• Advanced Life Sciences Holdings Inc., of Chicago, said it received notice that the FDA's Anti-Infective Drugs Advisory Committee is tentatively set to meet on June 2 to discuss the company's new drug application for cethromycin, a once-daily oral antibiotic, for the proposed indication of mild to moderate community-acquired pneumonia. The company submitted the NDA last year, and the agency has established a July 31 PDUFA date. (See BioWorld Today, Oct. 2, 2008.)

• Astellas Pharma Inc., of Tokyo, carried out its threats of hostility and launched a $16-per-share cash tender offer for all outstanding common shares of Palo Alto, Calif.-based CV Therapeutics Inc. The offer expires March 27. Astellas also filed a lawsuit against CV Therapeutics relating to recent stockholder rights amendments that would interfere with the tender offer and claimed that a previous agreement between the two companies has been violated. CV Therapeutics has been fighting Astellas' advances for more than a year and has turned down the $16-per-share offer twice. (See BioWorld Today, Jan. 28, 2009, and Feb. 24, 2009.)

• BioAlliance Pharma SA, of Paris, said it terminated a 2007 licensing agreement with SpeBio, a joint venture with Amsterdam, the Netherlands-based SpePharm Holdings BV, relating to the distribution of Loramyc, a muco-adhesive buccal tablet for treating oropharyngeal candidiasis. BioAlliance also initiated legal proceedings in Paris against SpeBio for allegedly violating contractual obligations and to obtain compensation for losses reportedly suffered due to delays in commercialization and sale of Loramyc.

• BioInvent International AB, of Lund, Sweden, reported preclinical data demonstrating antitumor activity of therapeutic cancer antibody BI-505, which is designed to target ICAM-1. Research to date suggested that by targeting ICAM-1, the drug directly inhibited tumor cell growth by inducting cell death through direct cell cytotoxicity. Data were presented at the International Myeloma Workshop in Washington. BI-505 has orphan designation in both the U.S. and Europe in multiple myeloma.

• BioTime Inc., of Alameda, Calif., said that its wholly owned subsidiary Embryome Sciences Inc., has entered into an agreement with Reproductive Genetics Institute of Chicago, granting Embryome rights to market new human embryonic stem cell (hES) lines selected by Embryome Sciences from 294 hES lines from the institute. Embryome Sciences initially will select 10 of the institute's hES cell lines, and may add additional cell lines at its option. The institute's hES lines include both normal cells and 88 cell lines identified as carrying a host of inherited genetic disease genes that Embryome Sciences plans to sell as research products to universities and pharmaceutical companies.

• Cell Therapeutics Inc., of Seattle, said it plans to lay off 62 workers at its Bresso, Italy, operation. The company said this is part of a move from from a preclinical research organization to a commercial enterprise, and it is now focusing on bringing its two late-stage drug candidates, Opaxio and pixantrone, to market as quickly as possible. The Italy layoffs will save $14 million in annual operating costs.

• Endo Pharmaceuticals Holdings Inc., of Chadds Ford, Pa., returned U.S. and Canadian rights for the Transdur-Sufentanil pain patch to Cupertino, Calif.-based Durect Corp. The two companies signed a potential $45 million deal in 2005, but Durect said the program is no longer a strategic fit for Endo. Durect plans to find a new partner for the Phase III-ready drug, which it believes may be advanced under the 505(b)(2) pathway. Endo, which ended the year with $775.7 million in cash and posted $1.3 billion in net sales, also discontinued its EN 3285 oral mucositis product, but entered into new cancer and pain deals with Harvard University, Aurigene Discovery Technologies Ltd., and Grunenthal GMBH. (See BioWorld Today, March 15, 2005.)

• Genzyme Corp., of Cambridge, Mass., said the European Commission approved the production of Myozyme (alglucosidase alfa) at the 4,000 liter bioreactor scale at its manufacturing facility in Geel, Belgium. The product will be made commercially available immediately. Myozyme is the only approved treatment for Pompe disease, a progressively debilitating and often fatal inherited disorder.

• Immtech Pharmaceuticals Inc., of New York, signed a memorandum of understanding confirming its interest in exploring a strategic alliance with Beijing Pharmaceutical Group Co. Ltd. The alliance would give BPGC rights to develop compounds from Immtech's library. Specific terms were not disclosed.

