Actelion Ltd., of Allschwil, Switzerland, said it initiated a clinical trials program to expand the use of Tracleer, its orally available dual endothelin receptor antagonist, for indications including scleroderma and idiopathic pulmonary fibrosis. The company completed enrollment of 120 patients in six countries in Europe and North America, evaluating Tracleer for the treatment of digital ulcers. The product is approved for the treatment of pulmonary arterial hypertension in the U.S., Canada and Switzerland.
BioImage A/S, of Copenhagen, Denmark, said it is the industrial partner in a multinational research project that will investigate the protein translocation events that are critical to cell signaling. The project, funded by Europe’s Fifth Framework Program, is expected to lead to fundamental discoveries that are likely to impact several therapeutic areas. The goal of the project is to investigate the function of the mitogen activated protein kinase pathway with emphasis on the dynamic interactions between intracellular signalling components. The signaling pathway plays a critical role in several diverse cellular processes, including cell differentiation, proliferation and apoptosis in many cell types, the company said.
Cell Pathways Inc., of Horsham, Pa., sold 2.4 million shares of stock at $3.70 per share, raising $8.84 million. With each share, the buyers also received a warrant to purchase one-quarter of a share of common stock at an exercise price of $4.74. The warrants expire on March 26, 2006. Cell Pathways focuses on the research and development of medications to prevent and treat cancer, the commercialization of these compounds and the marketing and selling of oncology-related products made by others.
Celltrion Inc., of Brisbane, Calif., a joint venture owned by VaxGen Inc., of Brisbane, and a group of South Korean investors reported the appointment of directors and interim senior officers to lead the company in its establishment of facilities for the manufacture of VaxGen’s AIDS vaccine candidates, including the appointment of interim co-chief executive James Panek. Previously, Panek was senior vice president of product operations at Genentech Inc., of South San Francisco.
Coley Pharmaceutical Group Inc., of Wellesley, Mass., said it initiated a multicenter Phase I study of its lead product candidate, CpG 7909, in combination with Rituxan, an approved monoclonal antibody product discovered by IDEC Pharmaceuticals Corp., of San Diego, and co-promoted in the U.S. by IDEC and Genentech Inc., of South San Francisco. The dose-escalation study will assess the safety and tolerability of CpG 7909 in combination with Rituxan in patients with relapsed or refractory non-Hodgkin’s lymphoma. Tumor response will be measured as a secondary endpoint.
CombiMatrix Corp., of Snoqualmie, Wash., withdrew its initial public offering. The company originally filed on Nov. 22, 2000. At the time, the company estimated the offering at $100 million. CombiMatrix develops semiconductor-based tools for use in identifying and determining the roles of genes, gene mutations and proteins. (See BioWorld Today, Nov. 27, 2000.)
Cytyc Corp., of Boxborough, Mass., extended the expiration date of its offer to purchase for cash and stock all the outstanding shares of Digene Corp., of Gaithersburg, Md. Cytyc elected to extend the offer following receipt on Monday of a formal request for additional information and documentary material from the Federal Trade Commission. Cytyc said the request was anticipated and the company will respond promptly. The exchange offer is now scheduled to close at midnight on April 11. The acquisition was announced in February and was valued at $554 million at the time. (See BioWorld Today, Feb. 20, 2002.)
DeveloGen AG, of Gottingen, Germany, said the European Commission supported the Growbeta diabetes project with a contribution of up to $1.6 million. The Growbeta project consists of a research consortium established to explore new mechanisms that may lead to treatments for Type I and Type II diabetes. The research is targeted to provide a bridge between developmental biology and the physiology and biochemistry of pancreatic islet cells.
Dyax Corp., of Cambridge, Mass., obtained exclusive rights from The Center for Blood Research to develop and commercialize therapeutic products aimed at an undisclosed inflammatory disease target. The target, a cell surface adhesion protein, is considered an essential mediator of inflammation. In its activated form, the protein directs immune cells to migrate into inflamed tissue. Dyax also has the option to license additional adhesion molecules discovered in the laboratory at the center. Dyax will focus on identifying potential peptide and protein therapeutic products that could specifically block only the active form of this protein and stop the inflammatory response. Financial terms were not disclosed.
