• Altachem Pharma Ltd., of Edmonton, Alberta, is proposing a non-brokered private placement of up to 6 million units at C$0.25 per unit, each unit consisting of one common share and one-half of one non-transferable share purchase warrant for gross proceeds of up to $1.5 million. Each full warrant entitles the holder to purchase one common share at a price of C$0.45 at anytime within 12 months from the closing date. Proceeds from the private placement will be used for general corporate purposes and for working capital.

• Aureus Pharma, of Paris, entered an agreement to establish Infocom Corp., of Tokyo, as the exclusive distributor of Aureus' products in Japan. Infocom will distribute Aureus' AurScope databases, AurScope GPCR, ADME/Drug-Drug Interactions and Ion Channel, as well as AurQuest, a web-based software for interrogating the databases. Financial terms were not disclosed.

• Biomira Inc., of Edmonton, Alberta, said it intends to file a Canadian prospectus supplement to a base shelf prospectus in Canada and in the U.S. a prospectus supplement to its registration statement in respect to a Dec. 8 private placement. The investors increased their subscription on the financing, which now totals about 4.9 million common shares at an issue price of $2.57, which represents a discount of 15 percent to the $3.02 closing price on Dec. 7. This increases the financing total from $10 million to $12.6 million. The financing is expected to close at the earliest opportunity and is subject to regulatory approval.

• BioMS Medical Corp., of Edmonton, Alberta, received an approval from UK authorities to begin its pivotal Phase II/III trial of MBP8298, a synthetic peptide to treat secondary progressive multiple sclerosis. The approval allows the company to expand its recently initiated trial beyond Canada. The trial is a double-blind, placebo-controlled study involving up to 553 patients in both countries combined. They will receive MBP8298 or placebo intravenously every six months for a period of two years.

• Chiron Corp., of Emeryville, Calif., said the FDA issued the company a warning letter in connection with the agency's October 2004 inspection of Chiron's Liverpool facility, which produces Fluvirin influenza virus vaccine. The warning letter cites inspectional observations concerning adherence to current Good Manufacturing Practices that the agency had previously issued. Chiron has since responded in the remediation plan the company submitted to the FDA in November. The warning includes asking Chiron for more detail in two areas - investigations into cGMP deviations and the design and conduct of studies to aid investigations - and requires a response within 15 working days.

• ConjuChem Inc., of Montreal, completed dosing in a Phase I multidose trial of its DAC:GRF compound being developed for growth hormone deficiency in children and adults. The study, in healthy volunteers, showed the compound to be safe and well tolerated, consistent with a positive profile observed in a previous single-dose, Phase I study. Also, a clinically significant response to DAC:GRF therapy in healthy volunteers should result in a 50 percent to 100 percent increase in their basal IGF-1 levels. For most subjects, that would raise plasma levels of IGF-1 to the desirable therapeutic range of 200-350 ng/ml.

• DOR BioPharma Inc., of Miami, appointed Michael Sember president and CEO and named former acting CEO Evan Myrianthopoulos chief financial officer. Sember brings more than 30 years of experience in both public and private pharmaceutical and biotech companies in the U.S. and Europe. DOR is focused on the development of biodefense vaccines and therapeutics.

• Enzon Pharmaceuticals Inc., of Bridgewater, N.J., said Peg-Intron is available in Japan for use in combination with Rebetol (ribavirin) capsules for chronic hepatitis C. Peg-Intron and Rebetol are marketed worldwide by Schering-Plough Corp., of Kenilworth, N.J. Peg-Intron is a longer-acting form of Intron A (interferon alfa-2b, recombinant) injection that uses proprietary PEG technology developed by Enzon.

• Genencor International Inc., of Palo Alto, Calif., gained an exclusive worldwide license to develop and commercialize two therapeutic product candidates for cancer from the Public Health Service and the National Cancer Institute. The two proteins, BL22 and HA22, are recombinant immunotoxins that target cancers derived from B cells that express the CD22 antigen. BL22 is in Phase II studies for hairy-cell leukemia. Phase I testing in subsets of treatment-refractory pediatric acute lymphoblastic leukemia, chronic lymphocytic leukemia and non-Hodgkin's lymphoma also is under way. HA22, an improved second-generation form of BL22, is in the investigational new drug application-enabling stage of development for expanded subsets of patients with those hematologic malignancies.

