AnorMED Inc., of Vancouver, British Columbia, said North American Scientific Inc., of Chatsworth, Calif., successfully performed human testing of a second-generation technology for AnorMED’s Apomate kit, a radiopharmaceutical intended for imaging cell death, as an early indicator of response to anticancer treatment. Apomate also is under study for its ability to determine the extent and location of myocardial cellular injury after a heart attack and the response to treatment of heart attacks. The second-generation technology was licensed from AnorMED for use in NASI’s radiopharmaceutical development program.
Array BioPharma Inc., of Boulder, Colo., signed a long-term lease agreement for additional laboratory space adjacent to its Longmont, Colo., site, which will increase its laboratory space to about 219,000 square feet and will be phased in over the next three years. The new lease provides an additional 29,000 square feet of laboratory space on its campus, and will offer space for 45 additional scientists.
Cetek Corp., of Marlborough, Mass., achieved a milestone under its research agreement with Millennium Pharmaceuticals Inc., of Cambridge, Mass., resulting in an undisclosed payment. The collaboration, which began in February 2001, resulted in the discovery of several families of compounds from the Millennium library that Cetek identified as having binding activity. Cetek’s president said the first milestone helps demonstrate that Cetek’s core Capillary Electrophoresis screening assay is effective in matching drugs with genomic targets.
CollaGenex Pharmaceuticals Inc., of Newtown, Pa., secured an $8.5 million equity line financing commitment from Kingsbridge Capital Ltd., of Ireland. CollaGenex retains the option to draw down funds as needed during a 12-month period to support its operational and capital requirements, subject to certain limitations. The price of the common shares issued under the agreement will be based on a discount to the volume-weighted average market price during the drawdown period. Kingsbridge is prohibited under the agreement from holding a net short position in CollaGenex’s common stock.
Columbia University and Rockefeller University, both of New York, signed an agreement to commercialize an engineered molecule used in a process that re-sensitizes resistant bacteria to vancomycin, the treatment of last resort for Gram-positive bacteria. A team of researchers at the universities identified an approach to address antibiotic resistance by identifying and blocking the mechanism through which resistance occurs. The universities are joint owners of this patent-pending technology. The researchers’ work was published in Science on Aug. 24, 2001.
Deltagen Inc., of Redwood City, Calif., said it signed a three-year target validation and research collaboration agreement with Stanford University, of Stanford, Calif. Stanford and Deltagen will mutually develop research projects for jointly selected genes under which Deltagen will provide Stanford nonexclusive access to knockout mice models using its high-throughput technology. Deltagen will have options to obtain exclusive licenses to commercially develop certain inventions developed by Stanford. Deltagen will have rights to use, commercialize and sublicense resulting products. Separately, Deltagen said it completed the acquisition of Bristol-Myers Squibb Pharma Research Labs LLC, of San Diego, formerly known as CombiChem Inc., from Bristol-Myers Squibb Co., of New York. Bristol-Myers Squibb received $23.5 million of newly issued Deltagen common stock in exchange for 100 percent of the units of membership interest of BMSPRL. The subsidiary will be renamed Deltagen Research Laboratories. (See BioWorld Today, Feb. 12, 2002.)
ICN Pharmaceuticals Inc., of Costa Mesa, Calif., said it had been in negotiations to acquire Bioglan Pharma plc, of Hertfordshire, UK. After little progress, the negotiations have been terminated with no agreement reached. INC focuses on anti-infectives, including antivirals, dermatology and oncology.
Gene Logic Inc., of Gaithersburg, Md., said Morphochem AG, of Munich, Germany, subscribed to components of Gene Logic’s GeneExpress Oncology Datasuite, which will offer Morphochem’s researchers nonexclusive access to a selection of gene expression and other associated genomic information focused on oncology. Morphochem also signed on to purchase a series of GeneExpress Reports, which provide assessment of targeted genes of interest. The agreement also called for data to be generated by Gene Logic from samples provided by Morphochem.
