multiple sclerosis

BioMS wins $10M milestone on pivotal trial progress

John Carroll — Thu, 14 Aug 2008 11:13:04 -0400

According to BioMS Medical, an independent monitoring board has recommended that a phase II/III study of dirucotide (MBP8298) in patients with secondary progressive MS should continue to completion. And that milestone is worth a $10 million payment from Eli Lilly, which is partnered on the project.

The interim analysis assessed the likelihood of the study reaching its primary endpoint in patients with a particular immune response genes. The DSMB analysis also included a scheduled review of safety information.

- check out the BioMS release

Merck Serono, Bionomics partner on MS programs

John Carroll — Wed, 18 Jun 2008 11:45:34 -0400

Merck Serono has signed up with Bionomics in a quest to develop new therapies for multiple sclerosis. Bionomics gains $2 million upfront, committed research funds and a partner who will pay up to $47 million for each new program they pursue. The collaboration will target the potassium ion channel Kv1.3, a key modulator of the immune system.

"This partnership with Bionomics reflects our long-term commitment to patients with MS as Kv1.3 inhibition represents an innovative approach for the discovery of oral compounds in the field of MS," said Dr. Bernhard Kirschbaum, executive vice president research at Merck Serono. "This R&D collaboration brings together Bionomics' expertise in Kv1.3 biology and Merck Serono's expertise in MS pharmacology in a combination that could speed up progress in the identification of novel drug candidates for the treatment of MS."

- see the release

Biovail focuses on CNS drugs

Maureen Martino — Fri, 13 Jun 2008 12:34:15 -0400

As the battle for Biovail continues, current CEO William Wells emphasized the company's focus on CNS drug development at Goldman Sachs' annual healthcare conference. Biovail is investing $600 million over the next four years for work on epilepsy, multiple sclerosis, and Parkinson's. Wells said the company will "maintain its drug delivery technology but [will seek] to license it or use it for drug development."

Biovail's development plans, however, hardly seem to be the focus these day. Found Eugene Melnyk launched a proxy battle for the company recently and is looking to sweep out its board and senior management. Melnyk has a dissident group of shareholders backing him, while the current management urges shareholders to reject Melnyk's interference. The fight will come to a head at annual shareholder meeting on June 25, when shareholders vote on the company's future management.

- see the CNNMoney article

ALSO NOTED: Acorda shares soar; Lexicon wins fast track; NIH grants $533N in research funds; and much more...

Tue, 03 Jun 2008 06:59:50 -0400

> News yesterday that Acorda Therapeutics' experimental MS drug helped patients walk better sent its shares up 27 percent. Report

> The FDA has provided fast-track status to Lexicon Pharmaceuticals' therapy for carcinoid syndrome. Story

> Cougar Biotech says it presented positive Phase I and Phase II data for CB7630, an experimental therapy for castration resistant prostate cancer. Release

> Arana Therapeutics and Greenovation Biotech have forged a pact to develop up to five anti-cancer antibodies. Report

> China's Genesis Pharmaceuticals Enterprises has raised $30 million in a private placement. Release

> Novartis "stole the show" at ASCO, Forbes says. Between the big Zometa news--that the bone drug may actually prevent breast cancer recurrence--and dramatic data on an experimental med, the Swiss pharma came out of ASCO looking pretty sweet. ASCO report

> Guess who's the new up-and-comer in pharma? Brazil. Report

> It's not a new question, but it's one whose urgency is growing: How long can Pfizer pay its big dividend? Report

> Eugene Melnyk (photo) said he'd do it, and now he has. The founder of Canada's Biovail launched a proxy battle for the company, looking to sweep out its board and senior management. Report

And Finally… The Scripps Transitional Research Institute was one of 14 research groups that will gain $533 million from the NIH over five years. The funds are earmarked to speed the development of new technologies. Report

SPOTLIGHT: Novartis touts new MS data

Wed, 16 Apr 2008 06:59:53 -0400

Researchers at Novartis say that after three years of therapy in an ongoing Phase II study, the oral FTY720 demonstrated positive results for patients with multiple sclerosis. Data demonstrate that 73 percent of patients who began the study on FTY720 5 mg remained free from relapses after three years. Release

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

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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

Bad trial design faulted for GW's Phase III failure

Tue, 08 Apr 2008 06:59:58 -0400

Blindsided by a big placebo effect, GW Pharma says its lead therapy Sativex for pain narrowly missed hitting the goal of statistically significant improvement for patients with multiple sclerosis. The news ripped right into the company's stock price, with shares plunging more than 20 percent after the numbers were released. Half of the patients in the trial reported a 30 percent reduction in pain, but so did about 45 percent of the placebo group.