• Helicon Therapeutics Inc., of Farmingdale, N.Y., began Phase I testing of HT-0712, an orally active drug that blocks the activity of PDE-4, resulting in an increase in the levels of cAMP. Helicon is assessing the safety and pharmacokinetic properties of escalating single doses of HT-0712 in normal healthy volunteers. HT-0712 (also known as IPL455,903) was discovered and tested preclinically in anti-inflammation by Inflazyme Pharmaceuticals Ltd., of Vancouver, British Columbia.

• ImaRx Therapeutics Inc., of Tucson, Ariz., entered an agreement with Guerbet SA, of Roissy, France, to jointly develop a targeted magnetic resonance contrast agent for use in MRIs. The contrast agent would be designed to be used to detect, diagnose and monitor cancers at the molecular level. Formulations will be developed using ImaRx's nanodroplet technology in combination with Guerbet's targeting ligands and magnetic resonance contrast agents. Financial terms were not disclosed.

• Intradigm Corp., of Rockville, Md., said its lead siRNA therapeutic product, ICS-283, is the subject of two separate peer-reviewed scientific publications that are the first demonstration in preclinical disease models of clinically viable systemically administered RNAi therapeutics. Intradigm's ICS-283 therapeutic inhibiting pro-angiogenic factors has been shown effective by systemic delivery as a candidate treatment for cancer in research published Nov. 1, 2004, by Nucleic Acid Research and as a treatment for ocular neovascularization diseases in research published in the December 2004 issue of American Journal of Pathology.

• Introgen Therapeutics Inc., of Austin, Texas, raised gross proceeds of $7.8 million through a placement of 975,000 common shares. The stock was placed with the same European institutional investors who invested in a placement announced on Dec. 8. The company expects to use proceeds for working capital and other general corporate purposes, including the development of Advexin, INGN 241, INGN 401 and INGN 225, its cancer product candidates which are in Phase III, II and I trials, respectively. Mulier Capital, of London, acted as the financial adviser and placement agent.

• Medarex Inc., of Princeton, N.J., and Bristol-Myers Squibb Co., of New York, said the FTC requested an extension of the review period in connection with the recently announced global development and commercialization collaboration for MDX-010, a fully human antibody targeting the CTLA-4 receptor in Phase III development in metastatic melanoma. The companies are cooperating with the request and are providing, on a voluntary basis, certain additional information related to the filing of their notification and report forms under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. In order to provide the FTC additional time to consider the new information, BMS elected to withdraw and refile its Hart-Scott-Rodino filing. It now is expected that the FTC review period will expire in January. The deal was announced in early November and is potentially worth $530 million to Medarex. (See BioWorld Today, Nov. 9, 2004.)

• Praecis Pharmaceuticals Inc., of Waltham, Mass., is the subject of a class-action lawsuit commenced on behalf of shareholders by the Law Offices of Charles J. Piven in Baltimore. The shareholders purchased stock between Nov. 25, 2003, and Dec. 6, 2004. The complaint alleges that the company, its officer and directors violated securities laws by issuing false and misleading statements that caused the stock to inflate. Praecis announced on Dec. 6 that the commercialization of its prostate cancer drug Plenaxis (abarelix for injectable suspension) in the U.S. has faced challenges, leading the company to forecast lower sales this quarter than it had in the preceding three-month period. The company said it has had trouble educating doctors and convincing them to prescribe the therapy due to concerns over insurance reimbursement.

• Sinovac Biotech Ltd., of Beijing, entered a share purchase agreement with China Bioway Biotech Group Co. Ltd., Beijing Keding Co. Ltd. and Shenzhen Bio-Port Co. Ltd. to purchase about 20.6 percent of Sinovac. The closing date is set for Dec. 30, or on such earlier or later closing date as may be agreed to in advance and in writing by each of the parties.

• ViroLogic Inc., of South San Francisco, and Aclara BioSciences Inc., of Mountain View, Calif., said stockholders of both companies approved the merger announced in June. The companies expected it to close later in the day on Friday. The total value of the merger was estimated to be about $180 million. Each outstanding share of Aclara stock is being exchanged for 1.7 shares of ViroLogic stock and 1.7 contingent value rights. Beginning Monday, the shares of the combined company will trade on the Nasdaq market under the symbol "VLGC." William Young, ViroLogic's CEO and chairman, will continue as CEO and chairman of the combined company. The company, which will be headquartered in South San Francisco and employ about 240 people, will focus on targeted therapeutics and molecular diagnostics for infectious diseases and cancer. Aclara board members John Mendlein and Thomas Baruch will join the ViroLogic board, and three members of Aclara's management also will take on roles at the new company: Alfred Merriweather as chief financial officer, Sharat Singh as chief technical officer, and Michael Dunn as chief business officer. (See BioWorld Today, June 2, 2004.)

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