposal

Accidental and intentional ingestion of transdermal patches has been reported. Safe storage and disposal of transdermal patches are critical to preventing accidental poisoning of children and pets. Some patches come with a containerfor safe disposal. It maybe safer to cut a used patch into pieces before disposing of it.

Strategies for Error Prevention

When possible, avoid prescribing, purchasing, or adding to the formulary any CLEAR patches.

To prevent duplication of therapy in the institutional setting, document the patch removal on the patient medication administration record (as if it were its own order), as well as the application of each new patch. Documentation of patch administration should include site of application - critical if there are multiple caregivers involved in the patient care.

In the inpatient setting, monitor medication cassettes for return of overlay patches to pharmacy, and follow up on this issue with the practitioners caring for that patient to rule out improper patch application.

Monitor patients with two-piece patches to ensure they are receiving active drug. If the therapy seems to be ineffective, rule out improper patch application.

Patient education can help prevent patch-related medication errors.

43. On June 5, 2002, Noven's licensing and marketing partner, Novartis, received

approval for Ritalin LATM extended release tablets. This new extended release tablet addressed a

methyiphenidate product configuration intended to mimic the use of immediate release Ritalin

tablets two times daily. The new productjoined Concerta as yet another once daily oral dosage form

capable of mimicking multiple daily administration of immediate release methylphenidate tablets.

44. On June 28, 2002, Deutsche Bank Securities reported on the announcement of

Noven's submission of an NDA application for MethyPatch®. The report was based on information

provided by defendant Strauss, and stated:

Yesterday after the close, Noven announced that it has filed a New Drug Application (NDA) with the FDA for MethyPatch, the company's novel once-daily, transdermal patch for the treatment of attention deficit hyperactivity disorder (ADDIADHD).

-19-


As a background, unlike currently available ADHD medications - which are all delivered orally and often dosed more than once per day - MethyPatch, if approved, would represent the first non-oral treatment of this condition with the convenience of once-a-day dosing. Specifically, Noven 's unique transdermal delivery technology could reduce the abuse issues associated with current pill formulations while potentially improving patient compliance.

The reduced dosingfrequency ofMethyPatch would represent a significant advantage, as it would spare children suffering from ADHD the potential embarrassment of having to leave class to receive their medication in the nurse's office. Importantly, MethyPatch would offer a more flexible dosing alternative than pill formulations as it could be removed immediately if discontinuation of dosing is desired.

45. On October 24,2002, Noven issued a press release entitled: "NOVEN ANNOUNCES

POSITIVE PHASE III STUDY RESULTS FOR ONCE-DAILY ADHD TRANSDERMAL

PATCH." The press release went on to state results of the Phase III clinical study:

Noven Pharmaceuticals, Inc. today announced positive Phase III clinical study results for its once-daily transdermal methylphenidate system. The double-blind, placebo-controlled, multi-center Phase III study was conducted to assess the efficacy and safety of Noven's developmental methyiphenidate patch for Attention-Deficit Hyperactivity Disorder (ADHD), which Noven intends to market under the trade name MethyPatch®.

The four-week study involved 212 patients (ages 6 to 12 years) meeting the DSM-IV criteria for ADHD. Patients were randomized to apply MethyPatch or a placebo transdermal patch once-daily to the hip area. Six MethyPatch dosage strengths were available for titration. The primary efficacy measure was improvement in patient behavior and attention as rated by community school teachers using the InattentionlOveractivity with Aggression (IOWA) Conners behavioral rating scale. Secondary efficacy measures included improvement in patient behavior as rated by parents and clinicians.

The study results indicated that MethyPatch was significantly superior to placebo on all primary and secondary efficacy measures. Compared with placebo, MethyPatch, worn for approximately 12 hours per day, resulted in significantly improved scores in teacher, parent and clinician ratings of patient behavior and attention. The p-value for each measure was less than 0.0001, reflecting high statistical significance.

At week four of the study, patient mean Inattention/Overactivity scores (scores range from 0 to 15) as rated by teachers showed highly significant improvement (p-value less than 0.0001) from baseline as compared to placebo (MethyPatch group improved 6.1 points; placebo group improved 2.0 points).

No serious adverse events occurred in patients receiving MethyPatch. The most common adverse events were reduced appetite, insomnia, abdominal pain and headache. Four patients (3.8%) in the MethyPatch group and three patients (2.9%) in the placebo group withdrew from treatment due to adverse events.

As part of the study, parents were asked to complete a MethyPatch satisfaction survey. 98.5% of responding parents agreed that being able to remove

-20-


the patch and discontinue treatment at any time provided them with a sense of control, and 64.2% indicated that they had no difficulty in properly applying MethyPatch.

