Hyphens Pharma has, through its subsidiary, Hyphens Pharma Pte. Ltd., entered into exclusive license and supply agreements with Cassiopea S.p.A., a subsidiary of Cosmo Pharmaceuticals N.V. for the exclusive rights to develop and commercialise Winlevi® across all 10 Asean countries in Southeast Asia.
Under the exclusive license and supply agreements, Hyphens Pharma will pay Cassiopea S.p.A. an upfront payment of US$1 million ($1.4 million). The group will also pay the Cosmo Pharmaceuticals subsidiary potential regulatory and sales milestones that could total up to US$4 million as well as customary double-digit royalties on net sales.
Winlevi® is a topical drug that treats acne for patients aged 12 years and older. The drug was approved by the US Food & Drug Administration (FDA) in August 2020.
In its statement dated Dec 21, Hyphens Pharma called the drug a “game-changer” for acne sufferers as it is so far the only topical cream to treat hormonal acne directly in the skin.
The drug was launched in the US in November 2021 and is said to be already “the most prescribed branded topical acne drug in the US based on IQVIA data.”
“We are very pleased to partner with Hyphens Pharma. Their strong expertise in Southeast Asia gives us great confidence in their ability to gain regulatory approval and commercialise Winlevi® in the region,” says Diana Harbort, president of Cosmo Pharmaceuticals’ dermatology division.
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“The success of Winlevi® in the U.S. has given us the opportunity to select the best partners in each region and to eventually make the product available to more patients around the globe,” she adds.
“Acne is a medical condition that affects millions in the Asean region. Yet, the medical management of acne remained largely similar due to the absence of new drugs. Winlevi® is the first new class of topical drug for the treatment of acne that is approved by US FDA in nearly 40 years. We are thus very proud to be able to bring Winlevi® to doctors and patients in the entire Asean region,” says Lim See Wah, executive chairman and CEO of Hyphens Pharma.
“We would like to thank Cosmo for this partnership and their confidence in Hyphens Pharma. This deal also affirms Hyphens Pharma’s strength as Asean’s leading specialty pharmaceutical company with a strong focus on skin health. We will continue to innovate, as well as to bring to market relevant innovations from the world to our region, so as to continue serving our doctors and patients.”
The exclusive license and supply agreements will not have a material effect on the net tangible assets (NTA) or earnings per share (EPS) of the group for the FY2022 and FY2023 ending Dec 31 and Dec 31, 2023, respectively.
As at 10.19am, shares in Hyphens Pharma are trading flat at 31 cents.
