SAN FRANCISCO – When AiCuris GmbH, of Wuppertal, Germany, analyzed the market for human cytomegalovirus (HCMV) therapies, it found a market with high medical need, neglected by big pharma, featuring a variety of disease manifestations. The market had also fallen under the radar of payers, all resulting in low competition, with the potential for high prices and low marketing and sales costs, according to Helga Rubsamen-Schaeff, AiCuris CEO. In her presentation for a panel featuring the nominees

Addex Therapeutics SA, of Geneva, disclosed positive preclinical data for its GABAB receptor-positive allosteric modulator in a rodent model of chronic alcohol dependence. The Addex alcoholism candidate, ADX71441, demonstrated robust and dose-dependent suppression of alcohol intake in animals lasting 24 hours. ADX71441 is an oral small molecule, with potential for once-daily dosing. In other news, Addex said dipraglurant demonstrated dose-dependent mGlu5 receptor occupancy in a nonhuman primate

LONDON – A more detailed understanding of the workings of the membrane-bound pump that many bacteria use to eject antibiotics will, researchers hope, lead to ways of making bacteria once again susceptible to antibiotics that currently fail to kill them. The work should make it possible to solve the structure of the pump and, eventually, find ways to either block the pump's function, or to prevent the pump's being assembled. Adrian Walmsley, professor of molecular microbiology at the University

LONDON – A 2.5-year investigation into the low level of uptake of biosimilars in Europe has concluded that – in the absence of automatic substitution – a hearts-and-minds education campaign covering physicians, payers and patients is the only lever that can be pulled at a pan-European level to drive the growth of the market. Among its findings, the Project Group on Market Access and Uptake of Biosimilars pinpointed a lack of understanding of biosimilars as a significant barrier to access. To

DUBLIN, Ireland – Opsona Therapeutics Ltd. raised €33 million (US$43.2 million) in a Series C funding round to take forward a first-in-class Toll-like receptor 2 (TLR-2) inhibitor, OPN-305, into a Phase II trial for preventing delayed graft function (DGF) in high-risk kidney transplant patients. The investment represents a shot in the arm for TLR biology, a field that has, so far, failed to deliver on its considerable promise. Despite intense interest in various TLR targets – there are 10 in

Oxford BioTherapeutics (OBT) Ltd. entered a target validation deal with Boehringer Ingelheim GmbH that will offer near-term revenues, with the added prospect of long-term development milestones and product royalties. The shape of the deal is markedly different from the headline-grabbing pact involving five antibody and antibody-drug conjugate (ADC) programs it entered last year with Menarini Group, of Florence, Italy. (See BioWorld Today, Oct. 30, 2012.) That deal is focused on what for OBT

LONDON – After struggling to maintain momentum and keep going during the capital markets crisis, Verona Pharma plc's recently appointed CEO, Jan-Anders Karlsson, has managed to line up the financing needed to shape the company's two lead programs for partnering. Since he replaced co-founder Michael Walker as CEO in June 2012, Karlsson has redrawn the development strategy for Verona's two lead respiratory programs, RPL554 for treating asthma and chronic obstructive pulmonary disease (COPD) and

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