• Advanced Biotherapy Inc., of Woodland Hills, Calif., said its Phase I trials in AIDS were presented at the Adult AIDS Clinical Trial Group meeting in Baltimore. The group is the largest clinical trial research program and network of the National Institutes of Health and has conducted more than 3,900 trials.

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., presented preclinical data from in vitro and in vivo studies using RNAi to silence expression of vascular endothelial growth factor at the 44th annual meeting of the American Society of Cell Biology in Washington. The data show that small interfering RNA can silence VEGF expression, thereby inhibiting VEGF protein production and showing the potential for RNAi therapeutics to treat ocular diseases, such as age-related macular degeneration.

• Altana AG, of Bad Homburg, Germany, said the 90-day phase of the European mutual recognition procedure is complete, and the company may market Alvesco (ciclesonide) in various European markets in 2005 to treat persistent asthma. Altana received approval for Alvesco in the UK in April. The company soon expects to receive national marketing licenses for Germany, the Benelux countries, Scandinavia and Eastern Europe.

• Amgen Inc., of Thousand Oaks, Calif., said its board authorized additional repurchases of up to $5 billion of the company's common stock. It currently has $968 million remaining under a previous stock repurchase program, and said the new authorization reflects confidence in its long-term prospects.

• Applied Biosystems, of Foster City, Calif., made available the Rat Genome Survey Microarray for use with its Expression Array System, a system for gene-expression analysis. The Rat Genome Survey Microarray contains 26,857 probes for the interrogation of 27,088 genes covering 43,508 rat transcripts.

• Array BioPharma Inc., of Boulder, Colo., expanded the intellectual property rights granted to InterMune Inc., of Brisbane, Calif., relating to certain compounds discovered under their existing hepatitis C drug discovery collaboration established in September 2002. Array will receive a one-time payment of $2.5 million in exchange for the expanded rights. All other economic terms remain unchanged. Array has granted InterMune an exclusive option through March 31 to access Array's small-molecule drug discovery platform for targets in the area of hepatology. If InterMune selects a new target, Array would be entitled to research funding, milestone payments and royalties.

• Ascend Therapeutics Inc., of Herndon, Va., said preliminary Phase II results showed that its investigational transdermal 4-OHT gel reduced cyclic breast pain among pre-menopausal women. Administration of a 4-mg dose to the breast yielded a statistically significant decrease in an objective measure of cyclic breast pain from baseline. Also, 4-OHT gel showed a statistically significant reduction in the patient's subjective assessment of pain, the physician's assessment of pain and the physician's clinical assessment of mastalgia.

• Catalyst Pharmaceutical Partners Inc., of Coral Gables, Fla., filed an investigational new drug application with the FDA to evaluate CPP-109 as a therapy for cocaine addiction. The company expects to soon begin a Phase I trial to assess the product's safety and interaction with cocaine. CPP-109 works by inhibiting an enzyme that normally breaks down GABA, a dopamine-modulating enzyme.

• Cell Therapeutics Inc., of Seattle, said that Nippon Shinyaku Co. Ltd., of Kyoto, Japan, launched Trisenox in Japan after receiving pricing approval from the Japanese Ministry of Health for patients with relapsed or refractory acute promyelocytic leukemia. CTI markets Trisenox in the U.S. and Europe. CTI also reported that it signed agreements with five new distributors of Trisenox in Latin America, Eastern Europe, Israel, Turkey and South Africa.

• Cephalon Inc., of West Chester, Pa., said the FDA received an abbreviated new drug application filed with a paragraph IV certification by Barr Laboratories Inc., of Woodcliff Lake, N.J., for a generic form of Actiq (oral transmucosal fentanyl citrate). In connection with Federal Trade Commission clearance of its acquisition of CIMA Labs Inc., of Eden Prairie, Minn., Cephalon granted a license to Barr covering any remaining intellectual property related to Actiq. The license agreement contemplates that Barr would file and gain approval for its own application to market a generic version of the drug, but Barr can only obtain a 180-day statutory exclusivity relative to other generic companies if it files the first application with a paragraph IV certification.

