Active Biotech AB, of Lund, Sweden, said it enrolled the first patients in its Phase II trial of its multiple sclerosis treatment, SAIK-MS. Initial recruitment was undertaken in Sweden, but the company plans to involve centers in the UK, the Netherlands and Russia. It aims to demonstrate that SAIK-MS, which is available in tablet form, reduces and slows the progression of brain lesions in patients with the relapsing form of MS. The study will run about 18 months.
Alizyme plc, of Cambridge, UK, said it received FDA approval to conduct its first study in the U.S. of renzapride in the treatment of constipation predominant irritable bowel syndrome. The compound is in Phase IIb trials in the UK and five other European countries. The company also announced that ATL-962, a lipase inhibitor for the treatment of obesity, will enter Phase IIb trials in the second half of 2002. The trial will be designed to show that ATL-962 causes weight loss in clinically obese patients, and to demonstrate potential advantages over existing products.
ExonHit Therapeutics SA, of Paris, announced the appointment of Christina Hedberg as senior director, business development of its U.S. subsidiary, ExonHit Therapeutics Inc., of Gaithersburg, Md. Hedberg, who will be responsible for developing the company’s therapeutic antibodies and diagnostics business in North America, as well as for commercializing and promoting other products and services, will report to Jim Lyddy, vice president, business development worldwide. Hedberg has 15 years of experience in the biopharmaceutical industry in the U.S. and previously was director of business development at Coagulation Diagnostics, of Bethesda, Md.
Genzyme Corp., of Cambridge, Mass., combined most of its operations in Germany into a single facility in Neu Isenburg, near Frankfurt, and opened the facility Thursday. The company specializes in treatments for genetic disorders and chronically debilitating diseases with well-defined, usually small, patient populations, such as Gaucher disease. Germany is the company’s second largest market, and it expects sales of approximately EUR75 million (US$66 million) there in 2002. Genzyme’s German operations, which employ about 100 people, had been distributed among locations in Luebeck, in the north, and Alzenau and Ruesselsheim, both near Frankfurt. The new headquarters is expected to improve coordination and communication among business units. Sales organizations for northern Europe and Eastern Europe will continue to operate from Hamburg and Constance, respectively.
GW Pharmaceuticals plc, of Salisbury, UK, which is developing pain killers derived from cannabis, said it is expanding the Phase III program to four further indications, bringing the total number of trials to seven. In the double-blind, placebo-controlled trials the cannabis extract, which has no psychoactive effects, is administered as a sublingual spray. The company expects to file for marketing approval in 2003.
Gyros AB, of Uppsala, Sweden, said Schroder Ventures Life Sciences added US$6 million to its recent second-round financing, boosting the total funding to US$36 million. Gyros disclosed the original US$30 million financing late last year, but, President and CEO Maris Hartmanis said, “the door was left open for Schroder Ventures Life Sciences to join at a later date.” Gyros, a spin-off from Uppsala-based Amersham Biosciences AB, is developing microlaboratory platform technology based on CD microfluidics. It introduced its first products last month, Gyrolab MALDI SP1, which integrates on a single CD the sample preparation steps required for MALDI mass spectrometry, and Gyrolab Workstation, which controls the entire process.
Hybrigenics SA, of Paris, named Anne-Fabienne Weitsch managing director, a newly created post in which she will report to the company’s CEO and chairman, Donny Strosberg. Weitsch has 13 years of experience in the international pharmaceutical industry, and previously was senior director, licensing and business development, at Johnson & Johnson.
Oxxon Pharmaccines Ltd., of Oxford, UK, strengthened its hold on the use of Modified Vaccinia virus Ankara (MKA) in therapeutic vaccines, agreeing to a license with Alphapharma Inc. covering the worldwide use of recombinant virus in infectious diseases and cancer. Oxxon will apply the technology to its PrimeBoost vaccine products, which involve sequential immunization with different vectors delivering the same antigen. The immune system is first primed with a DNA vaccine, followed by a booster with a recombinant MKA.
Phytopharm plc, of Godmanchester, UK, said it expanded the manufacturing capacity for its appetite suppressant, P57, in support of further development of the product. P57, derived from an extract of Hoodia gordonii, a South African succulent plant, is licensed to Pfizer Inc. In December, Phytopharm reported positive results in a proof-of-principle study.
SkyePharma plc, of London, a drug delivery specialist, reported a profit of £2.2 million in the second half of 2001, and said it expected to be profitable in 2002, joining the elite club of profitable UK biotechs. However, the results highlighted current concerns about accounting practices: The company would have recorded a profit in 2001 for the full year if it had not deferred recognition of £11.7 million of income from collaborations that still have costs attached.
Xenova Group plc, of Slough, UK, said patient dosing has begun in a Phase IIa dose-escalation trial of its vaccine, TA-CD, for the treatment of cocaine addiction. The aim is to mop up cocaine in the bloodstream, thus preventing it from crossing the blood-brain barrier and causing a high. In an earlier Phase IIa study, cocaine-specific antibodies generated by the vaccine persisted throughout the 12 weeks of the study and an attenuation of the usual euphoric effects of cocaine was reported by five of the six subjects who relapsed during the study, providing anecdotal evidence of a positive effect.