¿ Abbott Laboratories Inc., of Abbott Park, Ill., said the waiting period expired under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 applicable to Abbott¿s pending acquisition of Vysis Inc., of Downers Grove, Ill. The expiration of the waiting period satisfies a condition to consummation of the pending acquisition. The two companies announced on Oct. 24 that they entered into a definitive agreement for Abbott to acquire Vysis, a genomic disease management company that develops and markets clinical laboratory products, which provide information critical to the evaluation and management of cancer, prenatal disorders and other genetic diseases. (See BioWorld Today, Oct. 25, 2001.)
¿ AltaRex Corp., of Waltham, Mass., issued 7.2 million common shares and 7.2 million warrants upon the exercise of special units of the company, pursuant to a final prospectus filed with authorities in Canada. The units were sold in a private placement completed Oct. 31 at a price of C$1.75 (US$1.09) per unit. Each warrant is exercisable for a period of 24 months at a price of C$2 into one common share. The net proceeds of C$11.2 million are being used primarily for the continued funding of OvaRex MAb.
¿ Antisoma plc, of London, said its in-licensed vascular targeting agent, DMXAA, is able to enhance the impact of radiotherapy on tumors in animal models. Work carried out by scientists in Denmark and the United States also showed that the therapy is effective against tumors when given on its own. The research was published in the journal Radiation Research.
¿ American Biogenetic Sciences, of New York, said it negotiated a 10-year agreement with the Ministry of Health of the Russian Federation. The agreement covers human vaccines for anthrax, smallpox, botulism and other diseases. A second agreement with the Russian Agricultural Academy extends ABS¿s rights for livestock vaccines. The agreements govern vaccine distribution to specified global territories including North America, South America, the European Community and the Pacific Rim. In a release of its own, The Nasdaq Stock Market said it halted trading in ABS at 10:21 a.m. EST to request additional information on the news from the company. At the time of halting, ABS¿s stock (NASDAQ:MABA) was up 38 cents Monday, or about 109 percent, at 73 cents.
¿ Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, received clearance from the Health Canada Therapeutic Products Directorate to extend its study to assess the safety and efficacy of Paxceed, its systemic formulation of Micellar Paclitaxel, in the treatment of secondary progressive multiple sclerosis (SPMS) for another year. Approximately 100 patients will be enrolled, and all patients treated in Phase II will have the option of continuing treatment. To date, there have been no drug-related unexpected or serious adverse events. Patients in the one-year, open-label, extended study will receive a 75 mg/m(2) dose every four weeks for a total of 12 doses. Patients will receive premedication only prior to the first three treatments. Separately, Angiotech and Alcon will end their collaboration to develop therapeutic implants for the treatment of proliferative ophthalmic conditions. To date, the lead formulation developed in the collaboration has not met performance criteria.
¿ AnorMED Inc., of Vancouver, British Columbia, said AstraZeneca plc, of London, gave notice of its intention to discontinue its development of ZD0473 and return all rights for the product candidate to AnorMED. Results from studies, specifically in ovarian and lung cancer patients who have previously failed a platinum-based therapy, indicated the product does not meet the differential profile required by AstraZeneca, particularly in overcoming platinum resistance. AnorMED said its plans for ZD0473 will proceed once the transfer of clinical data is completed and following consultation with a clinical advisory board in conjunction with relevant market analyses. (See BioWorld Today, Sept. 4, 2001.)
¿ BioTissue Technologies AG, of Freiburg, Germany, said a research team created living cultures from periosteum samples from patients and implanted them in the upper jaw of the first patients. BioTissue said it has a world patent to grow bones in this way. The advantage of the method of treatment with the BioSeed Oral Bone autologous bone replacement product is that the body¿s own bone tissue is used so that the implant is not rejected.
¿ Cambridge Antibody Technology Group plc, of Melbourn, UK, and Lonza Biologics Ltd., of Basel, Switzerland, signed a long-term agreement for Lonza to manufacture and supply clinical-grade antibody drugs to CAT for up to five years. The agreement builds on the existing relationship between the companies and will guarantee Cambridge Antibody has access to manufacturing capacity for both ongoing and future projects, the companies said. Financial details were not disclosed.
¿ Cell Genesys Inc., of Foster City, Calif., and the pharmaceutical division of Japan Tobacco, of Tokyo, modified their collaboration for GVAX cancer vaccines. The companies had a 50-50 worldwide profit-sharing arrangement for GVAX prostate and lung cancer vaccines. Now, Japan Tobacco will pay Cell Genesys an undisclosed royalty on GVAX lung cancer vaccine sales in Japan, Taiwan and Korea, and Cell Genesys will pay Japan Tobacco the same royalty on sales in North America and the rest of the world. The companies will continue to share equally in the development costs of GVAX lung cancer vaccine products and Japan Tobacco will still pay Cell Genesys milestone payments. The original deal was signed in 1998 had a total net worth of up to $153 million. (See BioWorld Today, Dec. 21, 1998.)
