Affymax Inc., of Palo Alto, Calif., named Andrew Perlman CEO. Perlman joins Affymax from Tularik Inc., of South San Francisco, where he was executive vice president. The privately held biopharmaceutical company combines high-speed chemistry technologies to produce new drugs.
Amgen Inc., of Thousand Oaks, Calif., said that the United States Pharmacopeia (USP), an independent source for labeled and unlabeled drug information, accepted Aranesp (darbepoetin alfa) for the treatment of chemotherapy-associated anemia and anemia associated with chronic renal failure. The USP establishes standards and authoritative information for the use of medicines and other health care technologies. Meanwhile, Amgen is awaiting FDA word on a biologics license application supplement for Aranesp for the treatment of cancer patients suffering from anemia associated with certain types of chemotherapy. It was submitted in the third quarter of 2001.
Antigenics Inc., of New York, said the FDA granted fast-track designation for the company’s personalized cancer vaccine, Oncophage (HSPPC-96), for the treatment of metastatic melanoma. Last October, Oncophage received fast-track designation for the treatment of renal cell carcinoma (kidney cancer). Oncophage is the company’s flagship product and contains the antigenic fingerprint derived from each individual’s tumor. It is designed to reprogram the body’s immune system to target and destroy cancer cells.
AVI BioPharma Inc., of Portland, Ore., opened its good manufacturing practices (GMP) manufacturing facility for Neugene antisense drugs. The plant will produce the bulk Neugene drugs for preclinical and clinical development, product launch and commercialization. The facility also contains a series of finished dosage form suites designed to support the development of injectable products.
Cell Genesys Inc., of Foster City, Calif., received a $6 million payment from the pharmaceutical division of Japan Tobacco Inc., of Tokyo, following the completion of a multicenter Phase II trial of GVAX lung cancer vaccine. A Phase III trial of GVAX is expected to begin late this year. Japan Tobacco will pay Cell Genesys an undisclosed royalty on GVAX lung cancer vaccine sales in Japan, Taiwan and Korea, and Cell Genesys will pay Japan Tobacco the same royalty on sales in North America and the rest of the world. The companies will continue to share equally in the development costs of GVAX lung cancer vaccine products and Japan Tobacco still will pay Cell Genesys milestone payments. The original deal signed in 1998 had a total net worth of up to $153 million. (See BioWorld Today, Dec. 21, 1998.)
Cell Therapeutics Inc., of Seattle, said its investigational new drug application for CT-2106 (PG-CPT polyglutamate camptothecin) was reviewed by the FDA and studies can begin. It expects to initiate a Phase I trial with PG-CPT in the United States this quarter. PG-CPT will be the second chemotherapy agent attached to CTI’s polyglutamate polymer to enter clinical trials. In preclinical models, the PG technology appears to be capable of delivering more chemotherapy directly to the tumor, the company said.
Chemical Diversity Labs Inc., of San Diego, opened its Hit-to-Lead facility, 26,000 square feet of research lab space, to serve the North American market and support the growing contract research organization activities in Japan. The new laboratory will have kilo-lab capacity, and expanded analytical and purification instrumentation capabilities. The facility also provides new capacity for scale-up synthesis, high-throughput purification and custom synthesis.
Genencor International Inc., of Palo Alto, Calif., and Corn Products International Inc., of Bedford Park, Ill., said Genencor acquired Wisconsin-based Enzyme Bio-Systems Ltd. for about $30 million in cash plus working capital. Genencor receives EBS’s enzyme business, a manufacturing facility and a seven-year supply contract for the majority of the enzyme needs of Corn Products International, one of the world’s largest agri-processors and the former parent of EBS.
GenoMed Inc., of St. Louis, reported a drug treatment that delays the progression of kidney disease caused by Type II diabetes. In 1993 it was discovered that ACE angiotensin I-converting enzyme is a master disease gene that is associated with approximately 40 common, serious diseases such as kidney disease and other complications of Type II diabetes, the company said. Based on pilot data over three years, the drug regimen slowed the rate of progression of renal disease due to Type II diabetes by 200 percent in African-American men and 50 percent in Caucasian men. The disease was reversed altogether when patients were treated early in the course of the disease, before their serum creatinine, a standard measurement of kidney function, reached 2 milligrams per deciliter, it said.
Gentris Corp., of Research Triangle Park, N.C., and Nanogen Inc., of San Diego, entered into a development site collaboration under which Nanogen will provide its NanoChip Molecular Biology Workstation to Gentris, which it will use in combination with its current applications to develop one or more commercially viable SNP assays. Nanogen will have exclusive commercialization rights to assays developed under the agreement and will provide Gentris with certain payments resulting from the sale of such products.
