• Abgenix Inc., of Fremont, Calif., received a milestone payment pursuant to Rockville, Md.-based Human Genome Sciences filing an investigational new drug application with the FDA for a fully human monoclonal antibody to the CCR5 receptor (CCR5 mAb) created using Abgenix's XenoMouse technology. CCR5 mAb is designed to bind to and block the CCR5 receptor, which could prevent HIV's entrance into immune system cells. In May 2003, Abgenix granted HGS a license to develop and commercialize the CCR5 mAb.

• Alexion Pharmaceuticals Inc., of Cheshire, Conn., began the treatment section of the Phase III SHEPHERD trial, evaluating eculizumab in patients with the chronic orphan blood disorder paroxysmal nocturnal hemoglobinuria (PNH). The SHEPHERD trial, along with the already enrolling TRIUMPH trial, comprises the Phase III PNH program agreed on with the FDA under the special protocol assessment process. The SHEPHERD trial will generate safety data on eculizumab in hemolytic PNH patients with a history of transfusion. Additional endpoints include hemolysis and quality-of-life measures. The trial is expected to enroll about 75 patients in the U.S., Canada, Europe and Australia, and results from six months of therapy are expected during the second half of 2005. Alexion agreed to the SPA in July. (See BioWorld Today, July 21, 2004.)

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., presented preclinical data at the Keystone Symposium on the "Diverse Roles of RNA in Gene Regulation" held in Breckinridge, Colo. Alnylam scientists demonstrated positive in vivo efficacy data from the company's preclinical program to develop direct RNAi therapeutics for the treatment of respiratory syncytial virus infection. In addition, company scientists presented new data on therapeutic silencing of the endogenous gene for apoliprotein B using chemically modified short interfering RNAs.

• Amphora Discovery Corp., of Research Triangle Park, N.C., entered a multiyear partnership with Ortho-McNeil Pharmaceutical Inc. to discover and develop treatments for inflammatory diseases. Ortho-McNeil will license several lead series of compounds identified by Amphora focused on a widely recognized inflammation target, and will get exclusive rights to the existing compounds, as well as to those discovered in the course of the collaboration. Ortho-McNeil affiliate Johnson & Johnson Pharmaceutical Research & Development LLC will further develop licensed compounds and provide Amphora with research support. The agreement includes research support payments, an up-front licensing fee and potential milestone payments and royalties.

• Applied Biosystems, of Foster City, Calif., expanded its collaboration with Stanford University in Palo Alto, Calif., and the University of Miami to continue the study of genetic biomarkers associated with treatment response and survival in diffuse large B-cell lymphoma.

• ArQule Inc., of Woburn, Mass., achieved two milestone events, triggering payments from Wyeth, of Madison, N.J. Financial terms of the milestones were not disclosed. Wyeth has nominated a new compound to its development pipeline that was discovered through the collaborative Directed Array Program with ArQule. The compound for Alzheimer's disease has been nominated as a development-track compound preceding investigational new drug submission to the FDA.

• Avant Immunotherapeutics Inc., of Needham, Mass., said that its partner, GlaxoSmithKline plc, of London, launched Rotarix in Mexico, representing the first step in a series of global product launches. GSK plans to launch Rotarix in additional Latin American countries, as well as Asia-Pacific countries, during the course of 2005. Rotarix is an oral, two-dose, live attenuated vaccine against rotavirus disease in infants.

• Aventis Pasteur, of Paris, has changed its name to Sanofi Pasteur. Aventis Pasteur is the vaccine division of the Sanofi-Aventis Group. The Aventis Pasteur MDS joint venture, equally owned by Aventis Pasteur and Whitehouse Station N.J.-based Merck & Co. Inc. to market vaccines in Europe, also changed its denomination to Sanofi Pasteur MSD.

• CeMines Inc., of Golden, Colo., said Tallinn, Estonia-based CeMines OU, a wholly owned subsidiary of CeMines International Inc., has co-founded VTAK, a privately held company focused on research and commercialization of diagnostic and therapeutic products for cancer. VTAK was formed under the Competence Center Programme, in conjunction with "Partnership Estonia" and the Estonian government. The company said the mission of VTAK is to focus on applied scientific research, product development and product commercialization.

