Mayne Pharma secures exclusive Australian licence for Blissel®, targeting a $27m menopause market
Mayne Pharma Group Limited (ASX: MYX) has signed an exclusive five-year licence agreement with Italfarmaco S.A. for the Australian rights to Blissel®, an ultra-low-dose estriol (50µg/g) vaginal gel indicated for the treatment of vaginal atrophy in postmenopausal women. The deal adds a differentiated product to the company’s Australian women’s health portfolio at a time when the domestic vaginal estrogen topicals market was valued at approximately $27 million in 2025, growing at a two-year CAGR of 16% based on IQVIA pharmacy data.
The strategic rationale centres on a clear market gap: there are currently no ultra-low-dose or gel estriol formulations registered in Australia. Blissel® is targeted for launch in FY28, to be delivered via Mayne Pharma’s existing women’s health commercial team.
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Deal structure and financial terms
Under the terms of the agreement, Mayne Pharma holds the Australian marketing authorisation and is responsible for 100% of commercialisation activities. Italfarmaco retains beneficial ownership of the product and continues as manufacturing lead.
The financial structure is milestone-capped and royalty-based. Payments include signing and regulatory milestones, plus further one-off sales-based milestones as net sales scale, with sales-based milestones capped at a maximum of EUR300k in total. An ongoing royalty on net sales applies, subject to an agreed floor price. Because the commercial infrastructure for Mayne Pharma’s women’s health portfolio in Australia is already in place, Blissel® is not expected to add meaningfully to the company’s cost base.
| Term | Detail |
|---|---|
| Licence type | Exclusive, five-year |
| Licensee rights | Register, market, distribute in Australia |
| Sales-based milestones | EUR300k total |
| Royalty | Ongoing on net sales (floor price applies) |
| Manufacturing | Italfarmaco (retained) |
What is vaginal atrophy and why does Blissel® stand out?
Vaginal atrophy is a common condition in postmenopausal women, caused by declining estrogen levels that lead to thinning, drying, and inflammation of vaginal tissue. It affects comfort and quality of life and is a recognised, treatable medical condition.
Blissel® is differentiated by its ultra-low-dose formulation and delivery format. Key product characteristics include:
- Active ingredient: estriol 50µg/g
- Format: vaginal mucoadhesive gel
- Indication: treatment of vaginal atrophy symptoms in postmenopausal women
- Safety profile: almost negligible systemic absorption, which differentiates it from existing vaginal estrogen therapies
- Market gap: no ultra-low-dose or gel estriol formulations are currently registered in Australia
The absence of an equivalent product on the Australian market positions Blissel® as a differentiated entry into an uncontested formulation category.
The vaginal estrogen safety profile across Mayne Pharma’s portfolio has been substantially de-risked at a regulatory level, with a 9.5 million-woman post-marketing study finding no increased endometrial cancer risk from very-low-dose formulations, a finding consistent with the FDA’s subsequent move to remove box warnings from IMVEXXY® and BIJUVA® prescribing information.
Building Mayne Pharma’s women’s health platform in Australia
Blissel® is designed to deepen Mayne Pharma’s Australian women’s health presence. It targets the same prescribers and pharmacies already engaged through NEXTSTELLIS®, which is now PBS-listed, enabling commercial leverage without proportionate cost growth.
Mayne Pharma FY26 results reported gross margin expansion of 410 basis points to 64.7% and NEXTSTELLIS® PBS approval driving 127% demand cycle growth in the International segment, providing the commercial baseline from which the Blissel® FY28 launch will be executed.
The broader market context supports the timing. Mayne Pharma has cited consistent structural tailwinds across its global women’s health operations: an ageing population, growing clinical recognition that menopause symptoms are treatable, and improved patient willingness to seek treatment. The 16% two-year CAGR in the Australian vaginal estrogen topicals market reflects these same dynamics at a local level.
Management has stated a broader ambition to build the company into a leader in menopause care in Australia and globally.
Aaron Gray, CEO, Mayne Pharma
“This licence with Italfarmaco is a strategic and capital-efficient step in building Mayne Pharma’s presence in women’s health globally. Blissel® addresses a genuine gap in the Australian market as there is currently no ultra-low-dose vaginal estrogen gels available to Australian women at a time when the menopause category is undergoing a structural shift…”
For investors assessing the deal’s significance, several signals stand out:
- The FY28 launch leverages existing commercial infrastructure, with minimal incremental cost expected
- Blissel® complements the momentum of the NEXTSTELLIS® PBS listing by deepening relationships with existing prescribers and pharmacies
- The $27 million addressable market is growing at 16% CAGR, providing a defined and expanding commercial opportunity
- There are currently no competing ultra-low-dose gel estriol formulations registered in Australia
- The deal structure includes sales-based milestones capped at a maximum of EUR300k in total, limits downside financial exposure
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