Aastrom Bioscience Inc., of Ann Arbor, Mich., received a Small Business Innovation Research Phase II grant from the National Institutes of Health in Bethesda, Md. The two-year award from the National Institute of Diabetes and Digestive and Kidney Diseases, also in Bethesda, totals $740,000, of which $324,000 has been received for the first year of the study.
Able Laboratories Inc., of Cranbury, N.J., plans to liquidate the company after efforts to bring its generic products back to the market have failed. In May, the company voluntarily recalled its products, suspending all manufacturing and distribution, because of concerns about the integrity of data used to obtain FDA approvals. Since then, it has not generated any income or revenue, it has filed for Chapter 11 bankruptcy, and it was delisted from the Nasdaq National Market. The company submitted a proposal to address regulatory concerns, but the FDA rejected it, requiring abbreviated new drug applications for each product Able wanted to manufacture in the future. The FDA's reviews of the ANDAs could take up to 18 months in each case. Once Able is sold, it is unlikely that shareholders will receive any proceeds, it said, since the sale price probably will not be greater than the company's liabilities. Able's stock (Pink Sheets:ABRXQ) fell 76.1 percent, or 86 cents Tuesday, to close at 27 cents.
Bavarian Nordic A/S, of Copenhagen, Denmark, and Acambis plc, of Cambridge, UK, said they separately received the list of requirements regarding the purchase of 20 million doses of an MVA-based smallpox vaccine by the U.S. Department of Health and Human Services. The contract will be awarded to one or more companies who submit proposals by Sept. 29. Bavarian Nordic has ongoing contracts with the U.S. government to develop Imvamune, a third-generation smallpox vaccine that has received fast-track status from the FDA. Acambis' investigational vaccine, MVA3000, in development with partner Baxter Healthcare SA, is in Phase II studies.
Chlorogen Inc., of St. Louis, acquired an exclusive license to chloroplast transformation patents held by Rutgers, The State University of New Jersey. Those patents, developed at Waksman Institute, give the company freedom to operate in the field of chloroplast transformation technology.
Crucell NV, of Leiden, the Netherlands, and allied contract manufacturer DSM Biologics signed a PER.C6 research license agreement for recombinant protein production with Chiron Corp., of Emeryville, Calif. The agreement allows Chiron to evaluate the PER.C6 cell line for use in the manufacturing of Chiron's prophylactic hepatitis C vaccine.
CytoGenix Inc., of Houston, signed a contract with the engineering firm Alfa Laval Biokinetics Inc., of Philadelphia, for the design and construction of a prototype production module for CytoGenix's high-throughput DNA manufacturing technology. The production module will be a self-contained, closed-loop system that will produce gram quantities of high purity DNA in a single pass. Delivery is planned for the fourth quarter 2005.
Debiopharm SA, of Lausanne, Switzerland, and DeveloGen AG, of Goettingen, Germany, formed an exclusive worldwide collaboration in which Debiopharm will develop PTR-262, a peptide drug to treat myasthenia gravis, before out-licensing to global partners for commercialization. DeveloGen will receive milestone payments and potential royalties based on Debiopharm's revenues from worldwide sales.
Epimmune Inc., of San Diego, and IDM SA, of Paris, completed their previously announced merger. The combined company is headquartered in San Diego under the name IDM Pharma Inc., while the Paris facility operates as a wholly owned subsidiary. In closing the transaction, the company issued a 1-for-7 reverse stock split of all outstanding stock, including the shares issued to stockholders of IDM SA, leaving the firm with about 13.2 million shares outstanding. The new company's common stock (NASDAQ:IDMI) began trading Tuesday, closing at $6.99, down 4 cents. (See BioWorld Today, March 17, 2005.)
GeneMax Corp., of Vancouver, British Columbia, said a scientific paper co-authored by the company's chief scientific officer, Wilfred Jefferies, and his research collaborators from the University of British Columbia has been published in Cancer Research. The paper describes several aspects of Transporter Associated with Antigen Processing (TAP) deficiencies in metastatic murine carcinomas. The information will be useful in the development of new approaches to treat cancer by increasing cancer cell recognition by the immune system.
