• Agenix Ltd., of Brisbane, Australia, said its AGEN BioMedical subsidiary entered a license and supply agreement for the D-dimer protein with Biosite Inc., of San Diego. Biosite plans to incorporate AGEN's 3B6 antibody, specific for D-dimer, into its Triage Profiler S.O.B. Panel, a potential diagnostic test intended to help identify the cause of shortness of breath, a symptom common to congestive heart failure, heart attack and pulmonary embolism. Financial terms were not disclosed.

• Alexion Pharmaceuticals Inc., of Cheshire, Conn., filed a shelf registration statement with the SEC to sell up to $150 million worth of securities, including common and preferred stock, debt securities and warrants. The company said it would use any net proceeds for general corporate purposes.

• Altus Biologics Inc., of Cambridge, Mass., said the FDA designated TheraCLEC as a fast-track product for the treatment of malabsorption due to exocrine pancreatic insufficiency. TheraCLEC is an orally delivered enzyme replacement therapy intended to replace digestive enzymes in patients suffering from pancreatic insufficiency. Altus plans to begin a pivotal international Phase II trial in the first quarter of next year to determine TheraCLEC's safety and efficacy in treating malabsorption due to pancreatic insufficiency in patients with cystic fibrosis.

• Ariad Pharmaceuticals Inc., of Cambridge, Mass., said results of a study published in the current issue of Cancer Research define, for the first time, the cause of progression of early stage prostate cancer. The discovery was made using a newly developed, predictive animal model of prostate cancer created with Ariad's cell-signaling regulatory technology. The research provides a means of developing and testing molecularly targeted drugs to prevent progression of early stage prostate cancer, an early intervention strategy aimed at decreasing the mortality and morbidity of that cancer.

• Avigen Inc., of Alameda, Calif., launched a new product development program for the treatment of severe chronic pain. A paper published in the Dec. 1, 2003, edition of Nature Reviews Drug Discovery by Avigen's collaborators at the University of Colorado at Boulder explains a new paradigm for understanding and treating severe chronic pain that is the basis for Avigen's new initiative. Data from a number of studies presented at last month's Society of Neuroscience meeting in New Orleans demonstrated proof of principle of this approach in several preclinical pain models.

• Bayer HealthCare LLC, of Tarrytown, N.Y., filed counterclaims against Gen-Probe Inc., of San Diego, in the pending arbitration proceeding before the Judicial Arbitration and Mediation Service in Orange County, Calif. Bayer is seeking material compensation from Gen-Probe. At a minimum, Bayer said the counterclaims demand tens of millions of dollars in damages for Gen-Probe's alleged ongoing violations of the parties' collaboration agreement for the development of various nucleic acid diagnostic assays and instruments, signed in June 1998. Bayer Healthcare is a member of the Bayer Group.

• BioTime Inc., of Berkeley, Calif., said the American Stock Exchange accepted its plan of compliance and granted the company an extension until April 2005 to regain compliance with continued listing standards. The company, which develops blood plasma volume expanders, blood replacement solutions and other products, does not meet AMEX guidelines as its shareholders' equity fell below $2 million. BioTime said it registered with the SEC for various offerings for the purpose of raising a significant portion of the capital needed to meet the requirement.

• Bruker Daltonics Inc., of Billerica, Mass., and SurroMed Inc., of Mountain View, Calif., entered a strategic partnership that includes SurroMed's acquisition of multiple Bruker Daltonics microTOF ESI-TOF mass spectrometers for use in SurroMed's Biomarker Discovery Laboratory, as well as collaboration on development of advanced software and sample fractionation products. Financial terms were not disclosed.

The Buck Institute for Age Research in Novato, Calif., said its researchers published findings in this week's online edition of the Proceedings of the National Academy of Sciences showing that brains affected by Alzheimer's disease may try to heal themselves by growing new nerve cells. The discovery, which contradicts the belief that neurogenesis diminishes as the disease progresses, instead raises the possibility that treatments could be developed to boost the natural process of nerve cell birth.

