¿ Alliance Pharmaceutical Corp., of San Diego, said it will sell its Otisville, N.Y., facility to Breonics Inc., of Schenectady, N.Y., for $1 million. Alliance used the facility for LiquiVent manufacturing. LiquiVent is a partial liquid ventilation treatment for adults with acute respiratory distress syndrome. Breonics will take over manufacture of SatPad, an Alliance device for use with magnetic resonance imaging, and pay Alliance a royalty on SatPad sales.
¿ ALZA Corp., of Mountain View, Calif., said ALZA¿s shareholders approved the proposed merger with Johnson & Johnson, of New Brunswick, N.J. The companies anticipate closing the transaction today. The original proposal was announced March 27. The companies will merge in a stock-for-stock, tax-free exchange. ALZA shareholders will receive a fixed exchange ratio of .98 shares of Johnson & Johnson common stock for each share of ALZA.
¿ Cambridge Antibody Technology plc, of Melbourn, UK, said it was issued U.S. Patent No. 6,248,516, titled ¿Single Domain Ligands, Receptors Comprising Said Ligands, Methods for Their Production, and Use of Said Ligands and Receptors,¿ and called the ¿Winter II¿ patent. It covers antibody variable domain expression libraries carrying a diversity of CDR3 sequences and methods of making such libraries. CAT immediately filed suit in U.S. District Court for the Southern District of California in San Diego against MorphoSys AG, of Munich, Germany, for alleged patent infringement. The companies already are embroiled in one patent infringement suit centered on CAT¿s U.S. Patent No. 5,885,793. In that case in U.S. District Court in Washington a jury failed to come to an infringement verdict, and several post-trial motions remain pending. A related patent in Europe granted in 1994 was successfully opposed by MorphoSys, the German company said, at the European Patent Office in October 1999. That case resulted in substantial changes in the language of the key claim in the patent and a significant narrowing of the patent¿s protection scope, MorphoSys said.
¿ Cell Genesys Inc., of Foster City, Calif., initiated a second multicenter Phase I/II trial of its GVAX lung cancer vaccine in patients with advanced-stage non-small-cell lung cancer who have failed previous therapies. The trial will evaluate a new format of GVAX, and will enroll 40 patients.
¿ Cellomics Inc., of Pittsburgh, said Pharmacia Corp., of Kalamazoo, Mich., is the first company to take delivery of the Zeiss Multimode Reader, sold exclusively in North America by Cellomics. Pharmacia will use the reader to perform ultra-high-throughput screening. The Zeiss Reader is the first commercially available multimode detection system.
¿ Centocor Inc., of Malvern, Pa., had its product, ReoPro, evaluated in two studies, TARGET and ADMIRAL, that were published in The New England Journal of Medicine. The studies show that ReoPro ¿ a GPIIb/IIIa receptor blocker ¿ plus a stent reduces the chance of having a heart attack or the need for emergency revascularization in two different patient types. The TARGET study showed ReoPro was superior to tirofiban in a range of patients undergoing scheduled stenting procedures. In the ADMIRAL study, patients receiving ReoPro showed a nearly 53 percent relative risk reduction in the composite endpoint of death, second heart attacks and emergency revascularization out to six months, compared to placebo. Separately, preliminary long-term data from a 10-week study on Remicade (infliximab) done by the University of Medicine and Dentistry of New Jersey will be presented tomorrow at the International Psoriasis Symposium European Congress on Psoriasis in San Francisco. The new interim analysis on a 19-patient subset of infliximab-treated patients who have been enrolled in the study for at least six months showed more than half maintained clinical benefit for greater than eight months without the need for retreatment.
¿ Cephalon Inc., of West Chester, Pa., said purchasers of its $300 million aggregate principal amount 5.52 percent convertible subordinated notes due 2006 have exercised in full their option to purchase $100 million in additional notes. The notes are convertible into Cephalon¿s common stock at a conversion price of $74 per share, subject to adjustment in certain circumstances. Cephalon plans to use the proceeds for working capital and general corporate purposes. (See BioWorld Today, May 3, 2001.)
¿ Drug Royalty Corp. Inc., of Toronto, said its partner Cambridge Antibody Technology Group plc, of Melbourn, UK, and its licensing partner Abbott Laboratories, of Abbott Park, Ill., reported that all three doses of the fully human monoclonal antibody D2E7, tested in combination with methotrexate, reduced the signs and symptoms of rheumatoid arthritis in a double-blind, placebo-controlled study involving 271 patients. At the most effective dose of 40 mg, 66 percent of patients who had D2E7 injected weekly experienced a 20 percent improvement in their condition. Fifty-four percent reported a 50 percent improvement. Almost 27 percent experienced a 70 percent improvement. All patients had active rheumatoid arthritis and had failed one to four disease-modifying antirheumatic drugs.
¿ Enzon Inc., of Piscataway, N.J., completed a private placement of $400 million principal amount 4.5 percent convertible subordinated notes due 2008. The offering is expected to close on June 26. Enzon granted purchasers a $60 million greenshoe. The notes are convertible to Enzon common stock at a price of $70.98 per share. (See BioWorld Today, June 15, 2001.)