• Dyax Corp., of Cambridge, Mass., reported interim results from its Phase II trial of DX-88 in hereditary angioedema. Data from EDEMA2, based on 61 HAE attacks, show the compound is well tolerated with a median time to clinical response of 35 minutes. Dyax also announced plans to begin a Phase III trial in the same indication in the first half of 2005. It expects EDEMA3 to be a controlled, international trial similar in size to its completed 48-patient EDEMA1 trial. DX-88 is being developed in a joint venture with Genzyme Corp., also of Cambridge. Pending a positive Phase III study, Dyax expects to file a biologics license application during 2006 for DX-88 in HAE.

• Dynavax Technologies Corp., of Berkeley, Calif., said it is exploring development of an immunoregulatory sequences (IRS)-based treatment for autoimmune disease, including systemic lupus erythematosis. The company presented its IRS inhibitors as a possible treatment for lupus at a Keystone Symposia conference, Innate Immunity to Pathogens. Based on initial research, Dynavax received $500,000 from the Alliance for Lupus Research.

• Genaera Corp., of Plymouth Meeting, Pa., said results from its Phase II study of squalamine in choroidal neovascularization associated with age-related macular degeneration (wet AMD) are positive. Preliminary results from six patients treated with 40 mg of squalamine, who each suffered wet AMD in both eyes, showed 100 percent of eyes had preserved or improved vision at week three after two doses, week five (end of therapy) and two months after beginning therapy. The greatest improvement at two months was a gain relative to baseline of 28 letters, or 5.6 lines, while the greatest loss was 11 letters. Data will be presented at the annual meeting of the Macula Society in February.

• GenOway SA, of Lyon, France, merged with the transgenic company, Murinus, of Hamburg, Germany, which specializes in the design, production and housing of genetically modified animal models. The new operation in Hamburg, GenOway Germany GmbH, is expected to yield a further 25 percent in addition to GenOway's expected growth in sales in 2005, it said.

• Human Genome Sciences Inc., of Rockville, Md., received clearance from the FDA for its investigational new drug application to begin clinical trials of CCR5 mAB for the treatment of HIV/AIDS. CCR5 mAB (CCR5mAB004) is a fully human monoclonal antibody that specifically recognizes and binds the chemokine receptor CCR5. The CCR5 receptor is a co-receptor on the cell surface that, together with CD4, mediates the binding of HIV-1 and its entry into the cell.

• ID Biomedical Corp., of Vancouver, British Columbia, closed its asset-backed loan transaction with Second City Capital Partners, also in Vancouver, for $60 million. ID used proceeds to repurchase about 4.9 million subscription receipts held by Shire BioChem Inc., which were issued with the company's acquisition of the vaccine business of Basingstoke, UK-based Shire Pharmaceuticals Group plc. Separately, ID said it began a Phase I trial of a recombinant injectable plague vaccine candidate with DVC LLC. ID, which will serve as the project's manufacturing development partner, began a collaboration with DVC, the prime systems contractor for the Department of Defense Joint Acquisition Program, in 2003 to develop a subunit plague vaccine. Testing of the candidate, designed to protect against the plague bacterium Yersinia pestis, is underway in healthy volunteers ages 18 to 40 at the University of Kentucky Chandler Medical Center in Lexington.

• Idenix Pharmaceuticals Inc., of San Francisco, announced interim data on valopicitabine (NM283), its lead drug, for hepatitis C. Patients were randomized to receive valopicitabine monotherapy or the drug plus pegylated interferon. The data include analysis of all 19 treatment-na ve patients infected with HCV genotype 1 who completed 12 weeks of treatment in the Phase IIa trial. The combination-treated patients achieved a mean reduction of serum HCV RNA of 3.2 log10, or 99.4 percent, at week 12. Based on the data, to be presented at the JPMorgan Healthcare Conference Wednesday, Idenix has extended the trial to six months to evaluate longer-term treatment.

• Immutep SA, of Orsay, France, closed its second funding round of €2.5 million (US$3.27 million) in December, bringing the total amount raised by the company to €5 million. Proceeds will be used to push Immutep's lead product, IMP321, into Phase I/II testing in the second quarter. A natural human T-cell immunostimulatory factor, IMP321 is designed to amplify the T-cell immune response to kill tumors and infected cells. The round was led by Paris-based Innoven Partenaires and included new investment from H2I.