¿ DGI BioTechnologies Inc., of Edison, N.J., received a milestone payment from Novo Nordisk A/S, of Bagsvaerd, Denmark, as a result of a collaboration established in 1999 for the discovery of small-molecule mimics for insulin. DGI said it used its drug discovery platform, Diogenesis, to identify and simplify the interaction between insulin and its receptor. Financial details were not disclosed.
¿ NeoPharm Inc., of Lake Forest, Ill., said its tumor-targeting agent, IL13-PE38, was granted orphan drug status by the FDA for the treatment of malignant glioma. NeoPharm exclusively licensed IL13-PE38 from the National Cancer Institute and the FDA and is developing the compound under a Cooperative Research and Development Agreement with the FDA.
¿ Eli Lilly and Co., of Indianapolis, received FDA approval for Xigris (drotrecogin alfa) for patients with sepsis who have a high risk of death. The company plans to launch the drug in the U.S. within days. The approval was based on the results of PROWESS, an international Phase III trial, which were published in the March 8 issue of the New England Journal of Medicine. The relative risk of death was reduced by nearly 20 percent in the 1,690-patient trial. Mortality rates were 25 percent among drotrecogin alfa (activated) patients vs. 31 percent among patients with placebo (p=0.005). Lilly is seeking post-approval trials, including a study in adult sepsis patients with a lower risk of death and in pediatric patients with severe sepsis. Lilly in October got a mixed review from an FDA panel and then received an approval letter from the agency. (See BioWorld Today, Oct. 17, 2001, and Oct. 30, 2001.)
¿ Ethypharm SA, of Paris, said its oral microgranule formulation of morphine sulfate is due to be launched in the Japanese market under the name MS-Twicelon. The product is the first sustained-release morphine sulfate formulation based on microgranules to be approved in Japan for the management of cancer-related pain on a twice-daily basis. The compound received marketing authorization on March 15 from Japan¿s Ministry of Health. Ethypharm has developed a range of technology platforms for both oral and injectable delivery and now has 50 products sold in more than 70 countries.
¿ GlycoDesign Inc., of Toronto, started its expanded Phase II trial of GD0039, the company¿s lead anticancer drug, in the treatment of metastatic renal cancer. Patient treatment has begun in the ONC-B3 trial at the Institut Gustave Roussy in Paris. The University of Chicago and the Cleveland Clinic are screening patients for entry into the North American metastatic renal trial, ONC-B4. The protocol for each trial allows for the enrollment of up to 27 patients.
¿ GPC Biotech AG, of Martinsried, Germany, signed a development and manufacturing agreement with ICOS Corp., of Bothell, Wash., for GPC¿s anti-MHC class II antibodies. The agreement includes a nonexclusive license to ICOS¿s mammalian cell expression technology. ICOS will conduct development, scale-up and GMP manufacturing in its cell culture manufacturing facility. GPC will retain all rights to develop and commercialize the product. Financial terms were not disclosed.
¿ Hemosol Inc., of Toronto, received approval from the FDA to begin a clinical trial with the company¿s lead oxygen therapeutic, Hemolink, in primary cardiac bypass grafting surgery. The study will include 180 patients undergoing primary CABG surgery at more than 40 centers in the United States and the United Kingdom. The company recently redesigned its clinical program to meet the anticipated requirements of European and U.S. regulatory agencies. Data from the new studies will be used to strengthen the company¿s pending application in the UK. (See BioWorld Today, Aug. 15, 2001.)
¿ Hollis-Eden Pharmaceuticals Inc., of San Diego, completed a Phase I study with subcutaneously administered HE2200, an immune-regulating hormone drug candidate, in healthy adult volunteers. The company received clearance from the FDA to begin a similar Phase I trial using HE2200 in a buccal tablet formulation. Preclinical studies with the product have indicated it has the potential to provide benefit in a variety of settings of immune dysregulation, including inflammatory bowel disease, age-related loss of immunity and radiation-induced immune suppression, the company said.
¿ IGEN International Inc., of Gaithersburg, Md., and F. Hoffmann-La Roche Ltd., of Basel, Switzerland, settled a patent infringement action brought by Roche against IGEN in the U.S. District Court for the District of Delaware. Roche is dismissing all claims against IGEN and is reimbursing IGEN for the legal fees that IGEN incurred in defending that suit, which total about $5.7 million. Last week, IGEN said it concluded its presentation to the jury in its multicourt lawsuit against Roche Diagnostics in the U.S. District Court for the District of Maryland. The settlement does not affect the continuation of the Maryland litigation, IGEN said.
