Actelion Ltd., of Allschwil, Switzerland, reported initial positive results from a dose-optimization study evaluating Veletri (tezosentan), an intravenous dual endothelin receptor antagonist, in patients suffering from acute heart failure. Hemodynamic effects were achieved at doses of 5 mg/h and 25 mg/h. The primary endpoint of the study, improvement of cardiac index, was statistically significant for both doses. Data also showed a reduction of pulmonary capillary wedge pressure. The company said it will proceed with a Phase III study based on the results.
Aviva Biosciences Corp., of San Diego, appointed Norrie Russell president and CEO. Russell succeeds Peter Wilding, who will be appointed chairman. Russell was previously president and CEO of Lynx Therapeutics Inc. Aviva develops drug discovery technologies by combining biochips with cell biology.
Biochemie GmbH, of Kundl, Austria, entered a long-term agreement to manufacture and supply PEGylated antibody fragment-based drugs to Celltech Group plc, of Slough, UK. Celltech reserved from 2004 to 2010 a fixed annual manufacturing capacity in Biochemie's 3,000- and 13,000-liter fermenter systems for recombinant microbial products. The agreement gives Celltech flexibility in scheduling to meet the clinical timelines for its portfolio of PEGylated antibody fragment-based development products. Biochemie will provide technology transfer, scale-up, manufacturing and quality control testing services at its Kundl site. Financial terms were not disclosed.
BioDelivery Sciences International Inc., of Newark, N.J., received from the National Institutes of Health in Bethesda, Md., a two-year, $600,000 Small Business Innovation Research grant to develop an oral form of an HIV prophylactic/therapeutic vaccine with its Bioral drug delivery platform. Under a pre-existing research agreement, BioDelivery will work with Biokeys Pharmaceuticals Inc., of San Diego, to develop a product that is inexpensive, stable at room temperature, and intended to induce protective, systemic and mucosal cell-mediated immunity. BioDelivery will begin receiving funds in the fourth quarter in periodic installments totaling $300,000 per year.
BioLeads GmbH, of Heidelberg, Germany, entered an agreement to combine its natural products library with antimicrobial discovery technologies belonging to Elitra Pharmaceuticals Inc., of San Diego. Elitra will contribute an unspecified number of its drug targets and related cell-based assays and high-throughput screening capabilities, in combination with BioLeads' natural product libraries and chemistry capabilities, to identify potential new antibacterial and antifungal drugs. Both companies will contribute to preclinical development. Elitra retains the worldwide marketing rights for all collaboration compounds, and would pay milestones and royalties to BioLeads for successful programs. Specific financial terms were not disclosed.
Biolex Inc., of Pittsboro, N.C., and Debiopharm SA, of Lausanne, Switzerland, entered a collaboration to examine the feasibility of producing an undisclosed recombinant human therapeutic protein in Debiopharm's development portfolio using Biolex's Lemna System. The system combines the natural characteristics of Lemna, a green aquatic plant, with genetic engineering and protein recovery methods, a system through which Debiopharm said it expects to generate therapeutic proteins. Financial terms were not disclosed.
BioMarin Pharmaceutical Inc., of Novato, Calif., adopted a stockholders rights plan to protect stockholders in the event of a takeover. Stockholders of record at the close of business on Sept. 23 would receive one right for each outstanding share of common stock held. The rights will be exercisable if a person or group acquires 15 percent or more of BioMarin or announces a tender offer or exchange offer for 15 percent or more.
Biovitrum AB, of Stockholm, Sweden, and BioFocus plc, of Sittingbourne, UK, entered a drug discovery collaboration focused on G protein-coupled receptors (GPCRs). They will jointly identify drug molecules for a number of GPCRs. Financial terms were not disclosed.
CytoGenix Inc., of Houston, said it began animal testing with its first DNA product, a topical cream. The company said it could have applications against genital herpes and labial herpes or cold sores. CytoGenix's products are based on its single-stranded DNA expression technology.
DOR BioPharma Inc., of Lake Forest, Ill., began a program to produce orally administered vaccines to protect against exposure to biological agents that could potentially be used in bioterrorist attacks. The initial candidate vaccine is against ricin toxin, a potent biological toxin. DOR has an exclusive license to dominant intellectual property covering the oral delivery of encapsulated nonlive vaccines through its interest in Innovaccines Corp., a joint venture with Elan Corp. plc, of Dublin, Ireland. DOR said it plans to seek government assistance to research and test its oral biological defense vaccine products.
EraGen Biosciences Inc., of Madison, Wis., in collaboration with the University of Wisconsin-Madison Medical School and the Wisconsin State Laboratory of Hygiene, was awarded federal funding to develop an automated screening system for cystic fibrosis. It received fast-track funding from the National Institutes of Health in Bethesda, Md., to develop a genetic test system designed to detect cystic fibrosis. EraGen will use its Aegis technology to design the system to be sold in specialized testing laboratories.
