top 20 biologics 2009 rd pipeline news

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1/26 La Merie S.L. | Email [email protected] | Internet www.lamerie.com TOP 20 Biologics 2009 March 10, 2010 | Special Edition 1 TOP 20 Biologics 2009 TOP 28 Blockbuster Biologics 2009 TOP 14 Biologics Classes 2009 Blockbuster Biologics 2009 by Class Other Antibody Selected Proteins Selected Peptides Features: March 10, 2010 Special Edition 1/2010 March 10, 2009 Subscribe now!

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Page 1: Top 20 Biologics 2009 Rd Pipeline News

1/26 La Merie S.L. | Email [email protected] | Internet www.lamerie.com

TOP 20 Biologics 2009 March 10, 2010 | Special Edition 1

TOP 20 Biologics 2009

• TOP 28 Blockbuster Biologics 2009

• TOP 14 Biologics Classes 2009

• Blockbuster Biologics 2009 by Class

• Other Antibody

• Selected Proteins

• Selected Peptides

Features:

March 10, 2010 Special Edition 1/2010

March 10, 2009

Subscribe now!

Page 2: Top 20 Biologics 2009 Rd Pipeline News

2/26 La Merie S.L. | Email [email protected] | Internet www.lamerie.com

TOP 20 Biologics 2009 March 10, 2010 | Special Edition 1

No. Previous

Year Class of Products 2009 sales

(US$ bln.) 2008 sales (US$ bln.)

Selected Branded Products

1 2 Major Cancer Antibodies 18.18 15.59 Rituxan/MabThera, Herceptin, Avastin, Erbitux, Vectibix

2 1 Anti-TNF Antibodies 18.10 16.36 Enbrel, Remicade, Humira, Cimzia

3 3 Insulin and Insulin Analogs 13.34 10.90 Humalog, Humulin, Lantus, Levemir, Novorapid, Actrapid, Novolin, Apidra

4 4 Erythropoietins 9.56 10.05 Aranesp, Procrit Eprex, Epogen, Neo-Recormon, ESPO, Dynepo, Binocrit

5 5 Interferon beta 6.06 5.35 Avonex, Rebif, Betaferon / Betaseron

6 7 Rec. Coagulation Factors 5.73 4.94 Novoseven, Kogenate, Helixate, Refacto, Advate, Recombinate, Benefix

7 6 G-CSF 5.16 5.18 Neulasta, Neupogen, Neutrogin, GRAN

8 11 Anti-Inflammatory Antibodies

3.12 2.29 Tysabri, Xolair, Orencia, Soliris, RoActemra, Arcalyst

9 9 Human Growth Hormone 2.89 2.68 Genotropin, Norditropin, Humatrope, Nutropin, Saizen, Serostim, Omnitrope

10 10 Interferon alpha 2.61 2.56 Pegasys, Peg-Intron, Intron A

11 8 Enzyme Replacement 2.42 2.80 Cerezyme, Fabrazyme, Aldurazyme, Myozyme, Replagal, Naglazyme, Elaprase

12 12 Ophthalmic Antibody

2.34 1.76 Lucentis

13 14 Follicle Stimulating Hormone

1.21 1.16 Gonal-f, Puregon/Follistim

14 13 Antiviral antibody 1.08 1.23 Synagis

Total: 91.78 82.85

Currency exchange rates as of March 10, 2010: 1 € = 1.35529 US$; 1 CHF = 0.926783 US$; 1 Yen = 0.011117 US$; 1 DKK = 0.18214 US$; 1 SEK = 0.13961 US$

Page 3: Top 20 Biologics 2009 Rd Pipeline News

3/26 La Merie S.L. | Email [email protected] | Internet www.lamerie.com

TOP 20 Biologics 2009 March 10, 2010 | Special Edition 1

TOP 20 Biologics in 2009 (by generic name)

# Product Name

Target / Mechanism of Action

Class of Compound

Company Product Category

Indication 2009 sales (vs 2008)

1 etanercept: Enbrel

TNF antagonist

Dimeric fusion protein of soluble TNF-R + Fc of Ig

Amgen & Wyeth & Takeda Pharmaceutical Co.

Antibody Rheumatoid arthritis and all other approved indications

Total: US$ 6,580 mln (6,490)

2 infliximab: Remicade

TNF alpha antagonist

Rec chimeric IgG1 mab

Centocor (J&J) & Schering-Plough & Mitsubishi Tanabe Pharma

Antibody Rheumatoid arthritis et al.

Total: US$ 5,934 mln (5,335)

3 bevacizu-mab: Avastin

VEGF Rec humanized mab

Genentech & Roche & Chugai

Antibody Metastatic colorectal cancer with 5-FU; 1st line NSCLC plus carboplatin & paclitaxel

Total: US$ 5,777 mln (4,484)

4 rituximab: Rituxan / MabThera

CD20 Rec chimeric full mab

Genentech; Biogen-IDEC, Roche

Antibody Non-Hodgkin's lymphoma (NHL) and all other approved indications

Total: US$ 5,653 mln (5,099)

5 adalimu-mab: Humira Pen

TNF alpha antagonist

Rec fully human mab

Abbott & Eisai Antibody Rheumatoid arthritis et al.

Total: US$ 5,488 mln (4,521)

6 epoetin alfa: Epogen / Procrit / Eprex / ESPO

Erythropoietin receptor (EPO-R)

Rhu protein Amgen & Ortho Biotech / Janssen-Cilag (J&J) & Kyowa Hakko Kirin Pharma

Protein Renal anemia and all other approved indications

US$ 2.569 bln + half of US$ 438.4 mln + US$ 2.245 bln Total: US$ 5,033 mln (5,123)

Page 4: Top 20 Biologics 2009 Rd Pipeline News

4/26 La Merie S.L. | Email [email protected] | Internet www.lamerie.com

TOP 20 Biologics 2009 March 10, 2010 | Special Edition 1

TOP 20 Biologics in 2009 (by generic name)

# Product Name

Target / Mechanism of Action

Class of Compound

Company Product Category

Indication 2009 sales (vs 2008)

7 trastuzu-mab: Herceptin

HER2 Rec humanized mab

Genentech; Chugai, Roche

Antibody Her2 positive metastatic breast cancer et al.

