BOSTON – The rise in the number of new drug approvals granted by the FDA in the past three years looks encouraging – hinting as it does that the industry is putting the productivity woes of the previous decade behind it. However, volume alone is not enough to guarantee future viability: Half of the 39 approvals in 2012 were for orphan drugs with forecast peak sales of $400 million per annum. "You need peak sales of $600 million per year to cover the costs of development. Although approvals are

LONDON – One of the UK's oldest biotech companies looks to be on its way out after reporting the failure of the lead program in Parkinson's disease. Shares in Phytopharm plc fell 80 percent after the announcement Monday that the long-running trial of Cogane showed no difference between the active compound and placebo in the 400-patient Phase II trial. The Godmanchester, UK-based company has begun a strategic review, but Robin Davison, analyst at Edison Investment Research in London, said there

BOSTON – Recent advances in the tools and technology for drug discovery mean it now takes minutes and days to accomplish tasks that previously took months and weeks. One consequence of those developments has been the rise of target-based screening to become the overwhelmingly dominant approach to discovery – largely displacing the use of phenotypic screening. Rather than looking to see what effect compounds might induce in animal models, tissues and cells, the industry became fixated on looking

3SBio Inc., of Shenyang, China, said it inked an agreement and plan of merger with Decade Sunshine Ltd., an exempted company with limited liability incorporated under the laws of the Cayman Islands. Pursuant to the terms, each of the company's ordinary shares, including shares represented by American depositary shares (ADS), will be cancelled in exchange for the right to receive $2.20 in each per share, or $15.40 per ADS. The per-share consideration represents a premium of about 32.9 percent

Matthias Wymann, the Swiss scientist who discovered the first phosphoinositide 3-kinase (PI3K) inhibitor, is co-founder of a new cancer drug discovery start-up, Piqur Therapeutics AG, which recently completed a seed financing round that will enable it take forward a pipeline of next-generation kinase inhibitors. The company, a spinout from the University of Basel, where Wymann is based, is developing dual inhibitors of PI3K and mammalian target of rapamycin (mTOR). It has assembled a veritable

Biogen Idec Inc.'s move to buy all rights from Elan Corp. plc to the blockbuster multiple sclerosis (MS) therapy Tysabri (natalizumab) didn't take long for analysts to applaud, though Wall Street traders spent time digesting the $3.25 billion deal, which includes contingent payments. "Everybody's probably searching for [the answer to the question], 'Does this make sense on a net present value [NPV] basis?' We think it does," said Paul Clancy, chief financial officer of Weston, Mass.-based

LONDON – e-Therapeutics plc is copper-bottoming its future, raising £40 million (US$62.66) in a share issue which, added to existing resources of £8 million, will fund the network pharmacology specialist until 2017. As this money is dispensed through its clinical development programs, the company expects to receive £12 million in government R&D tax credits, bringing the total pot to £60 million. A biggish chunk of this cash is going into one basket, with plans to spend £25 million on getting

LONDON – The Innovative Medicines Initiative (IMI) officially launched the European Lead Factory, a €196 million (US$266 million) project in which seven pharma companies will make at least 300,000 compounds available for screening via an open platform. That will allow academic and small company partners access to industry-quality high-throughput screening and speed the translation of new target biology through to drug leads. The cash for the five-year project comes from the European Union's R&D

LONDON – Medgenics Inc. reached the higher end of its ambitions in an issue of stocks and warrants, raising $30 million to provide funding for further clinical development of its Biopump protein drug implant technology. "I think this speaks for itself: In this environment, raising $30 million is not easy," said Andy Pearlman, CEO. The aim was to raise between $20 million and $30 million, so this was at the higher end, and in the event "some folks didn't get in," Pearlman told BioWorld

LONDON – With the discovery of 24 new genes that are linked to myopia, or short-sightedness, most of the hereditary causes of this condition are now known, researchers contend. People with the faulty versions of those genes are 10 times more likely to have myopia than those without, the study found. The genes identified are involved in neurotransmission, modeling of the extracellular matrix, ion transport, retinoic acid metabolism and eye development. Caroline Klaver, professor of

