• Akesis Pharmaceuticals Inc., of San Diego, filed a preliminary investigational new drug application with the FDA for its lead product candidate AKP-020. Once the firm has an IND approved by the FDA, the company intends to start a Phase Ib/IIa trial to assess the safety and efficacy, and determine the pharmacokinetics of AKP-020 in patients with Type II diabetes. AKP-020 is the product designation for a novel vanadium compound otherwise known as bis(ethylmaltolato)oxovanadium (IV), or BEOV.

• AlphaVax Inc., of Research Triangle Park, N.C., received a three-year, $3.6 million award from the National Institute of Allergy and Infectious Diseases. The award will support advanced preclinical studies and manufacturing process development for adjuvant technologies based on the company's vector platform. It said the key experimental observations forming the basis of the programs are that alphavirus RNA replicon vectors, when appropriately configured and delivered in virus-like replicon particles, can function as potent adjuvants for co-administered protein immunogens, such as influenza vaccines. AlphaVax has several other active NIH grants supporting vaccine development for infectious diseases, biodefense and tumor immunotherapy.

• BioTrove Inc., of Woburn, Mass., entered an agreement with OncoMethylome Sciences SA, of Liege, Belgium, covering supply and use of BioTrove's OpenArray PCR screening technology. Under terms of the multiyear agreement, BioTrove will supply OncoMethylome with OpenArray nanoplates and instrumentation for use in research and development of DNA methylation-based biomarkers. Financial terms were not disclosed.

• Cibus LLC, of San Diego, and BASF, of Research Triangle Park, N.C., entered a collaboration to develop and commercialize non-GM herbicide tolerance in oilseed rape and canola. Cibus' gene-conversion plant breeding technology will be used to enhance BASF's Clearfield Production System in oilseed rape and canola. Terms of the agreement were not disclosed.

• Cipher Pharmaceuticals Inc., of Mississauga, Ontario, entered a definitive licensing and distribution agreement with ProEthic Pharmaceuticals Inc., of Montgomery, Ala., under which ProEthic got exclusive rights to market, sell and distribute Lipofen in the U.S. Lipofen is a patented formulation of the active ingredient fenofibrate, which is used in the treatment of hyperlipidemia, a cholesterol disorder. Cipher gets an up-front licensing fee of $2 million, and could receive milestone payments of up to $20 million based on sales targets. Cipher also would receive a sales royalty that escalates from the mid-teens to mid-20s under the 10-year, extendable deal.

• Ciphergen Biosystems Inc., of Fremont, Calif., entered a license and settlement agreement with Health Discovery Corp., of Savannah, Ga., pursuant to which it licensed more than 25 patents covering HDC's support vector machine technology for use with SELDI technology. Ciphergen received a worldwide, royalty-free, nonexclusive license for life sciences and diagnostic applications of the technology and has access to future patents resulting from the technology in conjunction with use of SELDI systems. In connection with the agreement, Ciphergen will pay HAD $600,000 over two years. The agreement settles all disputes between the companies.

• ConjuChem Biotechnologies Inc., of Montreal, has asked the U.S. Patent & Trademark Office to re-examine Patent No. 6,924,264. The patent, "Modified Exendins and Exendin Agonists," was issued in August 2005 to Amylin Pharmaceuticals Inc., of San Diego, but ConjuChem is seeking a re-examination of a number of claims in the patent as being invalid due to obviousness and/or lack of novelty. ConjuChem has a number of patents in the insulinotropic peptide field.

• Corcept Therapeutics Inc., of Menlo Park, Calif., has received orphan drug designation from the FDA for Corlux, a cortisol receptor (GR-II) antagonist, in the treatment of Cushing's Syndrome. Corcept said it has not yet determined its full development plan for the Corlux but will file an investigational new drug application soon.

• Crucell NV, of Leiden, the Netherlands, and DSM Biologics, of Sittard, the Netherlands, granted Masterclone, of Moscow, a nonexclusive PER.C6 research license. Masterclone will use the technology to develop an undisclosed antibody. Terms of the deal were not disclosed.