46. On November 20, 2002, defendants learned that the FDA had approved an NDA for

a methyphenidate formulation based on its ability to mimic the use of immediate release tablets taken

two or three times daily.

47. On, November 19, 2002, Noven announced presentations to the American Society

of Pharmaceutical Sciences in a press release entitled "NOVEN PRESENTS PRE-CLINICAL

STUDY DATA AT AAPS ANNUAL MEETING":

Noven Pharmaceuticals, Inc. announced that it presented the results of several pre-clinical transdermal research projects at the recent 2002 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition. The full text of these presentations is available on Noven's website at www.noven.com under "Research/Scientific Publications.

"We are very pleased with the results of our ongoing pre-clinical development programs," said Juan Mantelle, Noven's Chief Technical Officer. "The AAPS presentations represent just a small portion of our comprehensive development efforts, and reflect Noven's commitment to advancing transdermal science and to maintaining a robust new product pipeline."

At the AAPS meeting, David Kanios, Noven 's Associate Director - Research & Development, presented "In-Vitro Permeation of Low Molecular Weight Amine Drugs in Transdermal Drug Delivery Systems." The presentation summarized the results of three pre-clinical studies designed to establish formulation parameters for the transdermal delivery of methamphetamine and d-amphetamine, which could be used in the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Study results indicated that varying the ratios of acrylic and silicone pressure sensitive adhesives allows flexibility to attain a desired profilefor the delivery of both methamphetamine and d-amphetamine via an adhesive matrix transdermal system.

48. Within the aforementioned presentation entitled "In-Vitro Permeation Performance

of Low Molecular Weight Amine Drugs in Transdermal Drug Delivery Systems," Noven described

and illustrated the controlled output of drug predicted by the 705 patent for the MethyPatch®

methylphenidate transdermal drug delivery system (TDDS), while also demonstrating the

unpredictablity of the transdermal technology when applied to other low molecular weight amine

drugs:

I. PURPOSE

This investigation was initiated to establish formulary parameters for the delivery of low molecular weight amine drugs from TDDSs, primarily

- 21 -


Methamphetamine and d-Amphetamine, which could be utilized in the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The parameters to be determine [sic] were drug release profile, on-set (lag time), and drug delivery duration from TDDSs matrices consisting of acrylic PSA and silicone PSA. The in-vitro permeation studies were conducted against a control TDDS, Methylphenidate Transdermal System (MTS), which has recently been filed in a New Drug Application with the FDA for the treatment of patients diagnosed with ADHD. Although the three parameters previously mentioned still need to be defined for "in-vivo " studies for the drugs under investigation, it was theorized that the outcome of these studies would help define the formulary for clinical studies.

III. DISCUSSION OF RESULTS

A. Drug Permeation: Methamphetamine Study I

Figure 1 illustrates the graphical representation of the results for the three nonfunctional acrylic PSA to silicone PSA ratio formulations. It was surmised that the high acrylic PSA concentration formula (Formula 1) would have had the lowest on-set and near zero order delivery profile based on historical experience when formulating with a combination of acrylic and silicone PSAs. Surprisingly, the trend exhibited from this study shows that the silicone PSA offers solubility for the drug and controls the delivery profile and rate for which the drug is released. In essence, the non-functional acrylic PSA is exhibiting the inertness historically imparted by the use of silicone PSAs. Additionally, the permeation rates for the three formulas were 1.4 to 0.5 times the MTS control when calculated in descending order from Formulas I to 3.

75 • Formu!a 1. 675% Acrylic PSN 22.5% Silicone PSA

—Q--- Forms a 2 45 0% Acry.c PSA! 450% Silicone PSA ---k---- Formua 3 22 5% Acryic PSA/67 5% Silicone PSA

• Methyphemdate Transdermal System

ow 0 2

10 12

Hours

49. Figure 1 above, describing the controlled output of drug predicted by the 705 patent

for the MethyPatch® methylphenidate transdermal drug delivery system, demonstrates the zero order

kinetic release of the MethyPatch®. It is to be compared and seen as failing in all respects to

approximate the pharmacokinetics typical of approved immediate release dosage forms taken on a

divided schedule, or approved extended release dosage forms, as demonstrated by the plot taken

from the August 1, 2000 NDA approval for Concerta:

-22-


8)

.t 4 C-

8)0

EC

QO 1 Co (8 8)

0

0 4 6

-- CONCERTATM 18mgqd —0-- Meihylphenidate 5 mg lid

12 16 20 24 28 32

Time (h)

