Abgenix Inc., of Fremont, Calif., submitted an investigational new drug application to the FDA to initiate Phase I trials of ABX-MA1, a fully human monoclonal antibody candidate for the treatment of metastatic melanoma. ABX-MA1 targets a protein called MUC18, a cell-surface adhesion molecule that is highly expressed on metastatic melanoma cells but not on normal skin cells. In preclinical studies, binding of the MUC18 antigen by ABX-MA1 inhibited primary melanoma tumor growth and the formation of tumor metastases.
Accelrys Inc., a wholly owned subsidiary of Pharmacopeia Inc., of Princeton, N.J., and IBM Corp., of Armonk, N.Y., entered a global alliance through a collaborative information technology agreement to develop new drugs faster, more efficiently and at lower costs. As part of the four-year alliance, IBM becomes Accelrys’ preferred information technology and services partner for life sciences, with IBM’s eServer systems used for Accelrys’ life sciences applications. Accelrys will accelerate the delivery of its Discovery Studio platform, a set of Accelrys technologies that will offer broad access to life sciences applications.
Cel-Sci Corp., of Vienna, Va., sent a letter to stockholders saying it made a new discovery with its immunotherapy drug, Multikine, in a clinical trial at the Institute of Human Virology in Baltimore. The discovery showed that HIV-infected women with human papillomavirus-induced cervical dysplasia who are being treated with Multikine had a disappearance of dysplasia in most patients, both visually and confirmed by biopsy. Even women who did not have a complete disappearance of the disease showed some improvement, the letter stated. Cel-Sci’s stock (AMEX:CVM) jumped 34 cents Monday, or about 41 percent, to close at $1.17.
Cubist Pharmaceuticals Inc., of Lexington, Mass., reported successful results from a clinical research study examining the bioavailability of ceftriaxone in a variety of oral formulations. Certain formulations could make ceftriaxone bioavailable, demonstrating clinically relevant blood levels of ceftriaxone delivered intraduodenally, or directly to the small intestine, in human volunteers. The company will continue clinical research on oral ceftriaxone by developing and optimizing oral-dosage formulations, with a goal of filing an investigational new drug application by the end of the year.
Cypress Bioscience Inc., of San Diego, said its investigational new drug application filed last month with the FDA is now open, allowing the company to start clinical testing of milnacipran, a drug candidate for the treatment of fibromyalgia syndrome (FMS). The company expects to begin treating patients in a Phase II trial early this year. Cypress licensed the North American rights to develop and market milnacipran for the treatment of FMS and related chronic pain syndromes from Pierre Fabre Medicament, the pharmaceutical division of bioMerieux Pierre Fabre, of Paris.
Diversa Corp., of San Diego, and Givaudan Flavors Corp., of Cincinnati, entered into an agreement to discover and develop novel enzymes and processes for the cost-effective production of new products for consumer applications. Diversa is entitled to receive undisclosed payments.
Emisphere Technologies Inc., of New York, reported that enrollment of 2,292 patients for its PROTECT trial, conducted at more than 120 sites worldwide, was completed. The trial is investigating Emisphere’s lead product, an oral heparin solution formulation, for the prevention of deep-vein thrombosis following total hip replacement surgery. With 90 percent of the patients finished with the treatment phase, no significant adverse events attributed to the sodium N-[8-(2-hydroxybenzoyl)amino] caprylate delivery agent have been reported, and significant adverse events attributed to oral heparin or subcutaneous administration of Lovenox are running at less than 1 percent.
Exelixis Inc., of South San Francisco, entered into a collaboration with Schering-Plough Research Institute, of Madison, N.J., to create a customized high-throughput screening compound collection to enhance its drug discovery programs. Exelixis will employ its fully integrated chemistry platform technology to generate libraries of compounds, which will be jointly designed by scientists from Exelixis and Schering-Plough. The collaboration will focus on further enhancing the diversity and density of compound collections of both companies and the compounds will be available to each company for internal research programs. Financial terms were not disclosed.
GeneFormatics Inc., of San Diego, entered a collaborative partnership with Bristol-Myers Squibb Co., of New York, to jointly advance the development of nuclear magnetic resonance (NMR) software for the automated, high-throughput determination of 3-D protein structures derived from NMR data. This partnership marks the second between the companies, and involves a cross-license of the parties’ respective analytical NMR software. In July 2000, GeneFormatics and BMS entered into an alliance research agreement to evaluate the biological significance of potential therapeutic targets using GeneFormatics’ computational Fuzzy Functional Form platform technology to elucidate protein function and structure.
