• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., has granted Hayashi Kasei, of Osaka, Japan, a non-exclusive license to provide RNAi research products and services under the Kreutzer-Limmer patent family. That patent family covers small interfering RNAs (siRNAs) and their use to mediate RNAi in mammalian cells. Terms were not disclosed.

• Amgen Inc., of Thousand Oaks, Calif., completed its acquisition of Santa Clara, Calif.-based Ilypsa Inc. in a $420 million deal announced last month. The transaction provides Amgen with ILY101, a phosphate binder for hyperphosphatemia in chronic kidney disease patients on hemodialysis. The product has completed Phase II dosing studies, with results expected later this year. (See BioWorld Today, June 6, 2007.)

• Antares Pharma Inc., of Ewing, N.J., has signed a worldwide product development and license agreement with Jazz Pharmaceuticals, of Palo Alto, Calif., a deal that could bring Antares $16.5 million over the life of the agreement. The product candidate that is subject to the agreement is being developed to treat an undisclosed central nervous system disorder and is based on Antares' proprietary Advanced Transdermal Delivery (ATD) system. Jazz Pharmaceuticals will pay Antares up-front and product development milestone payments in addition to payments for any future development activities. Antares also will receive royalties on product sales upon commercialization, including minimum royalties. Jazz Pharmaceuticals is responsible for development and commercialization of the product candidate and will cover the costs of clinical trials, regulatory filings, and all manufacturing and marketing associated with the product candidate. The ATD platform employs gels as an alternative to patches to reduce skin irritation and minimize gastrointestinal impact.

• BrainStorm Cell Therapeutics Inc., of New York, has been awarded a grant from Israel's Chief Scientist Office for up to $500,000 for its work on Parkinson's disease using adult stem cells. The company has received the first installment, approximately $140,000. The 3 percent royalty-bearing grant is part of a government program that offers incentives to companies for research and development. The company's royalty obligations are capped at the amount of grant proceeds it receives from the CSO.

• Clinical Data Inc., of Newton, Mass., said its PGxHealth division established a relationship with George Washington University to examine the integration of genomic testing in warfarin treatment. The program will be implemented in an orthopedic practice setting, enrolling 80 patients who have been prescribed the blood thinner warfarin following orthopedic surgery. Half the patients will have their warfarin dose determined with the help of PGx technology to evaluate the use of the genetic test to determine optimal dosing.

• Codexis Inc., of Redwood City, Calif., has acquired BioCatalytics Inc., of Pasadena, Calif., a company that produces custom and off-the-shelf enzymes used in chemical manufacturing by pharmaceutical and chemical companies. The transaction has been approved by the boards of directors of both companies and has closed. David Rozzell, president of BioCatalytics is joining Codexis as vice president of enzyme products and services. BioCatalytics employees will remain at the current location in Pasadena. Financial terms were not disclosed.

• Cubist Pharmaceuticals Inc., of Lexington, Mass., reported that second-quarter net sales of the antibiotic Cubicin (daptomycin for injection) increased 52 percent from the prior year, from $45.7 million in the second quarter of 2006 to $69.5 million. Net income for the second quarter on a GAAP basis was $14.5 million, or $0.26 and $0.24 per basic and diluted share, respectively, vs. a net loss of $5.1 million a year earlier. Non-GAAP net income for the quarter was $17.2 million. As of June 30, Cubist had $352.8 million in cash and equivalents, with 55.5 million shares outstanding. Cubist's stock (NASDAQ:CBST) gained $2.80 Thursday, or 14 percent, to close at $22.79.

• DeCode Genetics Inc., of Reykjavik, Iceland, with researchers at Emory University in Atlanta, have identified the first gene associated with restless leg syndrome. The researchers report a population-attributable risk for RLS of at least 50 percent, and said the variant is common, with almost 65 percent of the population carrying at least one copy. A report was published July 18 in the online edition of the New England Journal of Medicine and will appear in an upcoming printed edition of the journal.

• DOR BioPharma Inc., of Miami, said the FDA extended the PDUFA date to Oct. 21, 2007, for the new drug application related to orBec (oral beclomethasone dipropionate) for the treatment of gastrointestinal graft-vs.-host disease. The original date was July 21. The extension is the result of DOR's July 13, 2007, provision of supplemental information to the orBec NDA, requested at a June review meeting.

• Elan Corp. plc, of Dublin, Ireland, and Biogen Idec Inc., of Cambridge, Mass., said they were informed by the European Medicines Agency that the Committee for Medicinal Products for Human Use adopted a negative opinion on the marketing application for the use of Tysabri (natalizumab) in patients with Crohn's disease. The companies plan to appeal the opinion, with a decision on that appeal expected by the first quarter of 2008. The companies filed for approval in Crohn's disease in the U.S. in December. The FDA is holding an advisory committee to discuss the application on July 31. The product is approved for treating multiple sclerosis.

• EpiCept Corp., of Tarrytown, N.Y., converted a sublicense agreement previously established with Epitome Pharmaceuticals Ltd., of Halifax, Nova Scotia, related to EpiCept's product candidate EpiCept NP-1, into a direct license with Dalhousie University in Halifax. EpiCept Np-1 is a topical analgesic cream in clinical development for the long-term pain relief in peripheral neuropathies. EpiCept entered the agreement with Epitome in August 1999 to license exclusive rights to certain patents from Dalhousie. EpiCept said the new arrangement provides more favorable terms, including a lower maintenance fee obligation and a reduced royalty rate on future product sales.