• MannKind Corp., of Valencia, Calif., provided an update on the status of its new drug application (NDA) for Afresa, an ultra rapid-acting insulin that has completed Phase III trials. As previously announced, the company's internal goal was to submit the NDA to the FDA by the end of February. Based on editorial decisions made during the final stages of preparing the dossier, the company said it has decided to extend the submission date by about three weeks. The document is fully drafted. However, several tens of thousands of pages of backup data are being removed and will be made available to the FDA upon request. That change will significantly reduce the size of the NDA and should make the NDA more reviewer-friendly, MannKind said.

• Mesoblast Ltd., of Melbourne, Australia, said data on its allogeneic adult stem cell treatment were presented at the American Academy of Orthopedic Surgeons annual meeting. Positive data from a clinical study using the cells in nonhealing fractures of the tibia and femur were presented, along with preclinical data in neck and knee indications.

• Nanobac Pharmaceuticals Inc., of Tampa, Fla., said it is actively pursuing strategic alliances and potential merger opportunities, citing limited access to capital due to the current state of the capital markets. The company also continues to pursue its original business plan, which includes the characterization of Nanobacteria or calcifying nanoparticles.

• Novagali Pharma SA, of Evry, France, reported in vivo toxicology results showing that Nova21027, its BAK (benzalkonium chloride)-free latanoprost formulation for glaucoma, was well tolerated and did not induce any ocular surface damages upon stress conditions. Data were presented at the Association for Ocular Pharmacology and Therapeutics meeting in Salzburg, Austria.

• Novavax Inc., of Rockville, Md., reported preclinical data indicating that its virus-like particle (VLP) vaccine candidate for respiratory syncytial virus (RSV) protected mice against RSV infection and resulted in strong neutralizing antibody responses. The vaccine targets fusion (F) protein, and Novavax expects it to provide longer-lasting protection than RSV-F antibodies.

• Oxygen Biotherapeutics Inc., of Costa Mesa, Calif., and Virginia Commonwealth University signed a memorandum of understanding to establish a federal defense appropriation-funded joint venture focusing on developing new treatments for military battlefield injuries. The joint venture intends to establish an entity to be known as the Purple Heart Injury Laboratories in Richmond, Va., as jointly managed and operated research laboratories focusing on healing battlefield injuries with new therapies and concepts. The initial $15 million funding for the joint venture will be sought through an appropriation request in the 2009-2010 federal defense budget.

• Panacos Pharmaceuticals Inc., of Watertown, Mass., said it notified Nasdaq of its decision to voluntarily delist its common stock. Following that delisting, the firm intends to voluntarily terminate the registration of its stock with the SEC and will cease filing reports with that agency. To further conserve capital, the firm also decided to reduce its board from seven to three directors. Those remaining are Jeremy Hayward-Surry, Laurent Fischer and President and CEO Alan W. Dunton.

• Source MDx Inc., of Boulder, Colo., and the Dana-Farber Cancer Institute reported that the company's whole blood RNA transcript-based Precision Profiles diagnostic test predicted survival in men with castration-resistant prostate cancer (CRPC). In a study involving 62 patients, the model separated them into a high-risk group (survival less than 2.2 years) and a low-risk group (survival greater than 2.2 years). The six-gene CRPC test was 96 percent accurate in predicting low-risk CRPC patients alive at study end and 93 percent accurate in predicting high-risk CRPC patients who died prior to study completion.

• ThromboGenics NV, of Leuven, Belgium, was awarded a grant of up to €3.2 million (US$4.1 million) to continue development of its Anti-VPAC1 antibody for thrombocytopenia. The funding came from the Institute for the Promotion of Innovation by Science and Technology in Flanders, and is tied to milestones over the next three years. The product is slated to begin clinical trials in 2011.

• Winston Pharmaceuticals Inc., of Vernon Hills, Ill., said it received orphan drug designation from the FDA for its lead compound, Civamide, a TRPV-1 receptor modulator in development as a dermal patch for postherpetic neuralgia. Orphan designation would guarantee the product seven years of marketing exclusivity upon approval. The company is testing the patch in a Phase II study.