Acacia Research Corp., of Newport Beach, Calif., said its subsidiary, CombiMatrix Corp., of Snoqualmie, Wash., entered an agreement with Nanogen Inc., of San Diego, to settle all litigation pending between the two companies. As part of the settlement, Nanogen acknowledged and agreed that CombiMatrix owns all rights to its issued patents, namely U.S. Patents Nos. 6,093,302, 6,280,595 and 6,444,111, all foreign equivalents and any new claims issued via open continuations of the patents. Nanogen also waived all rights to make any future claims of any type. CombiMatrix will issue Nanogen about 4 million shares of its stock and agreed to pay Nanogen $500,000 within 30 days and an additional $500,000 within one year. CombiMatrix also will pay a minimum of $37,500 per quarter for the period Oct. 1, 2003, through Oct. 1, 2004, and $25,000 per quarter thereafter until the patents expire. The payments can increase to a maximum $1.5 million annually, based on 12.5 percent of the first $12 million of CombiMatrix's annual net revenues from product sales.
Acusphere Inc., of Watertown, Mass., said it reached an agreement with Elan Corp. plc, of Dublin, Ireland, and affiliates, terminating, in a cash-free transaction, their joint venture established in June 2000. The joint venture was formed to develop and commercialize certain pulmonary drug delivery product candidates. The termination was a result of Elan's restructuring efforts and desire to focus on its core businesses in neurology, pain and autoimmune diseases. Acusphere was assigned all intellectual property and development rights to product candidates developed by the joint venture. In return, Acusphere agreed to pay Elan a royalty on certain revenues that may be realized on the product candidates.
Aegera Therapeutics, of Montreal, signed a nonexclusive license with Wyeth, of Madison, N.J., which grants access to Aegera's adenovirus technology. The license also grants Wyeth the right to practice the adenovirus transfection method. The agreement calls for an undisclosed up-front payment and annual maintenance fees to Aegera. The licensed technology strengthens Wyeth's capabilities to use functional genomics to identify and validate new neuronal disease targets.
Atrix Laboratories Inc., of Fort Collins, Colo., began enrollment in the Phase III study for extended-release Eligard (leuprolide acetate for injectible suspension). Atrix licensed the formulation from its North American marketing partner for Eligard, Sanofi-Synthelabo, of Paris. Atrix will receive reimbursement for R&D expenses and payments for certain regulatory and sales milestones and royalties on sales, and it will manufacture the Eligard products.
AVAX Technologies Inc., of Overland Park, Kan., signed a distribution agreement with Grupo Ferrer Internacional SA, of Barcelona, Spain, for sales and distribution of AC vaccine technology in Europe, Latin America and certain Asian territories. AVAX will retain all manufacturing rights and will sell the vaccine to Grupo Ferrer. The exclusive distribution agreement calls for payments to be made to AVAX for the manufacture of the vaccine on a cost-plus basis with an additional payment based upon the reimbursed cost of the vaccine. Additionally, AVAX will receive milestone payments upon the achievement of predefined marketing and registration goals. Product will be produced at the company's Lyon, France, facility.
AVI BioPharma Inc., of Portland, Ore., reported positive interim results from a Phase II trial measuring the safety and efficacy of its antisense compound, Resten-NG, when delivered via catheter during balloon angioplasty procedures. The trial was designed to assess the safety and efficacy of Resten-NG in preventing coronary artery restenosis after angioplasty and stent placement for the treatment of atherosclerotic lesions. Resten-NG targets and blocks c-myc, a regulatory gene that is the key factor in the cascade of effects that lead to restenosis in angioplasty patients, the company said.
Biolog Inc., of Hayward, Calif., licensed to The Institute for Genomic Research in Rockville, Md., its Phenotype MicroArray technology to characterize phenotypes of bacterial strains, including Salmonella typhimurium, Streptococcus pneumoniae, Staphylococcus aureus, Synechococcus sp. and Escherichia coli. Both parties will share certain intellectual property rights from new discoveries identified using the PM technology, and they will exclusively license any discoveries that have potential commercial applications. Specific financial terms were not disclosed.
Biopure Corp., of Cambridge, Mass., said its biologics license application for Hemopure [hemoglobin glutamer - 250 (bovine)] was accepted for review by the FDA. The acceptance is based on the agency's determination that the BLA is adequate to permit a substantive and meaningful review. Biopure submitted an electronic BLA to the FDA on July 31 seeking regulatory clearance to market Hemopure in the U.S. for the treatment of acute anemia in adult patients undergoing orthopedic surgery, and for eliminating or reducing the need for red blood cells in those patients. (See BioWorld Today, Aug. 2, 2002.)