50. Similarly, the MethyPatch® plot also fails to compare with that from the June 5, 2002

NDA approval for Ritalin LA:

5 10 11, 20 25

Time hi

51. The approval of new methylphenidate extended release formulations Concerta and

Ritalin LAW result from the FDA's acknowledgment that a methylphenidate dosage form capable

of multiphasic pharmacokinetics is necessary to overcome the problems associated with zero order

or constant output methyiphenidate drug formulations:

20

C

15 a,

C,

E

0

10

S a

a' 5

a,

0 0

- 23 -


The necessity of giving methylphenidate at lunchtime in a typical school setting is considered a major disadvantage to the immediate release form. While Rita/in SR should theoretically preclude the need for multiple daily administrations, in practice thisformulation has been viewed as less effective than immediate release methylphenidate given on a divided schedule. While it is not well understood why this is so, one view is that tolerance to the beneficial effects may occur as a result of constant input.

52. In February 2003, James Swanson published an article entitled "Development of a

New Once-a-Day Formulation of Methylphenidate for the Treatment of Attention

deficit/Hyperactivity Disorder" in thejournal Archives ofGeneral Psychiatry. This article reiterated

the basic sciencefindings of acute tolerance (tachyphylaxis) to clinical doses of methylphenidate

that justified the development of and the NDA approval on May 5, 2001 for the Alza Concerta®

formulation.

53. On February 27, 2003, Noven issued a press release entitled "NOVEN LICENSES

METHYPATCH® TO ADHD MARKET LEADER; Shire Pharmaceuticals to Commercialize

Noven's Transdermal Methylphenidate Patch; Noven to Receive Up to $150 Million and

Manufacturing Revenue." The press release stated:

Noven Pharmaceuticals, Inc. today announced that it has signed an agreement to license its once-daily methylphenidate transdennal system (intended to be marketed under the trade name MethyPatch®) to Shire Pharmaceuticals Group plc for payments of up to $150 million and ongoing manufacturing revenue.

MethyPatch is Noven 's developmental methylphenidatepatchforAttention-Deficit Hyperactivity Disorder (ADHD). A New Drug Application for the product, filed with the U.S. Food and Drug Administration in June 2002, is currently under FDA review and is expected to be approved in 2003. Once approved and launched, MethyPatch is expected to be the world's first transdermal patch indicated for the treatment of ADHD, and the first methyiphenidate product in Shire's portfolio of ADHD therapies.

Robert Strauss, Noven's President, CEO & Chairman, said: "We are very pleased with the appointment of Shire as our strategic development and marketing partner for MethyPatch. Shire is clearly the leader in ADHD. They have demonstrated their strong capabilities through the very successful development and launch of Adderall XR®. Shire's global development and marketing ability was another key factor in our decision to select Shire. We are very proud that our product will lead Shire's expansion into the market for long-acting methylphenidate products, and view this transaction as the first step towards a long term and successful relationship with the world leader in ADHD therapy."

Bill Nuerge, President & CEO of Shire US Inc., added: "This is an acquisition that is core to Shire's strategy. MethyPatch strengthens our position as the ADHD Support Company. Over the last twelve months, A dderall XR, taken once a day orally, has become the fastest growing product in the ADHD market,

-24-


reflecting the positive response to Adderall XRfrom doctors and patients alike. MethyPatch will be the first transdermal drug delivery based product offered to doctors and patients for the treatment ofADHD. MethyPatch provides flexibility as patients can now control the duration of medication effect by adjusting the wear time of the product. The addition of MethyPatch to the Shire portfolio will enable us to more completely serve the needs of ADHD patients."

Terms of the Transaction

In exchange for exclusive global rights to MethyPatch, Shire has agreed to pay $25 million upon closing of the transaction, $50 million upon receipt offinal FDA approval of MethyPatch, and payments of up to $75 million upon achievement of certain MethyPatch sales milestones. For accounting purposes, all payments will be deferred and recognized as Noven revenue over a period of years.

Noven remains responsible for securing MethyPatch final regulatory approval, and will manufacture the product for Shire.

Closing of the transaction is conditioned on, among other things, the expiration of any regulatory waiting period under the Hart Scott Rodino Antitrust Improvements Act of 1976, and is expected to take place within 45 days.

Benefits of the Transaction

Strauss continued: "The MethyPatch transaction should provide Noven significant financial, operational and strategic benefits, including:

Improved Commercialization Prospects. "Shire's resources and commitment to ADHD therapy make them an ideal partner to maximize the value of MethyPatch. Their large ADHD sales force has well-established relationships with physicians around the country. This commitment helped make Adderall XR (Shire's long-acting oral amphetamine product) the fastest growing ADHD product in 2002. We believe that MethyPatch will enjoy accelerated acceptance as well."

