| FDA Leaves Acura Pharma Red-Faced on Lead Product EP Vantage submits:It was red faces all around at Acura Pharmaceuticals (ACUR) Thursday after an advisory committee voted almost unanimously not to recommend approval of the group’s lead product Acurox, an instant release, tamper resistant form of oxycodone. In a damning and decisive looking 19-1 poll, the committee highlighted the fact that the niacin used to deter abuse by producing painful facial flushing if the drug was crushed and sorted or taken excessively orally, could easily be counteracted by eating food or taking aspirin. The other main concern of the panel was that very sick patients legitimately taking the drug could also experience this painful side effect, even at normal doses.Complete Story » seekingalpha.com |
Forest Pharma Makes a Big Deal About Diabetes The Burrill Report submits: By Michael FitzhughForest Laboratories (FRX) is pouring $50 million into a deal with TransTech Pharma intended to bring new glucose-lowering diabetes drugs to market. Combined with milestone payments, the agreement could yield $1.1 billion for TransTech in total. Forest will also pay TransTech royalties on worldwide product sales and cover all development and commercialization costs. TransTech Pharma, based in High Point, North Carolina, retains the rights to the Middle East and North Africa. “We believe this novel class of compounds has the potential to be a major therapeutic advance in the treatment of diabetes," says TransTech CEO and founder Adnan Mjalli. The small molecule compounds covered by the agreement rely on liver-selective Glucokinase Activators, which represent a novel class of glucose-lowering agents for the treatment of diabetes, Forest says. Glucokinase Activators, such as TransTech's lead diabetes molecule, TTP399, help lower blood glucose in diabetic patients in large part by inducing glucose-stimulated insulin release in the pancreas and by inducing glycogen formation and glucose breakdown in the liver. Amgen (AMGN) and Array BioPharma (ARRY) inked their own deal for a small-molecule glucokinase activator program in December of last year, creating an exclusive worldwide pact that came with an upfront payment of $60 million for Array and potential additional milestone payments. In April, Forest abandoned its marketing rights to a diabetes mellitus drug being developed by Phenomix just as positive late-stage data on the drug emerged, leaving Phenomix looking for a new partner.Complete Story » seekingalpha.com |
About Swedish Orphan Biovitrum's Partnership with Dongbao Pharma ChinaBio Today submits: Swedish Orphan Biovitrum (BIOVY.PK) announced it intends to set up a strategic commercial alliance with Tonghua Dongbao Pharma Co Ltd. (SHEX: 600867). Under the terms of the agreement, each company will become the “sales partner of choice” for products from the other entity. Biovitrum will represent Dongbao’s line of “biosuperiors” in Europe, while Dongbao will market and register Biovitrum’s portfolio drugs targeting rare diseases that require extensive pharmaceutical treatment. Complete Story » seekingalpha.com |
Governments Ditching Public Hospitals Faced with debt and looming costs from the new federal health-care law, many local governments are leaving the hospital business, shedding public facilities that can be the caregiver of last resort. online.wsj.com |
Chelsea Soars on Positive Result for Blood Pressure Drug Second Time Around EP Vantage submits:It might have involved moving the goal posts, but Chelsea Therapeutics (CHTP) has finally gotten the results it wanted from a pivotal trial of lead product Northera, a therapy to treat dangerously low blood pressure (Event - Chelsea hopes new droxidopa trial stands tall, August 24, 2010). Shares in the company surged by 25% to $6.30 in early trade Monday, in response to the positive data, and are now trading at their highest level for nearly a year. With enough cash to last only into the first quarter of next year, Chelsea could well swiftly capitalize on this healthy gain to top up its coffers, via a share sale. Complete Story » seekingalpha.com |