Despite six late-stage NME and NME-like opportunities in late-stage development, it is Lilly's mid-stage pipeline that is the most exciting, the firm's President, Global Brand Development Bryce Carmine told the UBS 2007 Global Life Sciences Conference in New York Sept. 25.

Carmine highlighted several programs in the mid-stage pipeline that fueled the company's optimism, including two novel approaches to treat Alzheimer's disease and a development in the firm's glutamate platform.

"I believe our mid-stage pipeline is more exciting than any other," Carmine said, noting the completion of several Phase II Alzheimer's studies of the small molecule gamma secretase inhibitor designed to reduce levels of A-beta peptide levels in the brain, for which pivotal trials are to begin in early 2008.

On the glutamate receptor platform, the firm will begin a Phase II dose-ranging trial for an mGlu2/3 prodrug receptor agonist for schizophrenia this month - which, if successful, would be the first non-dopamine or serotonin-blocking compound to show efficacy and tolerability in schizophrenia.

Lilly's six late-stage NME and NME-like opportunities include prasugrel, enzastauin, AIR Inhaled insulin, arzoxifene, a long-acting release (LAR) formulation of Byetta (exenatide), and a long-acting injectable formulation of Zyprexa (olanzapine).

"We are well on our way to achieving our goal of 15 new compounds into clinical this year. Beyond the numbers, we are pleased with the quality of the compounds in the pipeline and the balance between validated and novel targets, as well as between small and large molecules," Carmine said.

Lilly hopes to present Phase III results for prasugrel, the ADP receptor antagonist it is co-developing with Daiichi Sankyo, at the American Heart Association meeting in November. The Phase III TRITON study, which was completed in mid-July, compares prasugrel to the FDA-approved dose of standard of care clopidogrel, with a primary endpoint to evaluate the two agents' comparability to prevent major adverse cardiovascular events in acute coronary syndrome patients who undergo subcutaneous coronary intervention.

On the diabetes front, the firm has completed enrollment and awaits results in the fourth quarter of 2007 of a 30-week comparative study of the long-acting release formulation of exenatide, dosed twice weekly. Lilly is partnered with Amylin in marketing the twice-daily injectable formulation of the type 2 diabetes drug. The firm expects to use the pivotal trial findings to support an NDA submission for exenatide monotherapy in the first half of 2008.

Also in the diabetes marketplace the firm is executing Phase III trials on its AIR inhaled insulin product, partnered with Alkermes (¹ Also see "Lilly/Alkermes Broaden Inhaled Insulin Manufacturing Agreement" - Pink Sheet, 8 January, 2007.). Speaking at the Bear Stearns Healthcare Conference Sept. 11, Lilly CEO Sidney Taurel commented that Lilly's experience in the diabetes market will help it to overcome some of the difficulties of Pfizer's launch of Exubera , the first inhaled insulin to be approved. Lilly plans to submit the NDA for its AIR product in 2009.

Expressing high hopes for its selective estrogen receptor modulator arzoxifene, Lilly intends to seek three indications for the drug's label at launch - for prevention and treatment of osteoporosis, as well as reduction in risk of breast cancer. Enrollment is complete for two Phase III studies, and the NDA is on track for FDA submission in 2009.

Carmine said the higher potency and bioavailability of arzoxifene may prove it superior to the firm's Evista (raloxifene) for the treatment of osteoporosis. "While Evista has been a very successful treatment for osteoporosis, we believe there are several reasons why arzoxifene may be even better," he said.

Rounding out the late-stage opportunities, Lilly expects to present Phase III study results of its long-acting injectable formulation of Zyprexa, administered once monthly, at several psychiatric conferences in the second quarter of 2008.

Additionally, the firm plans to submit Phase III trial results for its protein kinase C{beta}-selective inhibitor enzastaurin in 2010 or early 2011, as maintenance therapy in the treatment of non-Hodgkin lymphoma.

- Jamie Hammon (j.hammon@elsevier.com)

Five Late-Stage Products In Lilly’s Pipeline Could Launch By End Of Decade

More from Archive

More from Pink Sheet