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 The therapy, Vyleesi, was approved in June and will be available in
September through the company's specialty pharmacy distribution
network that would deliver the treatment to patients' homes.
Women will be able to buy a pack of four injectors of which one
needs to be administered at least 45 minutes before anticipated
sexual activity, the company said on Tuesday. It will compete with
Sprout Pharmaceuticals' Addyi, a once-daily pill.
Both treatments aim to help women with HSDD, which affects about six
million American women.
But unlike Viagra for men, which increases blood flow to the male
sexual organ, Vyleesi - chemically known as bremelanotide -
activates pathways in the brain involved in sexual desire.
"It's not a one size fits all solution ... There is no ideal
desire," Dr. Julie Krop, Amag's chief medical officer, told Reuters.
"It's about trying to relieve the distress of individuals who are
suffering because their desire is not at the level that it needs to
be for them," Krop said.
Addyi has a list price of more than $400 for a pack of 30 tablets,
or about half of what it was just a year earlier, Sprout said. A
pack of four Vyleesi autoinjectors will amount to six to eight weeks
supply on average, according to Amag.
But the list price is not necessarily what patients actually pay for
a drug. "Out-of-pocket" costs vary based on the duration of the
treatment and individual healthcare plans.
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Sprout said out-of-pocket costs for patients on Addyi are nothing
for the first eight weeks and $25 per month thereafter if they have
insurance coverage or $99 per month for the uninsured.
Amag will initially offer the first pack of auto-injectors for free
and subsequent prescription refills will cost no more than $99.
Addyi was approved under intense pressure from advocacy groups
despite a review by FDA scientists that deemed the drug minimally
effective and possibly unsafe. The therapy was acquired by Bausch
Health Cos Inc, then known as Valeant Pharmaceuticals, but sold back
to the former owners after two years of dismal sales.
The FDA has recommended patients to not take more than one dose of
Vyleesi within 24 hours or more than eight doses per month and does
not place any restriction on the use of alcohol as in the case of
Addyi.
Vyleesi was developed by Palatin Technologies Inc and Amag holds
exclusive North American sales rights.
Palatin shares were up 11% at 86 cents, while Amag shares were up 3%
at $9.17.
(Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Sriraj
Kalluvila, Bernard Orr)
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