GenVec Inc., of Gaithersburg, Md., signed a three-year, $10.2 million contract with the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under which GenVec will use its adenovector technology to develop and manufacture clinical-grade preventive AIDS vaccine candidates. GenVec will also work on developing an advanced, scaleable vaccine production process using manufacturing technologies developed at GenVec and designed to support product commercialization. Preclinical studies suggested that using replication-deficient adenoviral vectors can elicit potent and protective B- and T-cell immune responses.
Idun Pharmaceuticals Inc., of San Diego, selected IDN-6734 as the lead clinical candidate in its cardiovascular program for planned toxicology studies required for filing an investigational new drug application. IDN-6734 is a small-molecule caspase inhibitor being developed for the treatment of acute myocardial infarction, or heart attack. Experiments in rodents showed that IDN-6734 decreased heart muscle damage by 27 percent to 55 percent when administered after a simulated heart attack. In studies with pigs, IDN-6734 provided a 22 percent to 32 percent reduction in heart muscle damage. The Phase I trial is planned to start late this year.
InKine Pharmaceutical Co. Inc., of Blue Bell, Pa., said results of a clinical study, which showed Visicol is effective using fewer tablets and a reduced volume of clear liquid for bowel cleansing prior to colonoscopy, were accepted for publication by Alimentary Pharmacology & Therapeutics, a publication focused on drugs used in gastroenterology. Patients scheduled for a colonoscopy were randomized to receive 28 or 32 tablets of Visicol, taken as 20 tablets in the evening before the procedure and either eight or 12 tablets the morning of the procedure.
Invenux Inc., of Denver, named Carl Pelzel president and CEO. Pelzel joined Invenux in March 2001 as president and CEO of Invenux’s wholly owned subsidiary, Evolutionary Medicine, which consolidated with Invenux in December. Invenux uses its technology to focus on the delivery of active, specific compounds for a range of therapeutic targets.
Ionix Pharmaceuticals Ltd., of Cambridge, UK, signed an agreement with Evotec OAI AG, of Hamburg, Germany, to collaborate on the design and synthesis of drug-like chemical compounds for evaluation as potential inhibitors of an Ionix drug target. In collaboration with Ionix, Evotec will synthesize a series of ion channel-focused libraries for lead generation. Ionix will provide lead structures for Evotec to produce related compound libraries. Evotec will select putative ion channel inhibitors from its drug discovery library. Ionix will conduct screening of compounds for target selectivity and functionality, and will optimize promising drug leads. Ionix will own, develop and commercialize drug candidates that derive from the collaboration. Evotec will receive program funding from Ionix, and downstream payments for successful development and commercialization of product candidates.
LaunchCyte LLC, of Pittsburgh, secured about $2 million in new funding, money it will use to close on new technology licenses and create biotechnology companies, it said. LaunchCyte licenses university technologies, maps them to marketplace opportunities, provides seed funding and propels them to market, the company said. The latest closing raises its total capitalization to date to about $4.6 million.
Lynx Therapeutics Inc., of Hayward, Calif., initiated an agreement to provide Keryx Biopharmaceuticals Inc., of Cambridge, Mass., immunological research services aimed at profiling the biological activity of several of Keryx’s compounds on immune cells. The services will be provided through Lynx’s wholly owned subsidiary, Lynx Therapeutics GmbH, of Heidelberg, Germany. Lynx will receive payments from Keryx for immunology research services performed over the term of the agreement.
MDS Proteomics Inc., of Toronto, acquired a collection of nearly 2,000 disease-related, full-length complementary DNA clones from the Kazusa DNA Research Institute, of Yana Kisarazu-shi, Chiba, Japan. The three-year deal provides cDNAs as key reagents and raw material for proteomics-based drug discovery research. Financial terms were not disclosed.
MesoSystems Technology Inc., of Kennewick, Wash., received $3 million from Ardesta LLC, of Ann Arbor, Mich., as part of a Series A preferred investment round. MesoSystems will use the funds to invest in human resources and working capital for product development, manufacturing, marketing, sales, customer service and associated infrastructure to support its growth. The company focuses on the development and manufacture of systems for the assessment and mitigation of environmental biological hazards.
MoliChem Medicines Inc., of Chapel Hill, N.C., received an additional $1.5 million in funding in connection with the exercise by two of its shareholders of warrants to purchase additional shares of its common stock. Dacha Capital Inc. and Multivox Marketing Inc., both of Montreal, each invested an additional $750,000. MoliChem develops products for the treatment of pulmonary and infectious diseases, with a lead product, Moli-1901, in U.S. clinical trials for the treatment of cystic fibrosis.