GenSci Regeneration Sciences Inc., of Toronto, sold its wholly owned subsidiary, Osteopharm Inc., to Charterbridge Holdings Ltd., as part of a previously announced strategy to focus on its primary orthobiologics business. Proceeds from this Dec. 15 transaction include cash, a note and a royalty interest in future Osteopharm products. GenSci has retained an exclusive license to Osteopharm’s technology for use in developing products for surgical applications. Osteopharm is located in Oakville, Ontario, and is focused on the commercialization of a series of anabolic peptide compounds for the potential diagnosis and treatment of osteoporosis.
Geron Corp., of Menlo Park, Calif., reported a licensing agreement with Genetic Therapy Inc., of Gaithersburg, Md., giving GTI nonexclusive rights to Geron’s human telomerase (hTERT) promoter for the development of therapeutic products targeting cancer. The agreement allows GTI to commercialize products using the hTERT promoter for cancer therapies. GTI will pay Geron a license fee, milestone payments and royalties on product sales. The hTERT promoter regulates telomerase activity in a cell. The telomerase enzyme is found in all cancers and is necessary for cancer cells to replicate indefinitely. Geron scientists have developed adenoviruses whose cancer-killing activity is controlled by the telomerase promoter. The virus is designed to infect and kill telomerase-positive cancer cells without impacting telomerase-negative normal cells.
Human Genome Sciences Inc., of Rockville, Md., said the FDA approved its investigational new drug application to begin clinical trials of Albuleukin, a novel recombinant human protein, for treatment of certain types of cancer. HGS will begin a Phase I multicenter, open-label, dose-escalation study to evaluate Albuleukin’s safety and pharmacology in patients with solid tumors. Albuleukin is a novel form of interleukin-2, a drug approved for cancer treatment. Preclinically, Albuleukin exhibited expanded tissue distribution, was longer acting and better tolerated than IL-2, the company said.
ICN Pharmaceuticals Inc., of Costa Mesa, Calif., said an investigational new drug application was submitted to the FDA for testing of ICN’s nucleoside analogue viramidine for the combination treatment of chronic hepatitis C. Pending approval from the FDA, ICN said it will proceed with initial studies to assess safety and tolerability in normal volunteers.
IDEC Pharmaceuticals Corp., of San Diego, and ExonHit Therapeutics SA, of Paris, signed a collaboration and research agreement for the discovery of antigen targets for antibody therapy, including prostate carcinoma. IDEC now has exclusive worldwide rights to certain antibody-based therapeutic applications of new target discoveries. ExonHit will receive an up-front payment, potential milestones and royalties on approved products. Further financial details were not disclosed.
InterMune Inc., of Brisbane, Calif., received fast-track designation from the FDA for Actimmune (interferon gamma-1b) injection for the treatment of idiopathic pulmonary fibrosis (IPF), a debilitating and usually fatal disease for which there is no effective therapy. In addition, the company reported that in its ongoing Phase III trial for IPF, approximately 60 percent of the trial is complete in terms of patient treatment days.
Isis Pharmaceuticals Inc., of Carlsbad, Calif., entered into an intellectual property licensing agreement with Eyetech Pharmaceuticals Inc., of New York. Privately held Eyetech licensed Isis’ patents necessary for Eyetech to develop, make and commercialize EYE001, a non-antisense compound for the treatment of ophthalmic diseases. Eyetech will pay Isis up-front fees and milestone and royalty payments in the multimillion-dollar transaction in exchange for nonexclusive, worldwide rights to the intellectual property licensed from Isis.
ISTA Pharmaceuticals Inc., of Irvine, Calif., released results of a pilot Phase IIa study of Vitrase, a drug being developed for the treatment of patients with diabetic retinopathy, a leading cause of adult blindness. The purpose of the 60-patient, prospective, randomized, placebo-controlled study was to evaluate the safety and efficacy of Vitrase in inducing a posterior vitreous detachment (PVD). Interim study results at 16 weeks post-treatment demonstrated that complete PVDs were documented in 60 percent of eyes treated with a single dose of Vitrase, compared with only 6 percent of patients in the saline control group.
Lexicon Genetics Inc., of The Woodlands, Texas, discovered and validated in vivo a new drug target, named LG527, to develop potential treatments for depression. The company found that mice lacking the enzyme LG527 showed an increase in activity levels and mobility. This type of response indicates a potential role for the new enzyme in the treatment of depression because typical symptoms of the disease include decreased energy, activity and mobility. Lexicon is working to discover a drug that inhibits the LG527 enzyme, which could lead to new therapy for depression.
