• Alexza Pharmaceuticals Inc., of Mountain View, Calif., said the FDA extended the PDUFA date of its new drug application (NDA) for Adasuve (Staccato loxapine) from Feb. 4 to May 4. The FDA designated Alexza's Jan. 10 submission to the NDA, updating its proposed risk evaluation and mitigation strategy program following the Dec. 12, 2011, psychopharmacologic drugs advisory committee meeting, as a major amendment. The company's shares (NASDAQ:ALXA) lost 3 cents Monday to close at 77 cents. (See BioWorld Today, Dec. 9, 2011, and Dec. 13, 2011.)

• Amarantus BioSciences Inc., of Sunnyvale, Calif., entered an exclusive, worldwide license agreement with Power3 Medical Products Inc. for the NuroPro Blood Test as it relates to Parkinson's disease diagnosis. The firm, which is developing a MANF-based therapy for Parkinson's, plans to tailor its development pathway toward a companion diagnostic product. Under the terms, Amarantus has the right to develop, manufacture, use, market and sell medical devices and methods under Power3's Parkinson's disease intellectual property. It paid a $25,000 exclusivity fee in common stock in November 2011 and will issue to Power3 $475,000 worth of common stock. Amarantus also has an option to purchase all of the Parkinson's disease IP for $500,000 in common stock and maintains a right of first refusal to acquire the balance of the NuroPro platform for Alzheimer's disease, amyotrophic lateral sclerosis and other neurodegenerative diseases. Concurrently, Amarantus raised $100,000 from a private, foreign investor.

• APP Pharmaceuticals Inc., of Schaumburg, ILL., and The Medicines Co. (MDCO), of Parsippany, N.J., settled litigation related to APP's abbreviated new drug application for a generic version of the anti-clotting drug Angiomax (bivalirudin for injection). MDCO licensed APP to begin selling APP's generic version of Angiomax in the U.S. on May 1, 2019, or earlier, in certain circumstances. The license also may include the right to market an authorized generic bivalirudin product supplied by MDCO. APP also entered an agreement to manufacture and supply Angiomax finished product to MDCO and to license and supply to MDCO a portfolio of generic products used in therapeutic areas in which MDCO focuses or plans to focus, including acute cardiovascular, neurological and infectious diseases. The settlement includes APP's agreement to dismiss its appeal of the August 2010 federal district court decision holding that MDCO's application for Hatch Waxman patent term extension of the Angiomax composition-of-matter patent was timely filed. (See BioWorld Today, March 23, 2010, and Aug. 9, 2010.)

• Ikaria Inc., of Hampton, N.J., said the FDA granted orphan drug designation for the use of inhaled nitric oxide with the INOpulse DS drug delivery system as a combination product for pulmonary arterial hypertension. Ikaria filed an investigational new drug application for the product in November 2011.

• MediGene AG, of Martinsried, Germany, signed an exclusive license and supply agreement with EIP Eczacibasi Ilac Pazarlama AS, of Istanbul, Turkey, for the supply and commercialization of Veregen ointment in Turkey. MediGene is entitled to successive payments, due upon the achievement of undisclosed regulatory and sales milestones, as well as double-digit royalties on sales of Veregen in Turkey. EIP Eczacibasi is responsible for regulatory approval activities for Veregen in Turkey. Additional details were not disclosed.

• NovaDel Pharma Inc., of Bridgewater, N.J., said it terminated license agreements with Talon Therapeutics Inc., of San Mateo, Calif., and Par Pharmaceutical Cos. Inc., of Woodcliff Lake, N.J., for the development and commercialization of the NovaDel's ondansetron HCl oral spray product. In return, Talon received the right to royalty payments in connection with the product.

• Pernix Therapeutics Holdings Inc., of The Woodlands, Texas, inked a license and supply agreement with an undisclosed private company for an undisclosed FDA-approved prescription product to treat gastroenterology disease. Under terms of the agreement, Pernix obtained exclusive marketing rights to the agent in the U.S. The product is expected to be available midyear 2012 and will be positioned as a first-line therapy in a niche market of more than $100 million annually. Pernix paid an up-front license fee of $2 million and expects to pay an additional $2 million upon commercial launch of the product. The agreement also calls for Pernix to pay royalties and milestones based on product sales.

• Trius Therapeutics Inc., of San Diego, said it earned a $5 million milestone payment from Bayer Pharma AG, of Leverkusen, Germany, for meeting efficacy and safety objectives in the pivotal Phase III study of the oral formulation of TR701-112 (tedizolid phosphate) compared to linezolid (Zyvox, Pfizer Inc.) in bacterial skin and skin structure infections (ABSSSI). The '112 study is the first of two pivotal trials designed to support the filing of a new drug application with the FDA and a marketing authorization application with the European Medicines Agency. Trius initiated the second Phase III trial of tedizolid phosphate in ABSSSI, designated TR701-113, for its intravenous-to-oral transition therapy in September 2011 and expects to report top-line data early next year. (See BioWorld Today, Dec. 20, 2011.)

• VentiRx Pharmaceuticals Inc., of Seattle, said preclinical data on its lead small molecule, VTX-2337, published in Clinical Cancer Research demonstrated a potent immunotherapeutic approach in cancer. The findings suggested the Toll-like receptor 8 (TLR8) agonist clearly distinguished TLR8 from other TLRs, activating human myeloid dendritic cells, monocytes and natural killer (NK) cells to result in the production of high levels of mediators known to orchestrate adaptive antitumor responses. Additionally, VTX-2337 has a direct effect on NK cells and augments antibody dependent cellular toxicity, supporting the opportunity to combine VTX-2337 with monoclonal antibodies. VentiRx has advanced VTX-2337 into a combination study with chemotherapy in late-stage ovarian cancer and a combination trial with cetuximab in head and neck cancer patients. A trial of VTX-2337 in combination with chemotherapy in metastatic breast cancer is slated to begin in mid-2012. (See BioWorld Today, May 6, 2010.)