Total: US$ 4,890 mln (4,384)

8 insulin glargine: Lantus

Insulin receptor

Rhu basal insulin analog for once-daily SC injection

Sanofi-Aventis Protein Type 1 and Type 2 diabetes

Total: US$ 4,185 mln (3,130)

9 pegfilgra-stim: Neulasta

G-CSF receptor

Pegylated rec methio-nyl human G-CSF

Amgen Protein Neutropenia Total: US$ 3,355 mln (3,318)

10 darbepo-etin alfa: Aranesp / NESP

Erythropoietin receptor (EPO-R)

Engineered variant of rhu protein AutoInjector

Amgen & Kyowa Hakko Kirin Pharma

Protein Anemia US$ 2.652 bln + half of US$ 438.4 mln Total: US$ 2,871 mln (3.344)

11 ranibizu-mab: Lucentis

VEGF Rec humanized Fab for intravitreal injection

Genentech & Novartis

Antibody Wet age-related macular degeneration (AMD)

Total: US$ 2,344 mln (1,761)

12 interferon beta-1a: Avonex

Interferon beta receptor

Rhu protein for IM injection once a week

Biogen Idec Protein Relapsing forms of multiple sclerosis

Total: US$ 2,323 mln (2,203)

13 interferon beta-1a: Rebif

Interferon beta receptor

Rhu protein (prefilled syringe)

Merck Serono Protein Relapsing forms of multiple sclerosis

Total: US$ 2,087 mln (1,699)

Page 5: Top 20 Biologics 2009 Rd Pipeline News

5/26 La Merie S.L. | Email [email protected] | Internet www.lamerie.com

TOP 20 Biologics 2009 March 10, 2010 | Special Edition 1

TOP 20 Biologics in 2009 (by generic name)

# Product Name

Target / Mechanism of Action

Class of Compound

Company Product Category

Indication 2009 sales (vs 2008)

14 rhu insulin: Actrapid (EU)/ Novolin (US)

Insulin receptor

Rhu insulin (short-acting) for injection, (S. cerevisiae)

Novo Nordisk Protein Type 1 and 2 diabetes

Total: US$ 2,066 mln (2,017)

15 rec Anti-hemophilic Factor: Advate

Coagulation factor VIII replacement

Rec full length factor VIII plasma / albumin free

Baxter Healthcare

Protein Hemophilia A

US$ 2,058 mln (> 1,500) Advate and Recombinate (in process of conversion)

16 insulin lispro: Humalog Mix 50:50 premix

Insulin receptor

Soluble rhu insulin ana-log (50 %) + insuline-protamine precipitate (50 %)

Eli Lilly Protein Type 1 and 2 diabetes

Total: US$ 1,959 mln (1,734)

17 insulin aspart: NovoLog NovoRapid

Insulin receptor

Rhu insulin analog (rapid-acting)

Novo Nordisk Protein Glycemic control in children and adults with diabetes mellitus

Total: US$ 1,780 mln (1,338)

18 interferon beta-1b: Betaseron / Betaferon

Interferon beta receptor

Rhu protein Berlex & Bayer Schering Pharma

Protein All relapsing forms of multiple sclerosis

Total: US$ 1,649 mln (1,449)

19 cetuximab: Erbitux

EGF-R Rec chimeric mab

Eli Lilly (from ImClone acq.) & BMS & Merck Serono

Antibody Metastatic colo-rectal carcinoma and other labels

Total: US$ 1,629 mln (1,470)

20 peginter-feron alfa-2a: Pegasys

Interferon alpha receptor

Pegylated rhu protein

Roche Protein Chronic hepatitis C virus infection + Copegus

Total: US$ 1,538 bln (1,408)

Page 6: Top 20 Biologics 2009 Rd Pipeline News

6/26 La Merie S.L. | Email [email protected] | Internet www.lamerie.com

TOP 20 Biologics 2009 March 10, 2010 | Special Edition 1

TOP 20 Biologics in 2009 (by generic name)

# Product Name

Target / Mechanism of Action

Class of Compound

Company Product Category

Indication 2009 sales (vs 2008)

21 epoetin beta: NeoRecor-mo / Epogin / Epoch

Erythropoietin receptor (EPO-R)

Rhu protein Roche Protein Renal anemia and all other approved indications

Total: US$ 1,450 mln (1,527) 971 + 479

22 filgrastim: Neupogen;

G-CSF receptor

Rhu protein Amgen Protein Neutropenia Total: US$ 1,341 bln (1,419)

23 eptacog alfa: NovoSeven

Induction of coagulation in the presence of alloantibodies to F. VIII

Rhu protein in BHK; now in room-temperature stable liquid formulation

Novo Nordisk Protein Prevention and treatment of hemorrhage in hemophiliacs with alloantibodies

Total: US$ 1,292 mln (1,127)

24 Rec Anti-hemophilic Factor: Kogenate FS

F. VIII substitution

Rhu protein formulated with sucrose (BHK)

Bayer Schering Pharma

Protein Hemophilia A Total: US$ 1,207 mln (1,074)

25 premix insulin aspart; NovoMix 50;

Insulin receptor

Soluble + protamine-crystallized rhu insulin analog

Novo Nordisk Protein Type 1 and 2 diabetes

Total: US$ 1,187 mln (1,032)

26 palivizu-mab: Synagis

Epitope on RS virus

Rec humanized full mab

MedImmune Antibody Propylaxis of RSV infection

Total: US$ 1,082 mln (1.230)

27 natalizu-mab: Tysabri

Alpha4/beta1/7 integrin

Rec humanized IgG4 mab

Biogen Idec & Elan

Antibody RR multiple sclerosis

Total: US$ 1,060 mln (815)

28 human insulin: Humulin 50:50

Insulin receptor

Rhu insulin (mix isophane suspension)

Eli Lilly Protein Type 1 and 2 diabetes

Total: US$ 1,022 mln (1,063)

Page 7: Top 20 Biologics 2009 Rd Pipeline News

7/26 La Merie S.L. | Email [email protected] | Internet www.lamerie.com

TOP 20 Biologics 2009 March 10, 2010 | Special Edition 1

Group 1: Cancer Antibodies

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company Product Category

Indication R&D Stage

Message

1891

Avastin; bevacizumab

Vascular endothelial growth factor (VEGF)

Rec humanized mab

Roche Antibody 1st and 2nd line metastatic colorectal cancer with 5-FU-based chemotherapy

Mar-ket

Roche PR Feb 3, 2010 - 2009 worldwide sales of Avastin were CHF 6,222 mln (+ 21 % in local currency vs 2008) corresponding to US$ 5,777 mln

1825

Rituxan / MabThera; rituximab;

CD20 Rec chimeric full mab

Roche (Genentech) & Biogen-IDEC

Antibody Non-Hodgkin's B-Cell Lymphoma

Mar-ket

Roche PR Feb 3, 2010 - 2009 sales of CHF 6,087 mln (+ 6 % in local currencies vs 2008) corresponding to US$ 5,653 mln

1869

Herceptin; trastuzumab

HER2 Rec humanized mab

Roche (Genentech & Chugai)

Antibody Her2 positive metastatic breast cancer and all other approved indications

Mar-ket

Roche PR Feb 3, 2010 - 2009 sales of CHF 5,266 mln (+ 8 % in local currencies vs 2008) corresponding to US$ 4,890 mln

