¿ Alza Corp., of Mountain View, Calif., and its unit Crescendo Pharmaceuticals Corp. said the FDA has issued an approvable letter for Concerta extended-release tablets, a once-daily treatment for children with attention-deficit disorder and attention-deficit-hyperactivity disorder. Upon final approval, Concerta will be co-promoted in the U.S. by McNeil Consumer Healthcare, a Johnson & Johnson company.
¿ Aradigm Corp., of Hayward, Calif., said a study conducted with 18 Type I diabetes patients found the relative bioavailability of pulmonary insulin delivered by the AERx System to be 13 percent as compared to subcutaneous injection, meeting the company's expectations. The full report of the study, conducted by Novo Nordisk A/S, of Bagsvaerd, Denmark, will be presented June 11 at the American Diabetes Association meeting in San Antonio, Texas.
¿ Aventis Pharmaceuticals, of Parsippany, N.J., the U.S. pharmaceutical company of Aventis SA, said it received a non-approvable letter from the FDA concerning Refludan for anticoagulation in adults with acute coronary syndrome. The action follows the recommendation of the FDA's Cardiovascular and Renal Drugs Advisory Committee earlier this month. Aventis will discuss with the FDA its next steps for the drug in this indication. Refludan will remain on the market to treat heparin-induced thrombocytopenia Type II and associated thromboembolic disease in order to prevent further thromboembolic complications.
¿ CollaGenex Pharmaceuticals Inc., of Newtown, Pa., said researchers found in a Phase I study of the angiogenesis inhibitor Col-3 administered to patients with Kaposi's sarcoma an overall tumor response rate of 33 percent. Four of nine patients responding were administered the highest doses, while two of the nine responding were administered the lowest dose. The agent was generally well tolerated. The trial included 18 patients, and the data were presented during the 4th International AIDS Malignancy Conference in Bethesda, Md.
¿ Elan Corp. plc, of Dublin, Ireland, said it completed the acquisition of Segix Italia, of Pomezia, Italy, a company that was founded in 1995. Segix Italia focuses on marketing, sales and manufacturing, promoting products in the anti-infective, cardiovascular and central nervous system (CNS) areas. Elan plans to launch several new products over the next two years in the CNS, pain and oncology areas.
¿ Exelixis Inc., of South San Francisco, said it signed a three-year cooperative research and development agreement with the National Institutes of Health, National Cancer Institute (NCI), to elucidate the mechanism of action of NCI anticancer compounds. Exelixis will use its proprietary model system genetics technology to rapidly identify the mechanism of action for NCI compounds that have a demonstrated in vivo or in vitro anticancer activity.
¿ Isotechnika Inc., of Edmonton, Alberta, said it successfully completed Phase Ia trials of its new immunosuppressive drug ISAtx247, which is designed to prevent organ rejection after transplantation and to treat autoimmune diseases. The drug, tested in 20 subjects, was well tolerated and showed no significant adverse events associated with its dosing. The data indicate that ISAtx247 is less toxic than presently used medications, such as cyclosporine, the company said.
¿ Karo Bio AB, of Stockholm, Sweden, said it completed a new share issue of 600,000 shares that have been allocated to Swedish and international investors. The share price was set at SEK336 (US$36.79) providing the company with SEK200 million (US$21.9 million). D. Carnegie AB acted as financial adviser.
¿ Ligand Pharmaceuticals Inc., of San Diego, said study results show that longer-term use of Panretin gel substantially improves response rates in patients with cutaneous AIDS-related Kaposi's sarcoma (KS). In the multicenter Phase III trial follow-up after completion of the initial 12 weeks of treatment, overall response rate improved to a 56 percent response rate. Panretin gel was approved in February 1999 as a topical treatment for KS. (See BioWorld Today, Feb. 4, 1999, p. 1.)
¿ Locus Discovery Inc., of Princeton, N.J., said Nicholas Landekic was appointed president and CEO and a member of the board. Landekic last served as senior vice president of corporate development and communications at Guilford Pharmaceuticals Inc. in Baltimore. Locus was formed in September 1999 to advance a new drug discovery technology based on a computational approach for rapidly designing small-molecule therapeutic compounds that can act as inhibitors or activators of protein activity.
¿ Lorus Therapeutics Inc., of Toronto, said on behalf of its subsidiary, NuChem Pharmaceuticals Inc., that the company has chosen NC 381 as its lead anticancer drug for further studies in preparation for clinical trials. In studies with more than 300 mice containing different tumors, NC 381 treatment was found to significantly reduce the growth of a variety of cancers. The drug also significantly inhibited the metastasis of malignant melanoma cells, the company said.
¿ Nexell Therapeutics Inc., of Irvine, Calif., said it has received approval to market Isolex 300i Magnetic Cell Selection System in Australia. It will be marketed for the ex vivo selection of functional stem cells from hematopoietic tissues, such as mobilized peripheral blood.
¿ Paradigm Genetics Inc., of Research Triangle Park, N.C., said it has exceeded the first milestone in its $55 million collaboration with Monsanto Co., of St. Louis, now known as Pharmacia Corp., in the field of functional genomics. By exceeding the milestone, Paradigm will receive an accelerated milestone payment. The two companies entered into their collaboration in January. (See BioWorld Today, Jan. 25, 2000, p. 1.)
¿ Parker Hughes Cancer Center, of Saint Paul, Minn., opened its doors Thursday, May 18, to become a cancer center focused on drug discovery and cancer prevention. The main emphasis area in research is the identification and isolation of powerful anticancer drugs using natural sources such as the marine sponge.
¿ Questcor Pharmaceuticals Inc., of Hayward, Calif., said patient enrollment and treatment have been completed in a clinical trial for Emitasol, a drug to treat diabetic gastroparesis. The company expects to start a pivotal Phase III trial before the end of the year. Emitasol, an intranasal form of metoclopramide, also has been tested as a treatment of chemotherapy-induced nausea and vomiting.
¿ Shire Pharmaceuticals Group plc, of Andover, UK, and Salix Pharmaceuticals Ltd., of Raleigh, N.C., entered into an agreement under which Shire will purchase from Salix the exclusive rights to balsalazide, a treatment for ulcerative colitis, for Austria, Belgium, Denmark, Finland, France, Germany, Iceland, Ireland, Luxembourg, Norway, the Netherlands, Switzerland, Sweden and the UK. Shire will pay Salix up to US$24 million, including $12.1 million in up-front fees.
¿ The City of Hope Cancer Center, of Duarte, Calif., said it has opened the Center for Biomedicine and Genetics (CBG), the largest academic research-based facility of its kind in the U.S. City of Hope researchers previously had to go to an outside source for production, but with CBG, discoveries can be produced on site, cutting costs and time.
¿ Vion Pharmaceuticals Inc., of New Haven, Conn., said it started an additional Phase I study of the anticancer agent Triapine to assess the safety and maximum tolerated dose when administered intravenously by continuous infusion over a 96-hour period. The new study will continue to evaluate the safety profile and feasibility of extending injections of Triapine over several days. In preclinical animal tumor models, such injections demonstrated Triapine's greatest antitumor activity, the company said.