¿ 3-Dimensional Pharmaceuticals Inc., of Exton, Pa., and Bristol-Myers Squibb Co., of Princeton, N.J., modified their discovery alliance to increase BMS' commitment to purchase ThermoFlouor high-throughput screening workstations from three to seven and removing nonexclusive licenses to 3DP's protein expression/refolding technology and planned GPCR structural genomics database. The modification will result in the return of $4.5 million of the $23.5 million in up-front fees BMS paid to 3DP. Other aspects of the alliance remain unchanged, and further financial details were undisclosed.
¿ Aclara BioSciences Inc., of Mountain View, Calif., said the trial judge in the trade secret lawsuit with Caliper Technologies Corp., also of Mountain View, Calif., issued an order on equitable relief. The order states that injunctive relief shall be limited to an injunction against Aclara's assertion of the '015 patent against Caliper. Aclara plans to appeal the judgement in the case, including the order of injunctive relief.
¿ AeroGen Inc., of Sunnyvale, Calif., initiated Phase II trials of its AeroDose insulin inhaler in diabetic patients. The studies are designed to characterize the delivery and efficacy of inhaled insulin in Type II diabetic patients.
¿ ALZA Corp., of Mountain View, Calif., licensed dapoxetine, for genitourinary therapies, including premature ejaculation, from PPD Inc., of Wilmington, N.C. Under the terms, ALZA will receive worldwide rights to develop and commercialize dapoxetine and is responsible for manufacturing, clinical, regulatory, sales and marketing costs resulting from the license. PPD will receive an undisclosed up-front payment, royalties on net sales, and milestone payments based on product approval and meeting certain sales levels.
¿ Amersham Pharmacia Biotech Ltd., of Piscataway, N.J., and BioImage A/S, of Copenhagen, Denmark, entered a collaboration to commercialize a cell-based screening technology based on green fluorescent protein (GFP). APBiotech will gain an exclusive license to BioImage's European patent portfolio on GFP. Financial details were undisclosed.
¿ Amylin Pharmaceuticals Inc., of San Diego, said its board approved a commercialization plan for Symlin (pramlintide acetate). The company submitted a new drug application for the diabetic drug earlier this month. Commercialization plans include the creation of a commercial team, staged hiring of sales and marketing personnel and deferment of costs until Symlin's approvability is determined. (See BioWorld Today, Dec. 8, 2000.)
¿ BioChem Pharma Inc., of Laval, Quebec, completed its purchase of the outstanding shares of CliniChem Development Inc. BioChem paid C$18.43 (US$12.129) per share for each CliniChem class A share for a total of about US$32.9 million. (See BioWorld Today, Oct. 30, 2000.)
¿ Biogen Inc., of Cambridge, Mass., said its board authorized a two-year stock repurchase plan for 4 million Biogen shares. Biogen will keep the stock as treasury shares for general corporate purposes and for employee stock options and stock repurchase plans.
¿ Biotechnology Industry Organization, of Washington, D.C., named Lee Rawls, chief of staff to U.S. Sen. Bill Frist, vice president for government regulations. BIO said it will face a "rapid-fire succession" of issues in the next Congress, including Medicare prescription drug coverage, FDA reform and user fees and protection of intellectual property. Rawls also has served as chief of staff to Sen. Pete Domenici and as assistant attorney general for legislative affairs for the U.S. Department of Justice. He also was a managing partner in a Washington law firm and an adjunct professor at the College of William and Mary.
¿ Cardion AG, of Erkath, Germany, completed its third round of financing for proceeds of US$35 million to fund clinical development of NOStentin, a nonviral, local gene therapeutic for prevention of restenosis. Cardion develops novel heart disease therapeutics and cell transplantation therapies.
¿ Circe Biomedical Inc., of Lexington, Mass., received $28 million in private equity funding to advance its work in therapeutic cell systems. Asahi Chemical, Burrill & Co., HLM Management, Advanced Technology Ventures, SenMed Medical Ventures, Polaris Venture Partners, BancBoston Ventures, Bessemer Venture Partners, Spray Venture Partners and Mayo Medical Ventures provided the financing. The funding will be used to complete Circe's Phase II/III trial, preparations for FDA review and the eventual manufacture of its HepatAssist Liver Support System. Circe focuses on bioartificial organs and cell therapy, fields that use living cells to treat diseases and conditions caused by a deficiency in the body's own cells or cell functions.
¿ Crucell N.V., of Leiden, the Netherlands, entered a licensing agreement with Eurogene Ltd., of London. The agreement gives Eurogene access to Crucell's PER.C6 technology. Eurogene will make an undisclosed up-front payment to Crucell in addition to annual payments and royalties on net sales of adenoviral gene therapy products developed through the agreement in return for access to the technology and an option to convert to a commercial license within five years.
