Actelion Ltd., of Allschwil, Switzerland, said the Swiss regulatory authority approved Tracleer for the treatment of primary pulmonary arterial hypertension (PAH). Tracleer, an orally available endothelin receptor antagonist, is available immediately. The Swiss Social Insurance Office is considering reimbursement for the drug. Tracleer for the treatment of PAH is already available in the U.S. and Canada. In the European Union, authorities issued a positive opinion last month. Regulatory review is ongoing in Australia and Actelion is preparing to file in Japan.
Adenosine Therapeutics LLC, of Charlottesville, Va., was awarded a fast-track Small Business Innovation Research grant of $137,000 from the National Institute of Neurological Disorders and Stroke. The grant, titled “A2a Adenosine Agonists as Neuroprotectants,” will fund additional research on the company’s selective A2a adenosine receptor agonist, ATL-146e, for the prevention of injury due to spinal cord ischemia. ATL-146e has been shown to inhibit spinal cord injury in rabbits and pigs.
Advanced Viral Research Corp., of Yonkers, N.Y., submitted to the FDA results of a Phase I study for the topical use of Product R in the treatment of genital warts caused by infection with the human papillomavirus. Results of the placebo-controlled, open-label, single-center, dose-escalation study in 30 healthy volunteers indicated that Product R was safe and well tolerated dermatologically in all doses applied.
Agensys Inc., of Santa Monica, Calif., named President and CEO Donald Rice to the additional post of chairman. Agensys, a private biotechnology company developing therapeutic antibodies to treat several types of solid tumor cancers, recently completed its third round of financing, raising $42.8 million in a private placement.
Agilon Products Group Inc., of San Diego, an intellectual property consulting company, signed a deal with PrimeGen Biotech Corp., also of San Diego, to expand and strengthen PrimeGen’s property in the stem cell and genetic research space while also accelerating the acceptance of PrimeGen’s Cellular Replacement Therapy. PrimeGen said Agilon’s business relationships and intellectual property capabilities will allow PrimeGen to better protect, fund and market its innovations. Financial terms were not disclosed.
Ambion Inc., of Austin, Texas, received a license from The Massachusetts Institute of Technology for patent applications covering small interfering RNA. RNA interference entails down-regulating the expression of specific genes in living cells. Financial details were not disclosed. Ambion focuses on RNA-based life science research and molecular diagnostic products.
Amersham Biosciences, of Piscataway, N.J., the life sciences business of Amersham plc, and the University of Washington at Seattle entered a proteomics collaboration. The partnership is designed to integrate protein and messenger RNA expression data generated using Amersham’s Two-Dimensional Differential In-Gel Electrophoresis (2-D DIGE) technology and DNA microarray platform. The system has been placed in the department of microbiology and the Regional Primate Research Center at the university. Financial terms were not disclosed.
AxCell Biosciences, of Newton, Pa., a subsidiary of Cytogen Corp., signed a research collaboration with Marius Sudol of the Mount Sinai School of Medicine to research protein interactions in the WW protein domain family, believed to play a role in the development of muscular dystrophy and neurodegenerative diseases such as Alzheimer’s disease. AxCell has an option to negotiate an exclusive, worldwide, royalty-bearing license from the school for peptide targets, gene targets and any other inventions that result from the research collaboration. The collaboration will use select data from AxCell’s ProChart database.
Biopure Corp., of Cambridge, Mass., registered with the SEC to sell $30 million of common stock from time to time. Biopure expects to use proceeds for general corporate purposes, including capital expenditures and to meet working capital needs. The company is developing Hemopure, an oxygen-carrying blood treatment.
Biovitrum AB, of Stockholm, Sweden, entered Phase I studies with BVT.3498, a selective 11B HSD-1 inhibitor for the treatment of Type II diabetes. In addition to demonstrating improved insulin sensitivity and glycemic control, the development program is designed to establish positive effects on body composition, lipid profile and other metabolic aberrations linked to insulin resistance, either as monotherapy or as an add-on treatment to other therapies.
Celgene Corp., of Warren, N.J., presented preclinical data on the mechanisms and efficacy of novel JNK (c-Jun N-terminal kinase) inhibitors, confirming their ability to block tumor cell proliferation in a variety of cancers. The data further demonstrate that the combination of JNK inhibitors and chemotherapy enhances the antitumor effects of both agents. When evaluated separately in an in vivo cancer model, a novel Celgene JNK inhibitor and Cytoxan each decreased tumor volume by 30 percent. However, when Cytoxan and the JNK inhibitor were combined, tumor volume was decreased by 92 percent relative to control.
Centocor Inc., of Malvern, Pa., received news concerning its product, Remicade (infliximab), and a group of rheumatic inflammatory diseases called spondyloarthropathies. A study published in the March 6, 2002, issue of Arthritis and Rheumatism found that patients treated with Remicade monotherapy experienced median improvements in disease activity of 73 percent and 78 percent as determined by validated patient and physician global assessment measuring tools. Spondyloarthropathies are a group of disorders of the joints, including ankylosing spondylitis, psoriatic arthritis and Crohn’s disease. Centocor recently received a third approval in the rheumatoid arthritis area for Remicade. (See BioWorld Today, March 1, 2001.)
