Eisai

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 drug flunks Parkinson's trial

Fri, 11 Apr 2008 06:59:57 -0400

Eisai's has halted development of Perampanel (E2007) for Parkinson's after the drug failed a late-stage trial. Compared with placebo, E2007 didn't show a significant difference in the primary endpoint of reduction of "off" time (how long it takes for the signs and symptoms of Parkinson's disease return as the effect of levodopa wears off).

Perampanel is in development for a number of other indications, including neuropathic pain, epilepsy, multiple sclerosis and migraine prophylaxis. Eisai stressed that this trial failure was not indicative of larger problems with the drug. "The decision to terminate the Parkinson's disease program is due to lack of efficacy over placebo seen in the recently completed two Phase III studies only, and is not predictive of activity in the other indications including epilepsy and neuropathic pain."

In three years Eisai will lose patent protection for Aricept, a Alzheimer's drug which accounts for 40 percent of the company's sales. Finding drugs to make up the gap is a top priority for the the company.

- see Eisai's release for more

Related Articles:
Eisai faces delay for cancer drug. Eisai report
Eisai expands U.S. ops with $3.9B MGI buyout. Eisai report
Eisai acquires Morphotek in $325M deal. Eisai report
Eisai plans $105M expansion in NC. Eisai report

ALSO NOTED: Pharmaxis reports Phase II CF data; New Zealand publishes biotech industry stats; and much more...

Fri, 04 Apr 2008 07:59:50 -0400

> Pharmaxis announced today that a Phase II clinical trial in children with cystic fibrosis demonstrated excellent lung function improvement following three months treatment with Bronchitol that matched that achieved by the current marketed product, Genentech's rhDNase. Release

> New Zealand has release new statistics on the country's biotech industry. Release

> Malaysian officials say the country is on track to become a biotech hub by 2020. Report

> The FDA has allowed Eisai to resume a Phase I clinical trial of E2012, an Alzheimer's treatment. Release

> Big Pharma looks more and more like a big ostrich these days, Forbes suggests. The brouhaha over Vytorin and Zetia this week is a case in point. Report

Most popular this week: Lilly readies Phase III Alzheimer's trial. Report

And Finally... Researchers are pushing ahead with the first human trials of an ebola vaccine. Report

Morphotek licenses anti-cancer antibody

Thu, 06 Mar 2008 06:59:57 -0500

Morphotek has inked a deal with Human Monoclonals International to get rights to a human monoclonal IgM antibody that is specific to a cancer cell surface antigen. The company hopes to develop a lead therapeutic MAb and high-titer cell lines suitable for scalable manufacturing. Morphotek, which was acquired by Eisai last year, has a pipeline of antibodies in development for cancer, rheumatoid arthritis, and infectious disease. Financial terms of the deal were not disclosed.

"This agreement provides yet another important addition to our therapeutic antibody portfolio," said Nicholas Nicolaides, Ph.D., Morphotek's president and CEO. "Safety data and positive clinical observations from an exploratory Phase I clinical trial in patients with metastatic melanoma have been reported. Our antibody optimization and development expertise will enable the further development of this promising antibody and clinical proof-of-concept studies in more types of cancer."

- check out the release

Related Articles:
Eisai acquires Morphotek in $325M deal. Report
Morphotek gains $40M in fourth venture round. Report

TorreyPines plans layoffs in streamlining

Thu, 14 Feb 2008 06:59:57 -0500

TorreyPines Therapeutics is taking a lashing from some of the analysts for its decision to cut staff as it restructures the company and focuses on its lead development programs. Those programs include tezampanel, NGX426 and the muscarinic agonist NGX267. Researchers plan to launch a Phase II trial of tezampanel in muscle spasticity and rigidity secondary to spinal cord trauma in the second half of the year; complete the ongoing Phase I maximum tolerated dose trial of NGX426, the oral prodrug of tezampanel, in the first half of the year; initiate a Phase I multiple dose trial of NGX426 in the second half of the year, and initiate a Phase II trial of NGX267 in xerostomia, or dry mouth, secondary to Sjogren's syndrome in the first half of the year.

At the end of this month, TorreyPines announced that with the conclusion of the discovery-phase GSM collaboration with Eisai, it will streamline operations by handing out pink slips. Out the door goes Chief Medical Officer Michael Murphy.

