• Anika Therapeutics Inc., of Woburn, Mass., signed an exclusive worldwide development and commercialization partnership for its hyaluronic acid-based cosmetic tissue augmentation (CTA) therapy with the Ortho Neutrogena Division of Ortho-McNeil Pharmaceutical Inc., a unit of Johnson & Johnson, of New Brunswick, N.J. CTA is under development for the correction of dermal defects and lip augmentation. Anika will receive an initial payment of $1 million with additional milestone payments to be made upon receipt of final marketing approval from the FDA and European regulatory authorities, as well as upon achievement of other sales and development targets. The agreement also provides royalties and transfer payments for the supply of CTA products.

• Arena Pharmaceuticals Inc., of San Diego, began a Phase Ib trial of APD356, its 5-HT2C selective anti-obesity compound. The double-blinded, placebo-controlled, dose-escalation, multiple-dose study is designed to evaluate safety at steady state drug levels during 14-day repeated daily dosing. It is enrolling healthy, overweight and obese volunteers, and should be completed in the second half of this year. If the results support further testing, the company expects to launch a Phase II trial in overweight and obese patients by the end of the year.

• Avant Immunotherapeutics Inc., of Needham, Mass., will receive $2.8 million from the Defense Department for its continued development of an oral combination vaccine to protect against anthrax and plague. The company expects the dedicated funding, which supports work that began in January 2003, to help fund the clinical development phase of the combination vaccine, as well as pilot vaccine production. Avant's stock (NASDAQ:AVAN) fell 22 cents Monday, or 11.7 percent, to close at $1.66.

• Biogen Idec Inc., of Cambridge, Mass., and Elan Corp. plc, of Dublin, Ireland, said the FDA accepted their biologics license application for Antegren (natalizumab). Last month, the agency designated the product for priority review and accelerated approval for the treatment of multiple sclerosis. As a result, the companies expect FDA action about six months from the submission date.

The Blanchette Rockefeller Neurosciences Institute in Morgantown, W.V., said its researchers and their collaborators published findings in the current edition of the Proceedings of the National Academy of Sciences detailing the therapeutic effects when the drug bryostatin was given to transgenic mice bred to develop Alzheimer's disease. They showed reduced degeneration of neurons, and the rate of premature death was reduced. Bryostatin is used as a cancer-fighting agent.

• Boston Life Sciences Inc., of Boston, filed an investigational new drug application with the FDA for the use of Axosine to enhance motor function recovery after stroke. The IND includes a proposed Phase I study protocol to test the safety of the drug administered to stroke patients for 28 days by continuous infusion into one of the fluid compartments of the brain. It is designed to enroll 27 moderate to severe stroke patients and calls for a dose-escalation of Axosine given to three groups of patients.

• Celera Genomics Group, of South San Francisco, received a milestone payment from Merck & Co. Inc., of Whitehouse Station, N.J., under the companies' cathepsin K inhibitor collaboration. The payment stems from Merck's advancement of a cathepsin K inhibitor into a Phase I trial for osteoporosis. If it or others developed under the agreement are successfully developed and advanced toward commercialization, Celera would receive additional milestone payments and royalties on net sales.

• Cell Therapeutics Inc., of Seattle, completed enrollment in the STELLAR 2 pivotal trial of Xyotax (paclitaxel poliglumex). One of three Phase III studies the company is conducting in non-small-cell lung cancer. Its primary objective is to determine if the drug improves the duration of patient survival when compared to docetaxel. Cell Therapeutics said it would focus on completing the trials to prepare for a projected new drug application filing and potential launch next year.

• CellFactors plc, of Cambridge, UK, entered administration following its failure to raise additional equity finance. Stephen Hull and John Twizell of Geoffrey Martin & Co. were appointed as the company's joint administrators. CellFactors has raised a total of £7 million (US$12.9 million) since its 1997 founding. Its lead product is Skeletex, a biological matrix derived from human cells designed to induce vascularized bone growth.

• Cobalis Corp., of Irvine, Calif., said it plans to conduct Phase II trials to test its anti-allergy product, PreHistin, as a preventative and treatment for migraine. Prior clinical research has shown that PreHistin demonstrated an ability to mediate IgE synthesis, the company said, adding that the common migraine might be dependent on serum IgE (immunoglobulin E) levels. Cobalis is planning to begin Phase III trials of PreHistin for the prevention of seasonal allergies.

• Corautus Genetics Inc., of Atlanta, closed on $5 million of the convertible debt facility made available by Boston Scientific Corp., of Natick, Mass., under their year-old loan agreement. The convertible debt facility provides for borrowing an aggregate of up to $15 million upon the satisfaction of certain milestones. Corautus will be entitled to an additional $2.5 million of debt proceeds from Boston Scientific upon treatment of the first patient in its upcoming Phase IIb trial for severe cardiovascular disease.