• Lexicon Genetics Inc., of The Woodlands, Texas, advanced two of its drug discovery programs into preclinical development in preparation for investigational new drug applications. The first, LX-1521, is a small-molecule compound to be developed as a cancer treatment. The second, LX-5431, is a protein to be developed as a biotherapeutic for thrombocytopenia, a condition that results in bleeding disorders.

• Lynx Therapeutics Inc., of Hayward, Calif., received a staff determination letter indicating its securities are subject to delisting from the Nasdaq SmallCap Market based on its failure to hold an annual meeting of stockholders by Dec. 31. Lynx said it will appeal the decision. The company delayed the meeting until its registration statement filed on Oct. 29 was approved by the SEC. It has tentatively scheduled the meeting on Feb. 17 to address, among other things, the proposed transaction to merge with Essex, UK-based Solexa Ltd. (See BioWorld Today, Sept. 30, 2004.)

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., said, in collaboration with Johnson & Johnson Pharmaceutical Research & Development, a unit of New Brunswick, N.J.-based Johnson & Johnson, it began VISTA (Velcade as Initial Standard Therapy in multiple myeloma: Assessment with melphalan and prednisone), an international Phase III trial of Velcade in combination with melphalan and prednisone vs. the latter two alone, in patients with newly diagnosed multiple myeloma who are not transplant candidates. The trial was reviewed by the FDA under the special protocol assessment program. Velcade was approved for use in relapsed or refractory multiple myeloma patients in 2003. (See BioWorld Today, May 15, 2003.)

• Nabi Biopharmaceuticals Inc., of Boca Raton, Fla., said results from its 40-patient U.S. Phase I/II trial of Altastaph (Staphylococcus aureus immune globulin intravenous [human]), for adult in-hospital patients with persistent S. aureus bloodstream infections, showed a 36 percent reduction in median time from drug administration to hospital discharge in treated patients compared to placebo (9 vs. 14 days). Patients also were able to maintain antibody titers at or above levels previously demonstrated to be protective against the infection in patients with end-stage renal disease. Altastaph was well tolerated, with no drug-related adverse events.

• Peplin Ltd., of Brisbane, Australia, reported positive safety and efficacy results from its U.S.-based Phase I trial and confirmed it was on track to start Australian-based Phase I trials this quarter for its product, PEP005, a topical treatment for actinic keratosis of sun spots and non-melanoma skin cancer. The trial demonstrated PEP005's ability to clear lesions with 40 percent of treated lesions either completely cleared or almost cleared. That compared with 15 percent of lesions treated with placebo.

• RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., completed about a $5.9 million private placement of its stock. Participants in the transaction included current RegeneRx investors, as well as a number of new institutional investors, and was led by Sigma-Tau Group, the company's largest stockholder. ThinkEquity Partners LLC acted as placement agent for the transaction. RegeneRx previously reported that the first $1.25 million closed on Dec. 31. Investors purchased shares of RegeneRx common stock at $3.25 a share and received warrants to purchase up to 25 percent additional shares of common stock at $4.06 per share, exercisable for 36 months.

• Resverlogix Corp., of Calgary, Alberta, closed its previously announced bought-deal financing and issued about 1 million common shares at $3 per share for gross proceeds of about $3 million. The bought deal represents the completion of an $11 million private placement with First Associates Investments Inc. as lead agent, on behalf of a syndicate that also included Haywood Securities, Loewen Ondaatje McCutcheon, Sprott Securities and Jennings Capital. The initial shares, about 2.6 million, were issued on Nov. 23. Resverlogix said it intends to grant 200,000 stock options to a company officer vesting over 24 months and valid for four years.

• Sangamo BioSciences Inc., of Richmond, Calif., submitted an investigational new drug application to the FDA for SB-509, a therapeutic designed to protect and stimulate the regeneration of peripheral nerve function in diabetics suffering from peripheral neuropathy. SB-509 is an injectable formulation of plasmid DNA that encodes a zinc finger DNA-binding protein transcription factor, designed to up-regulate the vascular endothelial growth factor-A gene.

