Aclara BioSciences Inc., of Mountain View, Calif., is collaborating with researchers at the Stanford University School of Medicine in Palo Alto, Calif., to apply Aclara’s eTag technology for proteomics research. In particular, the Stanford researchers plan to characterize serum autoantibody profiles in a variety of autoimmune diseases to develop immunology proteome panels for use in drug discovery, clinical medicine and academic research.
Alliance Pharmaceutical Corp., of San Diego, submitted documents to the FDA and to European regulatory authorities regarding resumption of clinical development of Oxygent (perflubron emulsion). Submissions included an interim integrated safety summary containing data from all clinical studies conducted with the product, as well as a new Phase III plan. Nearly 1,500 subjects have been involved, including a 492-patient, international Phase III study that showed a statistically significant reduction and avoidance of donor blood usage. Another Phase III study involving cardiac surgery patients was suspended voluntarily due to certain adverse events. Oxygent is being developed in conjunction with Baxter Healthcare Corp., of Deerfield, Ill., which made an additional investment of $2 million in Alliance convertible preferred stock.
Alteon Inc., of Ramsey, N.J., received almost $1.2 million from the sale of its net operating loss carryovers under New Jersey’s Technology Business Tax Certificate Transfer Program. During the three years of the program’s existence, Alteon has received more than $5.3 million in nonequity cash. Also, Alteon closed a stock purchase agreement disclosed last week to sell 4.45 million shares of common stock to a group of institutional investors, raising net proceeds of approximately $18.6 million. Investors include funds managed by Fiduciary Trust Company, Merlin BioMed of New York, SDS Merchant Fund, Oracle Partners, Scout Capital, MPM BioEquities and Domain Public Equity Partners.
Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, said ongoing trials using a paclitaxel-eluting stent technology report zero restenosis at nine months. Boston Scientific Corp., of Natick, Mass., is sponsoring the TAXUS program, which shows no change in status with an ongoing follow-up of patients in the 61-patient TAXUS I trial. This update bolsters previously reported six-month results of zero restenosis in the group treated with paclitaxel-eluting stents, released in November at the annual meeting of the American Heart Association. Boston Scientific acquired worldwide co-exclusive rights from Angiotech to use paclitaxel to coat its coronary stent products and other vascular and nonvascular products.
Array BioPharma Inc., of Boulder, Colo., filed a registration statement with the SEC relating to a potential public offering of 4.2 million shares of common stock. In addition, the underwriters will have an option to purchase up to an additional 630,000 shares from Array and selling stockholders to cover overallotments, if any. The sale of 4.2 million shares at Thursday’s opening price would gross $59 million. The stock (NASDAQ:ARRY) fell $2.05 Thursday, or 14.6 percent, to close at $12. The transaction is being led by Lehman Brothers Inc. and co-managed by UBS Warburg, Legg Mason Wood Walker Inc. and Thomas Weisel Partners LLC.
Cambridge Antibody Technology plc, of Melbourn, UK, and Drug Royalty Corp., of Toronto, entered into a definitive agreement pursuant to which CAT will make an offer by way of a takeover bid for all of the issued shares of DRC, a deal estimated at C$126 million (US$78 million). DRC shareholders, holding in aggregate approximately 30 percent of DRC’s fully diluted share capital, have agreed to tender their shares to the offer. CAT will indirectly acquire the benefits of its royalty-based obligations under its existing contract with DRC. CAT does not expect to continue investing in the acquisition or creation of new royalty interests and does not plan to retain DRC’s management. CAT’s offer price values DRC at C$3 per share, representing a 20 percent premium to DRC’s 60-day volume-weighted-average trading price. DRC shareholders can elect to receive CAT shares listed on the London Stock Exchange, or American depository shares listed on Nasdaq.
Cardiome Pharma Corp., of Vancouver, British Columbia, began patient dosing in its pivotal Phase II efficacy study of RSD1235, a candidate for the treatment of recent-onset atrial fibrillation. The 60-patient, 20-site trial is a randomized, placebo-controlled, double-blind, step-dose study in patients with recent-onset atrial fibrillation. The primary endpoint is conversion of atrial fibrillation following 10 minutes of drug infusion. The study is expected to end within six months.