1847

Erbitux; cetuximab; IMC-C225; EMD-271786

EGF-R Rec chimeric mab

Eli Lilly (from ImClone acquisition) & Bristol-Myers Squibb (BMS) & Merck Serono

Antibody Irinotecan refractory metastatic colorectal carcinoma and all other approved indications

Mar-ket

BMS PR Jan 28, 2010 - North American sales by BMS in 2009 were US$ 683 mln (- 9 % vs 2008); 2009 sales in Merck Serono territories were € 697 mln (+ 23 % vs 2008) corresponding to US$ 946.4 mln. Total sales of US$ 1,629 mln

1790

Vectibix; panitumu-mab

EGF-R Rec fully human IgG2 full mab

Takeda Pharmaceutical Co. & Amgen

Antibody 3rd line metastatic colorectal cancer et al

Mar-ket

Amgen PR Jan 25, 2010 - 2009 sales of US$ 233 mln (+ 52 % vs 2008)

Total = US$ 18.182 bln

Page 8: Top 20 Biologics 2009 Rd Pipeline News

8/26 La Merie S.L. | Email [email protected] | Internet www.lamerie.com

TOP 20 Biologics 2009 March 10, 2010 | Special Edition 1

Group 2: TNF Antagonist Biologics

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company Product Category

Indication R&D Stage

Message

6605

Enbrel; etanercept

TNF antagonist

Dimeric fusion protein of soluble TNF-R + CH2 and CH3 domains of Fc of Ig

Amgen & Pfizer (acquired Wyeth) & Takeda Pharmaceutical Co.

Antibody Moderate to severe rheumatoid arthritis

Mar-ket

Amgen PR Jan 25, 2010 - Amgen in US and Canada: US$ 3,493 mln (- 3 % vs 2008); Wyeth: 6-mth revenues outside US and Canado of US$ 1,363 mln extrapolated to 12-mths sales of US$ 2,726 source Takeda: 9-mths (Apr-Dec) 2009 sales of Yen 24.5 bln (+ 20.5 %), extrapolated to 1-yr: Yen 32.6 bln source corresponding to US$ 361.4 mln. Total sales of US$ 6,580 mln

6587

Remicade; infliximab

TNF alpha antagonist

Rec chimeric IgG1 mab

Centocor (J&J) & Merck & Co. (acquired Schering-Plough) & Mitsubishi Tanabe Pharma

Antibody Moderately to severely active rheumatoid arthritis

Mar-ket

Merck & Co 2009 Product Sales Feb 16, 2010 – Merck: US$ 2,327 mln (+ 9.9 %); J&J: US$ 3,088 mln (+ 9.9 % vs 2008) and exports to partners of US$ 987 mln source MTP’s forecast of fiscal year 2009 sales are Yen 46.8 bln source corresponding to US$ 519 mln. Total sales of US$ 5,934 mln

6571

Humira Pen; adalimumab;

TNF alpha antagonist

Rec fully human mab

Abbott & Eisai Antibody Moderate to severe rheumatoid arthritis

Mar-ket

Abbott PR JAn 27, 2010 - 2009 sales of US$ 5,488 mln (+ 21.4 % vs 2008); Eisai reports YOY sales of Yen 4.8 bln (+ 311 %) source corresponding to US$ 53.2 mln

650 CIMZIA; certolizumab pegol; CDP-870

TNF-alpha (soluble and membrane bound)

PEGylated rec human-ized Fab' fragment

UCB Pharma (ex Celltech)

Antibody Moderate to severe Crohn's disease and RA

Mar-ket

UCB PR Mar 2, 2010 - 2009 sales were € 70 mln (+ 600 % vs 2008) corresponding to US$ 95.1 mln

Total: US$ 18.097 bln

Page 9: Top 20 Biologics 2009 Rd Pipeline News

9/26 La Merie S.L. | Email [email protected] | Internet www.lamerie.com

TOP 20 Biologics 2009 March 10, 2010 | Special Edition 1

Group 3: Insulin - I

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company Product Category

Indication R&D Stage

Message

1379

Lantus; insulin glargine

Insulin receptor

Rhu basal insulin analog for once-daily SC injection

Sanofi-Aventis Protein Type 1 and Type 2 diabetes

Mar-ket

Sanofi-Aventis PR Feb 10, 2010 - 2009 sales of € 3,080 mln (+ 22.5 % vs 2008) corresponding to US$ 4,185 mln

1380

Actrapid (EU)/ Novolin (US); rhu insulin

Insulin receptor

Rhu insulin (short-acting) for injection, produced in S.cerevisiae

Novo Nordisk Protein Type 1 and 2 diabetes

Mar-ket

Novo Nordisk PR Feb 2, 2010 - 2009 sales of human insulin product group was DKK 11,315 (- 5 % in local currencies vs 2008) corresponding to US$ 2,066 mln

1324

Humalog Mix 50:50; premix insulin lispro

Insulin receptor

Mixture of soluble rhu insulin analog (50 %) with insuline-protamine precipitate (50 %)

Eli Lilly Protein Type 1 and 2 diabetes

Mar-ket

Lilly 2009 Product Sales Jan 28, 2010 - 2009 sales of US$ 1,959 mln (+ 13 % vs 2008)

1223

NovoLog (US) / NovoRapid (EU); insulin aspart

Insulin receptor

Rhu insulin analog (rapid-acting) for injection, produced in S.cerevisiae

Novo Nordisk Protein Glycemic control in children and adults with diabetes mellitus

Mar-ket

Novo Nordisk PR Feb 2, 2010 - 2009 sales of DKK 9.749 mln (+ 22 % in local currencies vs 2008) corresponding to US$ 1,780 mln

Page 10: Top 20 Biologics 2009 Rd Pipeline News

10/26 La Merie S.L. | Email [email protected] | Internet www.lamerie.com

TOP 20 Biologics 2009 March 10, 2010 | Special Edition 1

Group 3: Insulin - II

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company Product Category

Indication R&D Stage

Message

6984

NovoMix 50; premix insulin aspart

Insulin receptor

Soluble (50 %) and protamine-crystallized (50 %) rhu insulin analog aspart

Novo Nordisk Protein Type 1 and 2 diabetes

Mar-ket

Novo Nordisk PR Feb 2, 2010 - 2009 sales of product group was DKK 6,499 (+ 15 % in local currencies vs 2008) corresponding to US$ 1,187 mln

8893

Humulin 50:50; premix human insulin

Insulin receptor

Rhu insulin produced in E.coli, mix of 50 % soluble human insulin and 50 % insulin isophane suspension