• Celltech Group plc, of London, said it would take back full rights to a compound called CDP 870 from Pfizer Inc., of New York. Following Pfizer's request to renegotiate financial terms of the collaboration, originally established in March 2001 with Pharmacia, Celltech said it was unwilling to make material changes to the agreement. At the time, the company said Pfizer sought a larger commercial share. It expects the transfer to occur early next year. The drug remains in Phase III studies in rheumatoid arthritis, and Celltech recently held a U.S. investigator meeting to begin Phase III trials of the PEGylated anti-TNF-alpha antibody fragment in Crohn's disease patients. It now plans to explore further indications for which TNF inhibitors have shown promise, such as psoriasis, psoriatic arthritis and ankylosing spondylitis, indications in which Celltech did not have rights within the original agreement. In parallel, the company plans to take a few weeks to review whether to outlicense rheumatoid arthritis rights to a new partner or to develop the indication in-house. Celltech added that it has received interest from a number of potential partners since announcing last month Pfizer's plans to delay CDP 870's development. (See BioWorld Today, Nov. 14, 2003.)

• ChondroGene Ltd., of Toronto, completed the acquisition of GeneNews Inc., of Ontario, which was previously reported on May 16. The company acquired all of GeneNews' outstanding shares through the issuance of 4 million ChondroGene common shares at C50 cents (US38 cents) apiece. GeneNews' principal asset is technology in which ChondroGene holds certain licensing rights in the areas of osteoarthritis, rheumatoid arthritis and traumatic joint injury.

The Cleveland Clinic in Cleveland said its researchers published findings in the Nov. 28, 2003, issue of Science identifying the first gene confirmed as a cause of coronary heart disease in humans. The gene, MEF2A, was discovered by studying the genetic makeup of 21 members of an Iowa family plagued for generations by incidents of coronary artery disease and heart attack. Researchers discovered a deletion mutation, noting that the elements missing from the gene represent 21 base pairs of nucleotides and seven amino acids. The deletion affects coronary artery walls, making them less able to protect themselves from plaque buildup and heart disease, they concluded.

• Cyanotech Corp., of Kailua Kona, Hawaii, said the Nasdaq listing qualifications panel determined it has shown compliance with all requirements necessary for continued listing on the Nasdaq SmallCap Market. Cyanotech produces natural products from microalgae.

• Diversa Corp., of San Diego, licensed an enzyme for the biocatalytic synthesis of a pharmaceutical intermediate to BASF Pharma, of Ludwigshafen, Germany. BASF will produce the biocatalyst and apply it in one of its biocatalytic processes to synthesize a chiral intermediate. It is the first product licensed under the broad collaborative agreement between the companies to develop biocatalysts and biological processes for a variety of chemical opportunities.

• EpiTan Ltd., of Melbourne, Australia, said Sydney University researchers reported Phase II results showing that treatment with Melanotan resulted in a significant increase in skin melanin in volunteers treated with the drug. Also, fairer-skin people (Types I/II) recorded increases in melanin of up to 100 percent in some areas and reduced sunburn injury by more than 50 percent in fair-skinned volunteers. EpiTan plans to file an FDA-approved investigational new drug application in the middle of next year.

• Faulding Pharmaceutical Co., of Paramus, N.J., and Faulding Puerto Rico Inc. changed their names to Mayne Pharma (USA) Inc. and Mayne Pharma (PR) Inc., respectively, as part of a global branding strategy of their parent company, Mayne Group Ltd. Mayne Pharma will continue to focus on expanding its offerings of hospital injectable products in therapeutic areas such as oncology, anesthesia/pain and anti-infectives, as well as drugs for cardiac conditions and hypertension.

• Gamida-Cell Ltd., of Jerusalem, said preclinical results show that its technology can produce an expanded population of stem cells with limited differentiation, without using animal serum. The company is planning to develop a serum-free version of its lead product, StemEx, a unit of an expanded population of stem cells. Gamida-Cell focuses on hematopoietic stem cell therapeutics in clinical development for cancer and autoimmune diseases, as well as regenerative cell-based medicines.

• Hard to Treat Disease Inc., of Delray Beach, Fla., said an independent medical group advised the company that Tubercin passed the toxicity tests required to proceed into live cancer trials. Testing of Tubercin on melanoma, lung and breast cancer cells will begin immediately, said the company, which holds international marketing rights, except in South Korea, to the anticancer immunostimulant. Tubercin is a product from Mycobacterium tuberculosis.

• Hemosol Inc., of Toronto, completed the sale of about $5.9 million worth of special warrants, an offering first reported on Nov. 7, after issuing about 7.8 million warrants at 75 cents apiece. The maximum size of the offering was 11.5 million special warrants. Each warrant will entitle the holder to acquire, at no additional cost, one common share and one-half of one warrant. Each whole warrant will entitle the holder to purchase one common share for 90 cents at any time for a period of 36 months following the closing, unless the volume-weighted average share price of a Hemosol common share is $2.25 or more for 20 consecutive trading days, in which case the warrants must be exercised within 30 days of the date of notice by Hemosol of such event. Hemosol plans to use the net proceeds to complete nonclinical analysis of Hemolink.

