• Abbott Laboratories, of Abbott Park, Ill., received approval from the European Commission to market Synagis for use in infants less than 2 years of age born with hemodynamically significant congenital heart disease to prevent serious lower respiratory syncytial virus. Abbott and its U.S. partner for Synagis, MedImmune Inc., of Gaithersburg, Md., received approval for expanded use in children with CHD in the U.S. in September.

• Abgenix Inc., of Fremont, Calif., and AstraZeneca plc, of London, said their oncology agreement has been successfully closed following the satisfaction of all conditions. The companies announced a collaboration, license and investment alliance to discover, develop and commercialize fully human monoclonal antibodies to treat cancer on Oct. 16. Also, Abgenix has issued convertible preferred stock to AstraZeneca for $100 million. The alliance calls for the joint discovery and development of therapeutic antibodies for up to 36 cancer targets to be commercialized exclusively worldwide by AstraZeneca. Abgenix has the potential to receive milestone and royalty payments, as well as payments for preclinical studies, early clinical research, process development and both clinical and commercial manufacturing. The deal has a total potential of up to $500 million to Abgenix. (See BioWorld Today, Oct. 17, 2003.)

• Adenosine Therapeutics LLC, of Charlottesville, Va., was awarded a Phase I Small Business Innovation Research grant from the Department of Defense in Washington. The $198,360 grant funds research to develop A2A adenosine receptor agonists as adjuncts to antibiotics for the treatment of anthrax septicemia. The company has developed a series of A2A adenosine receptor agonist compounds that in preclinical studies have been useful in treating sepsis. The grant will allow the company to determine if the mechanism of action seen in the earlier studies applies to the treatment of anthrax.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., entered a research collaboration to apply its RNA interference (RNAi)-based therapeutic technology to a discovery of a causal pathway in Parkinson's disease by researchers at the Mayo Clinic in Rochester, Minn., and the National Institutes of Health in Bethesda, Md. The findings, published in the current issue of Science, pointed to the overexpression of a specific gene, alpha-synuclein, in Parkinson's disease patients. Alnylam will identify, synthesize and provide RNAi-based drug compounds targeted to the alpha synuclein gene expression. The Mayo Clinic will test and select the compounds for their efficacy in a series of in vitro and in vivo studies. Financial terms were not disclosed.

• Biopure Corp., of Cambridge, Mass., plans to respond by June 30 to the FDA's questions regarding Biopure's biologic license application for Hemopure (hemoglobin glutamer - 250 [bovine]). Biopure has applied for FDA approval to market Hemopure as a treatment for acutely anemic adult patients undergoing orthopedic surgery and for the elimination or reduction of red blood cell transfusions in those patients. Biopure has implemented cost reductions while it completes its response. It will reduce its work force by about 30 percent and decrease forecast manufacturing expenses for fiscal 2004. The measures should save about $12 million in fiscal 2004, it said. The company is in the process of renewing a standby equity distribution agreement to provide up to $15 million as needed. Biopure's cash and anticipated Oxyglobin revenues together with the standby facility are expected to fund operations through December 2004, it said. A Hemopure Phase II cardiac revascularization trial in patients undergoing elective percutaneous coronary intervention is scheduled to begin enrolling patients in Europe this year, and a Phase II trauma trial co-sponsored by the U.S. Army and Navy is anticipated in 2004. Its stock (NASDAQ:BPUR) fell $2.37 Thursday, or 39.2 percent, to close at $3.68.

• Biosynexus Inc., of Gaithersburg, Md., demonstrated the efficacy of lysostaphin in eradicating Methicillin-resistant S. aureus as well as Methicillin-susceptible S. aureus biofilms on artificial surfaces. The findings are described in the November issue of Antimicrobial Agents and Chemotherapy. Lysostaphin is an antibacterial enzyme that has been demonstrated to kill staphylococci, it said.