¿ CV Therapeutics Inc., of Palo Alto, Calif., said it initiated a Phase II trial of ranolazine, the first in a new class of drugs known as pFOX (partial fatty acid oxidation) inhibitors, in patients with congestive heart failure. CV Therapeutics is conducting a second Phase III trial with ranolazine in patients with chronic angina to examine the safety and effectiveness of the drug when compared to placebo, in combination with other anti-anginal medications.
¿ Direvo Biotech AG, of Cologne, Germany, closed its first round of equity financing for proceeds of EUR8.75 million (US$7.83 million). The funding was led by TVM Techno Venture Management.
¿ Enzon Inc., of Piscataway, N.J., submitted an investigational new drug application to the FDA for PEG-paclitaxel, a PEG-modified version of paclitaxel. It was designed to be delivered without the need for solubilizing agents or premedications.
¿ Epigenomics AG, of Berlin, said it will merge with ORCA Biosciences Inc., of Seattle. The transaction, approved by both companies' boards, is expected to reach completion in early 2001. Financial details were undisclosed. Epigenomics is focused on DNA methylation. ORCA, which will become Epigenomics Inc., a wholly owned subsidiary of Epigenomics AG, develops, manufactures and markets detection, diagnostic, monitoring and information tools based on DNA methylation.
¿ Evax Technologies AG, of Martinsried, Germany, acquired the Immune Complex Corp., of San Diego, a vaccine company. Evax will change its name to Apovia AG and ICC will become Apovia Inc., a wholly owned subsidiary. Details of the all-share transaction were undisclosed.
¿ Genzyme Corp., of Cambridge, Mass., said shareholders approved the formation of Genzyme Biosurgery. The division is formed from the combination of the business of Biomatrix Inc., Genzyme Tissue Repair and Genzyme Surgical Products.
¿ Gilead Sciences Inc., of Foster City, Calif., and the Southern Research Institute, of Birmingham, Ala., entered a licensing agreement granting Gilead exclusive worldwide development and marketing rights to 4'-thio-araC, a nucleoside analogue for the treatment of cancer. Gilead plans to initiate preclinical testing on the compound in 2001 and Phase I trials in early 2002.
¿ Gliatech Inc., of Cleveland, appointed Steven Basta president. Basta is the former CFO and vice president, finance and business development, for Creative BioMolecules Inc.
¿ Hollis-Eden Pharmaceuticals Inc., of San Diego, said results of its Phase I/II South African trial of HE2000 in treatment-naove HIV patients indicated statistically significant increases in a number of important immune system cell types. The data are from an interim analysis of the 37-patient, five-month, three-treatment-course trial.
¿ IBM Inc., of Armonk, N.Y., said it is building the world's largest supercomputer for NuTec Science Inc.'s Life Sciences Division, of Atlanta. The 7.5-teraflop computing cluster will have a processing capacity of 7.5 trillion calculations per second, and the company will use it to investigate gene interaction in disease.
¿ ICN Pharmaceuticals Inc., of New York, voted Chairman and CEO Milan Panic into an additional three-year term as chairman. Restructuring at ICN is ongoing.
¿ Idun Pharmaceuticals Inc., of La Jolla, Calif., said it was granted approval to begin a Phase I study of one of its caspase inhibitors. The study will investigate the safety of one of Idun's small-molecule caspase inhibitors in up to 75 normal adult subjects. Caspase inhibitors block apoptosis by stopping the action of caspases, a family of proteins that are a component of the apoptosis pathway.
¿ Immune Response Corp., of Carlsbad, Calif., said it purchased 25 percent ownership of MicroGenomics Inc., of San Diego. It issued 540,540 unregistered shares of common stock, valued at $2 million, to complete the purchase of MicroGenomics shares.
¿ InSite Vision Inc., of Alameda, Calif., said an independent research article published in a leading basic science journal in ophthalmology demonstrated the effect of the TIGR protein to increase intraocular pressure. The relationship of the TIGR protein to increased intraocular pressure and glaucoma also provides the concept behind InSite's diagnostic product, ISV-900.
¿ Luminex Corp., of Austin, Texas, and BioSource International Inc., of Camarillo, Calif., entered a partnership to develop reagents and assay kits for basic research and drug discovery. The assay detection system will be based on Luminex's proprietary LabMAP technology and will complement BioSource's line of cytokines, signal transduction, immunology and neuroscience products.
¿ MDS Proteomics Inc., of Toronto, and Zyomyx Inc., of Hayward, Calif., entered an agreement to enhance cell research through protein pathway identification and analysis. MDS also purchased a $2.5 million equity stake in Zyomyx as a part of a recently completed Series D financing. MDS will provide funding for Zyomyx research and development.
¿ Medivir AB, of Huddinge, Sweden, will commence Phase I trials of MIV-210, a hepatitis B therapeutic. The trial is designed to determine the pharmacokinetics of the compound and establish the dose levels for Phase II trials.
