By John Miller
ZURICH (Reuters) - With women hardest hit by migraine headaches, Swiss drugmaker Novartis is gearing up its marketing message to counteract sexism that it worries might become a barrier to adoption of its new medicine Aimovig.
The injectable monoclonal antibody that Novartis has developed with Amgen won approval in the United States this month and on Friday bagged a recommendation from a key European panel, clearing the way for likely approval on the continent.
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The drug is expected to be high priced, though countries negotiate their own terms with the company. In the United States, the drug is priced at $6,900 a year. Novartis is also considering new pricing models for Aimovig.
Novartis's top neuroscience developer Dan Bar-Zohar said he is keenly aware that most migraine sufferers are women. The Basel-based company has data to combat scepticism about the severity of migraines in women.
"We are tailoring quite a lot of our messages to this relevant population. We are extremely aware of this gender bias," Bar-Zohar said in an interview with Reuters.
"We have science-based evidence to show this is not just a headache."
To reflect the community of migraine suffers, Novartis said that about 85 percent of those who took part in its clinical trials were women.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday recommended the drug for treating migraine headaches in adults. The European Commission's backing usually follows in just a couple of months.
The medicine, also called erenumab or AMG334, is the first in a new class of treatments designed to prevent migraine by interfering with calcitonin gene-related peptide (CGRP), which is involved in the processes that kick off the severe headaches, such as dilation of blood vessels in the brain.
In the United States, Amgen and Novartis are pricing the self-injection drug at $575 a month, before discounts.
There, prescription benefits managers had taken aim at the drug, announcing in advance that they saw it as a test case to help rein in prices.
Bar-Zohar did not give details on potential pricing in Europe, where cost can differ widely from country to country. But he did say that Novartis is considering a variety of models -- including an approach in which it would quickly identify patients who respond to the treatment -- to help determine reimbursement levels.
"We are exploring some innovative methods in order to price it right," he said, adding Novartis wants to avoid the traditional "pay, fire and forget" model where it is reimbursed by the pill, in favor of an approach that delivers more value to health care systems and patients.
Studies of the Amgen-Novartis drug included patients who were new to migraine treatments, as well as patients who had tried other therapies unsuccessfully before abandoning them.
A late-stage trial of Aimovig found that it reduced episodic migraines by at least half in 30 percent of patients who had failed up to four previous treatments.
"These people live literally in the dark," Bar-Zohar said. "This is a breakthrough."
Though Aimovig has a head start, competition from makers of would-be rival medicines could eventually become fierce.
Companies including Teva Pharmaceutical Industries <TEVA.TA,>, Eli Lilly & Co and Alder Biopharmaceuticals Inc are developing similar treatments.
Analysts, on average, have forecast annual Aimovig sales of nearly $1 billion by 2022, according to Thomson Reuters I/B/E/S, with Novartis sharing a smaller piece of the proceeds.
Novartis and Amgen are selling Aimovig in the United States. Amgen has commercialization rights in Japan, while Novartis has the rights elsewhere.
(Reporting by John Miller in Zurich and Justin George Varghese in Bengaluru; Editing by Edmund Blair and Adrian Croft)