• AEterna Laboratories Inc., of Quebec City, Quebec, said its subsidiary Zentaris GmbH, of Frankfurt, Germany, entered an agreement with Produtos Roche QFSA in Sao Paulo, Brazil, for the marketing in Brazil of Impavido (miltefosine), an oral therapy for leishmaniasis. Roche will support Zentaris in the registration process and will market the product for Zentaris in Brazil. Also, Zentaris will supply Impavido to Roche. Both parties will begin clinical bridging trials, as requested by Brazilian health authorities.

• Alfacell Corp., of Bloomfield, N.J., completed a private placement of common stock and common stock purchase warrants with an unnamed institutional investor that raised $1.5 million in gross proceeds. The private placement completes the investment initiated by the investor last year. Alfacell researches ribonucleases for cancer and other therapeutic applications.

• Amarin Corp. plc, of London, entered a letter of intent to sell certain assets, including Amarin Pharmaceuticals Inc. and the majority of its marketed and development product portfolio, to Valeant Pharmaceuticals International, of Costa Mesa, Calif. Financial terms were not disclosed. Completion of the sale remains subject to a definitive agreement and approval of each company's board.

• Antisense Therapeutics Ltd., of Victoria, Australia, said Phase I data of ATL 1102, the company's antisense drug for multiple sclerosis, were favorable for both safety and pharmacokinetics. The company plans to begin a Phase IIa trial, following the selection of appropriate dose levels and regimens, in the second half of this year.

• AstraZeneca plc, of London, said Iressa (gefitinib) was recommended for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer after failure of both platinum-based and docetaxel chemotherapies, according to the American Society of Clinical Oncology's Clinical Practice Guidelines published in the Journal of Clinical Oncology. Iressa is the first lung cancer treatment other than surgery, radiation or chemotherapy to be included in the ASCO guidelines.

• Auxilium Pharmaceuticals Inc., of Norristown, Pa., and Bayer Inc., a division of Bayer AG, of Leverkusen, Germany, entered a distribution agreement for marketing in Canada Auxilium's Testim 1 percent testosterone gel. Auxilium will file an application for regulatory review in Canada early this year, and Bayer would provide marketing and distribution of the product in that country. Auxilium has marketed Testim in the U.S. since the first quarter of 2003.

• Bioenvision Inc., of New York, granted an exclusive sublicense to ILEX Products Inc., a wholly owned subsidiary of San Antonio-based ILEX Oncology Inc., to market and distribute clofarabine for cancer applications in the U.S. and Canada. As part of the option agreement, Bioenvision received a $3.5 million payment from ILEX. It also will receive two payments of $2 million each in 2004, pending ILEX's completion of filing a rolling new drug application. Bioenvision retains rights in the U.S. and Canada to market and distribute clofarabine for all indications other than cancer. It also holds rights to all indications in the rest of the world. ILEX will pay Bioenvision milestones and royalties on North American sales, and the companies will split research and development costs to develop clofarabine in Europe. ILEX will receive royalties on sales in Europe. In 2001, the companies entered into a co-development agreement to develop clofarabine. ILEX is covering clinical trials in the U.S., while Bioenvision is conducting them in Europe. The final section of the NDA submission of clofarabine to treat acute leukemia in children is expected to be filed by mid-year.

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., updated its developments of its calcium phosphate-based nanotechnology (CAP). The company completed a Phase I study showing the safety of injected CAP. The company also said it had positive results in animal models using CAP as a safer vaccine adjuvant, and in using it for the sustained-release delivery of therapeutic proteins.

• Biosite Inc., of San Diego, entered a collaboration to develop Omniclonal antibodies for targets provided by Amylin Pharmaceuticals Inc., also of San Diego. Biosite, which will receive development fees from Amylin for work on target-specific antibodies, also will receive certain exclusive diagnostic licenses to the selected targets provided by Amylin, which will receive royalties for diagnostic products that Biosite commercializes and are covered by licenses under the agreement.

• Cellegy Pharmaceuticals Inc., of South San Francisco, said SJ Strategic Investments increased its ownership position in Cellegy to 29.1 percent. The investment came after the company announced positive results of a preliminary analysis of Cellegesic, its Phase III product for anal fissure pain. (See BioWorld Today, Jan. 28, 2004.)

• Chiron Corp., of Emeryville, Calif., said that clinical trials of the Procleix Ultrio Assay on the Procleix Tigris system have started in San Diego. The Procleix Ultrio Assay, developed by Gen-Probe Inc., of San Diego, in collaboration with Chiron, is specifically designed for the simultaneous detection of HIV-1, hepatitis C virus and hepatitis B virus in donated blood, plasma, organs and tissues. The clinical trials for Tigris are expected to be completed in the first half of the year, with FDA submissions for the Tigris system for blood screening and for the Ultrio Assay planned for later in 2004.

• Corautus Genetics Inc., of Atlanta, closed a private placement by issuing 251,950 shares of common stock for $1 million. The shares were priced at 90 percent of the price at which the company's stock was traded one day prior. The investors also received warrants for 50,390 common shares, exercisable at about $6.76 per share. Corautus is dedicated to developing gene transfer therapy products.

• Dharmacon Inc., of Lafayette, Colo., published eight previously undisclosed siRNA design criteria, along with data validating their functionality in gene silencing, in next month's issue of Nature Biotechnology. The findings already appear in the journal's online site. Dharmacon has employed rational methods for siRNA design since 2002. Dharmacon will make all eight of the disclosed criteria publicly available through its free online siRNA design tool, siDesign Center.

