¿ Actelion Ltd., of Allschwil, Switzerland, filed for European Union marketing authorization for its oral dual endothelin receptor antagonist, bosentan (Tracleer), in the treatment of pulmonary arterial hypertension. Bosentan has been designated orphan drug status for this indication in both the United States and the EU. A new drug application for Tracleer for the same indication was filed in the United States in November.
¿ Amsterdam Molecular Therapeutics B.V., of Amsterdam, the Netherlands, said it has a license agreement with Wisconsin Alumni Research Foundation, of Madison, Wis., in the field of gene therapy for familial hypercholesterolemia. AMT gains a license on proprietary low-density lipoprotein receptor-related research originated from the University of Wisconsin-Madison, with an exclusive option to license future intellectual property in the field.
¿ Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, completed enrollment of its 189-patient Phase II study of Micellar Paclitaxel in treatment of patients with progressive multiple sclerosis. The double-blind, placebo-controlled study is designed to determine the difference in new lesion activity in the Micellar Paclitaxel group vs. control.
¿ Aurora Biosciences Corp., of San Diego, completed its merger with PanVera Corp. Aurora agreed to issue up to 1.9 million shares as payment for the transaction, announced in November. When announced, the deal was valued at about $86 million. (See BioWorld Today, Nov. 20, 2000.)
¿ Boston Biomedica Inc., of West Bridgewater, Mass., said it repurchased $2.04 million of convertible debentures from GCA Strategic Investment Fund Ltd. for $2.23 million in cash. There are now no outstanding debentures from the company's August 2000 private placement. The company also repaid in full the outstanding balance of $5.8 million related to its line of credit with Fleet Bank. BBI used $9.5 million in cash from the sale of BBI Clinical Laboratories for these activities.
¿ Celera Genomics, of Rockville, Md., signed a multiyear agreement with AMDeC LLC, allowing AMDeC member institutions to access Celera's database information through its Celera Discovery System. AMDeC is a consortium of 37 of New York's medical schools, academic health institutions and other research institutions. Financial terms were not disclosed.
¿ Genometrix Inc., of The Woodlands, Texas, released the VistaLogic Information System, an integrated, PC-based bioinformatics tool. The software is designed to handle the large number of data points produced by high-throughput microarray-based genomic analyses, and the company said it is the only software capable of analysis of both gene expression and genotyping data.
¿ Immunicon Corp., of Huntingdon Valley, Pa., said data showed that blood samples from patients with measurable advanced breast cancer contained a significantly higher number of epithelial cells than normal subjects. In 55 percent of patients with elevated levels of epithelial cells, the cells expressed HER-2/neu, an important cancer marker. The data came from a study designed to determine whether cells of epithelial origin, which are believed to be cancerous, exist in higher numbers than background in patients with advanced breast cancer and if the presence of HER-2/neu cell membrane receptor could be assessed in those cells.
¿ Interneuron Pharmaceuticals Inc., of Lexington, Mass., said its product, PRO 2000, a vaginal microbicide for sexually transmitted disease prevention, will be tested in a large government-funded Phase II/III trial to evaluate long-term safety and protective efficacy against HIV infection. The study will begin later this year in Zimbabwe, Malawi, South Africa and India.
¿ Ligand Pharmaceuticals Inc., of San Diego, signed an exclusive European territorial distribution agreement with Elan Pharma International Ltd., an affiliate of Elan Corp. plc, of Dublin, Ireland. The deal focuses on five Ligand oncology products: Ontak, Targretin capsules, Targretin gel, Panretin capsules and Panretin gel. The deal included an up-front payment to Ligand and it expects to receive milestone payments that could total, with the up-front payment, up to $10 million from the collaboration.
¿ LION Bioscience AG, of Heidelberg, Germany, launched its integrated solution for DNA chip applications to analyze the gene expression of the rat. The collection, which complements LION's proprietary mouse arrayTAG & arrayBASE collection, includes a non-redundant set of 10,000 cDNA clones, arrayTAG for rat and is linked to LION's annotation database.
¿ Millennium Pharmaceuticals Inc., of Cambridge, Mass., initiated a Phase II trial of LDP-341 (formerly PS-341) for multiple myeloma. LDP-341 is an investigational proteasome inhibitor for the potential treatment of several cancers. The trial is an open-label study of LDP-341 alone or in combination with dexamethasone, and an additional Phase II trial is scheduled to begin in the second quarter of 2001.