• Corixa Corp., of Seattle, entered a manufacturing and supply agreement with GlaxoSmithKline plc, of London, covering the production of Corixa's flagship adjuvant, monophosphoryl lipid A, or MPL. The product is a component in GSK's adjuvant systems used in the development of future vaccines currently undergoing clinical trials or awaiting regulatory approval. The agreement, which runs through 2012, guarantees payment to Corixa for supplying GSK with increasing annual quantities of MPL peaking in 2008 at the current maximum output of Corixa's MPL manufacturing facility. Corixa agreed to expand MPL production capacity in association with anticipated approvals of GSK vaccines that contain MPL adjuvant.

• Cyclacel Group plc, of Dundee, Scotland, postponed its initial public offering on Nasdaq and London stock exchanges because of market conditions. The company, which is developing drugs for cancers and other serious disorders, completed a $39 million private placement in January and intends to continue its business strategy as an unlisted company. It registered for the IPO earlier this month. (See BioWorld Today, July 6, 2004.)

• Generex Biotechnology Corp., of Toronto, received $3 million in equity financing through a private placement of common stock and warrants, including $1.75 million announced earlier this month. The investors purchased units of securities for $1.22 apiece; each unit consists of one common share and a warrant exercisable for 0.8 shares. The exercise price of the warrants is $1.68 per share. The investors also received additional investment rights. Generex, which develops drug delivery systems and technology, is required to register the shares issued in the private placement, as well as the shares issuable upon exercise of the warrants and the additional investment rights.

• ImClone Systems Inc., of New York, was downgraded by Smith Barney Citigroup on concerns over royalty payments ImClone must make to its partners related to the cancer drug Erbitux. The company's stock (NASDAQ:IMCL) fell $9.62 Monday, or 14.6 percent, to close at $56.42.

The Institute for Therapeutic Discovery in Albany, N.Y., said it is renewing its capital-raising efforts to fund its efforts to discover and develop therapeutic agents for chronic diseases. The not-for-profit organization said such agents are derived from naturally occurring molecules and are administered in low doses. Its low-level antibody therapy has shown promise for treating diabetes and other diseases that have an immune system component, including several types of dementia.

• ISTA Pharmaceuticals Inc., of Irvine, Calif., said the FDA accepted its new drug application for Xibrom (bromfenac sodium ophthalmic solution) 0.1 percent. The twice-daily, topical, non-steroidal, anti-inflammatory solution initially is being developed for ocular inflammation, eye pain and photophobia following cataract surgery. The company submitted the NDA two months ago. (See BioWorld Today, May 26, 2004.)

• Kinexus Bioinformatics Corp., of Vancouver, British Columbia, said findings to be published in the September 2004 issue of the Journal of Biological Chemistry validate its approach for protein kinase drug target discovery. In partnership with the Brain Research Centre at the University of British Columbia, Kinexus used its Kinetworks phosphoprotein profiling service to discover a new phosphorylation site on the abundant nuclear protein B23. The phosphorylation event was shown to be necessary for the duplication of centrosomes. Polo-like kinase-1 (PLK1) was identified as the principal protein kinase that carried out B23 phosphorylation at the site. The research also resulted in the development of an assay to screen for PLK1 inhibitory compounds that could serve as cancer drug candidates.

• Kosan Biosciences Inc., of Hayward, Calif., began a Phase Ib trial to evaluate KOS-862 (Epothilone D) with carboplatin in cancer patients with advanced solid tumors. The combination will be administered in a dose-escalating fashion to establish the maximum tolerated dose, pharmacokinetics, safety and potential clinical benefit of the drugs given together. They will be administered by intravenous infusion once a week for two out of every three weeks. Once the recommended Phase II doses are defined, additional patients will be treated to characterize the combination's tolerability, pharmacokinetics and potential clinical benefit.

• MedImmune Inc., of Gaithersburg, Md., said the FDA approved a new liquid formulation of Synagis (paliviz-umab). In 1998, the agency approved the monoclonal antibody's original formulation to prevent serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk of RSV disease. The liquid version offers improved convenience over the original freeze-dried preparation that is reconstituted with sterile water. MedImmune plans to end production of the current formulation in October for the U.S. and begin manufacturing liquid Synagis, which should be available for use in the U.S. for the 2005-2006 RSV season, it said.