• Ecopia BioSciences Inc., of Montreal, said its cancer drug candidate ECO-04601 showed inhibition of tumor growth in an animal model of glioma. The anticancer efficacy of ECO-04601 was tested in animals against C6 glioma tumor cells in a xenograft mouse model. Tumor growth in the model was reduced by ECO-04601, which was discovered by Ecopia last year with its Decipher technology.

• Epimmune Inc., of San Diego, received an undisclosed milestone payment from Genencor International Inc., of Palo Alto, Calif., after it filed an investigational new drug application for a DNA-based therapeutic vaccine to treat hepatitis B. Epimmune collaborated on the design and preclinical development of the vaccine through a $60 million collaboration with Genencor, which expects trials to begin later this month. (See BioWorld Today, July 11, 2001.)

• ExonHit Therapeutics SA, of Paris, completed an €8.3 million convertible bond financing, to which its existing shareholders and affiliate companies subscribed. The proceeds will provide capital to fund operations into 2006, before which the company expects to deliver on several milestones. Final efficacy results of its Ikomio clinical trial for the treatment of amyotrophic lateral sclerosis will be available by the fourth quarter. The company also expects to complete a Phase I trial of its second small molecule, EHT 0202, for neurodegenerative diseases later this year, as well as two preclinical packages for other products in its developing pipeline, EHT 0101 and EHT 0204.

• Genome Therapeutics Corp., of Waltham, Mass., and Genesoft Pharmaceuticals Inc., of South San Francisco, said their shareholders approved proposals relating to the pending merger of the companies. The completion of the merger, valued at $80 million, remains subject to conditions discussed in the prospectus filed by Genome Therapeutics with the SEC in December, including the condition of raising at least $32 million of capital to fund the combined company. (See BioWorld Today, Nov. 19, 2003.) Separately, Genome Therapeutics said its ongoing registered common stock offering would not require shareholder approval under Nasdaq's Marketplace Rules, said the staff of the Nasdaq Stock Market.

• Lonza Group Ltd., of Basel, Switzerland, entered a collaboration to gain access to a transient expression system for therapeutic proteins from Cytos Biotechnology AG, of Zurich, Switzerland. Lonza received a sole license to manufacture therapeutic proteins for preclinical studies, clinical trials and in-market supply, and was granted the right to sublicense the technology to its customers. Cytos, which retains rights to its expression technology for production and commercialization, received a one-time payment as an access fee. Lonza said it would invest significant resources to develop a manufacturing process for GMP material, and as the development program is carried out, Cytos could earn a development milestone, annual license fees and royalties on Lonza protein sales and technology sublicensing revenues.

• ProtoKinetix Inc., of Vancouver, British Columbia, entered an exclusive agreement with the University of Michigan in Ann Arbor for an exclusive option to license and develop certain fields of therapeutic products against breast cancer based upon the mammastatin molecule. The company plans to replicate the binding site of the mammastatin molecule, which it believes mimics the mechanism of action of the mammastatin protein. ProtoKinetix is focused on devleoping therapeutics for the treatment of malignancies.

• RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., reported the publication of new data confirming that Thymosin Beta 4 (TB4) stimulates epithelial cell migration and promotes lamanin-5 expression, each an important component of the wound-healing process. The data were published in the most recent issue of Experimental Cell Research. TB4 is a naturally occurring 43-amino-acid peptide.

• Titan Pharmaceuticals Inc., of South San Francisco, said all of the class-action and derivative lawsuits filed against the company have been dismissed. The plaintiffs agreed to voluntarily dismiss the lawsuits after speaking with Titan's counsel. The company made no payment in connection with dismissal and has no obligation to make any payments to any plaintiffs or their counsel. The lawsuits involved complaints that Titan officials boosted claims from December 1999 to July 2002 about their development program for the schizophrenia drug Zomaril, which fell short in the clinic. (See BioWorld Today, July 23, 2002.)

• Transition Therapeutics Inc., of Toronto, reported positive preclinical efficacy data for a second islet neogenesis therapy, GLP1-I. N.T. Following a short course of treatment, blood glucose levels normalized and remained normal for six weeks post-treatment in diabetic animals. GLP1-I. N.T. combines the current leading diabetes drug candidate, Glucagon-like Peptide (GLP-1), with Transition's gastrin analogue. The combination is designed to differentiate and regenerate new insulin-producing cells from islet precursor stem cells.

• TTP LabTech Ltd., of Royston, UK, entered a collaborative research and marketing agreement with BD Biosciences Clontech, of San Jose, Calif. BD Biosciences will provide nonexclusive access to a selection of its Novel Fluorescent Proteins for use upon TTP's Acumen Explorer in order to generate validated protocols predominantly for reporter-gene analysis. Financial terms were not disclosed.

• United Therapeutics Corp., of Silver Spring, Md., filed a supplemental new drug application with the FDA to add the intravenous route of delivery to the Remodulin label for the treatment of pulmonary arterial hypertension. Remodulin is approved by the FDA as a subcutaneous therapy for the treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise.

• Vasogen Inc., of Mississauga, Ontario, was granted CE Mark regulatory approval in Europe for its lead product, Celacade (immune modulation therapy) for the treatment of chronic heart failure. The regulatory approval positions Vasogen to market Celacade in the European Union. Vasogen plans to launch Celacade in Europe upon the successful completion of its ongoing pivotal Phase III Acclaim trial in 2,000 patients with advanced chronic heart failure. Celacade is designed to activate the immune system's physiological anti-inflammatory response to apoptotic cells.

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