• Adenosine Therapeutics LLC, of Charlottesville, Va., reported the award of a Phase II Small Business Innovation Research grant from the National Institutes of Health. The grant will fund research to identify an oral therapeutic candidate for the treatment of Type II diabetes. The award is worth about $1.4 million over a two-year period. The research will expand testing on a new family of compounds that are expected to be more efficacious than previous compounds.
• Adolor Corp., of Exton, Pa., is the target of a class-action lawsuit initiated by an institutional investor in the U.S. District Court for the Eastern District of Pennsylvania on behalf of purchasers of the company's stock between Sept. 23, 2003, and Jan. 14, 2004. The complaint charges that Adolor and its officers and directors provided false and misleading information regarding the company's product Entereg to treat postoperative ileus. The company sold 6.9 million shares in November, raising $119 million, then reported the failure of Entereg in a Phase III trial needed for a new drug application submission, at which point its stock dropped 37 percent. Milberg Weiss Bershad Hynes & Lerach LLP represents the plaintiff. (See BioWorld Today, Nov. 7, 2003, and Jan. 15, 2004.)
• Alkermes Inc., of Cambridge, Mass., completed patient enrollment in a Phase III safety study of Vivitrex (naltrexone) long-acting injection. The trial enrolled more than 400 patients dependent on alcohol, opiates and mixed substances at 24 centers. The trial is designed to evaluate the long-term safety of naltrexone administered by intramuscular injection once a month. Study participants are randomized to receive either the intramuscular injection or oral naltrexone daily.
• AngioGenex Inc., of New York, and BioCheck Inc., of Foster City, Calif., entered an agreement to develop cancer diagnostic and prognostic products based on the Id-gene platform technology licensed exclusively to AngioGenex by the Albert Einstein College of Medicine and the Memorial Sloan-Kettering Cancer Center. The companies will develop diagnostics based on the measurement of Id-proteins in blood and tumor tissue. A Phase I Small Business Innovation Research grant will provide seed funding for the collaboration.
• Antisoma plc, of London, acquired certain royalty rights from Inverness Medical Switzerland GmbH, a division of Inverness Medical Innovations Inc., of Waltham, Mass. The rights relate to any products based on the mouse and humanized variants of the antibody HMFG1, which form the basis of the drugs R1549 and R1550, respectively. Antisoma is making an immediate cash payment of $300,000 to Inverness, and will make further payments totaling $1.5 million subject to development milestones related to R1549. Inverness relinquished its royalty rights for products based on HMFG1 antibodies, providing Antisoma with additional retained royalties comprising about 2.7 percent of any future sales of R1549 and 1.5 percent of any future sales of R1550. Both products are being co-developed with F. Hoffmann-La Roche Ltd., of Basel, Switzerland. Roche has worldwide marketing rights to the drugs under a November 2002 agreement.
• Applied Imaging Corp., of Santa Clara, Calif., extended its existing loan facility through March 31, 2005, with Silicon Valley Bank. The loan agreement allows Applied Imaging to borrow up to $3.5 million, though the amount of borrowing depends on its level of North American trade receivables. Applied Imaging supplies automated imaging systems for genetics and pathology labs.
• Array BioPharma Inc., of Boulder, Colo., filed a shelf registration statement with the SEC to raise up to $70 million through the sale of common stock, preferred stock and warrants in one or more future offerings. Array focuses on creating orally active drugs for cancer and inflammatory diseases. Its pipeline includes small-molecule drugs that affect disease pathways.
• Arrowhead Research Corp., of Pasadena, Calif., reached an agreement with the California Institute of Technology and Michael Roukes, a professor of physics and bioengineering at the school, to form a company called Nanokinetics Corp., also in Pasadena. Established to focus on the development of processes and devices needed to commercialize various nanotechnology applications, Nanokinetics will be the third majority-owned subsidiary formed by Arrowhead, which funds university research primarily related to nanotechnology, in return for exclusive rights to commercialize technologies and associated intellectual property. Separately, Arrowhead agreed to take a majority position in Insert Therapeutics Inc., also of Pasadena. Founded by Mark Davis, a professor of chemical engineering at CalTech, Insert is expanding and leveraging its Cyclosert platform technology through an internal small-molecule drug development program and a gene-therapy collaboration with Canji Inc., of San Diego.