• Chiron Corp., of Emeryville, Calif., said the UK Medicines and Healthcare Products Regulatory Agency (MHRA) is extending the suspension of the company's license to manufacture influenza vaccines in Liverpool, UK, through March 2005. If the company does not begin production of its flu vaccine by early spring, it will not be a U.S. supplier for the 2005-06 influenza season. The company failed to provide half the country's supply of flu vaccines, about 48 million shots, for the 2004-05 season, following MHRA's suspension of the manufacturing facility in October due to contamination issues. Chiron said the three-month extension of the suspension is not due to new problems at the Liverpool facility, but it is meant to give the company more time to remedy the problems and it could be lifted at any time. In the meantime, companies such as Gaithersburg, Md.-based MedImmune Inc. and Vancouver, British Columbia-based ID Biomedical Corp. are stepping into the void. MedImmune has said it can produce between 8 million and 10 million doses of FluMist for next year's flu season, while ID Biomedical could supply its Fluviral vaccine for the 2005-06 season, if it receives accelerated approval and reaches the market two years earlier than expected.

• Cypress Bioscience Inc., of San Diego, completed enrollment in its first Phase III pivotal trial to evaluate milnacipran as a treatment for fibromyalgia syndrome. The company plans to announce the initial results in the fall of 2005. Cypress and its partner, Forest Laboratories Inc., of New York, launched a second Phase III pivotal trial in October. The Phase III program could be completed in 2006.

• Flamel Technologies SA, of Lyon, France, enrolled the first patient in a Phase I/II study of Flamel's Medusa formulation of long-acting interleukin-2 in comparison with Proleukin. Proleukin is the only treatment approved for renal cancer. Flamel's formulation resulted in measurable increases in levels of lymphocyte CD4 and CD8, as well as CD25, which are considered surrogate markers for stimulation of the body's immune system.

• Genentech Inc., of South San Francisco, said more than 250 abstracts citing Rituxan (rituximab) were reported at this week's American Society of Hematology meeting in San Diego. Among findings presented were five-year follow-up data showing that the addition of rituximab to CHOP significantly improved event-free, progression-free and overall survival in previously untreated patients with aggressive non-Hodgkin's lymphoma. Other data suggested that initial therapy with rituximab plus CHOP chemotherapy prolongs time to treatment failure in aggressive non-Hodgkin's lymphoma patients, and that treating patients with rituximab as a maintenance therapy after initial treatment with chemotherapy also might extend time to treatment failure. The product is partnered with Biogen Idec Inc., of Cambridge, Mass.

• InKine Pharmaceutical Co. Inc., of Blue Bell, Pa., said it plans to return its Colirest patent license to the licensor following a preliminary analysis of Phase IIb efficacy data in Crohn's disease. Though the results demonstrated a numerical trend favoring high-dose therapy over placebo, the company said the findings are not to the extent that it believes would warrant the additional costs associated with seeking a marketing partner. Instead, InKine will focus its development efforts on the commercialization of INKP-102, a sodium phosphate purgative tablet in a Phase III trial that completed enrollment. It is being compared to the company's marketed product for such a use, Visicol, and results are expected by the end of next quarter.

• Innovative Drug Delivery Systems Inc., of New York, merged with publicly held Intrac Inc. and raised $18 million through a private placement of its common stock priced at $3 apiece. IDDS stockholders received about 71.5 percent of Intrac's outstanding shares, the private placement investors received about 24 percent of Intrac's outstanding shares and existing Intrac shareholders received about 4.5 percent of its outstanding shares. Also, IDDS officers and directors will replace Intrac officers and directors, and Intrac will implement IDDS's business plan as a specialty pharmaceutical company.

• Invitrogen Corp., of Carlsbad, Calif., signed an agreement to acquire Shanghai, China-based Bio Asia in an all-cash transaction that will total up to $8 million. Founded in 1999, Bio Asia is a manufacturer and provider of sequencing reagents and supplies and custom research and development services. It has annual revenues of about $5 million. The transaction received approval from both boards and is pending government approval. New World Trade Organization guidelines recently opened the Chinese biotech industry to foreign-owned companies.

