• aaiPharma Inc., of Wilmington, N.C., signed a definitive merger agreement with CIMA Labs Inc., of Eden Prairie, Minn. Each aaiPharma common share will be exchanged for one share of the new company's common stock, while each CIMA common share will be exchanged for about 1.37 shares of the new company's stock. aaiPharma stockholders will own 59.4 percent of the combined company, and CIMA stockholders will own the remaining shares following the tax-free transaction. Both companies' boards have approved the agreement, though the transaction remains subject to shareholder and regulatory approval. The parties expect the merger to close in the fourth quarter. Banc of America Securities acted as aaiPharma's financial adviser, with Robinson, Bradshaw & Hinson its legal counsel. Deutsche Bank Securities Inc. acted as CIMA's financial adviser, with Latham & Watkins LLP and Faegre & Benson its legal counsels. The combined company is expected to have about 1,500 employees, 2003 pro forma revenues between $350 million and $365 million, combined 2003 operating income of $90 million to $95 million, more than $50 million in cash and $175 million in debt.
• Allos Therapeutics Inc., of Westminster, Colo., began submitting its new drug application to the FDA for its investigational radiation sensitizer, RSR13 (efaproxiral), for patients with breast cancer that has metastasized to the brain. The company said in May it was planning the rolling submission, which is expected to be complete by the end of the year. The first component contained the nonclinical section. The chemistry, manufacturing and controls and clinical modules will be submitted later this year. The electronic submission was produced in the common technical document format, which facilitates regulatory review in the U.S., Europe and Japan. To ensure sufficient funding through the process, Allos cut 30 percent of its staff two months ago, stopped a trial of the drug in lung cancer and suspended another product's development. (See BioWorld Today, May 30, 2003.)
• Amgen Inc., of Thousand Oaks, Calif., filed a shelf registration with the SEC to occasionally sell up to $1 billion worth of debt securities, common stock, preferred stock, warrants for the prior three investments, securities purchase contracts and securities purchase units, as well as depository shares. The company said it would use proceeds for general corporate purposes, including repaying, redeeming or repurchasing debt; acquisitions; share repurchases; capital expenditures; and working capital.
• Argonaut Technologies Inc., of Foster City, Calif., reported Nasdaq's approval of its application to have its common stock traded on the Nasdaq National Market. The transfer of Argonaut's stock to that market was effective at the opening of trading Tuesday. The stock will continue to trade under the symbol "AGNT." Argonaut is a provider of consumables, instruments and services.
• Bayer Pharmaceuticals Corp., of West Haven, Conn., and GlaxoSmithKline plc, of London, reported data at this week's National Medical Association meeting showing that Levitra (vardenafil HCl) improves erectile function in most men of African-American, Hispanic and Caucasian origin. In the 10-week, 391-patient study, up to 89 percent of participants reported improvement in erectile function based on the global assessment question after taking Levitra. Also, men from each group reported penetration on their first attempt was successful more than or equal to 80 percent of the time after taking Levitra, and success rates of more than or equal to 92 percent on subsequent attempts.
• Cambrex Corp., of East Rutherford, N.J., reported the availability of the PKLight HTS Protein Kinase Assay, a generic endpoint detection system for the determination of a range of protein kinases. The homogeneous assay provides a single endpoint for all kinase/substrate pairs, the company said.
• Cognia Corp., of New York, named John Chiplin chairman. Chiplin most recently served as president and CEO of GeneFormatics Inc., which recently merged with Structural Bioinformatics Inc. to form privately held Cengent Therapeutics Inc., all of San Diego. Cognia is a developer and distributor of information systems that facilitates the use of biological and chemical information.
• Encysive Pharmaceuticals Inc., of Houston, said its majority owned German affiliate, Revotar Biopharmaceuticals AG, reported positive results with bimosiamose in a 12-patient, double-blinded, crossover, allergen-challenge study in mild asthmatics. Results showed that the small-molecule selectin antagonist could decrease late asthmatic response (LAR), a standard measure of asthma, in patients following allergen challenge. The study achieved its primary endpoint of LAR decline vs. maximum FEV1 baseline values (p=0.05). Bimosiamose also was well tolerated.
