• Abbott Laboratories, of Abbott Park, Ill., submitted a supplemental biologics license application with the FDA and a Type II variation to the EMEA seeking approval to market Humira for the treatment of early rheumatoid arthritis. The company said results of a two-year Phase III premier study, involving 799 patients, found that nearly one in two with early rheumatoid arthritis experienced significant improvement in signs and symptoms while taking Humira in combination with methotrexate.

• Access Pharmaceuticals Inc., of Dallas, filed an investigational new drug application with the FDA for AP5346, its lead DACH polymer platinate compound. It uses Access's polymer drug delivery system to selectively deliver the cytotoxic DACH platinum to tumors. Upon receiving clearance, the company plans to begin a study of AP5346 in combination with two other cancer drugs, fluorouracil and leucovorin, in patients with progressive solid tumors.

• Alltracel Pharmaceuticals plc, of Dublin, Ireland, agreed to acquire London-based Westone Products Ltd. through a reverse takeover. Alltracel's shares were temporarily suspended pending the publication of an Alternate Investment Market admission document. Alltracel said the document was published and is being posted for all shareholders. The shares will begin trading again on AIM.

• Arena Pharmaceuticals Inc., of San Diego, started dosing patients in a Phase II trial of APD356, an orally administered small molecule designed to regulate satiety for the treatment of obesity. The trial will include 400 obese volunteers, and will compare doses of 1, 5 and 15 mg of APD356 to placebo in evaluating weight loss after once-daily administration for 28 days. The compound is a selective agonist of 5-HT2C serotonin receptors, which are concentrated in the hypothalamus. Initial results are expected in the second quarter of next year.

• Cell Therapeutics Inc., of Seattle, completed its previously announced sale of about 2.6 million common shares to several institutional investors at a negotiated price of $7.10 apiece. Upon announcing the deal, the company said the funds would prove useful as it advances several oncology programs. (See BioWorld Today, Dec. 22, 2004.)

• Centocor Inc., of Malvern, Pa., said the FDA approved Remicade (infliximab) for ankylosing spondylitis. The approval is the product's second in the U.S. in the past three months; its use in combination with methotrexate recently was approved as first-line therapy for patients with moderately to severely active rheumatoid arthritis. At the same time, the company noted that the FDA updated Remicade's existing warning label to describe a risk of pneumonia, and a warning on hepatotoxicity was added. The update describes rare post-marketing reports of severe hepatic reactions, including acute liver failure, jaundice, hepatitis and cholestasis, Centocor said.

• Cerus Corp., of Concord, Calif., acquired an exclusive license for the DNA sequence of mesothelin from Tokyo-based Chugai Pharmaceutical Co. Ltd. Terms of the agreement include an up-front payment, development milestone payments to Chugai and royalties on product sales. Cerus, which previously acquired rights for mesothelin from John Hopkins University, uses the antigen with its Listeria platform to develop active immunotherapies for treating pancreatic and ovarian cancers.

• Crucell NV, of Leiden, the Netherlands, signed a second PER.C6 license agreement with Chiron Corp., of Emeryville, Calif. The nonexclusive agreement allows Chiron to use the PER.C6 technology in manufacturing alphavirus vectors for its vaccine research programs. Financial details were not disclosed.

• Encysive Pharmaceuticals Inc., of Houston, reported topline results from STRIDE-4, a Phase III study of Thelin in patients with pulmonary arterial hypertension (PAH). For the primary endpoint of six-minute walk, patients treated with 100 mg of Thelin improved 58 meters vs. 22 meters for the 50-mg dose (p=0.014) and 34 meters with placebo (p=0.2). All other efficacy parameters, for which the trial was not powered, trended toward significance at the 100-mg dose vs. placebo: WHO class (p=0.038), time to clinical worsening (p=0.09) and Borg dyspnea scale (p=0.016). No patient receiving 100 mg of Thelin deteriorated in WHO class vs. 12 percent on placebo. There were three clinical worsening events with placebo vs. none on 100 mg of Thelin. The 50-mg dose showed no meaningful efficacy trends on any parameter. The company noted that the trial is unnecessary from a registration perspective; it expects to report pivotal results in February from its STRIDE-2 study.

• Enhance Biotech Inc., of New York, closed its merger with Ardent Pharmaceuticals Inc., of Durham, Calif. Ardent now is a wholly owned subsidiary of Enhance, a specialty pharmaceutical company developing a portfolio of products focused on lifestyle drugs. The new portfolio offers a pipeline ranging from preclinical new chemical entities to later-stage products addressing urology, dermatology and the central nervous system. Enhance's pre-existing stockholders own about 55 percent of the combined company, with former Ardent shareholders owning the remainder. Their deal was struck three months ago. (See BioWorld Today, Aug. 13, 2004.)