• Boston Life Sciences Inc., of Boston, said it accepted the FDA's recommendations on the design of its proposed Phase III study of Altropane for differentiating Parkinsonian from non-Parkinsonian syndromes in patients with tremors. The company said the proposed study design is similar to that proposed in its first Special Protocol Assessment, with some modifications in terms of patient recruitment and statistical treatment of the data, and it plans to submit within a week a revised protocol based on the modifications discussed with the agency to seek confirmation that the study would be sufficient for approval. The study will enroll subjects who have been referred to a movement disorder clinic with the tentative diagnosis of either a Parkinsonian or non-Parkinsonian tremor made by an internist or general practitioner.

• Celgene Corp., of Warren, N.J., advanced the development of Actimid (CC-4047) an immunomodulatory drug (IMiD), into Phase II work. The multicenter two-stage, open-label trial will investigate the safety and efficacy of Actimid as a single agent in hormone-refractory prostate cancer patients. Interim data from an ongoing Phase I/II trial in relapsed and refractory multiple myeloma patients indicate that Actimid demonstrated antitumor activity.

• Curis Inc., of Cambridge, Mass., reported that the current issue of the scientific journal Neuron contains a report demonstrating that the Hedgehog signaling pathway is essential for the generation of oligodendrocytes within the central nervous system. Curis is developing small-molecule activators of the Hedgehog pathway as drug candidates for the treatment of a variety of neurological disorders.

• CytoGenix Inc., of Houston, entered an agreement with the Albert Einstein College of Medicine, Department of Oncology for studies using CytoGenix's gene silencing DNA technology against a gene that is expressed in melanoma cells. The gene produces a protein known to counteract the effect of several chemotherapeutic agents in difficult-to-treat cancers, CytoGenix said. The studies will be conducted in the laboratory of Cy Stein, professor of medicine, urology and molecular pharmacology, who also is an outside director of CytoGenix and a member of its scientific advisory board. Financial terms were not disclosed.

• Depomed Inc., of Menlo Park, Calif., said the underwriters of its recent public offering of 6.5 million shares of common stock exercised their overallotment option in full to purchase 975,000 additional shares. Last week, Depomed reported that its offering had raised about $35.8 million. The overallotment, if exercised, was expected to raise another $5.4 million. Depomed is a specialty pharmaceutical company engaged in the development of products based its oral drug delivery technologies. (See BioWorld Today, Oct. 24, 2003.)

• Dyax Corp., of Cambridge, Mass., completed the sale of its Biotage LLC separations subsidiary to Pyrosequencing AB, of Uppsala, Sweden. Dyax received about $35 million for the unit. The sale was first reported earlier this month. (See BioWorld Today, Oct. 15, 2003.)

• Elan Corp. plc, of Dublin, Ireland, is planning to offer 35 million of its ordinary shares, and its wholly owned subsidiary, Elan Capital Corp. Ltd., intends to offer $250 million in aggregate principal amount of guaranteed convertible notes. The offerings are being made outside the U.S. to non-U.S. persons. The notes, which are expected to have a term of five years, will be fully and unconditionally guaranteed by Elan and will be convertible into Elan ordinary shares or, at the option of the holder, ADSs, at conversion ratios to be determined, commencing on the 120th day following the closing of the offering. Net proceeds will be used by Elan's subsidiary, Elan Finance Corp. Ltd., to repurchase outstanding liquid yield option notes (LYONs) due 2018, including LYONs tendered for purchase at the option of the holders as of Dec. 14, 2003. Any excess proceeds are expected to be used by Elan and subsidiaries for general corporate purposes.

• Emisphere Technologies Inc., of Tarrytown, N.Y., presented six posters on the application of its eligen oral drug delivery technology at the American Association of Pharmaceutical Scientists annual meeting this week in Salt Lake City. One study, presented Monday, used an in situ single-pass intestinal perfusion model in rats to evaluate insulin absorption into the portal vein and systemic circulation following administration with an Emisphere delivery agent. The delivery agent increased insulin absorption but did not reverse the portal to systemic insulin concentration relationship.