Versicor Inc., of Fremont, Calif., achieved a fifth milestone in its three-year collaboration with Novartis Pharma AG, of Basel, Switzerland, for the transfer of a proprietary assay package to identify antibacterial agents. Novartis will use the assay in its high-throughput screening lab to identify new anti-infective drugs. The companies began the collaboration, valued at up to $38 million, in 1999. (See BioWorld Today, April 2, 1999.)
Ortec International Inc., of New York, reported results of a six-month follow-up of all 36 patients enrolled in its venous ulcer pilot trial completed in August 2000. The results, which are to be submitted in a final report to the FDA later this month, show that 71 percent of the patients treated with a non-frozen version of OrCel achieved 100 percent wound closure. That compared to 37 percent for the control group, representing a 92 percent improvement using OrCel in the treatment of hard-to-heal ulcers over standard therapy. The rate of wound closure for the OrCel-treated group was double that of the control group and the OrCel-treated group consistently required fewer days to heal.
Paracel Inc., of Pasadena, Calif., a business unit of Celera Genomics, and The Institute for Genomic Research (TIGR), reported that TIGR selected Paracel Transcript-Assembler as its EST-based transcript assembly software. A high-capacity software solution for EST-based transcript assembly, TranscriptAssembler incorporates the earlier Paracel Clustering Package with a number of new capabilities to create a tool for transcript reconstruction. TranscriptAssembler will be used to create and maintain future releases of the TIGR Gene Index databases, a public resource that uses ESTs to reconstruct gene sequences for nearly 50 species.
Peregrine Pharmaceuticals Inc., of Tustin, Calif., closed an offering for $2.2 million from a shelf registration statement it filed with the SEC. Zimmer Lucas Partners LLP, of New York, led the offering. Also participating was Vertical Capital Holdings Ltd., of New York. The company issued 1.1 million common shares and warrants, exercisable on a cash basis only, to purchase an additional 275,000 common shares. In addition, the company issued 50,000 shares to Atlas Capital Services LLC, which acted as placement agent in connection with the sale to Zimmer Lucas Partners LLP, of New York.
Psychiatric Genomics Inc., of Gaithersburg, Md., and High Throughput Genomics Inc., of Tucson, Ariz., entered an alliance that will incorporate HTG’s Multiplexed Molecular Profiling ArrayPlate Kits and Omix Imager into PsyGenomics’ drug discovery platform (Multi Parameter High Throughput Screening). PsyGenomics will purchase ArrayPlate Kits from HTG. PsyGenomics will designate genes linked to psychiatric illnesses for inclusion into the custom-made kits. The ArrayPlate Kits and the Omix Imager will be incorporated into PsyGenomics’ automated drug discovery platform.
Synaptic Pharmaceutical Corp., of Paramus, N.J., began a Phase I trial of SNEC-2, its drug candidate for treatment of depression. The Phase I study is designed to assess SNEC 2’s safety and pharmacokinetic properties through escalating single doses administered to 40 healthy volunteers. The compound has shown positive results in several preclinical studies, producing effects similar to those of serotonin reuptake inhibitors such as Prozac. Unlike SSRIs or any drug candidates in clinical testing, though, SNEC-2 targets only SCT-11, a G protein-coupled receptor discovered by Synaptic.
ViaCell Inc., of Boston, established research and development laboratories in Singapore and Cambridge, Mass. The Singapore Research Center (SRC) was established by ViaCell’s wholly owned subsidiary, ViaCell Singapore Pte. Ltd. SRC and the facility in Cambridge will work in conjunction with ViaCell’s research team in Worcester, Mass., to develop stem cell therapies for the treatment of cancer, immune deficiencies, genetic and neurological diseases and diabetes.
Xcyte Therapies Inc., of Seattle, appointed Scott Minick chairman. Minick has more than 20 years of commercial and executive experience in the industry and served as a consultant to Xcyte for the past two years. He has been a venture partner with ARCH Venture Partners since 1998. Xcyte is developing therapies that use the immune system to treat cancer and other illnesses.
Xenova Group plc, of Slough, UK, began patient dosing in an open-label, Phase I trial at the University Hospital of Rotterdam with XR11576 (MLN576), a novel anticancer agent. The trial will be carried out in the UK and the Netherlands. XR11576 is one of a program of compounds for the treatment of solid tumors licensed to Millennium Pharmaceuticals Inc., of Cambridge, Mass., for the development and exclusive North American commercialization rights. Xenova retains responsibility for performing development activities associated with the program, which will be funded by Millennium beginning in 2003, to the end of Phase II trials.