¿ Affymetrix Inc., of Santa Clara, Calif., saw its stock fall about 36.5 percent Tuesday, or $14.94, to $26.01 following its disclosure that revenues for the second quarter are expected to be in the range of $44 million to $50 million. The predicted revenue is less than recent analyst expectations and is due to lower-than-anticipated orders for its GeneChip product line and a decline in the spotted array instrumentation marketplace, Affymetrix said. Affymetrix expects a net loss for the quarter to be $4 million to $7 million, excluding noncash, acquisition-related charges. Affymetrix blamed market factors related to the economic climate for the unanticipated weakness in sales.
¿ Aphton Corp., of Miami, said an article in the British Journal of Surgery 2001 (volume 88) established gastrin as an important growth factor in the progression of premalignant stomach cells from the earliest stage through adenocarcinomas. The article presented findings that the gastrointestinal hormone¿s genes and receptor are switched on at the earliest stage of premalignancy. Aphton is developing an antigastrin vaccine in a clinical trial that the company said might be pivotal.
¿ Cambridge Antibody Technology Group plc, of Melbourn, UK, said it began a Phase I trial of CAT-213, CAT¿s human monoclonal antibody that neutralizes eotaxin(1). The trial will assess the compound¿s safety, tolerability and pharmacokinetics in a single intravenous dose in 25 volunteers. CAT-213 is designed to inhibit the major stimulus that draws eosinophils, a type of white blood cell, to tissues.
¿ Cephalon Inc., of West Chester, Pa., granted Australian and New Zealand sales, marketing and distribution rights for Actiq (oral transmucosal fentanyl citrate) to Orphan Australia Pty. Ltd., of Melbourne, Australia. Actiq is marketed in the U.S. by Cephalon and in the UK by Elan Pharma Ltd., a joint venture between Elan Corp. plc, of Dublin, Ireland, and Parke Davis UK. Cephalon acquired Actiq through its acquisition of Anesta Corp., of Salt Lake City. (See BioWorld Today, July 18, 2000.)
¿ Corixa Corp., of Seattle, said it was awarded a $3.5 million, two-year contract from the Space and Naval Warfare Systems Center San Diego for a Defense Advanced Research Projects Agency-sponsored program to develop methods of enhancing immune responses to infectious diseases, including agents of biological warfare. Corixa will conduct preclinical testing of its portfolio of synthetic lipid A-like immunomodulatory agents to enhance innate immune responses. The drugs act on Toll-like receptors to generate protective immunity to a wide variety of infectious agents.
¿ Direct Therapeutics Inc., of Redwood City, Calif., received a Small Business Innovation Research grant from the National Institutes of Health for the development of techniques to evaluate the distribution of its DTI-015 product candidate for the treatment of solid tumors. DTI-015 is in two Phase I/II trials in patients diagnosed with glioblastoma multiforme.
¿ Genome Quebec, of Montreal, appointed Paul L¿Archeveque president and CEO. L¿Archeveque has worked in the pharmaceutical industry since 1977 and is chairman of PharmaVision Quebec. Genome Quebec is devoted to research and development in the fields of genomics and proteomics.
¿ Genomics Collaborative Inc., of Cambridge, Mass., said it registered its 100,000th patient sample in its Global Repository, an industrial-scale repository of purified human DNA, serum and tissue samples. All samples are accompanied by medical history and properly consented for use.
¿ KS Biomedix Holdings plc, of Guilford, UK, and Babraham Bioscience Technologies Ltd., of Cambridge, UK, are forming a company called Discerna Ltd., to be located in Cambridge. The company will be an equal joint venture and will bring together Babraham¿s ribosome display technology and KSB¿s therapeutic targets. KSB will provide funding for two years and certain therapeutic targets. Babraham will provide Discerna with exclusive worldwide rights to develop its ribosome display technology.
¿ Millennium Pharmaceuticals Inc., of Cambridge, Mass., said it initiated a Phase II trial of LDP-977, an orally active second-generation 5-lipoxygenase inhibitor. The multicenter, randomized, double-blind, parallel-group, dose-finding study will include 320 patients. Development, marketing and sales of LDP-977 in Europe and Asia are under an agreement with Taisho Pharmaceutical Co. Ltd., of Tokyo. The study will evaluate LDP-977¿s safety and efficacy.
¿ NaPro BioTherapeutics Inc., of Boulder, Colo., said it and its licensee, Abbott Laboratories, of Abbott Park, Ill., filed a patent infringement suit against Mylan Laboratories Inc., of Pittsburgh, in the U.S. District Court for the Western District of Pennsylvania. The suit centers on U.S. Patent Nos. 5,733,888 and 6,140,359, which relate to paclitaxel.
¿ Nastech Pharmaceutical Co. Inc., of Hauppauge, N.Y., initiated a Phase II at-home trial of its intranasal apomorphine HCl formulation for treatment of female sexual dysfunction. The randomized, double-blind, placebo-controlled trial is designed to assess the safety and efficacy of the intranasal apomorphine in increasing sexual satisfaction in 75 women diagnosed with sexual dysfunction.