• Encore Pharmaceuticals Inc., of Riverside, Calif., received a Phase I Small Business Innovation Research grant from the National Institutes of Health in Bethesda, Md. The $100,000 grant will further the collaborative research and development efforts between Encore researchers and scientists at Oklahoma Medical Research Foundation (OMRF). The grant will help the scientists identify natural products and natural-product-derived small molecules for use in inflammatory and degenerative neurological diseases such as Alzheimer's disease and stroke. OMRF is a nonprofit biomedical research institute.

• Genaissance Pharmaceuticals Inc., of New Haven, Conn., secured $11.1 million from two transactions with a potential for an additional investment of $4.3 million. RAM Trading Ltd., an affiliate of an existing investor, purchased 270,000 shares of newly designated Series A preferred stock at a price of $22.50 per share, totaling about $6.1 million. The proceeds will be used for working capital and general corporate purposes. The shares can be converted by RAM at any time into 2.7 million shares of common stock. The preferred stock pays an annual cash dividend of 2 percent. Genaissance also issued a warrant to RAM exercisable for an additional 190,000 shares of Series A preferred stock under the same terms until Dec. 31, 2005. If Genaissance's common stock price is above $4 for 23 consecutive business days, RAM would be required to purchase the additional shares at a specified time. If Genaissance sells the additional 190,000 shares, RAM's investment would total about $10.4 million. Also, Genaissance granted RAM certain other rights, including registration rights and certain put rights that can be exercised beginning on the third anniversary of the closing of the transaction. Genaissance also announced that on Sept. 30, 2003, it signed a three-year, $5 million term loan with Comerica Bank. The funds from that loan were primarily used to help repay all existing capital leases, substantially reducing Genaissance's annual principal and interest payments.

• Gilead Sciences Inc., of Foster City, Calif., said its board approved an amendment to its stockholders' rights plan. The original plan was implemented in 1994 and amended in 1999. The new amendment provides for, among other things, an increase in the exercise price of the rights from $100 (after adjusting for two 2-for-1 stock splits) to $400 and an extension of the term of the plan to Oct. 27, 2013.

• Hemispherx Biopharma Inc., of Philadelphia, raised about $4.1 million after closing a private placement of 6 percent senior secured convertible debentures due Oct. 31, 2005, and warrants to purchase an amount of common shares equal to 20 percent of the shares issuable upon conversion of the debentures. The debentures may be convertible into Hemispherx common stock at a price equal to the average closing price of the shares over the last 20 trading days, subject to adjustment. The warrants are exercisable at $2.32, subject to adjustment. The Oct. 28 closing price was $2.60. Cardinal Securities LLC acted as the placement agent in the transaction, which involved two institutional investors. Hemispherx said it would use proceeds to expand its Alferon N sales program in the U.S., and to finalize the process for its upcoming new drug application for Ampligen, an RNA-based compound in a Phase III study for chronic fatigue syndrome.

• LION bioscience AG, of Heidelberg, Germany, and Silicon Genetics, of Redwood City, Calif., completed their first joint products, the LION Target Engine and SRS-GeneSpring Connectors. The companies entered a multiyear joint development and marketing collaboration in June with the goal of integrating their software technologies, and completed that first step ahead of schedule. The combination of the products is expected to enable researchers to improve the speed and accuracy of their analysis.

• Medarex Inc., of Princeton, N.J., and Avalon Pharmaceuticals Inc., of Germantown, Md., entered an agreement for the companies to collaborate on the development of antibody products. The companies expect to share equally the cost and responsibility of the work and plan to jointly commercialize any resulting antibody products. Avalon has identified targets it believes are associated with cancers and Medarex plans to use its UltiMAb Human Antibody Development System to generate antibodies to them. Financial terms were not disclosed.

• MetaGen Pharmaceuticals GmbH, of Berlin, and Astex Technology Ltd., of Cambridge, UK, are merging. The merged company will operate as Astex Technology Ltd. The new company will continue work on Astex's fragment-based drug discovery and MetaGen's efforts in identifying and validating cancer targets will contribute to the effort. Financial terms were not disclosed.

