The backlog of new applications is growing again at the Patent and Trademark Office (PTO), thanks in part to sequestration. Using new fees included in the 2011 patent reform to hire and train more examiners, the office had been plowing through the backlog, reducing the pile of nearly 722,000 applications in December 2010 to about 593,000 in February. But since the sequester hit in March, the backlog has grown to more than 600,000. And patent experts expect it to continue growing because of the
By Mari Serebrov | BioWorld Today | Tuesday, May 21, 2013
Generic drugmaker Actavis Inc.'s plan to take over Dublin, Ireland-based Warner Chilcott plc in a stock-for-stock transaction worth about $8.5 billion, thus forming the world's third-largest specialty pharmaceutical firm, would put the combined firm – with about $11 billion in annual revenues – on even more solid footing in the busily consolidating biosimilars realm. "Due to the Irish takeover rules, there's very little we can say at the moment," Paul Bisaro, president and CEO of Actavis, told
By Randy Osborne | BioWorld Today | Tuesday, May 21, 2013
Elcelyx Therapeutics Inc., of San Diego, said it is enrolling patients with Type II diabetes in a Phase IIb trial of NewMet, a delayed-release formulation of generic metformin. Results of the trial's primary endpoint of change in fasting plasma glucose are expected in late summer, and the read-out for long-term glucose lowering and weight benefits is due in the fourth quarter. Intercept Pharmaceuticals Inc., of New York, reported initial results from OBADIAH, an ongoing Phase IIa trial of
For more than half a decade, researchers have understood translation to be a key step in gene expression, but it's only recently that drugmakers have begun looking at restoring translational control as a means of treating disease. "People thought of [translation] as the boring half of gene expression," said Steve Worlund, who co-founded and now serves as the president and CEO of Effector Therapeutics Inc., a recent start-up working to develop selective translation regulators. Translation is
By Jennifer Boggs | BioWorld Today | Tuesday, May 21, 2013
Major depression affects more than 15 percent of the population at some point in their lives, and about 7 percent in any given year. Currently approved antidepressants are effective only about half the time – and even then, with a lag time of several weeks after a patient starts taking them. The time lag of antidepressant's effectiveness is something of a mystery. The effects of the newest generation of antidepressants, selective serotonin reuptake inhibitors (SSRIs) seem to be dependent on the
By Anette Breindl | BioWorld Today | Tuesday, May 21, 2013
DUBLIN, Ireland – Elan Corp. plc continues to execute its M&A strategy at a dizzying pace, while its would-be acquirer, Royalty Pharma has tabled a revised offer for the company, worth $12.50 per share or $6.37 billion. On Monday, Elan unveiled an acquisition agreement with AOP Pharmaceuticals AG worth €263.5 million (US$339.3 million) in cash (€175.7 million) and shares (€87.8 million) initially – plus another potential €270 million in milestones – and a deal to acquire a 48 percent stake in
By Cormac Sheridan | BioWorld Today | Tuesday, May 21, 2013
Shares of Xenoport Inc. (NASDAQ:XNPT) dropped almost to the bottom of their 52-week range early Monday, opening at $5.04 after the company terminated its late stage arbaclofen placarbil (AP, previously XP19986) program in spasticity due to multiple sclerosis (MS) after a pivotal Phase III trial failed to demonstrate statistically significant improvement compared to placebo. The stock lost $1.03 on the day, or 15.3 percent, closing at $5.72. The Santa Clara, Calif.-based company said it would
By Marie Powers | BioWorld Today | Tuesday, May 21, 2013
Abbvie Inc., of Chicago, initiated a Phase III study called SONAR (Study Of Diabetic Nephropathy with Atrasentan) to assess the effects of the investigational compound atrasentan, when added to standard of care, on progression of kidney disease in patients with stage 2 to 4 chronic kidney disease (CKD) and Type II diabetes. SONAR is a multinational, double-blind, placebo-controlled clinical study that is expected to enroll more than 4,000 patients with diabetic nephropathy. The study will
Asmacure Ltee, of Quebec City, reported findings from four studies of ASM-024, its lead compound for asthma and chronic obstructive pulmonary disease (COPD), at the 2013 American Thoracic Society International Conference in Philadelphia. In a Phase II allergen challenge trial, ASM-024 was shown to reduce methacholine airway responsiveness and improve baseline lung function when delivered as a solution for nebulization formulation in people with mild allergic asthma. A second study evaluating
LONDON – Merck Serono is enlarging its venture fund from €40 million to €100 million (US$51 million to $128 million) – increasing its capacity to invest in early stage companies, technologies and products that can be shaped up for the company's internal pipeline. "We started four years ago with €40 million and that was always on the understanding it was not enough for a sustainable long-term fund," said Roel Bulthuis, head of the MS Ventures fund. "What the organization has seen is that the
By Nuala Moran | BioWorld Today | Tuesday, May 21, 2013
Company (Location) Company (Location) Value (M) Type/Product Area Terms/Details Date APRIL Actavis Inc. (Parsippany, N.J.) Valeant Pharmaceuticals International Inc. (Aliso Viejo, Calif.) ND Agreement for Actavis to be the exclusive marketer and distributor of an authorized generic of Valeant's Zovirax ointment Terms were not disclosed 4/8/13 Bial SA (S. Mamede do Coronado, Portugal) Ono Pharmaceutical Co. Ltd. (Osaka, Japan) ND Exclusive license agreement for the development and
Company (Location) Company (Location) Value (M) Type/Product Area Terms/Details Date I. Modified Agreements APRIL Affymax Inc. (Palo Alto, Calif.) Takeda Pharmaceutical Co. Ltd. (Osaka, Japan) $180 Amended collaboration for Omontys, changing the deal from a profit-sharing arrangement to a milestone and royalty-based compensation structure to Affymax Takeda assumes full responsibility for Omontys and, if it reintroduces the drug to market, Affymax would be eligible to receive royalties and
Company (Location) Company (Location) Value (M) Type/Product Area Terms/Details Date APRIL Aeterna Zentaris Inc. (Quebec City) Ergomed Clinical Research Ltd. ND Co-development and profit-sharing agreement for AEZS-108 in endometrial cancer Ergomed will receive a single-digit percentage of any net income received by Aeterna Zentaris in that indication, up to a specified maximum amount 4/11/13 Aeterna Zentaris Inc. (Quebec City) Merck KGgA (Darmstadt, Germany) subsidiary ND Deal for manufacturing
Total Value in 2013: $6,192M* Number of Deals in 2013: 97 Company (Location) Company (Location) Value (M) Type/Product Area Terms/Details Date APRIL Alchemia Ltd. (Brisbane, Australia) AstraZeneca AB (Sodertalje, Sweden; unit of AstraZeneca plc) $240 Deal for Alchemia's Diversity Scanning Array and Versatile Assembly on Stable Templates technologies to discover and develop small molecules for multiple targets in the oncology, respiratory, cardiovascular, metabolism, infection and neuroscience
Gilead Science Inc.'s oral targeted cancer drug, idelalisib (GS-1101), made a splash last week when the American Society of Clinical Oncology (ASCO) unveiled thousands of abstracts scheduled for presentation at next week's annual meeting in Chicago. In a press conference Wednesday afternoon, Jennifer R. Brown, director of the Chronic Lymphocytic Leukemia Center at the Dana-Farber Cancer Institute, provided Phase I findings suggesting idelalisib, as a single agent, has the potential to stave off
By Marie Powers | BioWorld Insight | Monday, May 20, 2013
