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Does the Latest HCV Breakthrough Therapy Spell Trouble for Gilead Sciences, Inc.?

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Gilead Sciences (NASDAQ: GILD  ) was the first to submit its highly anticipated hepatitis C virus (HCV) combination therapy to the FDA. Recently, Bristol-Myers Squibb (NYSE: BMY  ) earned a Breakthrough Therapy designation for its dual regimen, likely to compete with Gilead's. AbbVie (NYSE: ABBV  ) , and Merck (NYSE: MRK  ) are also developing combination HCV treatments of their own, both with breakthrough designations.

Gilead's combo carries an enormous price tag, but America's largest pharmacy benefit manager Express Scripts (NASDAQ: ESRX  ) has voiced its intent to curtail the pharmaceutical industry's pricing power. Here's a look at the competing therapies, and the expedited regulatory pathway that could result in several of them reaching the market at roughly the same time.

About the Breakthrough Therapy designation
The FDA has implemented expedited pathways in the past, but I don't think any has been as well defined as the Breakthrough Therapy designation. Implemented in 2012, the designation is reserved for targeted therapies that hit significant efficacy marks in early or mid-stage clinical trials. The nature of the condition must also be serious enough that patients are clearly willing to trade safety for speed, like HCV.

Without an expedited pathway, HCV therapies would likely need to provide data on the percent of patients surviving for several years after dosing. With the designation the FDA will work with the drug makers to define acceptable, shorter-term endpoints that should warrant approval. Of course, early approvals remain contingent on longer safety trials also designed in partnership with the agency. In the meantime, patients with unmet needs gain access to lifesaving new treatments.

Clash of the combos
From Gilead's perspective, the designation can erode the lead its HCV therapy had on its competitors. Gilead's Sovaldi as a single agent may have beat competitors to the US market in December last year, and last month in the EU, but it's the combination therapies that seem to have doctors warehousing patients by the thousands.

Fellow Foolish author Brian Orelli raised an important point recently. As a single agent, Sovaldi pills must be taken with pegylated interferon injections to be effective for genotype 1 (GT1) patients. Interferon injections produce very uncomfortable side effects. Sovaldi's first year on the market flying solo may be one of the most successful launches ever, but there are potentially millions of HCV patients that can wait for interferon and ribavirin free combination therapies. And that's where the trouble lies for Gilead in the years ahead.

In order to see a return on the $11 billion spent acquiring Sovaldi, Gilead has priced the single-agent therapy at $84,000 for a 12 week regimen in the US. If Express Scripts, America's largest pharmacy benefit manager, has its way, the combo will be far less expensive. During an interview with Bloomberg late last year, Express Scripts' Chief Medical Officer Steven Miller said his company would, "identify which drugs can be pitted against each other and make some really tough formulary decisions." Others may compete with Gilead on price, and the HCV combo field is getting more crowded each month.

A Breakthrough Therapy breakdown
AbbVie, Merck, and Bristol-Myers all have Breakthrough Therapy designated, HCV combinations in development. In a recent post I highlighted some data that makes AbbVie's and Merck's cocktails seem just as effective as Gilead's combination pill.

Since then Gilead has filed a New Drug Application with the FDA for the once-daily fixed-dose combination of ledipasvir and sofosbuvir for the treatment of GT1 HCV. On February 24, the FDA granted a Breakthrough Therapy designation to Bristol-Myers' daclatasvir and asunaprevir combination therapy for genotype 1b HCV patients. This is the second Breakthrough designation granted to Bristol-Myers' HCV combos.

While AbbVie and Gilead are widely expected to compete in order to remain on the Express Scripts formulary, Bristol-Myers' two drug combo was designated for the GT1b indication. Generally GT1b is more prevalent in Europe, so Gilead and AbbVie might not be competing with Bristol-Myers for a place on the Express Scripts formulary. At least not for a majority of GT1 patients.

Merck's two-pill HCV combination received its breakthrough designation last October for GT1 HCV. The company has remained quiet about the combo since reporting interim data at the American Association for the Study of Liver Diseases Meeting last November. During the latest earnings call, Merck's management mentioned its HCV program only in passing. The company's R&D head, Roger Perlmutter responsed to a direct question regarding the regimen by stating that data so far was not yet ideal. I'll keep my eyes open for more from the company. For now it doesn't seem that Merck is willing to enter the ring with AbbVie, Gilead, and Bristol-Myers just yet.

Final take
There may be three other HCV combination therapies in development with breakthrough designations, but for now it seems Gilead needs to concern itself with just one, AbbVie's. We can nitpick over the data, but the opinion that matters is that of major payers, like Express Scripts.

The late stage data from AbbVie and Gilead are outstanding, and Merck doesn't seem like it's willing to compete with them. If Bristol-Myers' combo's designation will only support an early approval for GT1b patients specifically, that should leave the majority of the US market to Gilead, and AbbVie. So far, it seems the only clear winner from that fight will be the payers.

