Drug Pipeline Progress - December 1-7 - Drug Discovery and Development

LATISSE (bimatoprost solution 0.03%)
Company: Allergan, Inc.
FDA Dermatologic and Ophthalmic Drugs Advisory Committee voted unanimously (9-0) to recommend that the FDA approve LATISSE, December 5, 2008
Company Comments: If approved, LATISSE would be the first and only FDA-approved pharmaceutical to enhance eyelash prominence.

PROMACTA (eltrombopag)
Company: GlaxoSmithKline
Positive Reports from a Phase 3 study were reported on December 4, 2008
Company Comments: Patients receiving PROMACTA were eight times more likely than those on placebo to maintain platelet counts between 50-400,000/mL during a six-month treatment period, thereby reducing patients’ bleeding symptoms and their need for concomitant and rescue ITP treatments.

Prochymal
Company: Osiris Therapeutics, Inc
Completes Enrollment in Worldwide Phase 3 Stem Cell Trial, December 4, 2008
Company Comments: This double-blinded, placebo controlled trial will assess safety and efficacy of Prochymal over a six-month period. A total of 244 patients were enrolled at 72 leading bone marrow transplant centers across the United States, Canada, United Kingdom, Spain, Italy, Australia, Germany, and Switzerland.

Tesetaxel (Oral Taxane)
Company: Genta Incorporated
Tesetaxel Receives FDA Designation as an Orphan Drug, December 4, 2008
Company Comments: Genta Incorporated received notice from the U.S Food and Drug Administration (FDA) that tesetaxel, the Company’s oral taxane in clinical development, has been granted designation as an ‘Orphan Drug’ for treatment of patients with advanced melanoma.

cethromycin
Company: Advanced Life Sciences Holdings, Inc.
Cethromycin NDA Accepted for Filing by FDA for the Treatment of Community Acquired Pneumonia, December 3, 2008
Company Comments: The FDA has established a goal of a standard 10-month review such that the anticipated target action date of the cethromycin NDA would be July 31, 2009.

OGX-011 (in combination with docetaxel and prednisone)
Company: OncoGenex Pharmaceuticals, Inc.
Announced positive survival results from a randomized Phase 2 clinical trial of OGX-011 in combination with docetaxel and prednisone, December 3, 2008
Company Comments: The study randomized 82 patients with metastatic or locally recurring prostate cancer refractory to hormone therapy. The median survival was 27.5 months for the patients in the OGX-011 arm and 16.9 months for those in the control arm.

ANA598 (investigational hepatitis C non-nucleoside polymerase inhibitor)
Company: Anadys Pharmaceuticals, Inc.
Received Fast Track Designation from the FDA for the Treatment of Chronic Hepatitis C Infection, December 2, 2008
Company Comments: The granting of fast track status for the ANA598 development program is consistent with the need for HCV treatments with novel mechanisms of action, oral administration, non-overlapping resistance profiles, and improved safety and efficacy over the existing standard of care for both treatment-naïve and treatment-experienced patients.

131I-TM601
Company: TransMolecular, Inc.
TransMolecular Reached SPA Agreement with FDA for Phase 3 Trial in Glioblastoma Patients, December 2, 2008
Company Comments: Through the SPA, the FDA has agreed that if the 131I-TM601 Phase 3 study successfully meets its stated endpoints, the design and planned analysis of the trial adequately addresses the objectives necessary to support an efficacy claim in a future NDA submission for regulatory approval.

naproxcinod
Company: NicOx S.A.
NicOx Signed Agreement with DSM for the Commercial Manufacture of naproxcinod Drug Substance, December 2, 2008
Company Comments: The agreement with DSM aims to secure commercial supplies of an appropriate scale to support the successful launch of naproxcinod. As per the agreement, NicOx envisages the first deliveries of significant quantities of commercial material being made from the fourth quarter of 2009 onwards.

HIV/AIDS Vaccine
Company: GeoVax Labs, Inc.
Phase 2a HIV/AIDS Vaccine Human Trials Began in North and South America, December 1, 2008
Company Comments: The Phase 2a human clinical trial will involve 150 vaccine participants and 75 placebo (control) participants. The vaccine regimen employs a two-component prime-boost strategy. Trial participants will first be administered a GeoVax HIV-1 DNA vaccine which primes the immune system followed by the second vaccine, GeoVax’s HIV-1 MVA (Modified Vaccinia Virus) boost. Both vaccines express the three major proteins of the AIDS virus.

Erbitux (cetuximab)
Company: Merck KGaA
European Commission Approves Erbitux for First-Line Use in Head and Neck Cancer Patients, December 1, 2008
Company Comments: Erbitux was approved for first-line use in combination with platinum-based chemotherapy in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck in Europe. Approval was based on the results of the EXTREME study.