The picture should become clear this year for regimens to treat hepatitis C without the need for injections, as closely watched Phase III data from Gilead and Abbvie reveals long-term cure rates for the liver disease.
An all-oral therapy with a high cure rate and low relapse rates would be sure to garner billions in annual sales. Gilead’s Sofosbuvir, acquired with the US$11 billion purchase of Pharmasset, is seen as the clear leader in a crowded race, but Abbvie has also had impressive early data for its products.
Cancer — the disease with the highest R&D investment — offers openings for a number of companies, with particular excitement centered on Lilly’s Ramucirumab, which could be filed to treat gastric cancer this year and has a far bigger commercial potential in breast cancer.
Lilly is a prime example of a pharmaceutical company that has the wind back in its R&D sails. While still facing the daunting patent expiration of its nearly US$5 billion a year antidepressant Cymbalta last month, Lilly now has 13 drugs in Phase III development — the most at any one time in its history.
Roche’s aim to consolidate its position as the leading player in cancer looks within reach this year with approval expected for new breast cancer treatment T-DM1.
The Swiss group may also start to show its promise in neuroscience, with pivotal trial data due this year for Bitopertin, a new kind of schizophrenia drug that analysts estimate could generate sales of more than US$3 billion a year.
GLAXOSMITHKLINE’S BIG YEAR
GlaxoSmithKline perhaps has the most riding on this year, with six new drugs submitted for approval in lung disease, diabetes, cancer and HIV, as well as Phase III clinical results due on two high-risk, high-reward projects in heart disease and cancer.
Darapladib, designed to fight clogged arteries in a different way to statins, could, in theory, become a US$10 billion-a-year seller, while MAGE-A3 may prove equally revolutionary for lung cancer and melanoma. However, in both cases GlaxoSmithKline is pushing the scientific boundaries and the chances of success are considered below average.
Drug development still remains a risky business.
Last year’s tally of drug approvals was lifted in part by a large number of niche drugs for rare diseases. Success in drugs for common diseases was more elusive, as highlighted by the failure of clinical trials for two experimental Alzheimer’s drugs.
“The industry has done a lot to try and improve productivity and has corrected a lot of past mistakes,” said Deutsche Bank analyst Richard Parkes, who highlights fewer failures in final Phase III testing as a key measure of success.
“It’s too early to say whether this is going to be a sustained break-out from the trend, but the efforts that have been put in place should at least improve the efficiency of what is being spent,” he said.