¿ Genentech Inc., of South San Francisco, and XOMA Ltd., of Berkeley, Calif., presented initial results from the first of two pivotal Phase III trials of their partnered product for psoriasis, the humanized monoclonal antibody Xanelim, at the International Psoriasis Symposium and European Congress on Psoriasis. In the 498-patient study, 39 percent of patients given 1 mg/kg of Xanelim and 27 percent of patients given 2 mg/kg of Xanelim achieved Psoriasis Area and Severity Index (PASI) score improvement of 75 percent or greater after 12 weeks, vs. 2 percent for placebo. Among 123 patients from both dose groups who received an additional 12 weeks of Xanelim treatment after not achieving 75 percent or greater PASI score improvement during initial treatment period, 20 percent more patients achieved the primary efficacy endpoint. Also, 61 percent of patients given 1 mg/kg and 51 percent of patients given 2 mg/kg of Xanelim achieved PASI score improvement of 50 percent of greater after 12 weeks of Xanelim treatment, vs. 15 percent for placebo. (See BioWorld Today, May 25, 2001.)
¿ Genetix Group plc, of New Milton, England, said it acquired exclusive rights to computer software for the identification and analysis of genes linked to disease from the University of Hertfordshire. The software allows researchers to visualize and isolate genetic fragments that have been robotically arrayed on nylon membranes and other surfaces. The software will be marketed as part of Genetix¿s new gene discovery system, scheduled for release in the third quarter.
¿ Genetronics Biomedical Corp., of San Diego, entered a material transfer and evaluation agreement with Boehringer Ingelheim Pharma KG, a unit of Boehringer Ingelheim GmbH, of Ingelhiem, Germany. The agreement will allow BI to investigate the use of Genetronics¿ electroporation technology for use in cardiovascular gene therapy. BI will provide a research site for the work at its own expense. Further financial details were not disclosed.
¿ Genzyme General, of Cambridge, Mass., said interim results from a postmarketing study of Thyrogen (thyrotropin alfa injection) indicates the drug can help doctors identify those at risk of a recurrence of thyroid cancer. Thyrogen was approved in late 1998 as an adjunct to serum thyroglobulin testing and whole-body scanning, which are common thyroid cancer screening tools. The 342-patient study indicated Thyrogen can be a useful tool in screening patients who have been treated for thyroid cancer but who are in the early stages of disease follow-up when the risk of recurrence is highest.
¿ Hoffmann-La Roche Inc., of Nutley, N.J., said it plans to transfer the viral diseases research formerly conducted in Welwyn, UK, to its research center in Palo Alto, Calif. The new research unit will employ a group of senior research staff, including project leaders from Welwyn. Roche said the move should create opportunities for synergies between marketing and research in the United States and its diagnostic viral test unit, Roche Molecular Systems, in Pleasanton, Calif.
¿ Inhibitex Inc., of Atlanta, said it received orphan drug designation from the FDA for the use of a human immunoglobulin to prevent hospital-acquired staphylococcal infections in very low-birth-weight infants. Inhibitex focuses on developing and commercializing antibody-based products for the treatment and prevention of bacterial and fungal infections.
¿ IntegraGen, of Evry, France, raised EUR6.3 million (US$5.4 million) in its first financing round. Investors were CDC Innovation 2000, of Paris; GenAvent, of Paris; BioAm, of Paris; and Bay Tech, of Munich, Germany. IntegraGen was founded in July 2000 as a spin-off of the Centre National Genotypage. Its core technology is GenomeHIP (Genome Hybrid Identity Profiling), a platform meant to analyze the entire genome in one step.
¿ Isis Pharmaceuticals Inc., of Carlsbad, Calif., initiated a Phase II clinical trial of topical ISIS 104838 in patients with psoriasis. ISIS 104838 is an inhibitor of tumor necrosis factor-alpha. The double-masked, paired-plaque, placebo-controlled trial will enroll 60 patients with psoriasis in eight U.S. sites. The study will evaluate the ability of ISIS 104838 to decrease thickness of psoriatic plaques.
¿ Kosan Biosciences Inc., of Hayward, Calif., received a Phase I Small Business Innovation Research grant from the National Cancer Institute. The funding will allow Kosan to generate epothilone analogues by genetic engineering. The amount was not disclosed.
¿ Large Scale Biology Corp., of Vacaville, Calif., and Plant Bioscience Ltd., of Norwich, UK, agreed to combine Large Scale¿s high-throughput gene discovery capabilities with Plant Bioscience¿s portfolio of technologies in the field. Plant Bioscience is granting Large Scale an exclusive license to certain viral-delivered gene silencing and overexpression technologies and an exclusive license to certain other viral-derived technologies for gene silencing and enhanced gene expression. Financial terms were not disclosed.
¿ Ligand Pharmaceuticals Inc., of San Diego, had researchers present studies at The Endocrine Society¿s 83rd Annual Meeting in Denver. One study introduced a new compound that is selective to the glucocorticoid receptor and may be used in place of steroids to treat inflammatory disease. A second study examined a new selective androgen receptor modulator and demonstrated it may be useful in enhancing bone mass and strength in elderly men and women.