British Biotech plc, of Oxford, UK, and GeneSoft Pharmaceuticals Inc., of South San Francisco, reported the start of Phase I testing of the antibiotic and peptide deformylase inhibitor BB-83698, which is targeted at community-acquired pneumonia in hospitalized patients. The dose-escalation study is the first clinical evaluation of a PDF inhibitor, a potential new class of antibiotics, British Biotech said, and also noted that targeting bacterial metalloenzymes represents a new approach to the treatment of infectious diseases.
Charles River Laboratories International Inc., of Wilmington, Mass., acquired privately held, Ohio-based Springborn Laboratories Inc. Charles River paid $27 million to acquire SLI, free of indebtedness and cash, or a multiple of five to six times trailing 12 months EBITDA (earnings before interest, taxes, depreciation and amortization). Charles River paid $21 million in up-front cash for the shares of SLI, and issued a three-year, $6 million unsecured, subordinated note for the balance of the purchase price. Charles River expects the acquisition of SLI to be neutral or slightly accretive to earnings per share in 2002 and to add between 5 and 6 cents to earnings per share in 2003 before amortization of acquisition-related intangibles. SLI employs a staff of 130 people, and focuses on short to mid-term toxicology studies.
Crucell NV, of Leiden, the Netherlands, and Applied Molecular Evolution Inc., of San Diego, signed a nonexclusive, worldwide research license agreement allowing AME to evaluate the production of monoclonal antibodies on the PER.C6 human cell line. AME also has an option for a nonexclusive, worldwide commercial product license to manufacture one or more specified monoclonal antibody products on the PER.C6 cell line. Additionally, Crucell has granted AME the right to enter into collaborations with third parties for the research and development of monoclonal antibody products produced through the AME programs on that cell line. Applied Molecular's stock (NASDAQ:AMEV) fell 52 cents Tuesday, or 13.3 percent, to close at $3.40.
Diversa Corp., of San Diego, licensed a product for improved enzymatic synthesis of a pharmaceutical intermediate used in the manufacture of a multibillion-dollar drug to the pharmaceutical services business of The Dow Chemical Co., of Midland, Mich. Diversa will receive license fees and is entitled to receive specific royalties on Dow's sales of the intermediate manufactured using the licensed enzyme. The product was derived from several enzyme platforms developed by Diversa to address the chiral pharmaceutical fine chemicals market.
EluSys Therapeutics Inc., of Pine Brook, N.J., formed a collaboration with the University of Texas at Austin to test a complete anthrax antitoxin in animals for the first time. The study will be done in rats and conducted in two phases. It will compare the antibody to anthrax toxin developed by UT Austin with an anti-anthrax antibody screened and selected by EluSys. Both antibodies will be inserted into heteropolymers developed by EluSys. The collaboration is scheduled for one year, but can be extended.
Epoch Biosciences Inc., of Bothell, Wash., closed two financing agreements with Silicon Valley Bank. The agreements include a $2.5 million term loan and a $750,000 working capital line of credit. The proceeds will be used to finance expansion of manufacturing capacity and for general corporate purposes. The term loan can be drawn through June 2003.
Genentech Inc., of South San Francisco, reported at the meetings of the Vitreous Society and the Retina Society in San Francisco positive preliminary data from a Phase Ib/II randomized, single-agent study with the investigational anti-vascular endothelial growth factor product, rhuFab V2 (ranibizumab), for patients with the wet form of age-related macular degeneration. Of the 53 patients treated with rhuFab V2, 50 had stable or improved vision, of which 14 improved 15 letters or more on the ETDRS chart, and 36 had stable vision at day 98. On average, patients treated with rhuFab V2 gained 9.0 letters at day 98 compared to patients treated with standard of care, who lost 4.9 letters. The most common side effects were mild, transient, reversible inflammation.
Genteric Inc., of Alameda, Calif., received a Phase I Small Business Innovation Research grant from the National Institutes of Health in Bethesda, Md., and the National Institute of Dental and Craniofacial Research to evaluate the use of DNA vaccination to the salivary glands for eliciting mucosal and systemic immune responses. Genteric technology has demonstrated that DNA administration to the salivary glands promotes an immune response to the encoded protein compared with DNA delivered via intramuscular injection on an equivalent DNA basis, it said.
Hybridon Inc., of Cambridge, Mass., said it will recognize about $26 million of previously deferred revenue as revenue in the third quarter of fiscal year 2002. The money was received since May 24, 2001, from Isis Pharmaceuticals Inc., of Carlsbad, Calif., under a collaboration and license agreement. The companies entered into an amendment to that agreement on Aug. 14, 2002, under which Hybridon and Isis agreed to cancel the remaining tranche payments due to each other under the original agreement.
