• Actelion Ltd., of Allschwil, Switzerland, reported positive results from a Phase IIIb trial of Tracleer (bosentan) in pulmonary arterial hypertension (PAH) associated with HIV infection. PAH occurs in approximately 0.5 percent of all HIV cases, and is a significant contributor to morbidity and mortality. In an open-label study of 16 patients, Tracleer demonstrated a statistically significant improvement in hemodynamic parameters, exercise capacity, functional status and quality of life compared to baseline after 16 weeks of treatment. The initial planned sample size was 30 patients, but enrollment was completed early, the company said, as the results obtained were deemed to be of clinical relevance and required immediate reporting. Olivier Sitbon of the H pital Antoine Béclère in Clamart, France, presented the data Tuesday at the European Society of Cardiology meeting in Vienna, Austria. Actelion spokesman Roland Haefeli said Tracleer's FDA label already allows it to access HIV patients with PAH, but the present study will provide physicians with additional knowledge.

• Antisoma plc, of London, said it is delisting from Nasdaq Europe as of Sept. 10 in advance of the closure of the market. Antisoma had its IPO on Easdaq, as it was then known, in December 1998, subsequently adding a listing on the London Stock Exchange. In March 2001, Nasdaq acquired a majority shareholding in Easdaq and said it would invest $60 million to turn it into a 24-hour global trading platform, expanding European order flow in all Nasdaq-listed stocks. However, it failed to attract sufficient business, and in June it was announced the market would close in November.

• British Biotech plc, of Oxford, UK, declared its takeover of Vernalis plc unconditional after receiving acceptance from 87 percent of Vernalis' shareholders by the second closing of Aug. 28. Following completion, British Biotech intends to change its name to Vernalis and move its headquarters to Vernalis' facility in Guildford, UK.

• Cenix BioScience, of Dresden, Germany, and Ambion Inc., of Austin, Texas, have completed siRNA designs for more than 98 percent of the human, mouse and rat genes in the public RefSeq database. The German company developed an algorithm to produce the short interfering RNA designs with a high degree of accuracy, and the Texas company produced chemically synthesized siRNAs corresponding to each design, both individually and as predefined libraries. The products are intended to ease research in genome-scale RNAi experimentation in mammalian cells.

• Codon AG, of Berlin, continues to struggle, and legal problems may soon be added to the uncertainty about financing and strategy. Co-founder and former board member Karl-Gerd Fritsch has asked the district attorney in Potsdam, Germany, for a criminal inquiry into possible disclosure of technologies and trade secrets, in connection with the search for a strategic partner. According to German media, the district attorney's office confirmed it is looking into the matter. The company is still working to produce an annual report for 2002, and its annual general meeting has been postponed until the second week of October. (See BioWorld International, Aug. 20, 2003.)

• Genzyme Corp., of Cambridge, Mass., said it received U.S. and European regulatory approval for its new plant in Haverhill, UK, where it manufactures sevelamer hydrochloride. That is the primary constituent of Renagel, a phosphate binder for patients on hemodialysis. A second plant at the site is in the final stages of approval. The material will be shipped to Genzyme's new tableting factory in Waterford, Ireland, which is expected to receive FDA approval in the second half of 2003.

• The High Court in London granted court orders to protect the UK facilities and staff of seven subsidiaries of Japanese pharmaceutical companies from the activities of animal rights group. The seven are believed to have been targeted by activists because they are customers of Huntingdon Life Sciences plc (HLS), an animal testing company. The court order sets up exclusion zones around the facilities and the homes of some staff, which protesters cannot enter, and bans protestors from e-mail, telephone or any other form of communication with the companies or their employees. The companies include Daiichi Pharmaceuticals Ltd., Sankyo Pharma Ltd., Yamanouchi Pharma Ltd and Eisai Ltd. In June HLS itself was granted similar injunctions under the Protection from Harassment Act 1997, which originally was introduced to prevent stalking. The animal rights protest group Stop Huntingdon Animal Cruelty has recently begun targeting protests at Japanese pharmaceutical companies that are customers of HLS. As well as the UK, SHAC's website boasts of protests at Japanese subsidiaries in Ireland, Holland, Germany and Russia.

• Ingenium Pharmaceuticals AG, of Munich, Germany, appointed Klaus Dembowsky as vice president for drug discovery. He will lead the company's research and development and focus on advancing its internal drug discovery pipeline toward clinical testing. He joins Ingenium from Bayer AG, where he worked for more than 10 years, most recently managing the Bayer-Millennium target discovery collaboration. Dembowsky also has been a professor of physiology at the University of Heidelberg, and his academic research is concentrated on neurobiology and recombinant proteins.