• CV Therapeutics Inc., of Palo Alto, Calif, said researchers have completed preliminary preclinical studies showing that ranolazine increased glucose-stimulated insulin secretion in pancreatic beta cells. In separate experiments using preclinical models of insulin resistance, ranolazine also improved glucose homeostasis. The data could illustrate an underlying first in class mechanism of action for the statistically significant reductions in HbA1c levels observed with Ranexa in cardiovascular patients with diabetes from the Phase III CARISA (n=189 with angina and diabetes) and MERLIN TIMI-36 (n=2,220 with acute coronary syndromes and diabetes) clinical trials.

• Epitome Biosystems, of Waltham, Mass., entered a second licensing and development agreement with EMD Chemicals Inc., an affiliate of Darmstadt, Germany-based Merck KGaA. They will focus on developing Epitome's EpiTag assays for the quantitative measurement of various targets, including membrane proteins. Products will be manufactured, marketed and sold worldwide for research applications by EMD through its Novagen brand. Sample analysis will be available as a service from Epitome. Terms of the agreement were not disclosed.

• Genzyme Corp., of Cambridge, Mass., completed its tender offer to acquire shares of Bioenvision Inc., of New York. A proxy statement now will be prepared by Bioenvision for a shareholder meeting to occur before the end of the year. Genzyme will purchase about 22 percent of the outstanding shares of Bioenvision common stock on an as-converted basis, including 100 percent of outstanding shares of preferred stock that already have been tendered. Each share of preferred stock can be converted into about two common shares. The companies reached agreement on a $345 million acquisition by Genzyme in May. (See BioWorld Today, May 30, 2007.)

• Gilead Sciences Inc., of Foster City, Calif., will initiate an expanded access program beginning in August to provide its investigational therapy, aztreonam lysine for inhalation, to patients with cystic fibrosis and Pseudomonas aeruginosa infection who have limited treatment options and are at risk for disease progression. The expanded access program will be open to participating treatment centers in the U.S. Based on results from two pivotal Phase III clinical studies, Gilead anticipates submitting a new drug application to the FDA by the end of 2007. Data from one recently completed pivotal Phase III study demonstrated improvement in respiratory symptoms for patients with CF, and data from a second Phase III study demonstrated that aztreonam lysine for inhalation significantly improved the time to need for inhaled or intravenous antibiotics following a course of inhaled tobramycin.

• International Stem Cell Initiative scientists identified a set of common gene expression markers that may be used to reliably characterize diverse human embryonic stem cell lines. The initiative represents the first internationally coordinated effort to provide a systematic and comparative survey of the hESC lines available from various research groups around the world, ISCI said. Results of the study were published in Nature Biotechnology.

• Luminex Corp., of Austin, Texas, and Exiqon A/S, of Copenhagen, Denmark, executed a distribution agreement for the FlexmiR line of products co-developed by the companies in 2006. Exiqon has nonexclusive rights to distribute FlexmiR products and to sell Luminex systems to laboratories around the world. In addition, the companies launched two more FlexmiR products, the FlexmiR MicroRNA Mouse/Rat Extension Panel and the FlexmiR MicroRNA Control Set. FlexmiR is a line of microRNA products that combines Luminex's xMAP technology and Exiqon's Locked Nucleic Acid technology.

• MacroChem Corp., of Wellesley Hills, Mass., got an exclusive option from Genaera Corp., of Plymouth Meeting, Pa., to acquire exclusive worldwide rights for drug uses of pexiganan, a small peptide anti-infective for topical treatment of patients with mild diabetic foot infection. Genaera previously conducted two Phase III trials of the product, but ran into trouble with its new drug application filing. MacroChem paid Genaera $250,000 in exchange for 90-day rights to gain exclusive rights. Further terms were not disclosed. Genaera last week said it was divesting noncore assets, including pexiganan. (See BioWorld Today, July 6, 2007.)

