MethylGene

Celgene terminates MethylGene licensing deal

John Carroll — Mon, 27 Oct 2008 11:42:41 -0400

MethylGene announced that Celgene has terminated their licensing agreement for oncology histone deacetylase inhibitors, including MGCD0103. As a result, MethylGene will reacquire the rights to these programs. Furthermore, the company announced that it will implement a strategic initiative to focus its resources on the clinical development of its proprietary pipeline. MethylGene release

FDA puts partial clinical hold on MethylGene program

John Carroll — Mon, 18 Aug 2008 12:14:34 -0400

Canada's MethylGene says that as a result of its voluntary decision to halt enrollment in a new drug study, the FDA has put a partial clinical hold on its lead development program in cancer. The agency says it is waiting to see data and a risk mitigation plan to protect volunteers in the study. MGCD0103 is partnered with Celgene as a therapy for solid tumors and hematological malignancies.

"Under the partial clinical hold, patients currently enrolled in MGCD0103 clinical trials who are confirmed to have no signs or symptoms of pericarditis or pericardial effusion may continue in their respective studies," the company stated in a release. "MethylGene and Celgene are working closely together with the FDA to complete this package and communicate it with the FDA to obtain approval to commence enrollment of new patients as soon as possible."

- read the press release
- check out the report on the Canadian Press

ALSO NOTED: CFOs are pharma's new power players; Progen axes staff in restructuring; MethylGene inks collaboration deal;and muc

Thu, 27 Mar 2008 07:59:50 -0400

> Australia's Progen is laying off workers in a restructuring that includes outsourcing the commercial manufacture of PI-88. Release

> Who's pharma's power forward these days? The CFO. Or so concludes Ernst & Young after slicing and dicing two global surveys. As companies shift focus from driving sales growth to managing returns, CFOs will have to be increasingly proactive. Report

> MethylGene will get $2 million up front and up to $50.5 million in milestones in its newly signed collaboration deal with Otsuka Pharmaceutical. MethylGene will be responsible for the design, synthesis, characterization and initial screening of kinase inhibitors. Otsuka will be responsible for and fund efficacy and toxicology studies, as well as preclinical and clinical development of compounds. Otsuka is also responsible for the global commercialization of any resulting product. Release

> When FDA reviewers cram, do they perform poorly on the test? A new study concludes that yes, when drugs are approved right on deadline, they're more likely to cause safety problems later. The Harvard analysis, published in this week's New England Journal of Medicine, concludes that drugs approved in the two months leading up to the deadline are four to five times more likely to be withdrawn or require serious safety warnings. Report

> The FDA will allow copper alloys to be sold as a weapon against bacteria and microbes. Report

> Japan's Ono Pharmaceutical has inked a discovery deal with Evotec. The collaboration applies Evotec's fragment-based drug discovery platform, EVOlution, to identify small molecular weight compounds active against a protease target. Release

> Novelos Therapeutics has raised $5 million in a private placement. Release

And Finally... People with larger stomachs in their 40s are more likely to have dementia when they reach their 70s, according to a new study. Release

ALSO NOTED: Dynogen goes public; Alpharma sells ingredients unit for $395M; Arizona launches new venture fund; and much more...

Wed, 06 Feb 2008 06:59:50 -0500

> Dynogen Pharmaceuticals is going public in a buyout deal with Apex Bioventures Acquisition Corp. Dynogen shareholders will initially receive $98 million in the deal, with Dynogen merging with a subsidiary of Apex. Dynogen will be left with about $65 million in cash on hand for development work. Dynogen has been focused on irritable bowel syndrome, nocturnal gastroesophageal reflux disease and overactive bladder. Release

> Alpharma plans to sells its active pharmaceutical ingredients unit to 3i for $395 million and use the proceeds to grow its drug and animal health business. Release

> A group of Arizona biotech leaders has created the state's first venture fund for early-stage developers. Translational Accelerator gets started with $20 million for the biotech field, with the money slated for developers either in the state or coming to the state. Companies engaged in research for cancer and central nervous system diseases and diagnostics can qualify for loans of $500,000 to $2 million. Report

> Investor Carl Icahn (photo), who has specialized recently in upending several biotech companies, says he's planning to start blogging about some of his favorite issues, like executive compensation. Report

> Researchers are focusing on a more efficient method for breeding transgenic animals to produce proteins. Report

> The FDA has agreed to review UCB's Cimzia for rheumatoid arthritis. Report

> Cook Pharmica, a contract manufacturer, is planning an $80 million expansion of its Bloomington, IN plant. Report

> MethylGene and EnVivo Pharmaceuticals today announced that MethylGene has exercised its right to opt-out of further funding in its collaboration with EnVivo signed in February 2005. Release

> Biogen Idec reported a surge in profits in the fourth quarter as revenue from its two biggest therapies--Rituxan and Avonex--spiked. Report

> Puerto Rico is the birthing center for 13 of the 20 top-selling drugs in the U.S., but plants there have had repeated quality-control problems, according to an investigation by the Associated Press. Report

> The UK's Wellcome Trust says it will pump up its research spending by 60 percent over the next five years as it ambitiously seeks a better understanding of diseases at a genetic level. Report

> Reporters took Fosamax's patent expiration today as an opportunity to remind us all that 20 billion worth of drugs will go off patent this year, cutting big-time into Big Pharma's sales. Report

> Think before you click. That's the moral of today's tale, the story of a lawyer, a reporter and a $1 billion potential settlement that Eli Lilly wanted to keep quiet--but ended up all over the news. Report

And Finally... DNA from the Black Rat can be used to show how diseases have spread around the globe. Release

ALSO NOTED: GSK cuts 5,000 jobs; Codexis opens Singapore lab; Reliant sets IPO terms;and much more...

Thu, 25 Oct 2007 06:59:50 -0400

> The closure of a GlaxoSmithKline's Puerto Rican plant has kicked off the plan to cut 5,000 jobs. Report

> Codexis has opened a laboratory in Singapore, its first research facility in Asia. Release

> Reliant Pharmaceuticals has set its IPO terms at $25 to $27 a share. The company has raised more than $500 million from investors. Report

> Pharmion Corporation and MethylGene have reported preliminary clinical data from the Companies' MGCD0103 Phase I/II combination trial with Gemzar. Release

> It's official: the UK's National Health Service will start using Johnson & Johnson's Velcade under an unprecedented money-back-guarantee program. Report

> Bristol-Myers Squibb's third-quarter results show what one big drug can do. Net income more than doubled to $858 million on revenues of $5.1 billion--and Plavix was the biggest reason. Report

> The European Union backed a trade protocol that will give poor countries better access to cheap generics in the event of an epidemic. Report

> The FDA slapped a new warning on Provigil, a drug for narcolepsy and other sleeping disorders made by Cephalon. Report

And Finally… Most people believe their sleep meds work better than the drugs actually do. Article