• Antisense Therapeutics Ltd., of Melbourne, Australia, and Isis Pharmaceuticals Inc., of Carlsbad, Calif., initiated a Phase IIa trial of ATL1102 in patients with multiple sclerosis. ATL1102 is a second-generation antisense inhibitor of VLA-4, which has demonstrated positive effects in multiple animal models of inflammatory diseases, including MS. The trial will enroll about 60 patients with relapsing-remitting MS. They will receive 400 mg of ATL1102 or placebo weekly by a subcutaneous injection over eight weeks.

• AVI BioPharma Inc., of Portland, Ore., entered a Cooperative Research and Development Agreement with the Walter Reed Army Institute of Research to examine the effect of AVI's antisense agents against dengue and other flavivirus infections. AVI's previous work with the Department of Defense and its experience with Neugene technology led to the establishment of the agreement with Walter Reed. Financial terms were not disclosed.

• Biogen Idec Inc., of Cambridge, Mass., and Elan Corp. plc, of Dublin, Ireland, initiated a head-to-head study comparing the safety and efficacy of Tysabri (natalizumab) to Rebif (interferon beta-1a) in relapsing-remitting multiple sclerosis. The randomized study will enroll more than 1,000 MS patients in North and South America, Europe, Australia, Turkey and Israel. Patients will either receive treatment with Rebif, administered subcutaneously at 44 mcg three times a week, or receive treatment with Tysabri, administered as a 300-mg intravenous infusion once every four weeks. The primary endpoint will compare the effect of Tysabri to Rebif on the rate of clinical relapses. Secondary endpoints include analysis of the proportion of patients remaining relapse-free, MRI brain scans, safety, tolerability and quality of life. Tysabri gained FDA approval in November. (See BioWorld Today, Nov. 29, 2004.)

• Cephalon Inc., of West Chester, Pa., submitted a supplemental new drug application to the FDA requesting marketing approval of Attenace tablets, a dosage form of modafinil, for the treatment of attention deficit hyperactivity disorder in children and adolescents. The company planned to file the application during the first quarter of 2005 but decided to proceed at the end of 2004 after announcing results from three multicenter clinical trials. Cephalon said it expects to launch the dose by early 2006.

• ChondroGene Ltd., of Toronto, entered a new two-year research collaboration with Pfizer Inc., of New York, for the identification of therapeutic targets and biomarkers for the treatment and diagnosis of osteoarthritis. The collaboration will continue the work in two research programs that were initiated in the first collaboration with Pfizer that started in October 2002, and provides Pfizer with access to ChondroGene's database of osteoarthritis tissue-specific clinical and gene-expression information to identify potential therapeutic targets. The agreement also will allow ChondroGene to accelerate its ongoing osteoarthritis biomarker research program. The collaboration is valued at up to about $7.4 million.

• CollaGenex Pharmaceuticals Inc., of Newtown, Pa., completed patient screening and enrollment of 528 patients for its two multicenter, double-blinded, placebo-controlled Phase III studies to evaluate Oracea in treating rosacea. CollaGenex anticipates the study will be completed in the second quarter. Patients will be dosed for 16 weeks with either Oracea or placebo and researchers will evaluate the clinical indices of rosacea. The Phase III studies are being conducted at 28 centers across the U.S.

• Flamel Technologies SA, of Lyon, France, signed an agreement with London-based GlaxoSmithKline plc, to provide its Micropump formulation of a marketed GSK drug. Provisions of the agreement include undisclosed payments, and Flamel will not have cash outlays in connection with the equipment used. Flamel's Micropump technology was licensed to GSK for the drug in March 2003.

• Genmab A/S, of Copenhagen, Denmark, and Medarex Inc., of Princeton, N.J., reported positive data from a Phase I/II trial using the antibody HuMax-Inflam/MDX-018 to treat patients suffering from an autoimmune disease, although the companies did not disclose details concerning the specific indication. Fifty-seven percent, or 16 of 28, patients who completed the study achieved a 50 percent or more reduction compared with baseline in the primary endpoint measure of disease activity one week after final dosing, at week 8. In the highest dose group (8/4 mg/kg), all seven patients saw a 50 percent or more reduction in disease activity. At one week after the initial dose, 14 patients achieved a 50 percent or more reduction in disease activity with five out of seven patients in the highest dose group seeing that level of disease improvement. In a pooled analysis of all dose groups after eight weeks, a statistically significant mean reduction in disease activity of 56 percent was gained.

• Iconix Pharmaceuticals Inc., of Mountain View, Calif., said that the National Cancer Institute in Bethesda, Md., awarded the company a Phase I SBIR grant to develop an in vitro system to detect specific forms of liver pathology. The grant will allow Iconix to expand the application of its chemogenomics technology designed to enable early, high-volume testing of drug candidates and environmental chemicals for their potential long-term effects on the liver.