Galileo Laboratories Inc., of Santa Clara, Calif., acquired Phytera Ltd., of Sheffield, UK, and the marine microbial libraries of Phytera Inc., of Worcester, Mass. The transaction was financed by cash and Galileo stock. Financial terms were not disclosed. The Phytera plant and marine microbe collections provide Galileo with natural product-derived chemical diversity, Galileo said. Phytera Ltd. has been renamed Galileo Laboratories Ltd. and is a wholly owned subsidiary of Galileo.
Gene Logic Inc., of Gaithersburg, Md., said Takeda Chemical Industries Ltd., of Osaka, Japan, subscribed to Gene Logic’s GeneExpress, which will be used as a primary research tool throughout Takeda’s global drug discovery and development infrastructure. Takeda will subscribe to a customized GeneExpress product, composed of two information segments of GeneExpress. Takeda researchers will gain access to a significant portion of the content in BioExpress and to ToxExpress. Financial details of the multiyear subscription agreement were not disclosed.
GenStar Therapeutics Corp., of San Diego, reported updated data on the first patient treated with MAX AD Factor VIII in a Phase I trial for severe hemophilia A. Data show that for eight months following treatment with the drug, the patient sustained an expression level of Factor VIII at about 1 percent. The news was reported at the New York Society of Security Analysts Biotechnology Conference this week. GenStar also said it had a successful pre-investigational new drug meeting with the FDA. The company expects to initiate Phase I trials for the treatment of prostate cancer in late 2002.
Genzyme General, a division of Genzyme Corp., of Cambridge, Mass., said it is expanding the program it launched last year to increase manufacturing capacity for Renagel, a phosphate binder for patients with end-stage renal disease. Genzyme has begun building an in-house Renagel inventory to increase its flexibility to respond to demand as the product enters additional global markets. The company said, however, it now expects first-quarter Renagel revenues of about $30 million, reflecting the reduction in inventory to six weeks. It lowered its first-quarter earnings-per-share estimate to between 21 cents and 23 cents per share, a decrease of 10 cents per share. Genzyme’s stock (NASDAQ:GENZ) fell $5.42 Wednesday, or about 11.1 percent, to close at $43.37.
MediGene AG, of Martinsried, Germany, and Evotec OAI, of Hamburg, Germany, completed the screening for active compounds to treat cardiac diseases. The substances identified block the activities of a protein that is involved in the onset of cardiac diseases. MediGene intends to develop more effective drugs for the treatment of specific cardiac diseases. The companies said the latest scientific results indicate that the newly identified substances suppress the activity of the disease-related protein.
Nabi Biopharmaceuticals, of Boca Raton, Fla., said that the FDA released for sale the initial production of Nabi-HB (hepatitis B immune globulin [human]) manufactured at Nabi’s biopharmaceutical manufacturing facility. Nabi’s facility received an approval letter from the FDA for the manufacture of Nabi-HB in October. Nabi develops products to power the immune system, the company said.
NPS Pharmaceuticals Inc., of Salt Lake City, completed patient enrollment in its Phase III study of Preos, an investigational treatment for osteoporosis. Preos is a full-length human parathyroid hormone. The study is designed to show the bone-building and fracture-reducing power of Preos over an 18-month period in women with osteoporosis. Also, it reported positive results from a pilot Phase II study of its compound, ALX-0600, in patients with short bowel syndrome. ALX-0600 is a peptide that stimulates the growth of cells that line the intestines.
Oxigene Inc., of Watertown, Mass., said its board appointed Frederick Driscoll as CEO. He replaces Bjorn Nordenvall, who will transition out of the CEO role by the end of June. Driscoll has nearly three decades of experience in the biomedical and biotechnology industries. Before joining Oxigene, he worked for four years as senior vice president of finance and operations at Collagenesis Corp., of Beverly, Mass.
