• Agendia BV, of Amsterdam, the Netherlands, acquired the rights to the discovery of a mechanism of resistance to Herceptin (trastuzumab, Genentech Inc.), a frequently-used breast cancer drug. That discovery, recently published in Cancer Cell, showed that biomarkers identified by Agendia have predictive value in patients treated with Herceptin to determine responsiveness and resistance.

• Aureon Laboratories Inc., of Yonkers, N.Y., entered a research collaboration with the University of California, San Francisco, to retrospectively analyze patient samples collected during a Phase I trial of treatment with granulocyte macrophage colony stimulating factor (GM-CSF) prior to radical prostatectomy. Aureon will use its Systems Pathology platform to analyze histological, molecular and clinical phenotypes with the goal of constructing models that assist in predicting response to prostate cancer treatment. Terms were not disclosed.

• AVI BioPharma Inc., of Portland, Ore., was awarded a $2.45 million research grant from Charley's Fund Inc., a nonprofit organization that funds drug development and discovery initiatives for Duchenne's muscular dystrophy. The money will support a new product development program using exon-skipping technologies developed by AVI and its partner, Ercole Biotech Inc., of Research Triangle Park, N.C., to overcome the effects of certain genetic errors in the dystrophin gene. The focus of the funded program will be to select and develop a lead molecule, based on AVI's Neugene chemistry, which is designed to skip dystrophin exon 50 to restore the proper RNA reading frame and production of functional dystrophin in patients with a particular type of mutation.

• Basilea Pharmaceutica Ltd., of Basel, Switzerland, said Swissmedic has accepted for review, the marketing authorization application for oral alitretinoin in severe refractory chronic hand eczema. Other applications are under review in various European Union states.

• Celera Group, of Alameda, Calif., said it has acquired Berkeley HeartLab Inc., of Burlingame, Calif., for $195 million in cash. BHL is a cardiovascular health care company with a broad portfolio of tests and disease management services focused on the secondary prevention market. BHL, which has about 300 employees, including 110 laboratory personnel and about 80 field-based sales representatives and clinical educators, will operate as a business unit of Celera. Celera also said it has identified five gene variants, KIF6, MYH15, PALLD, SNX19 and VAMP8, that can predict risk of coronary heart disease. Individuals with a high genetic risk score based on the five gene variants had a 57 percent increased risk of incident of coronary heart disease, which is similar to the magnitude of risk for heart disease associated with smoking, hypertension, hypercholesterolemia or obesity. The study is scheduled to appear in the October 2007 edition of Genetics in Medicine.

• Centocor Inc., of Malvern, Pa., presented data it said showed Remicade significantly reduces the incidence of colectomy surgeries for patients with moderately to severely active ulcerative colitis. According to a primary analysis of long-term extension data from the Active Ulcerative Colitis 1 and 2 trials, there was a 41 percent reduction in the incidence of colectomy in patients receiving Remicade through 54 weeks, compared to those receiving placebo (p=0.015). Remicade is the only biologic approved for the treatment of ulcerative colitis. The data were presented at the annual meeting of the American College of Gastroenterology in Philadelphia.

• Generex Biotechnology Corp., of Worcester, Mass., said its Middle Eastern master licensee, Leosons General Trading Co., of Albany, N.Y., has filed regulatory submissions for Generex Oral-lyn, an insulin spray. Leosons has filed submissions of the Generex Oral-lyn dossier with regulatory agencies in Kuwait, Qatar, Jordan, Yemen and the United Arab Emirates. In the U.S. and Europe, Generex plans to begin Phase III trials with the product in Type I and Type II diabetes.

• Illumina Inc., of San Diego, said the overseas charity Cancer Research UK will fund two studies designed to uncover genetic factors linked to the development of lung and ovarian cancers. Those studies are part of a dual agreement with UK-based research centers that will total more than 15,500 samples. Both studies initially will use Illumina's Infinium HumanHap550 Genotyping BeadChip, followed by customized analysis using the iSelect Genotyping BeadChip. Those studies mark the third and fourth service projects to be conducted for Cancer Research UK by Illumina's FastTrack Genotyping Services team.

• Innovive Pharmaceuticals Inc., of New York, received orphan drug designation from the FDA for Tamibarotene in relapsed or refractory acute promyelocytic leukemia (APL). Tamibarotene is a fully synthetic retinoid designed to overcome resistance to all-trans-retinoic acid and is approved in Japan for relapsed or refractory APL. Innovive expects to begin enrollment in a Phase II trial of the drug under a special protocol assessment in the fourth quarter.

• Knopp Neurosciences Inc., of Pittsburgh, said the FDA has granted orphan drug designation to KNS-760704 for the treatment of amyotrophic lateral sclerosis (ALS). The compound is completing Phase I studies to evaluate the safety, tolerability and pharmacokinetics of the compound in healthy human subjects. Knopp expects to initiate Phase II studies in ALS patients in the first quarter of 2008. The drug is an optical enantiomer of a selective, high affinity dopamine agonist marketed in other neurological indications

• Labopharm Inc., of Laval, Quebec, started the FDA's formal dispute resolution process, appealing the agency's decision regarding the company's once-daily formulation of tramadol. Labopharm received a second approvable letter from the FDA for its once-daily formulation of tramadol in May, but the company believes it has met the statutory standards for approval. (See BioWorld Today, June 4, 2007.)

• Leuchemix Inc., of Woodside, Calif., said results from preclinical studies of its lead oncology drug candidate LC-1 showed activity in acute myelogenous leukemia, chronic lymphocytic leukemia and acute lymphoblastic leukemia.