4-Antibody AG, of Basel, Switzerland, and the Ludwig Institute for Cancer Research in New York signed a multitarget research and development collaboration with Recepta Biopharma SA, of Sao Paulo, Brazil, the leading Brazilian developer of therapeutic antibodies founded by the Ludwig Institute and Brazilian investors. The deal represents an expansion of a partnership the Ludwig Institute and 4-Antibody initiated more than a year ago. Financial details were not disclosed. Addex Therapeutics SA

LONDON – The UK BioIndustry Association is stepping up its campaign to improve funding for the industry through the creation of Citizens' Innovation Funds (CIFs) that will enable the general public to invest in biotech start-ups. The BIA organized a lobbying day in Parliament last week, meeting with members of parliament and treasury ministers to promote the plan. The association also has built a coalition of other groups to support CIFs, including the Confederation of British Industry and the

LONDON – Edmond de Rothschild Investment Partners (EdRIP) gave a progress report on the raising of its BioDiscovery 4 fund as the investment group celebrated its 10th anniversary and set out plans to raise €500 million (US$677 million) for life sciences venture capital and growth capital for small- and mid-cap companies across all sectors, by 2016. Despite the difficult economic backdrop, Olivier Litzka, partner, life sciences, said the BioDiscovery 4 fund is now well advanced. Following the

Shares in Zealand Pharmaceuticals A/S hit an all-time high Monday on news that it will shortly start logging double-digit percentage royalty payments from its partner Sanofi SA, following formal European Union approval of the once-daily glucagon-like peptide 1 (GLP-1) agonist Lyxumia (lixisenatide, AVE0010) in Type II diabetes. "It marks the beginning of a new era. How many European biotechnology companies have commercial products?" Zealand CEO David Solomon told BioWorld International. "This

The drug development graveyard that is Alzheimer's disease has claimed yet another victim. This time it's AC Immune SA's ACI-91, a drug that had offered a new approach to tackling this most intractable of diseases. The Lausanne, Switzerland-based firm is terminating its development, following a placebo-controlled Phase II trial in which the drug was associated with a decrease in cognitive performance and function. AC Immune had kept the identity of ACI-91 under wraps but recently revealed it

LONDON – Successful treatment of cancer depends not on killing tumor cells, but in beating them into submission using the immune system, a team of German researchers reported. They have identified a type of immune cell that can "re-educate" cancer cells, so that they enter prolonged periods of growth arrest. Mice with tumors, which were treated with the immunotherapy, survived for many months in a healthy condition, compared with animals that were treated with a placebo. Finances permitting

Israeli biotech Gamida Cell Ltd. moved lead product StemEx one step closer to becoming potentially the first allogeneic biologic cell product to achieve marketing approval in the U.S. and Europe. The therapy, which uses the company's copper chelator technology, demonstrated overall survival – the primary endpoint – in a Phase II/III study comparing its use in a transplantation regimen to historical controls when treating patients with hematologic malignancies such as leukemia and lymphoma who

Say "emerging markets," and anyone within earshot is likely to think of Brazil, Russia, India and China, the so-called BRIC countries. Africa, not so much. Common ideas about the world's second largest land mass date back a decade or so, when The Economist famously dubbed Africa "the hopeless continent." Pharmaceutical firms, though, have recognized Africa's potential for a few years now, said Sarah Rickwood, director of European Thought Leadership with IMS Health. "People hear the bad news

Shares in Active Biotech AB fell almost 13 percent Monday on news that its immunotherapy Anyara missed the primary endpoint of a Phase II/III trial in advanced renal cell cancer. The trial was by no means a complete failure, however, as a subgroup analysis attained statistical significance in around a quarter of the patients recruited, and the Lund, Sweden-based company has a firm understanding of what happened from a biological perspective. "We're encouraged that we got a robust signal," CEO