¿ Nexell Therapeutics Inc., of Irvine, Calif., promoted William Albright to CEO. Albright also will take a seat on its board and will retain the title of president, but his previous position of chief operating officer will be eliminated.
¿ Novartis Oncology, of East Hanover, N.J., said it is submitting applications for marketing authorization for Glivec (formerly STI571) for the treatment of patients with chronic myeloid leukemia in the blast crisis, accelerated phase or in chronic phase after failure of interferon-alpha therapy. Submissions have taken place in the United States and the European Union. The filing for Switzerland is expected within the week and the company will file in Japan as well as in other countries.
¿ Novazyme Pharmaceuticals Inc., of Oklahoma City, and Neose Technologies Inc., of Horsham, Pa., restructured their collaboration agreements. Neose will relinquish its joint venture right for Novazyme's enzyme replacement therapy for Pompe disease and instead receive royalty interest for each of Novazyme's drug candidates for lysosomal storage diseases. Also, Neose will receive cash payments and additional equity in Novazyme. Additional terms were not released.
¿ Oncolytics Biotech Inc., of Calgary, Alberta, said researchers will present results of their work with Reolysin for the treatment of metastatic cancer in animal models. Results will be presented at the American Association of Cancer Research meeting in New Orleans on March 26.
¿ Oxigene Inc., of Watertown, Mass., said two peer-reviewed articles that document progress in developing vascular targeting therapeutics to fight invasive solid tumors were published in The Lancet Oncology and Cancer Research, respectively. Data on Combretastatin A4 Prodrug, Oxigene's most advanced vascular targeting agent (VTA), were reviewed and commented on in the report published in The Lancet Oncology. The second article commented on the success of a VTA technology being co-developed by Oxigene.
¿ Packard BioScience Co., of Meriden, Conn., completed the sale of its nuclear products division, Canberra Industries, to Cogema SA, of Velizy Cedex, France, for $170 million. Canberra will retain its Meriden headquarters and lease space within the facility to Packard. Packard will use the proceeds from the sale for debt repayment, research and development and general working capital.
¿ Proteome Systems Inc., of Sydney, Australia, and Kratos Analytical Ltd., of Manchester, UK, expanded their proteomics alliance to include partnering on software development for further automation of Kratos' AXIMA mass spectrometry proteomics applications. The partnership will address bottlenecks in high-throughput automation for MALDI applications in proteomics.
¿ Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., said patients who received Axokine therapy in the recently completed Phase II trial maintained their average weight loss for three months after their last treatment relative to patients who'd received placebo. The company also reported that patients who had received Axokine for eight weeks maintained their average weight loss for four months after the treatment. The company based its findings on preliminary analysis of interim data, and will continue to monitor patients through a year after the end of the trial. Regeneron released data on the Phase II trial in November. (See BioWorld Today, Nov. 29, 2000.)
¿ Ribozyme Pharmaceuticals Inc., of Boulder, Colo., submitted an investigational new drug application to the Canadian Therapeutics Products Programme to initiate clinical trials of Herzyme, the company's ribozyme for treatment of breast and ovarian cancer through the downregulation of the HER2/neu oncogene. The company plans to begin Phase I safety trials evaluating the drug's tolerability and pharmacokinetic profile upon clearance by Canadian officials.
¿ StemCells Inc., of Sunnyvale, Calif., was awarded a $300,000-per-year, two-year Small Business Innovation Research grant from the National Institutes of Health, of Bethesda, Md. The aim of the grant is to further characterize the human cells that can be infected by the human hepatitis virus.
Targesome Inc., of Palo Alto, Calif., received support from a new program sponsored by the National Cancer Institute, of Bethesda, Md., to further the development of its targeted molecular diagnostic imaging agents. The program, named DCIDE, will support Targesome's pharmacology, toxicology and stability studies using NCI resources to enable the filing of an investigational new drug application for its potential imaging product.
The Institute for Systems Biology, of Seattle, signed a lease to move into a recently built 56,000-square-foot facility. The new facility is located near the north end of Lake Union. Leroy Hood established the institute in January 2000.