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NICE (in Europe) to appraise hep C drugs Victrelis and telaprevir
  Published on 26/05/11 at 07:30am
NICE's next round of drug appraisals is set to include two new hepatitis C drugs - Merck Sharpe and Dohme's Victrelis and Johnson & Johnson's telaprevir.
Neither of the drugs is yet licensed in Europe but if they are they may meet a pressing unmet medical need for more effective hepatitis C treatments and NICE is already lining up to assess them.
Victrelis is set to be the first on the market, having just been recommended for European approval, while J&J's telaprevir could be licensed in Europe by the end of the year.
If approved the drugs will be among six treatments Ministers have referred to NICE to appraise.
NICE said it will assess Victrelis for use in previously untreated genotype 1 chronic hepatitis C patients - the licensed indication it is seeking in Europe.
It will also look to appraise Victrelis for previously treated patients who have used the NICE approved treatments ribavirin and Roche's Pegasys (peginterferon alfa).
Telaprevir, recently approved in the US as Incivek, would also be appraised for previously untreated genotype 1 chronic hepatitis C and previously treated with peginterferon alfa and ribavirin.
CHMP roundup
Published on 24/05/11 at 11:23am
The latest products to be recommended for European approval include MSD's Victrelis
The Committee for Medicinal Products for Human Use (CHMP) gave Merck Sharp & Dohme's hepatitis C drug Victrelis the nod after an accelerated assessment, and marketing authorisation from the European Commission is likely in the next few months.
Victrelis (boceprevir) is to be used to treat chronic hepatitis-C genotype-1 infection in combination with Roche's Pegasys (peginterferon alpha) and ribavirin, in adults with liver disease who are previously untreated or for whom previous therapy has failed.
It is a double whammy for Merck: earlier this month Victrelis became the first oral hepatitis C treatment to be approved by the FDA.
The drug has been seized upon by regulators as it may answer an unmet medical need. It works by directly inhibiting the replication of the hepatitis-C virus in hepatitis-C-virus-infected host cells.
Merck also entered a co-promotion agreement with Roche that will see both companies including the other's hepatitis C drugs in their sales presentations in the US.
Merck and Roche sign hepatitis C co-promotion deal
Published on 18/05/11 at 12:02pm


Merck & Co's Victrelis (boceprevir) is one of the drugs included in the agreement
Merck & Co and Roche have signed an agreement that will see them co-promote each other's hepatitis C drugs in the US and increase awareness of the disease in emerging markets.
Victrelis (boceprevir), the Merck drug which this month became the first oral hepatitis C treatment approved by the FDA, will now also be promoted to health professionals by Roche's Genentech arm.
It will be included by Genentech in presentations on the use of Roche's own Pegasys (peginterferon alfa-2a) - part of the current standard of care in chronic hepatitis C - in a triple combination therapy regimen.
The FDA has licensed Victrelis to treat hepatitis C genotype 1 infection, in combination with Pegasys and ribavirin, and Merck teams will also promote the established Roche treatment.
"Triple combination therapy for hepatitis C marks a major change in the way this disease is treated," said Pascal Soriot, chief operating officer of Roche Pharmaceuticals Division. "The use of these medicines in combination offers better treatment outcomes for patients."
Adam Schechter, Merck president, global human health, said: "These agreements are consistent with both companies' goal of improving healthcare outcomes for patients with chronic hepatitis C."
Researchers attached to Roche and Merck will also jointly look for novel combinations of marketed and investigational products from both manufacturers in the search for potential new treatments.
And the companies say they are working together to extend the agreement to other developed and emerging markets round the world.
"By working together we will be able to provide physicians, nurses and patients with education about the disease, its diagnosis and treatment options including the appropriate use of Victrelis," Schechter added.
Merck has high hopes for Victrelis, a first-in-class hepatitis C virus protease inhibitor, which clinically cured about two-thirds of patients in late stage trials, compared with less than 40% on current therapies alone.
A combination of its trial results and oral formulation has seen analysts predict blockbuster sales of over $1 billion a year at its peak. Adam Hill
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