In 2015, Gilead's GS-7977 Plus Ribavirin Will Earn Decision Resources' Proprietary Clinical Gold Standard Status for the Treatment of Non-Responder Patients with Hepatitis C Virus...

Press release posted 2/28/12 on Marketwatch.com. Although their output is always of exceptional high-quality, Decision Resources' ability to pick a 'whip-your-head-right-around, spill-your-coffee-and-read-at-all-costs' attention-grabbing headline in hopes that you'll buy their product, is unprecedented in the market analysis marketplace. That's the type of unexpurgated crassness we'd like to see more of.  You have to love them. Apparently, the oracles at DR have already decided that they will award GS-7977 plus RBV the "Decision Resources' Proprietary Clinical Gold Standard" for treatment of non-responders in 2015. That's some unshakable confidence, let's hope they're right because no one is going to let them forget this press release. Despite the puffery, some interesting analysis is to be gleaned from this press release. They've obviously been doing some serious homework. DR expects that "the overall HCV drug market will experience significant growth, expanding from almost $1.7 billion in 2010 to $14.4 billion in 2015 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. Thereafter, the market will decrease to $11.2 billion in 2020, owing to a decline in the size of the treatment-eligible population due to declining prevalence and effective new regimens." Compelling reason enough on why the HCV drug development marketplace is red hot at the moment.  


In 2015, Gilead's GS-7977 Plus Ribavirin Will Earn Decision Resources' Proprietary Clinical Gold Standard Status for the Treatment of Non-Responder Patients with Hepatitis C Virus

* GS-7977 Plus Ribavirin Will Displace the Current Proprietary Clinical Gold Standard, Telaprevir in Combination with Peg-IFNa/Ribavirin, According to Findings from Decision Resources


BURLINGTON, Mass., Feb 28, 2012 (BUSINESS WIRE) -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, based on clinical data and the opinions of interviewed thought leaders, telaprevir (Vertex's Incivek, Johnson & Johnson's Incivo) in combination with peg-IFNa (Roche's Pegasys or Merck's Victrelis) and ribavirin (Roche's Copegus; Merck's Rebetol; generics) has earned Decision Resources' proprietary clinical gold standard status for the treatment of non-responder patients with hepatitis C virus (HCV). Owing to its competitive advantages in safety and tolerability as well as delivery, the interferon-free combination of Gilead's GS-7977 (formerly PSI-7977) plus ribavirin will displace telaprevir plus peg-IFNa/ribavirin and earn proprietary clinical gold standard status for HCV non-responders in 2015, following its launch for the indication in 2014 in the United States.

Decision Resources' analysis of the hepatitis C virus drug market also finds that surveyed U.S. gastroenterologists and managed care organization (MCO) pharmacy directors agree that the percentage of genotype-1 null responders achieving sustained virologic response is one of the attributes that most influences their decisions regarding prescribing and formulary status determinations, respectively, in HCV non-responders.

"Clinical data and the opinions of interviewed thought leaders indicate that several emerging regimens utilizing novel, HCV-specific direct-acting antivirals have advantages over sales-leading telaprevir plus peg-IFNa/ribavirin on this attribute," said Decision Resources Analyst Seamus Levine-Wilkinson, Ph.D.

According to insights from surveyed U.S. gastroenterologists and MCO pharmacy directors, the absence of interferon-free treatment options for HCV is one of the greatest unmet needs in HCV. Clinical data and the opinions of interviewed thought leaders indicate that GS-7977 has demonstrated the potential to significantly fulfill this unmet need.

The findings also reveal that surveyed U.S. gastroenterologists indicate that they would prescribe the quadruple regimen of Bristol-Myers Squibb's NS5A inhibitor daclatasvir (BMS-790052) plus Bristol-Myers Squibb's protease inhibitor asunaprevir (BMS-650032) plus peg-IFNa/ribavirin to 41 percent of their HCV non-responder patients. Decision Resources' forecast for this quadruple regimen is more conservative due to anticipated reimbursement restrictions, positioning in later lines of therapy, competition from IFN-free regimens and competition asunaprevir will face from other protease inhibitors.

