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

Lilly continues string of positive trials

October 22, 2012

Eli Lilly and Co. is continuing a string of positive yet incomplete clinical trial results with results from experimental cancer and diabetes drugs.

The Indianapolis-based drugmaker said Monday its experimental diabetes drug dulaglutide lowered blood sugar in Type 2 diabetics better than three existing diabetes drugs in three Phase 3 clinical trials.

And on Oct. 15, Lilly announced that its cancer drug ramucirumab helped extend survival times for stomach cancer patients in a Phase 3 trial.

The results, when combined with the positive signs Lilly reported from its Alzheimer’s drug solanezumab, present an encouraging pattern that the company’s pipeline-driven strategy may, in fact, have a shot at succeeding. Its a stark reversal from a series of clinical trial failures that Lilly suffered this summer.

“This is great news for the pipeline, which continues the recent news on sola, ramucirumab and bariticinib,” UBS pharmaceutical analyst Marc Goodman said in a note to investors Monday. Baricitinib is another Lilly drug aimed at rheumatoid arthritis.

Investors have had similar thoughts, bidding up Lilly shares 24 percent over the past two months.

But Lilly still has a bit of proving to do. Its Alzheimer’s drug most likely will need to go through another Phase 3 clinical trial before it can win approval from regulators.

Meanwhile, the diabetes drug dulaglutide has to show that it is superior to Bydureon, a similar once-weekly injectable medicine already on the market. Both dulaglutide and Bydureon are known as glucagon-like peptides, or GLP-1 drugs. In 2005, Lilly helped launch the first GLP medicine, Byetta, in partnership with California-based Amylin Pharmaceuticals Inc. The two companies also launched Bydureon, which is a once-weekly version of Byetta, last year.

Patients receiving once-weekly injections of dulaglutide saw their levels of hemoglobin A1C—a key measure of blood sugar—go down more than did patients in the trials taking metformin, Byetta or Januvia.

But how much the levels went down, Lilly isn’t saying. Lilly said it would present more data about dulaglutdie during medical conferences in 2013 and 2014. Lilly plans to file for regulatory approval of dulagrlutide next year.

In its clinical trials, Bydureon also produced lower levels of blood sugar than either Byetta or Januvia, which is a popular oral diabetes medicine made by New Jersey-based Merck & Co. Inc.

Lilly gave up rights to both Byetta and Bydureon last year after a dispute with its former partner on the drugs, California-based Amylin Pharmaceuticals Inc. Lilly received a $250 million break-up fee, and royalties up to $1.2 billion over the life of Byetta.

"We're very encouraged by the results to date from our Phase III dulaglutide trials and are pleased to be one step closer to offering a new GLP-1 treatment option for Type 2 diabetes," Enrique Conterno, president of Lilly’s diabetes division, said in a prepared statement.

And as for the cancer drug ramucirumab, Lilly’s clinical trial data only showed that its drug was better than “best supportive care,” not better than another cancer drug. Lilly is still running a clinical trial that compares ramucirumab against an old cancer drug, paclitaxel.

Results from that second Phase 3 trial are expected a year from now.

“Ramu news encouraging but we need to see more data,” is how Morgan Stanley analyst David Risinger headlined his research note on the drug’s clinical trial results.

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