Illumina Inc., of San Diego, was awarded $9 million from the National Institutes of Health in Bethesda, Md., for large-scale genotyping aimed at understanding the genetic variations that predispose individuals to common illnesses such as cancer and Alzheimer's disease.
InterMune Inc., of Brisbane, Calif., said Eli Lilly and Co., of Indianapolis, elected to execute its option to buy down the royalty rate related to oritavancin per their original licensing agreement signed last year. InterMune will pay Lilly $15 million in exchange for a reduction in royalty payments due to Lilly on future worldwide sales. The payment will be recorded by InterMune in the third quarter and translates into a loss of 48 cents per share. The original deal was signed in September 2001, and InterMune paid at least $50 million for the rights. (See BioWorld Today, Sept. 21, 2001.)
ISTA Pharmaceuticals Inc., of Irvine, Calif., said it submitted to the FDA the chemistry, manufacturing and controls section of its new drug application for Vitrase, being developed for the treatment of vitreous hemorrhage. The product has fast-track designation. The nonclinical pharmacology and toxicology section of the NDA was submitted in January. ISTA said the clinical section is being finalized and should be submitted soon. Also, it plans to submit the manufacturing validation section in the first quarter of 2003. ISTA received in April FDA approval to submit its NDA - although it didn't hit its primary endpoint of clearing eye hemorrhages to enable diagnosis or treatment in two Phase III trials - with visual acuity as the primary endpoint. (See BioWorld Today, April 11, 2002, and March 27, 2002.)
LION bioscience AG, of Heidelberg, Germany, and PerkinElmer Inc., of Cambridge, Mass., launched SNPscorer, a dedicated software package for SNP genotype analysis. SNPscorer, created with software developed by LION, improves genotyping analysis with PerkinElmer's AcycloPrime-FP genotyping reagents and instruments. PerkinElmer Life Sciences is launching the product at this week's Genome Sequencing and Analysis Conference in Boston.
Morphotek Inc., of Exton, Pa., was awarded a follow-on Opportunity Grant by the Pennsylvania Department of Community and Economic Development to support the growth of the company's platform and infrastructure. The grant will be directed toward the company's gene-evolving platform technology, called morphogenics, for the development of therapeutic antibodies and high-titer producer strains for the manufacturing of biopharmaceutical products.
Nanogen Inc., of San Diego, and Bionomics Ltd., of Adelaide, Australia, entered a development and license agreement to develop a new-generation diagnostic product for epilepsy. The development program will use Nanogen's NanoChip molecular biology workstation, a gene-chip approach to the detection of gene variations and Bionomics' world-exclusive epilepsy gene discoveries.
NeoPharm Inc., of Lake Forest, Ill., said its board authorized a 12-month extension to the company's stock repurchase program, which allows NeoPharm to repurchase up to 1 million shares of its outstanding stock. NeoPharm has about 16.3 million shares outstanding.
Norak Biosciences Inc., of Research Triangle Park, N.C., signed a nonexclusive agreement with F. Hoffmann-La Roche Ltd., of Basel, Switzerland, to use Norak's Transfluor technology for G protein-coupled receptor drug discovery. Norak will provide its Transfluor cell lines expressing GPCR targets of interest to Roche, which will use the cell lines in a primary screen of its compound library. Norak also will sublicense a green fluorescent protein to Roche for use with Transfluor. Norak will receive up-front cash, assay development fees and could receive milestones.
Novactyl Inc., of St. Louis, entered a worldwide exclusive licensing agreement with Upsher-Smith Laboratories Inc., of Minneapolis, for PCL-016 and FSR-488, two antiviral agents evaluated for the topical treatment of herpes labialis (cold sores) and herpes genitalis (genital herpes). Novactyl will receive an up-front licensing fee, reimbursement for certain expenses, additional milestone payments and royalties. Upsher-Smith gains exclusive development and marketing rights on a worldwide basis for both compounds.
Novasite Pharmaceuticals Inc., a majority-owned subsidiary of Applied Molecular Evolution Inc., of San Diego, signed a Series B private financing round expected to raise $2.25 million from previous investor Crabtree Ventures LP, of Chicago. Novasite said it would use the funds to commercialize its Structure-Function approach to the discovery of highly selective, small-molecule drugs.
Optimer Pharmaceuticals Inc., of San Diego, acquired from Memorial Sloan-Kettering Cancer Center in New York an exclusive worldwide license to a cancer vaccine already in clinical development. Optimer will oversee the commercialization of the Globo H vaccine, which was shown to be safe and able to induce antibodies against breast and prostate cancer in trials conducted at Sloan-Kettering. The license also includes rights to commercialize combination vaccines in which Globo H is linked to other cancer antigens.
