7TM Pharma, of Horsholm, Denmark, said Johnson & Johnson Development Corp., a unit of New Brunswick, N.J.-based Johnson & Johnson, made an undisclosed investment in 7TM, which will use proceeds to advance its development and discovery programs focused on metabolic disorders. The company also has selected a second compound, TM30339, from its Y receptor agonists program, and has initiated preclinical development to test it for the treatment of obesity. Earlier this summer, 7TM started Phase I/II trials with the obesity compound TM30338.
Anadys Pharmaceuticals Inc., of San Diego, received a $10 million milestone payment from Novartis AG, of Basel, Switzerland, after the FDA accepted an investigational new drug application to begin clinical testing of Anadys' lead compound, ANA975. The companies signed a potential $570 million deal in June to jointly develop and commercialize ANA975, an oral Toll-like receptor 7 agonist, to treat chronic hepatitis C infections. (See BioWorld Today, June 3, 2005.)
Ariad Pharmaceuticals Inc., of Cambridge, Mass., said AP23573, its mTOR inhibitor, received orphan drug designation from the FDA for the treatment of both soft-tissue and bone sarcomas. Orphan drug status is intended to provide funding opportunities, study-design assistance and up to seven years of marketing exclusivity upon approval. AP23573 is in Phase I and Phase II trials in patients with solid tumors and hematologic cancers.
BioMS Medical Corp., of Edmonton, Alberta, said an independent data safety monitoring board recommended that the company continue with its pivotal Phase II/III trial of MBP8298 to treat secondary progressive multiple sclerosis. This was the first of several reviews that the DSMB will conduct over the duration of the trial, which is being conducted across Canada and in the UK.
Celera Genomics Group, of Rockville, Md., said one of its tumor surface antigen targets was selected as the first target for advancement by partner Seattle Genetics Inc., of Bothell, Wash., as part of a collaboration established last year. The companies agreed to jointly discover and develop cancer therapies consisting of either monoclonal antibodies or antibodies linked to cell-killing payloads using Seattle Genetics' antibody-drug conjugate technology. Terms call for the companies to co-fund preclinical and clinical work and share in any profits resulting from the collaboration.
Cortex Pharmaceuticals Inc., of Irvine, Calif., said it is testing a second-generation class of pharmaceuticals classified as ampakine compounds. Its lead compound, CX-717, is expected to treat the memory and thinking disorders associated with mild cognitive impairment, and Alzheimer's disease as well as other disorders. It is believed that loss of connections between brain cells is responsible for memory loss. Ampakine compounds are said to increase the signal strength at those connections.
Dendreon Corp., of Seattle, signed an agreement to lease 158,242 square feet of commercial manufacturing space in Hanover, N.J. Dendreon intends to develop the facility to meet clinical and commercial manufacturing needs for Provenge and its other active immunotherapy product candidates in development. Provenge is in development for prostate cancer.
Dyax Corp., of Cambridge, Mass., said it granted a nonexclusive license to its phage display libraries to Merck KGaA, of Darmstadt, Germany, for the discovery and development of antibodies and peptides. Under terms of the agreement, Dyax stands to receive an up-front technology license fee, as well as maintenance fees, milestone payments and royalties on sales of any resulting products. In addition, Merck has an option for Dyax to perform funded research on its behalf.
Encysive Pharmaceuticals, of Houston, said the European Agency of the Evaluation of Medicinal Products accepted for review the company's marketing authorization application for Thelin (sitaxsentan) 100 mg as a once-daily oral treatment for patients with pulmonary arterial hypertension. A new drug application for Thelin also is under review in the U.S., with a PDUFA date of March 24, 2006.
Genelabs Technologies Inc., of Redwood City, Calif., said a preliminary analysis of an open-label clinical trial, Study GL03-01, showed that its drug, Prestara, met the primary endpoint of maintaining bone mineral density (BMD) of women with systemic lupus erythematosus receiving glucocorticoids. Results showed that patients who received 200 mg of Prestara per day increased their BMD at the lumbar spine by about 0.9 percent during the 12-month study period. This trial followed the completion of the company's six-month trial of Prestara, which failed to meet statistical significance compared to placebo, according to results reported in October. Shares of Genelabs (NASDAQ:GNLB) gained 8 cents, or 16.3 percent, Thursday to close at 57 cents. (See BioWorld Today, Oct. 6, 2004.)
Human Genome Sciences Inc., of Rockville, Md., said GlaxoSmithKline plc, of London, exercised its option to jointly develop and commercialize HGS-ETR1 (mapatumumab). HGS-ETR1 is a human monoclonal antibody that specifically binds to the TRAIL-receptor 1 protein, induces apoptosis in human cancer cell lines expressing TRAIL receptor 1 and has activity in a range of tumor types. The option stemmed from a 1996 agreement.