• Genesis Bioventures Inc., of New York, signed a formal letter of intent to merge with Corgenix Medical Corp., of Denver. Genesis Bioventures will issue 14 million GBI shares in exchange for 100 percent of Corgenix's outstanding shares in a transaction valued at about $8 million, based on GBI's closing stock price on Monday. The letter of intent also provides for Corgenix's current management team to assume the responsibility of managing the combined entity, which will continue to be known as Genesis Bioventures and will be headquartered in Westminster, Colo. The parties expect to close the transaction by Jan. 31.
• Genesis Research and Development Corp., of Auckland, New Zealand, appointed Peter Lee chief executive of AgriGenesis Biosciences Ltd., its plant science subsidiary. Most recently, Lee served as vice president, global research and development for International Paper Company. Genesis offers microbe, plant and mammalian EST databases.
• Genome Therapeutics Corp., of Waltham, Mass., expanded its Ramoplanin program to investigate whether the oral antibiotic can reduce the transmission of vancomycin-resistant enterococci (VRE) by decreasing skin contamination through gastrointestinal decolonization. The study will enroll up to 50 patients, all of whom will be colonized with VRE. Early patients will not receive the drug, but will be observed as controls. The second group of patients will receive 400mg of oral Ramoplanin twice daily for seven days. Skin cultures and stool samples will be collected from all participants to measure the absence or presence of VRE. The product remains in a Phase III trial for the prevention of bloodstream infections caused by VRE and a Phase II study for the treatment of Clostridium difficile-associated diarrhea.
• GenSci Regeneration Sciences Inc., of Toronto, said the U.S. Bankruptcy Court for the Central District of California dismissed it from Chapter 11, giving it more flexibility to complete its proposed merger with IsoTis SA, of Lausanne, Switzerland. In order to effect the dismissal, IsoTis made a $200,000 payment on behalf of GenSci Regeneration, and both companies confirmed that reciprocal due diligence has been completed. GenSci Regeneration said it planned to proceed toward completing the planned merger of its wholly owned subsidiary, GenSci OrthoBiologics Inc., with IsoTis. GenSci OrthoBiologics will remain under the protection of Chapter 11 pending a confirmation hearing in October. If the merger is not completed by Jan. 31, the dismissal order will be vacated and the Chapter 11 case of GenSci Regeneration would be reinstated.
• Keryx Biopharmaceuticals Inc., of New York, said it contracted the Collaborative Study Group to conduct a U.S.-based Phase II/III program for KRX-101 (sulodexide) for diabetic nephropathy. Keryx said it expects the program to begin by the late this quarter or early next quarter. The first-in-class oral heparinoid compound is marketed in select European, Asian and South American markets for certain cardiovascular indications.
• Labopharm Inc., of Laval, Quebec, entered an agreement for Spanish and Portuguese marketing of its lead product, a once-daily version of the analgesic tramadol, with Esteve SA, of Barcelona, Spain. Labopharm will receive payments for certain milestones through to regulatory approval, which is expected in the middle of next year, and will earn a share of revenue from product sales. Esteve plans to dedicate three separate sales forces to distribution of the product, which will be supplied through Labopharm's European subsidiary.
• Lynx Therapeutics Inc., of Hayward, Calif., amended its technology licensing agreement that began in 2000 with Japanese firm Takara Bio Inc. As part of the amendment, Takara made a payment of about $3 million to Lynx in exchange for being relieved of its obligation to make technology access fee payments to Lynx totaling about $2 million during 2003 and 2004. It also was cleared of royalty payments with respect to Takara's sales. Takara also will acquire three additional Massively Parallel Signature Sequencing (MPSS) instruments for the company's use in providing genomics discovery services in its licensed territories. In addition, Takara, which currently owns about 13.5 percent of Lynx's outstanding stock, will no longer be required to make future equity investments in Lynx. However, Lynx will continue to receive payments from Takara in connection with the supply of reagents as well as the sale of any additional MPSS instruments.
• MDS Sciex, the analytical instrumentation and technology solutions division of MDS Inc., of Toronto, and LEAP Technologies Inc., of Carrboro, N.C., a provider of solutions to automation in the analytical lab, signed a distributorship agreement to deliver the new NanoLC proteomics system in the U.S. Financial terms were not disclosed.
