• Advanced Cell Technology Inc., of Los Angeles, has entered into an agreement with Pharming Group NV, of Leiden, the Netherlands, giving it an exclusive, global license to nonhuman use of certain patents associated with oocyte activation. Pharming will pay ACT a one-time license fee. Previously, Pharming had a nonexclusive license to the patents. Financial terms were not disclosed.

• Alpharma Inc., of Bridgewater, N.J., submitted a new drug application for Embeda, an abuse-deterrent, extended-release morphine product candidate. Embeda was developed using Alpharma's technology, which combines an extended-release opioid agonist with sequestered naltrexone, an opioid antagonist, to prevent potential abuse by crushing, chewing or dissolving the capsules.

• Applera Corp., of Norwalk, Conn., said in a form filed with the Securities and Exchange Commission that its board of directors had authorized management to pursue a possible separation of its Celera Group. The separation would be accomplished by a 1-for-1 redemption of the Applera Corp.-Celera Group tracking stock for new Celera Corp. shares. Upon completion of the separation, Celera Corp. would become a separate, publicly traded company. Applera said it expects that Celera Corp.'s common stock would be listed for trading on Nasdaq under the symbol "CRA." At Celera's request, Applera Corp.-Celera Group tracking stock would be delisted from the New York Stock Exchange. Kathy Ordoñez, currently president of Applera Corp.-Celera Group, is expected to serve as the Celera CEO.

• Jazz Pharmaceuticals Inc., of Palo Alto, Calif., received FDA approval for Luvox CR (fluvoxamine maleate) once-a-day, extended-release capsules in social anxiety disorder and obsessive-compulsive disorder. Jazz licensed U.S. rights to the drug, a selective serotonin reuptake inhibitor (SSRI), from Marietta, Ga.-based Solvay Pharmaceuticals Inc. In December, Jazz received an approvable letter due to chemistry, manufacturing and controls issues, which subsequently were resolved.

• Kosan Biosciences Inc., of Hayward, Calif., said President and CEO Robert G. Johnson Jr. has resigned, and that the company has reprioritized its development plans. The new priorities are to advance development of its lead product candidate, Hsp90 inhibitor tanespimycin, in multiple myeloma and in metastatic breast cancer, and its lead epothilone candidate, KOS-1584, in non-small-cell lung cancer, and potentially other indications. Kosan also said it will withdraw Hsp90 inhibitor alvespimycin from development to shift resources to the development of tanespimycin in breast cancer. Kosan stock dropped 42 percent in December when it announced that updated results from a Phase Ib trial with tanespimycin showed a lower response rate in multiple myeloma than the company reported earlier. (See BioWorld Today, Dec. 11, 2007.) Additionally, Kosan said it has licensed its motilin agonist KOS-2187 to Pfizer Inc., of New York, and it is expected to continue in Phase I trials as a potential treatment for gastrointestinal disorders. No financial terms were disclosed. The company also said Helen S. Kim, who joined Kosan in January as senior vice president and chief business officer, has been appointed president.

• Pipex Pharmaceuticals Inc., of Ann Arbor, Mich., said it completed a Type A meeting with the FDA regarding a refusal to file notice for its new drug application for oral tetrathiomolybdate in initially presenting Wilson's disease, reporting that the agency agreed with some revisions to the chemistry, manufacturing and controls section and agreed to allow a preclinical reproductive toxicology study to be conducted on a post-approval basis. The FDA also agreed with Pipex's plan to rectify the formatting and presentation of the NDA and will assess the adequacy of clinical evidence as review items for a refiled NDA. Based on those results, Pipex said it believes it has a course of action to resolve filing issues raised in the January RTF letter, though it said the FDA still has concerns regarding the drug's clinical efficacy, safety, study quality, data collection and overall risk/benefit profile. (See BioWorld Today, Jan. 30, 2008.)

• Solvay Pharmaceuticals Inc., of Marietta, Ga., and Wyeth, of Madison, N.J., ended their collaboration to develop the atypical antipsychotic bifeprunox and other psychiatric drugs. Last year, the companies received a "not approvable" letter from the FDA for bifeprunox in schizophrenia, and the agency requested additional clinical trials. Wyeth then determined that the market was not sufficient for the companies to share and terminated the deal, sending rights to the drugs back to Solvay.

• Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, said its new drug application for Type II diabetes drug alogliptin was accepted for review by the FDA. The acceptance triggers a $15 million milestone payment to contract research group PPD Inc., of Wilmington, N.C., from which Takeda licensed the drug in 2005. Alogliptin is oral, once-daily selective dipeptidyl peptidase-4 (DPP-4) inhibitor. (See BioWorld Today, July 15, 2005.)

• Vanda Pharmaceuticals, of Rockville, Md., said a study reported in the journal Pharmacogenomics suggested that a genetic variation in the ciliary neurotrophic factor gene (CNTF) may affect response to antipsychotic treatment. Data showed that its schizophrenia candidate Fiapta (iloperidone) was significantly more effective than placebo in treating both the positive and negative symptoms of schizophrenia. In addition, Fiapta showed significant improvement from baseline in all symptoms across all patient genotypes of CNTF. In patients carrying both intact copies of CNTF (representing 75 percent of the population), Fiapta treatment was significantly better than placebo in symptom improvement, the company said. In patients carrying at least one truncated copy of the CNTF protein, placebo- and Fiapta-treated patients had a significant improvement from baseline indicating an enhanced placebo response among that group of patients.