• ImmuneRegen BioSciences, of Scottsdale, Ariz., a wholly owned subsidiary of IR BioSciences Holdings Inc., made its test results on the Hong Kong influenza virus available for review. Company executives said they believe the research might indicate efficacy of their compound Viprovex in treating the Hong Kong respiratory virus in mice. Viprovex is the brand name for Homspera. Currently in development, Viprovex is a treatment for the application of infectious diseases such as severe acute respiratory syndrome.

• Immunicon Corp., of Huntingdon Valley, Pa., extended its research and development agreement with Pfizer Inc., of New York. Terms of the deal call for the company to collaborate with Pfizer to develop new reagents designed to detect certain undisclosed antigens on circulating tumor cells. It dates to February 2003 and was amended last April, and now has been amended to extend the term to February 2006. Immunicon will receive payments in support of its work with Pfizer, which has the right to terminate, with or without reason, upon written notice to Immunicon, in which case Pfizer's only obligation will be to pay for services performed up to the termination date, plus payment for any non-cancelable obligations.

• Insmed Inc., of Richmond, Va., said it believes recent allegations by South San Francisco-based Tercica Inc. are "without merit," and Insmed intends to "vigorously defend" its "position and right to make SomatoKine." Tercica brought legal action in the UK against Insmed and its contract manufacturer, Avecia Ltd., of Billingham, UK, challenging Insmed's right to make, use and sell its IGF-replacement hormone SomatoKine in the UK. Tercica said the companies are infringing a European patent under which Tercica holds an exclusive license. Insmed also received a cease and desist letter from Tercica regarding certain activities the company is conducting in the U.S. Tercica's legal actions are not expected to delay the filing of Insmed's new drug application for SomatoKine to treat growth hormone insensitivity syndrome.

• Inspire Pharmaceuticals Inc., of Durham, N.C., started a second Phase II trial to evaluate INS37217 Respiratory (denufosol tetrasodium) against cystic fibrosis. The study will compare two doses of INS37217 Respiratory to placebo in 72 CF patients. The drug or placebo will be administered three times daily for 28 days by standard jet nebulizer. The second study is to gain a greater understanding of safety and tolerability of the drug in a broader population of CF patients. The broader population will include patients using antibiotics and other therapeutics and the study will include patients with lower lung function as low as 60 percent.

• Invitrogen Corp., of Carlsbad, Calif., and Illumina Inc., of San Diego, entered a collaboration to leverage their respective strengths in nucleic acid synthesis and distribution to deliver oligonucleotides to the life sciences market worldwide. The collaboration is designed to expand Illumina's Oligator DNA synthesis technology and combine that with Invitrogen's sales, marketing and distribution channels.

• Lexicon Genetics Inc., of the Woodlands, Texas, said Roche Palo Alto LLC renewed its license agreement for nonexclusive rights under Lexicon patents that cover gene-targeting technologies for the generation of knockout mice in internal drug discovery research. Financial terms were not disclosed.

• Nabi Biopharmaceuticals, of Boca Raton, Fla., submitted a marketing authorization application to the European Agency for Evaluation of Medicinal Products under the centralized procedure for approval to market StaphVAX (Staphylococcus aureus polysaccharide conjugate vaccine) in the European Union. The indication sought under the EU license is for the prevention of S. aureus bacteremia in patients with end-stage renal disease on hemodialysis for up to 40 weeks.

• NeoPharm Inc., of Lake Forest, Ill., signed a collaboration agreement with an unnamed privately held biotechnology company involving its cationic cardiolipin-based NeoPhectin technology. NeoPharm will provide the partner with customized NeoPhectin formulations for their compounds, and is entitled to cash payments totaling $500,000 over the next six months. The partner is responsible for all future development costs of the customized formulations. The agreement allows for NeoPharm to negotiate a license agreement for any of the customized formulations that may be developed commercially.

• Neurocrine Biosciences Inc., of San Diego, said the FDA has not accepted the company's NDA for the insomnia drug indiplon immediate release due to difficulties encountered in navigating the electronic NDA, submitted in October. Neurocrine is working to resolve the issues and minimize any impact on the expected timeline for approval and launch. The indiplon modified-release filing is under review and the company also said it is working to address any potential formatting issues with that filing. The formatting issues are based solely on technical difficulties with the electronic navigation and do not pertain to the content of the filings. Neurocrine's stock (NASDAQ:NBIX) closed Tuesday at $48.65, down $1.41.

• NitroMed Inc., of Lexington, Mass., said that the underwriters of its recent public offering of common stock exercised their overallotment option with respect to the purchase of an additional 331,598 shares of common stock from NitroMed at the public offering price of $24.46 per share, before underwriting discounts and commissions. The closing occurred Monday. Including the overallotment option, the company sold about 3.6 million shares of its common stock in the public offering, raising net proceeds of $81.8 million.

