FDA Calendar Update: High Hopes for Amgen's Bone Drug

by: Mike Havrilla

The accompanying table (click to enlarge) includes an updated FDA calendar of 69 expected decision dates included in the ETF Innovators (ETFI) New Drug Regulatory Catalyst Index, with seven companies listed in red with overdue decisions. Since my last update, the following FDA action has occurred:

1.) Amgen (NASDAQ:AMGN) filed a BLA for bone drug denosumab in the following two indications: the treatment + prevention of osteoporosis in post-menopausal women and the treatment + prevention of bone loss in patients undergoing hormone ablation for either prostate or breast cancer, with the potential for over $3B in peak sales for the drug based on S&P analyst estimates. Since reporting positive Phase 3 results for the drug this summer and beating estimates the past two quarters, Amgen has posted a stock price gain of about 25% year-to-date despite the overall market malaise.

2.) Johnson & Johnson (NYSE:JNJ) received a complete response from the FDA for a biological agent, Stelara (ustekinumab), in the treatment of psoriasis which requests more information on the company's risk management strategy. The delay is a minor one for JNJ and it expects to respond to the agency in January with plans for a medication guide and communication strategy for the drug. Medarex (MEDX) is also set to receive royalties on the drug as part of the company's UltiMAb licensing agreement with JNJ.

3.) King Pharma (KG) filed a NDA for CorVue as a cardiac imaging agent and a near-term decision due for round two of an abuse-resistant opiate pain drug, Embeda, as part of its Alpharma (NYSEMKT:ALO) acquisition since receiving a complete response for Remoxy along with Pain Therapeutics (NASDAQ:PTIE).

4.) AstraZeneca (NYSE:AZN) filed a sNDA to expand the use of the "purple pill" Nexium in the short-term (up to six weeks) treatment of gastroesophageal reflux disease (GERD) for infants 0-1 years of age in a lower dose (2.5 + 5 mg) oral suspension.

5.) Barr Pharma (BRL) has a pending PDUFA date of 7/31/09 for Adenovirus Types 4 and 7 Live Oral Vaccines, as the Company prepares to be acquired by Teva Pharma (NYSE:TEVA).

6.) AMAG Pharma (NASDAQ:AMAG) – I bought shares of AMAG last week ahead of an expected FDA decision before year-end with a PDUFA date of 12/30/08 for the company's pending new drug application for ferumoxytol as a treatment for iron-deficiency anemia in patients with chronic kidney disease. In mid-November, AMAG bounced nicely off its 52-week lows in the high teens back to the thirties on word that the FDA accepted its complete response for the drug and designated the submission for a Class I review of 60 days.

The Class I designation by the FDA removed the risk of costly and time-consuming delays for AMAG to conduct additional clinical trials and improved the odds for approval by the agency. With AMAG still down by about 50% in the past year, over 14 bucks per share in cash + investments ($241M), zero debt, a short interest of 4.1M shares, and only 17M shares outstanding; the stock is poised for a major pop if it gets the FDA okay for ferumoxytol. AMAG is ready to launch the drug quickly in 1Q09 if it is approved and will be working closely with dialysis providers such as DaVita (NYSE:DVA) as a major source of patients with chronic kidney disease who would be candidates for ferumoxytol.