• Abgenix Inc., of Fremont, Calif., received a Drug Manufacturers License from California's Food & Drug Branch. The license allows Abgenix to manufacture and ship clinical material from its biologics manufacturing facility in Fremont. Abgenix's facility features four 2,000-liter and two 12,000-liter bioreactors, and is built to comply with both FDA and international biologics manufacturing regulations.

• Affymetrix Inc., of Santa Clara, Calif., expanded an agreement with bioMerieux Inc., of Durham, N.C., to develop tests in infectious disease and industrial testing to verify the authenticity and origin of food and animal feed. bioMerieux will have nonexclusive access to Affymetrix's GeneChip probe arrays for the determination of virulence factors, bacterial strain typing, and sepsis diagnosis, among other things. bioMerieux also gained rights in fields outside bacteriology to develop new assays for hepatitis B virus, respiratory and central nervous system infectious panels. bioMerieux will launch the first product this quarter. Affymetrix will receive up-front and milestone payments and royalties for all resulting products. Separately, Affymetrix entered a services agreement, whereby Paradigm Genetics Inc., of Research Triangle Park, N.C., will provide microarray-processing services using GeneChip technology. Also, the companies signed an agreement that provides Paradigm the right to use Affymetrix technologies for internal research. Also, Affymetrix agreed to license certain patents to Spectral Genomics Inc., of Houston, to manufacture and sell spotted DNA arrays for use in the research market. Financial terms were not disclosed.

• AlphaVax Inc., of Research Triangle Park, N.C., received a $16.8 million contract from the National Institute of Allergy and Infectious Diseases, a unit of the National Institutes of Health in Bethesda, Md., to support the development of an HIV vaccine. The five-year contract extends support AlphaVax has received for its HIV vaccine program from the institute, including $5.5 million awarded last year under a two-year cooperative agreement. Three weeks ago, the company received $16.6 million in contract funding from the institute to develop vaccines against botulinum neurotoxins and equine encephalomyelitis viruses over four-and-a-half years. (See BioWorld Today, Sept. 30, 2003.)

• Arena Pharmaceuticals Inc., of San Diego, said the Biotechnology Value Fund LP and certain of its affiliates accepted Arena's offer to purchase 3 million shares of Arena stock for $7.69 per share in cash. As a result of the acceptance, the standstill and certain other provisions under a stockholders agreement will be extended until Dec. 31, 2004. Arena develops drugs that act on G protein-coupled receptors.

• Avigen Inc., of Alameda, Calif., said it received an endorsement to begin a clinical trial of AV201 for advanced Parkinson's disease from the Recombinant DNA Advisory Committee of the National Institutes of Health in Bethesda, Md. The committee suggested minor protocol amendments to strengthen the methodology, but was satisfied with Avigen's preclinical work supporting the safety and rationale for clinical testing, the company said. The Phase I study is designed as an open-label, dose-escalation safety trial of the gene therapy product.

• Axaron Bioscience AG, of Heidelberg, Germany, named Friedrich Christ chairman. A senior vice president of BASF AG, he succeeds Klaus Jürgen Böhm, whose term expired. Axaron uses functional genomics and proteomics technology platforms to develop therapies for neurodegenerative diseases.

• Baxter Healthcare Corp., of Deerfield, Ill., completed its acquisition of certain assets from Alpha Therapeutic Corp., of City of Industry, Calif., including Aralast alpha-1 antitrypsin therapeutic. The company said the alpha-1 proteinase inhibitor, which received FDA approval last December for hereditary emphysema, would produce modest sales next year but could grow to about $200 million per year within the next five years. Concurrent with the acquisition, Baxter sold three plasma collection centers, a central testing laboratory and certain other assets acquired from Alpha, and is closing 38 U.S. plasma collection centers included in the deal. After the transaction closed, Baxter sold Alpha Therapeutic to Accredo Therapeutics Inc. and Hemophilia Health Services Inc., wholly owned subsidiaries of Accredo Health Inc., of Memphis, Tenn. The company provides pharmaceutical care for patient populations, including those requiring intravenous immunoglobulin and blood-related disorders such as hemophilia. Financial terms were not disclosed.

