FDA plays coming up:
Updates for: Progenics Pharmaceuticals, Inc. (NASDAQ:PGNX), Santarus, Inc. (NASDAQ:SNTS), Questcor Pharmaceuticals, Inc. (NASDAQ:QCOR), and Shire Plc. (ADR) (NASDAQ:SHPGY)
Progenics Pharmaceuticals, Inc.
(NASDAQ:PGNX)
PGNX announced a deal with Wyeth to re-acqurie all of the worldwide rights to the RELISTOR franchise after a one-year transition period. RELISTOR (subcutaneous injection) is the only drug approved to treat opioid-induced constipation (OIC) in patients with advanced illness receiving palliative care. PGNX will aggressively continue development to expand the utility of both subcutaneous and oral RELISTOR into a new population for patients with chronic pain who experience OIC. On 8/4/09, Wyeth and PGNX announced submission of a supplemental New Drug Application (sNDA) to the FDA and an Extension Application to the European Medicines Agency (EMEA) for RELISTOR (methylnaltrexone bromide) subcutaneous injection for a new delivery system, pre-filled syringes. RELISTOR was approved last year in single-use vials. RELISTOR is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has been insufficient. If approved, pre-filled syringes of RELISTOR are expected to be available in the U.S. and Europe as early as the first half of 2010. Single-use vials of RELISTOR will continue to be available. The estimated PDUFA action date is for a standard, 10-month review period.
Santarus, Inc.
(NASDAQ:SNTS)
SNTS announced that the FDA approved the Company’s NDA for immediate-release omeprazole / sodium bicarbonate / magnesium hydroxide tablets in 40 mg and 20 mg dosage strengths of omeprazole. The NDA for the new prescription tablet product was approved for all indications the company was seeking, including for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease, or GERD. The Agency has not yet approved a trade name for the new product. Santarus has submitted an NDA supplement requesting approval of a proposed trade name that includes the “ZEGERID” brand name and anticipates that the FDA will complete its review of this NDA supplement within 180 days.
