Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, said it was notified that Cook Inc., of Bloomington, Ind., received FDA approval to begin enrolling 200 patients at 20 sites in a pivotal U.S. clinical trial of its new paclitaxel-eluting coronary stent to combat restenosis. Cook has licensed the use of paclitaxel from Angiotech for use with its stents.
Cellegy Pharmaceuticals Inc., of South San Francisco, and Ventiv Health Inc., of New York, said they began planning for the launch this year of Cellegy’s lead product, Anogesic (nitroglycerin ointment), in the United States. Ventiv will provide Cellegy with sales and marketing support for the commercialization for four years. Cellegy filed a new drug application in June 2001 and at the beginning of October reported positive results from a final, confirmatory Phase III trial necessary for the NDA. (See BioWorld Today, June 27, 2001, and Aug. 13, 2001.)
Diabetogen Biosciences Inc., of London, Ontario, completed a first round of equity investment totaling C$7.8 million (US$5 million). These funds, of which C$3.3 million was disbursed on Dec. 17, will be used to advance its therapeutic products through preclinical and clinical studies. The company is focused on finding a cure for Type I diabetes, and the funds will allow it to continue developing products that attack the disease at various stages of progression.
F. Hoffmann-La Roche Ltd., of Basel, Switzerland, and Bruker Daltonics GmbH, of Bremen, Germany, expanded their alliance in proteomics. The collaboration will focus on the development of efficient methods for mass spectrometric protein analysis, with the goal of increasing these analyses by innovative sample preparation and high-performance automation on the level of laboratory procedures, mass spectral data acquisition, data processing and newly designed software for protein analysis. A high-throughput mass spectrometry system capable of processing more than 10,000 proteins per day will be developed. It will be made available by Bruker Daltonics.
Hydro Med Sciences, of Cranbury, N.J., completed a $7 million private placement of Series A convertible preferred stock with institutional investors. Sanders Morris Harris, of Houston, acted as manager and Corporate Opportunities Funds was lead investor. Hydro Med is a former wholly owned subsidiary of GP Strategies Corp., of New York, and with the financing becomes an autonomous company although GP retains a major stake in Hydro Med. The funds will be used for general operating expenses and growth strategies, the company said, including accelerating the completion of Phase III prostate cancer trials with Hydro Med’s 12-month histrelin implant.
ID Biomedical Corp., of Vancouver, British Columbia, completed construction of a pilot vaccine manufacturing plant, allowing it to produce clinical-grade materials in accordance with FDA Good Manufacturing Practices. The six-room facility is adjacent to ID Biomedical’s research and development facility near Seattle. The pilot plant includes a mid-commercial-scale fermentation suite capable of producing recombinant proteins, and a downstream processing suite appropriate for protein purification and vaccine formulation.
ImClone Systems Inc., of New York, disclosed in a filing to the SEC that it has received inquiries from the SEC and the Justice Department and Congress. In a separate filing, ImClone said Peter Peterson resigned from its board, citing “time restraints.” ImClone has been the subject of class action lawsuits since its rolling biologics licensing application for the colon cancer treatment Erbitux brought a “refuse-to-file” letter from the FDA in late December. Since that time, ImClone has been caught in an imbroglio of suits, sliding stock value and official investigations into its actions. Bristol-Myers Squibb Co., of New York, is partnered with ImClone for the development of Erbitux in North America and is said to be evaluating its options considering its shareholders and the drug. Merck KGaA, of Darmstadt, Germany, has a license to Erbitux rights outside North America and Japan and said the setback in the U.S. would not affect development in Europe. ImClone’s stock (NASDAQ:IMCL) fell another $3.09 Friday, or about 15.8 percent, to end the day at $16.49. (See BioWorld Today, Jan. 3, 2002; Jan. 22, 2002; and Jan. 25, 2002.)
Incara Pharmaceuticals Corp., of Research Triangle Park, N.C., said it reports in the February issue of Diabetes that its prototype catalytic antioxidant, AEOL 10113, significantly delayed the onset of elevated blood sugar in a mouse adoptive transfer model of Type I diabetes. Administration of AEOL 10113 protected mice treated with cloned, diabetes-producing T cells from developing diabetes as compared to controls. Additional experiments suggested the antioxidants act in this model by reducing the immune system’s ability to recognize insulin-producing pancreatic beta cells.
Novirio Pharmaceuticals Ltd., of Montpellier, France, was awarded EUR1.9 million (US$1.64 million) from the European Commission to fund a research project titled “Flavitherapeutics.” The consortium, comprised of Novirio and several academic research groups from France, Italy and Germany, is focused on the development of drugs for flaviviruses, including hepatitis C, dengue fever and West Nile viruses.
OSI Pharmaceuticals Inc., of Melville, N.Y., said it plans to offer $150 million of convertible subordinated notes, plus an additional $30 million to cover overallotments, to institutional buyers. The notes would be convertible into OSI stock at the option of the holder, at a price to be determined. The offering is expected to close on or about Feb. 4. Use of the proceeds may include continued development of its product pipeline, licensing and acquisition opportunities that add oncology products and late-stage drug candidates, and general corporate purposes.
Sinclair Pharmaceuticals Ltd., of Godalming, UK, said that following the recent FDA granting of 510(k) approval of Gelclair for the management of oral mucositis, it appointed Cell Pathways Inc., of Horsham, Pa., as U.S. distributor for the product. Cell Pathways will make an initial payment and commitments to purchase inventory from Sinclair in 2002 totaling $5 million. The 10-year agreement includes provisions for extension under certain circumstances, and it makes Cell Pathways the exclusive distributor for the United States, Canada and Mexico.