• Biopure Corp., of Cambridge, Mass., received a Wells Notice from the SEC indicating a preliminary decision to bring a civil injunctive proceeding against the company. The company's CEO and former senior vice president of regulatory and operations also received notices. Biopure intends to respond in writing. It believes the notices relate to the company's disclosures concerning its communications with the FDA about a trauma study protocol submitted to the agency in March 2003, as well as its biologics license application for Hemopure (hemoglobin glutamer - 250 [bovine]). Hemopure, an investigational product in North America and Europe, is approved in South Africa for the treatment of acutely anemic surgical patients and for the elimination, delay or reduction of red-blood-cell transfusions in those patients. The FDA placed a clinical hold on the proposed trauma trial due to safety concerns, and thus far, has failed to lift it. The company withdrew the protocol while it continues to develop its trauma program. (See BioWorld Today, Aug. 4, 2003.)

• BioSyntech Inc., of Laval, Quebec, appointed Claude LeDuc president and CEO. He will assume his new functions on March 1. Most recently, he was the Director of Asia Pacific for the entire portfolio of Genzyme Biosurgery, a unit of Genzyme Corp., of Cambridge, Mass. BioSyntech specializes in the manufacturing of regenerative medicine products and therapeutic delivery systems.

• Cambridge Antibody Technology Group plc, of Cambridge, UK, restructured an agreement with Amgen Inc., of Thousand Oaks, Calif., under which Amgen will take over responsibility for development of antibodies covered in the deal initially signed by CAT and Immunex Corp., of Seattle. Amgen inherited the agreement on acquiring Immunex. Terms of the restructured deal give Amgen responsibility for further development and marketing of the therapeutic antibody candidates isolated by CAT against two targets on which the parties agreed to collaborate. CAT will receive an undisclosed initial fee from Amgen, as well as potential milestones and royalties. One candidate has been delivered by CAT, and a second is the subject of research being funded by Amgen but conducted by CAT. More specific financial terms were not released. (See BioWorld Today, May 22, 2001.)

• Curis Inc., of Cambridge, Mass., filed a $40 million universal shelf registration statement with the SEC to allow the company to sell various securities in one or more future offerings. The terms of any such offering will be established at the time of sale, though the therapeutic drug development company noted that it has no immediate plans for an offering.

• Dyax Corp., of Cambridge, Mass., reported positive initial results from its Phase I/II study of DX-88 in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery. The study met its primary endpoints of safety and DX-88's pharmacokinetic profile. Related to a second endpoint, patients treated with DX-88 had about a 50 percent reduction in total blood transfusion needs, as compared to placebo. The double-blinded, placebo-controlled, dose-ranging study recruited 42 patients considered at low risk for peri- and post-operative complications. Thirty-one patients were treated with the recombinant small protein and 11 received placebo.

• Elan Corp. plc, of Dublin, Ireland, intends to sell its European sales and marketing business for about $120 million to Medeus UK Ltd., a new UK pharmaceutical business backed by Apax Partners Funds. Elan plans to retain operations in Athlone, Ireland, and its research and development operations in Stevenage, UK, and separately expects to sell certain rights to two products in the UK and Ireland for about $10 million. The transaction with Medeus includes the divestment of its sales and marketing operation in the UK and 100 percent of the equity in Elan sales and marketing affiliates in Germany, France, Spain, Italy and Ireland. In 2002, Elan recorded net revenue and gross profits for those products of $70.1 million and $50.7 million, respectively. For the first nine months of 2003, Elan recorded net revenue and gross profit for those products of $56.4 million and $38.7 million, respectively. Elan believes it will record a pretax gain of about $10 million from the transaction.

• Gen-Probe Inc., of San Diego, received FDA clearance for sexually transmitted disease testing on its Tigris DTS System, a fully automated, high-throughput instrument for molecular diagnostics. The system was approved to run the company's Aptima Combo 2 assay, an FDA-approved amplified nucleic acid test for simultaneously detecting Chlamydia trachomatis and Neisseria gonorrhoeae. Gen-Probe's stock (NASDAQ:GPRO) gained $4.17 Monday, or 12.6 percent, to close at $37.34.

• Immunomedics Inc., of Morris Plains, N.J., said findings published in the Dec. 15, 2003, issue of Clinical Cancer Research showed that its new candidate cancer therapeutic, IMMU-110, was successful in treating a human Burkitt non-Hodgkin's lymphoma that grows in severely immunodeficient mice. The agent consists of a humanized monoclonal antibody against the CD74 marker, conjugated with doxorubicin, a cancer drug.

