First approval in the world
The approval in Canada is the first marketing authorization for Estelle®
in any jurisdiction,
anywhere in the world. Regulatory reviews remain ongoing in the United States and European
Union, with expected marketing authorizations in H1 2021.
“Our teams are both proud and excited to see the outcome of so many years of research finally
made available to women”, said Leon Van Rompay, CEO of Mithra. “This approval is the first and
is highly symbolic since it is being announced on International Women's Day. We congratulate
Searchlight Pharma on becoming the first partner worldwide to achieve regulatory approval and
are supporting them fully to ensure a Canadian market launch in the summer of 2021. As one of
the most important global markets, the Canadian approval unlocks the opportunity to introduce a
product we believe represents a new era in Women’s Health and contraception in particular. We
look forward to obtaining the next approvals in Europe and the United States expected in the first
half of 2021.”
“We are excited that Canada is the first market globally to approve Nextstellis®
, and that
Searchlight Pharma can now move forward with its commercial launch and making this new
contraceptive option available to Canadian women,” said Mark Nawacki, President & CEO of
Searchlight Pharma. “The introduction of Nextstellis®
represents a major advancement in the
contraceptive options available, and we are proud to have played a part in helping to support
healthcare providers and women in their contraceptive choices.”
Currently, the Canadian hormonal contraceptive market is worth approximately EUR 228 million
a year, with combined oral contraceptives accounting for about 66% of the market1
. Nextstellis®
will complement and deepen Searchlight Pharma’s industry-leading women’s health product
portfolio which includes Addyi®
(flibanserin), a first-in-class medication in Canada for the treatment
of Hypoactive Sexual Desire Disorder (HSDD) in both pre and post-menopausal women up to
age 60, as well as market-leading brands such as Mona Lisa®
IUDs for contraception, and