• Altana AG, of Bad Homburg, Germany, said that new clinical data on its inhaled asthma drug, Alvesco (ciclesonide), and on its intranasal formulation of ciclesonide were presented at the 2004 American Academy of Allergy, Asthma and Immunology's 60th annual meeting in San Francisco. Safety studies with Alvesco showed that lower-leg growth in children was not affected. The data presented for the intranasal formulation of ciclesonide showed a dose response in patients with allergic rhinitis.

• Amersham Biosciences, the life sciences business of Amersham plc, of London, said a new study published this month in Proteomics shows that 2-dimensional difference gel electrophoresis (2-D DIGE) technology provided by Amersham Biosciences reveals statistically significant differences in protein abundance between normal and colorectal cancer samples that would not have been easily detected using classic 2-D gel separation. Using that method, 52 proteins that had a statistically significant difference in abundance between tumor and normal samples were identified.

• Amsterdam Molecular Therapeutics, of Amsterdam, the Netherlands, said its adeno-associated viral vector expressing lipoprotein lipase (LPL) product was designated an orphan medicinal product in Europe for the treatment of LPL deficiency. The company said preclinical data suggest it can treat LPL deficiency with its gene therapy.

• Antisoma plc, of London, reported progress Monday on two of its cancer drugs in development. The third and final Phase I study of AS1404 as a monotherapy was completed, providing data required to plan a Phase II program. AS1404 is considered most likely to provide a benefit when used alongside other therapies, the company said. AS1405 started its first trial in patients with glioma. That trial will provide information on safety, dosing and distribution of the drug, as well as evidence of any antitumor activity. Patients included in the study have suffered a relapse of their glioma with regrowth of the tumor after initial treatment.

• Arachnova Therapeutics Ltd., of Cambridge, UK, entered a data-access and licensing deal with Mitsubishi Pharma Corp., of Tokyo, involving a new use of MCI-225 for therapeutic use in pain, stress urinary incontinence and functional bowel disorder. Mitsubishi advanced it into Phase II studies for depression, but did not carry the compound into further development. Under the agreement, financial terms of which were not disclosed, Arachnova will receive access and rights to use the data, as well as raw material from Mitsubishi for development in the new indications. Arachnova said it would reconfigure the safety data to allow for entry into Phase II development.

• Astex Technology Ltd., of Cambridge, UK, said it will collaborate with the Wellcome Trust, the Institute of Cancer Research and Cancer Research Technology, all of London, to discover drugs against the cancer target BRAF. In 2002, scientists from the Institute of Cancer Research and the Cancer Genome Project at the Wellcome Trust Sanger Institute identified BRAF as a key target implicated in a variety of cancers. The gene is involved in up to 70 percent of certain cancer types, including malignant melanoma. The parties began a collaboration in 2003 with Cancer Research Technology to identify BRAF inhibitors. Astex now will provide its knowledge in fragment-based drug discovery. The partners will work together in drug discovery, cancer biology, and the preclinical and clinical development of cancer drugs.

• Australian Cancer Technology Ltd., of Perth, Australia, raised A$3 million (US$2.3 million) after placing about 9.5 million ordinary shares with investors. The shares were sold at about A$0.32 apiece, a 17 percent discount to the volume-weighted average trading price for the year to date. The company said the funding would provide additional working capital to develop its oncology projects and progress previously reported negotiations aimed at expanding its product portfolio in the U.S. and UK. The placement was fully underwritten by Jaguar Advisory Services Pty. Ltd.

• Bayer Healthcare, of Leverkusen, Germany, named Arthur Higgins chairman and CEO. Higgins resigned from his post as CEO of Enzon Pharmaceuticals Inc., of Bridgewater, N.J. He will remain Enzon's chairman through the election of his successor.

• Basilea Pharmaceutica AG, of Basel, Switzerland, is seeking around CHF215 million (US$170.1 million) in its initial public offering, based on the mid-point of its expected range. The company expects to offer 28.5 percent of its stock, or 2.1 million shares, at CHF90 to CHF115 per share, with a valuation of about CHF758.5 million, based on the mid-point. The company is due to unveil the final offer price today, and Basilea's shares are due to commence trading on the Swiss Stock Exchange in Zurich, Switzerland, Thursday. Credit Suisse First Boston LLC and Morgan Stanley & Co. Inc., both of New York, have been appointed joint global coordinators and bookrunners for the offering, while Swissfirst Bank AG, of Zurich, is acting as co-lead manager. Following the IPO, Basilea would have about 7.4 million shares outstanding, or about 7.7 million shares if an overallotment option of 315,000 shares is fully exercised. The company announced its IPO earlier this month. (See BioWorld International, March 10, 2004.)

• Bioneer A/S, of H rsholm, Denmark, was spun out by the Technical University of Denmark in Lyngby to offer research services to small and medium-sized companies in Denmark in the areas of biotechnology, biomedicine and medical technology. Its principal service areas include enzyme discovery and technology; DNA, RNA and protein detection; microbial detection and characterization; mammalian cell culture; protein production; development of bacterial vectors for delivery of vaccines and therapeutics; and identification of markers for probiotic bacterial strains. The new company has 42 employees.