• BioSource International Inc., of Camarillo, Calif., reported that Terrance Bieker was elected president and CEO, as well as a board member. Bieker previously served as CEO of Axya Medical and president and CEO of Transfusion Technologies Corp. BioSource is focused on providing solutions in the areas of functional genomics, proteomics and drug discovery.

• BioTrove Inc., of Woburn, Mass., said that its chief operating officer, Robert Ellis, was named president and CEO. BioTrove's founding CEO, Colin Brenan, becomes chief technology officer and senior vice president, research and engineering development. Before joining BioTrove in May 2003, Ellis was executive vice president of Affymetrix Inc., of Santa Clara, Calif. BioTrove is focused on leveraging revolutionary micro- and nanoscale engineering solutions to overcome current bottlenecks in pharmaceutical drug discovery and biotechnology.

• Celera Diagnostics, of Alameda, Calif., entered a research collaboration with Merck & Co. Inc., of Whitehouse Station, N.J., to identify and validate genetic markers for selected cancers. Celera Diagnostics gained access to certain gene expression data and intellectual property of Merck through its wholly owned subsidiary, Rosetta Inpharmatics LLC. Merck gained access to selected research data from Celera Diagnostics for use in developing cancer therapeutics. While the collaboration initially is focused on breast cancer, it could extend into other cancers. Additional terms were not disclosed.

• Cell Therapeutics Inc., of Seattle, is reducing the dose of Xyotax from 235 mg/m2 to 175 mg/m2 in its pivotal STELLAR 4 trial for non-small-cell lung cancer, following a planned safety analysis by an independent data monitoring committee. The change was based on a small percentage of study patients who appeared to develop first- or second-cycle neutropenic-related toxicities, which the company said might be prevented by a lower dose. The 175-mg/m2 dose was well tolerated in prior Phase II studies in more than 135 patients. All enrolled patients will continue treatment at the lower dose, while the comparator arm dosages will continue according to protocol. The study's targeted completion of enrollment remains unchanged for the end of the first quarter of next year. Cell Therapeutics' stock (NASDAQ:CTIC) fell $1.67 Monday, or 15.6 percent, to close at $9.06.

• Celltrion Inc., of South San Francisco, contracted Emerson Process Management, a business of Emerson, to automate Celltrion's large-scale biopharmaceuticals manufacturing facility in Inchon, South Korea. Celltrion, a joint venture between VaxGen Inc., of Brisbane, Calif., and a group of Korean partners, is building the 215,000-square-foot facility to manufacture VaxGen's AIDS vaccine candidates and other biopharmaceutical products.

• Debiopharm SA, of Lausanne, Switzerland, reported that it would start a Phase II trial this year, for dose-finding and efficacy assessment of a once-daily oral formulation of ZT-1, a cholinesterase inhibitor being developed at Debiopharm for Alzheimer's disease (AD). The multicenter trial is expected to enroll 180 patients suffering from mild to moderate AD. ZT-1's dual pharmacological mechanism of action offers the potential to slow deterioration, while improving cognitive function. ZT-1 also has neuroprotective properties, one of them being mediated possibly by the N-methyl-D-aspartate receptor.

• Discovery Partners International Inc., of San Diego, expanded its collaboration with Inspire Pharmaceuticals Inc., of Durham, N.C., to optimize lead compounds in the P2 receptor family. Within the family, Inspire's primary focus has been P2Y2 receptors, from which it has four active clinical programs, though the company also is pursuing non-P2Y2 receptors that show therapeutic promise. Financial terms were not disclosed.

• Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc., of Chadds Ford, Pa., received approvable letters from the FDA for both oxymorphone extended-release and immediate-release tablets. The agency requested that the company conduct additional clinical trials to further confirm the products' safety and efficacy in order to provide additional clarification and information. The extended-release formulation was developed in partnership with Penwest Pharmaceutical Co., of Danbury, Conn. Endo's stock (NASDAQ:ENDP) fell $4.78 Monday, or 23.9 percent, to close at $15.19.

