AltaRex Corp., of Waltham, Mass., received European orphan medicinal product status for OvaRex MAb (oregovomab) to treat ovarian cancer. The designation provides for a 10-year exclusive marketing period in all European Union member countries, full or partial exemption from product registration fees, and protocol and regulatory assistance. In the U.S., the FDA in 1996 granted the drug an equivalent designation, and two years later gave OvaRex MAb fast-track status.
Cambrex Corp., of East Rutherford, N.J., said its board approved a plan to build new laboratories and a pilot plant to support its recently expanded bioprocess development and scale-up services for clients with biologics in early stage development. The $5 million project is expected to take about nine months to complete and will add development and analytical laboratories and a scale pilot plant to the Cambrex Bio Science facility in Baltimore.
Cepheid Inc., of Sunnyvale, Calif., said it sold common stock to certain investors for net proceeds of about $10 million. The offered shares are registered under a universal shelf registration statement that was previously declared effective by the SEC. Cepheid is a developer, manufacturer and marketer of automated, integrated systems for on-site detection of DNA.
Endovasc Ltd. Inc., of Montgomery, Texas, said its Angiogenix studies investigated an animal model of chronic ischemia at Columbia University in New York, but did not involve an animal model of heart failure as initially indicated. Preliminary findings suggest that Angiogenix was capable of stimulating growth of new blood vessels and improving blood flow in the portions of the heart that were ischemic. The studies did not determine whether Angiogenix treatment induced growth of new heart muscle nor did they test the restoration of heart function, defined by improvement in heart strength.
Hemoxymed Inc., of New York, entered a merger agreement with Molecular Geriatrics Corp., of Vernon Hills, Ill., to establish a strategic alliance. After the proposed merger closes, shareholders from both parties will each own about 50 percent of the merged company, on a fully diluted basis. Based on Hemoxymed's stock price of 13 cents and 24.3 million shares outstanding, the deal would be valued at about $3.16 million.
Introgen Therapeutics Inc., of Austin, Texas, said it plans to file with European regulatory authorities an application for its adenoviral p53 product candidate, Advexin, to treat head and neck cancer simultaneously with a previously scheduled submission to the FDA of a biologics license application for Advexin in 2004. Introgen continues to enroll head and neck cancer patients in two global Phase III trials.
Invitrogen Corp., of San Diego, said its board authorized the repurchase of up to $300 million of its common stock over the next three years. This $300 million authorization supercedes an existing repurchase plan, which allowed for repurchases of up to $150 million. No shares were repurchased under the previous authorization, which was announced immediately following Sept. 11. Funds for the repurchase are expected to come primarily from cash generated from operations, or funds on hand. As of June 30, Invitrogen reported cash and marketable securities of about $1.1 billion.
Nymox Pharmaceuticals Corp., of Maywood, N.J., reported securing private placements with existing shareholders totaling $763,000. The placements were priced at $4 to $4.69 per share. The funds are for general corporate purposes.
Palatin Technologies Inc., of Cranbury, N.J., concluded an offering of 2.6 million shares that raised gross proceeds of $4.2 million. Investors included SCOR Picking, of Luxemburg; Credit Suisse Equity Fund Global Biotech, of Luxemburg; Perceptive Life Sciences Fund, of New York; Albert Fried and Co., of New York; and Finedix BV, of the Netherlands. Palatin said it would use the proceeds to continue development of its pipeline, including LeuTech, an infection imaging agent, as well as PT-141, a treatment for male and female sexual dysfunction.
Sangart Inc., of San Diego, reported no adverse events in a Phase I trial of Hemospan, a product designed to serve as an alternative to red blood cell transfusions. Hemospan, an oxygen transport technology, is chemically modified hemoglobin solution prepared from outdated human blood, designed specifically to maximize oxygen transport to tissues that need it most, the company said. Sangart also said it plans to file an investigational new drug application for Hemospan by year's end.
Thuris Corp., of Irvine, Calif., entered a research collaboration with Praecis Pharmaceuticals Inc., of Waltham, Mass., to use Thuris' RapidAging animal models to develop compounds for age-related therapeutic targets in the brain. Thuris will test certain compounds for Praecis and assess their effects against certain age-related pathologies. Specific terms of the agreement were not disclosed.