LONDON – TauRx Therapeutics Ltd. said it has recruited the first patients to two Phase III Alzheimer's disease trials in which it aims to provide the first definitive proof that breaking down tangles of tau protein in the brain has a disease-modifying effect in the mild to moderate stages of pathology. Details of the trials were described Tuesday to Alzheimer's disease clinical specialists gathered in Monte Carlo, Monaco, to discuss the latest state of play in attempts to develop therapies for

Addex Therapeutics SA, of Geneva, reported preclinical data showing that its oral GABA-B receptor-positive allosteric modulator candidate, ADX71441, demonstrated robust, dose-dependent and long-lasting suppression of alcohol intake in a rodent model of alcohol binge drinking, compared to naltrexone. Acute administration resulted in 80 percent reductions of alcohol intake at higher doses vs. vehicle treatment, and reductions in alcohol consumption in response to ADX71441 treatment were present

Three years after a new drug application was first submitted for leukemia drug omacetaxine mepesuccinate, during which the product moved twice into different hands via M&A transactions, the FDA granted a long-awaited nod Friday. Branded Synribo, the drug is approved for treating adults with chronic myelogenous leukemia (CML), a blood and bone marrow disease, specifically those whose disease has progressed following treatment from at least two tyrosine kinase inhibitors (TKIs) such as Gleevec

Sanofi SA, which reported third-quarter results last week, placed its pipeline challenges front and center, noting "business [earnings per share] reflects patent expirations." Though the pronouncement made for a boring headline, the Paris-based pharma put all comers on notice that addressing its patent cliff is an integral part of its business strategy. Loss of the antiplatelet drug Plavix (clopidogrel bisulfate) is the biggest shock to Sanofi's system. Global sales of Plavix plunged 70.1

LONDON – Kymab Ltd. called up two industry veterans to help with the commercialization of its new platform technology for generating monoclonal antibodies in transgenic mice, as it prepares both to out-license access to the technology and use it to start an internal drug discovery effort. David Chiswell, co-founder and former CEO of Cambridge Antibody Therapeutics plc, and Christian Itin, CEO of Cytos Biotechnology and former CEO of Micromet until its $1.2 billion cash acquisition by Amgen Inc

The management of Dutch drug delivery specialist OctoPlus NV agreed to a €27.4 million (US$35.8 million) cash offer from Indian generics firm Dr. Reddy's Laboratories Ltd. The €0.52 per-share-offer represents a 30 percent premium over the company's closing share price of €0.40 on Oct. 19, immediately before the deal was disclosed. Investors responded accordingly, pushing the OctoPlus share price (EURONEXT:OCTO) up 23 percent to close at €0.49 Monday. Dr. Reddy's, of Hyderabad, India, now plans

LONDON – Summit plc is making headway with its two lead programs, winning a £4 million (US$6.42 million) translation award from the Wellcome Trust for clinical trials of SMT19969, a narrow-spectrum antibiotic for treating Clostridium difficile infections, and starting Phase II development of SMT-C1100, a treatment for Duchenne's muscular dystrophy (DMD). The Wellcome grant means Summit now has sufficient funding to advance SMT19969 to Phase II proof of concept. "I'm really pleased. This is the

LONDON – There's a race to market for a new generation of pulmonary arterial hypertension (PAH) drugs with Actelion Ltd. announcing it has filed for FDA approval of Opsumit (macitentan) and Bayer Healthcare revealing positive Phase III data for riociguat and promising global filings in the first half of 2013. The two companies are firing the starting gun this week at the annual meeting of the American College of Chest Physicians in Atlanta. Bayer will be reporting that riociguat demonstrated a

LONDON – International Biotechnology Trust (IBT) reported strong returns for shareholders, driven by new drug approvals, high levels of merger and acquisition activity and the resilience of leading biotech companies in the current growth-stunting environment. The London-based investment trust saw net asset value (NAV) rise by 41.9 percent to £2.32 (US$3.70) per share in the year ended August 2012. And while – inevitably – the unquoted investments in IBT's portfolio mean the shares trade at a

