¿ Actelion Ltd., of Allschwil, Switzerland, said the Canadian Health Authority approved Tracleer (bosentan) tablets for the treatment of pulmonary arterial hypertension (PAH). The approval came after a review period of less than eight months, just after FDA approval. Tracleer 125mg, taken twice daily, is the first approved oral treatment for patients suffering from PAH. The company expects the drug to be commercially available in Canada near the end of the year, and in the coming days in the U.S. Elsewhere, Tracleer is under European Union review, and the drug is also under regulatory review in Switzerland and Australia.
¿ Advanced Cell Technology Inc., of Worcester, Mass., reported that it stimulated monkey eggs to become embryos without the use of sperm, a technique known as parthenogenesis. Some of the embryos formed blastocysts, a stage of development where stem cells can be harvested. The company made the announcement at a regenerative medicine conference Sunday in Washington, according to the publication Genetic Engineering News.
¿ Agilent Laboratories, the central research facility of Agilent Technologies Inc., of Palo Alto, Calif., is collaborating with the University of Colorado and the Defense Advanced Research Projects Agency to develop a two-step process for the chemical synthesis of nucleic acids. The $6.1 collaboration includes joint funding by Agilent and DARPA and could potentially speed up the process of DNA synthesis.
¿ Alliance Pharmaceutical Corp., of San Diego, completed its private placement and received proceeds of about $15.1 million. The initial closing involved about 4.3 million shares issued at $3.50 per share to institutional and individual investors who also received warrants to purchase about 4.3 million shares of common stock, exercisable at $4.20 per share. The number of shares issued to investors and the warrant exercise price were subject to adjustment based on the volume weighted average price of Alliance¿s stock during the 10 trading days ended Nov. 29, which was $3.38 per share. Alliance has now issued an additional 153,174 shares of its stock to the investors and reduced the warrant exercise price to $4.06 per share. (See BioWorld Today, Sept. 4, 2001.)
¿ Amnis Corp., of Seattle, completed a second round of financing, raising about $8.75 million. Orbimed Advisors LLC, Emerging Technology Partners, TVM Techno Venture Management, Sunshine Capital, Hillman Ventures, Integra Ventures, WRF Capital and Stratos Product Development LLC participated in the round. The funding will be used for additional hiring and to advance the company¿s research and development process, among other things. The company is focused on advancements in biological cell analysis.
¿ Amsterdam Molecular Therapeutics BV, of Amsterdam, the Netherlands, received EUR$1.9 million from the Dutch Ministry of Economic Affairs for preclinical research of gene therapy for patients suffering from lipoprotein lipase deficiency. AMT is collaborating with the Academic Medical Center, also of Amsterdam, and the University of British Columbia in Vancouver in this research. AMT recently entered into an exclusive sublicense agreement with Xenon Genetics Inc., also of Vancouver, for intellectual property related to LPL. The financial support is part of an effort by the Dutch Ministry of Economic Affairs to stimulate biotechnology in the Netherlands.
¿ Ardais Corp., of Lexington, Mass., added the University of Chicago to the National Clinical Genomics Initiative, a strategic collaboration between Ardais and medical institutions around the country. The National Clinical Genomics Initiative is enabling researchers to study disease at the molecular level on a large scale through access to an integrated repository of research-quality clinical materials, associated information and bioinformatics tools. Ardais collects, processes and archives human tissues left over following surgical procedures, and converts the samples and associated medical information into unique formats for research.
¿ Biomira Inc., of Edmonton, Alberta, said an independent data safety monitoring board reviewed data from all the patients enrolled in its Phase III trial with Theratope vaccine and recommended that Biomira continue its study for metastatic breast cancer as planned. This is the fourth monitoring board safety review of the trial. The study completed enrollment of 1,030 women and is looking for at least 900 to be evaluable.