• Myriad Genetics Inc., of Salt Lake City, said its Alzheimer's disease drug candidate, MPC-7869 (R-flurbiprofen), reduces levels of Abeta42 more effectively than any other compound tested in a study published in this month's issue of the Journal of Clinical Investigation. Abeta42, the primary constituent of senile plaques that accumulate in the brains of Alzheimer's patients, is thought to be the key initiator of the disease as the peptide has the tendency to aggregate, cause neuronal damage and initiate amyloid deposits in the brain. MPC-7869 is in a 200-patient Phase II trial.
• Nabi Biopharmaceuticals, of Boca Raton, Fla., completed its $100 million acquisition of PhosLo (calcium acetate) from Braintree Laboratories Inc., of Braintree, Mass. PhosLo is used to treat end-stage renal disease patients who are suffering from hyperphosphatemia. Nabi said PhosLo sales would contribute to 15 percent growth in biopharmaceutical revenues from last year. (See BioWorld Today, June 25, 2003.) Seperately, Nabi reported the start of its Phase II trial of NicVAX (Nicotine Conjugate Vaccine) being conducted with smokers at three sites in the U.S. NicVAX is a vaccine being developed to prevent and treat nicotine addiction. NicVAX stimulates the human immune system to produce nicotine-specific antibodies that bind nicotine molecules in the blood system, blocking it from reaching the brain.
• Norak Biosciences Inc., of Research Triangle Park, N.C., acquired the ChemFolio library of more than 500,000 compounds from LION bioscience AG, of Heidelberg, Germany. LION originally acquired the library through its 2001 acquisition of Trega Biosciences, of San Diego. Norak will combine the ChemFolio library with its existing libraries of more than 350,000 compounds to create a screening library of more than 800,000 compounds. Norak will screen the library against its own G protein-coupled receptors of interest in combination with Transfluor bioassay and automated high-throughput screening instruments to search for synthetic compounds.
• Nucleonics Inc., of Malvern, Pa., appointed Robert Towarnicki president and CEO. Previously, Towarnicki was president and CEO of Cell Pathways Inc. prior to that company's merger in June with OSI Pharmaceuticals Inc. Nucleonics is focused on the development of RNA interference-based therapeutics for viral and other diseases.
• Prestwick Pharmaceuticals Inc., of Washington, appointed Robert Whitehead president and CEO. Most recently, Whitehead served as senior vice president and chief business officer of ZymoGenetics Inc. Prestwick's lead product is tetrabenazine, a molecule that was approved to treat Huntington's chorea in Europe, Canada and Australia and is undergoing Phase III studies in the U.S.
• Serenex Inc., of Durham, N.C., entered a research agreement to use its chemoproteomics technologies within drug discovery programs belonging to Eli Lilly and Co., of Indianapolis. The pharmaceutical company will use Serenex's Proteome Mining and Functional Proteome Fractionation technologies to screen compounds against thousands of protein targets from multiple proteomes, simultaneously and in a single step. Financial terms were not disclosed.
• Streck Laboratories Inc., of Lavista, Neb., amended its nonexclusive license agreement for certain of its cell preservation technology patents with Immunicon Corp., of Huntingdon Valley, Pa. Privately held Streck's technology will be used in conjunction with Immunicon's cell isolation and analysis technology for additional types of cells. Financial terms were not disclosed.
• TransForm Pharmaceuticals Inc., of Lexington, Mass., said it would receive an undisclosed milestone payment after making the first crystalline form of a compound belonging to F. Hoffmann-La Roche Ltd., of Basel, Switzerland. TransForm, which said the findings would assist Roche in advancing the compound into clinical development, receives up-front research funding and success-based milestones for conducting crystallization studies on undisclosed development-stage Roche compounds.
• Vitra Bioscience Inc., of Mountain View, Calif., moved Friday into a new 21,000-square-foot building in Mountain View. The site is equipped with research and development laboratories in addition to manufacturing and customer training facilities. Vitra offers CellPlex technology, which is designed to transform rate-limiting steps in lead identification and optimization.
