* EMA recommends Gilead's Sovaldi and GSK's Tivicay
* Also backs Otsuka TB drug, Bristol/Astra diabetes pill
* Gilead shares rise 4.7 percent
LONDON, Nov 22 European regulators have
recommended approval of a new drug from Gilead Sciences
to treat hepatitis C and an HIV medicine from GlaxoSmithKline
, both of which are expected to be major sellers.
The European Medicine Agency (EMA) said on Friday its
committee of experts also gave the green light to a tuberculosis
drug from Japan's Otsuka, following a review of an
Recommendations for marketing approval by the EMA's
Committee for Medicinal Products for Human Use (CHMP) are
normally endorsed by the European Commission within a couple of
Analysts expect U.S.-based Gilead's sales to surge higher
next year on the back of its treatment known as Sovaldi, or
sofosbuvir, for people infected with the liver-destroying
hepatitis C virus (HCV). The all-tablet treatment obviates the
need for the injectable drug interferon, which can cause
debilitating side effects.
Investors see the treatment as the crown jewel of Gilead's
$11 billion purchase of biotechnology company Pharmasset and the
market is expecting substantial revenues.
Shares in Gilead were up 4.4 percent at 1632 GMT following
news of the European recommendation.
Analysts on average expect Gilead's drug to generate sales
of $4.4 billion in 2015, according to Thomson Reuters Pharma.
The often-undiagnosed hepatitis C virus is transmitted
through contaminated blood. While infection rates have dropped
since the early 1990s - due in part to the introduction of blood
and organ screening - many older adults remain at risk.
Two new antiviral drugs, Incivek from Vertex Pharmaceuticals
and Victrelis from Merck & Co, have cured more
HCV patients in recent years, but both are protease inhibitors
and are still used in combination with injections.
Sovaldi was recommended by an expert advisory committee of
the U.S. Food and Drug Administration last month and a final
decision from the FDA is expected by Dec. 8.
GSK's Tivicay, or dolutegravir, is also forecast to be a
significant new product for the British drugmaker. It will be
sold through the ViiV Healthcare business, in which GSK is the
biggest shareholder, alongside Pfizer and Shionogi
The once-daily drug belongs to a novel class known as
integrase inhibitors that block the HIV virus from entering
cells, and is designed to be used in combination with other HIV
drugs. Consensus forecasts point to sales of $1.6 billion by
2018. GSK shares were up 0.18 percent.
In addition, the European agency recommended approval of a
new two-in-one diabetes drug called Xigduo from Bristol-Myers
Squibb and AstraZeneca.