Genmab A/S, of Copenhagen, Denmark, initiated a Phase II study with HuMax-CD20 to treat patients with active rheumatoid arthritis who have failed treatment with one or more disease-modifying drugs. The trial will expand a previous 33-patient Phase I/II dose-escalation study to include about 200 patients randomized into four treatment groups. HuMax-CD20 is a human antibody designed to bind to the CD20 molecule on B cells.
Hawaii Biotech Inc., of Honolulu, said results of a third study showed that its West Nile vaccine candidate protected 100 percent of test animals from both illness and death after six months when challenged with a live virus, compared to 53.3 percent of animals in the control population. Two previous studies also demonstrated 100 percent protection, though the product's long-term durability was not assessed. An additional study to examine protection at one year is ongoing.
Intrac Inc., of New York, and its wholly owned subsidiary Innovative Drug Delivery Systems presented data Tuesday on the use of intranasal Ketamine for acute pain at the Departments of Defense's scientific event, the Advanced Technology Applications for Combat Casualty Care (ATACCC) 2005 conference.
Lantibio Inc., of Chapel Hill, N.C., and Apotex Fermentation Inc., of Winnipeg, Manitoba, signed an agreement to develop and supply Lantibio's lead compound, Moli1901, which is in development for dry eye syndrome and cystic fibrosis. Lantibio expects to start a Phase II trial with Moli1901 in the third quarter in dry eye syndrome. The agreement with Apotex provides access to the drug substance, method development, clinical batches, regulatory support, and supply of commercial batches in exchange for undisclosed royalties.
MassGeneral Institute for Neurodegenerative Disorders in Boston said a survey of the genome of patients with Huntington's disease (HD) has identified potential markers of disease progression. Researchers found a set of genes that are expressed at higher levels in blood samples from people with HD than in control samples, and the expression of those genes were observed to increase as the disease progressed from asymptomatic to symptomatic. The study was published in the Aug. 2 issue of Proceedings of the National Academy of Sciences.
Nektar Therapeutics, of San Carlos, agreed to sell about 1.4 million shares of its stock to an institutional investor at $16.71 a share. The total purchase price for the shares is about $24 million. Nektar will receive net proceeds of about $23.6 million after deduction of estimated offering expenses. Nektar granted the investor an option to purchase additional shares at any time before and including Sept. 15 at a price greater than 10 percent discount to the volume-weighted average price on the trading day immediately preceding the exercise date and $17.59, which if exercised in full would yield additional net proceeds of about $7.9 million to Nektar Therapeutics. Nektar will use the funds to pay for its acquisition of Aerogen Inc., disclosed Monday, for about $32 million.
Omnia Biologics Inc., of Rockville, Md., and lentiviral vector manufacturer Lentigen Corp., of Baltimore, signed a master services agreement for Omnia to provide Lentigen with access to its cGMP facilities and service. Financial terms were not disclosed.
Verus Pharmaceuticals Inc., of San Diego, launched in the U.S. its product Twinject, an epinephrine auto-injector indicated for the emergency treatment of severe allergic reactions. It is the only product approved by the FDA that contains two doses of epinephrine in a single device.
Vicuron Pharmaceuticals Inc., of King of Prussia, Pa., said its stockholders voted to approve the merger agreement in which Vicuron is being acquired by New York-based Pfizer Inc. The closing is expected to occur in the third quarter. Vicuron and Pfizer announced the $1.9 billion merger in June. (See BioWorld Today, June 17, 2005.)
ViroPharma Inc., of Exton, Pa., saw its shares jump almost 29 percent Tuesday after announcing a U.S. price increase for its Vancocin Capsules. According to an SEC filing, the wholesale acquisition for a 20-unit package of 125-mg capsules increased from $195.76 to $242.10, and a 20-unit package of 250-mg Vancocin Capsules rose from $368.86 to $446.32. ViroPharma bought all U.S. rights to the Vancocin antibiotic products last year from Indianapolis-based Eli Lilly and Co. for $116 million. Shares of ViroPharma (NASDAQ:VPHM) closed at $14.24 Tuesday, up $3.25. (See BioWorld Today, Oct. 20, 2004.)
Xenogen Corp., of Alameda, Calif., completed a private equity placement of common stock and warrants, raising $15 million in gross proceeds. Thomas Weisel Partners LLC served as the sole placement agent. The company sold about 5.2 million shares at $2.91 each and issued warrants to purchase 1.5 million shares at $3.29 each. (See BioWorld Today, Aug. 15, 2005