Eli Lilly Protein Type 1 and 2 diabetes

Mar-ket

Lilly 2009 Product Sales Jan 28, 2010 - 2009 sales of US$ 1,022 mln (- 4 % vs 2008)

1238

Levemir; insulin detemir

Insulin receptor

Rec human basal insulin analogue for once-daily injection

Novo Nordisk Protein Children and adults with insulin-dependent diabetes

Mar-ket

Novo Nordisk PR Feb 2, 2010 - 2009 sales of DKK 5,223 (+ 35 % in local currencies vs 2008) corresponding to US$ 954 mln

6982

Apidra; insulin glulisine

Insulin receptor

Mealtime short acting rhu insulin analog

Sanofi-Aventis Protein Type 1 and 2 diabetes mellitus

Mar-ket

Sanofi-Aventis PR Feb 10, 2010 - 2009 sales of € 137 mln (+ 38.8 % vs 2008) corresponding to US$ 185.9 mln

Total = US$ 13.339 bln

Page 11: Top 20 Biologics 2009 Rd Pipeline News

11/26 La Merie S.L. | Email [email protected] | Internet www.lamerie.com

TOP 20 Biologics 2009 March 10, 2010 | Special Edition 1

Group 4: Erythropoiesis Stimulating Agents (ESA) - I

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company Product Category

Indication R&D Stage

Message

52 Aranesp; darbepoetin alfa

Erythropoietin receptor (EPO-R)

Engineered variant of rec hu hormone + AutoInjector

Amgen Protein Chronic kidney disease (once monthly) and all other approved indications

Mar-ket

Amgen PR Jan 25, 2010 - 2009 sales of US$ 2,652 mln (- 15 % vs 2008)

165 NESP; darbepoetin; KRN-321

Erythropoietin receptor (EPO-R)

Glycoengineered rhu protein

Kyowa Hakko Kirin Pharma (from Amgen)

Protein Renal anemia Mar-ket

Kyowa Hakko Kirin 2009 Results Presentation Jan 29, 2010 - Combined sales of NESP and ESPO in 2009 were Yen 39.6 bln (+ 15 % vs 2008) = US$ 438.4 mln

161 Epogen; epoetin alfa

Erythropoietin receptor (EPO-R)

Rhu erythropoietin alfa

Amgen Protein Renal anemia and all other approved indications

Mar-ket

Amgen PR Jan 25, 2010 - 2009 sales of US$ 2,569 mln (+ 5 % vs 2008)

162 ESPO; epoetin alfa

Erythropoietin receptor (EPO-R)

Rhu protein Kyowa Hakko Kirin Pharma (from Amgen)

Protein Renal anemia Mar-ket

Kyowa Hakko Kirin 2009 Results Presentation Jan 29, 2010 - Combined sales of NESP and ESPO in 2009 were Yen 39.6 bln

1899

Procrit / Eprex / Erypo; epoetin alfa

Erythropoietin receptor (EPO-R)

Rec human glycoprotein

Ortho Biotech / Janssen-Cilag (J&J) (from Amgen)

Protein Chemotherapy induced anemia and all other approved indications

Mar-ket

J&J 2009 Product Sales Jan 26, 2010 - 2009 sales were US$ 2,245 mln (- 8.7 %)

163 Neo-Recormon; epoetin beta

Erythropoietin receptor (EPO-R)

Rhu protein Roche Protein Renal anemia and all other approved indications

Mar-ket

Roche PR Feb 3, 2010 - 2009 international sales of NeoRecormon except US and Japan were CHF 1045 mln corresponding to US$ 971 mln: combined sales of Epogin and NeoRecormon were CHF 1560 mln (- 11 % vs 2008)

Page 12: Top 20 Biologics 2009 Rd Pipeline News

12/26 La Merie S.L. | Email [email protected] | Internet www.lamerie.com

TOP 20 Biologics 2009 March 10, 2010 | Special Edition 1

Group 4: Erythropoiesis Stimulating Agents - II

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company Product Category

Indication R&D Stage

Message

164 Epogin; Epoch; epoetin beta

Erythropoietin receptor (EPO-R)

Rhu erythropoietin beta

Roche (Chugai)

Protein Renal anemia. Chemotherapy induced anemia

Mar-ket

Roche PR Feb 3, 2010 - 2009 sales in Japan of Epogin were CHF 515 mln (-1% vs 2008) corresponding to US$ 479 mln

207 Mircera; Methoxy polyethylene glycol-epoetin beta; CERA

Erythropoietin receptor (EPO-R)

Continuous erythro-poiesis receptor activator (pegylated)

Roche Protein Renal anemia due chronic kidney disease +/- dialysis

Mar-ket

Roche PR Feb 3, 2010 - Worldwide sales in 80 countries in 2009 was CHF 179 mln (+ 252 % vs 2008) corresponding to US$ 166 mln

173 Binocrit / Epoetin alfa Hexal / Abseamed; epoetin alfa

Erythropoietin receptor (EPO-R)

Rhu erythro-poietin

Sandoz (Novartis) & Medice

Protein Renal anemia Mar-ket

Novartis Results Presentation Jan 26, 2010 - 2009 sales of approx. US$ 50 mln (+ approx. 60 % vs 2008)

166 Dynepo; epoetin delta

Erythropoietin receptor (EPO-R)

Rhu protein from gene activation technology (human cell line)

Shire Protein Renal anemia. Renal anemia with two new dosing regimens

Mar-ket

Shire PR Feb 19, 2009 - Shire ceased commercialization of Dynepo at the end of 2008

Total: US$ 9.562 bln

Page 13: Top 20 Biologics 2009 Rd Pipeline News

13/26 La Merie S.L. | Email [email protected] | Internet www.lamerie.com

TOP 20 Biologics 2009 March 10, 2010 | Special Edition 1

Group 5: Interferon beta

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company Product Category

Indication R&D Stage

Message

1556

Avonex; interferon beta-1a

Interferon beta receptor

Rhu protein for IM injection once a week

Biogen Idec Protein Relapsing forms of multiple sclerosis

Mar-ket

Biogen Idec PR Feb 9, 2010 - 2009 sales of US$ 2,323 mln (+ 5 % vs 2008)

1534

Rebif; interferon beta-1a

Interferon beta receptor

Rhu protein (prefilled syringe)

Merck Serono Protein Relapsing forms of multiple sclerosis

Mar-ket

Merck KGaA PR FEb 23, 2010 - 2009 sales of € 1,537 mln (+ 15 % vs 2008) corresponding to US$ 2,087 mln

1501

Betaseron / Betaferon; interferon beta-1b

Interferon beta receptor

Rhu protein Berlex & Bayer Schering Pharma

Protein All relapsing forms of multiple sclerosis

Mar-ket

Bayer Briefing Feb 26, 2010 - 2009 sales of € 1,214 mln (+ 5.7 % in local currencies vs 2008) corresponding to US$ 1,649 mln

