Adams Respiratory Therapeutics Inc., of Chester, N.J., said Merrill Lynch & Co., Morgan Stanley, Deutsche Bank Securities and RBC Capital Markets, the underwriters of its recent initial public offering, exercised in full their overallotment option to buy about 1.2 million shares at $17 each. The exercise of the option increases the size of the IPO to about 9.1 million shares, of which 6.9 million were sold by Adams and 2.25 million were sold by selling shareholders. Net proceeds to Adams are expected to be about $106.6 million. Adams will use proceeds to build its Mucinex brand, to fund product development, and for potential acquisitions and product in-licensing.
Alnylam Pharmaceuticals Inc., of Cambridge, Mass., granted Ebersberg, Germany-based MWG Biotech AG a nonexclusive license to provide research products and services in RNA interference under the Kreutzer-Limmer patent family owned by Alnylam that covers short interfering RNAs (siRNAs) and their use to mediate RNAi in mammalian cells. Financial terms were not disclosed.
Aphton Corp., of Philadelphia, said its listing of common stock was transferred from the Nasdaq National Market to the Nasdaq SmallCap Market, starting Monday morning. The company's stock will continue to be traded under the symbol "APHT." Aphton develops targeted immunotherapies for cancer.
Applied Biosystems Group, of Foster City, Calif., and the National Institute of Genomic Medicine of Mexico, known as INMEGEN, in Mexico City are collaborating to establish a Mexico-based Applied Biosystems Sequencing and Genotyping Unit for conducting research studies focused on health issues in the Mexican population. IMNEGEN, part of Mexico's Institutes of Health, was established last July to apply knowledge gained from the human genome project to improve health care by investing in research, training and public education.
Catalyst Biosciences Inc., of South San Francisco, and Torrey Pines Institute for Molecular Studies in San Diego entered an exclusive worldwide license agreement for Catalyst's use of the institute's intellectual property covering protease engineering, selection and optimization. Catalyst is focused on advancing proteases as a new platform for drugs against inflammation, cardiovascular disease and other disorders.
Cellzome Inc., of Boston, expanded its research collaboration with Novartis Pharma AG, of Basel, Switzerland, in line with terms from the original agreement signed in September 2004 to combine Cellzome's experience in chemical proteomics and pathway mapping with Novartis' insights into particular disease pathways. During the past year, Cellzome has mapped the protein networks of several different signaling pathways implicated in various therapeutic areas, and has characterized several Novartis compounds using its proteomics methodology. The expanded agreement will focus on providing more in-depth functional analyses of target candidates and signaling aspects of the disease pathways.
Cerus Corp., of Concord, Calif., said the August 2005 issue of Nature Medicine published an article that details the development of a new class of vaccines, called KBMA vaccines, based on bacteria that have been killed at the genetic level, but maintain their metabolic activity and immunologic potency. Collaborators on the paper include scientists from Cerus and the University of California at Berkeley.
CollaGenex Pharmaceuticals Inc., of Newtown, Pa., said results from two Phase III trials of Oracea, a drug to treat rosacea, were presented at the summer meeting of the American Academy of Dermatology in Chicago. Each of the two double-blinded, placebo-controlled Phase III studies achieved their primary endpoint by demonstrating a greater mean reduction in inflammatory lesion count from baseline for the Oracea-treated patients (61 percent and 46 percent) compared to the placebo controls (20 percent and 20.8 percent).
Evotec AG, of Hamburg, Germany, and Procter & Gamble Pharmaceuticals Inc., a subsidiary of Cincinnati-based Procter & Gamble Co., entered agreements whereby Evotec will provide pharmaceutical discovery and chemical development services. P&G will access discovery and preclinical expertise offered by Evotec, ranging from assay development, screening, medicinal and computational chemistry to scale-up and pharmaceutical manufacture. The companies started a relationship at the end of 2004 with a pilot screening program for a P&G therapeutic target.
Exelixis Inc., of South San Francisco, initiated a Phase I trial to evaluate the safety, tolerability and pharmacokinetic profile of the cancer compound XL820. The product is a spectrum selective kinase inhibitor that inhibits the receptor tyrosine kinases VEGF, KIT and PDGF.
Forest Laboratories Inc., of New York, said the FDA has issued a non-approvable letter in response to its supplemental new drug application to expand the indication of Namenda (memantine HCl) to include the treatment of mild Alzheimer's disease. The FDA cited in its decision two studies of Namenda that failed to show statistical significance, though the drug met primary endpoints in a separate six-month study that served as the basis for the sNDA. Namenda was approved in October 2003 for the treatment of moderate to severe Alzheimer's disease.
Gilead Sciences Inc., of Foster City, Calif., and Royalty Pharma, of New York, completed the purchase of the royalty interest owed to Emory University for the hepatitis B compound emtricitabine. Gilead and Royalty Pharma made a one-time cash payment of $525 million to Emory for the university's worldwide royalties. Gilead also made a one-time payment of $15 million to Emory for amending the existing license agreement. (See BioWorld Today, July 20, 2005.)
HistoRx Inc., of New Haven, Conn., said researchers with Yale Cancer Center concluded that high expression of TRAIL-R2, a cell-surface receptor that triggers cell death, appears to be associated with a decrease in the survival rates of breast cancer patients. Researchers analyzed 20-year follow-up data from breast cancer patients using an automated quantitative analysis system to review tissue microarray specimens and identify increased intensity of TRAIL receptor expression. Results were published in Clinical Cancer Research.
