Parkinson's

Azilect data points to Parkinson's efficacy

John Carroll — Tue, 26 Aug 2008 11:12:18 -0400

Teva Pharmaceutical is touting the results of a late-stage study of Azilect, a treatment for Parkinson's disease. Researchers say the therapy hit all of its goals in the ADAGIO trial. Patients taking a once-daily oral dose of the drug reported a slowing of disease progression early on in the trial with a reduction in symptoms at a later point in the trial. The drug is already approved for treating symptoms of the disease, but Teva is looking to add an approval for disease modification.

- read the AP report

Bayer dumps Titan drug on mid-stage failure

John Carroll — Wed, 02 Jul 2008 10:55:28 -0400

Titan Pharmaceuticals announced this morning that its Parkinson's drug Spheramine failed to hit primary and secondary endpoints in a Phase IIb trial for moderate to advanced Parkinson's disease. Researchers said there was no significant difference in response between the Spheramine group and the placebo arm. Titan says that it will analyze the data gathered on the 71 patients in the study.

Bayer, for its part, swiftly washed its hands of the program. "We will not develop (this drug) further and we will not invest in it further," said Bayer spokesman Jost Reinhard.

- see Titan's release
- read the report from RTT News
- and check out the story from AFX

Related Articles:
Titan discontinues Phase II
The Biotech Haunted House

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

Study finds big gaps in clinical trial process

Thu, 03 Apr 2008 07:59:57 -0400

A new report out says that the clinical trial process routinely ignores women, the elderly, minorities, the disabled and people living in rural America. And the practice of ignoring large groups is creating a trial process that often avoids the very patients the drugs are intended to serve, according to the Chronic Disease Prevention & Control Research Center at Baylor College of Medicine. The elderly, for example, are often excluded from trials that test new drugs for Alzheimer's, Parkinson's and other conditions that primarily afflict older people. Excluding minorities, meanwhile, skews the data in such a way that trials fail to discover how genetics and cultural factors can affect outcomes.

"We've got a big problem," said Daniel S. Goldberg, chief policy adviser for the report. "And it's extremely urgent that we fix it. Because we're trying to figure out how to streamline healthcare and make people healthy, of course. And the fact that we have under-representation in clinical trials undermines both of these goals and undermines the quality of the evidence we come up with."

Altogether there are some 80,000 clinical trials mounted every year in the U.S. Many are duplications of other trials that have already been completed or are underway. And less than one percent of the population is recruited to participate.

- read the article in the Washington Post

Related Articles:
Researchers fight for ethnic diversity in trials. Report
Report: FDA lax in clinical trial oversight. Report
Safety oversight a rare feature in child drug trials. Report
Duke, FDA join forces to overhaul clinical trials. Report

Developers could face surge in clinical trial lawsuits

Thu, 31 Jan 2008 06:59:57 -0500

A surge in early-stage drug testing could well set the stage for a spike in lawsuits from patients who feel they've been hurt by the drugs they're volunteering to test, says a new report in The Wall Street Journal. The article starts off with the lawsuit brought by the family of Suzanne Davenport, who says she was hurt by an experimental medication for Parkinson's. Plaintiffs generally have a hard time making these charges stick, particularly as it's often difficult to link any worsening in their condition to the drug rather than the disease. Plaintiffs attorneys, though, are seeing plenty of fresh opportunities in the drug testing arena.

- read the report from The Wall Street Journal

Related Articles:
Report: FDA lax in clinical trial oversight. Report
Financial conflicts raise questions over trial results. Report

SPOTLIGHT: Merck partners with Addex

Mon, 03 Dec 2007 06:59:53 -0500

Addex Pharmaceuticals' approach to receptor modulation has been validated in a new deal with Merck. The pharma giant will pay $3 million up front, and up to $170.5 million in fees and milestones, in a collaboration to develop new therapies for Parkinson's disease. Switzerland-based Addex has been working on new technology that can modulate a receptor, rather than just turn it on or off. The new approach can fine tune the impact of a drug, which in turn could increase efficacy and decrease side effects. Release

ALSO NOTED: What to expect from Pfizer's new CFO; BrainStorm plans stem cell trials; Phoenix biotech plans San Diego move; and

Thu, 23 Aug 2007 06:59:50 -0400

> Newtown, PA-based CollaGenex says that it has reaped positive data from a mid-stage study of Col-118 for the treatment of erythema. Release

> BrainStorm Cell Therapeutics says it's on track to become the first developer to win approval for clinical trials on a new Parkinson's therapy that uses adult stem cells extracted from the patient. Report

> Ribomed Biotechnologies says the loss of its Phoenix lab space is forcing a move to San Diego. Report

> Cephalon says it is buying the North American rights to Amrix, a muscle relaxing drug, from ECR Pharmaceuticals for $100 million. Report

> Clinical Data is building its biomarker business with the $11.84 million acquisition of Epidauros Biotechnologie. Release