• Invitrogen Corp., of Carlsbad, Calif., signed a definitive agreement to acquire BioReliance Corp., of Rockville, Md., in a transaction estimated at about $500 million, including the assumption of about $70 million in debt. Invitrogen will make a cash tender offer of $48 per share of BioReliance, a contract service organization that provides testing, development and manufacturing services for biologic-based drugs. Invitrogen, which provides life science technologies for disease research, drug discovery and commercial bioproduction, expects to begin the tender offer within the next 10 business days. Both companies' boards approved the transaction, which is expected to close near the end of next quarter. Invitrogen said it expects the purchase to be accretive to its pro forma earnings per share by about 19 cents next year.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., began a Phase I study of ISIS 301012, a second-generation antisense inhibitor of ApoB-100, for cardiovascular disease. ApoB-100 is the carrier of low-density lipid cholesterol, the "bad" lipid involved in heart disease and a target of interest but considered undruggable by traditional approaches. The double-blinded, placebo-controlled, dose-escalation trial will enroll 40 healthy volunteers with elevated cholesterol to assess the candidate's safety, tolerability and pharmacokinetic profile, and its ability to reduce several components of cholesterol that are important in the management and prevention of cardiovascular disease.

• Linguagen Corp., of Cranbury, N.J., received a $2 million equity financing commitment from S.R. One Ltd., a wholly owned venture capital subsidiary of GlaxoSmithKline plc, of London, increasing Linguagen's Series A round of funding to $12.2 million. The privately held company, which develops ingredients used to improve the taste of food, beverages and pharmaceutical products, has investments from NJTC Venture Fund SBIC LP, Cargill Ventures, Danisco Venture A/S, DuPont Ventures, Aperture Venture Partners LLC and RK Ventures Group LLC.

• Lipid Sciences Inc., of Pleasanton, Calif., said it substantially completed the issuance of about 3.1 million common shares to individuals and entities who were stockholders of NZ Corp., its predecessor corporation, prior to the merger of NZ Corp. and the pre-merger of Lipid Sciences Inc., which perfected rights granted to them in connection with the merger. In order to perfect their rights, such stockholders were required to, among other things, hold their pre-merger shares for the 24-month period immediately following the merger, which was completed in November 2001. Each perfected right entitled the holder to receive one additional share of the company's common stock. As of Nov. 29, 2003, a total of about 3.1 million rights were perfected, while about 87,000 additional rights are still pending determination.

• Medicure Inc., of Winnipeg, Manitoba, received C$14.6 million (US$11.2 million) after investors exercised 99 percent of the company's common share purchase warrants and agents' compensation units. The warrants and units, which expired on Dec. 20, 2003, were part of Medicure's public offering that closed on Dec. 20, 2001. A total of about 16.8 million warrants were exercised at C81 cents per share, and about 1.5 million units were exercised at C65 cents apiece. Each consisted of one common share and one common share purchase warrant.

• Meridian Bioscience Inc., of Cincinnati, said it is extending the expiration date until Jan. 28 for its offer to exchange 5 percent convertible subordinated debentures due 2013 in the principal amount of $16 million for an equal amount of outstanding 7 percent convertible subordinated debentures due 2006 and related withdrawal rights, unless extended or earlier terminated by the company. Meridian makes diagnostic test kits, purified reagents and offers biopharmaceutical enabling technologies.

• Nabi Biopharmaceuticals Inc., of Boca Raton, Fla., completed its recently reported common stock offering, which generated net proceeds of about $92 million through the issuance of about 9.8 million shares. The company also issued an additional 1.3 million shares through the underwriters' exercise of an overallotment option. About $20 million will be used to develop or acquire internal commercial manufacturing capacity for StaphVAX, Nabi's lead product in development for preventing Staphylococcus aureus bloodstream infections, and $9.5 million will be used to repay a loan under an existing credit agreement. (See BioWorld Today, Dec. 19, 2003.)

• NaPro BioTherapeutics Inc., of Boulder, Colo., said the federal district court in the Western District of Pennsylvania ruled again in its favor in a case against Mylan Laboratories Inc., of Pittsburgh, regarding certain paclitaxel formulation patents. The court found that the patents are valid and that Mylan's claims that the patents were procured through inequitable conduct and fraud on the patent office were neither true nor justified. In October, the court ruled that Mylan infringed the patents. A trial to determine damages owed by Mylan was scheduled for May 24.

• NsGene A/S, of Copenhagen, Denmark, raised DKK18 million (US$3 million) after closing a second round or private equity funding from existing investors. The financing included NeuroSearch A/S, from which NsGene was spun off, as well as other investors, and it increased the company's total funding raised to date to DKK83 million. Privately held NsGene said the latest funding puts it in a position to further develop its technologies and products to the point of partnering opportunities in the next couple of years. The company is developing cell- and gene-based products for neurological diseases.

• PDI Inc., of Upper Saddle River, N.J., signed an agreement with Novartis Pharmaceuticals Corp., a U.S. affiliate of Novartis AG, of Basel, Switzerland, calling for 300 representatives to support Diovan and Lotrel. The contract replaces the one ending Dec. 31. The new contract is scheduled to end next Dec. 31.

• Trinity Biotech plc, of Dublin, Ireland, received FDA approval to market its Uni-Gold Recombigen HIV test for the detection of antibodies to HIV in human serum, plasma or whole blood. The company called the device the first to be approved for use with all three sample types. Uni-Gold Recombigen HIV, which demonstrated a test sensitivity of 100 percent and a specificity of more than 99.7 percent among 9,000 patients, requires only one step and produces a result within 10 minutes. Trinity's stock (NASDAQ:TRIB) gained $1.86 Monday, or 56.7 percent, to close at $5.14.