The launch of novel HCV-specific agents will increase the size of the drug-treated population mainly as a result of re-treatment of prior non-responders as well as increased referral and drug treatment rates. The overall HCV drug market will experience significant growth, expanding from almost $1.7 billion in 2010 to $14.4 billion in 2015 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. Thereafter, the market will decrease to $11.2 billion in 2020, owing to a decline in the size of the treatment-eligible population due to declining prevalence and effective new regimens.

Decision Resources' Robust Market Forecast and Opportunities Analysis

Decision Resources provides a comprehensive view of what is happening in a specific drug market now and in the decade ahead. The research includes analysis of the unmet need and near-term drug development opportunities that exist within a drug market powered by primary research from physicians and payers. The robust market forecast and opportunities analysis is comprised of the Pharmacor 2012 advisory service and the DecisionBase 2012 report series.

About Decision Resources

Decision Resources ( www.decisionresources.com ) is a world leader in market research publications, advisory services and consulting designed to help clients shape strategy, allocate resources and master their chosen markets. Decision Resources is a Decision Resources Group company.

About Decision Resources Group

Decision Resources Group is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources Group at www.DecisionResourcesGroup.com .

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SOURCE: Decision Resources

     
        Decision Resources
        Christopher Comfort, 781-993-2597
        ccomfort@dresources.com

Forbes article - "The Hepatitis C Wars: What Docs Say About The Newest Meds"

(Forbes article by Ed Silverman on the 'DAA Wars' and how HCV providers view Invicek vs Victrelis. Interesting insight, but the most compelling aspect to this is whether the reconfigured Rx data from IMS for the last two weeks of September will confirm a stall in the growth of both products)

The Hepatitis C Wars: What Docs Say About The Newest Meds

By Ed Silverman

Over the past several days, there has been a great deal of confusion about the extent to which physicians are embracing the new Incivek hepatitis C drug that is sold by Vertex Pharmaceuticals. The reason is that IMS Health, the market research firm that tracks prescriptions, has to restate mail-order activity for the drug for the last two weeks of September.

The uncertainty sent Vertex stock gyrating because the initial data suggested prescriptions had stopped growing. Investors are now waiting for IMS to release an update. Meanwhile, we thought it might be interesting to provide a different sort of look at how Incivek is faring along with its equally new rival, Victrelis, which is sold by Merck and Roche.

A survey conducted in August of 80 physicians – 29 gastroenterologists, 25 hepatologists, and 26 infectious disease specialists – finds that Incivek is edging out Victrelis in various ways, according to Decision Resources, which queried the doctors. The latest survey, by the way, was run three months after the meds launched and updates an earlier effort that was conducted one month after launch.

The survey found that a widening gap in physician satisfaction between the two treatments. One month after launch, 36 percent of the docs were satisfied with Victrelis and this rose to 48 percent after three months. Among those physicians prescribing Incivek, 40 percent were satisfied one month after product launch and this jumped to 55 percent after the three-month mark.

Interestingly, the average number of patients being treated was slightly lower three months after launch, although the percent of docs using both meds increased significantly. Both drugs have high recognition – 36 percent of the docs were able to cite either the brand or generic name for Victrelis; the figure was 34 percent for Incivek. And two-thirds reported receiving patient requests for the drugs.

Meanwhile, more than two thirds of the docs have begun using either med, compared with more than one half of physicians at one month after the launches. However, Decision Resources notes that most docs have prescribed both brands, suggesting they are still experimenting. So far, 29 percent say it it too soon to know whether they are satisfied with Incivek; the number was 27 percent for Victrelis.

Another nugget: most Americans with hepatitis C have genotype 1, which is the hardest to treat. The survey found that infectious disease specialists have more genotype 1 patients undergoing active treatment compared to two months earlier; Victrelis share among hepatologists is higher compared to gastroenterologists; and gastroenterologists view shorter duration of treatment and managed care access as significantly more important when choosing a drug compared to the other specialties.

Overall, the main benefit of this new class of hepatitis C treatments is the improvement in sustained viral load or SVR, according to the docs surveyed. While Incivek beat Victrelis on higher SVR, shorter duration and simpler protocol, the perception of superior efficacy was countered by concerns with rash, according to Decision Resources. “While it’s too soon to tell, Victrelis may fill a niche for patients who prefer it’s side effect profile,” the firm reports.