By Nuala Moran Staff Writer BOSTON – Mind the gap. It's not enough to chart a regulatory pathway and see biosimilar products through to approval; there remain problems with promoting uptake and delivering the promised cost savings to payers, as experience in Europe illustrates. One of the main causes of the gap between approval and sales is explaining the concept of biosimilars to clinicians, Steffen Thirstrup of the Danish Health and Medicines Agency told delegates at BIO 2012. "The question is
By Cormac Sheridan Staff Writer In a deal that is an asset disposal in all but name, Basilea Pharmaceutica AG is banking £146 million up front (US$226.8 million) and could get between £30 million and £50 million more in regulatory milestones from a global agreement on its hand eczema drug Toctino (alitretinoin) with Stiefel, the dermatology subsidiary of GlaxoSmithKline plc. Although Basel, Switzerland-based Basilea also stands to earn low double-digit royalties on U.S. sales of the product
By Anette Breindl Science Editor Co-developing a targeted therapeutic with a companion diagnostic can be crowned with spectacular success. But how early in development patients should be selected based on such a biomarker is a complex question. The story of Pfizer Inc.'s Xalkori (crizotinib) illustrates several of the issues that need to be considered during the development of such combinations. Sometimes, to select or not to select is not the question, but a moot point. Among the data presented
By Cormac Sheridan Staff Writer The strategic alliance between BioInvent International AB and ThromboGenics NV received a double whammy, as the two companies halted development of an anticoagulation antibody, TB-402, following unfavorable data from a Phase IIb head-to-head trial against Xarelto (rivaroxaban), while Roche Holding AG decided to exit a three-way alliance to develop an angiogenesis inhibitor, TB-403. Lund, Sweden-based antibody developer BioInvent took a severe hammering when the
By Mari Serebrov Washington Editor If Congress wants to curtail drug shortages, it needs to put some teeth in a PDUFA V provision that requires companies to notify the FDA six months in advance of events that could lead to a shortage, according to a panel at the annual meeting of the American Society of Clinical Oncology (ASCO). While both the House and Senate passed versions of the user fee package that call for early notification, neither grants the FDA any tools to enforce it. Richard
By Mari Serebrov Washington Editor WASHINGTON – While the differences between the House and Senate PDUFA bills are seemingly minor, they could add up to hundreds of millions of dollars. Because of provisions in the House FDA Reform Act, H.R. 5651, that would delay drug competition in some areas, the Congressional Budget Office (CBO) estimated the bill could increase federal spending by $244 million over the next decade. In comparison, the CBO projected that the bill passed by the Senate last
By Cormac Sheridan Staff Writer NeuroSearch A/S's task of securing backing for an additional Phase III trial of its Huntington's disease drug, Huntexil (pridopidine), has gotten a bit more difficult, following the release of data from a multiple-ascending-dose trial indicating that the compound causes QT interval prolongation in healthy volunteers. Huntexil – the first in a new drug class that NeuroSearch calls dopaminergic stabilizers – had not been administered previously to Huntington's
By Cormac Sheridan Staff Writer Shares in Active Biotech AB climbed more than 12 percent Monday on news that the company earned a €10 million (US$12.7 million) milestone payment from its partner, Ipsen SA, after reaching the halfway point in recruitment into a 1,200-patient, Phase III registration trial of tasquinimod in metastatic castrate-resistant prostate cancer. Lund, Sweden-based Active Biotech said it expects top-line data from the study by the end of 2014 and a regulatory filing, based
By Brian Orelli BioWorld Insight Contributing Writer The Ewing Marion Kauffman Foundation issued a report this month blaming the lackluster returns from venture capital on a lack of oversight from limited partners (LPs) that invest in the funds. Based on a strategic look at the Kauffman Foundation's experience investing its endowment in venture capital funds, the authors concluded that LPs are to blame because they haven't demanded higher returns for the riskier investment. "Institutional
By Mari Serebrov Washington Editor WASHINGTON – Drugmakers are keeping their fingers crossed as two separate bills to reauthorize PDUFA roll through Congress well ahead of its Sept. 30 expiration. S. 2516 may advance to the Senate floor as early as this week, and the House is expected to bring H.R. 5651 to the floor late this month. However, several proposed amendments, ranging from a curb on pay-for-delay settlements to importation of drugs from Canada, could stall the bills and hamper
By Cormac Sheridan Staff Writer PARIS – Despite managing to put together a star-studded lineup for a roundtable on innate immunity, which included two current Nobel prizewinners, Bristol-Myers Squibb Co. (BMS) and Innate Pharma SA found their best-laid plans were upstaged Tuesday by the French presidential inauguration at the Elysée Palace. One of the speakers, 2011 Nobel laureate Jules Hoffmann, of the University of Strasbourg, France, was a little late arriving at the roundtable due to his