• Flamel Technologies SA, of Lyon, France, said the waiting period expired related to its previously reported agreement with Bristol-Myers Squibb Co., of New York, to develop and market Basulin, a controlled-release, unmodified human insulin to be developed as a once-daily injection for patients with Type I or Type II diabetes. The clearance eliminates the remaining condition to the agreement and will result in a $20 million up-front payment from BMS to Flamel within 15 days. (See BioWorld Today, Aug. 28, 2003.)

• Genetronics Biomedical Corp., of San Diego, entered an agreement with Vical Inc., also of San Diego, which gained an option to a worldwide exclusive license for the use of Genetronics' in vivo electroporation delivery technology in combination with Vical's vaccine and therapeutic DNA technology for undisclosed targets. Upon completion of a collaborative research program, the partnership could lead to a definitive licensing agreement encompassing multiple indications with the potential for commercialization, the companies said. Financial terms were not disclosed.

• Genomic Solutions Inc., of Ann Arbor, Mich., signed an equipment manufacturing distribution agreement with Nonlinear Dynamics Ltd., of Newcastle Upon Tyne, UK. Nonlinear will supply products to anaylze 2D electrophoresis gels to Genomics Solutions, which will be exclusively distributed under the Investigator HT Analyzer brand. Genomic Solutions, a subsidiary of Harvard Bioscience Inc., will distribute Nonlinear's 1D electrophoresis gel analysis product under the same trade name. Financial terms were not disclosed.

• Genzyme Corp., of Cambridge, Mass., reported positive preliminary data from a Phase II trial of tolevamer sodium, an investigational polymer therapy for patients with Clostridium difficile-associated diarrhea. The 289-patient study, conducted at 58 sites in the U.S., Canada and the UK, showed that tolevamer met its primary endpoint - non-inferiority to vancomycin with respect to time to resolution of diarrhea - at the 6-gram dose level, was similar to vancomycin in median days to resolution of diarrhea, and had a risk ratio relative to vancomycin of 0.98. Genzyme, which declared the compound ready to enter a Phase III program, said it would seek a partner to jointly advance development and commercialization. It said it would report final data at a medical conference next spring.

• Meridica Ltd., of Cambridge, UK, entered an agreement with Pfizer Inc., of New York, which licensed Meridica's dry-powder inhaler, Xcelovair, to support the development and commercialization of its inhaled compounds for respiratory diseases. Pfizer will make an undisclosed up-front payment, followed by further milestone and royalty payments, to Meridica. Pfizer also is taking an equity stake in Meridica.

• Pharmacopeia Inc., of Princeton, N.J., entered an agreement with Neurocrine Biosciences Inc., of San Diego, to identify lead compounds from a portion of Pharmacopeia's collection of more than 7 million drug-like compounds. Pharmacopeia will receive undisclosed funding for small-molecule discovery research in identifying leads against selected Neurocrine targets. It will be entitled to additional payments upon certain milestones, plus royalties upon the commercialization of any resulting drugs. More specific financial terms were not disclosed.

• Prima Biomed Ltd., of Melbourne, Australia, said its Arthron Pty. Ltd. subsidiary showed that a receptor it is targeting is reponsible for the release of inflammatory chemicals responsible for rheumatoid arthritis. Arthron demonstrated that activation of its target, the Fc receptor on white blood cells, is a major release source of tumor necrosis factor alpha.

• Quantum Dot Corp., of Hayward, Calif., said data published in the Oct. 17, 2003, issue of Science showed that French researchers used the company's quantum dots to track the movements of individual glycine receptor molecules in the membranes of living cells. The company added that the results mark the first time researchers have been able to track single-molecule properties in living cells for extended periods within a single experiment.