Millennium Pharmaceuticals Inc., of Cambridge, Mass., began multiple Phase I trials of MLN341 (formerly LDP-341, PS-341), in combination with Taxotere (docetaxel), a chemotherapy agent used in the treatment of some breast and lung cancers belonging to Aventis Pharmaceuticals Inc., of Bridgewater, N.J. The studies are being conducted to assess the safety of MLN341 in combination with the commonly used cancer agent in advanced solid tumors.
NewBiotics Inc., of San Diego, said it began a Phase I/II trial of NB1011 in patients with colon cancer. NB1011 was developed through a joint venture with Elan Corp. plc, of Dublin, Ireland, and is derived from NewBiotics’ Enzyme Catalyzed Therapeutic Activation technology. The trial will be conducted at the University of California at Los Angeles and the University of Southern California cancer centers.
NicOx SA, of Sophia Antipolis, France, said its investigational new drug application was accepted by the FDA for the clinical testing of HCT 1026, its nitric oxide-releasing derivative of flurbiprofen, for the treatment of urinary incontinence. Approval allows future clinical studies to be carried out in the U.S., expanding on the first Phase I and II studies in Europe. A Phase II trial of the drug in overactive bladders was just completed in the UK and the results are being evaluated.
Novartis AG, of Basel, Switzerland, said that in an interim analysis of the ongoing Phase III study comparing Gleevec (imatinib mesylate) to standard therapy (interferon injections plus Ara-C [cytarabine] chemotherapy) for initial treatment in newly diagnosed CML patients, the Gleevec arm was found early on to demonstrate a substantially higher response. Based on this finding, the Independent Data Monitoring Board recommended a change to enable the patients on standard therapy who have not achieved a major cytogenetic response to switch to Gleevec.
NPS Pharmaceuticals Inc., of Salt Lake City, intends to file a shelf registration statement on Form S-3 with the Securities and Exchange Commission, which will permit the company, from time to time, to offer and sell up to $250 million of common stock, preferred stock and debt securities. NPS intends to use the net proceeds from subsequent offerings for general corporate purposes, including continued development and clinical trials of product candidates, research and development expenses, and potential acquisitions.
Pharmasset Inc., of Atlanta, received a Phase I Small Business Technology Transfer Program grant from the National Institutes of Health, of Bethesda, Md., worth $100,000. The National Cancer Institute will fund research to develop nucleoside analogues cytotoxic only to Epstein-Barr virus thymidine kinase-expressing cells. The grant will support research between Pharmasset and Beth Israel Deaconess Medical Center/Harvard Medical School.
Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., released positive preliminary results from its Phase Ib trial for Interleukin-1 Trap in rheumatoid arthritis (RA). Patients treated with the IL1 Trap experienced dose-dependent improvements in tender and swollen joints and C-reactive protein levels, as well as the composite American College of Rheumatology measure of disease activity. In the double-blind, placebo-controlled study, the IL1 Trap was evaluated in four groups of 15 to 20 patients. Each group received six weekly doses of IL1 Trap at dose levels of 0, 200, 400 or 800 micrograms/kilogram. Preliminary results indicated that the highest-dose group experienced the largest improvement.
Replicon Technologies Inc., of Danville, Calif., named Anthony Maida III president and CEO. Previously, Maida was chairman, CEO, founder and director of BioConsul Drug Development Corp., also of Danville, whose mission is to acquire, develop and ultimately divest promising biotechnology and pharmaceutical products and early stage companies. RTI is a biopharmaceutical company focused on developing therapeutic applications of replicons for human tumors.
Ribozyme Pharmaceuticals Inc., of Boulder, Colo., expanded its collaboration with Elan Corp. plc, of Dublin, Ireland, and its subsidiary, Medizyme Pharmaceuticals. Under terms of the amended agreement, the business venture will license Elan’s liposome technology for the development and potential commercialization of RPI’s ribozyme against the human epidermal growth factor receptor (HER2), Herzyme. It is being developed to treat breast and ovarian cancer as well as a broad spectrum of solid tumors. Herzyme is in Phase I trials at the British Columbia Cancer Agency in Vancouver, as part of the ongoing Medizyme business venture.
