• AEterna Zentaris Inc., of Quebec City, said a Phase II study of its targeted cytotoxic peptide conjugate AEZS-108 (formerly AN-152) in patients with platinum-resistant and taxane-pretreated ovarian cancer met its primary endpoint of five or more responders in 41 evaluable patients. The firm said that the responders and all patients with stable disease after completion of treatment with AEZS-108 will be followed to assess the duration of progression-free survival and ultimately overall survival. The company said more detailed analyses, including efficacy data from posttreatment follow-up of the ovarian cancer patients, currently are in preparation and will be presented at forthcoming scientific conferences.

• Albany Molecular Research Inc., of Albany, N.Y., said that a third compound being developed under its license and research agreement with Bristol-Myers Squibb Co., of New York, will proceed into preclinical development. AMRI will receive a $750,000 payment from BMS for the completion of this milestone. AMRI is potentially eligible to receive up to $66 million per compound in development and regulatory milestone payments for the first two compounds, and additional potential payments of up to $22 million per compound on subsequent compounds.

• Amgen Inc., of Thousand Oaks, Calif., said detailed results from its randomized, double-blind, placebo-controlled Phase III TREAT pivotal study of Aranesp (darbepoetin alfa) in 4,038 chronic kidney disease patients not on dialysis with moderate anemia and Type II diabetes showed that the risk of stroke increased by almost twofold in patients in the treatment arm vs. placebo, which is a higher magnitude than that seen in previous clinical trials. The results were published Oct. 30, 2009, in the New England Journal of Medicine and presented at the annual meeting of the American Society of Nephrology, with preliminary results reported in August. A post hoc analysis indicated that there were no significant differences between treatment arms in the incidence of cancer or of all-cause deaths in patients who developed cancer during the trial. However, the analysis also showed an excess in overall mortality among patients in the Aranesp arm with a history of cancer, a finding the company said requires further investigation. Amgen had announced in August that the TREAT trial had failed to meet its primary endpoint of demonstrating a reduction in all-cause mortality, cardiovascular morbidity or end-stage renal disease. Separately, 14 states and the District of Columbia filed a federal lawsuit in Boston against Amgen and two of its distributors alleging the firms had offered kickbacks to medical providers to increase sales of Aranesp. (See BioWorld Today, Aug. 27, 2009.)

• BAC BV, of Naarden, the Netherlands, entered a license agreement with Octapharma AG, of Lachen, Switzerland, to use BAC's anti-Factor IX CaptureSelect affinity ligand in the large-scale purification of recombinant Factor IX (FIX). Octapharma produces FIX for the treatment of bleeding in hemophilia B. Under the FIX agreement Octapharma will have license to use BAC's anti-FIX ligand for the purification of FIX from mammalian cell culture. BAC will perform ligand discovery and development to provide an antigranulocyte-colony stimulating factor ligand, which will then undergo feasibility studies at Octapharma.

• Bicycle Therapeutics Ltd., of Cambridge, UK, obtained a global license from Pepscan Therapeutics BV, of Lelystad, the Netherlands, to use its constrained peptide chemistry technology. The two companies will collaborate on the development of structurally modified peptides that will act as a novel class of therapeutic molecules. Financial details were not disclosed.

• Cellceutix Corp., of Beverly, Mass., has concluded an agreement with Toxikon Corp., of Bedford, Mass., to conduct the remaining preclinical studies required for an investigational new drug filing for its cancer drug Kevetrin. The terms were not disclosed. The studies are designed to confirm that Kevetrin meets FDA safety requirements for studies in humans.

• Cipher Pharmaceuticals Inc., of Mississauga, Ontario, said Purdue Pharma Products LP, of Stamford, Conn., and UK-based Napp Pharmaceutical Group Ltd. have filed a complaint against Cipher in the U.S. District Court for the Eastern District of Virginia alleging infringement of two U.S. patents. The action relates to Cipher's new drug application filed with the FDA for Cip Tramadol ER, the company's extended-release tramadol product.

• Complete Genomics Inc., of Mountain View, Calif., and the Institute for Systems Biology in Seattle are embarking on a large-scale human genome sequencing study of Huntington's disease. The institute has engaged Complete Genomics to sequence 100 genomes, the majority of which will be used to investigate the disease, with samples from affected individuals, family members and matched controls to study modifiers of disease presentation and progression.

