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Medical Forum / Diseases and Disorders / Hepatitis / April 2009

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Vertex - Telaprevir news

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Cactus Jammies - 22 Mar 2009 12:52 GMT
Friends,
 The big Pharmas appear to be racing to get their combination therapies out
on the market.  Will this race to package Telaprevir delay the release after
approval until after Vertex perfects their own type of combination therapy?
The Gold Standard is to be able to rid the bloodstream of 99.9% of RNA
virons within 72 hrs. of treatment.  (imagine that!).

cactus jammies ~~~~~~~~~~~~~~~~

From
http://www.hcvadvocate.org/news/newsRev/2009/NewsRev-300.html#_Vertex_Pharmaceut
icals_Closes


Vertex Pharmaceuticals Closes on Acquisition of ViroChem Pharma
http://www.businesswire.com/

-Purchase Price $100 Million and 10.7 Million Shares-

-Vertex Acquires Two HCV Polymerase Inhibitors in Deal-

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated
(Nasdaq: VRTX), completed its acquisition today of ViroChem Pharma Inc., a
privately-held company with two investigational HCV polymerase inhibitors in
clinical development. ViroChem shareholders received $100 million in cash
and approximately 10.7 million shares of Vertex common stock. The shares
issued in this transaction are expected to be available for resale upon
filing of the registration statement.

The acquisition advances Vertex's strategy to pursue novel combinations of
Specifically Targeted Antiviral Therapies for hepatitis C (STAT-Cs) in the
treatment of HCV infection. Vertex now owns worldwide rights to the ViroChem
HCV drug development portfolio, including VCH-222 and VCH-759, which have
demonstrated substantial reductions in plasma HCV RNA when dosed as single
agents and have been well tolerated in early clinical studies to date.
Vertex expects to begin clinical evaluation of novel combination regimens of
its HCV protease inhibitor telaprevir, currently in Phase 3 clinical
development, in the second half of 2009.

About Vertex
Vertex Pharmaceuticals Incorporated is a global biotechnology company
committed to the discovery and development of breakthrough small molecule
drugs for serious diseases. The Company's strategy is to commercialize its
products both independently and in collaboration with major pharmaceutical
companies. Vertex's product pipeline is focused on viral diseases, cystic
fibrosis, inflammation, autoimmune diseases, cancer, and pain. Vertex
co-discovered the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.

Lexiva is a registered trademark of the GlaxoSmithKline group of companies.

Vertex's press releases are available at www.vrtx.com.
////////////////////////////////////////////////////
March 13, 2009
////////////////////////////////////////////

Anadys CEO says in late-stage partnership discussions
http://www.guardian.co.uk
By Toni Clarke

*Says thinks its drug is ahead of VCH-222

*Suggests Anadys worth more than ViroChem

BOSTON, March 13 (Reuters) - Anadys Pharmaceuticals Inc said drugmakers are
lining up to examine, and potentially acquire, its experimental hepatitis C
treatment.

"We're in fairly advanced discussions," said Steve Worland, the company's
chief executive, in an interview on Friday. "Five companies have conducted
formal due diligence, and we have a couple more scheduled."

Worland said the company is wrapping up an important set of drug data that
will be available by the end of March, giving all potential acquirers or
licensing partners the opportunity to assess it on a level playing field.

Anadys's lead product, known as ANA598, is a non-nucleoside polymerase
inhibitor that the company is preparing for mid-stage, or Phase II, clinical
trials.

Many pharmaceutical companies are seeking to develop specifically targeted
antiviral therapies for hepatitis C. Vertex Pharmaceuticals Inc is leading
the charge with a protease inhibitor known as telaprevir that it hopes will
cut current 48-week treatment time for the disease in half.

Earlier this month, Vertex acquired Canadian drugmaker ViroChem Pharma Inc
in a deal valued at about $375 million in cash and stock. ViroChem's lead
product is a polymerase inhibitor known as VCH-222. It is in the early
stages of development.

Protease and polymerase inhibitors block proteins the hepatitis C virus
needs to replicate. Many experts believe the two classes of drug can
complement each other when combined.

The race is on not only to develop leading drugs in each class, but to be
first with a strong combination product.

Worland said the value of the ViroChem deal represents an important
benchmark for valuing Anadys, which currently has a market value of $170
million. He declined to place a value on the company but said ANA598 was
more advanced than VCH-222 and "it would make logical sense" for Anadys to
be more highly valued than ViroChem.

At first glance, however, ViroChem's drug appears to eliminate the virus
more effectively than ANA598. Worland said ANA598 eliminated roughly 99.4
percent of the virus within 72 hours while VCH-222 eliminated 99.9 percent
of the virus.

"They are both extremely potent and the difference is not necessarily a
measure of how they will work in combination," he said.

Vertex believes it will be first to the market with a treatment that
combines its protease inhibitor telaprevir with polymerase inhibitor VCH-222
because telaprevir is the most advanced protease inhibitor in development.
The company argues that the FDA would be more likely to approve a
combination faster if it were familiar with one part of it.

Telaprevir is currently being tested in combination with standard hepatitis
C treatments pegylated-interferon and ribavirin.

Anadys argues that the speed of approval for a combination product will
depend not on the stage of development of the most advanced part of the
combination, but on the "trailing part."

Worland said he believes ANA598 is more advanced than VCH-222, and assuming
Anadys partnered with a company having a more advanced drug, its combination
would be approved faster than a Vertex combination.

"The Food and Drug Administration has been fairly clear about what they want
to see," Worland said. "Both products need to clear certain hurdles and we
believe we will clear them before VCH-222."

Worland declined to identify which companies have conducted due diligence,
but the list could include the combined Merck & Co Inc and Schering-Plough
Corp, whose protease inhibitor boceprevir is slightly behind telaprevir in
development; and Johnson & Johnson, which has rights to telaprevir outside
the United States and Japan. J&J has a second-generation protease inhibitor
in development.

Roche Holding AG is also a big player in hepatitis C. Other interested
companies could include Pfizer Inc, Gilead Sciences Inc and Bristol-Myers
Squibb Co.

Anadys closed 2008 with $27.9 million in cash and expects to end the first
quarter of this year with $20 million.

In afternoon trading, Anadys shares were off 38 cents or 6.4 percent to
$5.60 on Nasdaq. (Reporting by Toni Clarke, editing by Gerald E. McCormick)
C K - 07 Apr 2009 03:09 GMT
Thank you for this article...I am waiting for this drug to be available
to me.
Cindy
Cactus Jammies - 07 Apr 2009 03:51 GMT
> Thank you for this article...I am waiting for this drug to be available
> to me.
> Cindy

Well that's two of us and I think the line-up goes from New Jersey to
Montana, single file.

maybe another year?  shorter tx, perhaps a new 'riba'?

cactus jammies
Thip - 07 Apr 2009 11:43 GMT
>> Thank you for this article...I am waiting for this drug to be available
>> to me.
[quoted text clipped - 6 lines]
>
> cactus jammies

There's definitely a line extending from Georgia too.
 
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