IHS Global Insight Perspective | |
Significance | Daiichi Sankyo and Eli Lilly finally obtained the U.S. FDA's approval for Effient, while Eli Lilly's Alimta has also secured EU approval as a non-small-cell lung cancer (NSCLC) monotherapy. |
Implications | The troubled regulatory review process means that gaining FDA approval for Effient had brought much relief for the two companies. On the other hand, Alimta's latest EU green light has been expected. |
Outlook | Eli Lilly is likely to see a significant boost to its sales and profile from the positive news on Effient and Alimta's conquering of the EU and U.S. markets. For Daiichi Sankyo, Effient's promising marketing prospects will inject much hope into its loss-stricken financial performance. |
U.S. drug heavyweight Eli Lilly and its Japanese development partner, Daiichi Sankyo, have announced that their blood thinner Effient—Efient in Europe—(prasugrel) has secured U.S. FDA approval for the prevention of atherothrombotic events in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). According to the companies, the approval was based on the results of Effient's pivotal Phase III clinical studies, which demonstrated that Effient used in combination with aspirin reduced relative risk of the combined endpoint of cardiovascular death, non-fatal heart attack, or non-fatal stroke by 19% compared to Sanofi-Aventis' (France) Plavix (clopidogrel bisulfate) used with aspirin. Eli Lilly and Daiichi Sankyo noted that they aim to launch the drug in the U.S. market within weeks.
Eli Lilly Clinches EU Nod for Alimta as NSCLC Monotherapy
On a separate note, Eli Lilly announced on the same day that its oncology therapy Alimta (pemetrexed for injection) has become the first treatment approved in Europe as maintenance therapy for advanced, nonsquamous non-small-cell lung cancer (NSCLC). The EU approval comes after the positive recommendation of the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) at the end of May (see United States - Europe: 1 June 2009: Eli Lilly's Alimta Secures CHMP's Positive Opinion for NSCLC Monotherapy). This follows hot on the heels of receiving the FDA's green light of the drug for the same indication (see United States: 8 July 2009: Lilly's Alimta Clinches FDA Nod as Maintenance Therapy for NSCLC).
Outlook and Implications
For Daiichi Sankyo and Lilly, the FDA's nod for Effient has been long-awaited and provides much relief, considering the events related to the drug's regulatory review since its filing in December 2007. The review process has been filled with concerns over the potential side effects of excessive bleeding and even cancer, the FDA's mistaken ban of cardiologist Dr Sanjay Kaul from the review panel, as well as consumer group's challenging the drug's safety and efficacy. In Europe, Lilly and Daiichi Sankyo have already launched the drug in markets including the United Kingdom following the European Commission's approval. The U.S. launch of the drug is likely to pose strong threat to Plavix, which is facing imminent patent expiry.
Regarding the EU approval for Alimta, the positive recommendation from the CHMP has come well within the expected timeline of two months. This, together with the drug's recent approval in the U.S. market, will extend its commercial value and pose direct competition to other key drugs in the field of NSCLC treatment, such as Swiss drug giant Roche's Avastin (bevacizumab) and Sanofi-Aventis's (France) Taxotere (docetaxel).
With both Effient and Alimta approved in the main markets of Europe and the United States, Lilly is likely to see a significant boost to its product portfolio and global sales as well as the company's profile. In terms of Daiichi Sankyo, the U.S. approval of Effient will also bring in much-needed revenue stream and improve the company's loss-stricken financial outlook (see Japan: 12 May 2009: Daiichi Sankyo Posts US$3.4-bil. Loss in FY 2008/09, Ranbaxy Deal Takes its Toll).