• Noven Pharmaceuticals Inc., of Miami, agreed to acquire JDS Pharmaceuticals LLC, of New York, for about $125 million in cash, plus the assumption of $10 million in liabilities. JDS is a privately held specialty pharmaceutical company that markets two psychiatry products through a targeted sales force and is advancing a pipeline of products in psychiatry and women's health. The deal is expected to close in August. Noven, which develops transdermal drug delivery technologies, expects to record a significant one-time charge for purchased in-process research and development expenses related to the price of acquired products in the development pipeline. Noven said the amount is expected to significantly exceed 50 percent of the transaction consideration. Noven, which had $184 million in cash and equivalents at the end of the first quarter, expects to use those funds to pay for JDS. JDS' marketed products are Lithobid (lithium carbonate) for bipolar disorder and Pexeva (paroxetine mesylate) for multiple conditions, which together are expected to generate $14 million in sales in the second half of the year. Its pipeline in psychiatry includes one pending new drug application and one product in Phase III trials. It also has a nonhormonal product entering Phase III for vasomotor symptoms (hot flashes/night sweats) associated with menopause.

• Phosphagenics Ltd., of Melbourne, Australia, and Nestle Nutrition, of Vevey, Switzerland, extended the period under which Nestle has the option to negotiate an exclusive license to use Phospha E to treat and prevent metabolic syndrome. To avoid development delays, the companies are continuing their planned clinical program of the vitamin E derivative, with the first human trial expected to start this quarter.

• Pipex Pharmaceuticals Inc., of Ann Arbor, Mich., acquired an exclusive license to zinc-monocysteine complexes, which initially are being developed as an oral treatment for dry age-related macular degeneration. Oral Z-monocys has completed a six-month, 80-patient, randomized, double-blind trial in dry AMD, demonstrating statistically significant improvements in major clinical features of dry AMD. Z-monocys was invented by David Newsome. Details on the license deal were not disclosed.

• Pozen Inc., of Chapel Hill, N.C., said it reached an agreement to settle the consolidated class-action lawsuit filed in the U.S. District Court for the Middle District of North Carolina against Pozen and its top officer. All claims will be dismissed without admission of liability or wrongdoing by any party. The settlement agreement, which remains subject to court approval, will be funded entirely with proceeds from the company's directors and officers' liability insurance, Pozen said.

• PTC Therapeutics Inc., of South Plainfield, N.J., was awarded a five-year, $15.4 million grant from the National Institute of Neurological Disorders and Stroke and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. The U54 grant will fund further research into Duchenne muscular dystrophy, supporting preclinical research by PTC and the University of Pennsylvania School of Medicine. The work will build on previous research and discovery efforts supported by Parent Project Muscular Dystrophy under an initiative known as Project Catalyst.

• Qiagen NV, of Venlo, the Netherlands, said a subsidiary completed its acquisition of eGene Inc., of Irvine, Calif., for $34 million in cash and stock. The deal was announced in April. eGene has developed a multichannel sample separation and analysis technology for nucleic acids based on capillary electrophoresis.

• QLT Inc., of Vancouver, British Columbia, said the U.S. District Court for the District of Massachusetts adopted the decision of a federal jury from November 2006 in a lawsuit brought by the Massachusetts Eye and Ear Infirmary in connection with U.S Patent No. 5,789,349. That jury recommended QLT be found liable and determined that QLT should pay MEEI damages in the form of royalties equal to 3.01 percent on past and future worldwide sales of Visudyne, a treatment for age-related macular degeneration. Visudyne sales since launch in 2000 through March 31 have been about $2.31 billion, meaning QLT could be liable to pay MEEI $69.6 million as past damages for royalties, plus 12 percent interest and $14.1 million in legal fees. QLT said it expects to appeal the decision.

• Upstream Biosciences Inc., of Vancouver, British Columbia, retained Genpathway Inc., of San Diego, to conduct analysis using its chromatin immunoprecipitation assays. The analysis is intended to provide information for the next phase of Upstream's program to validate its first two cancer biomarkers and drug response assay. Genpathway will apply its assays to help elucidate gene transcription factors and pathways. Terms of the deal were not disclosed.