DJ EMA Nod to Eli Lilly Drug Stokes Competition in Migraine Prevention Market

By Donato Paolo Mancini

Eli Lilly & Co.'s (LLY) preventive migraine drug galcanezumab has received a positive marketing recommendation from the European Medicines Agency, the company and the regulator said separately on Friday, opening the door to competition in Europe.

The approval matters because the drug is one of a new class of compounds that inhibit the activity of a molecule involved in migraine attacks, for which there is currently no cure. It is the second monoclonal antibody therapy for the prevention of migraines that the EMA recommends, after it recommended the approval of Aimovig, made by competitors Novartis AG (NOVN.EB) and Amgen Inc. (AMGN), in May.

In the U.S., Teva Pharmaceutical Industries Ltd. (TEVA) also received approval from the Food and Drug Administration for its own fremanezumab, after months of delays had weighed on investor sentiment. The move was seen as a victory for chief executive Kare Schultz, who has been tasked with returning the company to profit.

Emgality, the branded name of Eli Lilly's drug, was also conditionally accepted by the U.S. Food and Drug Administration in June 2018, the company said. Novartis' Aimovig was also approved in the U.S. this year.

Analysts say the three drugs are largely identical, with the biggest difference being how often and the manner in which they are administered.

Increased competition will be good for patients, as they will have access to a drug that works for less, said Aaron Gal of Bernstein. "My expectation is that pricing in Europe will be fairly low, especially in countries that are good at getting companies to compete with each other," he added, predicting peak sales of $5 billion in the U.S. for the four drugs, and of $2 billion in Europe.

Overall, the challenge will be more about penetrating the market, raising awareness about the drug and negotiating on pricing and reimbursement, rather than seeing direct competition between the drugs, analysts said.

Indeed, proprietary survey data released by Barclays on Thursday showed that U.S. migraine patients still aren't switching, and that new prescription rates have slowed down after a first wave of enthusiasm earlier this year. Barclays cited anecdotal evidence suggesting access issues remained, constituting a main obstacle for physicians wishing to prescribe the drug. For Aimovig alone, Barclays forecasts a sales range of $123 million to $204 million in FY18, adding that it will be a modest contributor to the Swiss pharma giant's sales overall.

About 15% of the population in the European Union suffers from migraines, the EMA said. The positive opinion is an intermediate step for full approval, which usually comes after 60 days. Once approved, European states will be able to negotiate pricing and reimbursement individually.

Write to Donato Paolo Mancini at donatopaolo.mancini@dowjones.com; @donatopmancini

(END) Dow Jones Newswires

September 21, 2018 10:44 ET (14:44 GMT)

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