Significant Earnings Contribution. "Given their resources and capabilities, we expect Shire will drive significantly greater market penetration than we could on our own. As a result, this transaction should deliver greater earnings to Noven than any other commercialization strategy considered, including marketing the product ourselves. And with no Noven launch expenses to be incurred, the recognized portion of the initial payments and launch-related orders are expected to add to our earnings promptly following FDA approval," said Strauss.

Revenue/Partner Diversity. "The transaction helps us diversify beyond hormone therapy. While we remain committed to women's health, our strategy is to expand into other therapeutic categories and forge new strategic partnerships. This transaction meets both of those goals."

Reduced Costs & Risk. "Shire is expected to fund all MethyPatch sales, marketing and promotional activities, which will significantly reduce Noven's expenses and risk compared to a self-marketing

-25-


strategy. The transaction should also free Noven research dollars that we had planned to spend on MethyPatch post-marketing studies. We expect to be able to channel those dollars into other new development projects in our pipeline."

Future Opportunities

"Only ten prescription compounds are currently approved for transdermal delivery in the U.S.," said Strauss. "If approved, MethyPatch will be the eleventh, and will be the fifth Noven FDA approval in the past eight years. We are proud of that track record, and there is more to come. We have two undisclosed molecules in clinical development targeting a combined U.S. market of over $1 billion. We have identified over 25 additional prescription compounds that we believe can be delivered through our patented systems. This presents tremendous opportunity for Noven and for potential partners who have an interest in these compounds. We have a number of business development activities underway, and we hope that news of this transaction will bring new potential partners to the table."

"Our goal is to maximize the value of our technology for the benefit of patients, our partners and our shareholders. We believe we have achieved that with the MethyPatch transaction, and we are committed to do even more in 2003 and thereafter. More broadly, this transaction further validates our technology and strategy, and advances us toward our vision of leadership and excellence in transdermal drug delivery."

54. On April 28, 2003, Noven issued a press release entitled "NOVEN RECEIVES 'NOT

APPROVABLE' LETTER FROM FDA FOR METHYLPHENIDATE TRANSDERMAL

SYSTEM." As a result of the disclosure, Noven's stock closed at $8.97, losing over a third of its

value, on volume approaching 20 times normal. The press release stated:

Noven Pharmaceuticals, Inc. has received notification from the U.S. Food and Drug Administration (FDA) that the New Drug Application (NDA) for its methylphenidate transdermal system is not approvable. A "not approvable" letter is issued if the FDA believes that the application contains insufficient information for an approval action at the time of issuance. The product is licensed to Shire Pharmaceuticals Group plc.

"We are disappointed with the Agency's determination, and continue to believe that our product represents a valuable new therapy for the management of Attention Deficit Hyperactivity Disorder," said Robert Strauss, Noven's President, CEO & Chairman. "In its letter, the FDA cited clinical and other issues as the basis for non-approval. We are developing our strategy for approval, and plan to meet with the Agency as soon as possible to clarify their concerns and to determine what additional studies, analysis or other actions would resolve the issues raised in the letter."

POST-CLASS STATEMENTS

55. During a conference call conducted on April 30, 2003 to address the Noven non-

approvable letter, defendant Strauss stated:

-26-


We have made the determination that... discussing the issues in a public forum while in dialogue with the FDA is inappropriate and we ask you to respect that determination.

56. In truth, major scientific issues addressing the safety or efficacy ofMethyPatch® were

raised by the FDA in their review of the MethyPatch® NDA. This precluded the agency from

approving it, resulting in the issuance of the non-approvable letter. The explanation for this

conclusion is two-fold:

(a) The definition offered by Noven for a non-approvable letter in the April 28,

2003 press release is false and misleading. The definition of a non-approvable letter for an

application to market a new drug found within 21 C.F.R. §314.3 (b) states:

Not app rovable letter means a written communication to an applicantfrom FDA stating that the agency does not consider the application or abbreviated application approvable because one or more deficiencies in the application or abbreviated application preclude the agency from approving it.

The FDA restates at its Web site the definitions for a non-approvable, approvable and approval

letters as follows:

Not Approvable Letter: Lists the deficiencies in the application and explains why the application cannot be approved.

Approvable Letter: Signals that, ultimately, the drug can be approved. Lists minor deficiencies that can be corrected, often involves labeling changes, and possibly requests commitment to do post-approval studies.

Approval Letter: States that the drug is approved. May follow an approvable letter, but can also be issued directly.

