• 454 Life Sciences Corp., of Branford, Conn., said it and collaborators at the Human Genome Sequencing Center and Baylor College of Medicine completed for the first time the sequencing of an individual genome for less than $1 million. The project involved sequencing the genome of James Watson, co-discoverer of the double-helix structure of DNA. The mapping of Watson's genome was completed using the Genome Sequencer FLX system. 454, now a unit of Roche Diagnostics, said it intends to work to reduce the sequencing cost to $10,000.

• Advanced Cell Technology Inc., of Alameda, Calif., said it entered into a letter of intent to acquire Mytogen Inc., of Charlestown, Mass., for $5 million in stock and assumption of about $1 million in liabilities. Mytogen was formed late in 2005. It acquired the myoblast cell program from GenVec Inc., of Gaithersburg, Md., and has completed Phase I trials. Following the acquisition, which is expected to close by July 15, ACT said it would plan to begin a 160-patient Phase II trial using an autologous myoblast stem cell therapy for the treatment of heart failure. Mytogen in the deal also would receive warrants to purchase 1.5 million additional shares of ACT at $1 per share. ACT's stock (OTC BB:ACTC) gained 3 cents Thursday to close at 65 cents.

• Avanir Pharmaceuticals Inc., of Alisa Viejo, Calif., received FDA approval for a new formulation of its currently marketed antipsychotic drug FazaClo (clozapine). The new formulation provides bottle packaging and a 12.5-mg dosage strength of the orally disintegrating tablets, in addition to 25-mg and 100-mg doses. Previously, FazaClo only was available in 25-mg and 100-mg doses in blister packaging. The new formulation in bottles is expected to be more convenient for health care professionals and patients, the company said, and soon will be available. Avanir acquired FazaClo through its purchase a year ago of Alamo Pharmaceuticals LLC, of Beverly Hills, Calif. On Thursday, Avanir's stock (NASDAQ:AVNR) gained 24 cents, or 19.3 percent, to close at $3.46.

• AVAX Technologies Inc., of Philadelphia, added the CEO position to President Richard Rainey's title. He joined the company in 1998 and was elected its president in 2003. AVAX is developing a universal cancer vaccine platform, with its autologous cell vaccine M-Vax in Phase III for metastatic melanoma.

• Bio-Rad Laboratories Inc., of Hercules, Calif., and Beckman Coulter Inc., of Fullerton, Calif., extended for eight years their development and manufacturing agreement in immunodiagnostic testing for blood virus and infectious disease. As part of the deal, Bio-Rad will develop new immunoassays for Beckman Coulter's UniCel and Access immunoassay systems, including hepatitis B envelope antigen and antibody, to be used as indicators of chronic hepatitis or active infection. Bio-Rad also will develop a next-generation HIV combo assay for the detection of HIV/AIDS. Financial terms were not disclosed.

• Cephalon Inc., of Frazer, Pa., will be added to the NASAQ-100 Index, effective today. That index includes 100 of the largest nonfinancial domestic and international securities listed on Nasdaq, based on market capitalization.

• Chembio Diagnostics Inc., of Medford, N.Y., and the Infectious Disease Research Institute in Seattle entered two research and development agreements to develop rapid diagnostic tests for leishmaniasis and leprosy. The tests will be developed by Chembio using its Dual Path immunoassay test platform and will incorporate its antigens.

• Critical Therapeutics Inc., of Lexington, Mass., and Dey LP, of Napa, Calif., said the FDA approved extended-release Zyflo CR (zileuton), a twice-daily leukotriene synthesis inhibitor for the prophylaxis and chronic treatment of asthma in adults and children 12 and older. Under a co-promotion agreement executed between the two companies in March, Dey will co-market the product and an already approved immediate-release formulation. On Thursday, Critical Therapeutics' stock (NASDAQ:CRTX) gained 57 cents, or 21.4 percent, to close at $3.23.