• Jerini AG, of Berlin, was awarded €847,000 (US$1.1 million) in funding from the German Federal Ministry for Education and Research to intensify its discovery and preclinical development activities for an orally available bradykinin B2 receptor antagonist. The project could increase the number of indications treatable with Jerini's products. The funding will be paid over a two-year period. Jerini's products include Icatibant, a peptidomimetic bradykinin B2 receptor antagonist, which is in Phase II studies for hereditary angioedema.

• Kosan Biosciences Inc., of Hayward, Calif., initiated a Phase I trial evaluating KOS-1584, a second-generation epothilone, in patients with advanced malignancies. The study is designed to establish the maximum tolerated dose, pharmacokinetics, pharmacodynamics, safety and clinical benefit of the drug when administered as an intravenous infusion every three weeks. KOS-1584 is a polyketide designed to inhibit cancer-cell growth in vitro by a mechanism similar to paclitaxel.

• Louisiana Fund I in Baton Route, La., said it had its initial close at $17.8 million. The fund targets companies developing and commercializing technologies with an emphasis on those originating at Louisiana universities at their start-up and early stages. The fund concentrates on investments in the life sciences. The fund was anchored by a $10 million commitment by the Teachers' Retirement System, of Louisiana, in August.

• MacroChem Corp., of Lexington, Mass., began a clinical study of Opterone, a topical cream for male hypogonadism. Opterone combines testosterone and the company's skin-absorption enhancer. The rate and extent of absorption of the hormone at different doses and application areas will be analyzed in the bioavailability study. MacroChem expects results from the study, added to results announced in August from a pharmacokinetic study, to lead to a Phase III program in 2005.

• Molecular Profiling Institute Inc., of Phoenix, was founded as a specialty reference laboratory by the Translational Genomics Research Institute and the International Genomics Consortium. It was established to use discoveries from the Human Genome Project to analyze cancers from individual patients, and completed its initial investment round by obtaining seed capitalization of about $1.4 million.

• Nabi Biopharmaceuticals, of Boca Raton, Fla., filed a $175 million mixed shelf registration statement with the SEC to occasionally offer and sell up to that amount of equity or debt securities. The company focuses on infectious, autoimmune and addictive diseases.

• Nanogen Inc., of San Diego, and Epoch Biosciences Inc., of Bothell, Wash., adjourned their special stockholder meetings in order for Nanogen to obtain the votes necessary to reach a quorum. Its vote was postponed until Dec. 15, as was Epoch's special meeting. They are voting on the firms' merger.

• National Center for Research Resources, a component of the National Institutes of Health in Bethesda, Md., will provide $32.8 million in additional funding to enhance its Biomedical Informatics Research Network (BIRN). The University of California at San Diego Medical School will receive $18.8 million over five years, while Massachusetts General Hospital will be granted nearly $14 million for three years of support. BIRN is an NIH initiative involving 15 universities and 22 research groups that fosters collaborations in biomedical science by using information technology innovations.

• Nutra Pharma Corp., of Boynton Beach, Fla., said it incorrectly published a press release last month stating that it had signed an agreement to acquire 100 percent of Portage BioMed LLC, of Kent, Ohio. The release should have said that the companies signed a non-binding letter of intent. Further exploring the purchase, Nutra Pharma engaged Eno Research and Development Inc., of Hillsborough, N.C., to validate the technology of Portage, a drug delivery firm. Nutra Pharma is a biotechnology holding company and incubator.

• Oragenics Inc., of Alachua, Fla., appointed David Gury chairman, replacing the company's founder and chief scientific officer, Jeffrey Hillman. Gury, the retired former chairman and CEO of Boca Raton, Fla.-based Nabi Biopharmaceuticals, has served on Oragenics' board since October 2003.

• Orion Genomics, of St. Louis, and researchers from North Carolina State University were awarded a two-year, $1.6 million grant from the U.S. Department of Agriculture to determine the gene sequence of parasitic nematode worms that cause human disease and destruction of crops. The USDA will fund the sequencing and annotation of the Northern root knot nematode genome.