Total: US$ 6.059 bln

Page 14: Top 20 Biologics 2009 Rd Pipeline News

14/26 La Merie S.L. | Email [email protected] | Internet www.lamerie.com

TOP 20 Biologics 2009 March 10, 2010 | Special Edition 1

Group 6: Coagulation Factors

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company Product Category

Indication R&D Stage

Message

106 Advate; octocog alfa; antihemo-philic factor plasma/ albumin-free

Coagulation factor VIII replacement

Rec full length coagulation factor VIII plasma/ albumin free

Baxter Healthcare

Protein Hemophilia A

Mar-ket

Baxter 2009 Product Line Sales Jan 28, 2010 - Combined sales of Advate and Recombinate in 2009 were US$ 2,058 mln (+ 5 % vs 2008) continued customer adoption of Advate over Recombinate

117 NovoSeven; eptacog alfa; rFVII

Substitution of coagulation F. VIIa

Rhu activated factor VII in BHK

Novo Nordisk (from Zymogenetics)

Protein Hemorrhage in hemophiliacs with alloantibodies

Mar-ket

Novo Nordisk PR Feb 2, 2010 - 2009 sales of DKK 7,072 mln (+ 10% in local currencies vs 2008) corresponding to US$ 1,292 mln

119 Kogenate FS (BAY 14-2222) + BIO-SET

F. VIII substitution

Rhu protein formulated with sucrose (BHK)

Bayer Schering Pharma

Protein Hemophilia A Mar-ket

Bayer Briefing Feb 26, 2010 - 2009 sales: € 888 mln (+ 3.2 % in local currencies vs 2008) = US$ 1,207 mln (incl. transfer sales to CSL)

150 BeneFix; nonacog alfa

F. IX substitution

Rec hu protein

Pfizer (acquired Wyeth) & Biovitrum

Protein Hemophilia B Mar-ket

Pfizer 2009 Financial Report - Sales in last 2.5 mths of US$ 98 mln, extrapolated to 12-mths sales of approx. US$ 479 mln

10106

Helixate FS / Helixate NexGen

F. VIII substitution

Rhu protein formulated with sucrose

CSL Behring (manufactured by Bayer Schering Pharma)

Protein Hemophilia A Mar-ket

CSL Presentation Feb 12, 2010 - Sales in H1 (Jul-Dec) of FY 2009/20 were US$ 247 mln and in H1 of 2009 were US$ 220 mln source calendar year 2009: US$ 467 mln

114 Xyntha (USA); moroctocog alfa (AF-CC)

Substitution of coagulation factor VIII

Albumin free (AF) rhu B-domain deleted factor VIII

Pfizer (acquired Wyeth) & Biovitrum

Protein Hemophilia A Mar-ket

Pfizer 2009 Financial Report - Combined product sales of Xyntha/ Refacto in last 2.5 mths after acquisition of Wyeth by Pfizer was US$ 47 mln extrapolated to 12-mths sales: approx US$ 225 mln

Total = US$ 5.728 bln

Page 15: Top 20 Biologics 2009 Rd Pipeline News

15/26 La Merie S.L. | Email [email protected] | Internet www.lamerie.com

TOP 20 Biologics 2009 March 10, 2010 | Special Edition 1

Group 7: Granulocyte Colony Stimulating Factor (G—CSF)

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company Product Category

Indication R&D Stage

Message

1874

Neulasta; pegfilgrastim

G-CSF receptor

Pegylated rec methionyl human G-CSF

Amgen Protein Myelosuppressive chemotherapy with at least 17 % risk of febrile neutropenia

Mar-ket

Amgen PR Jan 25, 2010 - 2009 sales of US$ 3,355 mln (+ 1 % vs 2008)

1943

Neupogen; filgrastim

G-CSF receptor

Rhu protein Amgen Protein Neutropenia Mar-ket

Amgen PR Jan 25, 2010 - 2009 sales were US$ 1,288 mln (- 4 % vs 2008)

9986

Neu-up; nartograstim

G-CSF receptor

Rhu protein Kyowa Hakko Kirin Pharma

Protein Neutropenia Mar-ket

Kyowa Hakko Kirin 2009 Results Presentation Jan 29, 2010 - Combined sales of Neu-up and Gran in 2009 were Yen 13.8 bln (- 3 % vs 2008) corresponding to US$ 153 mln

9983

Gran; filgrastim

G-CSF receptor

Rhu protein Kyowa Hakko Kirin Pharma (from Amgen)

Protein Neutropenia Mar-ket

Kyowa Hakko Kirin 2009 Results Presentation Jan 29, 2010 - Combined sales of Neu-up and Gran in 2009 were Yen 13.8 bln (- 3 % vs 2008)

2345

Neutrogin; lenograstim

G-CSF receptor

Rhu protein Chugai & Roche

Protein Chemotherapy-induced neutropenia

Mar-ket

Roche Results Presentation Feb 3, 2010 - 2009 sales by Chugai in Japan were CHF 385 mln (- 14 % vs 2008) = US$ 358 mln

9378

Zarzio; filgrastim

G-CSF receptor

Generic equivalent of Neupogen from Amgen

Sandoz (Novartis)

Protein Neutropenia

Mar-ket

Novartis Results Presentation Jan 26, 2010 - 2009 sales of approx. US$ 8 mln (launched during 2009 in Germany, France, Spain, Poland and Austria)

Total = US$ 5.162 bln

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TOP 20 Biologics 2009 March 10, 2010 | Special Edition 1

Group 8: Anti-Inflammatory Antibodies

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company Product Category

Indication R&D Stage

Message

1476

Tysabri; Antegren; natalizumab; AN100226

Alpha4/beta1/7 integrin

Rec humanized IgG4 mab

Biogen Idec & Elan

Antibody RR multiple sclerosis

Mar-ket

Biogen Idec PR Feb 9, 2010 - 2009 global in-market sales of US$ 1,060 mln (+ 30 % vs 2008) of which 509 mln were generated in the US and 551 mln outside the US

90 Xolair; omalizumab;

IgE Rec humanized mab

Roche (Genentech) & Novartis

Antibody Severe allergic asthma in adults and adolescents (age 12 or above)

Mar-ket

Roche Results Presentation Feb 3, 2010 - US sales by Roche: CHF 620 mln (+ 10 % vs 2008) = US$ 576 mln; Novartis sales: US$ 338 mln (+ 65 % in local currencies) source Total sales of US$ 914 mln

6537

Orencia; abatacept; CTLA4-Ig

B7-1 (CD80) and B7-2 (CD86)

Rec fusion protein of CTLA4+ Fc of IgG1 (hinge, CH2 + CH3)

