• Algeta ASA, of Oslo, Norway, and Avipep Pty Ltd., of Parkville, Australia, inked a collaboration to evaluate a targeted thorium conjugate based on combining Algeta's thorium-227 alpha-pharmaceutical payload with a next-generation antibody fragment, known as an Avibody, from Avipep that targets a number of solid tumor types. Avipep will provide access to an Avibody, and Algeta will provide access to chelation and conjugation technologies and its alpha particle-emitting payload. Both companies will contribute financially to the collaboration, which is expected to last for up to one year with an option for continued development. Financial terms were not disclosed.

• Critical Outcome Technologies Inc., of London, Ontario, reported positive results from preclinical studies involving lead cancer drug candidate, COTI-2, at the University of Texas MD Anderson Cancer Center. The studies, designed to determine the effect of COTI-2 in 32 common p53 mutations, confirmed that COTI-2 has a major mechanism of action that is dependent on p53 gene mutation status in human cancer cells, with an effect that can be augmented by the presence of mutations in the AKT signaling pathway. The studies also demonstrated that COTI-2 restores p53 protein to its normal function in human cancer cells with a wide range of common p53 gene mutations, including three of the most common mutations found in about 20 percent of all human cancers. In addition, investigators reported that COTI-2 is generally less effective in human cancer cells with no mutant p53 protein but is highly active in some cells where the p53 gene is not mutated – for example, in some cancers where the p53 gene has been lost.

• Immunogenes AG, of Zug, Switzerland, and Corvinius Kockazati Tokealap-kezelo Zrt, of Budapest, Hungary, formed a joint venture to fund the establishment for a scientific facility to develop and produce monoclonal and polyclonal antibodies and genetically modified animals in Godollo, Hungary. The venture, to be named ImmunoGenes-ABS Zrt, will provide funding for production capabilities for the ImmunoGenes programs known as Customized Antibody Solutions and Customized Transgenic Solutions. Capital totaling CHF250,000 (US$269,812) will start the joint venture and CELIN (Corvinus First Innovation Venture Capital Fund) will provide a first loan of an additional CHF250,000 to finance the capital expenditures needed to equip the laboratory.

• Oncosec Medical Inc., of San Diego, signed a sponsored research agreement with Old Dominion University and the Frank Reidy Research Center for Bioelectrics. Under the agreement, Oncosec and the university will collaborate on nonclinical research focused on developing new technology related to electroporation and delivery of different agents into solid tumors by electroporation.

• PDL Biopharma Inc., of Incline Village, Nev., filed a notice of arbitration against Genentech Inc. (part of Roche AG), of South San Francisco, with the American Arbitration Association in Voorhees, N.J., alleging, inter alia, that Genentech underpaid royalties going back to at least 2007 and impeded PDL's attempts to have Genentech's books and records inspected to determine whether Genentech's past payments to PDL were accurately calculated.

• Questcor Pharmaceuticals Inc., of Anaheim, Calif., acquired rights to Synacthen and Synacthen Depot for the U.S. and certain other territories from Basel, Switzerland-based Novartis AG for $60 million up front, and additional payments of at least $75 million over the next several years, plus milestone payments prior to FDA approval. Upon FDA approval, Questcor will pay another milestone to Novartis, plus royalties based on net sales in the U.S. The products are approved for autoimmune and inflammatory diseases outside the U.S., but have not been approved in the U.S.

• Salix Pharmaceuticals Ltd., of Raleigh, N.C., and Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., said the FDA will hold an advisory committee meeting to review Salix's supplemental new drug application (sNDA) for Relistor (methylnaltrexone bromide) subcutaneous injection in opioid-induced constipation (OIC) for patients with chronic pain. The FDA's action was taken in response to Salix' formal appeal of the agency's complete response letter (CRL) issued July 27, 2012, on the Relistor sNDA for OIC in patients with chronic pain. The FDA said the adcom will address the potential cardiovascular safety signal observed in the 12-month safety trial of another peripheral mu-opioid antagonist in patients with OIC who have chronic noncancer pain, the lack of control population in the long-term safety data from the Relistor sNDA and the need for the agency to provide consistent guidance regarding the need for major adverse cardiovascular event, or MACE, studies to applicants developing peripheral mu-opioid antagonist candidates for OIC. The FDA said it will act on the CRL appeal after receiving input from the adcom, whose meeting date has not been set. Relistor was approved in 2008 for OIC in patients with advanced illness who are receiving palliative care, and Salix licensed the drug's rights from Progenics in February 2011. On Tuesday, shares of Salix (NASDAQ:SLXP) gained $3.13, to close at $65.42, while shares of Progenics (NASDAQ:PGNX) shot up 31 percent, gaining $1.14, to close at $4.82. (See BioWorld Today, Feb. 8, 2011, and July 31, 2012.)

• Swedish Orphan Biovitrum AB, of Stockholm, Sweden, said it received approval from the FDA for the manufacture of drug substance for Kineret (anakira) at a microbial site in Vienna, Austria, owned by Boehringer Ingelheim GmbH, of Ingelheim, Germany. The approval allows for distribution of Kineret in the U.S. and comes as a result of the supplemental biologics license application filed in February. Kineret previously gained approval for treating adults and children with neonatal-onset multisystem inflammatory disease.

• Tianjin Sinobiotech Ltd. and Beijing Bio-Fortune Ltd., both of Beijing, signed a U.S. market patent license agreement with an undisclosed major global pharmaceutical company based on their recombinant human serum albumin fusion protein drug for neutropenia. Under the agreement, the pharmaceutical company will have a license to develop and commercialize the drug products in the U.S. market. Tianjin and Beijing Bio-Fortune will continue developing their own Phase I/II recombinant fusion protein drug for neutropenia in China.

• Vertical Pharmaceuticals Inc., of Sayreville, N.J., signed a co-promotion agreement with Nautilus Neurosciences Inc., of Bedminster, N.J., for Lorzone (chlorzoxazone), a muscle relaxant approved for musculoskeletal pain. The companies will use a combined sales force of 115 representatives to promote the drug in the U.S. market, with Nautilus focusing its efforts in the neurology field.

• ViroPharma Inc., of Exton, Pa., said the European Commission granted orphan drug designation for maribavir for treatment of cytomegaloviral disease in patients with impaired cell-mediated immunity. The FDA has done the same. (See BioWorld Today, Feb. 10, 2009.)