¿ NeoTherapeutics Inc., of Irvine, Calif., said its board decided not to change the terms or expiration date of its publicly traded warrants. The warrants trade under the symbol NEOTW, and are exercisable for one share of NeoTherapeutics common stock at an exercise price of $11.40 per share. They expire on Sept. 26.
¿ Nexell Therapeutics Inc., of Irvine, Calif., said it signed a letter of intent to transfer exclusive worldwide rights for sales, marketing and distribution of its cell-processing products to Baxter Healthcare Corp., of Deerfield, Ill. Nexell¿s cell-processing product line includes its Isolex 300i Magnetic Cell Selection System. Nexell said the move is intended to allow it to outsource most of its near-term market support requirements to enable it to focus on completing clinical development of specific therapeutic applications of its proprietary technology. The nonbinding letter is part of an effort to streamline ongoing operations and reduce spending that includes plans to reduce Nexell¿s staff by about two-thirds.
¿ Samaritan Pharmaceuticals Inc., of Las Vegas, said it signed a seven-year research collaboration with Georgetown University, set to begin July 1. The collaboration will attempt to develop one-molecule drugs and extend clinical studies to in vivo experiments in animal models simulating Alzheimer¿s disease, develop a diagnostic for neurodegeneration (Alzheimer¿s) and to focus on new drug development in oncology and neurology with the ability to protect the brain from neuronal damage and tumor growth. Samaritan receives worldwide exclusive rights to any therapeutic agents or diagnostic technologies that may result. Samaritan will pay the costs of research quarterly. Georgetown will receive warrants to purchase 500,000 shares of Samaritan¿s stock at $1.50 per share and royalty payments based on Samaritan¿s revenues for any new technologies.
¿ Serono SA, of Geneva, Switzerland, said an efficacy study of Rebif (interferon beta-1a) in treatment of secondary progressive multiple sclerosis is featured in the June 12, 2001, issue of Neurology. The SPECTRIMS study (Secondary Progressive Efficacy Clinical Trial of Rebif in MS) showed that the effect of Rebif on the delay of disability in patients with secondary progressive multiple sclerosis was more pronounced in the earlier stages of the disease than in later stages.
¿ SuperGen Inc., of Dublin, Calif., completed patient enrollment for its second of three pivotal Phase III studies of rubitecan, its oral chemotherapy compound in development for pancreatic cancer. This study enrolled more than 400 patients at 200 sites in the United States and compares rubitecan to the most appropriate chemotherapy as third-line therapy for patients who have previously failed multiple types of chemotherapy. Enrollment for the first study also has been completed and the third trial is more than 90 percent enrolled. SuperGen received an undisclosed equity milestone payment from Abbott Laboratories, of Abbott Park, Ill. Specific details of the payment were not disclosed.
¿ The Cleveland Clinic, of Cleveland, said a study coordinated by a vascular medicine and hematology/oncology specialist at the clinic showed that a bio-engineered version of recombinant t-PA, known as alteplase ¿ a Genentech Inc., of South San Francisco, product ¿ can safely be used to clear blocked central venous catheters. The study, called COOL-2, demonstrated that a regimen of up to 2-mg doses of recombinant t-PA is a safe, effective way to restore flow to occluded central venous catheters, the coordinator of the study said.
¿ The Forsyth Institute, of Boston, said a team that included two scientists from the Forsyth Institute sequenced the genome of Porphyromonas gingivalis, a bacterium believed to play a major role in adult periodontitis. It is the first oral disease-causing microbe to be completely sequenced. The annotated sequence was posted on the Internet Tuesday, making it freely available to researchers.
¿ The Fred Hutchinson Cancer Research Center, of Seattle, said it developed a method to induce a state of so-called suspended animation in zebrafish. The method is the subject of an article in the June 13, 2001, issue of The Proceedings of the National Academy of Sciences. The work is the first such demonstration of inducing suspended animation in a vertebrate model organism suitable to laboratory analysis.
¿ Viron Therapeutics Inc., of London, Ontario, licensed an undisclosed anti-inflammatory protein to Xenova Group plc, of Slough, UK. Terms were confidential. Xenova will move forward in research and development of the protein in a variety of inflammatory diseases.
¿ Vasogen Inc., of Toronto, and the Canadian Network for Vaccines and Immunotherapeutics entered a collaboration to undertake research associated with the development of Vasogen¿s immune modulation therapy. CANVAC is a scientific network drawing from more than 30 academic and clinical institutions that collaborates with various partners for the development of vaccine technology.
¿ Vernalis Group plc, of London, and F. Hoffmann-La Roche Ltd., of Basel, Switzerland, selected a lead clinical candidate from their research collaboration in obesity, triggering an undisclosed milestone payment to Vernalis. This is the third milestone passed in the collaboration. The compound is a selective 5-HT2c receptor agonist, predicted to stimulate the mechanism suppressing appetite in humans.