Monday, November 29, 2010

Vertex Pharmaceuticals and Telaprevir. A protease inhibitor for Hepatitis C.







In the absence of any major news today, I decided to take a look at Vertex Pharmaceuticals VRTX.

In summary,  whilst Vertex is not a binary event biotech company, it’s near term prospects will be guided by one drug, namely Telaprevir for Hepatitis C. This drug is a protease inhibitor, which is a new class of drug that competitors are also trying to develop. Vertex has submitted a New Drug Application for Telaprevir with the FDA.

Vertex Pipeline and Timeline



Indication
Event
Date
VX 765
Epilepsy
Ph II Top-line data
2010
VX509
Rheumatoid Arthritis

Ph II clinical data
2011
VX 809
Cystic Fibrosis
Ph II with VX 770
2011
VX 770
Cystic Fibrosis
PhIII clinical data
H1 2011
VX 222
Hepatitis C
PhII clinical data
H1 2011
Telaprevir
Hepatitis C
FDA Approval
H1 2011


source: Vertex

By far the most important event is Telaprevir. They filed an NDA in November. Telaprevir is a protease inhibitor and is likely to face future competition from Merck’s Boceprevir (which hasn’t been filed yet). Telaprevir is seen as being more convenient due to it having a shorter treatment duration (12 weeks vs. 24weeks) and also has a high efficacy in treatment of non-responders. It is also possible that Telaprevir could be used as a twice daily regimen.

Whilst Vertex could have the first mover advantage, Boehringer Ingelheim, Bristol Myers Squibb and Roche all have drugs for HCV in development and they are aiming for a once a day regimen. Moreover, Medivir recently announced excellent results in Phase II with their protease inhibitor for HCV.

The good news is that Vertex will likely be a couple of years ahead and shows superiority over its nearest rival Boceprevir. The more circumspect news is that Vertex' NDA filing is the first for this class of drug and assuming quick FDA approval may lead to disappointment. Any delay will hurt Vertex as rivals are in clinical trials. In a sense, buying Vertex would be a 'bet' upon FDA approval and expecting them to maintain a lead against the potential competition.

VX222 is being developed with the last point in mind. It is a polymerase inhibitor that is intended to be used in combination with Telaprevir. As such, it could shorten treatment time and help with efficacy with non-responders.

VX765 is interesting as it the first drug to target epilepsy via anti-inflammation, in this way seizures are believed to be able to be reduced. The upcoming Phase II data will be interesting and provide some upside potential. I would not proscribe a high chance of success with novel drugs in general.

VX770 and VX809 are being trialled in combination for cystic fibrosis. Although the phase II results for VX809 were not great, Vertex feel that-according to their laboratory research-in combination they could be efficacious in cystic fibrosis.

I did not take a position as I suspect that much depends upon Telaprevir approval. Although clearly efficacious,it is the first class of drug and I also see downside when/if Merck decide to file with Boceprevir.



Source:

Medical News Today "Telaprevir May Be Viewed More Positively By Clinicians Than Boceprevir For Hepatitis C Virus Treatment Following Their Launches In 2011"
Bloomberg "Medivir Gains as Early Study Shows Drug Kills Hepatitis C Virus"