Rigel Pharmaceuticals Inc., of South San Francisco, said its oncology drug discovery collaboration with Johnson & Johnson Pharmaceutical Research & Development LLC, of New Brunswick, N.J., was extended for two years. Rigel will continue to validate targets discovered during the collaboration. Johnson & Johnson will identify small-molecule drugs that modulate validated targets selected for drug discovery. Under the January 1999 agreement, J&J provided research funding and milestone payments in exchange for an exclusive, worldwide royalty-bearing license to cell cycle-based products resulting from the collaboration. Terms of the extension include continued research support for two years and an additional future development milestone for Rigel.
Santarus Inc., of San Diego, promoted Gerald Proehl from president and COO to president and CEO. Previous CEO Kenneth Widder will continue to serve as chairman. Santarus is a specialty pharmaceutical company focused on diseases related to gastroenterology.
Scios Inc., of Sunnyvale, Calif., and GlaxoSmithKline plc, of London, entered into an agreement under which Scios will license Natrecor (nesiritide), a treatment for acute heart failure, to GSK in all European markets. GSK will have the rights to sell and distribute the product, for which Scios will receive an up-front fee and milestone payments over four years, in addition to future royalties on European sales. Scios will manufacture and supply the bulk product to GSK. Both companies will work together to continue clinical development of Natrecor in Europe. In order to obtain European approval for Natrecor, GSK expects to use clinical data Scios submitted to obtain approval from the FDA in August 2001. The companies expect to launch Natrecor in Europe in the first half of 2004.
Symyx Technologies Inc., of Santa Clara, Calif., entered into an agreement with Eli Lilly and Co., of Indianapolis, to enhance the rapid discovery, identification and characterization of novel polymorphic forms of Lilly’s drug candidates. Lilly will purchase a Symyx polymorph Discovery Tools system and two Symyx solubility workflow systems. The polymorph system is designed to rapidly identify optimal crystalline salt and polymorphic forms of drug candidates. The solubility workflow system is expected to enable high-throughput automated testing of drug candidates. Financial terms were not disclosed.
Transkaryotic Therapies Inc., of Cambridge, Mass., received marketing authorization for Replagal (agalsidase alfa) enzyme replacement therapy for the long-term treatment of Fabry disease in Israel, Switzerland and the Czech Republic. Since August, Replagal, a human alpha-galactosidase A produced by a genetically engineered human cell line, has been approved for commercial use in more than 20 countries. Patients receive 0.2 mg/kg of Replagal every other week over a 40-minute intravenous infusion.
VaxGen Inc., of Brisbane, Calif., said the journal Vaccine published findings suggesting that the company’s HIV/AIDS vaccine, AIDSVAX B/B, induces antibodies to the five most common HIV subtypes. The article also describes laboratory experiments in which AIDSVAX B/B elicited antibodies able to recognize primary isolates, the type of HIV found in nature and considered the most difficult to protect against. The findings were made possible by a VaxGen laboratory test believed to be more accurate than previous methods at detecting the interaction of antibodies and primary isolates of HIV.
Vernalis Group plc, of London, selected a lead development compound in its Adenosine A(2A) receptor antagonist research program targeting Parkinson’s disease. Its research program targets adenosine, a neurotransmitter that plays an important role in motor coordination and movement control. The company will now complete the preclinical program on VER-11135 with the objective of beginning clinical trials next year. Vernalis said discussions are under way with pharmaceutical companies with an interest in marketing the compound.
Versicor Inc., of Fremont, Calif., began a Phase III trial with its novel investigational agent, anidulafungin, in an additional indication: the treatment of invasive aspergillosis, a life-threatening fungal infection that can occur in high-risk, hospitalized patient populations. Anidulafungin also is being evaluated in a Phase III trial for the treatment of esophageal candidiasis and a Phase II study for invasive candidiasis/candidemia. (See BioWorld Today, March 23, 2001.)
Vertex Pharmaceuticals Inc., of Cambridge, Mass., and Eli Lilly and Co., of Indianapolis, jointly selected LY570310 (VX-950), a novel small-molecule protease inhibitor for the potential treatment of hepatitis C virus (HCV) infection, as a development candidate. The compound is the first drug development candidate of a new class of antiviral drugs being studied to inhibit hepatitis C NS3-4A protease, an enzyme considered essential for HCV viral replication. Preclinical studies of LY570310 are under way. Vertex received a $5 million milestone payment from Lilly.
Xenon Genetics Inc., of Vancouver, British Columbia, signed a second drug discovery agreement with Discovery Partners International Inc., of San Diego, to identify small-molecule compounds active against a Xenon-discovered metabolic disease target. The companies announced their first agreement, also for screening a Xenon target, in September. Financial details were not disclosed.