• Achillion Pharmaceuticals Inc., of New Haven, Conn., nominated a first clinical candidate from its hepatitis C virus (HCV) protease program. ACH-1625, is a selective inhibitor of HCV NS3 protease that demonstrated in preclinical studies a pharmacokinetic profile characterized by rapid and extensive partitioning to the liver. Achillion said NS3 protease inhibition is complementary to the NS4A antagonist it is developing with Gilead Sciences Inc., of Foster City, Calif. A Phase I trial of ACH-1625 is expected to start in 2009.

• Bioject Medical Technologies Inc., of Portland, Ore., and ImmunoVaccine Technologies Inc., of Halifax, Nova Scotia, have entered a collaborative research agreement to test the efficacy of IVT's pandemic influenza vaccine formulation using Bioject's Biojector B2000 device. The research will compare the Bioject device to standard needle-injection procedures. If the research is positive, the two companies may enter into a joint development and commercialization agreement for the delivery of IVT's vaccine products using Bioject's needle-free injection device.

• BioMarin Pharmaceutical Inc., of Novato, Calif., introduced its third enzyme replacement therapy for mucopolysaccharidosis IVA, or Morquio A syndrome. Preliminary studies have shown that the drug candidate is able to bind naturally to the bone matrix and can adequately reach the growth cartilage after I.V. infusion. BioMarin intends to move the program into the clinic in the first quarter of 2009.

• Bionovo Inc., of Emeryville, Calif., said it has developed a novel analytical two-dimensional liquid chromatography mass spectrometry-based multiplexing platform that allows for the rapid, specific, sensitive automated quantification of the active pharmaceutical compounds of MF101, the company's most advanced drug candidate. The quantification has been developed initially for MF101 and has shown positive Phase II results for the treatment of hot flashes associated with menopause. The assay was validated in multiple matrices ranging from MF101 extracts for production quality control to plasma in pharmacokinetic and safety trials.

• Biopure Corp., of Cambridge, Mass., said a pharmaceutical assessor with the European Medicines and Healthcare Products Regulatory Agency accepted the company's proposed strategies for answering pending questions on its marketing authorization application for Hemopure [hemoglobin glutamer - 250 (bovine)]. No new issues were raised, and the company was not advised to withdraw its application. Biopure said it is confident that all issues can be resolved satisfactorily. The company submitted the application for Hemopure in the treatment of acutely anemic adult orthopedic surgery patients in July 2006 and later amended the indication to the treatment of anemia following orthopedic surgery blood loss when blood is not readily available or an option. Further clinical trial issues are expected to be discussed at a meeting to be scheduled later this month.

• Chembio Diagnostics Inc., of Medford, N.Y., said it received a one-year, $296,000 Phase I Small Business Innovative Research grant to develop a simple, rapid, accurate and cost-effective serological test for active tuberculosis that can be used in resource-limited settings. The test is expected to use the company's Dual Path Platform technology with selected antigens from a panel of recombinant antigens identified at the Infectious Disease Research Institute (IDRI), a Seattle-based research organization. Under the terms, Chembio will receive about two-thirds of the funds - about $200,000 - with the balance payable to IDRI as a subcontractor.

• ChemDiv Inc., of San Diego, has continued its multi-year collaboration with Schering Plough Corp., of Kenilworth, N.J. ChemDiv will provide a set of chemical libraries that will be produced through parallel synthesis based on the customer selected templates. Teams from both companies will work to develop exclusive small-molecule libraries enhancing Schering Plough's drug discovery efforts. Financial details were not disclosed.

• Compendia Bioscience, of Ann Arbor, Mich., signed a two-year licensing agreement with GlaxoSmithKline plc, of London, for Oncomine Enterprise Edition, a product extension of Compendia's Oncomine. The new edition integrates the ability to securely view gene expression data in comparison with existing public data already available in Oncomine.

• Computer Sciences Corp., of Falls Church, Va., said the DynPort Vaccine Co. LLC, a CSC firm, was notified by the Department of Defense that all future funding for advanced development of a plague vaccine will be allocated to the existing DVC contract. DVC will continue developing a recombinant plague vaccine candidate, rF1V, up to and including possible licensure by the FDA. RF1V, which is designed to provide protection against the bacterium Yersinia pestis in an aerosolized form, is in Phase II trials.

• Dyadic International Inc., of Jupiter, Fla., said it received notices of resignation from all its executive officers and certain key employees, effective June 20, upon the election of directors at the company's annual stockholders meeting. Executives include President, CEO and board member Wayne Moor; Chief Financial Officer Lisa De La Pointe; Chief Business Officer Alexander (Sasha) Bondar; Ken M. Sproat, executive vice president of manufacturing; Daniel Michalopoulos, senior vice president of research and development; and Charles W. Kling IV, senior vice president of sales and marketing. All cited Mark A. Emalfarb's return to (and anticipated re-employment by) the company as their reasons for resigning, and they alleged that they were constructively terminated without cause and are entitled to certain severance and other payments. The company's outside counsel has disputed the constructive termination claim. Emalfarb served as Dyadic CEO until September, when he was fired following an accounting investigation related to the company's Asian subsidiaries.

