17 Biotechnology Law Report 599 (Number 5, September-October 1998)

Earlier, Aviron announced that it had signed a supply agreement with Becton Dickinsonand Co. to obtain an intranasal delivery system for the vaccine. The vaccine, which is calledFluMist,has shown protective efficacy in both adults and children. Delivery of an influenzavaccine intranasally is desirable, not only because of the greater convenience and comfort ofadministration, but because it induces high titers of antiviral antibodies at the usual site of viralentry into the body.

# # #

{BLR 2746} Hepatitis C-

ICN-

Interferon-

Ribavirin-

Schering-Plough.

FDA Grants Priority Review Status to Rd3A\trin-InterferonCOMBINATION FOR HEPATITIS C—

Product Aimed at Treatment-Naive Patients

ROCKVILLE, MD 8/15/98-

The Food and Drug Administration has granted priorityreview status to an application for a product for previously untreated patients with chronichepatitis C. Priority status requires the agency to reach a decision on marketing approval within180 days.

The product, called Rebetron, combines oral ribivirin and injectable recombinantinterferon alfa-2b. It was developed jointly by ICN Pharmaceuticals, Inc. (New York City) andSchering-Plough (Madison, N.J.).

# # #

{BLR 2747} Breast Cancer-

Dako-

Gcncntcch-

HERl/ncu-

Oncor.

FDA Advisory Panels Recommend Approval ofHerceptin, HercepTestBoth Products Aimed at Aggressive Breast Cancers

ROCKVILLE, MD 9/4/98-

A joint committee of the Hematology and PathologyDevices Panel and the Immunology Devices Panel today unanimously recommended that theFood and Drug Administration approve the HercepTest for marketing provided the companywrites clear guidelines for its use. The test, made by DAKO A/S of Copenhagen, Denmark, is an

immunohistochemical assay for excessive expression of the HER2/neu protein in breast cancertissue.

17 Biotechnology Law Report 600 (Number 5, September-October 1998)

Oncor (Gaithersburg, Md.) has already introduced a genetic test called Inform thatidentifies tumors in which the HER2/«ew gene is amplified. That company reported on August17 that 19 more laboratories have completed the training and proficiency testing required beforea laboratory can provide the test to patients.

Physicians who treat breast cancer seem poised to be able to exploit the growingknowledge of HER2. On September 2, the FDA's Oncologic Drugs Advisory Committeeunanimously recommended approval of trastuzumab (Herceptin), a monoclonal antibody thatdelivers antineoplastic agents to cells expressing HER2/neu. The therapeutic Mab, which hasbeen tested alone and in combination with paclitaxel, is made by Genentech, Inc. (South SanFrancisco, Cal.) (see <BLR 2725>, vol. 17, no. 4, July-August 1998).

Overexpression of the HER2/neu protein, which often results from gene amplification, isa marker of increased aggressiveness of a cancer and therefore of a patient who requiresparticularly intensive treatment. It is seen in 25% to 30% of patients with metastatic breastcancer. Such patients would be logical candidates for Herceptin after their identification by theInform or HercepTest assay.

# # #

{BLR 2748} AIDS-

Alitretinoin-

AutoCyte-

Cervical Cancer-

Hepatitis B-

Kaposi's Sarcoma-

LigandPharmaceuticals

-

Nabi.

A ROUND-UP OF REPORTED NEW SUBMISSIONS

Screen for Cervical Cancer andPrecancerous Conditions

On July 6, AutoCyte, Inc. (Elon College, N.C.) announced that it had submitted aPremarket Approval Application for the use of its image-analysis and classification software.The system, called SCREEN, is intended to be a primary method of detecting cervical cancersand preneoplastic lesions. It is used with the company's PREP method of preparing the cytologyslides. The PMA for PREP is already under review by the FDA.

The goal of the PREP-SCREEN technique is to identify suspect cells for closer attentionby the cytotechnologist. The Papanicolaou smear, which is now the standard method ofperforming these examinations, requires the cytotechnologist to evaluate all cells individually.

In July, the FDA announced that it had granted priority review status to Panretin(alitretinoin) gel, a topical drug for the treatment of the Kaposi's sarcoma associated with AIDS.The submission was the first New Drug Application for Ligand Pharmaceuticals, Inc. of SanDiego.