• AusBiotech, Australia's biotechnology industry organization, provided A$83 million (US$60.7 million) to biotech and pharmaceutical companies through its Pharmaceutical Partnerships Program (P3). The P3 initiative is structured to increase the participation of companies in the pharmaceutical, biotechnology and generics industries in order to encourage partnerships across the sectors. Among the companies that received funding were Acrux Ltd., of Melbourne, Australia; AGT Biosciences Ltd., of Victoria, Australia; Amrad Corp. Ltd., of Melbourne; CSL Ltd., of Melbourne; Mayne Pharmaceuticals, of Melbourne; Novogen Ltd., of Sydney, Australia; and Pharmaxis Ltd., also of Sydney.
• Bodisen Biotech Inc., of Yang Ling, China, received $3.6 million in contracts from nine customers for product delivery this year. As a result, the company broke ground on a new manufacturing facility to double its production from 100,000 metric tons of organic fertilizer per year to 200,000. The new facility is expected to be operational in the fourth quarter, and will include a research facility to allow Bodisen to expand its research and development efforts.
• Carrington Laboratories Inc., of Irving, Texas, and Medline Industries Inc., of Mundelein, Ill., signed a three-year extension of their distribution partnership agreement under which Carrington granted Medline the exclusive rights to sell and market its wound and skin-care products. Carrington will receive a $1.25 million cash payment in royalties and will continue to manufacture the Carrington branded products now being sold by Medline, as well as other Medline-branded products. Privately held Medline manufactures and distributes health care supplies in the U.S.
• Ceres Inc., of Los Angeles, obtained a commercial license to PureIntro, a transformation tool for commercializing plants and plant-based products, from Japan Tobacco Inc., of Tokyo. Financial terms were not disclosed. Privately held Ceres is developing plants and plant-based products to benefit human health and agriculture.
• Cognia Corp., of New York, said its Cognia Molecular information-management system was licensed by BioSeek Inc., of Burlingame, Calif., and research groups at Harvard Medical School, Yale Medical School and the State University of New York at Binghamton. The technology allows researchers to explore the interactions between different aspects involved in human disease.
• CollaGenex Pharmaceuticals Inc., of Newtown, Pa., is restructuring its pharmaceutical sales organization into dental and dermatology sales forces. The company will have a 56-person dental sales force and a 33-person dermatology sales force, as opposed to a grouped 115-person force. The company believes the restructuring will increase sales representatives' focus in their respective therapeutic areas, and enhance the company's ability to attract product in-licensing opportunities. CollaGenex's marketed products include Periostat and Atridox for adult periodontitis. The company intends to begin two Phase III trials this quarter to evaluate Periostat MR in rosacea.
• Draxis Health Inc., of Mississauga, Ontario, closed its offering of about 3.1 million units at C$6.55 apiece for gross proceeds of about C$20 million (US$14.7 million). Each unit consists of one common share and a warrant to purchase half a share. Each whole warrant entitles the holder to acquire one share at C$8.50 any time prior to April 24, 2006. The underwriters have an overallotment option to purchase up to an additional 458,016 units at C$6.55 each. Draxis said it would use the proceeds to finance its C$13 million cash purchase of the 32.7 percent interest in its manufacturing subsidiary, Draxis Pharma Inc., that it did not previously own, and to repay about C$6.4 million in outstanding loans owed by Draxis Pharma. The company's stock (NASDAQ:DRAX) gained 51 cents Thursday, or 13.4 percent, to close at $4.32.
• Genaera Corp., of Plymouth Meeting, Pa., said it plans to begin Phase II trials of squalamine for age-related macular degeneration this quarter after the FDA clears the company's investigational new drug application. Genaera said the studies would run concurrent with the start of Phase III trials beginning early next year. The first Phase II study will evaluate two dose levels of the anti-angiogenic drug (20 mg or 40 mg) in 100 patients over a two-year period. At the end of 48 weeks of therapy, each patient will be followed for 12 months. The company's stock (NASDAQ:GENR) gained 45 cents Thursday, or 11.3 percent, to close at $4.42.
