[imark3000]

So they have com together(MedGenesis Therapeutix ,Biovail , Amgen ) after long time settling the money aspect of business while we hold our breath and touch wood that they will deliver a drug that will save our life ..

MedGenesis, Biovail to work together on a treatment for Parkinson's disease
(CP) – 1 day ago

VICTORIA, B.C. — MedGenesis Therapeutix Inc. says it's collaborating with Biovail Corp. (TSX:BVF), Canada's largest publicly traded pharmaceutical company, on developing a new way to treat Parkinson's disease.

The two companies have also struck licence agreements with Amgen Inc. (NASDAQ:AMGN) of Thousand Oaks, Calif.

..
MedGenesis is a privately held biopharmaceutical company that's focused on treatments for diseases of the central nervous system (CNS).

Biovail has a broader range of drug products for the treatment of depression, heart conditions and other health issues.

MedGenesis announced Tuesday that it has received a worldwide licence for GDNF (glial cell line-derived neurotrophic factor) protein from Amgen, which will now own a small equity stake in MedGenesis as a result.

"This license of GDNF from Amgen presents MedGenesis and Biovail with an exciting opportunity to develop a potential breakthrough therapy for the treatment of patients with Parkinson's disease," said Erich Mohr, chairman and chief executive of MedGenesis.

MedGenesis has also granted Biovail a license to its Convection Enhanced Delivery (CED) platform for use with GDNF to treat central nervous system conditions, initially Parkinson's disease.

CED is a technique for providing targeted, local treatment for central nervous system conditions such as epilepsy and brain cancer.

[Bob Dawson]

Do they view clinical trials the same way Amgen does? They should at least inform the next group of volunteers what happened to the first group of volunteers.
The name on the letterhead has changed. It is no longer Amgen, it is a nice Canadian company, partly owned by Amgen. Canada does not allow massive lawsuits. Amgen also leased the thing to a company in Holland, who seem to be a nice bunch.
But these are leases, I think. :Amgen still has a monopoly.
As they continue to insist that their conduct towards the volunteers was the right thing to do, it is not probable that this will end well. And poor Bio-Vail -= Canada's pride - they never see it coming, ever. They are not too bright. There is a nice bridge in Brooklyn I could sell them
Wonder if new volunteers are lining up for this one.
Probably some dumb Canucks.
Note: I am perfectly calm.

[Bob Dawson]

Oh, it's a match made in heaven. Love at first sight:
wikipedia:

SAC/Gradient Analytics lawsuit and SEC complaint
In March 2006, CBS program 60 Minutes featured Biovail in a story about its lawsuit against hedge fund SAC and Camelback (now known as Gradient Analytics), among others. According to Melynk , "there’s a group of people that got together and essentially attacked the company by putting out false reports, and we’re just fighting back for our shareholders." [1]
The alleged conspiracy began with Camelback, an Arizona stock-analysis firm that advertises that it publishes impartial financial reports on companies to help investors evaluate stocks. In the spring of 2003, the hedge fund SAC asked them for a report on Biovail. Darryl Smith, Mark Rosenblum, Demetrios Anifantis, and Robert Ballash, former Camelback employees, alleged that Camelback had allowed their client SAC to determine the content and timing of their reports on Biovail.[1]
Camelback said those former employees were lying and disgruntled, that Anifantis and Ballash were fired because of unethical conduct; Smith for poor performance; Rosenblum was laid off. These four say they were let go after they complained to their superiors about Camelback’s practices. SAC denied all the charges in Biovail's lawsuit and said that the decline in the Biovail's stock was due to earnings shortfalls and regulatory investigations.[1]
In March, 2008, the U.S. Securities and Exchange Commission sued Biovail and some of its former officers, alleging that "present and former senior Biovail executives, obsessed with meeting quarterly and annual earnings guidance, repeatedly overstated earnings and hid losses in order to deceive investors and create the appearance of achieving earnings goals. When it ultimately became impossible to continue concealing the company's inability to meet its own earnings guidance, Biovail actively misled investors and analysts about the reasons for the company's poor performance." Biovail settled for $10 million US. [2] Gradient Analytics, successor to Camelback, issued a press release stating that the SEC’s suit "confirms the validity of Gradient’s critical analysis of Biovail but raises serious questions about how companies retaliate against analysts with threats, intimidation, and lawsuits."[3][4]
60 Minutes has been accused of botching the Biovail story by the Columbia Journalism Review's Audit columnist and the New York Times's Joe Nocera, who felt Lesley Stahl accepted Biovail's conspiracy theories about short sellers without proper consideration.[5][6][7]
Legal issues
A class action suit has been filed against Biovail by investors who between December 14, 2006, and July 19, 2007, bought Biovail stock, alleging that the company had failed to disclose that the multi-dose study on depression drug Aplenzin would not be sufficient for the FDA to approve it.[8]
[References
1. ^ a b c "Betting on a Fall", Lesley Stahl, 60 Minutes story on Biovail lawsuit
2. ^ SEC Charges Biovail Corporation and Senior Executives With Accounting Fraud, U.S. Securities and Exchange Commission press release, March 24, 2008
3. ^ Gradient Analytics' Early Research Identified Same Issues as Charges in SEC Complaint Against Biovail. SEC Credits Analysts Who Questioned Biovail, but Retaliation Against Independent Researchers Through Lawsuits Continues, Gradient Analytics press release, March 25, 2008 (PDF)
4. ^ U.S. and Canada Accuse Drug Maker of Fraud, Ian Austin, New York Times, March 25, 2008
5. ^ 60 Minutes Blows Biovail Story
6. ^ 60 Minutes’s Biovail Trainwreck (cont.)
7. ^ http://select.nytimes.com/2006/04/01...nd&oref=slogin
8. ^ http://www.forbes.com/feeds/ap/2008/...ap5530646.html

[aftermathman]

at the Royal school of medicine that Stephen Gill was working on a new method of GDNF delivery.

Stephen was one of the biggest supporters of GDNF and was the primary player in the phase I trials. He believed the delivery mechanism was flawed at phase II.

He is listed as a scientific advisor in this venture.

He appears to be the best hope in neurotrophic compounds that the UK has to offer.

My main complaint is the waste of 5 years however this has to be good news.

All power to the canucks.

Neil.

[Bob Dawson]

Stephen Gill is a paradox, and not in the sense of 2 doctors - that would be pairofdocs.
He was the first, most successful booster of the success of GDNF, but as Nick Nelson relates in Monkeys in the Middle, Gill did not speak out at the trial or say in public what he would say in private - that Amgen was wrong, and that the experiment should continue. And yet Gill was very honest in saying that he did not want to burn bridges with Amgen, because they were on possession of the rights to the drug that Gill's patients took longer than anyone else and with better results. Gill seemed to have made a strategic decision about how to handle the crisis, and he may have accurately deciphered the best way of keeping a drug alive in that jungle. We have lost 5 years; it is good that Gill will share his unquestionable expertise by participatinig in this project. But, all of the same processes can take place again. Amgen won with ease, their battle against the volunteers. Nothing has changed since. So will the results be the same? Amgen pulls out at the last minute, leaves the volunteers shattered, and everyone is bitter and nothing is done... And then we lose another 5 years? Their PR people should tell them to have a look at that.
And as corny as it might sound, just a simple salute or recognition of the bravery of the 48 volunteers and at least a smidgen of regret that their lives were thrown into such turmoil - they offered up their living bodies for the experiment and then were treated in a manner that was quite stunning. Or was it all okay, as Amgen says, and so is still okay, and so will happen again. I'm not talking lawsuits or corporate hara-kiri. I'm just talking about putting a bit of common sense and ordinary politeness and consideration into a process where the last batch of volunteers we sent were treated like cattle. It is a bit of a branding problem, in marketing terms. The "new improved" GDNF - sounds great. "THIS time you can trust us." I want to believe, oh Lord, I want to believe.

[Fiona]

Bob - uh..yeah. What you said.

Thanks, Imad, for posting this.

[aftermathman]

"Stephen Gill is a paradox, and not in the sense of 2 doctors - that would be pairofdocs".