• Prana Biotechnology Ltd., of Melbourne, Australia, today announced that 9.5 million unlisted options expiring on Dec. 1 were exercised prior to that date. The options originally were largely owned by certain insiders and directors of the company then transferred to new owners, who, in turn, exercised them at a price of A$0.50 (US$0.38) per share. Prana focuses on research into Alzheimer's disease and other age-related degenerative disorders.

• PTC Therapeutics Inc., of South Plainfield, N.J., said the FDA granted orphan drug designation to PTC124 for the treatment of cystic fibrosis due to a nonsense mutation in the cystic fibrosis transmembrane regulator gene. PTC124 is a small-molecule drug being evaluated in Phase I trials involving healthy volunteers.

• Sinovac Biotech Ltd., of Beijing, began listing its common stock as "SVA" on the American Stock Exchange. The company, which is developing vaccines for infectious illnesses such as hepatitis A and B, influenza and severe acute respiratory syndrome, is the second mainland China-based firm to list on the exchange this year. Sinovac is conducting clinical trials on a SARS vaccine.

• Sirna Therapeutics Inc., of Boulder, Colo., is applying RNA interference to dermatology, with an initial focus on hair removal. Sirna Dermatology has targeted a critical gene essential for hair growth and has demonstrated that reduction of the gene's expression by a topically administered, chemically modified siRNA permanently disrupts hair follicle integrity in an animal model. The company anticipates starting human trials in 2006. Sirna, in the formation of its dermatology division, has acquired Skinetics Biosciences Inc. Through the acquisition Sirna is acquiring intellectual property and research data related to the development of siRNAs for permanent hair removal. Upon signing the deal, Sirna granted initial common stock shares to Skinetics' shareholders and consultants; additional shares will be granted upon the achievement of certain milestones, with royalties to be paid upon commercialization. Angela Christiano, co-founder of Skinetics will become an exclusive consultant for Sirna Dermatology in the area of RNAi. Also, Joseph Carroll, a co-founder of Skinetics, will join Sirna Dermatology. Colin Jahoda, of Skinetics, will serve as a consultant.

• The Immune Response Corp., of Carlsbad, Calif., said it is expanding its clinical development program for multiple sclerosis based on preliminary NeuroVax data that demonstrated a 94 percent immune response rate. As a result, the company plans to expand and complete an ongoing Phase II trial, begin a larger study to examine NeuroVax's clinical benefit and search for a corporate partner to help move the program toward commercialization. Also, the company applied for a grant from the National Institutes of Health in Bethesda, Md., and established a scientific advisory board to steer the program.

• Theravance Inc., of South San Francisco, announced results from a Phase II study of telavancin to treat complicated Gram-positive skin and skin-structure infections. The trial showed a clinical cure rate of 96.1 percent, compared with 93.5 percent for patients treated with standard therapy of vancomycin dosed twice a day or anti-staphylococcal penicillins dosed four times a day. The randomized, double-blind, multinational study of intravenous telavancin dosed once a day enrolled 201 patients at 18 clinical sites in the U.S. and South Africa. In the group of microbiologically evaluable patients with methicillin-resistant Staphylococcus aureus infection, eradication was achieved in 92.3 percent of the telavancin-treated group, compared with 68.4 percent in the group receiving vancomycin.

• Topigen Pharmaceuticals Inc., of Montreal, said the FDA approved initiation of a Phase I trial of ASM8, an inhalation drug designed to treat asthma by attacking multiple mediators of the inflammatory mechanism, rather than the single-mediator approach of current therapies. In the company's first clinical trial, expected to begin by the end of January, healthy male and female volunteers will be randomized to receive a single inhaled dose of nebulized ASM8, which comprises two antisense oligonucleotides. The study includes standard and airway-specific assessments of safety parameters. ASM8 is the lead product in the company's portfolio of respiratory disease therapeutics.

• Transgene SA, of Strasbourg, France, appointed Philippe Archinard CEO and board director, replacing Jean-Francois Carmier, who is leaving the company for personal reasons. Since March 2000, Archinard served as CEO of Innogenetics NV, of Ghent, Belgium. Before that he held various positions for 15 years with Paris-based bioMerieux. Transgene's board said the company's principal shareholders will cover Transgene's cash needs until the end of 2005, giving the new CEO time to develop and implement his strategy.

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