• ImClone Systems Inc., of New York, said its European partner, Merck KGaA, of Darmstadt, Germany, received Swiss regulatory approval for Erbitux (cetuximab) to treat patients with colorectal cancer who no longer respond to standard chemotherapy treatment with irinotecan. The approval, which allows the use of Erbitux in combination with irinotecan, stems from positive results from a 300-patient European trial. Merck has Erbitux rights outside the U.S. and Canada, though in Japan, Merck and ImClone have co-exclusive marketing rights. The product's FDA submission was accepted six weeks ago and is being reviewed under priority status. (See BioWorld Today, Oct. 14, 2003.)

• InKine Pharmaceutical Co. Inc., of Blue Bell, Pa., filed a registration statement with the SEC relating to a proposed public offering of 10 million common shares. InKine also granted the underwriters an overallotment option to purchase an additional 1.5 million shares. UBS Securities LLC, First Albany Capital and Rodman & Renshaw Inc. are the underwriters. UBS is the book-running manager.

• IsoTis OrthoBiologics SA, of Lausanne, Switzerland and Irvine, Calif., created a spin-off called EpiSource as an independent vehicle for its wound management portfolio, which includes EpiDex, Allox and AcuDress. EpiDex, a treatment for recalcitrant skin ulcers, was recently approved for sale in Switzerland. Meanwhile, the company said it completed patient recruitment for a Phase II dose-escalation trial of Allox, and AcuDress, a burn wound treatment, henceforth will be manufactured and shipped from EpiSource in Lausanne.

• Lorus Therapeutics Inc., of Toronto, said results were published in a November electronic version of the Journal of Pharmacology and Experimental Therapeutics from investigations aimed at characterizing a clotrimazole (CLT) analogue, NC 381. CLT is an antifungal drug that has demonstrated anticancer activity, but its potential is limited by high liver toxicity. The findings showed that when a chemical component of CLT responsible for toxicity was removed in designing the analogue NC 381, the new drug inhibited the growth of cancer cells in vitro by a mechanism of action that was similar to CLT. Also, NC 381 treatment significantly inhibited tumor growth in vivo in a mouse model of human lung cancer. The article also will be published in print in an upcoming issue of the journal. Lorus' stock (TSX:LOR) gained C16 cents Monday, or 15.7 percent, to close at C$1.18 (US90 cents).

• Monash University in Melbourne, Australia, entered a collaborative research and licensing agreement with Schering AG, of Berlin, which will fund the program for two years to develop potential therapies for prostate disease, male infertility and contraceptive options. Schering will combine its drug development processes with ongoing men's health research at the Monash Institute of Reproduction and Development, an institute of the university, and Prince Henry's Institute of Medical Research, also in Melbourne. Researchers initially will focus on the role of estrogens and cytokines in benign prostatic hyperplasia, and identify targets implicated in the control of male fertility as potential contraceptive candidates.

• Nabi Biopharmaceuticals, of Boca Raton, Fla., filed a registration statement with the SEC for an underwritten public offering of 8.5 million shares of its common stock. All shares will be offered by Nabi, and the underwriters will have an option to purchase up to an additional 1.275 million common shares to cover overallotments. Lehman Brothers Inc. will act as bookrunner, and Wachovia Securities, U.S. Bancorp Piper Jaffray and Harris Nesbitt Gerard will act as co-managers.

The Sidney Kimmel Cancer Center in San Diego said its researchers would publish preclinical cancer vaccine findings in the Dec. 9, 2003, issue of the Proceedings of the National Academy of Sciences showing that two injections of a vaccine suppress the growth of cancer cells for up to a year in mice. Those inoculated with the experimental vaccine developed an immune response to a marker that is present in increased levels on several types of cancer, including specific manifestations of cervical, breast, ovarian, colon and lung cancers. The researchers expect that the vaccine could be combined with chemotherapy or hormonal therapy to prevent the recurrence of breast and colon cancer that occurs in some patients following surgery.

• Taro Pharmaceutical Industries Ltd., of Hawthorne, N.Y., completed a $50 million offering of long-term, non-convertible debt to Israeli institutional investors. About $47 million of the debt was received in Israeli shekels and carries an annual interest rate of 5.8 percent linked to the Israeli Consumer Price Index. The balance was received in U.S. dollars and carries a fixed annual interest rate of 6.1 percent.

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