• Inpharmatica Ltd., of London, said it has extended its two-year drug discovery collaboration with Serono SA, of Geneva, for another year. Financial terms were not disclosed. In June, Inpharmatica received its first milestone payment from Serono for the successful development of an unnamed novel secreted protein identified using Inpharmatica's PharmaCarta chemogenomics system. To date, Inpharmatica has delivered 150 novel proteins to Serono, and under the terms of the extension, the Swiss company can select an unlimited number for further development.

• Oxford BioMedica plc, of Oxford, UK said that the charity Cancer Research UK will finance and conduct a Phase II trial of its cancer immunotherapeutic TroVax in colorectal cancer patients who have liver metastases. The trial will include 20 patients undergoing surgery for liver metastases who will receive injections of TroVax two weeks beforehand. Biopsies of the tumors will be taken and analyzed for TroVax-mediated immune activity. Further TroVax injections will be given after surgery. The trial is in addition to two ongoing Phase II trials in colorectal cancer and was agreed to following a review of the clinical data by Cancer Research UK.

• PhotoCure ASA, of Oslo, Norway, said it received the Confederation of Norwegian Business and Industry annual award for innovation, in recognition of its achievements in developing photodynamic therapy for cancer. Its lead product, the skin cancer treatment Metvix, has gained approval for treatment of basal skin carcinoma in most European countries and New Zealand. Its second product, Hexvix, which is designed for early detection of bladder cancer, is the subject of a marketing authorization application in Sweden and is undergoing a Phase III trial in the U.S.

• Protherics plc, of Runcorn, UK said it received FDA orphan drug status for Voraxaze in the treatment of methotrexate toxicity in patients receiving the drug in cancer chemotherapy. Sales of Voraxaze on a named-patient basis are expected to start later this year in the U.S. and Europe, where the product also has orphan status. Protherics acquired Voraxaze when it took over Enact Pharma plc earlier this year. Protherics expects to receive U.S. and European approval and launch the product formally within two years. The company also intends to conduct further trials to show that Voraxaze's ability to rapidly reduce serum methotrexate levels means it could be used to allow clinicians to increase the dose of methotrexate given without risk of toxicity.

• Pyrosequencing AB, of Uppsala, Sweden, unveiled the combined management team that will run the enlarged company after its forthcoming merger with Personal Chemistry i Uppsala AB, which is slated to close following an extraordinary general meeting Sept. 25. Jeff Bork, currently chairman and CEO of Pyrosequencing, will continue in both roles, while Personal Chemistry CEO Hans Johansson will become president and chief operating officer of the enlarged company. Mats-Olof Wallin and Marten Winge will continue as chief financial officer and vice president of marketing, respectively. Vice president of research and development at Personal Chemistry, Jon-Sverre Schanche, will assume that role in the merged company, and Scott Carr, head of Personal Chemistry's American sales subsidiary, will lead the combined operations of the two firms in the U.S. Erik Wallden, the current Pyrosequencing president and its former CEO, will leave the company once the merger closes.

• Tripep AB, of Huddinge, Sweden, said it entered a U.S. joint venture with the Vaccine Research Insatiate of San Diego (VRISD) to focus on development of vaccines for influenza A, Alzheimer's disease and allergies. The new company, called VLP Biotech Inc., is based in San Diego. Tripep has invested US$500,000 initially and holds a 30 percent stake in the venture, which will seek to develop vaccines based on VRISD's virus-like particle platform. Tripep recently pulled out of a planned acquisition of Swedish vaccine development firm Isconova AB, of Uppsala, citing complications with respect to that company's patent situation.

• Wilex AG, of Munich, Germany, appointed three new members to its supervisory board. David Ebsworth, the former CEO of Oxford GlycoSciences plc and former president of Bayer AG's global pharmaceutical division, joined as the board's new chairman. The other two new members are Jeremy Reffin, a director with Wilex investor Apax Partners Ltd., and Sven Warnaar, who had previously served as chief scientific officer at Wilex. The new members replace Heinrich Graeff, Paul Haycock and Peter Heinrich. In German corporate structure, a supervisory board has legal responsibilities for the company's overall operations that it shares with a board of directors, which is normally responsible for day-to-day operations.