• Encysive Pharmaceuticals Inc., of Houston, said regulatory officials in Canada approved Thelin (sitaxsentan sodium) 100-mg tablets for treating primary pulmonary arterial hypertension and pulmonary hypertension secondary to connective tissue disease. The approval applies to World Health Organization functional class III patients who have not responded to conventional therapy. It also is indicated in patients with WHO functional class II who did not respond to conventional therapy and for whom no appropriate alternative can be identified. Thelin is a once-daily, oral selective endothelin A receptor antagonist. It was approved in Europe in August 2006 and in Australia in March. The drug is under review by FDA. Encysive's stock (NASDAQ:ENCY) gained 34 cents Thursday, or 9.5 percent, to close at $3.93.

• Hemispherx Biopharma Inc., of Philadelphia, said preclinical data reported at the International Conference on Avian Influenza in Paris showed that its antiviral therapeutic product candidate Alferon-LDO can combat highly pathogenic avian influenza. Results on the experimental, low-dose oral formulation of the company's Alferon-N product, which already is approved for refractory genital warts, demonstrated that it reduces the severity of pathology resulting from infection of established animal model non-human primates, macaques, by a highly pathogenic strain of avian flu.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., said European regulators expanded the approval of Vantas (histrelin acetate subcutaneous implant) in five new countries after finalizing the prostate cancer product's referral procedure. Following approval in Denmark in 2005, Indevus filed for the mutual recognition procedure in the UK, Ireland, Germany, Spain and Italy. The company plans to complete the process of obtaining final marketing authorization over the next few months and to begin the mutual recognition procedure for the remaining European Union countries.

• Lev Pharmaceuticals Inc., of New York, completed dosing ahead of schedule in the prophylactic portion of its Phase III trial of C1-esterase inhibitor (C1-INH) for hereditary angioedema (HAE). Data are anticipated in the second half of 2007, but a BLA filing is slated for this quarter based on positive data from the recently completed acute portion of the trial. The prophylactic data, if positive, would be used to expand the label. (See BioWorld Today, March 15, 2007.)

• Macroflux Corp., of Mountain View, Calif., named M. Cory Zwerling president and CEO. Macroflux was founded in October as a Johnson & Johnson Internal Ventures spinout to progress product opportunities based on Macroflux transdermal technology, which provides a needle-free solution for delivery of peptides, small molecules, proteins and vaccines.

• Medarex Inc., of Princeton, N.J., entered a collaborative research agreement with Mitsubishi Pharma Corp., of Osaka, Japan, to generate and evaluate fully human monoclonal antibodies against a Mitsubishi target for autoimmune diseases. The companies plan to use Medarex's UltiMAb Human Antibody Development System to generate antibodies for research and possible development. They will share research responsibilities for any antibodies generated through the collaboration, but other terms were not disclosed.

• Nile Therapeutics Inc., of Berkeley, Calif., appointed Peter Strumph as CEO. Strumph previously served as the senior vice president of operations for Palo Alto, Calif.-based CV Therapeutics Inc. Nile, which was created by investment group, Two River Group Holdings LLC, is in Phase I with its lead compound, CD-NP, a second-generation natriuretic peptide for heart failure.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., entered a collaboration with Dios Therapeutics Inc., of Los Angeles. Peregrine will provide process development and manufacturing services and know-how to support early clinical development of Dios' humanized monoclonal antibody for the treatment of thyroid-associated ophthalmopathy, a severe form of Graves' disease. Peregrine has the option to convert its development fees into either cash or equity in Dios. Peregrine also could receive royalties on resulting product sales, while Dios would have the option to buy out the royalty obligation for a one-time fee of up to $50 million. Dios is responsible for all third-party expenses related to manufacturing process development and preclinical and clinical trial costs. Dios was founded last year and is focused on developing non-immunosuppressing therapeutics for autoimmune indications.

• Pluristem Life Systems Inc., of New York, said its fully owned subsidiary, Pluristem Ltd., received an $830,000 research and development grant from Israel's Chief Scientist Office to support ongoing development of PLX, cells designed to be multipotent with the ability to differentiate into a variety of cell types. PLX cells are derived from mesenchymal stem cells obtained from the placenta and expanded in PluriX, the company's 3D bioreactor. The 3 percent royalty-bearing grant is part of the Israeli government's Ministry of Trade and Industry Program and is designed to help Pluristem develop its first product, PLX-1, which is aimed at resolving the global shortfall of matched tissue for bone marrow transplantation.