The FDA Center for Drug Evaluation and Research ("CDER") Handbook tells us:

CDER makes every effort to communicate promptly to applicants easily correctable deficiencies found during the review of an application. CDER also informs applicants of the need for more data or information, or for technical changes in the application needed to facilitate the agency's review. This type of early communication would not ordinarily apply to major scientific issues, which require consideration of the entire pending application by agency final decision makers as well as by reviewing staff. Instead, major scientific issues are usually addressed in an action letter at the end of the initial review process.

(b) The term "clinical," as it applies to medical review conducted by the CDER

at the FDA applies to the examination of the safety and efficacy of a drug. Again, the FDA CDER

handbook tells us:

-27-


Medical/clinical reviewers, often called medical officers, are almost exclusively physicians.... Medical reviewers are responsible for evaluating the clinical sections of submissions, such as the safety of the clinical protocols in an IND or the results of this testing as submitted in the NDA.

* * *

Much of the primary review process involves reviewer attempts to confirm and validate the sponsor's conclusion that a drug is safe and effective for its proposed use.

57. In summary, the citation of "clinical and other issues" in the MethyPatch® NDA

decision letter from the FDA actually means that the FDA had undertaken a thorough scientific

evaluation of clinical and other data and concluded that it had serious concerns about the safety or

efficacy of MethyPatch®. With regard to safety, Noven made the following representations during

the Class Period: (a) that the once-daily MethyPatch® was designed to offer the safety and efficacy

of immediate release oral methyiphenidate products for school-age children; (b) that MethyPatch®

represented a significant advance since it would eliminate in-school dosing; (c) that an effective

means of therapeutic control was possible, simply by allowing parents and physicians at any time

to discontinue dosing as needed by removing the patch; (d) that the technology could reduce the

abuse issues associated with current pill formulations.

58. Regarding safety, Noven knew at all times during the Class Period that (a) while the

zero-order kinetics described in the 705 patent might assure a more predictable dosing in adults, the

inherent variability of skin thickness and blood flow raises serious safety issues for the use of

patches in children; (b) the elimination of in-school dosing is replaced with potential issues related

to the use of a patch, for example, inadvertent patch removal or error in the application of the

patch; (c) the type of therapeutic control necessary to overcome the tolerance effect typical of

constant input methylphenidate formulations can never be achieved with MethyPatch® simply by

allowing parents or physicians to discontinue dosing by removing the patch; and (d) despite the fact

that patches and pills are inherently different dosage forms, transdermal patches provide their own

unique opportunities for misuse.

59. Defendants avoided, but had particularly good reasons to be concerned about, the

efficacy of any methylphenidate product designed as a "constant input"/sustained release dosage

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form. Defendants knew or should have known that the clinical efficacy of methylphenidate was

limited by a tachyphylaxis effect, associated with the use of "sustained release" methylphenidate

dosage forms. The pharmacokinetic profile of a sustained dosage form is different and quite unlike

the multiphasic profiles for immediate release tablets typically taken two or three times a day.

Noven knew that their R&D staff had designed a "sustained release" constant input drug delivery

system, following zero-order kinetics for that delivery, in accordance with the 705 patent.

60. Defendants knew or should have known from the very beginning of the Class Period

that the efficacy of MethyPatch® could not be compared to immediate release tablets used two or

three times a day. As previously indicated, extended release tablets are designed to mimic the use

of immediate release tablets taken two or three times daily. ConcertaTM is an ingenious phased-

delivery capsule that releases rising doses of methylphenidate during the day. The impetus to design

such a dosage form was explained by the FDA Psychiatric Drug Products Group:

With respect to sustained release Ritalin, this was approved without efficacy trials, and some have suggested that its efficacy is not as robust as immediate release Ritalin, possibly due to insufficient Cmax values, or to tachyphylaxis of the stimulant effect (see Swanson et al. C/in Pharmacol Ther 1999, 66: 295-305).

61. The FDA cites the Swanson paper for the following reasons. First, Swanson observed

that the use of a sustained release form of methylphenidate is limited by "pharmacodynamic

tolerance." This phenomenon is sometimes referred to as tachyphylaxis, a process whereby a

diminishing CNS response to the drug occurs over time. Second, the FDA understood that this

tachyphylaxis effect could be overcome by administration of drug given on a divided schedule or by

an increasing dosage of the drug over time. An extended release dosage form devised to do this

would eliminate the need to administer an immediate release dosage form given on a divided

schedule. To respond to this perceived need, Alza created the ConcertaTM, an extended release tablet

formulation to offer the safety and efficacy of immediate release oral methylphenidate tablets taken

three times daily.

