MGI Pharma

Eisai wins expert panel's approval for new sedative

Thu, 08 May 2008 06:59:57 -0400

Backed by a positive review from FDA staffers, an expert panel at the agency has recommended the agency approve Eisai's fospropofol disodium, a sedative designed for use in a number of procedures, including colonoscopies. Data for the therapy suggests that the drug produces a slow onset of sedation, helping avoid potentially dangerous cases of sudden general anesthesia, which can trigger breathing difficulties.

The sedative is for patients with a minimum to moderate need of sedation. And the experts said that the drug could help fill a gap in hospitals and clinics that may be shorthanded in people trained in general anesthetics. Panel members asked Eisai, which acquired the drug with its buyout of MGI Pharma, for more studies on the sedative's impact on the elderly and obese.

- see Eisai's release
- read the report in the Wall Street Journal

FDA staffers say that Eisai sedative appears safe

Mon, 05 May 2008 06:59:54 -0400

FDA staffers say that an experimental sedative developed by Eisai appears to be safe, but wants outside experts to consider whether it's safe enough to be administered by workers untrained in general anesthetics. Eisai gained rights to fospropofol disodium with its acquisition of Minneapolis-based MGI Pharma. And an FDA expert committee is scheduled to meet on Wednesday to consider Eisai's application for marketing approval. The sedative is designed for use during a number of procedures, including colonoscopies. Researchers say the sedative has a safer profile than existing meds.

- read the report in the Wall Street Journal

Eisai expands U.S. ops with $3.9B MGI buyout

Mon, 10 Dec 2007 06:59:58 -0500

A little over a week after announcing that it would explore its "strategic alternatives," MGI Pharma announced that Japan's Eisai had agreed to buy the company for $3.9 billion, a 23 percent premium over the December 7 close. For Eisai, which will lose patent protection for its bestselling drug Aricept in 2010, the news marked the latest in a string of oncology deals, including the $325 million acquisition of Morphotek in April. Earlier, Eisai also paid $205 million for four oncology therapies from Ligand Pharmaceutical.

MGI's two biggest sellers are Dacogen and Aloxi. The biotech has 10 development programs underway for everything from preclinical therapeutics to late-stage studies on approved medications. One of the winners in today's announcement: Carl Icahn, who snapped up $17.8 million in MGI shares even as one analyst was downgrading the biotech. For Eisai, it's another big stride into the U.S., where it is building a new research and development center.

- see this release
- read the report from the Wall Street Journal

ALSO: Adams Respiratory Therapeutics is being acquired by the Reckitt Benckiser Group for $2.3 billion. Release

Related Articles:
Lehman helps MGI study its 'strategic alternatives'. Report
Eisai acquires Morphotek in $325M deal. Report
Eisai plans $105M expansion in NC. Report

Lehman helps MGI study its 'strategic alternatives'

Thu, 29 Nov 2007 06:59:55 -0500

The speculation swirling around MGI Pharma is heating up with this morning's terse announcement that it has brought in Lehman Brothers to help the board evaluate its "strategic alternatives." Let's see. In recent weeks MGI has been downgraded by one analyst--Brean Murray--because its programs were so risky it couldn't be a takeover target as the rumor mill had it. Carl Icahn (photo) also took a tiny piece of its equity--always a sign of something interesting about to happen. But don't expect much more from MGI, which is steadfastly refusing to discuss any of those rumors.

- see MGI's announcement
- check out the report from Trading Markets

Related Articles:
MGI lands $255M buyout option in drug deal. Report
MGI therapy "approvable," but FDA wants new trial. Report
MGI sets sights on late-stage Aquavan trials. Report

DEALS: Solvay, Merck Serono ink deals with Gene Logic

Thu, 30 Aug 2007 06:59:52 -0400

Solvay, Merck Serono ink deals with Gene Logic

DEALS
WHO	WITH	WHAT	SCOOP
Invus	Lexicon Pharmaceuticals	$550 investment	Lexicon will use the money to finance its 10 to 10 program, which has the goal of advancing 10 drug candidates into human clinical trials by 2010.
MGI Pharma	AkaRx	$255M deal	MGI Pharma has shelled out $45 million as a down payment for AkaRx's Phase II therapy for thrombocytopenia.
Pfizer	Xoma	$30M licensing pact	Pfizer has licensed Xoma's tech for screening and manufacturing antibody products for $30 million upfront and a schedule of royalties and milestones.
Merck Serono	Gene Logic	Development pact	The companies will seek alternative development paths for several Merck Serono drug candidates which have been discontinued or de-prioritized.
Solvay	Gene Logic	Development deal	Gene Logic will take a second look at drugs Solvay either discontinued or chose not to prioritize.
Abraxis BioScience	The Scripps Research Institute	Licensing agreement	Abraxis and Scripps have inked an exclusive licensing agreement for the worldwide development and commercialization of a novel epothilone therapeutic for the treatment of cancer.

