• Acambis plc, of Cambridge, Mass., completed a Phase I trial of its vaccine designed to prevent dengue fever. The trial involved 56 adults and tested ChimeriVax-DEN2, a component of Acambis' ChimeriVax-Dengue vaccine. The component was well tolerated and there were no serious side effects, the company said. A Phase I trial of the tetravalent vaccine, ChimeriVax-Dengue, is planned for the first half of 2003.

• Achillion Pharmaceuticals Inc., of New Haven, Conn., expanded its drug discovery laboratories to include a chemistry facility to accommodate its expanding programs to discover drugs to treat viral, bacterial and fungal infections. The near-doubling addition increased Achillion's total space to about 27,000 square feet.

• Aderis Pharmaceuticals Inc., of Hopkinton, Mass., said final analyses of data from a Phase II trial of rotigotine CDS (constant delivery system), a once-a-day skin patch, in the treatment of restless legs syndrome, conducted by Schwarz Pharma AG, of Monheim, Germany, indicate the drug was well tolerated at all dose levels and induced a statistically significant reduction in symptoms. The primary endpoint of the randomized, double-blind, placebo-controlled trial was a reduction in symptoms as measured by the International Restless Legs Syndrome Study Group Rating Scale. Treatment with rotigotine CDS resulted in a statistically significant, dose-dependent reduction of symptoms. The drug also was well tolerated and there were no serious adverse events.

• Allergan Inc., of Irvine, Calif., entered into a collaboration and license agreement for the exclusive right to develop and commercialize PEP005 in North and South America for the topical treatment of non-melanoma skin cancer and actinic keratosis from Peplin Biotech Ltd., of Brisbane, Australia. Allergan said Peplin's technology has shown early promise in the treatment of a range of cancers. In return, Peplin may receive up to $23 million in milestone and other payments, and sales royalties.

• Argenta Discovery Ltd., of Harlow, UK, extended its collaboration with Amedis Pharmaceuticals Ltd., of Cambridge, UK. Under the agreement, first reported in June 2002, Argenta is creating a series of silicon-based small-molecule inhibitors and screening them against a range of medically relevant protease enzyme targets. Amedis has identified a range of silicon-based inhibitors to specifically target certain protease enzymes across several families. Argenta is using synthetic chemistry techniques to create those compounds.

• BioMarin Pharmaceutical Inc., of Novato, Calif., and Genzyme General, of Cambridge, Mass., a division of Genzyme Corp., released additional data from an ongoing open-label Phase III extension study of Aldurazyme (laronidase), designed to treat mucopolysaccharidosis I. The companies released data regarding the study's two primary endpoints: pulmonary function as measured by percent predicted forced vital capacity (FVC) and endurance as measured by distance covered in a six-minute walk test. The 22 patients who received Aldurazyme for 62 weeks demonstrated a mean FVC change of +5.4 percentage points compared to pre-treatment baseline. In the walk test, those patients had a mean +40.0-meter change from pre-treatment baseline. For both endpoints, results indicate that patients maintained the improvements after 50 weeks of treatment. In October, BioMarin and Genzyme said the FDA notified the companies that the BLA for Aldurazyme will be reviewed by the FDA's Endocrinologic and Metabolic Drugs Advisory Committee on Jan. 15. In September, the FDA granted the Aldurazyme BLA 6-month priority review status. (See BioWorld Today, July 30, 2002, and Sept. 17, 2002.)

• Cell Therapeutics Inc., of Seattle, announced interim data from a Phase I study of escalating doses of Xyotax in combination with cisplatin for patients with solid tumors. The primary objectives of the trial are to determine the maximum tolerated dose of Xyotax in combination with cisplatin and to determine the overall safety of that regimen. Eleven of 13 evaluable patients, or 85 percent, achieved durable disease control with five patients, or 38 percent, achieving a partial remission, and six patients, or 46 percent, with stable disease. Xyotax links paclitaxel to a biodegradable polyglutamate polymer.

• Discovery Partners International Inc., of San Diego, entered into a multiyear agreement to license certain intellectual property rights to Mimotopes Pty. Ltd., a subsidiary of Fisher Scientific International Inc., of Hampton, N.H. Discovery Partners also named Mimotopes its nonexclusive, worldwide distributor of certain products in its Irori combinatorial chemistry instruments product line. Financial terms were not disclosed.

• Ethypharm SA, of Saint-Cloud, France, entered a research and development alliance with Conba Pharmaceutical, of Shanghai, China, with the goal of developing enhanced Chinese medicines using Ethypharm's oral controlled-release and Fast Melt Flashtab technologies. Ethypharm will contribute its technologies, while Conba will invest US$2 million in cash. Additionally, the companies signed a multiproduct development agreement worth US$1.2 million under which they will collaborate to develop and register new Chinese medicine preparations using several patents and technologies of Ethypharm for the Chinese market.

• Evotec OAI AG, of Hamburg, Germany, reported a one-year extension of its focused library agreement with Solvay Pharmaceuticals BV, of Brussels, Belgium, a deal originally signed in January 2001. Applying Evotec's expertise in high-speed and computational chemistry, Evotec chemists will design and synthesize collections of small, drug-like molecules around selected Solvay templates. Solvay will use the compounds in screens against its targets to identify novel drug candidates.

• Galapagos Genomics, of Mechelen, Belgium, was awarded a €1.2 million technology development grant in Belgium for bone disease research by the Flemish Institute for the Promotion of Industrial Scientific-Technological Research. The project is aimed at the identification and validation of drug targets in related bone diseases, focusing on rheumatoid arthritis, osteoarthritis and osteoporosis. Galapagos will use its adenoviral target discovery platform in combination with cellular assays to identify genes that are key players in the bone disease processes.