• EPIX Pharmaceuticals Inc., of Lexington, Mass., said it achieved a key milestone related to the third of three discovery programs under its collaboration with London-based GlaxoSmithKline plc. Using its computational-medicinal chemistry approach, EPIX identified three lead candidates to move forward into optimization in its G-protein coupled receptor discovery programs. Under the terms, EPIX is entitled to a $3 million milestone payment and an additional $2.5 million payment for its overall progress in all three discovery programs under the 2006 GSK deal. EPIX previously received two milestone payments totaling $6 million. (See BioWorld Today, Dec. 13, 2006.)

• Genocea Biosciences Inc., of Cambridge, Mass., signed a research and collaboration deal with PATH, an international, nonprofit organization, to speed the development of a new vaccine against Streptococcus pneumonia. Genocea, PATH and Richard Malley, an associated professor of pediatrics at Children's Hospital Boston, will work together on a protein-subunit pneumococcal vaccine for use in the developing world.

• ImmuCell Corp., of Portland, Maine, started a pivotal effectiveness field trial of Mast Out to target several hundred cows in major dairy sheds across the U.S. Mast Out is a Nisin-based intramammary infusion product in development as an alternative to traditional antibiotics used in treating mastitis in lactating dairy cows.

• Laboratory Corp. of America Holdings, of Burlington, N.C., and Vanda Pharmaceuticals Inc., of Rockville, Md., have entered into an exclusive alliance to develop and commercialize a series of diagnostic tests for genetic markers identified by Vanda in its clinical development of Fanapta (iloperidone), an atypical antipsychotic drug candidate under FDA review for the treatment of schizophrenia. Financial terms of the agreement were not disclosed.

• Medistem Laboratories Inc., of Scottsdale, Ariz., said an article in the June 2008 issue of the journal Clinical Immunology showed for the first time the prolongation of heart transplant survival using specific types of immune cells generated in vitro and subsequently administered therapeutically. Medistem is developing a "universal donor" stem cell product for treatment of critical limb ischemia, an advanced form of peripheral vascular disease that causes an estimated 150,000 amputations per year in the U.S.

• Nanogen Inc., of San Diego, was awarded a $10.4 million, two-year contract from the Centers for Disease Control and Prevention to develop a multi-analyte molecular diagnostic assay for influenza. That contract calls for Nanogen to develop a fast molecular test designed to simultaneously detect and differentiate influenza Type A, Type B, seasonal flu strains and respiratory syncytial virus. The test will be developed in partnership with the Medical College of Wisconsin and HandyLab Inc., of Ann Arbor, Mich.

• Novartis AG, of Basel, Switzerland, said high blood pressure drug Rasilez (aliskiren), known as Tekturna in the U.S., showed kidney-protective benefits independent of its blood pressure reductions. The study, recently published in the New England Journal of Medicine, also showed that Rasilez/Tekturna added to the maximum dose of losartan had similar rates of adverse events to the placebo plus losartan group. Speedel Holding Ltd., of Basel, Switzerland, is a partner in Tekturna.

• Nuvelo Inc., of San Carlos, Calif., said preclinical data of its Wnt therapeutics programs showed that the R-spondin family of proteins activated the Wnt pathway, a signaling pathway needed for cell growth and differentiation during homeostasis and pathogenesis. R-spondin proteins also amplified the activity of Wnt proteins and modulated the Wnt pathway by a common mechanism. Those data were published in the June 2008 issue of Molecular Biology of the Cell.

• Regado Biosciences, of Durham, N.C., said the journal Circulation published clinical data from the company's REG1 anticoagulation system Phase Ib dose-escalation study. REG1 is a two-component system composed of an aptamer-based anticoagulant, RB006, and its matched antidote, RB007, which binds to and neutralizes RB006. The study is the first to show in patients that RB006 effectively inhibited the activity of Factor IXa, a protein essential to blood clotting and that RB006's activity was reversed rapidly and safely by RB007.

• Sangamo BioSciences Inc., of Richmond, Calif., and Dow AgroSciences LLC, of Indianapolis, have completed research milestones as part of their joint research and commercial license agreement. The milestones represent the successful application of Sangamo's zinc finger DNA-binding protein technology to the generation of specific traits in two major crop species - maize and canola.

• SemBioSys Genetics Inc., of Calgary, Ontario, said it has demonstrated that its safflower-produced Apo AI(Milano) is functional in mice. Data showed that safflower Apo AI(Milano) increased cholesterol mobilization substantially in mice which, in conjunction with analytical and in vitro assays, indicated that safflower Apo AI(Milano) is physiologically and pharmaceutically comparable to microbially produced Apo AI, the company said.

• Senesco Technologies Inc., of New Brunswick, N.J., said it has expanded on its preclinical multiple myeloma research on Factor 5A gene encapsulated in nanoparticles, which has been shown to induce apoptosis in multiple myeloma tumors when injected intratumorally. Senesco has continued its research in both preclinical animal models and human multiple myeloma cell lines, while also studying intravenous delivery of its therapy.

• SpePharm Holding BV, of Amsterdam, the Netherlands, said Loramyc has been granted approvals in the UK, Denmark, Germany, Belgium, the Netherlands, Luxembourg, Finland and Sweden, as well as in Spain under the trade name Sitamic. Loramyc 50 mg, a muco-adhesive buccal tablet of miconazole, is indicated for the treatment of oropharyngeal candidiasis in immuno-compromised patients.