Eli Lilly expects approval on Cymbalta

Medical Marketing and Media, Jul 2003

AS A POSSIBLE indication that its manufacturing problems will soon be cleared up, Eli Lilly executives reported that the company expects approval from the FDA for its antidepressant Cymbalta in the fourth quarter.

The FDA late last year had delayed the launch of approved products because of problems the agency had discovered at Lilly's manufacturing facilities. Earlier this year, the company noted that FDA approval of Cymbalta was tied to successful re-inspections of the manufacturing facility where Cymbalta will be produced. Cymbalta, which treats depression and urinary incontinence, could reach annual sales of $2 billion or more, according to estimates.

Many analysts note that Lilly currently has one of the industry's strongest pipelines, led by Cymbalta, Cialis (marketed by a Lilly/ICOS joint venture) and an injectable form of Zyprexa. Cialis also could be approved before year's end.

"Our thesis for Lilly remains that the company possesses the best late-stage pipeline in the industry, regardless of current and ongoing manufacturing problems," Lehman Brothers pharmaceutical analyst Tony Butler noted in a recent report.

Executives at the drug company made comments about Cymbalta's progress at a Goldman Sachs investor conference, and also said they expect that earnings will hit the high end of expectations in the second quarter.

Some investors took the earnings news to mean sales of Lilly's key products-such as Zyprexa, Evista and recently approved Strattera-are better than expected. Strattera, a treatment for attention deficit hyperactivity disorder, and Forteo, a medication for treating osteoporosis, both received FDA approval in November 2002.