• GenVec Inc., of Gaithersburg, Md., reported interim Phase I results from its lead oncology product candidate, TNFerade, in patients with a rare form of cancer known as soft tissue sarcoma. A total of 14 patients will receive the gene-based therapy. Data from the first two groups, or seven patients, were presented at the Molecular Targets and Cancer Therapeutics conference in Frankfurt, Germany. TNFerade was well tolerated with no dose-limiting toxicities, and the maximum tolerated dose was not reached. TNFerade also showed evidence of activity on the tumors. TNFerade plus radiation therapy resulted in an overall objective tumor response rate of 71 percent (five out of seven patients). Two of seven patients experienced a complete response.

• ICN Pharmaceuticals Inc., of Costa Mesa, Calif., settled a civil lawsuit filed in 1999 by the SEC regarding alleged violations of securities laws nearly eight years ago. ICN consented, without admitting or denying the allegations, to a final judgment that requires ICN to comply with detailed corporate governance and disclosure-related undertakings for five years. ICN will be able to apply for early termination of the undertakings after 18 months. As part of the settlement, ICN is required to pay $1 million in civil penalties. The suit is related to ICN's drug application for a hepatitis C product. (See BioWorld Today, April 20, 1995.)

• Intercell AG, of Vienna, Austria, said it started a Phase II study of its therapeutic hepatitis C vaccine. The trial will involve hepatitis C virus-positive patients who exhibit no response to interferon-ribavirin combination therapy. The study is scheduled to be completed near the end of 2003, the company said.

• Invitrogen Corp., of San Diego, announced the expiration of the initial offering period for all outstanding shares of common stock of InforMax Inc., of Bethesda, Md. Invitrogen's wholly owned subsidiary, Babcock Inc., accepted for purchase all shares validly tendered and not withdrawn prior to the expiration of the offer at the price of $1.36 per share in cash. Based on preliminary information, about 26.2 million shares of InforMax common stock were tendered out of about 30.5 shares currently outstanding, or about 85.9 percent of outstanding shares. The deal was originally made public in October and valued at about $42 million. (See BioWorld Today, Oct. 16, 2002.)

• Ligand Pharmaceuticals Inc., of San Diego, earned a $2.1 million milestone payment from Eli Lilly and Co., of Indianapolis, as Lilly's investigational new drug application for LY674 cleared its FDA waiting period, paving the way for initiation of Phase I studies. LY674 is a peroxisome proliferation activated receptor modulator for the treatment of dyslipidemias. The collaboration began in 1997 and has selected multiple clinical candidates and advanced three PPAR modulators into early clinical studies. The 1997 deal, valued at $190 million for Ligand, was extended to November 2003 in April. (See BioWorld Today, April 15, 2002; and Oct. 21, 1997.)

• NeoPharm Inc., of Lake Forest, Ill., reported additional Phase I trial data on LErafAON, its NeoLipid liposomal antisense agent. The data indicate that a dose level of 4mg/kg/week appears to be the likely maximum dose to be used in future studies. The data were presented at the Molecular Targets and Cancer Therapeutics conference in Frankfurt, Germany. NeoPharm is conducting Phase I/II trials of LErafAON for radiation-resistant tumors and multiple myeloma.

• Neose Technologies Inc., of Horsham, Pa., and Monsanto Protein Technologies, a unit of Monsanto Co., of St. Louis, entered into a research agreement to investigate the use of Neose's GlycoAdvance technology to enhance the glycosylation of therapeutic monoclonal antibodies produced in plants. The research will combine Monsanto's knowledge of transgenic plant production of monoclonal antibodies with Neose's knowledge of glycosylation, a pairing the companies expect to enhance the ability of plant-produced monoclonal antibodies to begin complement activation. Financial terms were not disclosed.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., said European regulatory authorities granted orphan medicinal product designation to Cotara to treat glioma (brain cancer). That would entitle the product to 10 years of market exclusivity in Europe. Cotara already has received orphan drug status and fast-track designation in the U.S. Peregrine's stock (NASDAQ:PPHM) on Monday jumped 46 percent, or 32 cents, to close at $1.02.

• Progen Industries, of Brisbane, Australia, said encouraging interim Phase I/II trial data on its lead cancer drug, PI-88, were presented at the Molecular Targets and Cancer Therapeutics conference in Frankfurt, Germany. The results showed that PI-88 was well tolerated and demonstrated encouraging anticancer activity in some patients with advanced cancer. PI-88 is a semi-synthetic sulfated oligosaccharide that has several modes of action.

• SangStat Medical Corp., of Fremont, Calif., received a notice of compliance from the Biologics and Genetic Therapies Directorate of Health Canada for Thymoglobulin (anti-thymocyte globulin, [rabbit]). The notice provides Thymoglobulin with an indication to treat renal transplant acute rejection in conjunction with concomitant immunosuppression and for induction in adult renal transplant recipients, which is the use of Thymoglobulin at the time of transplant surgery.

• SR Pharma plc, of London, began a Phase II, randomized, placebo-controlled trial of SRP299 (a killed Mycobacterium vaccae suspension) for the treatment of moderate-to-severe atopic dermatitis in children aged 5 to 16. SR Pharma and Genesis Research and Development Corp., of Auckland, New Zealand, are jointly developing SRP299 for atopic dermatitis. SR Pharma plans to recruit 120 patients for the trial.