• Crucell NV, of Leiden, the Netherlands, provided a nonexclusive, worldwide license to its PER.C6 technology to NeoTropiX Inc., of Gaithersburg, Md., for research and clinical development of viral therapy products in the field of oncology, with an option for a commercial license. Crucell will receive up-front and annual payments. Separately, Crucell said ML Laboratories plc, of London, decided to renew its PER.C6 license agreement. The parties negotiated research and commercial terms for gene therapy products developed and manufactured with the technology. Further financial terms of the agreements were not disclosed.

• Diatos SA, of Paris, expanded its operations with the opening of a new research and development center in Leuven, Belgium. Last year the company reported a €7 million round of financing, of which €3 million came from the venture fund Biotech Fund Flanders, earmarked for the new research and development subsidiary in Flanders, Belgium. Diatos is focused on therapies for cancer and other diseases.

• Gambro AB, of Stockholm, Sweden, appointed Maris Hartmanis senior vice president and chief science officer. Hartmanis, currently president and CEO of Gyros AB, of Uppsala, Sweden, will assume his position on Sept. 1. Gyros said it has initiated a search for a successor.

• Genmab A/S, of Copenhagen, Denmark, said F. Hoffmann-La Roche Ltd., of Basel, Switzerland, selected two antibodies as candidates for clinical development. The antibodies were developed under a collaboration between the companies that began in May 2001. Under the agreement, Genmab creates human antibodies to a range of disease targets identified by Roche, and Genmab is entitled to milestone and royalty payments based on successful products. The collaboration is potentially worth $100 million to Genmab, plus royalties.

• Inpharmatica Ltd., of London, entered an agreement with GlaxoSmithKline plc, of London, allowing GSK to access its ADME (absorption, distribution, metabolism and excretion) technologies. Inpharmatica will apply its in silico ADME technology to an undisclosed number of GSK drug discovery programs in the UK and Europe. The ADME platform provides a framework in which large collections of molecules or chemistry ideas can be ranked and prioritized for progression based upon their likelihood of success.

• Intercell AG, of Vienna, Austria, is working with the Statens Serum Institut (SSI) in Copenhagen, Denmark, to develop a prophylactic tuberculosis vaccine. The vaccine uses recombinant tuberculosis antigens developed by SSI along with IC 31, a synthetic adjuvant, from Intercell. The vaccine already has shown effectiveness in animal models, and the partners plan to begin a Phase I trial in 2005. SSI will handle development, with Intercell receiving up-front payments and potentially milestone payments, as well as royalties. The commercial partnership follows an earlier technical collaboration.

• Jerini AG, of Berlin, entered an agreement for the production and supply of its lead compound, Icatibant, with Bachem AG, of Bubendorf, Switzerland. The product, a synthetic decapeptide (peptidomimetic) with a similar structure to bradykinin, is being tested in several clinical trials to treat refractory ascites in liver cirrhosis, as well as hereditary angioedema. Bachem will supply Jerini with the product for its trials, and will oversee process validation and necessary documentation for the registration process. Jerini said it plans to bring Icatibant to the market for angioedema by 2006. Financial terms were not disclosed.

• LION bioscience AG, of Heidelberg, Germany, and the EMBL-European Bioinformatics Institute in Cambridge, UK, expanded their relationship, with LION allowing the EBI, as well as other academic institutions, to use the latest versions of SRS to provide research critical content to researchers worldwide with no restrictions. The SRS Server at EBI will be set up as a public reference server worldwide.

• MediGene AG, of Martinsried, Germany, was awarded a U.S. patent for cancer-killing (oncolytic) viruses. U.S. Patent No. 6,699,468 covers a specific method of eliciting an immune response to tumor cells using genetically modified herpes simplex viruses (HSV). Following in situ infection of tumor cells, modified HSVs are expected to trigger the patient's immune system to attack both the tumor as well as distant metastases.

• MorphoSys AG, of Martinsried, Germany, was awarded two additional patents covering the company's human combinatorial antibody library (HuCAL). The first, U.S. Patent No. 6,696,248, titled "Protein/(Poly)Peptide Libraries," covers the genetic constitution of synthetic, fully modular human antibody libraries based on in silico consensus sequences. U.S. Patent No. 6,692,935 B1, titled "Targeted Hetero-Association of Recombinant Proteins to Multi-Functional Complexes," covers methods for developing multifunctional protein complexes, such as the combination of antibody fragments with different specificities.

• Novozymes A/S, of Bagsvaerd, Denmark, intends to expand its operations in South Africa by purchasing the remaining 51 percent of Enzymes SA Pty. Ltd. The company currently owns the other 49 percent. It expects the acquisition to be completed in July. Novozymes plans to increase its focus on the growing sub-Saharan and South African market. The Enzymes management team will continue to lead Novozyme's South African subsidiary. Financial details were not disclosed.