Cepheid Inc., of Sunnyvale, Calif.; Northrop Grumman Corp.’s Automation and Information Systems Division, of Baltimore; and Environmental Technologies Group Inc., a subsidiary of Smith’s Aerospace, of London, are collaborating on the adaptation of DNA-based biothreat detection technology for use on the U.S. Postal Service mail sorting system. Cepheid’s stock (NASDAQ:CPHD) rose $1.89 Monday, or 68.9 percent, to close at $4.85.
Ciphergen Biosystems Inc., of Fremont, Calif., said its board approved the adoption of a share purchase rights plan. The plan is designed to assure that Ciphergen stockholders receive fair and equal treatment in the event of any proposed takeover of the company and to guard against partial tender offers and other abusive tactics to gain control of the company without paying all stockholders the fair value of their shares. The plan was not adopted in response to any specific attempt to acquire the company, Ciphergen said.
Digene Corp., of Gaithersburg, Md., received a recommendation for approval, with conditions, from the FDA’s Microbiology Devices Panel for its supplemental premarket approval application for the DNA Pap. Approval would allow Digene to market its Hybrid Capture 2 HPV DNA Test, in conjunction with the Pap test, as a primary screening test for cervical cancer and its precursors in women 30 and older. The panel recommended that, prior to receiving FDA approval, Digene should provide the FDA with recommendations for the clinical use of the combined test and furnish the FDA with a demonstration of the positive clinical outcomes that Digene’s DNA Pap provides. Digene anticipates providing the requested information this year.
Entelos Inc., of Menlo Park, Calif., and the American Diabetes Association entered a collaboration and research effort in Type II diabetes, the first time the association has formed an alliance to specifically support drug discovery and development. Using Entelos’ Diabetes PhysioLab technology, the association and Entelos will generate novel theories, hypotheses and discoveries relating to Type II diabetes and provide that research to a research forum comprised of a select number of pharmaceutical and biotechnology companies.
GeneData AG, of Basel, Switzerland, and AstraZeneca Pharmaceuticals plc, of London, entered into a multiyear collaboration to analyze the genomes of pathogenic bacteria and fungi. GeneData’s Phylosopher bioinformatics software system will be used to analyze the genomes of pharmaceutically relevant pathogens by comparing them to all currently available and completely sequenced genomes from microbial and higher organisms. This will yield a complete set of protein families and allow the application of tools that go beyond homology modeling to phylogenetic pattern matching and metabolic profile analysis.
Genencor International Inc., of Palo Alto, Calif., licensed the Rosetta Resolver Gene Expression Data Analysis System from Agilent Technologies Inc., of Kirkland, Wash. The system is a data storage, retrieval and analysis solution for gene expression data. Financial details were not disclosed.
Geron Corp., of Menlo Park, Calif., said the U.S. Patent and Trademark Office’s Board of Patent Appeals and Interferences declared a second interference involving one of the series of patent applications covering nuclear transfer technology licensed to Geron from the Roslin Institute, of Edinburgh, Scotland. The newly declared interference is between the same Roslin/Geron application and a patent application owned by Infigen Inc., of DeForest, Wis. Last month, the patent office granted Geron’s request for an interference between a Roslin/Geron patent application and a University of Massachusetts patent licensed to Advanced Cell Technology Inc., of Worcester, Mass. In both interferences, Roslin/Geron has been declared to be the senior party.
Interleukin Genetics Inc., of Waltham, Mass., entered a collaboration with Kaiser Permanente’s Center for Health Research, of Oakland, Calif., to investigate the value of testing for genetic differences among people with Type II diabetes to determine their relative risk of developing cardiovascular disease. Results of this study will enable the company to develop diagnostic tools for assessing diabetic patients’ genetic risks for heart disease. This study is the first of a number planned as part of a research collaboration, announced in December, between the companies. Financial terms were not disclosed.
Large Scale Biology Corp., of Vacaville, Calif., said it collected more than 16,000 distinct human full-length cDNA clones (FLcDNA). Known as the LSBC Human Transcript Collection, it contains previously undiscovered transcripts that do not exist in the public human full-length gene collection. LSBC said it adds thousands of FLcDNAs each month. The company expects to commercialize its collection through collaboration partners for other drug and biomarker efforts.
Neurogen Corp., of Branford, Conn., said Pfizer Inc., of New York, began Phase I trials of NGD 96-3, a candidate for treating insomnia, and one of several drug candidates being developed as a result of their collaboration. The trial is a randomized, double-blind, placebo-controlled evaluation of the safety and pharmacokinetics of single rising oral doses of NGD 96-3, which selectively modulates receptors of the GABAA (gamma aminobutyric) neurotransmitter system. Pfizer is responsible for development and commercialization, while Neurogen receives milestone and royalty payments on GABA-based drugs. Pfizer is conducting a Phase IIa study with Neurogen’s lead drug candidate for the treatment of Alzheimer’s disease, NGD 97-1.
