Via the European Decentralized Procedure (Netherlands is the Reference Member State), Apricus (APRI) gets its ED treatment Vitaros approved. The company believes it will "capture a significant share of the ~$1B PDE-5 inhibitor market." APRI says it will work with partners Sandoz, Takeda (TKPHF.PK), and Bracco to obtain national phase approvals. Shares +9.38% premarket. (PR)
NPS Pharmaceuticals (NPSP) has bought back the none-North American rights to two drugs from Takeda for $50M in shares and possible milestone payments, giving NPS with full global rights to the treatments. The drugs are Revestive (Gattex in the U.S.), a medicine for short bowel syndrome, and Preotact, a thyroid hormone replacement therapy. (PR)
Affymax (AFFY) and Japan's Takeda Pharmaceutical (TKPHF.PK) have voluntarily recalled all lots of anemia treatment Omontys in the U.S. following reports of "serious hypersensitivity reactions," including fatalities in "0.02%" of over 25,000 patients after an initial injection. The recall comes after Fresenius said earlier this month that it was halting a pilot program using Omontys. (PR)
Affymax (AFFY +5.4%) and Japanese drug maker Takeda Pharmaceuticals (TKPYY.PK) have entered into a supply agreement for sourcing and supply of Omontys Injection with DSI Renal. Financial terms weren't disclosed, but the agreement allows DSI Renal to purchase the drug for use within its organization, provide discounts and rebates on the product in its selected centers, and then, based on ongoing evaluation, potentially expand to additional facilities.
Affymax (AFFY +0.4%) and Takeda Pharmaceuticals (TKPYY.PK) announce that the J-code assigned by the Centers for Medicare and Medicaid Services for Omontys Injection is now effective. This permanent billing code provides streamlined reimbursement for dialysis organizations prescribing the drug for anemia in the United States.
Sucampo Pharmaceuticals (SCMP) and Takeda Pharmaceuticals (TKPYY.PK) say the FDA,has granted priority review of their supplemental new drug application for an additional indication for Amitiza, a treatment for opioid-induced constipation in patients with chronic, non-cancer pain. A decision is expected by late January 2013. Shares +7% AH.
Apricus Biosciences (APRI) +12.5% premarket after announcing it has licensed Takeda Pharmaceuticals (TKPHF.PK, TKPYY.PK) to market Vitaros, its erectile dysfunction drug, in the U.K. Takeda will pay APRI an undisclosed upfront payment and milestone payments of up to 35M euros.
Furiex Pharmaceuticals (FURX +5.5%) ramped higher into the close after confirming that Takeda Pharmaceutical (TKPYY.PK) has resubmitted New Drug Applications to the FDA for alogliptin and fixed-dose combination therapy alogliptin and pioglitazone for treating adult type 2 diabetes. Under it's agreement with Takeda, FURX is eligible to receive a $25M milestone payment for the approval of the first of these two NDAs, as well as additonal royalties and sales-based milestones.
Piper Jaffray looks at other potential takeout candidates in the biotech space post-Amylin, highlighting BioMarin (BMRN +3.8%), Affymax (AFFY +1%), Theravance (THRX +8.3%), and Rigel Pharmaceuticals (RIGL +2.3%) all as potential candidates. Piper notes that BioMarin could fetch as much as $79 per share, and notes that Japanese drug heavyweight Takeda Pharmaceuticals (TKPYY.PK) could be the most likely suitor for Affymax.
Furiex Pharmaceuticals (FURX) -27% premarket after the company says the FDA requested further data from partner Takeda Pharmaceutical (TKPYY.PK) regarding the new drug applications for alogliptin and the fixed-dose combination therapy alogliptin and pioglitazone.
Amylin (AMLN +48.6%) investors cheer the rumor it rejected a $3.5B offer from Bristol-Myers Squibb, and analysts expect higher bids. Deutsche Bank says AMLN could be worth up to $31/share given an "acquirer with diabetes sales force can cut SG&A by 80% and R&D by 40%." Piper Jaffray names BMY, MRK and TKPYY.PK as potential sutiors; Leerink Swann suggests AZN.
Seattle Genetics (SGEN -4.8%) and Takeda Pharmaceutical (TKPYY.PK -1.00%) dip after the FDA says it's seen three cases of serious brain infection among patients being treated with their jointly-produced lymphoma drug Adcetris, and strengthened the drug's warning label.
Affymax (AFFY) says Takeda Pharmaceuticals (TKPYY.PK) will not commercialize peginesatide, an investigational therapy for treating patients with anemia due to chronic kidney disease, in Japan. Takeda said commercialization in the area was "not strategically optimal." The companies will continue to collaborate in developing the drug for commericalization outside Japan, including preparing to file for regulatory approvals in the U.S. and Europe. Shares -6.5% AH.