Active Biotech AB, of Lund, Sweden, and Ipsen SA, of Paris, said they now plan to conduct the primary progression-free survival analysis for the 10TASQ10 global Phase III trial of tasquinimod in 2014, at the same time as the first interim overall survival analysis, when more mature data are available. The product, a small molecule that binds to S100A9, is the subject of a study across 37 countries in 1,245 metastatic castrate-resistant prostate cancer patients who have not yet received

Genticel SA raised €18.2 million (US$23.6 million) in a Series C round led by Wellington Partners, to move ProCervix, its bivalent therapeutic vaccine for combating human papillomavirus (HPV) infection into Phase II trials. The vaccine is designed to elicit a T-cell response against infections involving HPV serotypes 16 or 18, which, respectively, are responsible for 50 percent and 20 percent of all cervical cancers. The upcoming trial, which will get under way in the second half of this year

DUBLIN, Ireland – Two days after the board of Elan Corp. plc unanimously rejected Royalty Pharma's $7.3 billion takeover offer, CEO Kelly Martin set out, as best he could, the contours of the company's M&A strategy during a first-quarter results call with analysts last week. The Dublin, Ireland-based firm, which has sequentially shed and adopted several identities during its 44-year existence, has almost completed its latest transition, from being a neurology-focused biotechnology firm to

Novo Nordisk A/S is the first taker for Kymab Ltd.'s second-generation transgenic mouse antibody platform Kymouse, providing all-important industry validation for the fledgling technology, as well license fees, development milestones and royalties on eventual product sales. Terms of the antibody discovery deal were not disclosed. It involves multiple targets, but it is not exclusive, Tom Shepherd, chief business officer of Cambridge, UK-based Kymab, told BioWorld International. "Our strategy is

CHICAGO – Officials from the China Food and Drug Administration (CFDA) stammered through a question-and-answer period in which the audience sought the agency's definition of an "innovative" drug, its stance on orphan therapies and its policy with regard to biosimilars, during the first day of the BIO 2013 International Convention here. The session seemed lost in translation, figuratively and sometimes literally. Chang Weihong and Haixwei Wang from the renamed, revamped entity – formerly called

ActoGeniX NV closed a Series B equity financing round, raising €€10.7 million (US$14 million) to move its ActoBiotics program to the investigational new drug application (IND) stage in a second indication of inflammatory bowel disease (IBD). The financing, which brings the company's total raise to €46.2 million across three equity rounds, was led by new investor Saffelberg Investments with participation from the company's founders and current investors GIMV, Biotech Fund Flanders, Baekeland

LONDON – A huge international study has established that a rare liver disease, which often occurs simultaneously with inflammatory bowel disease, is, in fact, a separate disease. In a genetic association study, researchers identified nine genetic regions, linking those for the first time with an increased risk of primary sclerosing cholangitis (PSC), which affects approximately four people in every 100,000. The total number of genetic regions (or loci) associated with PSC now stands at 16, and

While the development and approval of biosimilars, especially monoclonal antibodies (mAbs), are moving at a snail's pace in developed countries, the copycat drugs are racing forward in Asia and Latin America. Intas Biopharmaceuticals Ltd., of Ahmedabad, India, launched its Mabtas (rituximab), making it the second copy of Rituxan/MabThera to be approved in India to treat non-Hodgkin's lymphoma. Dr. Reddy's Laboratories launched Reditux, its copy of rituximab, in 2007 before India adopted a

Allecra Therapeutics GmbH, a Franco-German start-up raised €15 million (US$19.6 million) in a Series A round to take two antibiotic development programs into the clinic and through clinical proof of concept. The company has licensed intellectual property from an Indian pharmaceutical firm, Chennai-based Orchid Chemicals & Pharmaceuticals Ltd., although further details are limited. "We're not at the moment revealing the exact technology we've licensed from Orchid – or the structure of the

LONDON – Horizon Discovery Ltd. is in line for undisclosed up-front and milestone payments, followed by a potential $75 million from AstraZeneca plc in a deal that signals a move-up for the company, from providing services and products to applying its genome-editing technology in-house to uncover novel targets. At the same time, the agreement exemplifies changes to AstraZeneca's business development and partnering strategy, following the announcement of the reshaping of its R&D in March. (See