• Savient Pharmaceuticals Inc., of East Brunswick, N.J., completed patient dosing in a Phase II trial of Puricase, a polyethylene glycol conjugate of recombinant porcine uricase (urate oxidase), for the treatment of refractory gout. The trial involved 41 patients and compared three dosage levels and two dosage regimens over a 12-week period. Savient reported that preliminary data suggest that administration of Puricase every two weeks or every four weeks maintains a level of plasma uric acid within the normal range. Data analysis is expected to be completed this quarter.

• Serono Inc., of Rockland Mass., the U.S. affiliate of Geneva-based Serono SA reported the availability of Saizen (somatropin [rDNA origin] for injection) for use in the treatment of patients with adult growth hormone deficiency, following its FDA approval. Saizen can be administered using a needle-free device, cool.click, the only FDA-approved needle-free device for the administration of growth hormone, the company said.

• Solvay Pharmaceuticals Inc., of Marietta, Ga., and CV Therapeutics Inc., of Palo Alto, Calif., said the FDA formally notified Solvay that its supplemental new drug application for Aceon (perindopril erbumine) tablets seeking an expansion to the label will receive a priority review, pending FDA filing of the application. The proposed label expansion is based on the EUROPA (European Trial on Reduction of Cardiac Events with Perindopril in Patients with Stable Coronary Artery Disease) study, which assessed the ability of perindopril to reduce cardiovascular mortality, nonfatal myocardial infarction and cardiac arrest in a broad population of patients with stable coronary artery disease, but without heart failure or substantial hypertension.

• Sunesis Pharmaceuticals Inc., of South San Francisco, extended its research collaboration with Johnson & Johnson Pharmaceutical Research & Development LLC, a unit of Johnson & Johnson, of New Brunswick, N.J., through the end of 2005. Initiated in May 2002, the collaboration is focused on the discovery of small-molecule enzyme inhibitors targeting cathepsin S, an enzyme involved in the activation of T cells. Sunesis receives research funding and the potential to receive additional research and development milestone payments, as well as royalty payments upon the advancement and commercialization of small-molecule cathepsin S inhibitors. J&JPRD has an exclusive, worldwide license to products resulting from the collaboration. Specific terms were not disclosed. (See BioWorld Today, May 7, 2002.)

• Symyx Technologies Inc., of Santa Clara, Calif., and General Electric Co., acting through GE Global Research, of Niskayuna, N.Y., extended the intellectual property licensing agreement entered in May 2002 to include the license of Symyx's Renaissance software. The expected term of the agreement is three years. GE Global Research will continue to practice certain Symyx combinatorial research methodologies covered under Symyx's issued patents and will deploy Symyx's Renaissance software for use within its central research facility. The Renaissance software is designed to offer global integration of experimental information by enabling and linking experiment design, execution and data capture, analysis and storage via a common database.

• Tercica Inc., of South San Francisco, said it would be ready to submit an electronic new drug application to the FDA for recombinant human insulin-like growth factor-1 for severe primary IGF-1 deficiency in March. Tercica is working of the chemistry, manufacturing and controls section of the NDA. The company also announced it appointed Thorsten von Stein to the newly created position of chief medical officer and senior vice president, clinical and regulatory affairs.

• Xencor Inc., of Monrovia, Calif., entered an agreement with Tokyo-based Chugai Pharmaceuticals Co. Ltd. to create monoclonal antibodies. Chugai will use Xencor's XmAb technology on Chugai's antibodies against a cancer target. Xencor will receive technology access and license fees and is eligible for additional license fees, milestone payments and royalties if Chugai takes compounds into development. Financial terms were not released.

• Xenova Group plc, of Slough, UK, licensed its TA-CIN vaccine to Cancer Research Technology Ltd., of London, which will facilitate a further Phase II study to evaluate the vaccine in combination with an immune modulator in subjects with vulval intra-epithelial neoplasia. CRT will license TA-CIN patents, procedures and materials from Xenova and will market TA-CIN to potential commercial partners. Net receipts from sub-licensing TA-CIN will be shared between CRT and Xenova after certain direct costs have been recouped.

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