• Oncolytics Biotech Inc., of Calgary, Alberta, received proceeds of $5 million from about $1.3 million warrants issued in a private placement June 19, 2003. Of the proceeds, $1.7 million was received by Sept. 30 and was included in the company's quarterly reports. A total of 6,700 warrants expired Dec. 20, 2004, and, at the close of business Monday, there were nearly $32 million common shares issued and outstanding.

• Osel Inc., of Santa Clara, Calif., closed a private round of financing and completed the in-clinic portion of a Phase I trial for its first product, Lactin-V, for the treatment of recurrent bacterial vaginosis. The product also is midway through a second Phase I trial for recurrent urinary tract infection. Osel said it plans to initiate two follow-on Phase II trials for both indications late in the first quarter. Osel also appointed Michael Cannon as a board member.

• Pharmexa A/S, of Hoersholm, Denmark, obtained regulatory approvals to begin a Phase II trial of its HER-2 Protein AutoVac breast cancer vaccine in Poland. The company already has received approval to begin the study in Hungary. In total, the trial will include up to 50 breast cancer patients and is expected to conclude by the middle of 2006.

• Pozen Inc., of Chapel Hill, N.C., will have its MT 100 presented to an advisory committee in May to examine the risk of tardive dyskinesia. MT 100 is a combination of naproxen sodium and metoclopramide hydrochloride in a sequential release formulation. In the summer, the company received a non-approvable letter from the FDA regarding the drug, in part because of safety issues, including the risk of tardive dyskinesia. (See BioWorld Today, June 2, 2004.)

• QLT Inc., of Vancouver, British Columbia, its development partner MediGene AG, of Martinsried, Germany, and its marketing partner Tokyo-based Yamanouchi Pharmaceuticals Co. Ltd. completed the mutual recognition procedure and gained approvals in 24 of 26 countries throughout Europe for the Eligard one-month, 7.5-mg, and three-month, 22.5-mg, products. Each of the European Union member states gained market approval for the product using the approvals obtained for Eligard a year ago in Germany as a reference. Yamanouchi launched the products in Germany in May. Eligard works by lowering the levels of testosterone in the body, which might result in a reduction of symptoms related to prostate cancer.

• Rigel Pharmaceuticals Inc., of South San Francisco, began a Phase I trial of R406, a product candidate for the treatment of rheumatoid arthritis. The goal is to establish safety and pharmacokinetics with the escalating single-dose, placebo-controlled trial, which will include 36 volunteers and will be followed by a multiple-dose study including 24 more. Results are expected by the second half of 2005.

• Sertanty Inc., of San Jose, Calif., signed a collaboration and service agreement with Specs, of Delft, the Netherlands, to design and produce small-molecule libraries targeting several kinase families. Sertanty will apply its Kinase KnowledgeBase and predictive eScreen technology to design targeted libraries that Specs will offer to its customer base of pharmaceutical and biotechnology companies. Financial terms were not disclosed.

• Sinovac Biotech Ltd., of Beijing, entered a financial advisory agreement with Credit Suisse Advisory Partners AG for the subsidiary of the Zurich, Switzerland-based Credit Suisse Group to act as the company's financial adviser. Sinovac has three vaccines that have completed all clinical trials, including a flu vaccine for which the company will seek approval in 2005, and a vaccine designed to prevent severe acute respiratory syndrome that is undergoing clinical testing.

• Vivus Inc., of Mountain View, Calif., initiated a pivotal Phase III study of its investigational drug Evamist, a low-dose estrogen-only treatment for vasomotor symptoms associated with menopause. The study will enroll up to 500 patients and will seek to determine whether Evamist, designed as a transdermal spray, reduces the frequency and severity of moderate to severe vasomotor symptoms.

• YM Biosciences Inc., of Mississauga, Ontario, said preliminary results from a randomized Phase II pivotal trial assessing the efficacy and safety of its EGF receptor monoclonal antibody, TheraCIM h-R3 (nimotuzumab), combined with radiation compared to radiation alone in locally advanced, Stage III-IV, nasopharyngeal carcinoma, which is a subset of head-and-neck cancer. Of the 130 patients in the intent-to-treat analysis, those in the combination arm were reported to have a 90.6 percent complete response compared to 51.5 percent in the radiation-alone group. The study was conducted by YM's licensor, Havana-based CIMAB SA, the commercial arm of the University of Havana's Center for Molecular Immunology, and Biotech Pharmaceuticals Ltd., CIMAB's joint venture partner in China. YM's stock (AMEX:YMI) closed Tuesday at $2.50, up 18 cents.

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