62. Ritalin LATM is another methyiphenidate dosage form capable of multiphasic

pharmacokinetics necessary to overcome the problems associated with zero order or constant output

-29-


methylphenidate drug formulations. Citing the anticipated use of methylphenidate at lunchtime by

children in the typical school setting, the FDA review for Ritalin LATM noted:

The necessity of giving methylphenidate at lunchtime in a typical school setting is considered a major disadvantage to the immediate release form. While Ritalin SR should theoretically preclude the need for multiple daily administrations, in practice this formulation has been viewed as less effective than methyiphenidate given on a divided schedule. While it is not well understood why this is so, one view is that tolerance to the beneficial effects may occur as a result of constant input.

63. The true facts which were known by each of the defendants, but concealed from the

investing public during the Class Period, were as follows:



(b) The utility and advantages for MethyPatch® had been misrepresented by



(c) The FDA was aware of the reasons why MethyPatch® would not be

considered as safe or efficacious as Noven had claimed;

(d) Transdermal drug delivery systems have been the source of serious medication




FIRST CLAIM FOR RELIEF

For Violation of §10(b) of the 1934 Act and Rule 10b-5 Against All Defendants

64. Plaintiff incorporates ¶J1-63 by reference.

65. During the Class Period, defendants disseminated or approved the false statements

specified above, which they knew or deliberately disregarded were misleading in that they contained

misrepresentations and failed to disclose material facts necessary in order to make the statements

made, in light of the circumstances under which they were made, not misleading.

66. Defendants violated § 10(b) of the 1934 Act and Rule lOb-5 in that they:

(a) Employed devices, schemes, and artifices to defraud;

-30-


(b) Made untrue statements of material facts or omitted to state material facts

necessary in order to make the statements made, in light of the circumstances under which they were

made, not misleading; or

(c) Engaged in acts, practices, and a course of business that operated as a fraud

or deceit upon plaintiff and others similarly situated in connection with their purchases of Noven

common stock during the Class Period.

67. Plaintiff and the Class have suffered damages in that, in reliance on the integrity of

the market, they paid artificially inflated prices for Noven common stock. Plaintiff and the Class

would not have purchased Noven common stock at the prices they paid, or at all, if they had been

aware that the market price had been artificially and falsely inflated by defendants' misleading

statements.

68. As a direct and proximate result of these defendants' wrongful conduct, plaintiff and

the other members of the Class suffered damages in connection with their purchases of Noven

common stock during the Class Period.

SECOND CLAIM FOR RELIEF

For Violation of §20(a) of the 1934 Act Against All Defendants

69. Plaintiff incorporates ¶Jl-68 by reference.

70. The Individual Defendants acted as controlling persons ofNoven within the meaning

of §20(a) of the 1934 Act. By reason of their positions as officers and/or directors of Noven, and

their ownership of Noven stock, the Individual Defendants had the power and authority to cause

Noven to engage in the wrongful conduct complained of herein. Noven controlled each of the

Individual Defendants and all of its employees. By reason of such conduct, the Individual

Defendants and Noven are liable pursuant to §20(a) of the 1934 Act.

CLASS ACTION ALLEGATIONS

71. Plaintiff brings this action as a class action pursuant to Rule 23 of the Federal Rules

of Civil Procedure on behalf of all persons who purchased Noven common stock (the "Class") on

the open market during the Class Period. Excluded from the Class are defendants.

-31-


72. The members of the Class are so numerous that joinder of all members is

impracticable. The disposition of their claims in a class action will provide substantial benefits to

the parties and the Court. Noven had more than 22 million shares of stock outstanding, owned by

hundreds if not thousands of persons.

73. There is a well-defined community of interest in the questions of law and fact

involved in this case. Questions of law and fact common to the members of the Class which

predominate over questions which may affect individual Class members include:

(a) Whether the 1934 Act was violated by defendants;

(b) Whether defendants omitted and/or misrepresented material facts;

(c) Whether defendants' statements omitted material facts necessary to make the

statements made, in light of the circumstances under which they were made, not misleading;

(d) Whether defendants knew or deliberately disregarded that their statements

were false and misleading;

(e) Whether the price of Noven's common stock was artificially inflated; and

(f) The extent of damage sustained by Class members and the appropriate

measure of damages.

74. Plaintiffs claims are typical of those of the Class because plaintiff and the Class

sustained damages from defendants' wrongful conduct.

75. Plaintiff will adequately protect the interests of the Class and has retained counsel

who are experienced in class action securities litigation. Plaintiff has no interests which conflict with

those of the Class.

76. A class action is superior to other available methods for the fair and efficient

adjudication of this controversy.