Genset SA, of Paris, said both U.S. and international cash tender offers for its securities expired at noon yesterday. Serono France Holding SA, a wholly owned subsidiary of Serono SA, of Geneva, launched both offers on July 16. The U.S. tender offer was made for all outstanding ADSs and for all ordinary shares, convertible bonds (OCEANEs) and warrants of Genset held by U.S. residents. The international offer was made for all ordinary shares, all OCEANEs and certain warrants held by non-U.S. residents. The offer was made in June and valued at €107.4 million at the time. (See BioWorld Today, June 27, 2002.)
Geron Corp., of Menlo Park, Calif., reported publication in the Sept. 1, 2002, issue of Cancer Research of data providing validation for the use of telomerase as an antigen for cancer immunotherapy. The research, conducted at Duke University Medical Center in Durham, N.C., shows that RNA encoding the protein component of telomerase (TERT RNA), when introduced into dendritic cells, is effective in priming telomerase-specific cytotoxic T-lymphocytes to target and destroy malignant tumors. The TERT RNA-modified dendritic cells also induced a helper T-cell response.
Inhibitex Inc., of Atlanta, began a Phase I trial of its lead product, Veronate, for the prevention of Staphylococcus infections in premature infants. The open-label study will evaluate the safety and tolerability of two different doses of Veronate in 36 hospitalized, very low-birth-weight infants. Blood levels of active antibodies will be measured in all participating infants.
InKine Pharmaceutical Co. Inc., of Blue Bell, Pa., received notification from Nasdaq that it has demonstrated compliance with the bid price and market value of listed securities for continued listing on the Nasdaq SmallCap Market. The company had said earlier that it had failed to comply with the SmallCap Market continued listing requirements and that it had requested a hearing before the Nasdaq Listing Qualifications Panel. At Nasdaq's request and based on sustained increases in the market capitalization of InKine, the hearing was cancelled and the file closed, the company said.
Ligand Pharmaceuticals Inc., of San Diego, received two undisclosed milestone payments as Wyeth, of Madison, N.J., began clinical development of NSP-989 for contraception and hormone replacement therapy, and also advanced a back-up compound into late preclinical testing. NSP-989 is a nonsteroidal progestin.
Neuron Therapeutics Inc., of Malvern, Pa., received FDA approval for its investigational new drug application to treat patients suffering from subarachnoid hemorrhage (SAH). The condition typically occurs when an aneurysm forms on a blood vessel inside the skull and bursts. A clinical trial investigating the use of NeurySol, Neuron's artificial cerebrospinal fluid, for removal of aneurysmal blood in SAH patients is in progress. The IND will expand investigational use of NeurySol as Neuron begins to study it in combination with a clot dissolver.
OSI Pharmaceuticals Inc., of Melville, N.Y., and F. Hoffmann-La Roche Ltd., of Basel, Switzerland, completed patient enrollment in a randomized Phase III trial evaluating Tarceva (erlotinib HCl) as a first-line agent in combination with standard chemotherapy in non-small-cell lung cancer patients. Conducted by Roche, about 1,200 patients were enrolled in the worldwide, multicenter trial to assess the potential incremental survival benefit of 150mg/day of Tarceva when combined with an approved first-line regimen of gemcitabine and cisplatin. Tarceva treatment of non-small-cell lung cancer is part of a worldwide program that involves Genentech Inc., of South San Francisco.
Perlegen Sciences Inc., of Mountain View, Calif., said it developed a high-density oligonucleotide array-based genotyping platform to analyze more than 1 million genetic variations in thousands in people to search for genomic regions that cause disease or affect drug response. The company is using the technology in its research.
Proteom Ltd., of Cambridge, UK, entered an agreement with SC BioSciences Corp., of Tokyo, for SC to manage the introduction of Proteom's technology to Japanese pharmaceutical and biotechnology companies. Proteom uses its bioinformatics technology to design peptide ligands, identify binding sites on proteins and define protein-protein interactions. Financial terms were not disclosed.
SciClone Pharmaceuticals Inc., of San Mateo, Calif., reported at the International Society for Oncodevelopmental Biology and Medicine meeting in Boston that treating colorectal cancer cells with Zadaxin increases the expression of a detectable antigen that can be used by the body's immune system to target cancer cells for destruction. The percent of cancer cells in culture with a colorectal cancer-specific protein, called TLP, on their surface normally ranges from 10 percent to 20 percent, but after Zadaxin treatment the number increased to 90 percent. SciClone's stock (NASDAQ:SCLN) rose 70 cents Thursday, or 29.7 percent, to close at $3.06.
Theratechnologies Inc., of Montreal, said it achieved a milestone in its drug delivery-based collaboration with ALZA Corp., of Mountain View, Calif. Positive preclinical feasibility study results were observed with the combination of parathyroid hormone with ALZA's Macroflux transdermal technology. Based on the results, the companies will move forward with development plans for a transdermal product to treat osteoporosis.