Company Product/Description/Indication Status (Date) Active Biotech AB Anyara, antibody linked to a toxin designed to stimulate immune system to target and kill cancer cells; for non-small-cell lung cancer Phase I data of Anyara in combination with Taxotere showed it was safe (10/07) Adventrx Pharmaceuticals Inc. A vein-saving emulsion equivalent for Navelbine (vinorelbine), the vinca alkaloid; for non-small-cell lung cancer The product was found to be equal to Navelbine in a market ing

Company Product/Description/Indication Status (Date) BioMarin Pharmaceutical Inc. 6R-BH4 Tetrahydrobiopterin; enzyme cofactor that plays a role in the production of nitric oxide; for hypertension Phase IIa data failed to show any benefit compared to placebo (2/07) Chelsea Therapeutics International Ltd. Droxidopa, oral synthetic amino acid for neurogenic orthostatic hypertension for hypertension European Phase IIb trial showed statistical significance in reducing the fall in orthostatic

Company Product/Description/Indication Status (Date) Achillion Pharmceuticals Inc.a Elvucitabine L-cytosine nucleoside analogue reverse transcriptase inhibitor for HIV Phase II trials showed that 96% of patients reached undetectable viral load, compared to 94% in the group getting 3TC, and 8 of 14 patients achieved 0.5 log10 reduction or more in viral load (2/08) Ardea Biosciences Inc. RDEA806, non-nucleoside reverse transcriptase inhibitor HIV Phase IIa data showed robust reductions in

Company Product/Description/Indication Status (Date) Biolex Therapeutics Inc. and OctoPlus NV Locteron, a controlled-release interferon alfa for chronic hepatitis C virus Phase I data showed bioactivity over a two-week period and resulted in flu-like side effects that were milder than with PEG-Intron (3/08); Started patient dosing in a Phase IIa trial (2/08) Gilead Sciences Inc. and Achillion Pharmaceuticals Inc. GS 9132, small-molecule inhibitor of hepatitis C virus replication for

Company Product/Description/Indication Status (Date) Akesis Pharmaceuticals Inc. AKP-020, a novel vanadium compound for Type II diabetes Phase IIa data are showing encouraging results (3/08) Altea Therapeutics Inc. A small transdermal patch delivering recombinant human insulin for Type I diabetes Achieved sustained and steady basal levels of insulin (10/07) Alteon Inc. ALT-2074, glutathione peroxidase mimetic for diabetes Started a Phase II trial (6/07) Amylin Pharmaceuticals Inc

Company Product/Description/Indication Status (Date) Abbott Laboratories Humira (FDA-approved); Adalimumab; tumor necrosis factor-alpha blocker agonist for Crohn's disease Received marketing authorization from the European Commission (6/07); FDA approved Humira as a treatment for reducing the signs and symptoms, in adults who have had an inadequate response to conventional therapy (2/07) Biogen Idec and Elan Corp. plc Tysabri, natalizumab, for Crohn's disease FDA approved for moderate

Company Product/Description/Indication Status (Date) Abraxis BioScience Inc. and Taiho Pharmaceutical Co. Ltd. Abraxane (FDA-approved), a proteinbound nanometer-sized solvent free taxane for breast cancer Filed a Japanese NDA (3/08); European Commission granted marketing approval (1/08) Abraxis BioSciences Inc. and Biocon Ltd. Abraxane (FDA-approved), paclitaxel protein-bound particles for injectable suspension; albumin-bound; for breast cancer Received approval in India (10/07

Company Product/Description/Indication Status (Date) Affymax Inc. and Takeda Pharmaceutical Co. Ltd. Hematide, synthetic, peptide-based erythropoiesis stimulating agent for anemia in cancer patients Dosed the first patient in a 100 patient clinical trial (1/08); Dosed the first patient in the Phase III program in chronic renal failure patients (10/07) AMAG Pharmaceuticals Inc. Ferumoxytol Intravenous treatment for anemia FDA accepted for review the NDA (2/08) Amgen Inc. Aranesp and

All figures are in U.S. dollars unless otherwise indicated. Abbott Laboratories *health care company YE 2007 YE 2006 Revenue $25.914B $22.476B Net income $3.606B $1.717B Earnings per share $2.31/share $1.12/share Average shares outstanding 1.560B 1.537B Total assets $39.714B $36.178B Market capitalization 84.63B (3/08)** 83.48B (3/07)** Amgen Inc. *biotechnology company YE 2007 YE 2006 Revenue $14.771B $14.268B Net income $3.166B $2.950B Earnings per share