In an eagerly awaited milestone for the company – and for Belgian biotech – the FDA recently approved ThromboGenics NV's biologic drug Jetrea (ocriplasmin) for treating symptomatic vitreomacular adhesion (VMA). Following a 10-0 vote by the FDA's Dermatologic and Ophthalmic Drug Advisory Committee in favor of its approval earlier this year, there was little doubt that Jetrea would get over the line. (See BioWorld Today, Jul. 27, 2012.) Crucially, however, there was no sting in the tail, in

AB Science SA, of Paris, said masitinib has been submitted in a marketing authorization application in Europe for the treatment of pancreatic cancer. The tyrosine kinase inhibitor also is in development for gastrointestinal stromal tumors. APIM Therapeutics A/S, of Trondheim, Norway, closed a financing round to fund ATX-101, its lead compound, toward clinical trials. Preclinical studies showed the drug has activity in some solid tumor and blood cancer molecules, and potentiates the action of

Covagen AG signed its first drug discovery deal last week, a pact worth potentially up to €112.25 million (US$146 million) with Mitsubishi Tanabe Pharma Corp. that involves its Fynomer protein scaffold technology. Schlieren, Switzerland-based Covagen is getting €4 million of the total up front, with the rest coming in potential research, development and regulatory milestones. The company will receive additional research funding, and would receive tiered royalties based on eventual product sales

Aided by a generous dollop of government cash, a French consortium of biotechnology companies and academic medical centers is investing €80 million (US$104 million) to develop an industrial-scale facility for the production of cell therapy, including stem cell therapy. It is intended to provide a pharmaceutical-grade GMP platform to a fledgling sector that currently relies on small-scale processes cooked up in academic labs. The facility, which will be based in Les Ulis, on the southwestern

LONDON – A protein that determines how well cells can move and spread could provide a new target for drug designers who want to prevent metastasis of cancer cells. The protein, N-WASP, helps cells gather together key components that they need in order to be able to move, at the place in the cell where movement will be initiated. Researchers at the Cancer Research UK Beatson Institute in Glasgow, UK, have been able to view the movement of the cells in three dimensions, and compare how they move

Genmedica Therapeutics SL raised €12 million (US$15.5 million) in a Series B round to move its first-in-class drug candidate, GMC-252, into a Phase I trial in Type II diabetes. The deal structure is as distinctive as the company's approach to treating diabetes. It has established a subsidiary, GMC-252 SL, which holds exclusive worldwide rights to the drug in that indication. London-based Asclepios Bioresearch (UK) Ltd. has paid €12 million to gain 24 percent of that entity's future earnings

LONDON – A better understanding of the molecular and cellular interactions that help to trigger inflammatory bowel disease in mice could one day lead to new ways of treating conditions such as ulcerative colitis and Crohn's disease in humans. Recent investigations have shown that a molecule called T-bet plays an important part in keeping the gut healthy, by controlling the production of inflammatory cytokines. Graham Lord, professor of medicine at King's College London, told BioWorld

Affitech A/S, of Copenhagen, Denmark, was not delisted from Danish trading as planned, but will continue on the exchange while regulators consider whether the exchange's decision to delete Affitech was a violation of the Danish Securities Trading Act. Almirall SA, of Barcelona, Spain, said it granted Invida Holdings Private Ltd., part of the Menarini Group, of Florence, Italy, the commercial rights for Aclidinium, a long-acting inhaled muscarinic antagonist, in Australia and New Zealand, for

LONDON – It's where everyone says the funding gap lies, but having announced a €150 million (US$200 million) fund to specialize in bringing early stage compounds out of academia, Index Ventures is now finding it difficult to locate enough "standout" high-quality assets in which to invest. Part of the problem, said Kevin Johnson, partner at Index's London office, is convincing academics to become entrepreneurs. "Too many people are thinking of security instead of opportunity. They seem to be

GlaxoSmithKline plc (GSK) took extraordinary steps toward data transparency last week, disclosing plans to accelerate its "open innovation" approach to R&D by allowing researchers access to detailed patient-level data underlying clinical trials both in approved medicines and failed investigational compounds. The London-based pharma also said it will make its library of potential tuberculosis (TB) compounds freely available to researchers and increase funding for its Open Lab for independent