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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