RiboTargets Ltd., of Cambridge, UK; Cancer Research Ventures Ltd., of London; and The Institute of Cancer Research, of London, entered a collaboration to identify and develop inhibitors of the HSP90 “chaperone” family as potential anticancer drugs. Oncogenic proteins are responsible for uncontrolled cell division a characteristic of tumor growth in cancer. The institute will continue to evaluate the inhibitors of HSP90, and provide the expertise in the biology of HSP90 and the preclinical and clinical trials necessary for drug development. RiboTargets will provide chemistry and structure-based design capability to identify new inhibitors, will manage the emerging intellectual property and take responsibility for development and commercialization of any products that arise from the collaboration. Financial details have not been disclosed.
Scios Inc., of Sunnyvale, Calif., said the lead article and editorial published in this week’s issue of the Journal of the American Medical Association support the use of the company’s flagship product, Natrecor (nesiritide), for the treatment of acutely decompensated congestive heart failure in patients with shortness of breath at rest or with minimal activity. The article reported the results of the Vasodilation in the Management of Acute Congestive Heart Failure study, a randomized double-blind trial involving 489 patients with acute heart failure.
Synthematix Inc., of Research Triangle Park, N.C., reported a collaboration with Cubist Pharmaceuticals Inc., of Lexington, Mass., to develop and deploy chemical information tools in anti-infective drug discovery. The collaboration, formally initiated in January, is based on Synthematix’s Arthur system for storing and searching databases of chemical procedures. The database is being mined with Arthur’s tools. Financial details were not disclosed.
The Medicines Co., of Parsippany, N.J., said a Phase II trial of its probiotic, CTV-05, as an adjunct to antibiotic treatment in bacterial vaginosis did not improve clinical cure rates at 30 days, the primary endpoint of the trial. The trial did show CTV-05 resulted in vaginal colonization by lactobacillus crispatus in 62 percent of patients at 30 days, compared to 2 percent on placebo (p<0.001). More than 400 women were enrolled in the trial.
Theratechnologies Inc., of Montreal, said all outstanding warrants allowing their holders to purchase Ecopia BioSciences Inc., of Montreal, common shares without any additional consideration have been exercised and underlying shares to the warrants have been delivered. The warrants were issued pursuant to transactions effective in May 1999 and May 2000. Ecopia BioSciences is a bacterial genomics company in which Theratechnologies has held an interest since its founding in January 1998 and which became a public company by way of a spin-off. (See BioWorld Today, April 27, 2000.)
Therion Biologics Corp., of Cambridge, Mass., appointed Mark Leuchtenberger president and CEO. Leuchtenberger has experience in biopharmaceutical marketing, product commercialization and business development, and formerly was vice president, international, of Biogen Inc., also of Cambridge. Therion’s former president and CEO, Dennis Panicali, will take on the role of the company’s chief scientific officer. He also will remain a member of the board.
Viragen Inc., of Plantation, Fla., said its majority-owned subsidiary, Viragen International Inc., is trading under the new stock symbol “VGNI.” The company formerly traded under the symbol “VERP.” Viragen researches, develops and manufactures human monoclonal antibodies for the treatment of diseases, particularly cancer. Also, Viragen International’s wholly owned Swedish subsidiary, BioNative AB, was renamed ViraNative AB.
Xenova Group plc, of Slough, UK, reported the publication of results from a physician-initiated Phase IIa trial of its TA-HPV therapeutic vaccine at the meeting of the British Society of Investigative Dermatology held in Norwich, UK. TA-HPV contains certain disease-associated HPV genes inserted into a carrier vaccinia virus vector. Results of the trial in 12 women with high-grade human papillomavirus-positive ano-genital intraepithelial neoplasia of up to 15 years duration showed at least a 50 percent reduction in total lesion diameter over 24 weeks. One patient showed complete regression of her lesion.