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ADAM
- 28 Dec 2005 17:45
See www.ukbiotechs.com - a nice site dedicated to the discussion and informtion on UK Biotechs
Enter into the 2006 Biotech Investor Challenge at Biotechs.com
I currently have interests in ARA, ASM, AZM, CENS, PTI and VER (Last Updated 27/12/2005)
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ADAM
- 10 Aug 2006 08:42
- 19 of 21
By Stephanie Kirchgaessner and Christopher Bowe
FT.com
Published: August 8 2006 19:26 | Last updated: August 8 2006 19:26
The criminal investigation into Bristol-Myers Squibb and Sanofi-Aventis centres around the disclosure by a generic drugmaker that it had secured a verbal agreement with them over an authorised generic version of their blockbuster drug Plavix.
For regulators at the Federal Trade Commission, last months revelation by Canadas Apotex, which has been fighting to enter the market for Plavix, was significant enough to alert criminal investigators at the Department of Justice.
Just a few days later, having secured a warrant from a judge, the FBI raided the offices of the chief executive and another senior officer at Bristol and sent subpoenas to the offices of Sanofi. The companies jointly market Plavix, the worlds second-biggest selling drug.
The companies involved in the probe have not been charged with wrongdoing. But a person familiar with the investigation says prosecutors are examining whether Bristol-Myers and Sanofi sought to arrange a side agreement with Apotex in order to secure regulatory approval of a legal settlement both companies knew was out of favour with the FTC, but was critical to their profits.
For investors, the legal wrangling over the future of Plavix appeared to have ended last March, when Bristol-Myers and Sanofi announced that they had agreed what is known as a reverse settlement with Apotex. Although such settlements are legal, they are heavily scrutinised by the FTC, which has argued that they are anticompetitive, particularly when they include payments to delay generic competition for a blockbuster drug.
Under the terms of the deal, Apotex would abort its legal challenge to the companies patent for Plavix for reimbursement payments of at least $40m.
It also allowed it to launch a cheaper generic version of Plavix almost a year before the blood thinners maximum patent lifespan expired in mid-2012.
What was not disclosed at the time was that the two companies also promised not to launch their own generic version of Plavix to compete with Apotexs generic.
Such authorised generics are increasingly being launched by branded drug companies as a way to counter generic threats. By launching their own low-priced generic drugs, the companies aim to discourage and punish generic rivals.
For Plavix with more than $4bn in US sales this year the provision could have secured Apotexs eventual significant and lucrative revenue stream against price competition from a Bristol and Sanofi generic.
A person familiar with the probe said Bristol-Myers took the authorised generic provision out of its agreement and resubmitted the deal to the FTC in June in the hopes of addressing some of the FTCs early concerns with the agreement.
But the disclosure by Apotex, at the same time, that it had secured a verbal agreement that, in effect, kept the provision alive, prompted the FTC to involve criminal authorities in the probe.
One attorney familiar with the pharmaceutical market said it would be difficult for any criminal prosecutor to prove such an agreement existed without written evidence.
Bristol has said its conduct has been entirely appropriate and that it was co-operating fully with the investigation.
But the probe nevertheless raises the spectre of continued, if not significantly threatening, legal problems for Bristol. The group has expended enormous energy to put behind it a series of legal problems, ranging from shareholder litigation over failed heart drug Vanlev to a federal criminal investigation into an accounting scandal.
Last year the group entered into a deferred prosecution agreement with the US attorneys office in New Jersey to help settle allegations that Bristol manipulated wholesaler inventories of its drugs artificially to boost profits.
Under the agreement, Bristol pledged to abide by strict corporate governance provisions for two years.
The agreement included Peter Dolan, chief executive, relinquishing his role as chairman of the company, a $300m payment to shareholders and the installation of an independent corporate monitor. The monitor, former federal judge Frederick Lacey, did not return calls for comment.
But the prosecution could be reinstated if Bristol is found to have committed any criminal conduct.
The US attorneys office in New Jersey said it was watching the ongoing investigation by the antitrust division of the Department of Justice closely.
Bristol yesterday said it was not possible to assess the impact, if any, of the pending criminal investigation on the deferred prosecution agreement
ADAM
- 26 Oct 2006 12:53
- 20 of 21
Overall the total percentage gain for the companies listed above is -9% YTD.
http://www.ukbiotechs.com/PercentageGains.htm
ADAM
- 03 Dec 2006 10:29
- 21 of 21
Under a month to go and all change at the top of the Biotech Challenge Leader Board.
After leading for most of the year disappointing performances from PTI and AZM have dragged my score down and I am currently now in 3rd place!
http://www.ukbiotechs.com/Leaguetable.htm
Only an outstanding recovery by AZM will save me now.
Also it is nearly time to update the UKBiotechs table for 2007 and I was wondering how many people were find this thread of use as it takes quite a lot of time and effort.
Also the UKBiotechs website is up for renewal soon and I would like to know whether people are using that site as well.
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