• Orphan Medical Inc., of Minneapolis, licensed European sales and marketing rights for Xyrem (sodium oxybate) oral solution to Celltech Pharmaceuticals, a division of Celltech Group plc, of Slough, UK. Orphan Medical received FDA approval in July 2002 to market Xyrem as a treatment for cataplexy in patients with narcolepsy. Celltech has indicated that it expects to file a Xyrem marketing authorization application for the cataplexy indication in Europe in early 2004 and would use its specialist sales forces to market the product to a target audience of neurologists and sleep specialists. Celltech will be responsible for the registration, sales and marketing of Xyrem in Europe. Celltech has made an up-front payment of $2.5 million to Orphan Medical and could make further payments of up to $6 million tied to product development milestones and up to $7 million tied to sales-related milestones. Celltech also will pay Orphan Medical a royalty on sales of the product, which will begin no earlier than 2005. The licensing agreement includes the use of Xyrem in narcolepsy and provides Celltech with rights to negotiate in regard to other potential future indications, including fibromyalgia syndrome.

• Ortec International Inc., of New York, entered an agreement with Cambrex Bio Science Walkersville Inc., a subsidiary of Cambrex Corp., of East Rutherford, N.J., for the commercial manufacture of Ortec's tissue engineered product, OrCel. Under the terms of the six-year agreement, Cambrex will provide Ortec with manufacturing services and personnel to produce OrCel in accordance with FDA requirements. Cambrex's capacity in Walkersville, Md., is expected to meet requirements for the first 12 months following the market launch of OrCel. The contract also specifies that Cambrex will invest in additional capacity as required to meet the market demand for OrCel. Financial terms were not disclosed.

• Pharmexa A/S, of Horsholm, Denmark, and Bavarian Nordic A/S, of Copenhagen, Denmark, entered a collaborative agreement that will test the use of Bavarian Nordic's MVA-BN vector technology in combination with Pharmexa's HER-2 DNA AutoVac vaccine. The parties expect that Phase I/II trials could begin in Germany and Italy within 18 months. In the spring of 2003, Pharmexa received approval to continue into a Phase II trial with the HER-2 DNA AutoVac vaccine from the UK and Denmark. In addition to testing HER-2 AutoVac MVA-BN directly in patients, the parties also expect to test another possibility where HER-2 AutoVac MVA-BN will be combined in a way to stimulate the immune system.

• Repligen Corp., of Waltham, Mass., published in Psychopharmacology a study that documents that secretin inhibits anxiety in a well-recognized animal model. In the model, secretin decreased the level of expression of the startle response in rats in response to fear, a response known to be dependent on a brain structure called the amygdala. Previous studies have established that activity in the model is correlated with anxiolytic activity in patients. The study also provides additional evidence that secretin modulates the activity of the amygdala, which is part of a neural network implicated in the acquisition and expression of emotional and social behaviors, including fear and anxiety. Repligen is currently conducting two Phase III trials of secretin in autism and plans to initiate a Phase II study in schizophrenia later this year.

• Targacept Inc., of Winston-Salem, N.C., reported the completion of two randomized, double-blind, placebo-controlled, Phase I trials for its neuronal nicotinic receptor agonist compound, TC-1734, in development for the treatment of cognitive and memory disorders. The first trial was a single rising-dose trial conducted in 48 healthy volunteers. The second trial was a multiple rising-dose trial conducted in 24 healthy volunteers. TC-1734 was designed by Targacept using Pend, its in silico drug discovery engine.

• Telik Inc., of Palo Alto, Calif., reported plans to offer 6 million shares of stock in an underwritten public offering under its existing shelf registration statement. Five million of the shares are expected to be offered by the company, and 1 million shares are expected to be offered by a corporate selling stockholder. In addition, the underwriters will have an option to purchase from the company up to an additional 900,000 shares to cover overallotments.

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