• Genelabs Technologies Inc., of Redwood City, Calif., completed the sale of its diagnostics business to MP Biomedicals LLC, of Irvine, Calif. Genelabs sold all of the outstanding common and preferred stock of Genelabs Asia Pte. Ltd., the parent company of Singapore-based Genelabs Diagnostics Pte. Ltd. GLD develops, manufactures and markets diagnostics products mostly in Europe and Asia. Genelabs divested the business to focus on its core drug discovery and development operations, including Prestara to treat lupus and efforts to discover new treatments for hepatitis C virus.
• GeneProt Inc., of Geneva, established a collaboration with H. Lundbeck A/S, of Copenhagen, Denmark, to study the proteomics of bio-fluid samples taken from a rodent model of central nervous system disease. GeneProt will apply its MicroProt process to the samples, and Lundbeck will have exclusive right to commercialize the results. GeneProt's technology is used to analyze polypeptides and smaller proteins. Financial terms were not disclosed.
• GTx Inc., of Memphis, Tenn., entered a collaboration with Hybritech Inc., a wholly owned subsidiary of Beckman Coulter Inc., of Fullerton, Calif. GTx will provide clinical samples from its Phase IIb trial program evaluating Acapodene for the reduction in the incidence of high-grade prostatic intraepithelial neoplasia. Information resulting from the collaboration will be evaluated by Beckman Coulter to determine its usefulness in research, development and evaluation of assays for prostate disease.
• ILEX Oncology Inc., of San Antonio, met its enrollment target of 240 patients in its Phase II trial of Campath (alemtuzumab) for multiple sclerosis. Three months ago, the company said it would expand the global, multicenter trial from 150 patients based on growing interest among investigators and patients, as well as recommendations of an independent Data Safety Monitoring Board. The randomized, open-label study is investigating Campath and Rebif (interferon beta-1a, from Serono SA) for effectiveness in delaying the sustained accumulation of disability in previously untreated relapsing/remitting multiple sclerosis patients. The company also said that global net sales of Campath/Mabcampath reached $21.1 million in the first quarter, up 52 percent from $13.9 million reported in the first quarter a year ago. Global net sales of Campath are recorded by ILEX's marketing and distribution partner, Schering AG, of Berlin, and its U.S. affiliate, Berlex Laboratories Inc., of Montville, N.J.
• Illumina Inc., of San Diego, reported the first in a line of fixed-content genotyping products based on a new assay and Sentrix BeadChip configuration. The line of microarrays is designed to allow large-scale interrogation of variation in the human genome at many levels of resolution. The first product will target at least 100,000 single nucleotide polymorphisms.
• Immunicon Corp., of Huntingdon Valley, Pa., closed its initial public offering of 6 million common shares at $8 apiece for gross proceeds of $48 million. All the shares were sold by the company, which also granted the underwriters a 30-day, 900,000-share overallotment option that expires May 16. The diagnostic company said it would use its $43 million in net proceeds for product commercialization, including manufacturing, research and development, capital expenditures, as well as working capital and other general corporate purposes. (See BioWorld Today, April 19, 2004.)
• Introgen Therapeutics Inc., of Austin, Texas, said preclinical studies provide insight into the molecular pathways by which p53 kills tumor cells. P53 is the active component in Introgen's Advexin, which is in Phase III trials to treat head and neck cancer. The studies, which were conducted at Okayama University in Japan and at The University of Texas M.D. Anderson Cancer Center, provide evidence supporting Advexin's ability to attack cancer cells through multiple molecular pathways.
• Iogen Corp., of Ottawa, Ontario, produced its first commercial shipment of bioethanol, which unlike conventional ethanol is not made from grain but from cellulosic biomass such as wheat straw, sugar cane bagasse, and corn stovers and stalks left after harvesting. The Biotechnology Industry Organization in Washington said the alternative fuel, compatible with current automobile engines, could reduce greenhouse gas emissions. Iogen said it produced bioethanol using recombinant DNA-produced enzymes to break apart cellulose to produce sugars that can be used to make greener versions of ethanol and plastics.
• MDS Nordion, of Ottawa, Ontario, launched Theryttrexa, its radiopharmaceutical-grade yttrium-90 (Y-90) at the German Congress of Nuclear Medicine in Rostok, Germany. Theryttrex is used as a precursor to radiolabel Zevalin, the first radioimmunotherapeutic product approved in the EU for the treatment of non-Hodgkin's lymphoma. Zevalin was developed by Biogen Idec Inc.