> Nucryst Pharmaceuticals has named Thomas Gardner as chairman, president and CEO. Release

> Alltracel plans to buy Synpart, an oral care business. Report

> It might sound like a candidate for the So What? award, but the FDA's approval of the "atypical" antipsychotic Risperdal for use in children and adolescents is a landmark decision. Report

> As Frank D'Amelio takes over as Pfizer's financial fix-it guy, what changes are in store for the company? FiercePharma

And Finally… Scientists are deeply skeptical, but China's Beike Biotechnology has been touting miracle cures spurred by stem cell therapies that are still years away from approval in most other countries. Article

New tests planned after Parkinson's drug fails trial

Wed, 22 Aug 2007 06:59:58 -0400

Merck KGaA and its development partner, Newron, say that a late-stage study of their experimental therapy for Parkinson's failed to demonstrate any significant effect. But the two developers refuse to walk away from safinamide. Researchers are planning to mount new trials with lower doses to find the right formula.

"The primary endpoint, time to intervention, did not reach statistical significance when data from both safinamide dose groups were pooled," the companies said, after reviewing 18 months of combined data from patients taking the 50-100 mg and 120-200 mg doses. But researchers said that a lack of response among patients taking the highest dose could have skewed the data. Adding safinamide to dopamine agonist therapy at 50-100 mg daily could delay the time to therapeutic adjustment.

- see the release on the trial data
- read the AFX report

Related Articles:
Italy's Newron gains $99 million in IPO. Report
Newron launches a Phase III trial on eve of IPO. Report
Serono licenses Newron Parkinson's therapy. Report

Press Release: Roche and Synosis Therapeutics Announce Partnership to Explore Potential of Five Compounds Targeting the CNS

Maureen Martino — Fri, 05 Jan 2007 11:53:10 -0500

Roche and Synosis Therapeutics Announce Partnership to Explore Potential of Five Compounds Targeting the Central Nervous System

BASEL, Switzerland and SAN FRANCISCO, CA, USA -- Roche and Synosis Therapeutics today announced a new partnership that could lead to the development of treatments for schizophrenia, cognitive disorders, Parkinson's, drug dependency and pain

The broad partnership centres on five drug candidates that Synosis will acquire from Roche, including four phase 1 molecules, which target the central nervous system (CNS). Roche had discontinued the development of these compounds in previous reprioritization processes. Under the terms of the deal, Synosis will be responsible for the clinical development and, in some cases, commercialisation of the drug candidates in multiple indications. Roche will retain the right to opt-in to two pre-selected programs. Financial terms of the deal were not disclosed.

"By partnering with Synosis, we're giving these potential medicines the best chance of success by creatively extending our innovation base in an important therapeutic area," said Peter Hug, Roche's Global Head of Pharma Partnering. "There is a real need for new treatments for CNS diseases, such as schizophrenia and Parkinson's, and we're excited by the potential of this partnership."

Dr Ian Massey, Chief Executive Officer of Synosis Therapeutics said: "Roche has a long and distinguished record in the field of CNS discovery. Our combined understanding of the possibilities of these programs in addition to Synosis' focus on translational medicine gives us the opportunity to explore their full therapeutic potential."

One of the founding investors Brad Bolzon, Managing Director of Versant Ventures, said:

"Unlike the traditional licensing model, this deal shows how venture capitalists and pharma can build partnerships based on a whole portfolio of promising clinical-stage drug candidates. This investment should unlock the potential value of these compounds in new indications."

Terms of the Agreement

Under the terms of the agreement, Synosis will assume responsibility for the clinical development of the five drug candidates. Roche retains the right to opt-in to potential products resulting from two of these programs on completion of agreed milestones. Synosis retains full commercial rights to three pre-selected programs and can bring these products to market either alone or with a partner. Financial terms were not disclosed.

About Synosis Therapeutics

Synosis Therapeutics is a privately-owned, drug development company, focused on developing new treatments for disorders of the central nervous system. Its leadership team has over 180 years of combined experience in drug development, including senior roles at Roche and Novartis. Synosis has offices in Basel, Switzerland, and is headquartered in South San Francisco, CA. The company was spun out of EuroVentures Inc., a wholly-owned incubator of Versant Ventures. Synosis Therapeutics has raised $32.5 million funding from Versant Ventures (Menlo Park, CA), Abingworth Management (London), 5AM Ventures (Menlo Park, CA) and Novo A/S (Copenhagen, Denmark). For more information, visit www.synosis.com

About Roche as a Partner

Roche is a valued partner to around 80 companies worldwide. Over the past two years, Roche has led the pharmaceutical industry in the number of clinical compound deals signed. In 2006, Roche entered into nine partnerships to jointly develop products for optimal patient benefit and value. Partnerships continue to strengthen Roche's positions in oncology, virology, transplantation, and primary care. Roche's partnering culture encourages innovation through a unique pairing of collaboration and autonomy.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com)