Genta Inc., of Berkeley Heights, N.J., began a multicenter trial in patients with non-Hodgkin’s lymphoma to test its lead antisense drug, Genasense, in combination with Rituxan (rituximab) co-developed by Genentech Inc., of South San Francisco, and IDEC Pharmaceuticals Corp., of San Diego plus standard chemotherapy. The trial initially will employ Genasense alone, followed by combined therapy with Rituxan and a standard chemotherapy regimen known as CHOP. The Lancet and the Journal of Clinical Oncology have reported preliminary safety and efficacy results of Genasense used alone as treatment for patients with advanced non-Hodgkin’s lymphoma, with more recent preclinical data revealing high levels of synergy when Genasense was combined with both standard chemotherapy and Rituxan.
IGEN International Inc., of Gaithersburg, Md., said the U.S. District Court for the District of Maryland issued a final order of judgment in its case against Roche Diagnostics GmbH, a division of F. Hoffmann-La Roche Ltd., of Basel, Switzerland. The judgment awards IGEN $505 million in damages and confirms the company’s right to terminate the Roche license agreement. Once the agreement is terminated, Roche will be prohibited from commercializing all Origen-based products, including its Elecsys diagnostics product line, and IGEN will be free to operate, either independently or with new partners, in the field currently licensed to Roche. (See BioWorld Today, Jan. 14, 2002.)
ImClone Systems Inc., of New York, which Friday adopted a stockholder’s rights plan, has been the subject of an unsolicited takeover attempt by Carl Icahn. Icahn is seeking to purchase $500 million of ImClone stock, which translates to about 40 percent of the company. ImClone’s stockholder rights plan makes it prohibitively expensive for an investor to continue to buy shares of the company after it has acquired 15 percent of the stock.
Immtech International Inc., of Vernon Hills, Ill., completed an initial phase of a private placement of more than $4 million in restricted Series A convertible preferred stock with a predetermined conversion price and warrants to purchase common stock. This included a private placement reported in a 10-Q and filed Feb. 14 and funds received to that date, the company said. Immtech focuses on the discovery, development and commercialization of drugs to treat fungal diseases, tuberculosis, hepatitis, pneumonia, diarrhea and cancer.
Immuno-Designed Molecules SA, of Paris, and Sanofi-Synthélabo SA, of Paris, said Sanofi-Synthélabo exercised its first option to develop and market IDM’s cell drug known as IDD3 for melanoma. After reporting their partnership in January, Sanofi chose the melanoma target since it is likely to be responsive to an immuno-therapeutic treatment. IDD3 successfully completed initial Phase II trials with promising results. The cell drug selected is a dendritic cell-based therapeutic vaccine using IL-13, a compound Sanofi discovered and which formed the basis of the first partnership between the companies in 1999. Sanofi’s exercising of its option triggered the payment of milestones, the reimbursement of clinical development costs incurred by IDM for this drug, and the reimbursement of the clinical development program as it advances. (See BioWorld Today, Jan. 23, 2002.)
Insmed Inc., of Richmond, Va., and Oxagen Ltd., of Abingdon, UK, entered a collaborative research agreement to investigate the genetic profile associated with polycystic ovary syndrome (PCOS) and other metabolic disorders related to insulin resistance. Insmed will have the rights to use the research results to develop drug targets and therapeutics for the prevention and treatment of the disease. Oxagen may, at its option, co-develop novel targets with Insmed and retains rights to diagnostic applications involving the detection of predisposition to PCOS or prediction of therapeutic response.
Interneuron Pharmaceuticals Inc., of Lexington, Mass., said its PRO 2000 and other vaginal microbicides designed to prevent HIV transmission will be tested by a collaboration of UK and African research groups that were awarded a £16 million (US$22.7 million) grant from the UK’s Department for International Development. The grant will support a five-year program that will include a multinational, randomized, double-blind, placebo-controlled Phase III trial of candidate microbicides. PRO 2000 previously was selected for a European Commission-funded Phase II safety trial in at-risk African women and a Phase II/III pivotal trial in Africa and India sponsored by the National Institutes of Health, both of which are scheduled to begin this year.
Luminex Corp., of Austin, Texas, is analyzing legal, accounting and tax implications of various structuring alternatives for its development-stage business unit recently named Rules-Based Medicine (RBM), which is intended to identify the combinations, levels or absences of proteins associated with various disease states. Luminex could transfer the business of RBM to a separately financed entity in exchange for a less than 20 percent equity interest in such an entity and a royalty based on revenues from products developed by that entity, or operate RBM as a subsidiary that would seek funding from private equity or other strategic sources outside of Luminex. The company also may continue to operate and fund RBM as a business unit within Luminex or implement another structuring alternative.