Continuing a flurry of 2013 dealmaking, nanomedicine firm BIND Therapeutics Inc. kicked off the BIO International Convention with a potential $199 million-plus deal with AstraZeneca plc to develop and commercialize an Accurin therapeutic based on a molecular targeted kinase inhibitor. Cambridge, Mass.-based BIND nailed down that partnership only weeks after inking a deal with Pfizer Inc. valued at more than $210 million and about three months after signing Amgen Inc. to a $180.5 million

LONDON – TiGenix NV unveiled positive Phase IIa results for its Cx611 allogeneic stem cell therapy in the treatment of 53 rheumatoid arthritis patients whose disease was not responsive to disease-modifying anti-rheumatic drugs (DMARDS) or biologics. "This is an extremely tough patient population, and was [to my knowledge] the most refractory rheumatoid arthritis patient group ever in a rheumatoid arthritis trial," said CEO Eduardo Bravo. "You will appreciate how happy we are to report these

Addex Therapeutics SA, of Geneva, reported preclinical data showing that its mGlu5 negative allosteric modulator oral small molecule, dipraglurant, dose-dependently prevented the abnormal excitatory effect observed on brain slices of transgenic primary generalized torsion dystonia 1 (DYT1) mice overexpressing the human mutant TOR1A gene by decreasing the paradoxical neuronal activity induced by the dopamine D2 receptor agonist quinpirole. DYT1 is a common and severe genetic form of dystonia

UK-based GW Pharmaceuticals plc set the terms for its proposed U.S. initial public offering (IPO), which would provide a listing on Nasdaq and nearly double its cash position ahead of the anticipated launch of lead cannabinoid product Sativex in the U.S. The firm, in its F-1 filing as an emerging growth company, said it plans to offer about 3.5 million American depositary shares (ADS) – each representing about 12 ordinary shares – priced according to GW's shares as listed on the London AIM

LONDON – A new study has connected known differences in the metabolism typical of cancer cells to the pathway leading to apoptosis, or cell death. Researchers working in Finland have, for the first time, linked metabolic changes in cancer cells to the mechanism that, in normal cells, prevents abnormal cellular proliferation. The discovery is likely to encourage drug developers to consider whether existing drugs that modify cellular metabolism could be used in the future to treat cancer. Juha

LONDON – Immune Targeting Systems Ltd. (ITS) presented positive data on its universal influenza vaccine, Flunisyn, showing that it induced T-cell responses in 95 percent of subjects in an elderly population, ages 65 to 74, in a Phase IIa trial. The results pave the way for a challenge study of the vaccine, which is designed to be effective against all strains of influenza A. That would, for example, include influenza A (H7N9), the avian influenza virus that is the source of the current outbreak

In one of Switzerland's – and Europe's – largest biotech private equity deals for some time, Auris Medical AG landed CHF47.1 million (US$50.8 million) in a Series C funding from the two Sofinnovas, Sofinnova Ventures and Sofinnova Partners, to take forward its two lead drug candidates, AM-101 and AM-111, in acute tinnitus and acute inner ear hearing loss, respectively. The Basel, Switzerland-based firm plans to start recruiting 600 patients with acute peripheral tinnitus into two placebo

DUBLIN, Ireland – Royalty Pharma upped the ante in its efforts to land Elan Corp. plc by raising its bid to $12 per share, an offer that values the Dublin, Ireland-based biotech at around $7.3 billion. It had originally signaled its interest in Elan with an indicative offer of $11 per share, or about $6.5 billion in total. The increased offer was hardly a surprise, particularly as Elan has traded up to around that level since Royalty Pharma's initial expression of interest. (See BioWorld Today

Santaris Pharma A/S is getting $10 million up front and could earn up to $90 million more in per-product milestones from a multiproduct drug discovery alliance with Bristol-Myers Squibb Co., based on its Locked Nucleic Acid (LNA) antisense technology. It also will receive research funding and royalties on eventual product sales. New York-based BMS will hold worldwide rights to whatever products emerge from the alliance. The targets involved were not disclosed; nor was the therapeutic focus of