¿ AltaRex Corp., of Waltham, Mass., reported positive results from its first long-term safety and survival results from an OvaRex MAb clinical trial, involving 44 previously treated patients in Germany with recurrent ovarian cancer. Fifty-six percent of patients survived more than one year and 34 percent survived more than two years from first treatment. Out of the 34 percent who survived more than two years, 11 percent survived five years or more. Four out of 44 patients were still alive as of April 2001, with survival ranging from five to eight years.
¿ Antigenics Inc., of New York, completed the acquisition of Aronex Pharmaceuticals Inc., of The Woodlands, Texas. Under the terms of the agreement, Aronex shareholders will receive 0.0594 shares of Antigenics¿ shares for each Aronex share. Additionally, each share of Aronex common stock will be entitled to a contingent value right potentially worth an additional 15 cents. The acquisition adds two advanced-stage cancer products to Antigenics¿ current portfolio of 22 clinical trial programs in cancer, infections, and immune and degenerative disorders. The deal was valued at $28.6 million when disclosed in April. (See BioWorld Today, April 25, 2001.)
¿ AtheroGenics Inc., of Atlanta, entered into an exclusive licensing agreement with National Jewish Medical and Research Center in Denver to develop therapeutics based on MEK kinases and related technology for the treatment of inflammation. Other licensed technology focuses on naturally occurring substances including interleukins and peptide neurotransmitters and their applications in asthma.
¿ Aventis Pharmaceuticals Inc., of Bridgewater, N.J., entered a licensing agreement with Ajinomoto Co., of Tokyo, to develop and market AVE8062, a novel compound designed to attack tumor cells by cutting off the tumor¿s supply of blood. Aventis receives rights to develop and market the product in exchange for certain milestone payments and, eventually, royalty payments to Ajinomoto.
¿ Axcan Pharma Inc., of Mont Saint-Hilaire, Quebec, filed a supplemental new drug submission (SNDS) with the Therapeutic Products Directorate of Health Canada for its Photofrin for the treatment of high-grade dysplasia associated with Barrett¿s esophagus, a condition that can lead to esophageal cancer. The SNDS was filed on July 5, pursuant to the completion of a Phase III study evaluating the safety and efficacy of Photofrin. Health Canada granted the company priority review status.
¿ Biosearch Italia SpA, of Milan, Italy, received orphan drug status from the European Commission for its Ramoplanin antibiotic, currently in Phase III clinical trials for the prevention of infections due to vancomycin-resistant Enterococci in cancer patients. This offers a 10-year period of marketing exclusivity, following successful registration.
¿ Cangene Corp., of Winnipeg, Manitoba, said it stopped its Phase II trial of anti-hepatitis C hyperimmune in liver transplant recipients. After reviewing data from 18 patients enrolled in the trial, an independent monitoring board found no statistical difference between patients receiving drug and those receiving placebo. The product did show a favorable safety profile. The data are not yet unblinded and Cangene has not conducted a full analysis of results. The company said it would look at further approaches to evaluate the product as an immunoprophylactic in liver transplantation.
¿ Cell Matrix Inc., of Los Angeles, received $200,000 for two Phase I Small Business Innovation Research grants from the National Cancer Institute. The grants will further the company¿s target and therapeutic antibody discovery program for selective inhibitors of angiogenesis.
¿ Cellomics Inc., of Pittsburgh, acquired Momentum Healthcare Ltd., of Southampton and Cardiff, UK. All of Momentum¿s technologies will be integrated into Cellomics¿ core business, which is developing high-content screening, informatics, cellular bioinformatics and other products for research, drug discovery and clinical diagnostics. Momentum developed a suite of software components for drug discovery. Terms of the deal were not disclosed.
¿ Charles River Laboratories International Inc., of Wilmington, Mass., and Sangamo BioSciences Inc., of Richmond, Calif., entered a technology partnership agreement to apply Sangamo¿s gene regulation technologies to the creation of transgenic rat research models. The collaboration initially will involve the creation of a novel rat model for use in developing new drugs and therapies for cancer.
