• Alkermes Inc., of Cambridge, Mass., licensed a long-acting Fc fusion technology platform, Medifusion, from Acceleron Pharma Inc., also of Cambridge, Mass. The technology is designed to extend the circulating half-life of proteins and peptides. Under the terms, Alkermes gains worldwide rights to Medifusion in return for an up-front payment and equity investment in Acceleron, plus future development, regulatory and sales milestones and royalties on product sales. Specific financial details were not disclosed. Acceleron will retain all rights to the technology for products derived from the TGF-beta superfamily.

• Endo Pharmaceuticals Holdings Inc., of Chadds Ford, Pa., received a complete response letter for its extended-duration testosterone undecanoate injection, Aveed, in men with hypogonadism. The agency requested information regarding rare but serious adverse events, including post-injection anaphylactic reaction and pulmonary oil microembolism. The complete response also noted that the company's risk evaluation and mitigation strategy was not sufficient. Endo said it is evaluating the FDA's action. Aveed, known as Nebido outside the U.S., was acquired in Endo's $637 million purchase of Lexington, Mass.-based Indevus Pharmaceuticals Inc. early this year. Prior to that acquisition, Nebido had received an approvable letter, with the FDA asking for additional safety data. Shares of Endo (NASDAQ:ENDP) dropped $1.01 Thursday to close at $21.41. (See BioWorld Today, June 5, 2008, and Jan. 7, 2009.)

• Enzon Pharmaceuticals Inc., of Bridgewater, N.J., said its board authorized the repurchase of up to $50 million of its outstanding shares of common stock, to be funded by the company's available cash. As of Sept. 30, Enzon had cash, equivalents, short-term investments and marketable securities totaling $201.3 million.

• Genzyme Corp., of Cambridge, Mass., said it plans to move straight into seeking approval of 4,000 L Lumizyme (alglucosidase alfa) following discussions with the FDA, which rejected for the second time last month a biologics license application for the 2,000 L version, citing deficiencies at the company's troubled Allston Landing manufacturing plant. A BLA is expected to be filed this month. The 2,000 L Lumizyme product was supposed to have been a stepping stone to a submission for the 4,000 L version of Pompe disease drug Myozyme, but problems at Allston - most recently the detection of particulate matter in a small number of drug vials - stalled that approval. Genzyme said the 4,000 L Lumizyme product is produced at its manufacturing facility in Geel, Belgium, sidestepping Allston altogether. But Credit Suisse Securities analyst Michael Aberman warned that an approval of the 4,000 L Lumizyme is not certain and noted that the decision to abandon the 2,000 L approval "could signal that the manufacturing deficiencies at Allston could take longer to resolve." The plant was shut down for six months earlier this year after a virus was detected in the bioreactors that produced Gaucher drug Cerezyme (imiglucerase) and Fabry drug Fabrazyme (agalsidase beta). In related news, the company said it will reopen enrollment in the Alglucosidase Alfa Temporary Access program to provide access to treatment for severely affected adults with Pompe disease prior to the approval of Lumizyme. (See BioWorld Today, June 17, 2009; Nov. 16, 2009; and Nov. 17, 2009.)

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., added two new drugs to its pipeline: ISIS-FXIRx, which is designed to treat clotting disorders without increased risk of bleeding, and ISIS-SMNRx, a candidate for spinal muscular atrophy.

• MDRNA Inc., of Bothell, Wash., said nonhuman primate data showed the significant knockdown of a primate liver gene following a single intravenous dose of 0.3 mg/kg of an RNAi-based therapeutic developing using its UsiRNA construct and DiLA2 delivery platforms. No increase in ALT or AST levels were observed 24 hours or 48 hours post dose, nor was there elevation in other liver enzymes or kidney function markers. Those and other data were presented at the Informa Life Sciences conference, EuroTIDES, in Amsterdam, the Netherlands.

• Midway Pharmaceuticals Inc., of Spring House, Pa., said its nonabsorbed, oral co-polymer therapy demonstrated the ability to protect against damage to healthy gastrointestinal tissues and prevent lethal bacterial infections in animal models of radiation damage. Results, published in the December issue of the American Journal of Physiology, also suggested that the compound, a high-molecular-weight co-polymer of polyethylene glycol could provide a way to prevent serious GI side effects of radiation in patients receiving fractionated radiotherapy for abdominal cancers or in accidental exposures to harmful radiation.

• NeoPharm Inc., of Lake Bluff, Ill. , said that it has reached a settlement agreement with Diosynth Biotechnology, of Research Triangle Park, N.C., after NeoPharm had sought dispute resolution under a contract agreement. As part of the settlement, NeoPharm has agreed to pay Diosynth $150,000.

• Noxxon Pharma AG, of Berlin, Germany, achieved a milestone in its discovery and development partnership with Eli Lilly and Co., of Indianapolis, by successfully identifying a Spiegelmer (L-aptamers), chemical entities based on synthetic mirror-image oligonucleotides, with picomolar affinity and high selectivity for its target and met contractually specified milestone criteria, triggering a payment of an undisclosed amount. Lilly and Noxxon entered into the agreement last year to discover and develop Spiegelmers for the treatment of migraine.

• Tripep AB, of Stockholm, received approval from the Swedish Medical Products Agency and the local ethical committee to give three patients in the highest dose group in the ChronVac-C study one additional treatment with the therapeutic vaccine. All 12 patients in the study have earlier received four treatments at three different doses and one month apart. The highest dose was given to six patients. Three patients in the high dose group will now be offered to receive a fifth therapeutic vaccination six to 12 months after the last vaccination before receiving standard of therapy with interferon and ribavirin.

• Viral Genetics Inc., of San Marino, Calif., and the University of Colorado executed an exclusive license agreement that expands on a previous agreement allowing the company to develop treatments for autoimmune diseases, graft rejection, HIV and cancer based on the university work. That work uncovered a drug target that may offer a new strategy in treating a wide variety of immune-related disorders and diseases.