A Mayne Pharma Group Limited (ASX: MYX) US subsidiary has entered into a license and supply agreement with Galderma for an unbranded authorized generic version of ORACEA (doxycycline).
The 40 mg capsules (30 mg immediate release / 10 mg delayed release) capsule is manufactured pursuant to NDA 050805 and indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.
The agreement grants Mayne Pharma an exclusive three-year license of the authorised generic for the US market.
For calendar year 2022, the ORACEA market was valued at approximately US$210 million, according to IQVIA, a leading healthcare data and analytics provider.
This agreement provides another example of how we are building on our core strengths and expanding our portfolio of dermatology products,” Mayne Pharma’s CEO, Shawn O’Brien, said.
“We continue to focus on identifying and taking advantage of strategic expansion opportunities, and generic ORACEA fits well within our roster of products to help patients have healthier skin. Our goal, as always, is to ensure widespread access, reducing the burden on prescriber and patient ability to get high quality dermatology medications. This will allow us to drive revenue growth and deliver value to shareholders.”
About Mayne Pharma
Mayne Pharma is an ASX-listed specialty pharmaceutical company focused on commercialising novel and generic pharmaceuticals, offering patients better, safe and more accessible medicines.
Mayne Pharma also provides contract development and manufacturing services to clients worldwide. It has a 40- year track record of innovation and success in developing new oral drug delivery systems. These technologies have been successfully commercialised in numerous products that continue to be marketed around the world.