PRAYER FOR RELIEF

WHEREFORE, plaintiff prays for judgment as follows:

A. Declaring this action to be a proper class action pursuant to FRCP 23;

B. Awarding plaintiff and the members of the Class damages, interest and costs; and

-32-


C. Awarding such equitable/injunctive or other relief as the Court may deem just and

proper.

JURY DEMAND

Plaintiff demands a trial by jury.

DATED: August , 2003 MILBERG WEISS BERSHAD HYNES & LERACH LLP

MAYA S. SAXENA Florida. Bar No. 0095494

MAYA S. SAXENA

The Plaza, Suite 900 5355 Town Center Road Boca Raton, FL 33486 Telephone: 561/361-5000 561-367-8400 (fax)

MILBERG WEISS BERSHAD HYNES & LERACH LLP

WILLIAM S. LERACH DARREN J. ROBBINS 401 B Street, Suite 1700 San Diego, CA 92101 Telephone: 619/231-1058 619/231-7423 (fax)

FARUQI & FARUQI, LLP NADEEM FARUQI 320 East 39th Street New York, NY 10016 Telephone: 212/983-9330 212/983-9331 (fax)

Attorneys for Plaintiff

F:\BOCA\PLEADING\Noven\NOVEN.CPT

-33-


CERTIFICATION OF MILLER DONOVAN INS1J!PORTDF CLASS ACT1ON,9MPLA1NT

Miller Donovan ("plaintiff') declares, as to the claims asserted under the federal

securities laws, that:

Plaintiff has reviewed the complaint prepared by counsel and has

authorized its filing.

Plaintiff did not purchase the security that is the subject of the complaint at

the direction of plaintiffs' counsel or in order to participate in any private action arising under the

federal securities laws.

Plaintiff is willing to serve as a representative party on behalf of a class,

including providing testimony at deposition and trial, if necessary.

4. During the proposed Class Period, plaintiff executed the following

transactions relating to Noven Pharmaceuticals, Inc.:

.Purchase of 100 shares at S20 5/8 per share on 07/03/02

In the past three years, plaintiff has not sought to SclVc as a represcntative

party on behalf of a class in an action filed under the federal securities laws.

6. Plaintiff will not accept any payment for serving as a representative party

on behalf of a class beyond plaintiff s pro rata share of any recovery, except such reasonable costs


and expenses (including lost wages) directly relating to the representation of the Clam as ordered

or approved by the Court.

The foregoiog are, to the best of my knowledge and belief, true and correct statements.

August 6, 2003

MILLER DONOVAN


JS 44 (Rev. 12/96)

CIVIL COVER SHEET The JS-44 civil cover sheet and the information contained herein neither replace nor supplement e filing and service of pleadings or other papers as require law, except as provided by local rules of court. This form, approved by the Judicial Conference - e ted Stat in Se tember 1974, is required fir the use me ulerk of Court for the purpose of initiating the civil docket sheet. (SEE INSTRUCTIONS ONqLFEqWFVEQfiE 141

'Cl 41 I. (a) PLAINTIFFS

MILLER DONOVAN, on behalf of himself and all others similarly situated

(b) COUNTY OF RESIDENCE OF FIRST LISTED PLAINTIFF New 'orI J,2___)EXCEPT U.S. PLAJIFFAS) \

ATTORNEYS (FIRM NAME. ADDRESS, AND TELEPHONE NI. Milberg Weiss Bershad Hynes & Lerach LLP 5355 Town Center Road, Suite 900 Boca Raton, FL 33485 Tel: 561-361-5000

NOVEN PHARMACEUTICALS, INC., ROBERT C. STRAUS JAMES B. MESSIRY and JUAN A. MANTELLE

IV-JORDAN COUNTY OF ' çSIDENCE OF FIRST LISTED DEFENDANT Miami Dade County

(IN U.S. PLAINTIFF CASES ONLY) NOT IN 4.AND CONDEMNATION CASES, USE THE LOCATION OF THE

AT ROWN

I CIRCLE COUNTY WHERE ACTION AROA

II. BASIS OF JURISDICTION (PLACE AN -X - I'QN( ONLY)

0 1 U.S. Government'K.FederaI Question Plaintiff ' (U.S. Government Not a Party)

o 2 U.S. Government 0 4 Diversity Defendant (Indicate Citizenship of Parties

in Item Ill)

PALM BEACH. MARTIN. ST

(For Diversity Cases Only) PTF DEF

Citizen of This State 131 0 1

Citizen of Another State )l(2 0 2

Citizen or Subject of a 03 0 3

tE. INDIAN RIVER. ,QkEECHQSE HIq4-fANDS

PARTIES (PLACE A.)4iN ONEpX F'LAINTIFF AND ONE1SCik1OR ENDANT)

c PTpF Incorporated or Principal Pice 04 4

of Business in This S1(e..... '

Incorporated and Principal-Pcç' .0 5 0 I of Business in This Stte .