The trial design may be the primary culprit, points out The Times. Volunteers were allowed unlimited access to under-the-tongue spray, allowing the placebo group easy access to an alternative therapy. Sativex, a therapy derived from cannabis, will now be studied for MS spasticity and cancer pain.

- see the release
- read the report from Hemscott
- and check out the story from The Times

Related Articles:
GW inks $273M deal for Sativex. Report
FDA approves late-stage Sativex study as GW seeks partner. Report
New Sativex trial planned. Report
Sativex faces more delays. Report

Q Therapeutics raises $15M

Fri, 15 Feb 2008 06:59:55 -0500

Salt Lake City-based Q Therapeutics has raised $15 million in a second round of financing. The company is developing cell-based therapies for the central nervous system. It is currently running preclinical studies and hopes to file an IND for a treatment for transverse myelitis, a rapidly paralyzing subset of multiple sclerosis. Q expects clinical trials to begin in 2009. VSpring Capital led the round, and Invitrogen was among a group of investors that also participated.

"This investment will help accelerate our efforts to bring important new treatments to the clinic for these extremely debilitating neurodegenerative diseases. As a leader in providing many of the necessary tools for stem cell research and production, Invitrogen's participation will further enhance our development going forward."

- see this release for more

Related Articles:
Invitrogen puts up $57M for CellzDirect buyout. Report

Lilly sees pipeline hope in MS drug

Mon, 11 Feb 2008 06:59:54 -0500

An article in the Indianapolis Star details Lilly's development program for MBP9289, a multiple sclerosis drug offering hope to both patients and a drug developer that hasn't launched a new drug for humans since 2005. MBP9289 is currently in Phase II and III trials and has shown promise in delaying progression and worsening of MS. The opportunity here for Lilly is huge--roughly 2.5 million people worldwide have the disease, and MS-related drugs did $6 billion in sales last year. Moreover, those who treat the MS say the disease is under-served by current treatments.

"Given Lilly's prominence in neurosciences, an expansion into multiple sclerosis makes strategic sense," said Linda Bannister, a drug analyst at Edward Jones in St. Louis. "But whether this compound is the answer, it's too soon to say."

- read this IndyStar article

ALSO: Take a look at Lilly's pipeline. Report

Related Articles:
Lilly snares MS drug rights in $497M deal. Report
BioMS gains $38.5 million. Report
Natural protein used to combat multiple sclerosis. Report

Teva snaps up CoGenesys in $400M buyout

Tue, 22 Jan 2008 06:59:56 -0500

Teva has whetted at least part of its appetite for fresh acquisitions with the announcement this morning that it is buying CoGenesys for $400 million in cash. The Israeli generic drug company says the buyout will give it a better position to compete in the fledgling biogeneric field. CoGenesys has drug candidates in the pipeline for cardiovascular disease, multiple sclerosis, diabetes and autoimmune diseases. It uses technology that retains therapies in the body for a longer period of time, reducing dosage requirements.

"CoGenesys' acquisition reflects our commitment to capture the significant long-term prospects we believe the biogenerics market will offer," said Teva CEO Shlomo Yanai in a statement. CoGenesys was a 2007 Fierce 15 company.

- see this release
- read the AP report

ALSO: It took a much sweeter offer, but Roche has prevailed in its bid to buy Ventana Medical Systems. Report

Related Articles:
Teva earmarks $1B for India. Report
Waiting game continues for biogenerics. Report
Dr. Reddy's make risky biogenerics move. Report