Drug Pipeline Progress - April 27-30 - Drug Discovery and Development

Fluidosomes-tobramycin
Company: Axentis Pharma
Orphan Drug Designation for Innovative Treatment against Lung Infections, April 30, 2009
Company Comments: Pre-clinical and Phase 1 clinical trials support improved safety and efficacy profiles for Fluidosomes-tobramycin as compared to currently marketed treatments for infectious and respiratory tract in patients with cystic fibrosis.

DYSPORT (abobotulinumtoxinA)
Company: Medicis
FDA Approved DYSPORT for Therapeutic and Aesthetic Uses, April 29, 2009
Company Comments: The approval includes two separate indications, the treatment of cervical dystonia in adults to reduce the severity of abnormal head position and neck pain, and the temporary improvement in the appearance of moderate to severe glabellar lines in adults younger than 65 years of age. Reloxin, which was the proposed US name for Ipsen’s botulinum toxin product for aesthetic use, will be marketed under the name of DYSPORT.

Tyvaso (inhaled treprostinil)
Company: United Therapeutics Corporation
FDA Extended Action Date for Inhaled Treprostinil, April 28, 2009
Company Comments: United Therapeutics Corporation announced that the US Food and Drug Administration (FDA) will require additional time to complete its review of the New Drug Application (NDA) for Tyvaso (inhaled treprostinil).

IMX942
Company: Inimex Pharmaceuticals
Began First Clinical Study of an Innate Defense Regulator, April 28, 2009
Company Comments: IMX942 is the first of a new class of drugs known as Innate Defense Regulators, which modulate innate defenses to improve survival, reduce bacterial infections and suppress inflammation.

OGX-011
Company: OncoGenex Pharmaceuticals, Inc.
Received Confirmation from FDA on the Design of a Second Phase 3 Trial Evaluating OGX-011 for the Treatment of Advanced Prostate Cancer, April 28, 2009
Company Comments: The Phase 3 trial evaluating durable pain palliation will be a randomized, controlled, international trial in approximately 300 men with metastatic CRPC who responded to first-line docetaxel therapy, but subsequently have progression of disease, including prostate cancer-related pain, and are able to receive docetaxel retreatment as second-line chemotherapy.

Degarelix
Company: Ferring Pharmaceuticals
Launched Phase 3B Trial of Degarelix as Intermittent Therapy, April 27, 2009
Company Comments: The Phase 3B trial will investigate the use of degarelix for intermittent androgen deprivation therapy (IADT) in patients with advanced prostate cancer who have rising serum PSA levels after previous curative therapies. The study will compare IADT to continuous androgen deprivation therapy (ADT) for 14 months with either leuprolide or degarelix. The trial evaluates whether IADT minimizes the negative effects of ADT and maximizes quality of life, while maintaining tumor response as measured by PSA suppression.

CONBRIZA (bazedoxifene)
Company: Wyeth Pharmaceuticals
CONBRIZA Approved in the European Union for Treatment of Postmenopausal Osteoporosis, April 27, 2009
Company Comments: Wyeth Pharmaceuticals announced that the European Commission has granted marketing authorization for CONBRIZA (bazedoxifene), a selective estrogen receptor modulator (SERM), for the treatment of postmenopausal osteoporosis in women at increased risk of fracture.

RISPERDAL CONSTA (risperidone)
Company: Alkermes, Inc.
RISPERDAL CONSTA Approved in Japan, April 27, 2009
Company Comments: Alkermes, Inc. announced that Janssen Pharmaceutica K.K. received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan to market RISPERDAL CONSTA (risperidone) long-acting injection for the treatment of schizophrenia.

Prodarsan
Company: Pharming Group NV
Prodarsan Granted Orphan Drug Designation from FDA, April 27, 2009
Company Comments: Prodarsan is a combination of two small molecules, formulated for oral use, which are believed to reduce the accumulation of DNA-damage, the underlying biochemical cause of Cockayne Syndrome.

Nexavar (sorafenib)
Company: Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc.
Phase 3 Trial of Nexavar in Chemotherapy-Naive Patients with Advanced Melanoma Does Not Meet Primary Endpoint, April 27, 2009
Company Comments: The multicenter, randomized, double-blind, placebo-controlled Phase 3 study enrolled patients with unresectable stage III or stage IV melanoma at more than 200 clinical sites in the United States and Australia. The primary efficacy endpoint was overall survival, and secondary endpoints included progression-free survival and response rate.