• Acorda Therapeutics Inc., of Hawthorne, N.Y., said it intends to sell 3.4 million shares of common stock in an underwritten public offering. Shares have not yet been priced. In addition, Acorda plans to grant underwriters a 30-day option to purchase up to an additional 525,000 shares. Proceeds are expected to help the company complete its second Fampridine-SR Phase III trial and for other activities related to the filing of a new drug application for Fampridine-SR. Funds also will go toward research and development activities and general corporate purposes. Bank of America Securities LLC and Deustche Bank Securities are acting as joint book-running managers.
• Amazon Biotech Inc., of New York, effected a reverse split of its outstanding voting securities on a 1-for-3 basis. The move is expected to provide financing for the company's upcoming clinical trials. Amazon is developing AMZ0026, an immunomodulator drug for HIV/AIDS.
• Copernicus Therapeutics Inc., of Cleveland, said a research team demonstrated that the company's DNA nanoparticles corrected vision defects in a mouse model of retinitis pigmentosa. Copernicus, which is developing nucleic acid nanoparticles, said those positive data suggest that the technology also might be efficacious in treating more complex disorders, such as diabetic retinopathy and macular degeneration. Findings were presented at the American Society of Gene Therapy meeting in Seattle.
• Danube Pharmaceuticals Inc., of New York, and Aptuit Inc., of Greenwich, Conn., entered a deal in which Aptuit will provide Danube with a full range of drug development services and employ five of its facilities to develop and manufacture Danube's investigational compound to support upcoming Phase II studies. Financial terms were not disclosed.
• Hemispherx Biopharma Inc., of Philadelphia, said in vitro studies of Ampligen combined with the neurominidase inhibitor oseltamivir (Tamiflu) against avian influenza showed synergistic inhibition of viral-induced cell destruction, at doses exceeding a certain threshold. Similar results were seen when Ampligen was combined with zanamivir (Relenza). Results were presented at the International Conference on Avian Influenza in Paris.
• Immunomedics Inc., of Morris Plains, N.J., said Phase II data reported at the Society of Nuclear Medicine meeting in Washington, showed that its anticarcinoembryonic antigen antibody, labetuzumab, labeled with the radioisotope iodine-131, was found to be safe and active when given in two doses to patients with colorectal cancer that has metastasized to the liver. At the time of reporting, 10 of 16 patients in the adjuvant group, or 62.5 percent, remained disease-free. For the 16 in the non-adjuvant group, 25 percent reported no cancer relapse.
• Pharmaxis, of Sydney, Australia, said the European Mutual Recognition Procedure has completed evaluating its lung function test Aridol, meaning the 13 European countries involved can issue a marketing authorization. The countries are Germany, France, the UK, Italy, the Netherlands, Belgium, Denmark, Greece, Spain, Finland, Ireland, Norway and Portugal. Aridol already is being marketed in Sweden and Australia. Aridol is administered as a dry powder in a hand-held inhaler, and doctors can use the test results to identify airway hyper-responsiveness.
• Pharmion Corp., of Boulder, Colo., said the French regulatory authority has granted a temporary authorization for use (ATU) for Thalidomide (thalidomide) for the treatment of untreated multiple myeloma. An ATU makes non-approved drugs available to patients in France, when a genuine public health need exists. The ATU allows Pharmion to supply Thalidomide to elderly patients with untreated multiple myeloma on a cohort basis, and expands the ATU previously granted for Thalidomide for the treatment of relapsed/refractory multiple myeloma patients to include previously untreated multiple myeloma patients. The ATU was based on the three-arm IFM 99-06 study involving 447 subjects that demonstrated the superiority of melphalan/prednisone plus Thalidomide (MPT) over standard therapy of melphalan/prednisone (MP) or a combination of chemotherapies (vincristine/adriamycin/dexamethasone, or VAD) followed by melphalan and transplantation (MEL 100) in the treatment of newly diagnosed elderly multiple myeloma patients. At final analysis, the median overall survival in the MPT arm was 53.6 months, compared to 32.2 and 38.6 months, respectively, for the MP and MEL 100 arms.
• Qiagen NV, of Venlo, The Netherlands, has purchased Digene Corp., of Gaithersburg, Md., in a $1.6 billion cash and stock deal that will result in Digene's merger into a subsidiary of Qiagen. The agreement, already approved by the boards of directors of each company, will be effected as an exchange offer. Digene shareholders may elect to receive for each Digene share either $61.25 in cash or 3.545 shares of QIAGEN stock, subject to pro-ration so that the total consideration issued for Digene stock is 55 percent cash and 45 percent Qiagen stock. The $61.25 per share is a 37 percent premium on the companies' closing stock prices on June 1. The companies expect that the stock portion of the consideration will be tax-free to Digene shareholders and Qiagen shareholders will own approximately 78 percent of the combined company on a fully diluted basis, and Digene shareholders will own approximately 22 percent. Qiagen said it expects the deal will contribute revenues of about $58 million to $60 million in the fourth quarter 2007 and approximately $260 to $270 million for the full year of 2008. Excluding one-time charges, integration and restructuring costs and amortization, the acquisition is expected to dilute Qiagen's adjusted EPS by 3 cents to 4 cents in the fourth quarter 2007. The transaction is expected to be accretive to Qiagen's adjusted earnings per share in 2008 by 2 cents to 4 cents. The new company combines Qiagen's portfolio of sample and assay technologies, including a panel of molecular diagnostic tests, with Digene's work in HPV-targeted molecular diagnostic testing. In 2008 the combined company is expected to have more than $350 million of molecular diagnostics revenues and more than $800 million in revenues. Qiagen stock (NASDAQ:QGEN) traded down $1.70, or 9.8 percent, Monday, closing at $15.58.