Foreign Nation fl 6

ORIGIN (PLACE AN "X" IN ONE BOX ONLY) Transferred from

1 Original 0 2 Removed from 0 3 Remanded from 0 4 Reinstated or 0 5 another district 0 6 Multidistnct ,Proceeding Slate Court Aooellate Court Reopened (soecifiv) Litiaation

L

- -: 0 7AppI tD district Judge

o 120 Marine o 130 Miller Act o 140 Negotiable Instrument o 150 Recovery of Overpayment

& Enforcement of Judgment 0151 Medicare Act

B 0 152 Recovery of Defaulted Student Loans (Excl. Veterans)

o 153 Recovery of Overpayment of Veteran's Benefits

\SL160 Stockholders Suits Other Contract

IJ 195 Contract Product Liability

0210 Land Condemnation B 0 220 Foreclosure

230 Rent Lease & Ejectment o 240 Torts to Land 0 245 Tort Product Liability o 290 All Other Real Property

0 310 Airplane 0 382 Personal injury. I] 315 Airplane Product Med. Malpractice

Liability 0 365 Personal Injury - o 320 Assault, Libel & Product Liability

Slander 0 368 Asbestos Personal O 330 Federal Employers injury Product Liability

Liability o 340 Marine PERSONAL PROPERTY o 35 Marine Product 0 370 Other Fraud

Liability 0371 Truth in Lending 0 350 Motor Vehicle 0 380 Other Personal 0 355 Motor Vehicle Property Damage

Product Liability 0 385 Property Damage 0 360 Other Personal Product Liability

o 441 Voting B 0 510 Motions to Vacate 0 442 Employment Sentence o 443 Housing/ HABEAS CORPUS

Accon'wnodations BO 530 General o 444 Welfare AD 535 Death Penalty 0 440 Other Civil BO 540 Mandamus & Other

Rights BO 550 Civil Rights B D 555 Prison Condition

B 0 620 Other Food & Drug B 0 625 Drug Related Seizure

of Property 21 USC 881 B 0630 Liquor Laws BO64ORR&Truck B 0 650 Airline Regs B 0 660 Occupational

Safety/Health B 0 690 Other

Act 0 720 Labor/Mgmt Relations 0 730 L.abor/Mgmt Reporting

& Disclosure Act 0 740 Railway Labor Act 0 790 Other Labor Litigation

AD 791 EmpI Ret Inc Security Act

0 423 Withdrawal 28 USC 157

830 Patent 840 Trademark

0 862 Black Lung (923) 0863 D1WC/DIWW

(405(g)) 0864 SSID Title XVI o 865 RSI (405(g))

FEDERAL TAX SUITS A 0870 Taxes (U S Ptaintit

or Defendant AD 871 IRS — Third Party

26 USC 7609

0410 Antitrust 0430 Banks and Banking o 450 Conyrwrce/ICC Rates/e 0 460 Deportation O 470 Racketeer Influenced a

Corrupt Organizations O 810 Selective Service

850 Exchange

o 875 Customer Challenge 12 USC 3410

O 891 Agricultural Acts 0 892 Economic Stabilization o 893 Environmental Matters (J 894 Energy Allocation Act 0 895 Freedom of Information D 900 Appeal of Fee DeterrTn

Under Equal Access to J 0 950 Constitutionality of

State Statutes o 890 Other Statutory Actions A OR B

E OF ACTION (CITE THE U S CIVIL STATUTE UNDER WHICH YOU ARE FILING AND WRITE BRIEF STATEMENT OF CAUSE DO NOT CITE JURISDICTIONAL STATUTES UNLESS DIVERSITY)

LENGTH OF TRIAL 15 U.S.C. Section 78j(b) and 78t(a) via - days estimated (for both sides to try entire case)

VII. REQUESTED IN DEMAND $ CHECK YES only if de;7ESd in complaint:

COMPLAINT: '$.CHECK IF THIS IS A CLASS ACTION JURY DEMAND: 0 NO

UNDER F.R.C.P. 23

VIII. RELATED CASE(S) (See instructions): IF ANY JUDGE DOCKET NUMBER

ust 7. 2003

&7

RECEIPT# AMOUNT APPLYINGIFP JUDGE MAG JUDG / 7

case 1:03-cv-22120-pas document 1 entered on flsd...

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