Clinical Trials and Eli Lilly and Co. and FDA and Drug discovery and Health Care & Life Sciences and Health Care & Insurance and Pharmaceutical

Lilly aims to submit five new drugs for approval

February 4, 2013

With Eli Lilly and Co. set to see patents expire on its best-selling drug at year’s end, it is in the company’s interest to say its pipeline is about to produce new drugs. But the Indianapolis drugmaker may be in a position to submit five new drugs for regulatory approval this year.

Lilly will lose patent protection in western markets for the antidepressant Cymbalta at the end of 2013, which will wipe out most of that drug’s $5 billion in annual sales. That hurts because Lilly is already reeling from the late 2011 patent expirations on its antipsychotic drug Zyprexa, also a $5-billion-a-year blockbuster.

Lilly said it will submit its drug ramucirumab, for the treatment of gastric cancer, to the U.S. Food and Drug Administration and the European Medicines Agency this year—even before waiting for results from another Phase 3 clinical trial.

That decision surprised some analysts, who noted that ramucirumab clinical trials so far have shown that the drug extends patients’ lives for just 1.4 months, on average, even though it also extends the time they live without further progression of gastric cancer.

Goldman Sachs analyst Jami Rubin called the drug’s overall survival data “underwhelming.” And Alex Arfaei, an analyst at BMO Capital Markets, said he’s “cautious” about the prospect of the FDA's approving the drug before seeing results of a second Phase 3 trial.

Still, with Lilly testing ramucirumab, which goes by the nickname RAM, in a total of five cancers, bullish analysts think the drug could grow to more than $3 billion in annual sales.

“It is scientifically plausible that ramucirumab may show a much superior profile compared with Roche’s Avastin in breast and gastric cancer,” wrote Citigroup analyst Andrew Baum in a Jan. 30 research note.

Lilly also might submit ramucirumab for approval to treat breast cancer this year, after it sees results of yet another Phase 3 trial it has under way.

Also, Lilly hopes to submit enzastaurin, a drug designed to treat lymphoma, for market approval this year.

Referring to Lilly by its ticker symbol and speaking of the company’s net present value, Barclays Capital analyst Tony Butler wrote, “LLY’s oncology pipeline assets currently make up approximately 3-5% of total company NPV but could stand to comprise nearly 15-18% of FY20 revenues.”

The other three drugs Lilly hopes to submit for market approval this year are all aimed at Type 2 diabetes: dulaglutide, empagliflozin and a long-lasting insulin called insulin glargine.

“In 2013, we could see up to five regulatory filings,” said Derica Rice, Lilly’s chief financial officer, in a Jan. 29 conference call with analysts. Noting that Lilly has 13 drugs in Phase 3 testing and another 23 in Phase 2 testing, Rice added, “This is the most robust mid- to late-stage pipeline in our history, and it positions us to drive growth post-2014.”

 

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