Clinical data on a long-awaited new class of migraine treatments is promising, yet there are still overhangs, based on historical hurdles.

1. Headaches Still Evident
in Migraine Market
Elizabeth Krutoholow and Curt Wanek
Bloomberg Intelligence analysts

2. Doctors Chime in on Migraine Drugs;
Marketing, Payer Access Key

3. Clinical data on a long-awaited new class of migraine treatments
is promising, yet there are still overhangs, based on historical
hurdles. Even if efficacy data remain on par with other migraine
treatments, doctors are excited to give their patients an option
that targets the calcitonin gene-related peptide. They are also
wary about the commercial side, given historical problems with
formulary access with triptans and Botox. Phase III data are
needed before the full potential of the class can be assessed.
Safety will be key to watch in Phase III trials, given Merck’s
telcagepant, now discontinued, didn’t show signs of liver toxicity
until Phase III. Allergan, Amgen-Novartis, Eli Lilly, Alder and Teva
are all developing anti-calcitonin gene-related peptide treatments
for migraines.

4. Marketing May Give Bigger Benefit Than First-Mover in CGRP Race

5. Amgen and Eli Lilly are neck-and-neck to introduce the first CGRP
receptor agonist, yet marketing may be more important than a first-
mover advantage. For migraine specialists, a good patient support
system and marketing is key, said Dr. Robert Cowan, director of the
Stanford Headache Clinic. This may help secure payer coverage and
lower the cost for patients. Allergan, Amgen-Novartis, Eli Lilly and
Teva should find patient support and marketing easier than Alder,
which lacks commercial experience.

6. CGRPs Show Marginal Benefits but Novel Mechanism Wins Doctors

7. CGRP agonists are only slightly better than existing therapies in
reducing migraine days vs. placebo. Intravenous and subcutaneous
delivery may induce an elevated placebo response, according to
Dr. Audrey Halpern of NYU Langone Medical Center.
Amgen showed a 6.6-day reduction in headache days per month
but only a 2.4-day benefit over placebo. Even though the difference
is low, it’s still effective in terms of its standalone benefit, Halpern said.
Even if the CGRPs achieve lower-than-expected efficacy, as long as
it’s statistically significant, doctors are still excited about giving their
patients another treatment option with a new mechanism of action.

8. Amgen, Teva CGRP’s May Face Same Formulary Scrutiny as Botox

9. A new class of migraine treatments being developed by Amgen,
Teva, Eli Lilly, Alder and Allergan may face difficulty getting covered
by payers if they prove to be marginally better than placebo in
Phase III trials. Currently, they appear as effective as Botox with two
migraine days less than placebo. It is challenging to get payers to
pay for Botox for chronic migraine, according to Dr. Robert Cowan,
director of the Stanford Headache Clinic. Out-of-pocket costs for
patients may be $1,500 every three months.

10. Eli Lilly Strategy to Early Market in Cluster Headache May Fail

11. Eli Lilly’s plans to beat its peers in the CGRP antibody space
to market by gaining approval for galcanezumab in cluster
headache may not be successful since it is unlikely that
neurologists would be able to use the drug in episodic or
chronic headache off label, said Dr. Robert Cowan, director of
the Stanford Headache Clinic. Several neurologists said that
payer pushback for migraine coverage can be a hurdle for use.
Lilly plans to submit an application in cluster headache in 2017,
which would allow for 2018 approval, potentially beating peers
such as Amgen to market.

12. Teva, Allergan May Have Edge in CGRP Commercialization

13. Teva and Allergan may have an edge against peers vying for a
share of the CGRP migraine market, given expertise in neurology
and their existing sales relationships. Unless Phase III trials show
very differentiating factors, most anti-CGRPs in development
appear similar in efficacy with slight differences in side-effect
profiles and modes of administration. Their success is more likely
to be tied to marketing, said Dr. Robert Cowan, director of the
Stanford Headache Clinic.

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