• Aeterna Zentaris Inc., of Quebec City, reported preclinical results showing that disorazol Z cytotoxic candidates such as AEZS-125 have potential in treating luteinizing hormone-releasing hormone receptor (LHRH)-positive tumors. For all conjugates, including AEZS-125, proof of concept could be demonstrated in an LHRH receptor-positive A2780 ovarian cancer xenograft model. Data from the study, which is funded through a grant from the German Ministry of Education and Research, were presented at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Dublin, Ireland. The company anticipates selecting a candidate for further preclinical development to start in the first quarter of 2013.

• Albireo AB, of Gothenburg, Sweden, said A4250, an inhibitor of the ileal bile acid transporter, was granted orphan drug designation by the FDA in progressive familial intrahepatic cholestasis (PFIC) and primary biliary cirrhosis (PBC). The candidate previously received orphan drug designation in the same indications from the European Commission, based on a preclinical data package showing A4250 has high potency, minimal systemic exposure and benefits in an animal model of cholestasis, the predominant feature of PFIC and PBC.

• Alexion Pharmaceuticals Inc., of Cheshire, Conn., said its board of directors authorized the repurchase of up to $400 million of Alexion common stock. The open-ended program allows purchases on the open market or through privately negotiated transactions, block transactions or other means, in accordance with prevailing market conditions and the requirements of the Securities and Exchange Commission. Alexion expects to fund all purchases from cash on hand and future cash flows from operations.

• Bionomics Ltd., of Adelaide, Australia, said licensee Ironwood Pharmaceuticals Inc., of Cambridge, Mass., filed an investigational new drug application with the FDA for a clinical trial of anti-anxiety drug candidate IW-2143. Ironwood plans to initiate Phase I studies in healthy volunteers to assess the pharmacokinetics of IW-2143. Preclinical studies conducted by Bionomics suggested IW-2143 has anti‐anxiety activity and promotes neurite outgrowth.

• Cerus Corp., of Concord, Calif., said the FDA approved the submission of a modular premarket application for its Incercept plasma technology.

• Cornerstone Therapeutics Inc., of Cary, N.C., acquired from Chiesi Farmaceutici SpA, of Parma, Italy, the U.S. rights to market Bethkis (tobramycin inhalation solution) for the management of cystic fibrosis patients with Pseudomonas aeruginosa. Bethkis was approved by the FDA in October. Cornerstone will make an initial payment of $1 million, a milestone payment of $2.5 million upon first commercial sale and royalties based on a percentage of net sales. The companies signed a strategic partnership in 2009, making Chiesi Cornerstone's largest shareholder. Last week, Cornerstone's new drug application for lixivaptan received a complete response letter from the FDA. (See BioWorld Today, May 8, 2009, and Nov. 2, 2012.)

• GlaxoSmithKline plc (GSK), of London, reached an agreement with XenoPort Inc., of Santa Clara, Calif., to terminate their collaboration for Horizant (gabapentin enacarbil) extended-release tablets, for which GSK had commercialization rights and certain development rights in the U.S. GSK said it will provide certain assistance during the transition period ending April 30, 2013. The decision to return the asset is due to GSK's efforts to streamline its portfolio to focus on its core franchise opportunities. The agreement also resolves all litigation between the parties related to GSK's role in promotion of the drug. Horizant is FDA-approved for postherpetic neuralgia in adults with restless legs syndrome. XenoPort licensed worldwide rights, excluding Asian territories, to Horizant to GSK in 2007 for $75 million in cash up front, $65 million in milestones leading up to the filing of a new drug application and an additional $210 million in other development and regulatory milestones, plus as much as $290 million in sales milestones. Xenoport also was entitled to royalties on sales outside the U.S. The deal gave XenoPort a co-promotion option that would give it a net profit share. (See BioWorld Today, Feb. 9, 2007.)

• The Grünenthal Group, of Aachen, Germany, and Amura Therapeutics Ltd., of Cambridge, UK, signed a collaboration agreement to develop cathepsin inhibitors in pain and inflammation. Amnura will generate advanced lead compounds, and Grünenthal will continue development of the small-molecule drugs and assume responsibility for additional research and development. Grünenthal will hold exclusive rights for worldwide clinical development, manufacturing and commercialization of pharmaceutical products arising from the collaboration. Grünenthal, which is funding costs under the running agreement, made an undisclosed up-front payment to Amura and will make additional milestone payments.

• Immune Pharmaceuticals Ltd., of Herzlyia-Pituach, Israel, and EpiCept Corp., of Tarrytown, N.Y., entered a merger agreement, anticipated to close in the first quarter of 2013, that will create a combined company – Immune Pharmaceuticals Inc. – focused on developing antibody therapeutics and other targeted drugs. Terms of the deal call for EpiCept, which has been exploring strategic options for the past several months, to issue shares of its common stock to Immune shareholders in exchange for all outstanding shares of Immune. Following the transaction, EpiCept shareholders will hold about 22.5 percent of the combined firm. The deal will give privately held Immune a U.S. base and stock listing, and the newly merged firm will continue focusing on Immune's lead product, bertilimumab, a fully human monoclonal antibody designed to target eotaxin-1. That drug is in Phase II testing in ulcerative colitis. The combined firm also will continue EpiCept's efforts to seek a partner for Phase III-stage AmiKet in chemotherapy-induced neuropathic pain and postherpetic neuralgia.

