Tag Archives: Idenix Pharmaceuticals

Why Idenix Pharmaceuticals Shares Flopped

By Sean Williams, The Motley Fool

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Although we don’t believe in timing the market or panicking over market movements, we do like to keep an eye on big changes — just in case they’re material to our investing thesis.

What: Shares of hepatitis-C-focused research company Idenix Pharmaceuticals  dipped as much as 16% after the company received an unfavorable initial ruling from the U.S. Patent and Trademark Office in regards to a patent dispute filed against Gilead Sciences .

So what: The patent dispute — which covers certain 2′-methyl-2′ fluoro nucleoside compounds used in hepatitis-C treatment — was filed by Idenix last March. Today, the U.S. Patent and Trademark Office in the first phase of its judgment determined that Gilead is the senior party and that Idenix is the junior party. In short, their determination was that Gilead was the first party to file for a patent application for the above nucleoside compounds. The next phase of the trial will determine which party is the first to invent.

Now what: I had always thought Idenix’s patent dispute with Gilead was a bit of a stretch. Now, with the company being named the junior party in the initial phase of its patent trial, there appears a much slimmer hope that it’ll be declared the inventor and patent holder of these nucleoside compounds. Idenix has had a miserable past year with its previous leading compounds placed on clinical hold following the death of a patient in a Bristol-Myers Squibb trial for BMS-096984, which shares some nucleoside similarities to Idenix’s pipeline. To add, Gilead’s Sofosbuvir is cleaned up in all four late-stage trials and looks well on its way to becoming a blockbuster. To conclude, even after today’s tumble, Idenix still has plenty of caution tape draped all over it.

Craving more input? Start by adding Idenix to your free and personalized watchlist so you can keep up on the latest news with the company.

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The article Why Idenix Pharmaceuticals Shares Flopped originally appeared on Fool.com.


Fool contributor Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, track every pick he makes under the screen name TrackUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.

The Motley Fool recommends Gilead Sciences. Try any of our Foolish newsletter services free for 30 days. We …read more
Source: FULL ARTICLE at DailyFinance

The Perfect Cure for Hepatitis C?

By Brian Orelli, The Motley Fool

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Gilead Sciences‘ sofosbuvir with Johnson & Johnson and Medivir‘s simeprevir are a match made in heaven. So far, the combination has cleared hepatitis C virus from patients no matter how it’s administered.

Interim data from a phase 2a showed 100% of patients were free from virus 12 weeks after treatment. The trial was divided into four treatment groups: Patients were treated for either 12 or 24 weeks with either the just the two experimental drugs or adding an approved generic called ribavirin to the mix.

The results are especially impressive because these patients had already failed to respond to treatment with a pegylated interferon — Roche‘s Pegasys or Merck‘s Pegintron — and ribavirin. Retreatment with those drugs and adding Vertex Pharmaceuticals‘ new drug Incivek only results in cures about 32% of the time for patients that failed a first treatment. More importantly, unlike Incivek, the sofosbuvir-simeprevir combination doesn’t require pegylated interferons that produce nasty side effects.

We have to be careful drawing too much from the data. The trial is scheduled to enroll 80 patients, but only 10 have reached 12 weeks post treatment. Nineteen patients have been treated completely, and all of them were free of virus at the end of treatment. But the virus can be knocked below the limits of detection for hepatitis C tests but not eradicated by drugs, and then relapse and build back up after the treatment ends. Being free from virus 12 weeks after treatment is essentially a cure.

Despite the awesome data, this combo therapy isn’t likely to ever see the pharmacy, at least not in a single pill. The deal to run a clinical trial testing the two drugs was established between Johnson & Johnson and Pharmasset, before Gilead bought the biotech.

Gilead has made it abundantly clear that it’s planning on pushing on with a combination of sofosbuvir and drugs it has developed in-house. It shunned Bristol-Myers Squibb , which also has a hepatitis C drug that produced solid data with sofosbuvir. I doubt Gilead will be interested in teaming up further on a sofosbuvir-simeprevir combination.

Fortunately for Johnson & Johnson and Medivir, simeprevir is being tested with additional hepatitis-C drugs, including Vertex’s VX-135, Idenix Pharmaceuticals‘ IDX719 and Bristol-Myers’ daclatasvir. If any of those combinations can hit 100% efficacy and the partners can agree to produce a convenient combination pill, they should have a shot at taking on Gilead.

Is bigger really better?
Involved in everything from hepatitis C drugs to baby powder, Johnson & Johnson’s critics are convinced that the company is spread way too thin. If you want to know if J&J is nothing but a bloated corporate whale — or a well-diversified giant that’s perfect for your portfolio — check out The Fool’s new premium report outlining the Johnson & Johnson story in terms that any investor can understand. Claim your copy, and a year of free analyst updates, by clicking …read more
Source: FULL ARTICLE at DailyFinance