• Aphios Corp., of Woburn, Mass., said it received a two-year, $2.4 million Phase II SBIR grant from the National Institute on Aging for work on Alzheimer's disease candidate APH-0703, a protein kinase C modulator designed to activate the alpha-secretase pathway. The company is developing formulations of the drug using hydrophobic-based and SFS-PNS polymer nanosphere technologies for preclinical studies.

• BioTime Inc., of Alameda, Calif., said it obtained an exclusive license from the Wistar Institute in Philadelphia for technology related to a gene designated SP100. Wistar researchers have demonstrated roles for that gene in both cancer and stem cell biology. Scientists at BioTime's OncoCyte Corp. and ReCyte Therapeutics subsidiaries will apply the technology to develop products in cancer and vascular disease. In conjunction with the license agreement, BioTime agreed to fund research at Wistar to advance the technology and will hold certain rights to negotiate additional licenses for any technologies invented as a result of the research. Specific financial terms were not disclosed.

• Critical Outcome Technologies Inc., of London, Ontario, said it finished synthesizing compounds from its acute myelogenous leukemia (AML) program and has initiated confirmatory preclinical tests. The firm plans to pursue licensing opportunities based upon the scientific results of the AML program.

• Depomed Inc., of Menlo Park, Calif., said it received a Paragraph IV certification notice of an abbreviated new drug application filed by Actavis Group, of Zug, Switzerland, seeking approval for a generic version of Gralise (gabapentin) 300-mg and 600-mg tablets. Actavis' notice alleges that Depomed's six U.S. patents for Gralise will not be infringed by Actavis' proposed product, or alleges that they are invalid and/or are unenforceable. Depomed, which gained approval of Gralise last year in postherpetic neuralgia, said it is evaluating the certification and intends to vigorously enforce its intellectual property rights. (See BioWorld Today, Feb. 1, 2011.)

• EpiCept Corp., of Tarrytown, N.Y., confirmed its engagement of SunTrust Robinson Humphrey to assist in exploring strategic alternatives to maximize the commercial opportunity of AmiKet, a topical cream intended for the treatment of neuropathic pain. Those include the evaluation of potential transactions involving the sale of the company. EpiCept recently disclosed that it had received FDA guidance for Phase III development and a subsequent new drug application filing for AmiKet in chemotherapy-induced peripheral neuropathy.

• Evotec AG, of Hamburg, Germany, said it completed the squeeze-out process to acquire all of the remaining shares of DeveloGen AG, of Gottingen, Germany, from its minority shareholders. Evotec now holds 100 percent of DeveloGen's shares, and the former minority shareholders will receive a payment of €12.75 (US$16.61) per share, for about €180,000. Evotec agreed last year to buy the biotech, which develops immunomodulatory peptide fragment DiaPep277 for Type I diabetes, in a staggered deal involving an initial payment of €12 million in cash plus €8 million in stock, with up to another €6 million worth of shares as a conditional earnout. DeveloGen shareholders also could earn up to 30 percent of future milestone and royalty income arising from assets acquired in the deal. (See BioWorld Today, July 16, 2010.)

• Genzyme Corp., of Cambridge, Mass., a subsidiary of Sanofi SA, said the FDA approved its manufacturing plant in Framingham, Mass., for the production of Fabry disease drug Fabrazyme (agalsidase beta). The plant previously was approved by the European Medicines Agency. Approval of the site will allow Genzyme to restore unconstrained supply of the drug, enabling patients to return to full dosing schedules. The Framingham facility also is expected to advance the full recovery of production woes that have plagued Genzyme since summer 2009, when a virus was discovered in one of the bioreactor's at the firm's Allston Landing manufacturing facility. Beginning in March, Genzyme said, all patients in the U.S. currently on therapy will return to full dosing and the firm will begin to transition new patients onto Fabrazyme, also at full dosing levels. (See BioWorld Today, June 17, 2009, and Feb. 17, 2011.)

• The National Institutes of Health (NIH) is accepting comments for 30 days on its proposal to grant an exclusive worldwide license to Kite Pharma Inc., of Los Angeles, for patents covering T cells engineered to express MAGE-A3, MAGE-A12 or SSX-2 T-cell receptors or EGFRvIII chimeric antigens, as well as methods of using the T cells to treat or prevent various types of cancer. NIH would receive royalties under the license.

• Millennium, of Cambridge, Mass., a unit of Takeda Pharmaceutical Co. Ltd., said the FDA approved a supplemental new drug application for Velcade (bortezomib), which updates the label to include the subcutaneous method of administration in all approved indications: multiple myeloma and mantle cell lymphoma after at least one prior therapy. The approval was based on results from a Phase III noninferiority study conducted in 222 bortezomib-naïve patients with relapsed multiple myeloma, which showed consistent efficacy but a reduced risk of peripheral neuropathy with the subcutaneous version.

• Priaxon AG, of Munich, Germany, and Boehringer Ingelheim GmbH, of Ingelheim, Germany, agreed to extend their 2010 research and development collaboration on mdm2/p53 inhibitors in cancer. The firms will continue working jointly to identify and advance drug candidates into preclinical development, after which Boehringer Ingelheim will drive the development and commercialization of any emerging compounds. Under the terms, Priaxon is entitled to up to €86 million (US$112 million) in milestones, plus royalties on future net product sales. (See BioWorld Today, Jan. 20, 2010.)