Company Product Marketer (at time of approval) Indication (U.S. Approval Date, Month/Year) 1982 Genentech Inc. Humulin Eli Lilly and Co. Diabetes (10/82) 1985 Genentech Inc. Protropin Genentech Inc. Growth hormone inadequacy; growth failure associated with chronic renal insufficiency in children (10/85) 1986 Biogen Inc.* Intron-A Schering-Plough Corp. Hairy cell leukemia (6/86); genital warts (6/88); AIDS-related Kaposi’s sarcoma (11/88); hepatitis C (2/91); hepatitis B (7/92

Biotech Investment Outperforms its Environment Arguably — since nothing is absolute — it can be said that the only reason biotechs fail is because they run out of money. The general industry has never run out of innovation or enticing discoveries or technologies in laboratory and clinical environments. Biotechnology's 2007 could have used more drug approvals to bolster the business repute and mercantile allure of its industry, but the biotech pipeline and startup innovation are vigorous enough

Kathleen Jaeger has been the president and CEO of the Generic Pharmaceutical Association (GPhA) since 1992. GPhA is the U.S. trade association that represents manufacturers, distributors and suppliers of generic medicines. She was previously a partner in the Washington, D.C., office of Kirkpatrick & Lockhart LLP. The following interview was conducted by Michael Harris, BioWorld Executive Editor, in May 2008. Biogenerics may be inevitable, but how much longer can the imminent legislation be

The debate regarding the establishment of a policy, particularly in the U.S., for biotechnology generic drugs is a vigorous, problematic, controversial and imperative factor in the evolving narration of both the biotechnology and pharmaceutical drug industries. Generic drugs represent a unique market situation in which both the producer and the consumer can be contented. Drugmakers generate significant revenue, but not at the highest end of expense for payers and patients. After paying the

Proper name: Venlafaxine Drug Developer: Wyeth Location: Madison, N.J. Website: www.wyeth.com Indication(s): Depression, generalized anxiety disorder and social anxiety disorder Approval Date: 1993 2007 Revenue: $3.794 billion Percentage of Wyeth's Total Revenue: 13.62 percent Wyeth's Effexor is indicated for the treatment of major depressive disorder and also has been used to treat hot flashes in women going through menopause. Effexor XR received approval in 2006 for the treatment of

Proper name: Quetiapine fumarate Drug Developer: AstraZeneca plc Location: London, UK Website: www.astrazeneca.com Indication(s): Bipolar disorder and schizophrenia Approval Date: 1997 2007 Revenue: $4.027 billion Percentage of AstraZeneca's Total Revenue: 13.62 percent Seroquel is an antipsychotic that is approved for the treatment of schizophrenia and bipolar disorder. It was first approved for schizophrenia, in 1997. In January 2004, the drug was approved for bipolar mania, and it

Proper name: Enoxaparin sodium injection Drug Developer: Sanofi-Aventis Location: Paris, France Website: www.sanofi-aventis.com Indication(s): Deep vein thrombosis, prophylaxis of ischemic complications of unstable angina, and myocardial infarction Approval Date: 1993 2007 Revenue: $4.100 billion Percentage of Sanofi-Aventis' Total Revenue: 9.36 percent Lovenox is a low-molecular-weight heparin, which is a class of antithrombotic agents. It is approved for the treatment of deep vein

Proper name: Montelukast sodium Drug Developer: Merck & Co. Inc. Location: Whitehouse Station, N.J. Website: www.merck.com Indication(s): Asthma and allergies Approval Date: 1998 2007 Revenue: $4.3 billion Percentage of Merck's Total Revenue: 17.77 percent About 20 million Americans suffer from asthma, including 9 million children. Worldwide, about 150 million people are asthmatic, and BioWorld research estimates the asthma market at about $15 billion. The allergy market is estimated to

Proper name: Olanzapine Drug Developer: Eli Lilly and Co. Location: Indianapolis, Indiana Website: www.lilly.com Indication(s): Schizophrenia and bipolar disorder Approval Date: 1996 2007 Revenue: $4.761 billion Percentage of Eli Lilly's Total Revenue: 25.55 percent Eli Lilly and Co.'s largest product, Zyprexa, was first approved in September 1996 for schizophrenia. The next year it won an FDA nod for acute bipolar mania, and it was approved for schizophrenia maintenance in 2001. The

Proper name: Valsartan Drug Developer: Novartis AG Location: Basel, Switzerland Website: www.novartis.com Indication(s): Hypertension Approval Date: 1996 2007 Revenue: $5.012 billion Percentage of Novartis' Total Revenue: 13.16 percent In 1994, Merck & Co. Inc.'s Cozaar became the first angiotensin II receptor antagonist on the market, and Diovan followed two years later. Hypertension affects about 65 million people in the U.S. Worldwide, BioWorld research estimates the hypertension