Bristol-Myers Squibb

Antibody Adult rheumatoid arthritis and juvenile idiopathic arthritis

Mar-ket

BMS PR Jan 28, 2010 - 2009 sales of US$ 602 mln (+ 37 % vs 2008)

37 Soliris; eculizumab; H5G1.1

Complement C5 antagonist

Rec human-ized (hybrid IgG2/4) full mab

Alexion Phar-maceuticals

Antibody Paroxysmal nocturnal hemoglobinuria (PNH)

Mar-ket

Alexion Pharmaceuticals PR Feb 11, 2010 - 2009 sales of US$ 386.8 mln (+ 46 % vs 2008)

6545

RoActemra (EU); Actemra; tocilizumab

Interleukin-6 receptor (IL-6R) antagonist

Rec humanized mab

Roche (Chugai)

Antibody Moderate to severe rheuma-toid arthritis (RA)

Mar-ket

Roche PR Feb 3, 2010 - Available in 25 countries, 2009 sales were CHF 146 mln (+ 289 % vs 2008) corresponding to US$ 135.5 mln

6546

ARCALYST; rilonacept; Il-1 trap

Interleukin-1 (IL-1) antagonist

Trap (2 IL receptor do-mains + CH2 +CH3 of Fc)

Regeneron Pharma-ceuticals

Antibody Cryopyrin-asso-ciated periodic syndromes (CAPS)

Mar-ket

Regeneron Pharmaceuticals PR Feb 18, 2010 - 2009 net product sales of US$ 18.4 mln (+ 192 % vs 2008)

Total: US$ 3.117 bln

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TOP 20 Biologics 2009 March 10, 2010 | Special Edition 1

Group 9 Human Growth Hormone (hGH)

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company Product Category

Indication R&D Stage

Message

1289

Genotropin; somatropin

hGH) receptor

Rhu protein with SC inj. devices

Pfizer Protein Growth hormone deficiency

Mar-ket

Pfizer 2009 Financial Report - 2009 sales of US$ 887 mln (- 0.6 % vs 2008)

1291

Norditropin; somatropin

hGH receptor Rhu protein Novo Nordisk Protein Growth hormone deficiency

Mar-ket

Novo Nordisk PR Feb 2, 2010 - DKK 4,401 mln (+ 10 % in local currencies) = US$ 804 mln

1290

Humatrope; somatropin

hGH receptor Rhu protein for SC injection

Eli Lilly Protein Growth hormone deficiency

Mar-ket

Lilly 2009 Product Sales Jan 28, 2010 - 2009 sales of US$ 448.8 mln (- 4.1 % vs 2008)

1288

Nutropin; Nutropin AQ; somatropin

hGH receptor Rhu protein Genentech (Roche)

Protein Growth hormone deficiency

Mar-ket

Roche Results Presentation Feb 3, 2010 - 2009 sales in Roche territories were CHF 400 mln (+ 3 % in local currencies vs 2008) corresponding to US$ 371.8 mln

1292

Saizen; somatropin

hGH receptor Rhu protein Merck Serono Protein Growth hormone deficiency

Mar-ket

Merck KGaA PR Feb 23, 2010 - 2009 sales of € 191 mln (+ 11 % vs 2008) corresponding to US$ 259.6 mln

1239

Omnitrope; somatropin

Human growth hormone (hGH) receptor

Rhu protein (Generic equivalent of Genotropin from Pfizer

Sandoz (Novartis)

Protein Growth hormone deficiency

Mar-ket

Novartis Results Presentation Jan 26, 2010 - 2009 sales of approx. US$ 60 mln (+ approx. 55 % vs 2008)

8750

Nutropin AQ; somatropin

hGH receptor Rhu protein Ipsen (from Genentech)

Protein Growth hormone defiency

Mar-ket

Ipsen PR Feb 1, 2010 - 2009 sales of € 40.4 mln (+ 26.5 % on a constant currency exchange rate basis vs 2008) corresponding to US$ 54.8 mln

Total: US$ 2.886 bln

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TOP 20 Biologics 2009 March 10, 2010 | Special Edition 1

Group 10: Interferon alpha

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company Product Category

Indication R&D Stage

Message

861 Pegasys; peg-interferon alfa-2a

Interferon alpha receptor

Pegylated rhu protein

Roche Protein Chronic hepatitis C virus infection + Copegus

Mar-ket

Roche PR Feb 3, 2010 - 2009 sales of CHF 1,655 mln (+ 5 % in local currencies vs 2008) corresponding to US$ 1,538 mln

794 PegIntron; pegylated interferon alfa-2b

Interferon alpha receptor

Pegylated (12 kDa) rec human protein

Merck & Co. (acquired Schering-Plough)

Protein Hepatitis C virus infection plus/minus ribavirin; retreatment after previous IFN treatment failure

Mar-ket

Merck & Co 2009 Product Sales Feb 16, 2010 - 2009 sales of US$ 844 mln (- 7.7 % vs 2008)

920 Intron A; interferon alpha-2b

Interferon alpha receptor

Rhu protein Merck & Co. (acquired Schering-Plough)

Protein HCV infection Mar-ket

Merck & Co 2009 Product Sales Feb 16, 2010 - 2009 sales of US$ 231 mln (-1 1.3 % vs 2008)

Total: US$ 2.613 bln

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TOP 20 Biologics 2009 March 10, 2010 | Special Edition 1

Group 11: Enzyme Replacement Therapies

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company Product Category

Indication R&D Stage

Message

7822

Cerezyme; imiglucerase

Beta-gluco-cerebrosidase enzyme replacement

Rhu protein Genzyme Protein Type 1 Gaucher disease

Mar-ket

Genzyme PR Jan 12, 2010 - 2009 sales were US$ 793 mln (- 34 % vs previous year) - due to manufacturing problems

1176

Fabrazyme; agalsidase beta

Alpha-galactosidase A enzyme replacement

Rhu protein Genzyme Protein Fabry disease Mar-ket

Genzyme PR Jan 12, 2010 - 2009 sales were US$ 431 mln (- 13 % vs previous year) - due to manufacturing problems

1157

Elaprase; idursulfase; iduronate-2-sulfatase

Iduronate-2-sulfatase enzyme replacement

Rhu protein Shire & Genzyme

Protein Hunter syndrome (MPS-II)

Mar-ket

Shire PR Feb 19, 2010 - 2009 sales of US$ 353 mln (+ 20 % on a constant exchange rate basis vs 2008)

1192

Lumizyme; Myozyme; alglucosidase alpha

Alglucosidase alpha replacement

Rec hu enzyme

Genzyme Corp

Protein Pompe disease Mar-ket

Genzyme PR Jan 12, 2010 - 2009 sales of US$ 324 mln (+ 9 % vs previous year)