¿ Cellegy Pharmaceuticals Inc., of South San Francisco, submitted a supplement to its new drug application for Anogesic to include data from a recently completed confirmatory Phase III trial using Anogesic to treat pain associated with chronic anal fissures. The Anogesic NDA was filed in June 2001. (See BioWorld Today, June 27, 2001.)
¿ ChemBridge Laboratories LLC, of San Diego, entered a two-year agreement with Tularik Inc., of South San Francisco, to apply CRL¿s chemistry platform to Tularik¿s research for the discovery of novel therapeutics. CRL on a nonexclusive basis will provide Targeted Combinatorial Libraries that are designed to map binding-site recognition features of a target family. CRL will receive a technology access fee and success-based milestones. Tularik has the option to expand the deal to other target families.
¿ Collateral Therapeutics Inc., of San Diego, said preclinical in vitro and in vivo results showed male reproductive cells were unaffected following intracoronary delivery of Collateral¿s adenovirus serotype 5 ¿ Ad5. The findings confirm other studies in which potential risks associated with inadvertent germ line transmission following adenoviral administration have been shown to be unlikely. The results were published in the Dec. 1, 2001, issue of Molecular Therapy.
¿ DGI BioTechnologies Inc., of Edison, N.J., launched Proteome Panning, a proteome mining technology that led to the identification of DGI-3, an anticancer agent. Proteome Panning allows rapid mining of DGI¿s Rapidlib random surrogate peptide libraries. The surrogate peptides isolated in the Proteome Panning process are available to identify the natural partner and protein network for the target protein and also to regulate its activity in model systems to complete target validation.
¿ DNAPrint Genomics Inc., of Sarasota, Fla., entered a collaboration with the New York University School of Medicine to develop pharmacogenomics classifiers for organ transplant patients. The Mary Lea Johnson Richards Organ Transplantation Center of NYU will provide informed consent-qualified patient specimens and matching clinical data. DNAPrint will genetically screen the specimens for markers and/or marker sets that can be used to distinguish between drug responders and nonresponders. Financial details were not disclosed.
¿ Endorex Corp., of Chicago, completed its acquisition of Corporate Technology Development Inc., of Miami. Endorex shareholders approved the issuance of Endorex common stock, options and warrants for the acquisition and also approved a name change to DOR BioPharma Inc. The new name signifies a shifting of strategic direction to encompass a wider range of delivery of oral biopharmaceuticals, ranging from small-molecule drugs to macromolecular drugs.
¿ Evotec OAI AG, of Hamburg, Germany, entered an agreement with Merck & Co. Inc., of Whitehouse Station, N.J., to synthesize small-molecule chemical libraries. Evotec will synthesize drug-like library compounds using its combinatorial chemistry and autopurification platforms. Merck will use the compounds in its drug research and development programs. Financial details were not disclosed.
¿ ExonHit Therapeutics SA, of Paris, completed its third round of financing, raising EUR30 million (US$26.7 million). Investors included Dresdner Kleinwort Capital, Danske Bank, LCF E. de Rothschild, Sudinnova, BNP-Paribas¿ Banexi Venture III, CDC Innovation, AGF Private Equity, Oxford Bioscience Partners and Sofinnova Partners. The funds will be used to develop EHT-201 and EHT-202, which are expected to enter Phase I/II trials in 2002. The compounds are being developed to treat amyotrophic lateral sclerosis and other central nervous system diseases, the company said.
¿ GeneProt Inc., of North Brunswick, N.J., and Waters Corp., of Milford, Mass., formed a partnership that will expand GeneProt¿s proteomics capabilities through its new industrial-scale proteomics facility in the U.S. Waters, through its wholly owned subsidiary, Micromass UK Ltd., of Manchester, UK, will purchase equity securities of GeneProt with a maximum value of $10 million. At the same time, GeneProt will purchase approximately $20 million of mass spectrometry equipment, related systems and services from Micromass. The companies will collaborate on product development to advance the application of these instruments to industrial-scale proteomics, based on GeneProt¿s first six months of successful operations in Geneva.