¿ EntreMed Inc., of Rockville, Md., enrolled the first patients in a Phase I/II clinical trial to asses the safety and efficacy of recombinant human Endostatin, a naturally occurring angiogenesis inhibitor. M.D. Anderson Cancer Center in Houston will conduct the trial. Thirty patients are expected to participate in the open-label, dose-escalation study. The study is recruiting patients with many types of cancers, emphasizing those with sarcoma and melanoma.
¿ Enzo Biochem Inc., of Farmingdale, N.Y., received approval from the Ministry of Health in Israel to begin a Phase I trial for an immune regulation medicine for the treatment of Crohn¿s disease. The clinical study is based on successful preclinical results in an animal model system. The study will be conducted at Hadassah-Hebrew University Medical Center in Jerusalem.
¿ Genaissance Pharmaceuticals Inc., of New Haven, Conn., said it published in the journal Science the most detailed examination of human genes ever conducted. The research shows there is no single form on any given gene, the company said. The study of 313 genes in 82 unrelated individuals showed a massive amount of previously undiscovered gene variability. Also, Genaissance researchers were able to identify the relationship between DNA variation and the different versions of a gene, defined by its haplotype, that exist in the human population.
¿ GenStar Therapeutics, of San Diego, reported early Phase I clinical trial data from its study of its Maximum AD Factor VIII hemophilia A treatment. The findings, based on the dosing of the first patient, demonstrated an increase in Factor VIII clotting factor levels from less than 1 percent up to 3 percent. The U.S. trial is a multicenter, single-dose, dose-escalating study.
¿ Inpharmatica Ltd., of London, and Serono SA, of Geneva, signed a two-year collaborative agreement for the discovery of novel protein therapeutics. Serono will provide research funding for Inpharmatica, which will develop technology for the identification of novel protein therapeutics. In return, Serono will have the right to select an unlimited number of proteins for clinical development and commercialization, as well as develop antibodies and small molecules against identified protein targets. Depending upon the achievement of certain developmental milestones, Inpharmatica will receive a series of undisclosed payments from Serono, and potential royalties. Total milestone payments, excluding royalties, could exceed $20 million. The full rights to any unselected proteins will revert to Inpharmatica. As part of the agreement, Serono will gain nonexclusive access to Biopendum, Inpharmatica¿s target discovery resource.
¿ Lilly ICOS LLC, a joint venture between ICOS Corp., of Bothell, Wash., and Eli Lilly & Co., of Indianapolis, filed an application with the European Medicines Evaluation Agency for the centralized approval of Cialis, its oral drug for the treatment of erectile dysfunction. Lilly ICOS filed a new drug application for Cialis with the FDA on June 28. (See BioWorld Today, June 29, 2001.)
¿ MetaPhore Pharmaceuticals Inc., of St. Louis, released initial results from its Phase I study of the first candidate from its family of free-radical fighting enzyme mimetics. The double-blind, placebo-controlled trial involved single, escalating doses of the enzyme mimetic drug M40403 administered intravenously in 36 healthy subjects. No dose side effects were observed or reported, the company said. The study was significant, MetaPhore said, because it was the first time that a small-molecule drug developed to mimic an enzyme¿s activity has been tested in humans. The company plans to proceed with a Phase II trial to assess the efficacy the drug as a co-therapy with interleukin-2 in small groups of patients with advanced skin and end-stage kidney cancers.
¿ Microcide Pharmaceuticals Inc., of Mountain View, Calif., and NAEJA Pharmaceutical Inc., of Edmonton, Alberta, entered a research and license agreement to develop and commercialize drugs based on NAEJA¿s proprietary azole antifungals and Microcide¿s fungal efflux pump inhibitor leads in order to overcome resistance mechanisms in clinically important fungal pathogens. The collaboration gives Microcide exclusive rights to develop and commercialize compounds based on NAEJA¿s proprietary azoles. Microcide will make milestone payments to NAEJA upon the selection of an azole and its advancement through clinical trials, and will pay royalties on the sale of products.
¿ Millennium & ILEX Partners LP, a joint venture of Millennium Pharmaceuticals Inc., of Cambridge, Mass., and ILEX Oncology Inc., of San Antonio, said the European Commission granted marketing authorization to its MabCampath humanized monoclonal antibody for patients with B-cell chronic lymphocytic leukemia who have been treated with alkylating agents and have failed fludarabine therapy. The drug will be marketed by Schering AG, of Berlin. Campath was approved in the U.S. in May. (See BioWorld Today, May 9, 2001.)
