With declining Zyprexa sales and the costs of a legal settlement cutting into year-end results, Eli Lilly could use a boost - and is hoping for one next week, when an FDA advisory committee meets to review its platelet inhibitor prasugrel.

Lilly, which is partnering prasugrel in North America with Daiichi Sankyo, is counting on the drug to boost sales in 2009 as foreign exchange and generics continue to negatively impact more established products. The review by the Cardiovascular and Renal Drugs Advisory Committee should shed light on whether the agency will ultimately approve the drug.

"Lilly needs to secure FDA approval of prasugrel, and we think it will," Credit Suisse analysts said in a note, adding that firm should also augment its 2012 to 2015 growth outlook with external product opportunities.

Lilly reported weak sales for some of its major products, including its largest revenue driver Zyprexa (olanzapine), as well as Evista (raloxifene), Strattera (atomoxetine), Humulin (human insulin), Forteo (teriparatide) and Gemzar (gemcitabine) during a year-end sales and earnings call to investors Jan. 29.

Zyprexa sales dipped 1 percent for the full year 2008 to $4.70 billion from $4.76 billion, including a fourth-quarter drop of 10 percent. Evista sales also declined slightly for the full year to $1.08 billion from $1.09 billion in 2007, with a 6 percent drop in the fourth quarter. Overall, company sales grew 9 percent for the full-year and were flat for the fourth quarter.

Zyprexa/ ImClone hit ripples into '09

Lilly's $1.4 billion settlement for misbranding Zyprexa (¹ Also see "Lilly’s Zyprexa Off-Label Settlement: Record Fine, Routine Compliance Deal" - Pink Sheet, 19 January, 2009. p. 34) and its $6.5 billion acquisition of ImClone led to a full-year net loss of $2.07 billion and a loss per share of $1.89, compared to a net income in 2007 of $2.95 billion and earnings per share of $2.71. On a non-GAAP basis, 2008 earnings rose 14 percent to $4.02 per share.

At the close of business Jan. 29, shares were $37.97, down $1.12.

Looking ahead to 2009, Lilly's earnings per share guidance is on track with the company's earlier predications of $4.00 to $4.25. The firm expects Cymbalta (duloxetine), Alimta (pemetrexed), Cialis (tadalafil) Humalog (insulin lispro injection), in addition to the anticipated launch of prasugrel, to grow sales.

Lilly plans to resubmit its supplemental NDA for Cymbalta for the management of chronic pain in the first half of the year, adding data from a recently completed study of chronic osteoarthritis pain of the knee. The firm withdrew its initial sNDA last December after FDA raised concerns about efficacy and dosing (² Also see "Lilly Feels Statistical Pain, Withdraws Cymbalta sNDA" - Pink Sheet, 1 December, 2008.).

Lilly is hopeful on prasugrel

At the advisory meeting on prasugrel, FDA could raise concerns about increase in bleeding among patients on the drug; increase in risk of colorectal cancer compared to Plavix (clopidogrel) and a formulation issue either related to the active ingredient or excipient substance (³ Also see "FDA Confirms Prasugrel Advisory Committee Review; What Will Panel Membership Entail?" - Pink Sheet, 4 January, 2009.). FDA is expected to release briefing documents for the meeting Jan. 30.

A favorable committee recommendation would be a milestone for the drug, which has been subject to repeated regulatory delays. In June, the agency extended prasugrel's NDA review until late September, and then stayed mum as that date passed by (⁴ Also see "Lilly Prasugrel Review Extended: Why No News May Be Good News" - Pink Sheet, 29 September, 2008.).

But Lilly execs are "hopeful" prasugrel will gain approval soon, VP science and technology Steven Paul said at the JP Morgan Conference earlier this month, mentioning that the Committee for Medicinal Products for Human Use has issued a positive opinion on the drug. The European Commission still has to take final action.

Prasugrel, if approved, could capture roughly 15 percent to 25 percent of the anti-platelet market share from Bristol-Myers Sqibb's blockbuster drug Plavix, Phil Johnson, VP investor relations, said on the investor call. U.S. launch plans for prasugrel were not discussed.

-Carlene Olsen (c.olsen@elsevier.com)

Lilly’s 2009 Growth Rides On Prasugrel; Advisory Committee’s Review Is Feb. 3

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