1381

Replagal; GA-agalsida-se alfa

Alpha-galactosidase ERT

Rhu protein Shire & Dainippon Sumitomo

Protein Fabry disease Mar-ket

Shire PR Feb 19, 2010 - US$ 194 mln (+ 16 % on a constant exchange rate basis vs 2008)

1161

Naglazyme; galsulfase; rhASB

Arylsulfatase B enzyme replacement

Rhu protein Biomarin Pharmaceutical & AnGes MG

Protein Mucopolysaccharidosis VI (MPS VI)

Mar-ket

BioMarin Pharmaceuticals PR Feb 24, 2010 - 2009 sales were US$ 168.7 mln (+ 27.1 % vs 2008)

1159

Aldurazyme; laronidase

Alpha-L-iduronidase enzyme replacement

Rhu protein Biomarin Phar-maceuticals & Genzyme

Protein Mucopolysaccharidosis I (MPS I)

Mar-ket

BioMarin Pharmaceuticals PR Feb 24, 2010 - 2009 sales reported by Genzyme were US$ 155.1 mln (+ 2.5 % vs 2008)

1385

VPRIV; velaglucer-ase alfa

Human gluco-cerebrosidase ERT

Rhu protein, gene-activated

Shire Protein Type 1 Gaucher's disease

Mar-ket

Shire Presentation Feb 19, 2010 - 2009 sales of US$ 3 mln; launches in EU and US start in 2010

Total: US$ 2.422 bln

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TOP 20 Biologics 2009 March 10, 2010 | Special Edition 1

Group 12: Ophthalmic Antibody

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company Product Category

Indication R&D Stage

Message

6306

Lucentis; ranibizumab; RG3645; RG-3645

Vascular endothelial growth factor (VEGF)

Rec humanized Fab for intravitreal injection

Roche (Genentech) & Novartis

Antibody Wet age-related macular degeneration (AMD)

Mar-ket

Roche PR Feb 3, 2010 - US sales by Roche (Genentech) in 2009 were CHF 1,198 mln (+ 24 % vs 2008) corresponding to US$ 1,112 mln; 2009 sales by Novartis in more than 80 countries were US$ 1,232 mln (+ 47 % in local currencies vs 2008) source Total sales of US$ 2,344 mln

Group 13: Follicle Stimulating Hormone (FSH)

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company Product Category

Indication R&D Stage

Message

1319

Puregon / Follistim; follitropin beta

Follicle Stimulating Hormone (FSH) receptor

Rhu glycoprotein produced in CHO cells, available in vials and cartridges

Merck & Co. (acquired Schering-Plough) (ex Organon))

Protein Development of multiple follices in ovulatory women and in anovulatory infertile women

Mar-ket

Merck & Co 2009 Product Sales Feb 16, 2010 - 2009 sales of US$ 546 mln (- 5.4 % vs 2008)

1260

Gonal-f; rec follitropin alpha; GONALEF; FSH

Follicle Stimulating Hormone (FSH)

Rec human protein

Merck Serono Protein Induction of ovulation and pregnancy in functionally infertile pts

Mar-ket

Merck KGaA PR Feb 23, 2010 - 2009 sales of € 486 mln (+ 5.8 % vs 2008) corresponding to US$ 660.4 mln

Total: US$ 1.206 bln

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TOP 20 Biologics 2009 March 10, 2010 | Special Edition 1

Group 14: Antiviral Antibody

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company Product Category

Indication R&D Stage

Message

734 Synagis; palivizumab; MEDI-493;

Epitope on RS virus

Rec humanized full mab

AstraZeneca (MedImmune)

Antibody Propylaxis of RSV infection

Mar-ket

AstraZeneca PR Jan 28, 2010 - 2009 sales of US$ 1,082 mln (- 12 %)

Group: Other Antibodies

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company Product Category

Indication R&D Stage

Message

217 ReoPro; abciximab

Glycoprotein IIb/IIIa antagonist

Fab fragment of chimeric mab 7E3

Eli Lilly & Centocor (J&J)

Antibody Adjunct to PCI (percutaneous coronary interventions)

Mar-ket

Lilly 2009 Product Sales Jan 28, 2010 - 2009 sales of US$ 231.5 mln (- 9.7 %)

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TOP 20 Biologics 2009 March 10, 2010 | Special Edition 1

Group: Selected Proteins - I

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company Product Category

Indication R&D Stage

Message

440 Pulmozyme; dornase alfa

DNA Rhu enzyme delivered with nebulizer

Roche (Genentech)

Protein Cystic fibrosis Mar-ket

Roche Results Presentation Feb 3, 2010 - 2008 sales by Roche were CHF 501 mln (+ 5 % in local currencies vs 2008) corresponding to US$ 466 mln

10016

InductOs; rhBMP-2/ACS; dibotermin alfa applied to Absorbable Collagen Sponge

Bone regeneration

Rhu bone morphogenic protein on collagen matrix

Pfizer (acquired Wyeth) & Astellas Pharma

Medical device & biomaterial

Acute tibia fractures; lower back spine fusion surgery (plus cage)

Mar-ket

Medtronic PR Feb 23, 2010 - Medtronic sales of Biologics from Jan to Dec 2009 were US$ 866 mln of which Wyeth usually received 50 % = US$ 433 mln (+ 11 % vs 2008)

151 TNKase; Metalyse; tenecteplaseTNK-t-PA

Plasminogen activator

Rec engineered t-PA (3 aa substituted)

Roche (Genentech) & Boehringer Ingelheim

Protein Acute myocardial infarction

Mar-ket

Roche Results Presentation Feb 3, 2010 - 2009 sales Activase and TNKase in Roche territories were CHF 455 mln (+ 34 % in local currencies vs 2008) corresponding to US$ 423 mln; BI results not yet published

10063

Thyrogen; TSH alfa for injection

Thyroid hormone receptor stimulator

Rec human thyrotropin (TSH) for injection

Genzyme Protein Adjunctive treatment in thyroidectomy for well-differentiated thyroid cancer

Mar-ket

Genzyme PR Feb 17, 2010 - 2009 sales of US$ 170.6 mln (+ 15 % vs 2008)

64 Xigris; drotrecogin-alpha; rhu activated protein C

F. Va + F. VIIIa; PAI-1; TNF; thrombin

Rec hu protein

Eli Lilly & Teijin

Protein Severe sepsis Mar-ket

Lilly 2009 Product Sales Jan 28, 2010 - 2009 sales of US$ 127.3 mln (- 20.8 %)

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TOP 20 Biologics 2009 March 10, 2010 | Special Edition 1

Group: Selected Proteins - II

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company Product Category

Indication R&D Stage

Message

6686

Kineret; anakinra;

Interleukin-1 receptor (IL-1R) antagonist

Rhu protein (non-glycosylated, N-terminal methionin)