MGI lands $255M buyout option in drug deal

Wed, 29 Aug 2007 06:59:57 -0400

MGI Pharma has shelled out $45 million as a down payment for a Phase II therapy for thrombocytopenia, an abnormal drop in blood cells involved in forming blood clots. MGI says the deal to commercialize AKR-501 gives it a potential blockbuster, and MGI is keeping an option to buy the developer, AkaRx, for another $255 million payment. MGI plans to launch a Phase III study of the drug in the next 18 months, which could take two years to complete. MGI also licensed AKR-201 for thyroid cancer in the deal.

"We are pleased to have obtained the rights to this advanced-stage product with significant revenue potential that is being developed for multiple indications. AKR-501 provides MGI PHARMA with a tremendous opportunity for sustained revenue growth in future years, with U.S. peak revenue potential exceeding $1 billion," said CEO Lonnie Moulder.

- see this release
- read the report from the Minneapolis Star-Tribune

Related Articles:
FDA approves Dacogen for MDS. Report
MGI therapy "approvable," but FDA wants new trial. Report
MGI sets sights on late-stage Aquavan trials. Report

ALSO NOTED: Quest Diagnostics buys HemoCue; Affymax pockets $10M milestone;Pozen to file response on Trexima; and much more...

Wed, 31 Jan 2007 19:01:30 -0500

> Quest Diagnostics has acquired Sweden's HemoCue, from the private equity firm EQT II for $420 million in cash. Release

> Affymax has nailed a $10 million milestone payment from Takeda. Release

> The FDA has called MGI Pharma's ad for a brain cancer drug "misleading." Report

> Pozen says it will file a response to the FDA on its Trexima migraine therapy in a few days. Report

> Aastrom has received an orphan drug designation for its Tissue Repair Cells used in chronic heart disease. Release

> Targacept is expanding its lab and office space in the Piedmont Triad Research Park. Release

> Generex is launching a Phase II trial for a breast cancer therapy. Release

> Heart muscle created from embryonic stem cells. Report

> New allergy vaccine works in a matter of weeks. Report

And Finally… A major new study concludes that fine grit in the air is a serious health threat to women, raising the risk of cardiovascular disease. Article

Late-stage data backs new application for Aloxi

Wed, 13 Dec 2006 19:01:34 -0500

MGI Pharma and Helsinn Healthcare plan to file a new marketing application for the nausea drug Aloxi after two late-stage trials demonstrated its effectiveness against nausea and vomiting after surgery. The data demonstrated a complete response by patients up to 72 hours after surgery. The drug is already approved to prevent nausea and vomiting after chemotherapy.

- here's the AP report on the new data

Related Articles:
Exelixis shares sink after Helsinn halts study. Report
FDA approves MGI's Dacogen for MDS. Report

MGI therapy "approvable," but FDA wants new trial

Thu, 12 Oct 2006 20:01:37 -0400

The FDA has issued an approvable letter for MGI Pharma's therapy for oral mucositis, but is requiring the drug developer to do a new Phase III trial before a full approval is made. The news of a new trial requirement sent its shares down as investors considered the likely impact on MGI. MGI CEO Lonnie Moulder said that the company will evaluate ways to "maximize the value of Saforis." He also noted that MGI hadn't been anticipating a significant financial contribution from the therapy next year.

- here's the AP report on MGI

FDA gives Dacogen orphan drug status

Wed, 09 Aug 2006 20:01:35 -0400

MGI Pharma announced that the FDA had given orphan drug status to Dacogen as a therapy for leukemia. Dacogen is currently in late-stage trials for leukemia and was approved for bone marrow disorders in May. European regulators have given Dacogen orphan drug status for Myelodysplastic Syndromes and leukemia. Orphan drug status provides seven years of market exclusivity for a drug aimed at a small group of patients.

- read the AP report on Dacogen