By Mari Serebrov Washington Editor If patient advocacy groups have their way, it could be a lot harder and take longer for biosimilars to come to market. While the groups want the price breaks the follow-on drugs might offer, they are concerned about safety. Seemingly the most insignificant changes in manufacturing, packaging, handling and storing of biologics can have unintended consequences that can be life threatening, Dolph Chianchiano, of the National Kidney Foundation Inc., testified
By Anette Breindl Science Editor Scientists have reported they were able to improve memory in patients with amnestic mild cognitive impairment – a neurological condition somewhere between normal age-related memory loss and outright dementia that often progresses to Alzheimer's disease – by treating them with low doses of the anti-epileptic drug Keppra (levetiracetam, from Brussels, Belgium-based UCB SA). The drug appears to work by reducing activity in the hippocampus, a brain structure that is
By Trista Morrison BioWorld Insight Editor Biotech firms have long borrowed ideas from the high tech world. The venture-backed start-up business model on which the entire biotech industry is based came from high tech, and it has served both industries well despite their very different timelines and cost structures. Even so, current capital constraints have put "unprecedented strain" on biotech business models, according to Ernst & Young's Lead Analyst Gautam Jaggi, requiring a rethink of
By Trista Morrison Editor Biotech has become increasingly virtual over the last few years, and several recent studies and surveys indicate the trend is likely to continue, particularly when it comes to outsourcing of research and development. Yet some biotechs are grumbling about the high fixed costs inherent in the current contract research organization (CRO) model, while others complain about the quality of outsourced work. When Spectrum Pharmaceuticals Inc. acquired Allos Therapeutics Inc
By Anette Breindl Science Editor The Sonic Hedgehog pathway is a critical developmental pathway that is reactivated in a number of cancers. Results with targeting the pathway to treat cancers have been mixed, as drug development is wont to be. But the successes have been enough to keep trying. Roche AG unit Genentech Inc.'s and Curis Inc.'s hedgehog inhibitor Erivedge (vismodegib) was approved in January for advanced basal cell carcinoma, after previously failing in colorectal and ovarian cancer
By Mari Serebrov Washington Editor WASHINGTON – When it comes to discovering new uses for failed drugs, serendipity is about to be replaced by translational science in what National Institutes of Health (NIH) Director Francis Collins is calling a "win-win-win" pilot program for researchers, industry and patients. Under the crowd-sourcing program, NIH's National Center for Advancing Translational Sciences (NCATS) will serve as the matchmaker – hooking up failed compounds with researchers who
By Catherine Shaffer Staff Writer After dropping its price drastically from a target range of $12 to $14, Supernus Pharmaceuticals Inc., of Rockville, Md., priced an initial public offering of 10 million shares of common stock at $5 per share. But the stock (NASDAQ:SUPN) opened strong and by the end of the day had gained 37 cents, or 7.4 percent, to close at $5.37. The company, which first filed its S-1 in late 2010, will use net proceeds of $47.8 million – or $55.5 million if underwriters
By Cormac Sheridan Staff Writer Shares in Actelion Ltd. rose 13 percent Monday on news that macitentan, its dual endothelin receptor antagonist (ERA), hit the primary endpoint in a pivotal Phase III trial in pulmonary arterial hypertension (PAH), raising the prospect that the company will be able to revitalize its aging PAH franchise with a safer, more potent drug. Both the low (3 mg once daily) and the high doses (10 mg once daily) of macitentan lowered the risk of a morbidity/mortality event
By Trista Morrison Editor When Nabi Biopharmaceuticals Inc. revealed its plans to serve as a public shell for a reverse merger with Aussie biotech Biota Holdings Ltd., Raafat Fahim knew he'd face some opposition from shareholders. The biotech industry has a few trademark reverse merger success stories – like Cougar Biotechnology Inc., which saw its stock jump 150 percent in three years and secured a billion-dollar acquisition by Johnson & Johnson, and OncoGenex Pharmaceuticals Inc., which has
By Nuala Moran Staff Writer BOSTON – Mind the gap. It's not enough to chart a regulatory pathway and see biosimilar products through to approval; there remain problems with promoting uptake and delivering the promised cost savings to payers, as experience in Europe illustrates. One of the main causes of the gap between approval and sales is explaining the concept of biosimilars to clinicians, Steffen Thirstrup of the Danish Health and Medicines Agency told delegates at BIO 2012. "The question is