OSI Pharmaceuticals Inc., of Melville, N.Y., initiated two Phase I trials of OSI-211, a liposomal formulation of the topoisomerase l inhibitor lurtotecan. The first study will compare OSI-211 with the approved dose and regimen of topotecan in a randomized, controlled study involving patients with relapsed epithelial ovarian cancer. A second study will evaluate the efficacy and safety of OSI-211 in an open-label setting for patients with recurrent small-cell lung cancer. OSI is developing OSI-211 as a potential competitor to topotecan in those indications.
Pain Therapeutics Inc., of South San Francisco, completed two safety studies using multiple doses of OxyTrex and MorViva, its two lead candidates. The company believes OxyTrex and MorViva could represent a new generation of safer, more efficacious narcotic painkillers. The studies were randomized, double blind and designed to assess the occurrence of adverse safety events in patients after multidose OxyTrex or MorViva treatment was initiated, while tracking patients' analgesic response.
Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., reported publication in the Journal of Virology that it developed vaccine candidates that contain critical surface proteins whose form closely mimics the structures found on the virus. Until now, the instability of such surface spikes has hampered efforts to produce an effective prophylactic vaccine. The new vaccine components are designed to elicit an immune response capable of neutralizing HIV before it can establish infection.
Proligo LLC, of Boulder, Colo., is transferring its genetic medicines business, which produces large-scale oligonucleotides for therapeutic applications, to Raylo Chemicals Inc., of Edmonton, Alberta. The facility is the GMP manufacturing operation of the fine chemicals business unit of Proligo's parent company, Degussa AG, of Dusseldorf, Germany. The transfer is targeted for Nov. 1.
Rubicon Genomics Inc., of Ann Arbor, Mich., completed its Series B round of financing to raise $3.5 million. The round was led by ARCH Development Partners, with participation from Duchossois TECnology Partners, Sloan Ventures and individual investors. Rubicon Genomics is advancing genome-wide genetic analysis with its OmniPlex technology, a strategy for amplifying, archiving and analyzing DNA to improve the diagnosis and treatment of disease. Rubicon was first funded in May 2000 and has raised $7.22 million to date.
Stanford University Medical Center, of Stanford, Calif., is starting the first placebo-controlled trial of a drug to treat kleptomania. The study will examine whether a selective serotonin reuptake inhibitor, currently on the market for depression, can reduce the urge to steal in kleptomaniacs. The study will be funded by Forest Laboratories Inc., of New York.
SurroMed Inc., of Mountain View, Calif. and Callida Genomics Inc., of Sunnyvale, Calif., entered a collaboration funded in part by a National Institute of Standards and Technology Advanced Technology Program grant. The grant supports the development of a high-throughput universal genotyping system, combining SurroMed's Nanobarcodes particles technology with Callida's universal probes technology. The companies plan to develop a system capable of rapidly scoring more than 100,000 single nucleotide polymorphisms per patient using a solution array approach.
Symyx Technologies Inc., of Santa Clara, Calif., said North Dakota State University in Fargo agreed to purchase four Symyx Discovery Tools modules. The school will use the units in the synthesis, analysis and evaluation of large numbers of polymers and coatings formulations. Financial terms were not disclosed.
Valentis Inc., of Burlingame, Calif., said it would terminate and withdraw its previously announced tender offer to purchase 16,940 shares, or 55 percent, of its outstanding shares of Series A convertible redeemable preferred stock and 55 percent of the related outstanding common stock purchase warrants, Class A and common stock purchase warrants. Valentis said it is pursuing other options with respect to restructuring the Series A preferred stock. Valentis' stock (NASDAQ:VLTS) fell 12 cents Tuesday, or 35.3 percent, to close at 22 cents.
Viventia Biotech Inc., of Toronto, optioned a single-chain immunotoxin from the University of Zurich in Switzerland to be developed as a lead candidate for Viventia's Armed Antibodies targeted therapeutics platform. Viventia initially will develop and assess the therapeutic, VB4-845, as a treatment for head and neck cancer. VB4-845 is a humanized single-chain Pseudomonas exotoxin immunotoxin, targeting an epithelial cell-surface antigen found on most head and neck cancers. Viventia will complete all preclinical development, including antibody production in its GMP manufacturing facility, with the goal of initiating clinical trials both in Switzerland and North America in 2003.
Xenon Genetics Inc., of Vancouver, British Columbia, reported the publication of studies describing two new gene discoveries made using its platform for genetic analysis. One study, published Oct. 1, 2002, in Nature Genetics, described the discovery of a gene for a rare eye disease known as familial exudative vitreoretinopathy. In an earlier study published in the same journal in July, researchers in China and at Xenon reported the identification of a gene that is the most common cause of hereditary childhood cataracts.