• Medical Discoveries Inc., of Twin Falls, Idaho, received its second preclinical report on MDI-P as a potential agent to treat the symptoms of asthma. In the study, 36 female mice were examined in a chronic asthma model, using various doses of MDI-P as a therapeutic agent as measured against saline control. More than 70 percent of the MDI-P-treated mice exhibited no increase in mucus secretions, comparable with saline control animals, with a marked reduction in eosinophil infiltration. Untreated mice had more than a ninefold increase in mucus build-up, compared with saline controls.
• Nymox Pharmaceutical Corp., of Maywood, N.J., announced progress in its spheron developments for Alzheimer's disease. Unique spheron cellular "fingerprints" have been shown by sensitive measurement techniques, bolstering the company's development work. Spherons are masses of protein and toxins closely associated with the brain plaques and cell death found in Alzheimer's disease.
• Parexel International Corp., of Boston, acquired 3ClinicalResearch AG, of Berlin, a clinical research organization with expertise in Phase I and Phase IIa proof-of-concept studies. 3C has Phase I/IIa facilities at the Charite University Hospital in Berlin and in Hennigsdorf, Germany. Parexel said it has been affiliated with 3C for years, having established a minority ownership stake in the entity in June 2000. It acquired the remaining outstanding shares in March for about $12 million.
• Purely Proteins Ltd., of Cambridge, UK, and Inhibox Ltd., of Oxford, UK, launched commercial drug discovery services based on their combined computational and laboratory-based screening technologies. The platform is beginning with the immediate launch of discovery-ready drug screening programs for families of human phosphatases, kinases and proteases.
• QLT Inc., of Vancouver, British Columbia, said its partner Novartis Ophthalmics, a unit of Novartis AG, of Basel, Switzerland, reported global Visudyne sales of about $101 million for the first quarter, representing a 23 percent increase from that time last year. Visudyne was first approved in the U.S. in April 2000 for wet age-related macular degeneration. The label was expanded in August 2001 for the form of subfoveal choroidal neovascularization that occurs in people 30 and older.
• Schering-Plough Corp., of Kenilworth, N.J., said its Japanese subsidiary Schering-Plough K.K. submitted a new drug application in Japan seeking marketing approval for Peg-Intron powder for injection to be used in combination with Rebetol capsules to treat chronic hepatitis C. If approved, Peg-Intron and Rebetol would be the first and only pegylated interferon-based combination therapy approved in Japan to treat chronic hepatitis C. Schering-Plough K.K. markets Rebetol in Japan for use in combination with Intron A injection for chronic hepatitis C. Peg-Intron is a longer-acting form of Intron A that uses PEG technology developed by Enzon Inc., of Bridgewater, N.J. Schering-Plough holds an exclusive worldwide license to Peg-Intron.
• Spectrum Pharmaceuticals Inc., of Irvine, Calif., completed a $25 million private placement of about 3.2 million shares to institutional and other investors at $7.75 per share. The purchasers also received warrants to buy about 1.1 million shares at $10 per share. Spectrum will use net proceeds for general corporate purposes. SG Cowen Securities acted as the exclusive placement agent. (See BioWorld Today, April 22, 2004.)
• SuperGen Inc., of Dublin, Calif., said the FDA granted the company's request for a rolling new drug application submission for Dacogen (decitabine) for injection. The company will seek approval of Dacogen for patients with myelodysplastic syndromes. It expects to begin submitting data this quarter and complete the submission by the end of the third quarter. Dacogen was granted fast-track status last year. Patients diagnosed with MDS, a cancer of bone marrow, have a life expectancy of six months to five years. About 20,000 to 30,000 new cases are diagnosed in the U.S. each year.
• Vivus Inc., of Mountain View, Calif., began enrolling patients in a study designed to evaluate avanafil (formerly TA-1790), an oral medication intended to treat erectile dysfunction. The at-home, double-blind, randomized, crossover trial will enroll about 250 patients at 20 U.S. sites. Enrollment is expected to be completed by the end of this year, with data available during the first half of next year.
