These healthcare stocks flew under the radar on Wednesday as the focus was on the big market drop.
Alexza Pharmaceuticals (ALXA) fell 8% after the company announced that its AZ-004 NDA would be submitted later than expected. It announced that the resubmission of its AZ-004 New Drug Application (NDA) to the FDA is now planned for Monday, August 8, 2011, (expectations were for late July). The company completed the writing of the NDA sections earlier this week. The documents have been transferred to Alexza's electronic submission vendor, which is assembling and processing the files for eCTD (electronic Common Technical Document) submission to the FDA.
Affymax (AFFY) fell 2% despite the company and Takeda announcing that the FDA accepted for review the NDA for peginesatide (formerly known as Hematide) for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis. If approved, peginesatide will be the first once-monthly erythropoiesis stimulating agent available for the treatment of anemia associated with CKD patients on dialysis in the United States.
Repligen (RGEN) announced an update on its NDA filing. The company said that it is developing RG1068 (SecreFlo) to improve detection of pancreatic duct abnormalities in combination with magnetic resonance imaging (MRI) in patients with pancreatitis. They have completed a Phase 3 clinical trial and plan to submit an NDA for marketing authorization in the U.S. as well as the equivalent regulatory filings in Europe and Canada later this year. The company intends to build a targeted sales force to commercialize SecreFlo in the U.S. and to secure commercial partners or distributors to sell the product outside of the U.S. In addition, Repligen will seek to acquire products that are complementary to SecreFlo, which can be sold by its sales force. There are approximately 300,000 MRI procedures conducted in patients with pancreatitis in the U.S. and Europe each year that could directly benefit from the addition of SecreFlo.
Columbia Laboratories (CBRX) announced that it entered into a license agreement with Invaron Pharmaceuticals, a privately held Canadian pharmaceutical company, for STRIANT (testosterone buccal system) in Canada. Under the terms of the agreement, Invaron will seek regulatory approval for and will market STRIANT in Canada. Columbia will receive a royalty on annual net sales of STRIANT in Canada, assuming Invaron receives Health Canada regulatory approval. Revenue to Columbia are not expected to be material.
Trius Therapeutics (TSRX) rose 5%, one of the few stocks in the green on Wednesday, after it announced an agreement with Bayer for Torezolid Phosphate. Therapeutics and Bayer Pharma announced that they have signed an exclusive agreement to develop and commercialize Trius' lead Phase 3 antibiotic, torezolid phosphate (torezolid), in China, Japan and all other countries in Asia, Africa, Latin America and the Middle East, excluding North and South Korea. Under the collaboration agreement Trius retains full development and commercialization rights outside the licensed territory including the United States, Canada and the European Union.
In exchange for development and commercialization rights in its licensed territory, Bayer will pay Trius $25 million upfront and will support approximately 25% of the future development costs of torezolid required for global approval in acute bacterial skin and skin structure infections ((ABSSSI)) and pneumonia. In addition, Trius is eligible to receive up to $69 million upon the achievement of certain development, regulatory and commercial milestones and will receive double-digit royalties on net sales of torezolid in the licensed territory.
Disclosure: I am long ALXA.