Igeneon AG, of Vienna, Austria, and Celltrion Inc., of Incheon, South Korea, signed a licensing and commercialization agreement and a deal related to the manufacturing, marketing and distribution of Igeneon's clinical product candidate IGN311. Igeneon is a wholly owned subsidiary of Aphton Corp., of Philadelphia, and IGN311 is a humanized monoclonal antibody targeting the Lewis Y antigen that is being developed as a potential new therapy for the treatment of certain epithelial tumors. Igeneon granted Celltrion a license to commercialize IGN311 in certain Asian countries, including Japan. In return, Igeneon gets from Celltrion milestone payments totaling $6 million. Celltrion will provide development and manufacturing services related to the optimization and up-scaling of the compound and will produce material for further clinical development. Celltrion will manage clinical development activities in Asia. Igeneon gets royalties on sales as part of the transaction, expected to close on Oct. 1, 2005.
OriGene Technologies Inc., of Rockville, Md., entered a collaboration with the laboratory of Brian Seed at Massachusetts General Hospital to use OriGene's FlagArray platform for high-throughput functional analysis of genes. The system consists of expression-ready arrays of full-length cDNA plasmids for use in high-throughput, genome-wide target identification and validation. Seed is a professor of genetics at Harvard Medical School and director of the Center for Computational and Integrative Biology at MGH.
Oxford BioMedica plc, of Oxford, UK, said the UK Motor Neurone Disease Association has awarded the company a research grant to support preclinical evaluation of MoNuDin to treat amyotrophic lateral sclerosis. The initial grant of £350,000 will fund a preclinical efficacy study and support preparations for clinical trials. Oxford BioMedica plans to start clinical development in the 2006-2007 timeframe.
Picchio Pharma Inc., of Montreal, said its subsidiary PP Luxco Holdings II s.a.r.l. exercised a warrant to acquire an additional 2.8 million common shares of Neurochem Inc., of Laval, Quebec. As a result, PP Luxco's holdings in Neurochem would increase to about 9.9 million common shares, representing a 26.4 percent stake. PP Luxco also has 1.2 million additional warrants to purchase Neurochem shares, which, if exercised, would raise that stake to 28.7 percent.
SciClone Pharmaceuticals Inc., of San Mateo, Calif., said SCV-07 was effective in preclinical studies, reducing lesions in a model of human papillomavirus and increasing survival in a model of Lassa fever. The data were presented at the International Union of Microbiological Societies conference in San Francisco. The company expects to initiate Phase I studies in healthy volunteers later this year, and move into a Phase II study in a viral or infectious disease indication in 2006.
Sirna Therapeutics Inc., of Boulder, Colo., said a recent study demonstrated a 95 percent knockdown of hepatitis B virus using the company's chemically optimized short interfering RNA (siRNA) at 1, 3 and 5 mg/kg together with encapsulating and delivery technology provided by Seattle-based Protiva Biotherapeutics Inc. The siRNA formulation was administered by intravenous injection to mice carrying replicating HBV. Researchers also saw reductions in hepatitis B surface antigen protein levels, and reported that anti-viral activity persisted for at least seven days. Study data were published in Nature Biotechnology.
Spectrum Pharmaceuticals Inc., of Irvine, Calif., launched a Phase I/II trial in the U.S. to explore the safe and efficacious dose range of ozarelix (formerly SPI-153) as a treatment for hormone-dependent prostate cancer. Ozarelix is a fourth generation luteinizing hormone releasing hormone.
Tapestry Pharmaceuticals Inc., of Boulder, Colo., is reducing its work force by about 30 percent - eliminating 14 positions - and reducing its cash burn to focus resources on advancing the cancer drug, TPI 287, through the clinic. The company expects savings to total about $7.4 million through the end of 2006. There will be a one-time cost of $270,000 to implement the downsizing. Tapestry expects to begin a second Phase I trial for TPI 287 before the end of the year, and to initiate a Phase II study in mid-2006.
TEVA Pharmaceutical Industries Ltd., of Jerusalem, is acquiring Miami-based generics company, IVAX Corp., for about $7.4 billion. As a result of the transaction, IVAX shareholders will own about 15 percent of TEVA on a fully diluted basis. The companies' boards have approved the transaction, which involves a triangular merger structure that will cause IVAX to become a subsidiary of TEVA. The acquisition is expected to close in late 2005 or early 2006.
Trimeris Inc., of Durham, N.C., and F. Hoffmann-La Roche Ltd., of Basel, Switzerland, said researchers are evaluating two new methods for self-injecting the HIV drug, Fuzeon (enfuvirtide), in an effort to identify viable alternatives. At the International AIDS Society conference in Rio de Janeiro, Brazil, studies were presented on the administration of Fuzeon with a CO2-powered needle-free injection device and with a short, ultra-fine needle/syringe commonly used by diabetic patients taking insulin therapy.
Valeant Pharmaceuticals International, of Costa Mesa, Calif., plans to initiate the development of Viramidine in Japan following the first meeting of the company's hepatitis C Japanese advisory board held in Tokyo. Valeant is developing Viramidine, a nucleoside analogue, in oral form for administration in combination with pegylated interferon to treat chronic hepatitis C in treatment-na ve patients. The company is conducting two pivotal Phase III trials for the product.