• Microbix Biosystems Inc., of Toronto, signed a contract to develop a portfolio of recombinant adenoviruses for use with sub-cellular imaging systems from GE Healthcare, of Chalfont St. Giles, UK. Microbix's work will deal with the IN Cell Analyzer 3000 and IN Cell Analyzer 1000.

• Mylan Laboratories Inc., of Pittsburgh, said it would pay about $4 billion to acquire King Pharmaceuticals Inc., of Bristol, Tenn. The stock-for-stock transaction calls for King shareholders to receive 0.9 Mylan common shares for each outstanding common share of King, which are valued at about $16.66 per share, based on Mylan's July 23 closing price. Both companies' boards have approved the deal, which Mylan said combines its generic business with King's branded specialty pharmaceutical operations to create the second largest pharmaceutical company based on the number of U.S. prescriptions dispensed.

• Onconova Therapeutics Inc., of Princeton, N.J., began enrollment in its Phase I trial of ON 01910.Na, an investigational antitumor agent. The product is the first in a new class of non-ATP competitive kinase inhibitors that can discriminate between cancerous and normal cells by targeting specific checkpoints in the cell cycle, it said. The study, which will evaluate data from up to 28 patients, is designed to measure the safety of ON 01910.Na when administered intravenously to patients with advanced and metastatic cancers.

• Ruxton Pharmaceuticals Inc., raised $5.2 million in its Series A financing. The company said it would use the proceeds to identify and prepare drugs for clinical studies; it is focused on discovering, developing and marketing drugs for neurodegenerative diseases. Domain Associates, New Enterprise Associates and Aberdare Ventures co-led the financing.

The Scripps-PARC Institute for Advanced Biomedical Sciences, a joint venture of the Palo Alto Research Center in Palo Alto, Calif., and The Scripps Research Institute in La Jolla, Calif., launched a drug discovery technology called a nanocalorimeter to allow researchers to measure the level and nature of chemical activity of pharmaceutical prototypes.

• Titan Pharmaceuticals Inc., of South San Francisco, said the U.S. Department of Veterans Affairs began a 150-patient Phase II study of DITPA (3,5-diiodothyropropionic acid), Titan's agent in development for congestive heart failure. Patients in the study will be treated with DITPA or placebo for six months. In addition to safety, endpoints include change in the New York Heart Association class and change in global clinical assessment. The study is funded by a $3.8 million grant from the Department of Veterans Affairs Cooperative Studies Program.

• TolerRx Inc., of Cambridge, Mass., said it withdrew its registration statement for an initial public offering because of difficult market conditions. TolerRx, which is developing products for immune-mediated diseases such as Type I diabetes, psoriasis and hemophilia A, registered for the offering 11 months ago, seeking $75 million at the time. (See BioWorld Today, Aug. 28, 2003.)

• Transkaryotic Therapies Inc., of Cambridge, Mass., completed enrollment in a Phase I/II study to evaluate the safety and clinical activity of GA-GCB, its investigational enzyme-replacement therapy for Gaucher's disease. The company, which said the open-label study enrolled 12 patients from several countries, expects to release top-line data in the second half of next year.

• Vical Inc., of San Diego, received a $1.2 million milestone payment from Gencell SAS, a wholly owned subsidiary of Aventis SA, of Strasbourg, France, under the companies' license agreement for certain cardiovascular applications of Vical's DNA delivery technology. Under the June 2000 pact, Gencell is developing plasmid-based delivery of Fibroblast Growth Factor 1 as a potential treatment for peripheral arterial disease and other indications characterized by blood vessel blockage. Gencell is conducting double-blinded, placebo-controlled Phase II trials in the U.S. and Europe.

• Weill Cornell Medical College in New York said findings published in the July 29, 2004, issue of The New England Journal of Medicine detail its researchers' discovery of a genetic mutation that causes muscle protein dysfunction and is linked to a crippling muscle disorder called trismus-pseudocamptodactyly syndrome and a heart tumor called a myxoma. They found a change in one amino acid in a gene for a muscle protein called perinatal myosin. The mutation appears to undermine myosin's role in normal muscle growth in a developing fetus. Relative to the formation of the heart tumor, the researchers said it is possible that the mutation promotes survival of embryonic cells that are still able to divide in an adult heart.

• Y's Therapeutics Co. Ltd., of Tokyo, said it submitted applications to German regulatory authorities to begin Phase II trials of its two most advanced projects, YSIL6 for rheumatoid arthritis and YSTH2 for asthma. Both studies are randomized, double-blinded, placebo-controlled, dose-ranging, multinational, multicenter trials designed to test the small molecules' safety and efficacy for their respective indications. The privately held company also said it would establish two subsidiary companies in Germany and the U.S.

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