On 10/14/09, Progenics Pharma (NASDAQ:
PGNX) announced a deal with Wyeth to re-acquire 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 6/4/10 for a standard, 10-month review and possible FDA decision on this sNDA.
On 10/14/09, Somanetics (NASDAQ:
SMTS) announced that it has signed an Exclusive Sublicense Agreement with Raba Equity Partners II and obtained exclusive rights to new cerebral auto-regulation technology developed at The Johns Hopkins University. Integration of this technology into Somanetics' INVOS Cerebral / Somatic Oximeter would yield the first noninvasive monitor providing cerebral auto-regulation data for routine clinical use. SMTS plans to utilize this patent-pending method of combining blood pressure measurements and signals from the INVOS System to continuously monitor and display cerebral auto-regulatory function information.
SMTS plans to file a new 510(k) pre-market notification with the FDA to support marketing the new module in the U.S. by late 2010 and initiate product shipments for sale early in 2011. Cerebral auto-regulation refers to the body's ability to maintain constant blood flow to the brain despite changes in blood pressure.