Biovitrum (from Amgen)

Protein Rheumatoid arthritis

Mar-ket

Biovitrum 2009 Results Presentation Feb 18, 2010 - 2009 global sales of SEK 440.7 mln corresponding to US$ 61.6 mln

1149

Increlex; mecasermin; rhIGF-1

Insulin-like growth factor-1 ( IGF-1) receptor agonist

Rhu growth factor

Ipsen (acquired Tercica)

Protein Severe forms of primary IGF deficiency (IGFD) in children

Mar-ket

Ipsen PR Feb 1, 2010 - 2009 sales of € 21 mln (+ 286 % on a constant currency exchange rate basis vs 2008) corresponding to US$ 28.5 mln

1785

Kepivance; palifermin; rhu KGF-1; FGF-7

Keratinocyte growth factor receptor

Rec human KGF

Biovitrum (from Amgen)

Protein Severe oral mucositis in pts with hematologic cancers undergoing bone marrow transplantation

Mar-ket

Biovitrum 2009 Results Presentation Feb 18, 2010 - 2009 global sales were SEK 109.9 mln corresponding to US$ 15.4 mln

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TOP 20 Biologics 2009 March 10, 2010 | Special Edition 1

Group: Selected Peptides - I

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company Product Category

Indication R&D Stage

Message

10105

Copaxone; glatiramer acetate

MHC class II modulator

4-aa poly-peptide at 20 mg daily SC dose

Teva Phar-maceutical Industries & Sanofi-Aventis

Peptide Relapsing-remitting multiple sclerosis

Mar-ket

Teva PR Feb 16, 2010 - 2009 global in-market sales of US$ 2,826 mln (+ 25 % vs 2008)

10107

Botox; onabotuli-numtoxinA

Neuromus-cular transmission (SNAP-25 cleavage)

Neurotoxin from Clostridium botulinum type A

Allergan Phar-maceuticals & GlaxoSmith-Kline Japan & China)

Peptide Medical and esthetic indications

Mar-ket

Allergan SEC 10-K Feb 26, 2010 - 2009 Allergan sales of US$ 1,309.6 mln (vs 1,310.9 mln in 2008); 52 % for medical and 48 % for cosmetic indications

10021

Sandostatin LAR; octreotide/IM injection

Somatostatin receptor

Somatostatin analogue, once-monthly

Novartis Peptide Acromegaly; gastro-entero-pancreatic neuroendocrine (GEP NE) tumors

Mar-ket

Novartis PR Jan 26, 2010 - 2009 sales of US$ 1,155 mln (+ 7 % in local currencies vs 2008)

2403

Velcade; bortezomib; PS-341

Proteasome inhibitor

Modified dipeptidyl boronic acid

Takeda Pharmaceutical Co. (ex Millennium) & Johnson & Johnson (J&J)

Peptide Multiple myeloma and all other approved indications

Mar-ket

J&J 2009 Product Sales Jan 26, 2010 - 2009 sales ex US reported by J&J were US$ 933 mln (+ 18.6 % vs 2008)

1169

Forteo; teriparatide; rec hu PTH(1-34);

PTH receptor Rec variant of human parathyroid hormone

Eli Lilly Peptide Osteoporose in postmenopausal women and all other approved indications

Mar-ket

Lilly 2009 Product Sales Jan 28, 2010 - 2009 sales of US$ 816.7 mln (+ 4.9 % vs 2008)

2392

Lupron / Leuplin; leuprorelin

LH-RH agonist

Nonapeptide Takeda Pharmaceutical & Abbott

Peptide Prostate cancer Mar-ket

Abbott PR JAn 27, 2010 - Abbott reported 2009 sales in its territories of US$ 800 mln (+ 22.8 % vs 2008); Takeda territories not yet reported

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TOP 20 Biologics 2009 March 10, 2010 | Special Edition 1

Group: Selected Peptides - II

ID No.

Product Name

Target / Mechanism of Action

Class of Compound

Company Product Category

Indication R&D Stage

Message

7948

Byetta; exenatide; LY2148568

GLP-1 receptor agonist

SC 39-aa synthetic peptide bid

Amylin Phar-maceuticals & Eli Lilly

Peptide Type 2 diabetes monotherapy et al

Mar-ket

Lilly PR Jan 28, 2010 - 2009 worldwide sales of US$ 796.5 mln (+ 6 % vs 2008)

10060

Decapeptyl SR; triptorelin acetate

LHRH agonist/ GnRH analog

Synthetic decapeptide with slow release formulation

Ipsen Peptide Locally advanced prostate cancer; endometriosis; uterine fibroids prior to surgery

Mar-ket

Ipsen PR Feb 1, 2010 - 2009 sales of € 250.5 mln (+ 1.4 % on a constant currency exchange rate basis vs 2008) corresponding to US$ 340 mln

231 Integrilin; eptifibatide

GP IIb/IIIa Cyclic heptapeptide

Merck & Co. (acquired S-P) & Takeda (ex Millennium)

Peptide Acute coronary syndrome

Mar-ket

Merck & Co 2009 Product Sales Feb 16, 2010 - 2009 sales of US$ 295 mln (- 6 % vs 2008)

1564

Dysport (EU); Reloxin (US); abobotuli-numtoxinA

Neuromus-cular transmission (SNAP-25 cleavage)

Peptide for injection

Ipsen Peptide Cervical dystony

Mar-ket

Ipsen PR Feb 1, 2010 - 2009 sales of € 163.8 mln (+ 18 % on constant currency exchange rate basis vs 2008) = US$ 222.4 mln; Ipsen's sales figure includes supply to Medicis and Galderma

1172

Somatuline Autogel / Depot; lanreotide acetate

Somatostatin analog

Peptide in ready-to-use prefilled syringe

Ipsen Peptide Acromegaly Mar-ket

Ipsen PR Feb 1, 2010 - 2009 sales of € 140 mln (+ 18.2 % on a constant currency exchange rate basis vs 2008) corresponding to US$ 190.2 mln

874 Fuzeon needle free device; enfuvirtide

HIV entry inhibitor (fusion of HIV with CD4)

Linear 36-aa peptide + needle-free device

Trimeris & Roche

Peptide HIV Mar-ket

Trimeris PR Feb 02, 2010 - 2009 sales as repoted by Roche were US$ 112.2 mln (- 33 % vs 2008)

1205

Symlin; pramlintide

Amylin receptor

Synthetic amylin analog

Amylin Phar-maceuticals

Peptide Type 1 and 2 diabetes

Mar-ket

Amylin Pharmaceuticals PR Jan 27, 2010 - 2009 sales of US$ 86.4 mln (vs 86.8 mln in 2008)

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TOP 20 Biologics 2009 March 10, 2010 | Special Edition 1

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