"Our 2008 strategic plan builds on the clinical successes of our lead compounds and our on-going genetics collaboration with Eisai while enabling us to be opportunistic and fiscally prudent," said CEO Dr. Neil Kurtz. "Our goal is to exploit the versatility of our product candidates by moving them forward strategically through at least proof-of-concept, while being aggressive in our pursuit of corporate partnerships."

- see this release
- check out the report from

Related Articles:
TorreyPines strikes IP deal with CalciMedica. Report
Axonyx and TorreyPines agree on merger. Report

Eisai faces delay for cancer drug

Fri, 01 Feb 2008 06:59:55 -0500

The FDA has delayed Eisai's NDA submission for E7389 (eribulin mesylate) for third-line treatment of advanced breast cancer. The company was hoping to gain accelerated approval for the drug, but can't because Bristol-Myers Squibb won approval for another drug for the same indication last October. The drug is also in Phase II trials for prostate cancer.

- see this release for more

Related Articles:
Eisai expands U.S. ops with $3.9B MGI buyout. Report
Eisai acquires Morphotek in $325M deal. Report
Eisai plans $105M expansion in NC. Report

ALSO NOTED: Agennix OK'd to launch late-stage lung cancer trial; QLT reorganizes; Ventana still resisting Roche bid; and much m

Thu, 17 Jan 2008 06:59:50 -0500

> Houston-based Agennix has been given a green light to launch a late-stage trial of a new therapy for lung cancer that includes an ingredient found in mother's milk. Talactoferrin closely resembles human lactoferrin, which establishes a baby's immune system. Report

> QLT is laying off more than a hundred workers and selling its QLT USA division and its Vancouver HQ is it undertakes a restructuring that will leave it focused on marketing Visudyne. Report

> Roche has extended its offer for Ventana Medical Systems, but Ventana is still urging shareholders not to tender their shares. Report

> Targacept has priced an offering of 3.8 million shares at $7.07 apiece. Report

> Eisai's takeover of MGI Pharma has been approved by federal regulators. Report

> RNCOS estimates that the global vaccines market should hit $21 billion by 2010. Report

> Doctors overprescribe brand-name meds, and it's pharma's fault. Or so says a new report from the UK's Committee of Public Accounts. Report

> Did Schering-Plough execs peek at the Vytorin trial data and, spooked, bail out of millions worth of stock? Report

And Finally… In what may become the most far-reaching effects of the failed Vytorin trial, experts are questioning the sacred link between cholesterol and heart disease. Report

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

ALSO NOTED: CMC to boost production at Bothell facility; Eisai buys antibody; Vectura pockets milestone, equity pay; and much m

Tue, 04 Dec 2007 06:59:50 -0500

> The Copenhagen-based CMC Biopharmaceuticals says it plans to increase production of therapeutic proteins after buying the former Icos's plant in Bothell. Icos was acquired at the beginning of the year by Eli Lilly. Report

> Japan's Eisai has acquired the rights to an antibody therapy for Alzheimer's from Sweden's BioArtic Neuroscience. Report

> Skystar BioPharmaceutical has established a new research and development center in Shanghai. Release

> Vectura Group has picked up €15 million from a milestone payment and equity investment by Boehringer Ingelheim. Report

> Biomarin Pharmaceutical and IGAN Biosciences have started to develop an IgA protease for treating kidney disorder. Report

> Blocking a single critical protein reversed the effects of aging on the skin of mice, suggesting that researchers may be on to a short-term therapy that could help older people heal from an injury. Report

> Scientists at Johns Hopkins were able to damaged skulls by transplanting human embryonic stem cells directly to the site of massive injuries. Report

> Merck issued its initial earnings outlook for 2008 today, and in it specifies Fosamax sales at $1.1 billion to $1.4 billion, down from $2.9 billion to $3.1 billion in 2007. Report

> Look, world--our house-cleaning is working. That's what China's drug regulators are saying today with a new, statistics-filled report. Report

And Finally... In one of the most closely watched research programs at a biotech company, Sirtris has unveiled three new chemicals that could play a big role in fighting the effects of aging and resisting diabetes. Report