• Epigenomics AG, of Berlin, identified a set of DNA-methylation biomarkers that correlate with prostate cancer aggressiveness. The research is part of a program to develop a prostate cancer classification test in partnership with Roche Diagnostics, a unit of F. Hoffmann-La Roche Ltd., of Basel, Switzerland. Meeting the milestone triggered an undisclosed payment to Epigenomics, which now has identified biomarkers for all five initial products in its diagnostic collaboration with Roche.

• Generex Biotechnology Corp., of Toronto, ended its buccal morphine joint venture with Elan Corp. plc, of Dublin, Ireland. As a result, a related agreement will result in the conversion of $14.3 million of Generex preferred stock owned by Elan into Generex common stock at a voluntary conversion ratio of about $25.28 per share, specified in the original terms of the preferred stock. Shares of Generex closed Monday at 65 cents, increasing the company's net worth by $14.3 million.

• Genzyme Corp., of Cambridge, Mass., completed its $1 billion stock acquisition of ILEX Oncology Inc., of San Antonio. The deal, announced earlier this year, adds to the foundation of Genzyme's oncology business. ILEX brings with it a marketed product, a second product nearing approval and a third in Phase II development. Genzyme will continue to maintain operations in San Antonio and has retained a large majority of ILEX employees. ILEX shares have ceased trading and were delisted from Nasdaq. (See BioWorld Today, March 1, 2004.)

• Hemosol Corp., of Toronto, received an additional 180-day extension from Nasdaq to regain compliance with the $1 minimum bid price requirement. In June, the company was granted an extension to Dec. 20. The company's stock (NASDAQ:HMSL) rose 6 cents Wednesday to close at 74 cents.

• Icoria Inc., of Research Triangle Park, N.C., said it has a June deadline to bring its share price above the $1 minimum bid price required for listing on the Nasdaq SmallCap Market. Icoria focuses on applying systems biology to gain a better understanding of how genes and proteins function in biological systems. Earlier this month, Icoria transferred the listing of its common stock from the Nasdaq National Market to the Nasdaq SmallCap Market.

• ID Biomedical Corp., of Vancouver, British Columbia, entered an asset-backed loan agreement with Vancouver-based Second City Capital Partners for $60 million in proceeds. ID Biomedical has agreed to issue to SCC warrants to acquire an aggregate of 1.2 million common shares at US$16.91 per share. The transaction is expected to close in January. ID Biomedical will use the proceeds to repurchase about 4.9 million subscription receipts from Shire BioChem Inc. as part of the $120 million acquisition of Basingstoke, UK-based Shire Pharmaceuticals Group plc's vaccine business, which was completed in September. (See BioWorld Today, April 21, 2004.)

• ImmuCell Corp., of Portland, Maine, announced a product development and marketing agreement with Pfizer Animal Health, a division of New York-based Pfizer Inc. for Mast Out, a Nisin-based treatment for mastitis in lactating dairy cows. ImmuCell will receive an up-front payment from Pfizer, contingent milestone payments and royalties on sales. Shares for ImmuCell (NASDAQ:IMMC) rose 121 percent, to close at $9.39.

• Innogenetics, of Ghent, Belgium, said it achieved its first milestone under a May 2001 research and development collaboration with Roche Diagnostics, a unit of F. Hoffmann-La Roche Ltd., of Basel, Switzerland, regarding the development of a rapid molecular microbiology testing assay. Innogenetics is set to receive a payment of ]5 million from Roche before the end of the year. The agreement also provides for additional milestones to Innogenetics upon completion of specified deliverables defined in the development program, and it would receive royalties.

• NexMed Inc., of Robbinsville, N.J., closed a private placement with institutional and other accredited investors resulting in gross proceeds to the company of more than $7 million. NexMed sold 5.5 million shares at $1.28 each, and the investors also received five-year warrants to purchase 2.2 million shares at $1.47 per share, and one-year warrants to purchase 549,536 shares at $2 per share. NexMed plans to use the proceeds for general corporate purposes and for its product development programs based on the NexACT technology.

• OxiGene Inc., of Waltham, Mass., began a Phase I trial of OXi4503 in advanced cancer patients. The company said animal studies have shown the product's antitumor activity as both a single agent and in combination therapy. The dose-escalating trial's primary endpoints will evaluate its safety, tolerability and pharmacokinetics.

• Pharmexa A/S, of Hoersholm, Denmark, acquired a portfolio of intellectual property rights within the field of immunotherapy from Vectron Therapeutics AG, of Marburg, Germany. The technologies cover targeted liposomal delivery systems and recombinant antibody-like proteins known as single-chain diabodies. Vectron is in liquidation. Specific financial terms were not disclosed, but Pharmexa said the deal would not have an effect on its financial expectations for this year or next.