Ligand Pharmaceuticals Inc., of San Diego, said it received FDA approval to produce Avinza (morphine sulfate extended-release capsules) at the Cardinal Health facility in Winchester, Ky. Ligand and Cardinal Health also have a long-standing relationship for the production of Targretin soft-gel capsules. Financial terms were not disclosed.
Manhattan Pharmaceuticals Inc., of New York, said that researchers in Barcelona, Spain, discovered that the levels of the signaling molecule Oleoyl estrone in people who are very overweight may result in significant weight loss. Scientists showed in animal studies that OE regulates appetite and gives the feeling of satiety.
Medicis Pharmaceutical Corp., of Scottsdale, Ariz., said its board amended and restated its existing shareholder rights agreement, which was due to expire on Aug. 17. The agreement would encourage anyone seeking to acquire Medicis to negotiate with the board prior to attempting a takeover. Medicis is focused on treating dermatological and podiatric conditions and aesthetics medicine.
Millennium Pharmaceuticals Inc., of Cambridge, Mass., initiated a 110-patient Phase II trial of MLN1202 in patients at risk for atherosclerotic cardiovascular disease. MLN1202, a humanized monoclonal antibody designed to target CCR2 chemokine receptors found on the surface of certain white blood cells, is in development as an anti-inflammatory drug to treat several diseases, including atherosclerosis, rheumatoid arthritis, multiple sclerosis and scleroderma.
Novartis AG, of Basel, Switzerland, signed an agreement with SeBo GmbH, of Heidelberg, Germany, to acquire the global rights for an oral phosphate binder in development to treat elevated serum phosphate levels (hyperphosphatemia) in late- or end-stage renal disease patients. Novartis has obtained the rights to develop, manufacture and commercialize the compound for patients with chronic kidney disease or those already on dialysis. The compound is in Phase I development.
NPS Pharmaceuticals Inc., of Salt Lake City, said results from a Phase II trial of teduglutide in subjects with short bowel syndrome, published in the September 2005 issue of the gastroenterology journal Gut, showed that daily subcutaneous injections of the drug achieved significant growth of the intestinal lining and improved dietary absorption of nutrients and fluids. Teduglutide is an analogue of the naturally occurring hormone glucagon-like peptide-2. The company started an 80-patient Phase III efficacy study on the basis of these results.
Nuvelo Inc., of Sunnyvale, Calif., said the Aug. 19 issue of Science published data from a study of NU206, a secreted protein in preclinical development, showing that it acts as a specific and potent stimulator of the human epithelial cells that line the gastrointestinal tract and mouth. The study gives Nuvelo direction for its clinical program for the compound as a supportive cancer treatment for chemotherapy- and radiation therapy-induced oral and gastrointestinal mucositis.
Oncolytics Biotech Inc., of Calgary, Alberta, is sponsoring studies by University of Alabama at Birmingham researchers, who said a common virus may become a new weapon in the treatment of deadly brain tumors. They are preparing to test the experimental cancer therapy, Reolysin, for treating recurrent malignant gliomas, some of the most aggressive and deadly brain tumors. The reovirus is able to replicate in cancer cells with an activated Ras pathway, without harming healthy cells, according to studies published by lead scientist Matthew Coffey.
PhytoMedical Technologies Inc., of Vancouver, British Columbia, said it has been accepted for listing on the Frankfurt Stock Exchange, under the symbol "ET6." The company will continue to trade on the Over-the-Counter Bulletin Board. The company focuses on plant-derived pharmaceutical and nutraceutical compounds that target cachexia, obesity and diabetes.
V.I. Technologies Inc., of Watertown, Mass., completed the change of its corporate name to Panacos Pharmaceuticals Inc., and began trading on Nasdaq under the ticker symbol "PANC." The company said the name change is intended to signify its focus on discovering and developing antiviral products based on the technology of Panacos, which merged with Vitex in March. The company's lead compound, PA-457, an oral maturation inhibitor, is in Phase II studies in HIV. (See BioWorld Today, March 11, 2005.)
VioQuest Pharmaceuticals Inc., of Monmouth Junction, N.J., said sodium stibogluconate (SSG) appeared effective in cancer cell lines with a specific blood profile. VioQuest has partnered with investigators at the Cleveland Clinic Taussig Cancer Center, who have found that SSG reduces specific proteins called tyrosine phosphatases. Researchers believe that inhibition of PTPases may, in fact, enhance the activity of certain interferons, thereby improving efficacy as anticancer agents. A Phase I/II study in patients with refractory cancers has been initiated at the Cleveland Clinic.
WEX Pharmaceuticals Inc., of Vancouver, British Columbia, reported data from the Phase IIa double-blind, placebo-controlled trial of tetrodotoxin (Tetrodin) in reducing withdrawal symptoms in methadone-maintained subjects. The results of the study in 14 subjects suggest the use of a four-day pretreatment regimen of subcutaneous tetrodoxin, two times a day, prior to the initiating of withdrawal symptoms with naloxone, does not alleviate the withdrawal symptoms.