PanaMed Corp., of Camarillo, Calif., said it plans to test a line of immuno-modulating therapeutic compounds for the treatment of HIV/AIDS. The company said it plans to start clinical trials in continental Africa in April. PanaMed said the therapeutics are expected to provide advantages over conventional AIDS medications.
PowderJect Pharmaceuticals plc, of Oxford, UK, and its wholly owned subsidiary, SBL Vaccin, submitted a European marketing authorization application for its cholera and travelers’ diarrhea vaccine, Dukoral, a drinkable vaccine that protects against diarrhea caused by Vibrio cholerae (cholera) and enterotoxigenic E. coli (ETEC). Dukoral is licensed for combined protection against both cholera and ETEC in 15 countries worldwide, including a recent approval by the regulatory authorities in New Zealand.
Procyon Biopharma Inc., of Montreal, received approval from the UK regulatory authorities to begin a Phase IIa trial in hormone-refractory prostate cancer with PCK3145, the synthetic peptide analogue of prostate secretory protein (PSP94). The open-label, dose-escalation trial is designed to study efficacy parameters such as disease progression and prostate-specific antigen level changes in addition to safety and tolerability of the drug in late-stage prostate cancer patients who have developed resistance to anti-androgen hormone treatment.
ProMetic Life Sciences Inc., of Montreal, met its first commercial milestone to provide a linked process for purifying monoclonal antibodies with Merck KgaA, of Darmstadt, Germany. Merck said it now has a powerful, generic platform that can be applied to most types of antibodies produced by different techniques. The alliance was formed last year to commercialize an alternative approach to the purification and production of monoclonal antibodies. The initial phase focused on co-development and optimization work.
Protein Design Labs Inc., of Fremont, Calif., initiated a Phase II study to evaluate its humanized antibody Nuvion (visilizumab) in patients with steroid-resistant, acute graft-vs.-host disease. The single-arm multicenter trial will aim to enroll 80 patients and be conducted at up to 20 centers in the U.S. Nuvion is a humanized monoclonal antibody directed at the CD3 antigen, a receptor for stimulating T cells.
RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., received $1.7 million from a private placement of its common stock. The lead investor in the transaction is Defiante Farmaceutica Unipessoal L.d.a., a division of Sigma-Tau, of Rome. Investors received a total of about 7.3 million restricted shares of RegeneRx common stock at a price of 23.5 cents per share, representing 24.9 percent of the company’s equity on a fully diluted basis. RegeneRx is developing thymosin beta 4 for dermal wound healing and for the treatment of a variety of human diseases involving tissue repair.
Scios Inc., of Sunnyvale, Calif., added a drug candidate to its pipeline that it said could become the first oral inhibitor of transforming growth factor-beta. TGF-beta is a multifunctional cytokine, a signaling protein that is produced in a range of diseases characterized by unregulated scarring and eventual organ failure. Research has indicated that excessive activation of TGF-beta is involved with driving scar tissue formation, thought to contribute to the progressive loss of function seen in a variety of conditions. TGF-beta may play a role in congestive heart failure, chronic obstructive pulmonary disease, liver cirrhosis and kidney disease.
Serono SA, of Geneva, launched Rebif (interferon beta-1a) in the U.S. after receiving FDA approval Thursday for the treatment of patients with relapsing forms of multiple sclerosis to decrease the frequency of relapses and delay the accumulation of physical disability. (See BioWorld Today, March 11, 2002.)
Silico Insights Inc., of Woburn, Mass., and the Huntsman Cancer Institute at the University of Utah said they entered a collaboration to develop a better understanding of cancer mechanisms leading to diagnostic and drug development targets. The agreement will use data resources available at the university to study genealogically related families in clinical settings for the diagnosis and treatment of cancer. The focus of the effort initially will be on melanoma.
Synt:em, of Nimes, France, signed a nonexclusive agreement with Corixa Corp., of Seattle, designed to develop vaccines based on Corixa’s antigens aimed at infection prophylaxis and cancer therapy. Synt:em will contribute its Pep:trans technology, a system that helps compounds reach their target across biological membranes, including cellular membranes. Synt:em has received license fees and has the potential for milestones and royalties, along with a share of any sublicense income that Corixa receives for vaccines using Pep:trans vectors. Further financial terms were not disclosed.
Wyeth, of Madison, N.J., is the new name of American Home Products Corp., a 76-year-old pharmaceutical company with 2001 revenues in excess of $14 billion. It also changed its trading symbol from AHP to WYE on the New York Stock Exchange. The company said it is streamlining and unifying the branding of its operating subsidiaries.
Xencor Inc., of Monrovia, Calif., exclusively licensed U.S. patent No. 6,190,856 B1 titled, “Methods of Detection Utilizing Modified Bacteriophage,” from the Johns Hopkins University School of Medicine in Baltimore, expanding the company’s patent estate for its chemical genomics platform, ProCode. Xencor said by connecting drug molecules to the genes they act upon, the ProCode technology relieves a bottleneck in the drug discovery process.