EMA Nod to Eli Lilly Drug Stokes Competition in Migraine Prevention Market
September 21 2018 - 11:14AM
Dow Jones News
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 10:59 ET (14:59 GMT)
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