Vertex Pharmaceuticals (VRTX) is developing VX-222, a hepatitis C treatment. VX-222 is currently in Phase II clinical trials. Phase IIa results are positive. After 12 weeks of treatment with VX-222, 83% of patients were reported to have undetectable amounts of hepatitis C virus. However, this trial has been conducted on a very small subject pool size of 46 patients. The effectiveness of the drug cannot be determined until the subject pool is much larger.
The trial also reported that there were two adverse reactions that resulted in both patients discontinuing the study. This is actually a pretty high percentage of patients receiving adverse side effects, which could possibly cause a problem in gaining FDA approval in a few years. Vertex is also facing some upstanding competition in the race for hepatitis C drug development.
Achillion Pharmaceuticals (ACHN) is currently developing ACH-1625, a hepatitis C treatment that will be a competitor of VX-222. Clinical results are very positive thus far. Sixty hepatitis C infected patients received a daily dose of ACH-1625 throughout this study. The clinical trial was run for 12 weeks. The public was given access to the interim clinical data for 35 patients. 100% of patients treated were virus-free after week 12. The majority of patients were genotype 1a/b. Also enrolled in the study were IL28B genotype CT/TT infected patients. IL28B genotype CT/TT is a highly robust viral strain, making it a highly difficult virus to treat. The fact that all genotypes were cured conveys the effectiveness and efficacy of ACH-1625. There was one serious adverse reaction reported, but was stated to be caused by something unrelated to ACH-1625. There were other side effects, but they did not cause the patients any danger or irritation. Overall, it appears that ACH-1625 is a safe and effective drug. The FDA will most likely approve ACH-1625.
Another competitor of Vertex in the hepatitis C market is Roche Holding AG (RHHBY.PK). Currently, Roche is working on the hepatitis C drug Mericitabine, as well as two additional hepatitis C drugs. Phase II testing has recently commenced for Mericitabine and the research results will not be released to the public for at least the remainder of this year. That sets the drug to be release on the market in late 2014. However, Mericitabine must gain FDA approval before that may happen. The interim Phase II clinical trial data showed that 91% of enrolled patients had been rid of the hepatitis C virus by week 24 of the daily dose regiment. Unfortunately, 24% of patients that developed an undetectable remainder of hepatitis C virus relapsed only 12 weeks after ceasing treatment. The reported side effects from treatment with Mericitabine were deemed few and not serious enough to warrant any further attention. Overall, if Mericitabine continues to show such a high relapse percentage, then it will not be received on the market very well.
Merck (MRK) is developing two hepatitis C drugs within its pipeline that will attempt to muscle Vertex out of the market. It does seem as if Vertex will hold its own against Merck, based on the status of Merck's hepatitis C trials. One hepatitis C drug is in Phase II trials. The more promising Hepatitis C drug Vaniprevir, is in Phase III trials. Vaniprevir is projected to be released on the market very soon, upon FDA approval of its new drug application.
If it gains FDA approval, Vaniprevir will create much competition for Vertex's hepatitis C drug. The most current data showed that 85% of patients receiving treatment had no trace of hepatitis C virus at the end of the 24 week follow-up. However, 15% of patients had relapsed. The side effects were rather serious and could cause the FDA to deny the drug approval. 19% of patients developed blood and lymphatic disorders. 52% developed gastrointestinal problems such as diarrhea, vomiting, or nausea. 43% of patients developed rashes. These are high numbers for side effects, and the FDA will not turn a blind eye in its evaluation for approval.
Lastly, Bristol-Myers Squibb (BMY) is a hepatitis C competitor, currently developing and pushing its hepatitis C treatment through Phase III clinical trials. Bristol-Myers' current study was conducted to determine the ability and safety of the hepatitis C drug Daclatasvir when used in conjunction with the antiretroviral drug Tenofovir. Tenofovir is used to fight HIV. The data acquired showed that Tenofovir and Daclatasvir did not create any negative drug interactions when administered together. This study signifies the versatility, strength and effectiveness of Daclatasvir in treatment options.
Doctors will now have the ability to choose Daclatasvir for treatments that were initially dangerous or create new treatments for a situation that calls for it. This preference doctors will surely show for Daclatasvir gives Bristol-Myers a very solid stance in the hepatitis market. That being said, the market for hepatitis C treatment is in very high demand. Many companies are devoting time and resources to developing hepatitis C drugs. While a company may stand dominant for the time being, it will not be long before multiple companies release possibly more effective drugs for hepatitis C.
Overall, there is much risk in investing in Vertex at the moment. VX-222 is only in Phase II clinical trials, so market release is still years away. While the drug has shown to be effective and share will most likely rise, it is still too early to predict the future of VX-222. When it goes through Phase III trials and is administered to a larger patient pool, the efficacy, effectiveness, and dangers of the drug will become apparent. It is at that point we can form the prospects of market release for the drug. In any case, it is never safe to invest based on a drug that is not FDA approved, so keep an eye on Vertex for the next few years. If the FDA approves VX-222, then it will be time to invest.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.