• Endotis Pharma, of Paris, said it formed a strategic alliance with Catalent Pharma Solutions, of Somerset, N.J., to develop certain oral formulations of small-glyco drugs. The firms currently are focusing on the preclinical development of Endotis' EP37151, a first-in-class oral anticoagulant compound. No financial details were disclosed.

• EnzymeRx LLC, of Paramus, N.J., said it started enrolling patients in a Phase I study of single intravenous doses Uricase-PEG 20, a recombinant uricase derived from Candida utilis, modified by the attachment of multiple 20 kilodalton molecules of polyethylene glycol. EnzymeRx is pursuing the development of Uricase-PEG 20 as an intravenous agent for the management of elevated uric acid associated with tumor lysis syndrome, and as an intramuscular agent for the treatment of refractory gout.

• Gilead Sciences Inc., of Foster City, Calif., and its partner GlaxoSmithKline plc, of London, said they plan to conduct an international, event-driven randomized, double-blind, multicenter trial to evaluate Letairis (ambrisentan), an endothelin receptor antagonist, in combination with tadalafil, a PDE5 inhibitor, in the first-line treatment of pulmonary arterial hypertension vs. monotherapy of Letairis or tadalafil alone. Letairis is approved as a once-daily treatment for PAH in patients with WHO functional class II or III symptoms to improve exercise capacity and delay clinical worsening. The firms said they plan to begin enrollment in 2010.

• InteRNA Technologies BV, of Utrecht, the Netherlands, and the Dana-Farber Cancer Institute in Boston have entered a research agreement in which InteRNA's lentiviral-based miRNA overexpression library will be applied in multiparametric, high-throughput functional screening assays to identify the biological role of individual miRNAs and therapeutic targets in diverse cancer pathways. No financial details were disclosed.

• Ligand Pharmaceuticals Inc., of San Diego, amended it license agreement with South San Francisco-based Exelixis Inc., entitling Ligand to receive royalties on net sales of future products from a mineralocorticoid receptor program and a one-time $75,000 payment for providing access to certain patent rights. The amendment also eliminated certain minimum annual royalties that might have been payable by Exelixis, as a result of Ligand's settlement with the Salk Institute for Biological Studies last year.

• Meda AB, of Stockholm, said that its partner for Retigabine, Valeant Pharmaceuticals International Inc., of Aliso Viejo, Calif., has completed both the new drug application and the marketing authorization application submissions. Retigabine has been documented to treat epilepsy and has a different mechanism of action compared to current antiepileptic therapies.

• Novavax Inc., of Rockville, Md., said data from a 241-healthy volunteer study of its trivalent seasonal influenza virus-like particle vaccine, which contained VLPs matched to the influenza strains recommended for the 2008-2009 influenza vaccine including H1N1 A/Brisbane/59/2007, H3N2 A/Brisbane/10/2007 and B/Florida/04/2006, showed that the vaccine was well tolerated and immunogenic, with an incidence of adverse events comparable to placebo. There were no serious vaccine-related adverse events reported. Novavax's VLP vaccine induced robust hemagglutination inhibition antibody responses against all three strains in the vaccine and a drifted strain. Seroconversion rates met the FDA-suggested criteria for licensure of seasonal influenza vaccines for all three strains. The data were presented Saturday in Washington at the annual meeting of the Infectious Diseases Society of America.

• Nuevolution AS, of Copenhagen, Denmark, has received a milestone payment from its collaboration with Merck & Co. Inc., of Whitehouse Station, N.J. The undisclosed payment was triggered following identification of several candidate molecules that conformed to the prespecified criteria established under the terms of the original agreement. They include several accepted drug-like characteristics and nanomolar potency.

• Rockwell Medical Technologies Inc., of Wixom, Mich., said data on its lead drug candidate soluble ferric pyrophosphate (SFP) showed that all available iron present in SFP was delivered to both iron-binding sites on human apo-transferrin, rapidly and completely. Further, 50 percent of iron uptake was complete within one minute, while there was approximately 90 percent saturation of the iron- binding sites on transferrin, the blood plasma protein for iron ion delivery, within 10 minutes. Data were presented at the American Society of Nephrology annual meeting in San Diego.