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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline

« Good Mistakes? | Main | There's Toxicity and There's Toxicity »

February 7, 2007

Vertex, Hepatitis, and Gripping the Arms of Your Chair

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Posted by Derek

Antiviral drugs are one of those big unmet medical needs that we talk about in the drug industry. The reason we talk about them is, of course, that from a business standpoint - and this is a business, for sure - "unmet need" is equivalent to "unmade profit".

The problem is, the reason that some of these big opportunities are unclaimed is that they're not easy to address. As I've said here before, one big problem with antivirals is that there are a very limited number of good targets for drugs. After all, viruses are pretty stripped-down to start with: they do a limited number of things, but they do them very well indeed. Compared to a relatively target-rich therapeutic area like cancer, infectious disease is a desert.

One well-known oasis, though, contains the viral proteases. Many viruses carry these as a key part of their machinery, to help "unpack" necessary proteins from larger precursors. Famously, that's how many of the anti-HIV drugs work, and the same general strategy should be applicable to several other viral types.

Hepatitis C has been one of the big targets for many years now. Various development programs have come and gone, but no one has been able to really nail this one. Vertex is now in the middle of trying to, and as Adam Feuerstein points out, they're really betting a large part of the company on the attempt. Over the next few months, results should start coming out for their PROVE trials of telaprevir (VX-950), and for Vertex's sake, the drug had better work. A herd of competitors, probably led by Schering-Plough, is ready to take over should anything slip.

"Work" is defined as "work well enough so that people don't have to take injections of interferon". That'll depend, as always, on the balance of efficacy and toxicity, and it's the side effect profile that everyone will be watching, since it's widely assumed that the drug will in fact do some good against the disease. The nerve-wracking thing about working for a small-to-medium sized company has always been that your future ends up depending on single events like this, and I wish everyone at Vertex good luck. (Of course, as people at Pfizer will tell you, your future even at a gigantic company can end up depending on the results of one clinical trial - this industry is getting altogether too exciting for a lot of people to take).

Comments (12) + TrackBacks (0) | Category: Clinical Trials | Infectious Diseases


COMMENTS

1. milkshake on February 7, 2007 10:00 AM writes...

I am amazed this stuf is actualy orally-available.

Permalink to Comment

2. MolecModeler on February 7, 2007 10:09 AM writes...

Yeah for real, I'd figure it would get proteased out in a hurry. AFAIK these keto-peptides are not a novel structural class.

Permalink to Comment

3. Anonymous on February 7, 2007 10:52 AM writes...

Dosing is a real problem. I think currently it's a 750 mg horsepill QD. There was a push to try TID though.

Alot of the message boards (investor and HepC paient sites) are talking about a nasty rash as a side effect.

Permalink to Comment

4. Anonymous on February 7, 2007 11:41 AM writes...

I wouldnt be surprised if Vertex' protease inhibitor will crash and burn like BI's.

Somebody once speculated that all HCV protease inhibitors are likely to have adverse cardio-vascular events.

Lets see how it goes but if I were Vertex, I would be looking for backups.

Permalink to Comment

5. Anonymous on February 7, 2007 1:46 PM writes...

I believe it is 450-750 mg TID

Permalink to Comment

6. Pfizerbull on February 7, 2007 10:49 PM writes...

You want to know what will be the biggest antiviral drug company in the world in 10 years...Alnylam Pharma.

RNAi is perfectly suited for the development of antivirals. Results for the crucial Human clinical trial (initially for RSV) will be out within 12-18 months. If it works, the floodgates will open and RNAi will be used against any and all RNA viruses. Wait and see. Small molecule antivirals will be out like the cart and buggy.

Permalink to Comment

7. billy on February 9, 2007 2:06 PM writes...

PPHM-

Bavituximab is about to release IB results, monotherapy. IA were stellar...May be Intereferon replacement...

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8. david on February 12, 2007 11:57 AM writes...

Watch what happens to InterMune--it will follow whatever happens to the Vertex drug

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9. Anonymous on February 12, 2007 5:45 PM writes...

WRT Alnylam and RNAi, while I admire some people's enthusiasm, can anyone offer cogent reasons to expect that RNAi will not run into the same problems encountered by previous RNA-based therapies (delivery, PK, distribution,? Simply being different may be necessary to succeed where others have failed, but it usually isn't sufficient.

Permalink to Comment

10. kbr on March 9, 2007 9:30 PM writes...

All the test results refer to HCV and not what type of HCV

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11. riggns on April 27, 2007 11:57 PM writes...

I just hope they hurry for those of us suffering with this terrible virus and who have endured interferon treatments.....Gods speed to all of them, vertex, intermue, schering, etc etc.

Permalink to Comment

12. wavefunction on October 4, 2007 2:23 PM writes...

So what happened to this? Any updates?

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