Vertex/Telaprevir Plan B

[jmjm530]

http://www.reuters.com/article/marketsNews/idINN1948277620080619?rpc=44

SAN DIEGO, June 19 (Reuters) - Vertex Pharmaceuticals Inc (VRTX.O: Quote, Profile, Research, Stock Buzz) will be prepared to launch its experimental hepatitis C drug next year even though U.S. regulators have not said whether they would review it based on a mid-stage trial, the company's chief executive said.

"That's Plan B," CEO Joshua Boger said late on Wednesday at an event at the BIO International Convention in San Diego.

He said Plan A continues to be completion of a pivotal trial of the drug, telaprevir, in hepatitis C patients not previously treated, with data expected in the first half of 2010. If positive, Vertex would then file for regulatory approval in the second half of 2010.

But the company "has to be ready," despite the expense, to launch in the third quarter of next year should the U.S. Food and Drug Administration agree to a faster timeline, Boger said.

Vertex last week reported positive interim results from a Phase 2b study of the drug in hard-to-treat patients who failed to respond to prior treatment, leading many observers to expect accelerated approval of the drug.

The interim results found 52 percent of the patients who received telaprevir as well as the standard interferon/ribavirin combination had undetectable levels of the hepatitis C virus after 36 weeks, compared with 30 percent of patients treated only with the standard therapy.

Boger said Vertex expects to take the final data from the trial to the FDA late this year or early next year.

Should the agency agree to review it, he said the application would be only for patients who have stopped responding to other therapies.

Boger said preparing Vertex to scale up for a launch next year is expensive, but needs to be done because having telaprevir on the market as soon as possible will save lives.  

epatitis C is a viral infection of the liver. An estimated 170 million people worldwide are chronically infected with the hepatitis C virus, according to the World Health Organization.

Vertex is developing telaprevir in partnership with Johnson & Johnson (JNJ.N: Quote, Profile, Research, Stock Buzz). (Reporting by Deena Beasley; Editing by Braden Reddall)

[foofighter]

I am a 1A.  I meant being a 4/cirrhotic with PHT. And I know that statistics are just statistics, but I want to make this darn treatment decision armed with as much info as I can get. And I gotta say the docs haven't been much help (with the exception of HR).

Last week Hector posted one of the best links I have visited (for my situation) since I found this board in 06. Although it was a little disheartening ANYBODY that is a stage 4 should view this. At first I thought, well this isn't me, this is for people who are way sicker. But the whole first half is for anyone that has been diagnosed with cirrhosis:

http://www.uctv.tv/search-details.asp?showID=14086

Good for me though as sometimes I am a little too much of Pollyanna. A dose of reality to get me treating. I will be irrationally excited about this with you! I have an appointment with a new doc on Monday and believe me, we will be discussing this.

And you are right, I am lucky and I will beat this thing. Don't know the battle plan quite yet, but am prepared and I will win!

[willows]

When you say quick get started treating, are you expecting less than wonderful results with soc?  I know they figure now that geno 4's are as hard to tx as geno 1's, but I've got good thoughts for you and treatment.  I always pick the sunny side of stuff.....any other perspective is too hard to maintain...it's easy to be COMPLETELY POSITIVE  that you will have wonderful luck.  I just know it.

Willow

p.s.  perhaps I am irrationally excited about all this, but I think it is one good step in an arena frightfully devoid of any good news.  Makes my day.

[foofighter]

Thanks for this Jim. I was so excited (it's no secret how I feel).

And as important as it is to me, it is more important for so many others. There are a lot of stage 4's out there that have failed and desperately need a new drug, so I pray that this is the magic bullet.

Actually made me think I should quick get started treating. I know it seems negative but odds are pretty stacked against us 4s. Now if I am a nonresponder it might not be as hard to handle, knowing there might be  a "Plan B" in the not too distant future.

Yes Willow, very hopeful news indeed.

Foo

[willows]

I read the article on Yahoo and was kind of excited.  There has been hints and comments here and there about Vertex asking for approval for Telaprevir for non responders, but this was the first article (other than the conference calls) that specifically gave a time frame.  I'm still excited!!

I'm crossing my fingers for this..some good news after a long long while of not much good news.

Willow

[Marcia2202]

thanks for posting these news.

marcia