The antitrust crackdown in pharma has moved to Australia. Once again, Pfizer finds itself in the middle of a legal fight over its efforts to hang onto Lipitor sales after the drug went off patent and faced competition from cheaper generics.
Pfizer's third-quarter results perfectly capture the forces shaping Big Pharma these days. Patent losses linger, with hundreds of millions lost to generic competition old and new. But Pfizer had growth in emerging markets and cancer sales to help stanch the flow, so overall sales only shrank by 2% to $12.6 billion. But shrink they did, and so did Pfizer's expectations for the full year.
Allergan is taking a tried-and-true route to fighting off competition for a key drug. It has asked the FDA to set a higher bar for approving generic versions. Like Sanofi and Teva before it, Allergan argues that knockoff versions--in this case, versions of its eye drug Restasis--should be tested in humans before approval, not just in a lab.
CEO Jeremy Levin, in addressing a disappointing quarter, had to acknowledge Thursday that his plans may not play out as he had anticipated after a U.S. appeals court last week invalidated the patent on Copaxone.
Eli Lilly's second-quarter earnings are up, but the company hasn't done it through rolling out new products or expanding its market. Bracing for the patent loss of top-seller Cymbalta, Lilly has implemented cost-cutting measures, slashed jobs and upped prices on the blockbuster antidepressant to do what drugmakers often do at the end of a patent's life: pump it for sales while they can.
The FDA says it won't need a clinical trial for approval of copycat versions, meaning the treatment for chronic dry eye could face cheaper rivals years earlier than previously expected.
Two days ago the U.S. Supreme Court said pharma companies can be sued for pay-for-delay deals, and now the European Commission has fined Lundbeck and a cadre of companies €146 million ($195.5 million) for the same thing.
Amgen was delivered a nasty surprise about its superblockbuster Enbrel this week when a new study found that a cocktail of generics already on the market was as effective at treating rheumatoid arthritis.
Generic competition, sales woes and R&D disappointments have put revenue on the decline and Merck in hot water, with the pharma giant earlier this month promising to buy back as much as $15 billion in shares. And yesterday, the company started in on a big chunk of that buyback, inking a deal to buy $5 billion of its own shares from Goldman Sachs.
Japan's drugmakers aren't any more immune from generic competition than U.S. pharma companies are. Still the country's second- and third-largest drugmakers are predicting sales growth this year, even as low-cost copies drain away sales of their key products. New drugs are coming in to pick up the slack, the companies said.