• Glenmark Pharmaceuticals SA, of Mumbai, India, has completed the purchase of two new biological entities, CHR-1103 and CHR-1201, from Chromos Molecular Systems Inc., of Burnaby, British Columbia. The two entities are humanized monoclonal therapeutic antibodies. Glenmark has purchased all rights to the two products as well as rights to use Chromos' proprietary ACE System technology for cell line development with CHR-1103 and CHR-1201. Glenmark holds the worldwide rights for further development, registration and commercialization of those products. Financial terms were not disclosed. The two compounds are part of a class of drugs known as selective adhesion molecule inhibitors. Glenmark plans to initiate Phase I trials in 2008 and complete Phase I on CHR-1103 by March 2009. CHR-1201 is an anti-thrombolytic humanized monoclonal antibody, which Glenmark plans to develop initially to treat acute stroke, starting with a Phase I trial by March 2009.

• ImmuCell Corp., of Portland, Me., said Pfizer Animal Health has terminated its product development and marketing agreement covering Mast Out, its nisin-based mastitis treatment. ImmuCell said it believes the decision was market-driven and not because of any unanticipated efficacy, technical or regulatory issues. The company expects to recognize the remaining deferred income from nonrefundable milestone payments received from Pfizer and to write off the remaining unamortized cost of technology license rights acquired in November 2004. That will result in a net increase to income before income taxes of approximately $602,000 during the third quarter of 2007, with no impact on cash. Shares of ImmuCell (NASDAQ:ICCC) lost $1.40 Thursday, or 23.3 percent, to close at $4.60.

• ImmuneRegen BioSciences Inc., of Scottsdale, Ariz., disclosed adjuvant activity of its immunomodulator, Viprovex, when administered in conjunction with peptide vaccines in development at GenPhar Inc., of Mt. Pleasant, Calif. Preliminary results from preclinical tests in small animals on Viprovex in conjunction with Tamiflu (oseltamivir, F. Hoffmann-La Roche Ltd.) show that treating subjects with both Viprovex and Tamiflu protect lungs against the damaging inflammatory effect of influenza infection more successfully than treating with Tamiflu alone. Viprovex is a brand name for homspera, which ImmuneRegen calls its synthetic peptide Sar9, Met (O2)11-Substance P, an analogue of the naturally occurring human neuropeptide Substance P, found throughout the body.

• Liponex Inc., of Ottawa, Canada, said it successfully developed an enteric-coated granule formulation of CRD5, its candidate for dyslipidemia and heart disease, designed to minimize the loss of drugs in a simulated human gastric system. That formulation is expected to improve bioavailability when used in future trials. The company began revising the drug's formulation after CRD5 failed to significantly increase high-density lipoprotein in a 56-patient Phase I/II study in dyslipidemia. Data, reported in March, indicated a high variation from patient to patient, and company executives attributed the failure to a formulation problem. Liponex also has been working to develop an animal model using mini-pigs to predict CRD5's effect in humans, and is working to design a new Phase I/II trial aimed at showing efficacy in raising HDL in dyslipidemic patients. (See BioWorld Today, March 9, 2007.)

• Neopharm Inc., of Waukegan, Ill., said it believes it has enough cash on hand to continue its product development plans into 2009. In April the company cut its work force by 42 percent and reshuffled the executive ranks after the FDA requested another Phase III trial for cintredekin besudotox in the treatment of recurrent glioblastoma multiforme. In December the drug failed to meet its primary endpoint in a Phase III trial. (See BioWorld Today, April 20, 2007.) The company reported that as of June 30, it had $25 million in cash, with a burn rate of about $5 million per year, before clinical and legal costs. It said it is confident it can take several products through Phase II trials without raising additional money.

• NuGEN Technologies Inc., of San Carlos, Calif., and Kreatech Biotechnology BV, of Amsterdam, the Netherlands, signed an agreement that will enable NuGEN to market FL-Ovation cDNA Fluorescent Modules, designed to complement its family of Ovation RNA amplification products. The nonexclusive agreement calls for Kreatech to supply components for a NuGEN-validated fragmentation and labeling system for one- and two-color microarray analysis utilizing its patented Universal Linkage System technology for labeling with Cy3 and Cy5 mono-NHS esters licensed by NuGEN from UK-based GE Healthcare.

• Profectus BioSciences Inc., of Baltimore, received about $200,000 in a Phase I Small Business Innovative Research grant from the National Institute of Allergy and Infectious Diseases to develop more effective anti-HIV antibodies based on the company's Antiviral Immune Modulation (AIM) therapy technology, in collaboration with the Institute of Human Virology at the University of Maryland. The AIM platform uses immune modulation drugs, such as Rapamycin, to improve the activity of antiviral antibodies.

• Senomyx Inc., of San Diego, has extended its discovery and development collaboration with Kraft Foods Global Inc. through December 2008. The extension allows Kraft Foods to continue evaluation of novel flavor modifiers under development by Senomyx in the dessert and powdered beverage categories. Senomyx and Kraft Foods also are working on the discovery and development of novel flavor modifiers in the chilled and processed meat product category. Upon commercialization, Senomyx will receive royalty payments based on sales of products using the new flavor ingredients.

• ValiRx plc, of London, has signed a memorandum of understanding with Brussels, Belgium-based BIO.Be for a joint venture to develop and commercialize products in the epigenomics sector. Under the terms of the agreement, ValiBIO SA, an oncology diagnostics company, is being created and located in Gosselies, Belgium. ValiRx will invest cash and equity in return for a 77 percent share of the equity of ValiBio. Also, the joint venture company will be financed by partly repayable government grants and loans. ValiRx said ValiBio will use the funds to build a team and laboratory facilities, and to develop HyperGenomics-based cancer diagnostic products. Financial details were not disclosed.