In 2012, California companies were responsible for nine of the FDA’s 39 approved new molecular entities (NME), or about 23 percent. A NCE or NME is a drug that is without precedent among regulated and approved drug products and is an indication of innovation in the development of new drugs and therapeutic biological products. In total, 63 products were approved, 208 were marketed and 28 were in registration. The following snapshot features Medivation, which received FDA approval this year for XTANDI® (enzalutamide) capsules for the treatment of patients with metastatic castration-resistant prostate cancer who have received docetaxel. XTANDI® is marketed in the U.S.
| Company | Product | Approved | Description | Disease Area | Indication |
|---|---|---|---|---|---|
| Affymax Inc. | Omontys | 3/27/12 | Erythropoietin (EPO) receptor agonist | Hematology | Anemia |
| Arena Pharmaceuticals | Belviq | 6/27/12 | Serotonin (5-HT2C) receptor agonist | Endocrine / Metabolic | Obesity |
| Genentech Inc. | Erivedge | 1/30/12 | Smoothened antagonist | Cancer | Basal cell carcinoma (BCC) |
| Genentech Inc. | Perjeta | 6/8/12 | Antibody to (EGFR2) (HER2) (ErbB2) (neu) | Cancer | Breast cancer |
| Gilead Sciences | Stribild | 8/27/12 | HIV integrase inhibitor; HIV reverse transcriptase inhibitor; Cytochrome P450 3A (CYP3A) inhibitor | Infectious | HIV / AIDS |
| Medivation Inc. | Xtandi | 8/31/12 | Androgen receptor antagonist | Cancer | Prostate cancer |
| Onyx Pharmaceuticals | Kyprolis | 7/20/12 | Proteasome inhibitor | Cancer | Multiple myeloma (MM) |
| Vivus Inc. | Qsymia | 4/27/12 | Low-dose combination of phentermine and topiramate | Obesity | Obesity |
| Exelixis, Inc | COMETRIQ | 11/29/12 | CABOZANTINIB | Cancer | Thyroid Cancer |
SNAPSHOT:
FDA APPROVALS
Medivation
(NASDAQ: MDVN)
“Innovation is important to the life sciences industry because human diseases are complex, generally multifactorial in origin and constantly changing and adapting to and resisting therapeutic approaches to combat them.”
David Hung, M.D.
Co-Founder and CEO, Medivation
SNAPSHOT:
RESEARCH
City of Hope
“The center’s work in recombinant DNA technology, gene therapy and monoclonal antibodies have advanced their fields, leading to breakthroughs affecting people worldwide. Here, scientific discoveries can, and do, become real-world care.”