• Point Therapeutics Inc., of Boston, reduced its work force by about 60 percent in the wake of an FDA hold on the company's Phase III program with talabostat in non-small-cell lung cancer. The hold resulted from an interim analysis indicating that neither trial was likely to meet its endpoints. Point Therapeutics had $9 million in cash and restricted cash as of March 31 and continues to evaluate its options. (See BioWorld Today, May 22, 2007.)

• ProBioGen AG, of Berlin, agreed to license its so-called designer avian cell lines to Virbac SA, of Carros, France. Specifically, Virbac will use the permanent cell lines based on duck retina AGE1.cr and somite cells AGE1.cs as the production platform to develop biologicals. Financial terms were not disclosed.

• Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., and Wyeth, of Madison, N.J., said the FDA has accepted for review a new drug application for subcutaneous methylnaltrexone as a treatment for opioid-induced constipation in patients receiving palliative care, as have European regulators. The FDA plans to complete its review by Jan. 30. The investigational drug is a peripherally acting opioid-receptor antagonist designed to treat the condition without interfering with pain relief. The FDA's acceptance of the NDA triggered a $5 million milestone payment to Progenics by Wyeth, following a previously announced $4 million milestone payment from Wyeth based on the validation for review in the European Union.

• Qiagen NV, of Venlo, the Netherlands, entered a license and marketing agreement for the exclusive distribution of room temperature DNA storage technology belonging to Biomatrica Inc., of San Diego, for biological sample storage and sample management systems. In addition, during the course of the partnership, Biomatrica's SampleMatrix technology and Qiagen's rights are expected to be expanded for uses including the stabilization, shipping and storage of DNA molecules in blood and buccal swab samples for subsequent purification of the stabilized DNA for any kind of downstream application. Financial terms were not disclosed.

• Sequenom Inc., of San Diego, said it would provide quantitative gene expression services to the Immune Tolerance Network, a collaborative research organization that solicits, develops, implements and assesses clinical strategies and biological assays to induce, maintain and monitor tolerance in humans for kidney, liver and islet transplantation, autoimmune diseases, and allergy and asthma. Financial terms were not disclosed.

• Targeted Genetics Corp., of Seattle, said academic collaborators presented data describing a novel cell line-based method for manufacturing AAV-based vaccines. Targeted Genetics also presented a poster demonstrating the utility of an assay that can be used for testing the stability and relative potency of different lots of AAV-HIV gag-based vaccines. Data were presented at the American Society of Gene Therapy meeting in Seattle.

• Theravance Inc., of South San Francisco, said European regulators accepted an application for the marketing of its antibiotic telavancin for complicated skin and soft tissue infections in adults. Astellas Pharma Europe BV, a European subsidiary of Astellas Pharma Inc., of Tokyo, filed for approval there in April under the centralized procedure and applied for marketing clearance in the 27 European Union member states plus Iceland, Liechtenstein and Norway. The submission is based on data from two Phase III studies in which telavancin achieved its primary endpoint of non-inferiority, comparing favorably to standard therapy in clinical cure, microbiological eradication and overall therapeutic response rates. This acceptance news signals that the submission is complete and the review process has begun.

• Vical Inc., of Seattle, said a measles DNA vaccine formulated with its Vaxfectin adjuvant elicited protective levels of neutralizing antibodies in 1- to 2-year-old non-human primates, confirmed by complete protection following challenge more than one year after vaccination, and sterilizing immunity as evidenced by no clinical signs of disease and no detectable virus after challenge. In a separate study, the same vaccine elicited protective levels of neutralizing antibodies in 6-week to 10-week-old non-human primates, with no vaccine-related adverse events.

• Wyeth Pharmaceuticals, of Madison, N.J., gained FDA approval for Torisel (temsirolimus) in the treatment of advanced renal cell carcinoma. Torisel is the first specific mTOR kinase inhibitor approved and the first targeted renal cancer therapy proven to extend median overall survival vs. interferon-alpha (10.9 months vs. 7.3 months, P=0.0078). Launch is slated for July 2007, and Wyeth has agreed to submit post-marketing data on QT prolongation and hepatic impairment. Torisel also is in Phase III trials for mantle cell lymphoma.