Palatin Technologies Inc., of Princeton, N.J., reported positive results from its most recent Phase I safety study of PT-141, its lead investigational drug for the treatment of male and female sexual dysfunction. The double-blind, placebo-controlled study evaluated escalating doses of PT-141 in 88 healthy male subjects to define the maximum tolerated dose and investigate the safety and pharmacokinetics of both intranasally and subcutaneously administered PT-141. Investigators reported that neither dosage form of PT-141 had any serious side effects. Results indicate that within five minutes, intranasally administered PT-141 appears in the blood, with maximum levels reached at approximately 30 minutes. Analysis indicates that therapeutic levels of PT-141 are achieved in a rapid and consistent manner following nasal administration.
Pharmacyclics Inc., of Sunnyvale, Calif., said preclinical study findings published in this week’s issue of the Proceedings of the National Academy of Sciences provide evidence that Xcytrin, or motexafin gadolinium, an agent being evaluated by the company in clinical trials for cancer, may inhibit HIV-1 replication by selectively destroying HIV-infected cells. One of a new class of drugs called texaphrins, acts on HIV-infected CD4-positive T lymphocytes. According to the paper, Xcytrin inhibits HIV transcription and replication through a novel mechanism of action that selectively eliminates HIV-infected cells while sparing uninfected lymphocytes.
Protein Design Labs Inc., of Fremont, Calif., was the subject of a research note by analyst Bill Tanner, of New York-based SG Cowen Securities Corp. The note said conversations with experts concerning Zenapax maintaining remission in psoriasis patients suggest the drug may not be efficacious. The Phase II trial results are still blinded and the data have not been analyzed, however. SG Cowen said it expects PDL to unblind the data and report results in the second half of March. PDL’s stock (NASDAQ:PDLI) fell $3.81 Tuesday, or 18.3 percent, to end the day at $16.99.
Trimeris Inc., of Durham, N.C., and Hoffmann-La Roche Inc., of Nutley, N.J., reported 48-week results from two Phase II trials evaluating T-20, the furthest in clinical development of an investigational class of antiretrovirals called fusion inhibitors. The results indicated that T-20 contributes to the suppression of plasma viral load and was well tolerated over the course of nearly a year as part of antiretroviral combination therapy. Forty-six triple-class, treatment-experienced patients participated in T20-208, a formulation comparison study of T-20.
Ricerca LLC, of Concord, Ohio, entered a small-molecule drug discovery and development partnership with Gvk bioSciences Private Ltd., of Hyderabad, India, under which Gvk will build a new facility in Hyderabad to do medicinal chemistry and biology under Ricerca’s direction for client drug discovery programs and lead optimization of each company’s own drug targets. Ricerca will be the exclusive worldwide partner for access to Gvk’s medicinal chemistry services. Ricerca will provide Gvk with some of its drug targets or early hits for joint drug development. In addition, Gvk will license to Ricerca its bioinformatics tools in exchange for access to Ricerca’s ADMET and related pharmaceutical data.
SurroMed Inc., of Mountain View, Calif., was awarded a subcontract to undertake clinical phenotyping under a National Institutes of Arthritis and Musculoskeletal and Skin Diseases contract. The contract provides funding for a research study involving 240 subjects with rheumatoid arthritis administered anti-TNF therapies, including Remicade (Centocor Inc., of Malvern, Pa.) and Enbrel (Immunex Corp., of Seattle). The primary objective will be to identify biological markers associated with patient response and nonresponse to these therapies.
United Therapeutics Corp., of Research Triangle Park, N.C., said the Canadian Therapeutics Products Directorate accepted for review the Remodulin new drug submission for the treatment of pulmonary arterial hypertension. Priority review status was also granted to Remodulin, which would be distributed in Canada by Paladin Labs Inc., of Montreal. United Therapeutics earlier this month received an approvable letter from the FDA, and the company has submitted marketing applications for Remodulin in France and Switzerland.