American Pharmaceutical Partners Inc., of Schaumburg, Ill., expects to take a third-quarter charge of $10 million due to a delay in upgrading its manufacturing plant in Melrose Park, Ill. The plant is expected to be fully operational by late September, but the delay will affect some of the company's key generic products, resulting in an anticipated $15 million impact on third-quarter sales. APP said it has enough inventory of its Abraxane, used in the treatment of breast cancer, to meet demand. Since its initial public offering in 2001, APP has spent more than $120 million to expand and upgrade.
Arena Pharmaceuticals Inc., of San Diego, received positive results during its Phase II trial of APD356, an orally administered drug candidate for the treatment of obesity. Follow-up echocardiograms were taken 90 days after patients received their first doses of APD356, and researchers found no apparent drug effect on heart valves or pulmonary artery pressure after four weeks of dosing. Arena also has completed enrollment of 460 patients for a Phase II trial. The company concentrates on small molecule drugs in the areas of metabolic, cardiovascular, inflammatory and central nervous systems that act on drug targets called G protein-coupled receptors.
BioVision AG, of Hannover, Germany, published an article on "Correlation-Associated Peptide Networks [CAN]" by Jens Lamerz, member of the BioVision bioinformatics team, in collaboration with the ETH Zurich and the Swiss Institute of Allergy and Asthma Research in a recent issue of Proteomics. CAN supports the statistical analysis of peptide profiling data and allows associating peptides, which are closely related in terms of peptide biochemistry, it said.
ConjuChem Inc., of Montreal, said that it is progressing to clinical development the first compound from its new platform technology, PC-DAC (Pre-formed Conjugate-Drug Affinity Complex). Pre-formed conjugates represent a natural extension of ConjuChem's core DAC platform technology, and builds on the company's albumin bonding expertise and intellectual property.
EPIX Pharmaceuticals Inc., of Cambridge, Mass., said articles published in the July and September issues of Radiology indicate that MS-325, a contrast agent designed for vascular imaging with magnetic resonance angiography (MRA), provides higher images of the aortoiliac vessels and results in better agreement with X-ray angiography than non-contrast MRA. MS-325 (gadofosveset trisodium) is being co-developed by Schering AG, of Berlin.
Flanders Interuniversity Institute for Biotechnology in Ghent, Belgium, said its scientists discovered the function of a mediator involved in suppressing the development of tumors. Using a mouse model, the researchers showed that the absence of that mediator makes mice susceptible for the development of cancer. Data were published in the EMBO Journal.
Immtech International Inc., of Vernon Hills, Ill., along with its partner, the University of North Carolina at Chapel Hill, initiated a pivotal Phase III trial of its oral drug, DB289, in the Democratic Republic of Congo to treat trypanosomiasis (African sleeping sickness.) The study, expected to enroll 250 patients, is designed to compare the effectiveness of DB289 to pentamidine, the existing first-line therapy in Africa. The trial's special protocol assessment received FDA approval in June. (See BioWorld Today, June 17, 2005.)
Invitrogen Corp., of Carlsbad, Calif., entered a collaboration with the Scripps Research Institute in La Jolla, Calif., to develop improved methods for expression, isolation and characterization of membrane proteins. Scripps Research and Invitrogen will co-develop technologies for the study of membrane proteins, and Invitrogen will have the right to commercialize the resulting technologies.
Lipid Sciences Inc., of Pleasanton, Calif., said that as part of its strategic plan to broaden the scope of the company's HDL therapy platform, it plans to initiate an expansion of HDL therapy development program in collaboration with the Washington Hospital Center and the Cardiovascular Research Institute of the MedStar Research Institute in Washington.
Neurobiological Technologies Inc., of Emeryville, Calif., enrolled the first patients in an open-label, extended-use study of Xerecept (hCRF). The study is an extension of the two ongoing pivotal Phase III trials to evaluate the dexamethasone-sparing effects of hCRF in brain tumor patients being treated for peritumoral brain edema. The trial will collect safety information and allow treating physicians to attempt a maximum dexamethasone reduction and possible elimination. The company launched a second Phase III program earlier this month to test its anti-stroke drug, Viprinex. (See BioWorld Today, Aug. 23, 2005.)
Peregrine Pharmaceuticals Inc., of Tustin, Calif., agreed to license intellectual property rights to Medarex Inc., of Princeton, N.J., relating to its Vascular Targeting Agent technology platform. The license allows Medarex to develop and commercialize an anti-PSMA monoclonal antibody conjugated to therapeutic agents, and to use the resulting conjugate for the treatment of solid tumors. Peregrine expects to receive an up-front payment, as well as annual maintenance fees and possible milestone and royalty payments. Further financial terms were not disclosed.
Prima Biomed Ltd., of Melbourne, Australia, acquired 100 percent of the issued shares of three subsidiaries from the Austin Research Institute - Cancer Vac Pty. Ltd., Panvax Ltd. and Oncomab Pty. Ltd. - and 92.5 percent of the issued shares of Arthron Ltd. Prima said the agreements give greater flexibility and potential for commercial benefits. Prima also updated its agreement with ARI that provides Prima first rights on ARI technologies, excluding xenotransplantation, in the fields of immunology and cancer immunotherapy.
Pro-Pharmaceuticals Inc., of Newton, Mass., a developer of carbohydrate compounds that enable the targeted delivery of chemotherapy drugs to cancer cells, reported the dosing of a colorectal cancer patient in a Phase II trial of its Davanat/5-FU chemotherapy at Ochsner Cancer Institute in New Orleans. The Phase II trial is a third- or fourth-line therapy for metastastic colorectal cancer patients who have disease progression after receiving standard chemotherapeutic regimens.
ProtoKinetix Inc., of Vancouver, British Columbia, reported results of the in vitro effect of its synthetic antifreeze glycoprotein (AFGP) on embryonic human fibroblast skin cells. The company said that 5 mgm per ml of monomeric AFGP demonstrated a better survivability at all temperatures from 22 degrees C to -3 degrees C. Prior work confirmed that synthetic AFGP is able to preserve human kidney cells, red blood cells and platelets, as well as rat cardiac cells and tissue.
Salix Pharmaceuticals Ltd., of Raleigh, N.C., said results of a study published in the International Journal of Radiation Oncology-Biology-Physics suggest balsalazide might have potential to prevent or reduce symptoms of radiation-induced toxicities in patients undergoing radiation therapy for prostate cancer. The incidence of proctitis, the most severe toxicity, decreased by more than half in patients receiving three Colazal (balsalazide disodium) capsules 750 mg, compared to placebo, and symptoms such as diarrhea, dysuria and fatigue also were lower in patients on Salix's treatment.
SIRS-Lab GmbH, of Jena, Germany, entered a collaboration agreement with Biosite Inc., of San Diego, for the evaluation and potential commercialization of sepsis markers. SIRS-Lab will provide access to selected biomarkers for sepsis. Biosite will then make antibodies to those selected targets using the company's antibody development process, which combines immunization of mice and phage display to generate diverse libraries of Omniclonal antibodies with high affinity and low cross-reactivity.