• Arena Pharmaceuticals Inc., of San Diego, signed a co-development and license agreement with Ildong Pharmaceutical Co. Ltd., of Seoul, South Korea, for temanogrel, Arena's inverse serotonin 2A receptor agonist. Ildong gained exclusive rights to commercialize temanogrel in South Korea for myocardial infarction, acute coronary syndrome, stroke, peripheral artery disease and other cardiovascular diseases. Ildong will be responsible for funding and conducting, under the direction of a joint steering committee, an additional Phase I trial in healthy volunteers and a Phase IIa proof-of-concept trial in patients. Arena retained ownership of temanogrel outside South Korea and the rights to use data generated by Ildong to develop and commercialize temanogrel outside South Korea by Arena or other licensees. Ildong also agreed to pay Arena a $2 million development milestone if its planned clinical trials of temanogrel support continued development and either Arena or a licensee initiates a Phase IIb trial. Arena also is eligible to receive a royalty on net sales of temanogrel in South Korea, while Ildong is eligible to receive a share of future payments to Arena for licensing transactions and sales of temanogrel in other countries.

• AVEO Oncology Inc., of Cambridge, Mass., and Astellas Pharma Inc., of Tokyo, said the FDA accepted the new drug application (NDA) for tivozanib, tentatively branded Tivopath, in the proposed indication of advanced renal cell carcinoma (RCC). The filing included results from the global Phase III TIVO-1 (TIvozanib Versus SOrafenib in 1st line Advanced RCC) trial evaluating the efficacy and safety of tivozanib compared to sorafenib in advanced RCC, as well as data from 16 additional AVEO-sponsored studies involving tivozanib. The NDA has a PDUFA date of July 28, 2013, and its acceptance triggered a $15 million milestone payment to AVEO. On Wednesday, AVEO's shares (NASDAQ:AVEO) fell 63 cents, or 9 percent, to close at $6.48. (See BioWorld Today, Feb. 17, 2011, June 16, 2011, and Jan. 4, 2012.)

• Beactica AB, of Uppsala, Sweden, inked a research services agreement with Janssen Research and Development, a division of Janssen Pharmaceutica NV, of Beerse, Belgium, to use its Sprint drug discovery platform to identify allosteric modulators of certain central nervous system proteins. Beactica has a prior research services agreement with Janssen dating to early 2011.

• Cadence Pharmaceuticals Inc., of San Diego, and Perrigo Co., of Allegan, Mich., with its subsidiary, Paddock Laboratories LLC, agreed to resolve pending patent litigation over Ofirmev (acetominophen) injection. Under the settlement, the lawsuit filed by Cadence in the U.S. District Court for the District of Delaware related to Paddock's abbreviated new drug application filing with the FDA will be dissmissed with prejudice. Litigation against Exela Pharma Sciences LLC, Exela PharmaSci Inc. and Exela Holdings Inc. will continue.

• Evotec AG, of Hamburg, Germany, entered a collaboration with Probiodrug AG, of Halle, Germany, under which Evotec will set up and validate assays to support the preclinical and clinical development of glutaminyl cyclase inhibitors for the treatment of Alzheimer's disease. Glutaminyl cyclase is an enzyme target discovered and validated by Probiodrug which plays a crucial role in the pathogenesis of the condition as well as potentially other diseases. Financial terms were not disclosed.

• Gilead Sciences Inc., of Foster City, Calif., said the European Commission granted marketing authorization for two new indications for once-daily Viread (tenofovir disoproxil fumarate). The first new indication permits the use of Viread in combination with other antiretroviral agents for the treatment of HIV-1-infected pediatric patients, ages 2 to younger than 18, with nucleoside reverse transcriptase inhibitor resistance or toxicities precluding the use of first-line pediatric agents. Viread is also now approved in Europe for the treatment of chronic hepatitis B virus (HBV) infection in adolescent patients, ages 12 to younger than 18, with compensated liver disease and evidence of immune active disease. Viread was approved for use in combination with other antiretroviral agents as a treatment for HIV-1 infection in adults and for chronic HBV in 2002 and 2008, respectively.

• Intellect Neurosciences Inc., of New York, said new findings on ponezumab (PF-04360365), an investigational anti-amyloid beta monoclonal antibody that specifically targets the neoepitope at the C-terminus of the peptide, were published in the October 2012 edition of Current Alzheimer Research. The new data describe the properties of a version of ponezumab in which naturally occurring sugar, bound to the surface of the murine antibody, was removed to improve the safety of the drug. The aglycosylated murine surrogate of ponezumab was administered by intraperitoneal injection once weekly for up to 26 weeks at doses of 0 mg/kg, 10 mg/kg, 30 mg/kg or 100 mg/kg. Drug exposure and plasma amyloid beta levels increased with increasing dose. After 26 weeks, the 100-mg/kg group had significantly greater plasma levels of A1-x and Ax-40 than the vehicle group (p < 0.001). There was no evidence of vasogenic edema or other drug induced pathologies, the company said.

• IntelliCell BioSciences Inc., of New York, entered a sponsored research agreement with the New Jersey Center for Biomaterials at Rutgers – the State University of New Jersey. Under the terms, the center will be conducting a series of research projects to further define the characteristics and properties of IntelliCell's cellular population. Initial research will focus on documenting any differences between the firm's cellular population and similar cell populations isolated from human adipose tissue using conventional methods of cell isolation.

• Ironwood Pharmaceuticals Inc., of Cambridge, Mass., and partner Almirall SA, of Barcelona, Spain, received marketing authorization from the European Commission for Constella (linaclotide 290 mg) for irritable bowel syndrome with constipation. Almirall plans to launch Constella in Europe in the first half of 2013. It licensed exclusive marketing rights for linaclotide in Europe from Ironwood in 2009. Linaclotide gained approval in late August in the U.S., where it is marketed as Linzess. (See BioWorld Today, Aug. 31, 2012.)