¿ Matrix Pharmaceutical Inc., of Fremont, Calif., initiated a study in head and neck cancer patients with IntraDose (cisplatin/epinephrine injectable gel) in combination with other chemotherapeutic agents, marking the first time IntraDose has been studied in combination with chemotherapy in humans. The open-label, multicenter trial will measure the endpoints of tumor response, duration of response and overall survival. Patients will receive weekly IntraDose injections and systemic chemotherapy treatments every 28 days starting two weeks after initial IntraDose injections.
¿ MorphoSys AG, of Munich, Germany, and ImmunoGen Inc., of Cambridge, Mass., entered a collaboration that grants ImmunoGen a license to MorphoSys¿ HuCAL (human combinatorial antibody library) technology for the generation of research antibodies. The agreement is an extension of an October 2000 deal, which called for MorphoSys to develop fully human antibodies to a single ImmunoGen target. The new agreement calls for ImmunoGen to pay MorphoSys technology access and annual subscription fees over the four-year term. Further financial details were not disclosed.
¿ NaPro BioTherapeutics Inc., of Boulder, Colo., and JCR Pharmaceuticals Co. Ltd., of Osaka, Japan, entered a mutually exclusive development, supply and distribution agreement for NaPro¿s paclitaxel in Japan. The agreement calls for NaPro to manufacture and supply the finished drug product, and NaPro and JCR will share responsibility for the JCR-funded clinical and regulatory program seeking marketing approval in Japan. JCR will be responsible for sales and distribution of the product in Japan upon approval. Financial terms were not disclosed.
¿ NeuroSearch A/S, of Ballerup, Denmark, completed a private placement to a limited number of Danish and international investors, raising about DKK128.6 million (US$14.7 million). The 643,000 shares were priced at DKK200 apiece. The company will use the funds to complete an in-house development plan for Phase III trials of NS2330 for the treatment of Alzheimer¿s disease, expected to begin in the third quarter of 2002. Acetylcholine, noradrenaline and dopamine are impaired in Alzheimer¿s patients, but NS2330 is thought to enhance their effects.
¿ Novuspharma SpA, of Monza, Italy, said recruitment has begun for a Phase II trial of its novel tri-platinum complex, BBR 3464 for treatment of advanced pancreatic cancer. The open-label trial will evaluate the compound in 50 chemotherapy-naove patients.
¿ Paratek Pharmaceuticals Inc., of Boston, said Scott Franzblau, director of the Institute for Tuberculosis Research at the University of Illinois at Chicago, will screen Paratek¿s library of more than 1,000 novel tetracyclines for those showing activity against pulmonary infection. Once the most effective compounds against TB are identified, they will be tested in animals, Paratek said.
¿ Prana Biotechnology Ltd., of Melbourne, Australia, said the findings of a Harvard researcher published in the June 21, 2001, issue of Neuron indicate Clioquinol, Prana¿s lead compound, reduced Alzheimer¿s brain pathology within nine weeks in a mouse model. Beta amyloid accumulation was decreased by 50 percent over that period.
¿ Prescient NeuroPharma Inc., of Toronto, said it identified novel genes that may rescue brain cells that die due to Parkinson¿s disease. A neurotrophic factor produced by a rat brain cell, PRE04, rescued dopaminergic neurons from death in an animal model, the company said.
¿ Specialty Laboratories Inc., of Santa Monica, Calif., said it has an agreement with Axis-Shield plc, of Dundee, Scotland, for exclusive U.S. rights to a new gene-based test for predisposition to osteoporosis. The test uses a Cambridge, UK-based Gemini Genomics plc patent on the Type 1 collagen gene and detects changes in this gene associated with predisposition to osteoporosis. Specialty is validating the assay for commercial-scale offering and expects to make it available to physicians and their patients in the second half of 2001.
¿ UroGenesys Inc., of Santa Monica, Calif., changed its name to Agensys Inc. to reflect its expanded activities from urological cancers to multiple cancers. Also, it acquired new facilities that nearly triple in size its headquarters. Agensys¿ expanded portfolio of tumor antigens includes kidney, bladder, lung, colon and ovarian cancers.
¿ Viragen Inc., of Plantation, Fla., and Viragen (Europe) Ltd. said the Medicines Control Agency approved Viragen¿s application for its natural alpha interferon, Omniferon, to begin human trials for the treatment of multiple sclerosis. Omniferon is in Phase II trials in Europe for hepatitis C. The MS trials are expected to begin later this year. Omniferon also is being evaluated for use against cancer and genital herpes.
¿ Xenova Group plc, of Slough, UK, completed a strategic review of its enlarged research and development pipeline and other activities, following its merger with Cantab Pharmaceuticals, of Cambridge, UK. Xenova expects the implementation of the review, along with the elimination of duplicated resources and other efficiency improvements, will result in a reduction of operating expenses. (See BioWorld Today, Feb. 21, 2001.)