CellCept

ALSO NOTED: Salix gets approvable letter; Intermune drug hits the fast track; and much more...

Mon, 19 May 2008 06:59:50 -0400

> Should Fred Hassan (photo) give back his bonus? That's what Forbes is asking this week, saying that the Schering-Plough CEO's 2007 compensation package was probably artificially inflated by the fact that sales-damaging study results were held back until early January 2008. Report

> Salix says it has received an approvable letter from the FDA for balsalazide tablet studied as a treatment of mild-to-moderate active ulcerative colitis in patients 18 years and older. The company says it should be able to provide a complete response to the letter in a matter of days. Release

> The FDA has put Intermune's drug pirfenidone--for idiopathic pulmonary fibrosis--on the regulatory fast track. Story

> Holmes Biopharma announced that its clinical research operations in Omaha, Nebraska have been disrupted due to a working capital deficiency. Release

> MorphoSys has extended its research contract with Schering-Plough by a year. Report

> Biophage Pharma has sold the assets of its Immunotox Labs Division to Validapro BioSciences Inc. for $400,000 in cash and the assumption by Validapro Biosciences of certain liabilities. Release

> In a deal with the U.S. Department of Justice, the Canadian drugmaker agreed to pay almost $25 million to settle claims that it paid docs and their office managers to get patients onto its Cardizem heart drug. Report

> The FDA is warning doctors again that organ-transplant drugs CellCept (from Roche) and Myfortic (Novartis) have been linked to miscarriages and birth defects when taken by pregnant women. Report

And Finally... A simple gene test may soon be available that will eliminate up to half of the potential patients for the therapy. Report

ALSO NOTED: Antisoma gets $25M milestone; Takeda pays out retention bonuses; and much more...

Fri, 11 Apr 2008 06:59:50 -0400

> Novartis has kicked off a late-stage trial of ASA404 combined with first-line chemotherapy in non-small cell lung cancer, triggering a $25 million milestone payment to Antisoma. Release

> Following the $8.8 billion acquisition of Millennium, Takeda will fork over retention bonuses to Millennium employees to prevent them from jumping ship. Report

> Health experts say that an outbreak of mumps two years ago among college students occurred even though most of them had received a recommended vaccine. Report

> Shares of Crucell jumped after the developer announced that an early-stage trial of an experimental tuberculosis vaccine demonstrated a promising immune response in volunteers. Report

> An outbreak of dengue fever in and around Rio de Janeiro has afflicted more than 75,000 people since the beginning of the year, with 12 people dying in just the past week. Report

> The transplant drug probe is widening. FDA says it's identified 16 cases of an often-fatal neurological disease among patients taking Roche's CellCept drug, used to prevent organ rejection. Report

> Pharma knows that self-regulation is the best kind. That's why 12 drug and device makers have promised Sen. Chuck Grassley that they are working on plans to disclose CME grants. Report

> When Jean-Pierre Garnier makes his exit from GlaxoSmithKline next month, he'll walk away with the promise of a $4.9 billion options bonus that will pay off sometime in 2010. Report

And Finally... If you want to market your drug to patients, a new study shows the Web is not the place to do it. Report

Aspreva agrees to $915M buyout offer

Thu, 18 Oct 2007 06:59:57 -0400

Switzerland's Galenica is buying out Canada's Aspreva Pharmaceuticals for $915 million. The deal values Aspreva's shares at $26 each, a 16 percent premium from yesterday's close. The buyout comes just weeks after Aspreva and Roche shelved plans to file for approval of CellCept, a new therapy for lupus. CellCept failed a late-stage trial, unable to demonstrate superiority to intravenous cyclophosphamide. That news took a serious bite out of Aspreva's stock value, paving the way to the deal announced today.

- see this release on the buyout

Related Articles:
Aspreva, Roche put CellCept on ice. Report
Aspreva's CellCept fails late-stage superiority study. Report
Aspreva Pharmaceuticals drug fails Phase III trial. Report
Buyouts a sign of industry's health. Report

Aspreva, Roche put CellCept on ice

Mon, 10 Sep 2007 06:59:56 -0400

Shares of Aspreva Pharmaceuticals slipped a bit this morning after the company and Roche announced that they would not be pushing ahead with a regulatory filing for CellCept, a new therapy for lupus nephritis. The therapy missed its late-stage primary endpoint--it was unable to demonstrate superiority to intravenous cyclophosphamide. There have been no new therapies approved for lupus in the U.S. in more than 40 years.

- check out the announcement

Related Articles:
Aspreva's CellCept fails late-stage superiority study. Report
Aspreva Pharmaceuticals drug fails Phase III trial. Report
CellCept wins orphan status. Report