• Pharming Group NV, of Leiden, the Netherlands, said the FDA approved its investigational new drug application for recombinant human C1 inhibitor (rhC1INH). Based on the approval, the company has expanded the clinical development of rhC1INH for the treatment of hereditary angioedema to the U.S. Pharming will assess the safety and efficacy of rhC1INH to treat acute attacks of hereditary angioedema in its U.S. clinical trials; the protocol involves a randomized, double-blinded, placebo-controlled trial. Pharming will test two doses of rhC1INH.

• PPD Inc., of Wilmington, N.C., and Syrrx Inc., of San Diego, submitted an investigational new drug application to the FDA for a Syrrx-designed human dipeptidyl peptidase IV (DPP IV) inhibitor, SYR619, for the treatment of Type II diabetes. The product stems from a year-old collaboration to jointly develop and commercialize Syrrx-designed DPP IV inhibitors for diabetes and other diseases. The companies already submitted an investigational new drug application for another product from the agreement, SYR322, and it has advanced into multidose studies in patients. It is expected to enter Phase II studies next quarter.

• Santarus Inc., of San Diego, said the FDA approved the new drug application for Zegerid (omeprazole) powder for oral suspension 40 mg, for the reduction of risk of upper gastrointestinal bleeding in critically ill patients and the short-term treatment of active benign gastric ulcers. Zegerid is the first immediate-release oral proton pump inhibitor and the only one approved for use in critically ill patients, the company said. Santarus and its co-promotion partner, Otsuka America Pharmaceutical Inc., of Rockville, Md., plan to launch the product in the first quarter.

• Serologicals Corp., of Atlanta, closed its public offering of 4.8 million shares of common stock at $22.80 per share. The company reported net proceeds of $105.2 million with an additional $13.7 million resulting from the overallotment option. The company said $80 million will repay term indebtedness stemming from its October acquisition of Upstate Group Inc., of Charlottesville, Va.

• St. Jude Children's Research Hospital in Memphis, Tenn., said its researchers published findings online in the Dec. 16, 2004, issue of the EMBO Journal detailing their discovery that the shape of a protein on the surface of pneumonia bacteria helps it invade the human bloodstream. The protein, called CbpA, binds to a molecule on the cell called pIgR, which takes antibodies from the bloodstream on one side of the cell and transports them to the other side. There it releases the antibody at the lining of the throat and lungs.

• Stratagene Corp., of San Diego, released its Mx3005P Real-Time PCR System. The product's open-platform design supports all fluorescent dyes and chemistries, including Stratagene's FullVelocity reagents.

• Tapestry Pharmaceuticals Inc., of Boulder, Colo., submitted an investigational new drug application to the FDA for its novel taxane TPI 287. The company said preclinical testing demonstrated the product's ability to inhibit tumor cell growth in a number of in vitro cell lines. Tapestry expects to begin Phase I trials with TPI 287 in the first half of 2005.

• Theratechnologies Inc., of Montreal, received $12 million from ALZA Corp., of Mountain View, Calif., for its interest in co-development products using ALZA's Macroflux transdermal technology. The company also requested a meeting with the FDA in March 2005 to discuss advancing its growth hormone-releasing factor, ThGRF, into late-stage development. Theratechnologies said the compound showed promising results in Phase II testing for the treatment of HIV-related lipodystrophy, a metabolic disorder that affects HIV patients.

• Therion Biologics Corp., of Cambridge, Mass., said results of its Phase I study for the therapeutic cancer vaccine, CEA/TRICOM, were published in the Journal of Clinical Oncology. The company said researchers studying multiple dosing regimens in 58 patients found that disease stabilization was achieved for at least four months in 40 percent of the participants and for more than six months in 24 percent.

• Tripos Inc., of St. Louis, agreed to acquire molecular discovery software company Optive Research Inc., of Austin, Texas, to provide customers with a broader range of informatics solutions. Tripos will issue 599,521 shares of its common stock and $4.75 million in cash to Optive's shareholders. The cash portion will be funded by a group of new investors through0 the issuance of $3.5 million of subordinated debt, 111,606 shares of common stock and warrants to purchase 156,250 shares of common stock. The acquisition is expected to close in January.

• Vivus Inc., of Mountain View, Calif., filed a $50 million shelf registration statement to sell common stock from time to time or in one or more offerings. The company said it plans to use the proceeds for any future offering for general corporate purposes, including clinical research and development programs, capital expenditures and working capital for manufacturing needs.

No Comments