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Read/Post Comments (13) | Recommend This Article (4)

Comments from our Foolish Readers

Help us keep this a respectfully Foolish area! This is a place for our readers to discuss, debate, and learn more about the Foolish investing topic you read about above. Help us keep it clean and safe. If you believe a comment is abusive or otherwise violates our Fool's Rules, please report it via the Report this Comment Report this Comment icon found on every comment.

  • Report this Comment On February 26, 2014, at 5:51 PM, pebble3k wrote:

    Can you please tell Brian Orelli to take his baseball cap off...really ??? Yes..Brian..please tell us about all your comments about Gilead..Do better research next time..Motley tell me what the scripts were for last week..and week over week ok??? how many scripts and new scripts ??? Doesn't look like GILD is in trouble now do they ??? I love how Motley loves to make controversy..

  • Report this Comment On February 26, 2014, at 5:56 PM, pebble3k wrote:

    Cory...2012 a member ??? and commenting on GILEAD ??

  • Report this Comment On February 26, 2014, at 6:23 PM, badeconomy wrote:

    Why did you write this article about Gild? You don't know anything about Gild? It seems like you just want attention . Motley, what is the point of publishing such a article?

  • Report this Comment On February 26, 2014, at 9:28 PM, jeffw wrote:

    Cory, when you put some skin in the game and purchase shares then you can comment about a stock. Don't sit on the sidelines and make some stupid commnets so you can try to short the stock! Until then, go comment on Hair Care Now!!

  • Report this Comment On February 26, 2014, at 9:38 PM, Wcclubchamp wrote:

    I ha

  • Report this Comment On February 26, 2014, at 9:42 PM, Wcclubchamp wrote:

    I have lost all respect for this site after some recent post. The author is uninformed on HCV and the current prescription numbers for Sovaldi. What a joke article written by a POS sideliner. What a waste of time reading this. How does one become an author on this site? Unintelligent, lacking knowledge, and poorly written. Wasn't that express scripts crap like 2 months ago? Nothing new here and in fact Express Scripts has back peddled off those remarks since they were taken out of context. Dude, get your s%#€ together before publishing this garbage

  • Report this Comment On February 26, 2014, at 10:53 PM, ralph0865 wrote:

    This is a poorly researched article when it comes to Gilead and their HCV potential. This article is full of holes and errors.

  • Report this Comment On February 27, 2014, at 3:53 AM, sylvia07 wrote:

    motely fool is always looking for attention they never know what they are talking about that's why I don't subscribe to their info cos they are wrong so much!

  • Report this Comment On February 27, 2014, at 6:22 AM, eaglei1 wrote:

    Just wanted everyone who has skin in the game, that sovaldi is being prescribe with a Janssen combo for g1 patients with cirrhosis, not necessarily interferon, and or ribovrin combo.

  • Report this Comment On February 27, 2014, at 2:46 PM, badeconomy wrote:

    Motely, why would you put your name behind such an article by publishing it? I know that you guys are not stupid so the only logical reason would be that you are in it to profit from the stock movement based on this nonsense article.

  • Report this Comment On February 27, 2014, at 3:54 PM, Fatso wrote:

    My wife had type 1 HCV and was very sick. She was in a Gilead trial for Sofosbuvir/Ledipasvir. One pill once a day, no side effects, for 8 weeks. She was 100%cured three months after the trial ended. Six monts later and still no trace of the vurus. Her friend did a trial with Sofosbuvir/5816 for 12 weeks and she is also 100% cured. When the numbers start to come out, the naysayers will be looking pretty stupid and pretty broke.

  • Report this Comment On March 28, 2014, at 2:25 PM, jili222 wrote:

    Not sure what is the purpose of author written such an article without doing his research. Gild has a superior combo Sofosbuvir/Ledipasvir to treat the most difficult type 1 HCV and the combo is waiting for FDA approval. The Hep B research is also way ahead of its peers. The company has enormous potential considering millions Hep B patients out there waiting to be cured from the disease.

  • Report this Comment On August 03, 2014, at 8:34 AM, JTRANTHAMFOOL01 wrote:

    I have Hep C and have had (2) series of 48 weeks of interferon and Ribaviran. That is hell on earth. I have followed the clinical trials through the protease prohibitory with Vertex. This Gilead combination is real, they are using J&Js pill until the Led pill is completely approved. October by my doctor. But take a look at the pipeline it is a freight train coming. 2015 they will release a drug that aids the healing of fibrosis in the liver and the fibrosis leads to cirrhosis of fibrosis and then cancer. My bet is on Gilead at 25% of 1m portfolio.

    I will not make a prediction but allot of investors I fell are going to be left sitting on the bench but I have been wrong it is my money.

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Cory Renauer

Cory is a long-term minded analyst mainly focused on the biotechnology and pharmaceuticals. He genuinely enjoys cutting through the industry's complexities to help everyday investors make better decisions. You can contact Cory on Twitter @coryrenauer

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