• Rigel Pharmaceuticals Inc., of South San Francisco, discovered peptides with antiproliferative activity from a functional screen using retroviral-delivered random peptide libraries. The results appeared in two related scientific papers co-authored by Rigel researchers and published in the October issue of Chemistry & Biology. The peptides discovered exhibited dose-dependent antiproliferative effects on tumor cells while showing no signs of cytotoxicity, the company said.

• Salix Pharmaceuticals Ltd., of Raleigh, N.C., entered an agreement with Chong Kun Dang Pharmaceutical Corp., of Seoul, South Korea, to market Salix's Colazal for mild to moderate ulcerative colitis in that country. Chong Kun Dang said it would apply for product approval as soon as possible, with launch plans scheduled for the second half of 2005. Salix also will have a first right of negotiation for Chong Kun Dang's gastrointestinal products available for commercialization in the U.S. Financial terms were not disclosed.

• SkyePharma plc, of London, said it welcomed the report by its partner, GlaxoSmithKline plc, of London, that the FDA approved an additional therapeutic indication for Paxil CR for the treatment of social anxiety disorder. Paxil is approved and on the market in the U.S. for the treatment of depression, panic disorder and, most recently, premenstrual dysphoric disorder. SkyePharma developed the controlled-release formulation used in Paxil CR and receives royalties on GSK's sales.

• Takeda Pharmaceuticals North America Inc., of Lincolnshire, Ill., reported preclinical data at the American Neurological Association meeting in San Francisco, showing that ramelteon (formerly TAK-375) has no affinity for either GABA or opiate receptors. The studies examined the effects of combinations of ramelteon, a compound in a new class of drugs known as selective Ml-1 receptor agonists, to exogenous melatonin, and benzodiazepine, opiate, and ML-2 receptor agonists on sleeping behavior, learning abilities, memory, motor coordination and abuse potential in different animal models. The company is developing ramelteon for transient and chronic insomnia.

• Vasogen Inc., of Mississauga, Ontario, filed a preliminary short-form shelf prospectus with the securities regulatory authorities in the provinces of Canada and a corresponding registration statement with the SEC on Form F-10. Once the prospectus is cleared and the shelf registration statement becomes effective, the filings would provide the potential offering of up to an aggregate of $10 million of the company's common shares, from time to time, in one or more offerings.

• Vical Inc., of San Diego, said it entered a Cooperative Research and Development Agreement with the Vaccine Research Center of the National Institutes of Health in Bethesda, Md., for the development and preclinical evaluation of DNA vaccines against the West Nile virus. The agreement provides an option for Vical to secure exclusive commercialization rights to West Nile virus technology developed under the arrangement.

• XOMA Ltd., of Berkeley, Calif., reported the exercise of the underwriters' option to purchase about 1.4 million common shares to cover overallotments, raising an additional $10.8 million. The exercise of the option increases the total gross proceeds of the offering from $72 million to $82.8 million. XOMA intends to use proceeds for general corporate purposes, including research and development projects, the development or acquisition of new products or technologies, equipment acquisitions, general working capital and operating expenses. (See BioWorld Today, Sept. 12, 2003.)

• Zonagen Inc., of The Woodlands, Texas, said its board approved a Dutch Auction tender offer to purchase up to about 9.8 million shares of its outstanding common stock at a per-share price no greater than $2.10 and not less than $1.83. Zonagen will pay no more than an aggregate of $18 million for all tendered shares, which will result in it retaining about $4 million in cash or more following the proposed tender offer. Zonagen will select the lowest purchase price that will allow it to purchase the lesser of all the shares tendered prior to the expiration date or a number of shares with an aggregate purchase price of $18 million. If more shares are tendered than Zonagen can purchase for $18 million, Zonagen will first purchase all shares held by stockholders with less than 1,000 shares and then buy the remaining shares on a pro rata basis. The offer remains subject to at least 30 percent of the shares being tendered, among other things. Its stock (NASDAQ:ZONA) gained 20 cents Monday, or 12.1 percent, to close $1.86.

No Comments