¿ Genetronics Biomedical Corp., of San Diego, completed a private placement of 5,212,494 special warrants at a price of 45 cents per warrant for gross proceeds of approximately $2.3 million. Each warrant entitles the holder to acquire one common share of Genetronics and one-half of a nontransferable warrant. Each full warrant entitles the holder to purchase one common share at a price of $0.75 within 18 months of closing. If Genetronics fails to qualify the resale of the securities within 90 days of closing, then 20 percent of the gross proceeds from the transaction will be refunded to the purchasers.
¿ Genta Inc., of Berkeley Heights, N.J., said underwriters exercised their overallotment option in its recent private equity placement for an additional 300,000 common shares, thereby increasing total proceeds from the 2.5 million share offering to $32.7 million. The shares sold for about $13 apiece. (See BioWorld Today, Nov. 29, 2001.)
¿ Immune Network Ltd., of Vancouver, British Columbia, granted a sublicense option to InNexus Corp., of Seattle, for the application of SuperAntibody technology to Immune Network¿s monoclonal antibodies hNM01 and 1F7. InNexus will pay Immune Network $1 million in the form of its common shares issued annually in three installments, in addition to a single-digit royalty. The agreement with InNexus also provides for repayment of approximately $125,000 in funds already advanced by IMM to InNexus this year under the terms of the now-expired option agreement signed in January.
¿ Lucile Packard Children¿s Hospital, of Stanford, Calif., researchers identified a gene family that appears critical to the development of asthma in mice. Researchers used a special technique to look at the effects of only small stretches of DNA at a time, and identified a previously unknown group of nearby genes, called the Tim family, as primary culprits.
¿ Orphan Medical Inc., of Minneapolis, said it gained approval in Canada for Anntizol (fomepizole) to treat confirmed or suspected methanol poisoning and that it gained approval of Busulfex (busulfan) in South Korea in combination with cyclophosphamide to treat certain leukemias, lymphoma and myelodysplastic syndrome. Marketing partners for both products and territories already are in place.
¿ Ortec International Inc., of New York, said OrCel has been approved by the Centers for Medicare and Medicaid Services for inclusion on the Outpatient Prospective Payment Pass Through List. The bilayered cellular matrix is approved to treat epidermolysis bullosa and burn donor site wounds and is being studied in other indications.
¿ Photogen Technologies Inc., of New Hope, Pa., said it obtained positive preclinical results for its agent PH-50 in cardiovascular imaging indications. Experiments showed the agent stayed within the vascular system for at least 20 minutes with little diffusion outside the vascular system.
¿ Trellis Bioscience Inc., of San Francisco, completed a Series A financing from Forward Ventures, of San Diego, and Easton Hunt Capital, of New York. The company was founded to develop products based on technology for protein pathway analysis. The focus is protein translocation. Trellis¿ founders are Larry Kauvar, former founder and chief scientist at Telik Inc., and John Sedat, professor of biochemistry at the University of California at San Francisco.
¿ Vion Pharmaceuticals Inc., of New Haven, Conn., said it believes a preclinical study at Johns Hopkins University Oncology Center validated Vion¿s approach of using bacteria as anticancer agents and as tumor-selective drug delivery agents. Hopkins researchers administered genetically engineered Clostridia bacteria into tumor-bearing mice. Regardless of administration route, the bacteria colonized tumors and destroyed tumor cells. When used with chemotherapy, there was greater antitumor activity than with the chemotherapy or bacteria alone. Vion has reported similar observations using its modified Salmonella bacteria.
¿ Xoma Ltd., of Berkeley, Calif., is the subject of a class action suit filed in the U.S. District Court for the Northern District of California. The suit seeks damages for alleged violations of federal securities laws on behalf of all investors who bought XOMA Ltd. between May 24 and Oct. 4. The complaint alleges XOMA issued false and misleading statements about its plans for its product, Xanelim.