• Ligand Pharmaceuticals Inc., of San Diego, said it earned a $250,000 milestone payment from Madison, N.J.-based Wyeth, following Wyeth's Sept. 5 submission of a market authorization application in Europe for use of bazedoxifene in the prevention and treatment of osteoporosis. The milestone arises from a December 2005 agreement between the two firms related to bazedoxifene, a selective estrogen receptor modulator designed to reduce the risk of osteoporotic fractures while protecting breast and uterine tissues. Wyeth received an approvable letter from the FDA in April for the treatment of osteoporosis and submitted a second new drug application in July for disease prevention.

• Merck & Co. Inc., of Whitehouse Station, N.J., said the FDA granted its HIV treatment, Isentress (raltegravir) tablets, accelerated approval for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents. The indication is based on analyses of plasma HIV-1 RNA levels up through 24 weeks in two controlled studies of Isentress. The studies were conducted in clinically advanced, three-class antiretroviral (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors and protease inhibitors treatment-experienced adults.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., said the FDA expanded the label for Velcade (bortezomib) to include refractory multiple myeloma patients with impaired kidney function, including those requiring dialysis. The company said impaired kidney function affects about 30 percent of multiple myeloma patients at diagnosis and many more with later-stage disease. The label for competitor Celgene Corp.'s Revlimid (lenalidomide) contains a precaution regarding use in patients with renal impairment. Millennium also is planning to apply for a label expansion early next year to cover newly diagnosed multiple myeloma patients, based on recent positive Phase III data. (See BioWorld Today, Sept. 19, 2007.)

• NicOx SA, of Sophia Antipolis, France, said it has opened its U.S. headquarters in Warren, N.J. where the firm will base its commercial affairs and U.S. clinical operations departments. Sanjiv Sharma, who was appointed in April as vice president of commercial affairs, will head the U.S. office. In addition to commercial activities, U.S. clinical orations will be based in the New Jersey office, led by Joan Sutphen, who joined NicOx in February as director of U.S. clinical operations. Naproxcinod, NicOx' lead investigational product, is in phase III clinical development for the treatment of the signs and symptoms of osteoarthritis.

• Pozen Inc., of Chapel Hill, N.C., submitted a response to the approvable letter for Trexima. That action came after Pozen and partner GlaxoSmithKline plc, of London, met jointly with the FDA. The approvable letter was disclosed in early August for Trexima, a migraine drug combining 85 mg of sumatriptan with 500 mg of naproxen sodium. (See BioWorld Today, Aug. 3, 2007.)

• Senex Biotechnology Inc., of Albany, N.Y., presented results describing the identification of the first drug candidates that block aging cells from producing excessive amounts of several proteins involved in Alzheimer's disease, including amyloid precursor protein, BACE1 that converts APP to beta-amyloid and tissue transglutaminase that cross-links beta-amyloid to form amyloid plaques. The signaling pathway targeted by Senex's compounds also was implicated in cancer and some other diseases of old age. Data were reported at the Alzheimer's disease drug discovery conference in New York.

• Sucampo Pharmaceuticals Inc., of Bethesda, Md., presented preclinical data indicating that SPI-8811 (cobiprostone) may be able to reduce cellular death and promote the regrowth of intestinal cells damaged by the nonsteroidal anti-inflammatory drug (NSAID) indomethacin. The data, which also indicated that SPI-8811 works by activating chloride channels, were presented at the American College of Gastroenterology annual meeting in Philadelphia. Last month, Sucampo initiated a Phase II trial of SPI-8811 in NSAID-induced ulcers and other gastrointestinal injuries.

• Upstream Biosciences Inc., of Vancouver, British Columbia, signed a letter of intent with the Ministry of Health in Uganda regarding a collaboration to develop drugs for parasitic diseases. Upstream's recent acquisition of Pacific Pharma Technologies Inc. provided lead compounds for leishmaniasis and African sleeping sickness (trypanosomiasis), which will form the initial focus of the collaboration. Terms were not disclosed. (See BioWorld Today, Aug. 28, 2007.)

• ValiRx plc, of London, has signed a full license agreement with Chroma Therapeutics, of Abingdon, UK, to commercialize a noninvasive diagnostic technology patent developed by Chroma that identifies epigenetic signal changes, in particular changes to the histone code, which occur in cancer-related illnesses. ValiRx said the technology, called Nucleosomics, has the potential to complement its own existing cancer diagnostics technology, HyperGenomics, to create a noninvasive, mass screening, cancer diagnostics package that can deliver early stage diagnosis, specific diagnosis, prognosis, evaluation and therapeutic strategy. Under the terms of the agreement, ValiRx will pay Chroma royalties on any future sales resulting from commercialization of the Nucleosomics technology.

• Xanthus Pharmaceuticals Inc., of Cambridge, Mass., reported preclinical results showing that Symadex, the lead compound from its FLT3 autoimmune program, directly targets macrophages and monocytes, key cells responsible for driving the autoimmune response. Using a model of autoimmune encephalomyelitis, which was designed to represent multiple sclerosis, researchers found that Symadex brought elevated levels of monocyte- and macrophage-related biomarkers associated with disease back to normal. In vitro studies supporting that mode of action showed that Symadex is an inhibitor of FLT3, a receptor tyrosine kinase known to regulate dendritic cells, as well as CSF-1R, a related receptor expressed particularly on macrophages. Data were presented at the multiple sclerosis conference in Prague, Czech Republic. Xanthus is preparing to initiate a human proof-of-concept trial of Symadex in 2008.