¿ NeoTherapeutics Inc., of Irvine, Calif., retained Cantor Fitzgerald & Co., of New York, as investment banker and financial adviser. The company also filed a registration statement with the SEC for a controlled equity offering of its common stock from time to time with Cantor Fitzgerald acting as underwriter. NeoTherapeutics can authorize Cantor Fitzgerald to sell shares of common stock on its behalf up to an aggregate total of $8.4 million.
¿ Oxford GlycoSciences plc, of Oxford, UK, submitted a marketing authorization application to the European Medicines Evaluation Agency for Vevesca, its oral treatment of Type I Gaucher disease. The submission includes data on the use of Vevesca as oral monotherapy in combination with Genzyme Corp.¿s Cerezyme and switch/maintenance after Cerezyme therapy. The company said it currently is submitting a rolling new drug application to the FDA.
¿ Pharmacopeia Inc., of Princeton, N.J., said it is reviewing alternatives to its current drug discovery business model. The company said that its drug discovery capabilities would be optimized by access to a greater number of drug targets than has been achieved using its current customer-funded approach. Alternatives under consideration include acquisitions, joint ventures and separating its drug discovery and software businesses. The company said the second-quarter drug discovery revenues were about $6.8 million and drug discovery revenues will be in the $19.5 million to $20 million range. Second-quarter pro forma losses will be from 8 to 10 cents per share. Actual results will be released August 1. Its stock (NASDAQ:PCOP) fell $2.05 Thursday, or 10.5 percent, to close at $17.50.
¿ Synt:em, of Nimes, France, and SangStat Inc., of Fremont, Calif., formed a three-year research collaboration for the discovery of next-generation RDP58 molecules. The focus of the collaboration will be to develop novel RDP58-like compounds for the inhibition of inflammation in new in vivo applications, using Synt:em¿s Acti:map drug design technology. RDP58 is a small molecule that inhibits TNF synthesis by preventing the translation of TNF mRNA.
¿ The Port of Technology, of Philadelphia, reported that the first biotechnology company will occupy its newly constructed 20,000-square-foot wet lab facilities. Plant Genix, founded in Wayne, Pa., will use the labs and office space for research related to plant health and aging, and in efforts to enhance the use of plants to develop a range of pharmaceutical and chemical products. The Port of Technology, currently with 32 client companies, is a business incubator for information technology and life science start-ups.
¿ Tularik Inc., of South San Francisco, acquired the computer-aided molecular design (CAMD) unit of Protherics plc, of Macclesfield, UK. The key technology of Protheric¿s CAMD division is a set of computational software tools called Prometheum. These tools help to identify novel compounds that bind with high affinity to the active site of cellular receptors or enzymes, aiding in early drug leads. Tularik develops novel oral drugs that act through the regulation of gene expression.
¿ Vion Pharmaceuticals Inc., of New Haven, Conn., was awarded a six-month Small Business Innovation Research grant from the National Cancer Institute. The $100,000 grant supports further research on Vion¿s family of sulfonyl hydrazine prodrugs, the first member of which, VNP40101M, recently entered Phase I trials.
¿ Viragen Inc., of Plantation, Fla., and Viragen (Europe) Ltd. signed a letter of intent to acquire BioNative AB, of Umea, Sweden. According to Viragen, the merger will create the world¿s most efficient, high-volume manufacturer of highly purified alpha interferon from human white blood cells. Financial terms were not disclosed and the final agreement is still subject to approval from both companies¿ boards. BioNative¿s drug, Alfanative, has been approved in Sweden to treat two forms of leukemia. Viragen¿s natural interferon currently is in Phase II European clinical trials for hepatitis C. Viragen said it expects to file an investigational new drug application with the FDA to begin U.S. clinical trials for the treatment of hepatitis C upon completing the BioNative acquisition.
¿ XenoPharm Inc., of San Diego, initiated laboratory operations at its San Diego facility. The company is focused on the application of its XenoSensor technology, the Steroid Xenobiotic Receptor, Constitutive Androstane Receptor and the Cytochrome P-450 3A4 gene promoter, to improve the safety profiles of existing and developmental medicines.