• Eli Lilly and Co., of Indianapolis, received FDA approval for Forteo (teriparatide [rDNA origin] injection) to treat osteoporosis in postmenopausal women who are at high risk for a fracture. The drug also was approved to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for a fracture. These include men or women with a history of osteoporosis-related fracture, or who have multiple risk factors for fracture, or who have failed or are intolerant to previous osteoporosis therapy, based upon physician assessment. Lilly called Forteo the first in a new class of drugs called bone formation agents, which work primarily to stimulate new bone by increasing the number and action of bone-forming cells called osteoblasts.

• Genset SA, of Paris, said that following recent tender offers from Serono SA, of Geneva, and the subsequent delisting of Genset's American depositary shares from Nasdaq, it is terminating its American depositary receipt facility. The ADR facility will be terminated effective Dec. 27, after which The Bank of New York will no longer register transfers of ADSs, distribute dividends to holders, or give any notices under the deposit agreement.

• Intradigm Corp., Rockville, Md., named John Spears its chairman and CEO. Most recently, Spears was the president and CEO of Novavax Inc., of Columbia, Md. Intradigm develops RNAi delivery in vivo, enabling rapid discovery and validation of targets.

• Kiadis BV, of Leiden, the Netherlands, and Biofrontera Pharmaceuticals GmbH, of Leverkusen, Germany, entered a collaboration to develop compounds to treat neuropathic pain. Biofrontera has identified disease targets, for which Kiadis will apply its screening technology. Kiadis then will assume responsibility for lead optimization and scale-up. Candidates arising from the partnership will be advanced through preclinical development, and then outlicensed for clinical-stage work. Financial terms were not disclosed.

• Lorantis Ltd., of Cambridge, UK, and PowderJect Pharmaceuticals plc, of Oxford, UK, said they began preclinical studies to optimize treatment protocols for development of a clinical candidate as part of their collaboration to develop a selective allergy treatment. The collaboration combines therapeutics based on Notch, a cell surface protein that is able to switch off an immune response to a specific allergen, with PowderJect's needle-free, particle-mediated delivery technology.

• MedMira Inc., of Halifax, Nova Scotia, entered into an agreement under which Octagon Capital Corp., of Toronto, will act as exclusive agent in a private placement to qualified investors of about 500,000 units of MedMira. Each unit will comprise one common share of MedMira plus one common share purchase warrant. Each warrant will be exercisable for one share for a two-year period from the date of the closing at a price of C$1.50. MedMira develops in vitro diagnostic tests to detect antibodies to certain diseases such as HIV in human serum, plasma or whole blood.

The National Institutes of Health in Bethesda, Md., reported publication in Nature of the possibility of an individual becoming infected with two closely related strains of HIV. The NIH said such findings underscore a challenge in developing broadly applicable vaccines against HIV. Such a case shows that a hypothetical vaccine against one strain of HIV may not necessarily protect against another closely related strain.

• NeoTherapeutics Inc., of Irvine, Calif., reported at the Society for Neuroscience meeting results of studies showing that its therapeutic agent to treat attentional deficit disorder, NEO-339, has similar effects to Ritalin (methylphenidate, from Novartis Pharmaceuticals Corp.) in an efficacy model of attention in young mice. The data further showed that NEO-339 does not have the stimulatory effects seen with methylphenidate treatment. NeoTherapeutics said it is seeking a partner to jointly file an investigational new drug application and begin clinical studies of NEO-339.

• Seattle Genetics Inc., of Bothell, Wash., promoted Clay Siegall to president and CEO. Previously he was the company's president and chief scientific officer, but now replaces outgoing CEO H. Perry Fell, who will remain company chairman and chief strategy officer. Seattle Genetics recently reported a bit of internal realignment, dropping a clinical program in favor of advancing two others. (See BioWorld Today, Nov. 8, 2002.)

• Transition Therapeutics Inc., of Toronto, closed a C$2 million private placement, funds it said it would use primarily to further develop its technologies and advance its products through clinical trials. The placement issued 5.7 million common shares at 35 cents apiece. Separately, Transition acquired 17.6 million Series A special warrants and 4 million Series B special warrants of privately held Stem Cell Therapeutics Inc. (SCT), of Seattle. Upon exercise of the warrants, Transition would own about 46 percent of the outstanding shares of SCT, a company developing regenerative therapies for stroke and Parkinson's disease, technologies Transition labeled as synergistic to its own. In addition, Transition would hold share purchase warrants that, if exercised, would increase its holdings in SCT to about 57 percent. Transition, which issued 8.129 million Class B non-voting shares from treasury as consideration for the special warrants, said it assumes no financial liabilities for ongoing operations of SCT as a result of the purchase. Transition said SCT's current net liquid assets of about $500,000 are enough to cover its current commitments and budgeted expenditures until the end of this year. SCT was not a party to this transaction. Three directors of Transition, including its CEO, are also directors and/or officers and/or shareholders of SCT. But Transition said none of the individuals was a vendor in the transaction.

• United Therapeutics Corp., of Research Triangle Park, N.C., reported publication of an article titled "Treprostinil Therapy for Pulmonary Hypertension" in the current issue of Expert Opinion of Investigational Drugs. The article, which provides an overview of Remodulin (treprostinil sodium) Injection therapy, summarizes pivotal trial data and describes a favorable relationship between the dose of Remodulin and the improvement achieved. A similar analysis relates the magnitude of benefit to disease severity. The article concludes with an opinion as to the practical indications for the use of Remodulin in relation to other available treatment options with regard to the risk/benefit profile of each therapy.