Curis Inc., of Cambridge, Mass., and AGY Therapeutics Inc., of South San Francisco, formed a collaboration to develop novel small-molecule drugs from stem cells for therapeutic, diagnostic and other applications relevant to neurodegenerative diseases, diabetes, oncology and central nervous system diseases. Curis will share its stem cell and developmental biology expertise with AGY, which will apply its imAGYne technology platform to identify, analyze and validate novel small-molecule targets. Products of this collaboration will be used by both companies to further their own internal drug development programs, as well as in partnerships with third parties. Financial terms were not disclosed.
Exelixis Inc., of South San Francisco, delivered additional novel targets and assays to partner Bayer AG, of Leverkusen, Germany, in the companies’ ongoing crop protection joint venture named Genoptera LLC. The delivery triggers undisclosed milestone payments to Exelixis. The 2000 joint venture included a $20 million up-front payment and performance-based milestone and royalty payments to Exelixis, as well as $80 million in research funding over the course of the eight-year collaboration.
Genzyme Corp., of Cambridge, Mass., established Peptimmune Inc. as a wholly owned subsidiary. Genzyme will provide initial capitalization of Peptimmune by purchasing $5.5 million in shares of preferred stock. The new unit will focus on developing specific immunotherapies for treating autoimmune and allergic diseases. Genzyme acquired Peptimmune in 1999 and has made advances with lead products in Peptimmnune’s core areas of focus. Several products are anticipated to enter clinical trials in the next two years for diseases such as pemphigus vulgaris, rheumatoid arthritis and multiple sclerosis.
InterMune Inc., of Brisbane, Calif., said the Data Safety Monitoring Board for the company’s Phase III trial of Actimmune (interferon gamma-1b) injection for the treatment of idiopathic pulmonary fibrosis recommended that InterMune continue the study as currently designed. The recommendation to maintain the size of the 330-patient study was based upon a one-time, prespecified sample-size analysis. Also, the company reported that approximately 65 percent of the trial is complete in terms of patient treatment days. Fewer than 5 percent of patients have withdrawn from the study prior to completion. (See BioWorld Today, Aug 22, 2001.)
Melacure Therapeutics AB, of Uppsala, Sweden, and BioFactor Therapeutics AB, of Stockholm, Sweden, merged to create a new company with a broader project portfolio. The new company will be called Melacure Therapeutics AB and will be based in Uppsala. The company will have 31 employees, including Chairman Carl-Johan Dalsgaard, BioFactor’s former president; President and CEO Per-Olof Wallstr m, the former CEO of Q-Med AB; and Claes Post, Melacure’s previous CEO who will be the head of research. Melacure focused on melanocortin receptors. BioFactor focused on gastrointestinal conditions.
Mixture Sciences Inc., of San Diego, was awarded a $600,000 Phase I Small Business Innovation Research grant by the National Institutes of Health. MSI will use its technology involving large combinatorial peptide libraries to identify and optimize peptide mimics of HIV-1 epitopes for use in the design of prophylactic vaccines for the treatment of HIV infections. These studies are being conducted in collaboration with the Karmanos Cancer Institute in Detroit.
Osiris Therapeutics Inc., of Baltimore, said its board appointed Alfred Seidel CEO. Seidel spent more than 25 years with Sandoz Pharma as head of Southeast Asian operations based in Hong Kong, and then head of strategic planning of the U.S. operations. The company also named Richard Power to its board. Osiris develops adult mesenchymal stem cells for the regeneration of bone marrow stroma, bone, cartilage and heart-muscle tissue that has been damaged by injury, aging or degenerative disease.
Prolinx Inc., of Bothell, Wash., released two products for protein detection, Versalinx Rapid Protein-Enzyme Conjugation Kits, HRP and AP. These products expand upon the company’s proteomics product portfolio, incorporating Versalinx affinity technology used for immobilization of macromolecules in genomics, proteomics and bioresearch assays.
Viragen Inc., of Plantation, Fla., and Viragen International Inc. received Swedish regulatory approval to expand use of its natural alpha interferon. The broadened approval extends use of the drug to include the treatment of patients afflicted with any and all diseases in which patients were or became resistant to recombinant interferon. Viragen’s natural alpha interferon had previously been approved in Sweden and certain other countries for the treatment of patients with hairy-cell leukemia and chronic myelogenous leukemia who did not respond to recombinant interferon regimens.