Eli Lilly and Company (LLY) recently presented disappointing results on its cancer drug, Alimta (pemetrexed), at the annual meeting of the American Society of Clinical Oncology (ASCO).
Eli Lilly said that Alimta failed to achieve the primary endpoint in the randomized, open-label phase III superiority study – PRONOUNCE. The study was conducted in patients suffering from advanced nonsquamous non-small cell lung cancer (NSCLC).
The study compared Alimta plus carboplatin to a triplet regimen consisting of Taxol (paclitaxel), carboplatin and Avastin (bevacizumab).
The Alimta regimen failed to show superiority in improving progression-free survival without grade four adverse events (G4PFS). As far as secondary endpoints like progression-free survival, overall survival, overall response rate and disease control rate were concerned Eli Lilly said that there was no major difference between the treatment arms. No unknown toxicity issues were observed in the study.
The failure to show superiority is disappointing news for Eli Lilly. The company is currently working on protecting Alimta from generic competition from companies like Teva (TEVA) and APP Pharmaceuticals.
Alimta is protected by a compound patent that is set to expire in 2017 (including pediatric exclusivity) and a vitamin dosage regimen patent that will expire in 2022 (including pediatric exclusivity). Eli Lilly is currently seeking rulings in favor of the vitamin dosage regimen patent. A trial is slated to commence in August this year.
Alimta is a key product in Eli Lilly’s portfolio. The product, which posted sales of $2.6 billion in 2012, accounted for 11% of total revenues. With Eli Lilly facing generic competition for Zyprexa and products like Cymbalta and Evista slated to lose patent protection in late 2013 and 2014, respectively, a favorable ruling in the vitamin dosage regimen patent case would give the company an additional 5 years of protection.
Eli Lilly currently carries a Zacks Rank #3 (Hold). Companies like Salix Pharmaceuticals Ltd. (SLXP) and Santarus, Inc. (SNTS) currently look attractive with both being Zacks Rank #1 (Strong Buy) stocks.
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