• IntelliCell BioSciences Inc., of New York, said the FDA validated its registration to recover, process, package, store and label human cells and tissue products, including its autologous stromal vascular fraction cellular product.

• Inviragen LLC, of Fort Collins, Colo., expanded its partnership under an existing memorandum of understanding with the International Vaccine Institute to assess the total health burden of dengue cases in Colombia and Thailand. The Mahidol University Department of Tropical Pediatrics in Thailand and PECET (Programa de Estudio y Control de Enfermedades Tropicales) at the Universidad de Antioquia in Medellin, Colombia, will manage the studies, which aim to detail the burden of dengue disease from epidemiological, economic, behavioral and market-demand perspectives. The study is designed to help advance the development of Inviragen's Phase II tetravalent DENVax vaccine.

• Medigene AG, of Martinsried, Germany, said Veregen was launched in Switzerland by Medigene`s partner Abbott Park, Ill.-based Abbott. In addition, market approvals for the drug were granted in the Netherlands, Belgium, Finland, Slovenia, Hungary, Romania, Bulgaria, and Cyprus. Veregen is being marketed in the U.S., Germany, Austria and Spain. Veregen (sinecatechins) is an ointment derived from an extract of green tea leaves used to treat external genital warts.

A former chief financial officer at Seattle-based Omeros Corp. received a $3.94 million payment to settle his wrongful termination and federal False Claims Act whistleblower lawsuit, according to law firm Davis Wright Tremaine LLP. Richard J. Klein filed the lawsuit three years ago, alleging that Omeros falsified timekeeping records on a National Institutes of Health research grant. Omeros terminated Klein shortly after he communicated those allegations to the firm's audit committee. Omeros admitted to no wrongdoing in the settlement, and Davis Wright Tremaine reported that the federal government was not a party to the lawsuit and may still take additional action against the company.

• Pevion Biotech AG, of Bern, Switzerland, launched a new program called Defensomes, a platform for broad spectrum immune enhancement via mechanisms of innate immunity. Defensomes, influenza virus-like particles, offer opportunities for a wide range of prophylactic and therapeutic indications, where boosting of the body's own natural defense is beneficial.

• PharmaMar SA, of Madrid, Spain, a subsidiary of Grupo Zeltia, reported data from preclinical trials testing lurbinectedin (PMO1183) at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Dublin, Ireland, including results showing that the compound induced a specific degradation of RNA polymerase II in tumor cells. Trials performed in animal models found that the distribution of lurbinectedin inside various types of tumor cells – pancreatic, ovarian and non-small-cell lung cancer – ruptures the DNA double-strand and induces apoptosis, significantly reducing the size of the tumor. In combination with gemcitabine, lurbinectedin produced a synergistic antitumor effect on xenotransplants of tumors in pancreatic, ovarian and NSCLC by increasing apoptosis. A separate presentation featuring PharmaMar's other cancer drug, Yondelis (trabectidin), in combination with olaparib (AZD-2281), a PARP inhibitor from London-based AstraZeneca plc, showed that the two drugs had a synergistic effect on tumor lines, including breast cancer cells with and without BRCA-1 gene expression.

• Soligenix Inc., of Princeton, N.J., said its program for development of SGX203 (oral beclomethasone 17,21-dipropionate or oral BDP) for the induction treatment of mild-to-moderate pediatric Crohn's disease received FDA fast-track designation. It previously received FDA orphan drug designation for oral BDP as a treatment for pediatric Crohn's disease.

• Stem Cell Therapeutics Corp., (SCT) of Toronto, signed an agreement with University Health Network (UHN), through its commercialization agent MaRS Innovation, which provides Stem Cell Therapeutics with an option to an exclusive worldwide license to a cancer stem cell program. That technology reportedly provided compelling evidence that tigecycline, an FDA-approved antibiotic, is able to selectively target leukemia cells and leukemic stem cells by shutting down their energy supply through the inhibition of mitochondrial protein synthesis. SCT was granted an option by UHN under which, and prior to April 30, 2013, SCT may conclude the exclusive license provided SCT has secured additional financing sufficient to support its product development operations. The worldwide, exclusive license agreement includes undisclosed provisions for an initial license consideration, milestones, royalties on sales and sublicensing terms.

• Sun Pharmaceutical Industries Ltd., of Mumbai, India, is acquiring DUSA Pharmaceuticals Inc., of Wilmington, Mass. Under the terms of the agreement, a 100 percent subsidiary of Sun will commence a tender offer for all of the outstanding common stock of DUSA at a price of $8 per share in cash, a 38 percent premium to the closing price of DUSA's common stock on Nov. 7. The transaction has a total cash value of approximately $230 million. The transaction was unanimously approved by the boards of directors of both firms. DUSA's board recommended that its shareholders tender their shares pursuant to the tender offer. Upon the completion of the tender offer, Sun Pharma will acquire all remaining shares at the same price of $8 per share through a second-step merger, subject to approvals as may be necessary.

• Vical Inc., of San Diego, released animal data documenting the benefits of combining the company's Allovectin immunotherapy with anti-CTLA-4, anti-PD-1 and anti-PD-L1 antibodies, which are emerging immunotherapies for metastatic melanoma. The company's poster presentation at the 9th International Congress of the Society for Melanoma Research this week summarized the results of studies in melanoma mouse models evaluating the combination of Allovectin with emerging antibody immunotherapies. Allovectin produced a marked antitumor effect in the mouse melanoma model stronger than that produced by any of the evaluated antibodies. The company said the data warrant further evaluation in humans.