GSK aims to file up to 20 new drugs for approval by 2020

By Ben Hirschler

LONDON (Reuters) - GlaxoSmithKline said on Tuesday it could file up to 20 new drugs for regulatory approval before 2020 as it seeks to revitalise a portfolio hit by falling sales of best-selling inhaled lung treatment Advair.

Seven of these products may reach the market before the end of decade, it added.

Britain's biggest drugmaker is trying to boost low investor expectations for its product pipeline by hosting its first research and development (R&D) day in more than a decade.

Investors, however, saw little to spark immediate earnings upgrades and the shares slipped 1 percent by 1350 GMT.

The company highlighted advanced and early-stage projects in six core areas: HIV and other infections, respiratory medicine, oncology, immuno-inflammation, vaccines and rare diseases.

"The level of innovation in this portfolio is substantial. We believe this is critical in today's operating environment as payers look to balance pressures of pricing and demand," Chief Executive Andrew Witty said.

Around 80 percent of the medicines and vaccines presented have the potential to be first-in-class with novel mechanisms of action, the company believes.

GSK also announced a deal with Merck, which will involve a clinical trial to test its experimental OX40 cancer drug alongside the U.S. company's Keytruda in solid tumours.

GSK is still investing in oncology, despite having sold its marketed cancer drugs to Novartis in a $20 billion three-way asset swap that closed in March.

The Novartis deal marked a shift of focus by GSK towards greater reliance on consumer healthcare products and vaccines but the company wants to show it remains a major force in drug research.

PAST SETBACKS

Investor confidence in its ability to bring important new medicines to market has been shaken by past setbacks, including the late-stage failures of a new kind of heart medicine and a cancer vaccine.

Near-term hopes now hinge on new injection Nucala for severe asthma, for which a U.S. approval decision is due by Nov. 4, as well as experimental shingles vaccine Shingrix, sirukumab for rheumatoid arthritis, a long-acting HIV medicine called cabotegravir and daprodustat for anaemia.

Only Nucala and Shingrix were included in a forecast made by GSK in May that new drugs would generate sales of at least 6 billion pounds ($9 billion) by 2020 and Witty said this figure now looked conservative.

Still, the company kept unchanged its forecast that core earnings per share would grow at a mid-to-high single digit rate at constant currencies over 2016-2020.

GSK said cabotegravir had shown promise in a mid-stage trial and would enter final Phase III testing in 2016, along with daprodustat, which boosts red blood cells by mimicking the body's response to high altitude.

Fibrogen, which has deals with AstraZeneca and Astellas, already has a similar anaemia product in Phase III.

GSK also announced a new collaboration with Regulus Therapeutics in hepatitis C, as well as plans for a pivotal study of next-generation antibiotic gepotidacin.

Its R&D event in New York is one of three high-profile investor days being held by major European pharmaceutical companies this week. Roche will hold a pharma day in London on Nov. 5, while Sanofi is hosting a strategy seminar in Paris on Nov. 6. [nL8N12Y1Y0]

($1 = 0.6506 pounds)

(Editing by Keith Weir and Jason Neely)