• PharmaMar SA, of Madrid, Spain, began a Phase I study of Aplidin, its marine antitumor agent, for pediatric solid tumors and hematological malignancies. The multicenter European trial is expected to recruit 35 to 41 patients with solid tumors and leukemias, including acute lymphoblastic leukemia, with a primary endpoint of determining a recommended dose for Phase II studies. The company said it began the trial following positive results from Phase I studies in adults with advanced solid tumors and non-Hodgkin's lymphoma, together with preclinical data. Aplidin was three to 10 times more selective toward leukemia and lymphoma cells than toward normal hemopoietic cells in preclinical studies.

• Pharmexa A/S, of Hoersholm, Denmark, said data reported at the European Breast Cancer Conference in Hamburg, Germany, showed that its HER-2 Protein AutoVac vaccine is safe, well tolerated and induces HER-2-specific antibodies in breast cancer patients. More specifically, responses were detected in six of 10 patients. The first responses, detected after two injections, were significantly boosted following subsequent immunizations. Additional responders also were detected after the third and fourth immunizations. Based on those results, Pharmexa plans to continue the vaccine's development through additional clinical investigations in the second half of this year.

• Pluristem Life Systems Inc., of Haifa, Israel, said by using its PluriX bioreactor, the firm has expanded hematopoietic stem cells to quantities large enough for transplantation in more than one adult. The company believes its technology could affect the field of cord blood transplantation and also provide an effective and immediately available source of those stem cells for bone marrow transplants in adults.

• PPL Therapeutics plc, of Edinburgh, UK, is in talks with a potential buyer that could save it from bankruptcy. The company has been selling off its assets since last September, when it failed to secure shareholder support for a restructuring plan. Two weeks ago the company that created Dolly the cloned sheep said it was "almost certain" to go into liquidation after an attempted management buyout of the remnants of PPL failed. The board stressed that the latest talks are at an early stage. The failed management buyout valued PPL at £6.7 million (US$12.4 million). Since then the share price has fallen to 4.25 pence, a market capitalization of £5.15 million.

• Proteome Sciences plc, of Cobham, UK, said it agreed to in-license key biomarkers in Alzheimer's disease from Bayer Pharmaceuticals, a division of Bayer AG, of Leverkusen, Germany. The biomarkers will expand the panel of biomarkers included in a diagnostic test Proteome is developing for the early detection of the disease.

• Serono SA, of Geneva, said Swiss regulatory authorities approved Raptiva (efalizumab) for adult patients with moderate to severe plaque psoriasis. The first biological therapy for psoriasis approved in Switzerland, the injectable product is marketed in the U.S. through a partnership between Genentech Inc., of South San Francisco, and XOMA Ltd., of Berkeley, Calif. It received FDA approval last fall.

• TaiGen Biotechnology Co. Ltd., of Taipei, Taiwan, raised $38 million through the first closing of its Series B round of financing. The company said it expects a second closing later this year, with the private placement's initial funding led by China Steel. Returning investors included MPM Capital, Development Fund, YFY Group, China Development Industrial Bank, Shin Kong Life Insurance and Cathay Life Insurance. TaiGen said it would use the funds to further its internal research and development programs, as well as clinical development of in-licensed drug candidates. The company is focused on immune disorders, cancer and viral infection. Its $37 million Series A financing closed in July 2001, after which TaiGen advanced three of its discovery programs - stem cell mobilization, Th1-mediated chronic inflammation and an antiviral for severe acute respiratory syndrome - into preclinical development. A partnered compound for brain cancer is scheduled to enter the clinic early next year.

• The Genetics Company AG, of Schlieren, Switzerland, entered a three-year agreement for the supply of its Alzheimer's diagnostic kits to JSW-Research Forschungslabor GmbH, of Graz, Austria. JSW-Research will use the kits in preclinical and clinical research studies it is conducting on behalf of several pharmaceutical and biotechnology companies.

• Tissera Inc., of Tel Aviv, Israel, completed an equity private placement with a group of individual and institutional investors representing gross proceeds of $5.5 million. Tissera is focused on the development and commercialization of tissue-transplantation therapies using tissue precursor regeneration technologies for the treatment of disease and organ transplantation.

• Transgene SA, of Strasbourg, France, reported Phase II data of MVA-HPV-IL2 in human papillomavirus-related disease. The trial's primary endpoint aimed to show efficacy as measured by the elimination of the cervical intraepithelial neoplasia lesions at six weeks. Analysis of 27 evaluable patients showed an excellent tolerance of the product candidate. Partial clinical or histological responses, which in some cases cleared the virus, were seen in five out of 15 patients treated with the high dose. The company plans to conduct more studies of the product in cervical dysplasia and the earlier stage of silent HPV infection. MVA-HPV-IL2 also was tested in 20 people with vulvar intraepithelial neoplasia, but it showed no significant difference from placebo, possibly due to the low dose used and the advanced stage of the patients, the company said.

• Tripep AB, of Huddinge, Sweden, received a warning from the disciplinary committee of the Stockholm Stock Exchange, following its communication of new research results to a journalist in Sweden the day before it released the information to the market. The new information appeared in the publication Dagens Industri on Oct. 29, 2003, prior to its communication in a press release that morning, which the committee interpreted as a breach of its rules. In separate news, Tripep said it has identified two new substances that inhibit replication of HIV. Both are analogues of an existing preclinical drug candidate, alpha HGA.