¿ Matrix Pharmaceutical Inc., of Fremont, Calif., submitted an application for the approval of IntraDose Injectable Gel for the treatment of recurrent or refractory head and neck cancer to the European Medicines Evaluation Agency. The application is based on results from two randomized, placebo-controlled Phase III studies, one of which was conducted predominantly in Europe. On Nov. 2, Matrix received a nonapprovable letter from the FDA for its IntraDose new drug application as a treatment for recurrent or refractory head and neck cancer. Matrix is evaluating its next steps for IntraDose in the United States with the FDA.
¿ MPB Cologne GmbH, of Cologne, Germany, said its recombinant single-chain antibody produced in potato tubers has proved to be functionally equivalent to its bacteria-produced counterpart in stimulating outgrowth of neurites from cultured neurons. The antibody is directed against the neural recognition molecule L1 from mice and stimulates neurite outgrowth of cultured mouse neurons. Antibodies against the human L1 protein may have potential as a biotherapeutic agent for the treatment of neurodegenerative diseases such as Alzheimer¿s, Parkinson¿s and multiple sclerosis.
¿ Peptor Ltd., of Rehovot, Israel, said the experimental drug DiaPep277 showed in a Phase II trial to arrest the progression of Type I diabetes, prevent destruction of insulin-producing pancreatic cells, and reduce the need for injected insulin in newly diagnosed patients. Results were published in the Nov. 24, 2001, issue of The Lancet. Peptor funded the study.
¿ Oxford Gene Technology Ltd., of Oxford, UK, was ruled by the European Patent Office¿s Opposition Division to be the holder of a patent that had been challenged by Affymetrix Inc., of Santa Clara, Calif.; Abbott Laboratories, of Abbott Park, Ill.; F. Hoffmann-La Roche Ltd., of Basel, Switzerland; Nanogen Inc., of San Diego; and three others. Oxford Gene Technology¿s European array patent decision was made following a three-day hearing at the EPO in Munich. Affymetrix had withdrawn its opposition prior to the hearing. (See BioWorld Today, Nov. 3, 2000, and Nov. 13, 2000.)
¿ Oxigene Inc., of Watertown, Mass., signed an agreement to out-license, on a nonexclusive basis, its benzamide technology platform to Active Biotech AB, of Lund, Sweden, for all indications for the use of the benzamide compound declopramide. The companies signed a research agreement in 1999 to investigate Oxigene¿s benzamide technology platform. The new agreement grants Active the right to further develop and commercialize positive leads for all indications. Active will bear all costs for the development and commercialization efforts and Active will share with Oxigene any milestone and royalty payments resulting from the program. Financial details were not disclosed.
¿ Pharmacopeia Inc., of Princeton, N.J., expanded its drug discovery collaboration with Otsuka Pharmaceutical Factory Inc., a division of Japan-based Otsuka Group. As part of the initial collaboration, Pharmacopeia developed a cell-based assay and used its high-throughput screening technology to test several million compounds against an Otsuka target. The lead compounds identified, which up-regulate a metabolic enzyme, were licensed to Otsuka. Otsuka agreed to expand the collaboration for two years to pursue chemical optimization of these lead compounds. Pharmacopeia will maintain an interest in these programs, in the form of milestone and royalty payments, as the programs progress through development.
¿ Rosetta Inpharmatics Inc., of Kirkland, Wash., said its business unit, Rosetta Biosoftware, licensed the Rosetta Resolver Gene Expression Data Analysis System to COR Therapeutics Inc., of South San Francisco. The Rosetta Resolver system provides data storage, retrieval and analysis of gene expression data. Financial details were not disclosed.
¿ Signalmen Inc., of Montreal, said it is relocating its drug discovery unit located in Guelph, Ontario, to new facilities. The construction is expected to be completed in 2002¿s second quarter. The company said the expansion will enhance its ability to produce small-molecule lead compounds for internal drug discovery programs in areas of cancer, hormone replacement and other steroid-related disorders.
¿ Skyline Ventures, of Palo Alto, Calif., completed the final closing on $150 million in committed capital for its new fund, Skyline III, and affiliated funds. With the closing, the fund now has $250 million under management. Skyline¿s funds focus on early stage investments in health care and life sciences companies.
¿ Stanford University Medical Center, of Stanford, Calif., and the University of California at San Francisco researchers identified a gene, osteopontin, which is involved in the development of multiple sclerosis. Osteopontin is known to be a factor in the inflammatory immune response characteristic of MS, but now researchers believe it may be positioned at a number of checkpoints in the progression of the disease. Researchers said the findings could lead to targeted therapies for MS.