¿ Myogen Inc., of Denver, entered a co-development agreement with Knoll AG, now a division of Abbott Laboratories Inc., of Abbott Park, Ill., for BSF 208075, a type-A selective endothelin receptor antagonist. Myogen will pay an up-front fee and complete Phase II testing in exchange for a portion of the commercial value of the compound.
¿ NeoTherapeutics Inc., of Irvine, Calif., said clinical data from study of its nerve regeneration drug Neotrofin showed the compound facilitates brain activity in Alzheimer's disease patients. The study indicated statistically significant improvement in memory, attention and judgement. The 19-patient, double-blind, dose-escalating Phase II pilot study showed improvements were dose-related.
¿ Nanogen Inc., of San Diego, said it filed a lawsuit against CombiMatrix Corp., of Snoqualmie, Wash., and Donald Montgomery, senior vice president and chief technology officer at CombiMatrix, concerning U.S. Patent No. 6,093,302. Nanogen alleges the naming of Montgomery as the sole inventor on the patent by CombiMatrix was incorrect, stating instead that the invention was made by Nanogen employees. It also alleges inventions disclosed in the patent were Nanogen trade secrets and CombiMatrix and Montgomery misappropriated those secrets by their actions. Montgomery was employed by Nanogen in 1994 to work on its electronic microarray technology and left in 1995 to join CombiMatrix.
¿ NicOx SA, of Sophia Antipolis, France, advanced three candidates to Phase I clinical trials in France: NCX701, a nitric oxide-releasing derivative of paracetamol for pain; NCX1015, a nitric oxide-releasing derivative of prednisolone for treatment of inflammatory bowel disease; and NCX 1022, a nitric oxide-releasing derivative of hydrocortisone for treatment of psoriasis.
¿ Nymox Pharmaceutical Corp., of Montreal, devised a unique high-throughput screening system for Alzheimer's disease therapeutics. The company used its Spheron technology for the new screening and testing methods.
¿ OxiGene Inc., of Watertown, Mass., initiated a Phase II efficacy study for decloporamide, an apoptosis-inducing and NF-K-beta-inhibiting anticancer agent. The compound will be administered in combination with chemotherapeutics as a second-line therapy for colorectal cancer. The trial is designed to evaluate the compound's efficacy and safety.
¿ Packard Bioscience Co., of Meriden, Conn., and BioLinks Informatics Inc., of Shanghai, China, entered an agreement for the purchase of a large number of Scan-Array microarray analysis systems from Packard subsidiary Packard BioChip Technologies LLC. Shipments are expected to begin this week, and will continue through April, Packard said.
¿ Regneron Pharmaceuticals Inc., of Tarrytown, N.Y., initiated a Phase I trial to assess the safety and tolerability of its interleukin Cytokine Trap in patients with rheumatoid arthritis. The placebo-controlled, dose-escalating, multicenter trial includes a single-dose phase and a multiple-dose phase.
¿ Stem Cell Pharmaceuticals Inc., of Seattle, said a study reported for the first time that administration of transforming growth factor-alpha into damaged areas of rat brains stimulated stem cells to multiply and differentiate into fully developed neurons, restoring the rats' movement deficit in the animal model of Parkinson's disease. The study was published in the Dec. 19, 2000, issue of the Proceedings of the National Academy of Sciences.
¿ Trinity Biotech plc, of Dublin, Ireland, acquired the assets of Bartels Inc., a division of Intracel Corp., of Issaquah, Wash., a manufacturer of cell-dependent organism diagnostics. The total purchase was for $9.3 million, including $3.2 million of Trinity stock and the balance in cash.
¿ Unigene Laboratories Inc., of Fairfield, N.J., completed a clinical study of its nasal calcitonin product. The study demonstrated equivalent bioavailibility to an existing nasal cacitonin product. A second study of the compound is expected to conclude early next year.
¿ United Therapeutics Corp., of Silver Spring, Md., said its wholly owned subsidiary, Unither Pharmaceuticals Inc., is acquiring all the assets of Cooke Pharma Inc., of Belmont, Calif., for 300,000 shares of stock, which were valued at about $4.7 million as of Monday's opening price. Cooke makes HeartBar, a medical food for angina and other cardiovascular conditions. Unither will pay a single-digit cash royalty to Cooke on sales of Cooke Pharma products up to an additional $49 million. Cooke will be re-created as a wholly owned subsidiary but will operate under its original name and be controlled by existing management. Separately, United Therapeutics approved the adoption of a shareholder rights plan designed to discourage takeovers that involve abusive tactics or do not provide fair value to stockholders.
¿ Viragen Inc., of Plantation, Fla., reported "encouraging" interim results from its Phase II trial of the hepatitis C therapeutic Omniferon, a multi-subtype alpha interferon. Enrollment for the second stage of the study is under way.