Specialty pharmaceutical company, Mayne Pharma Group Limited (ASX: MYX) made an announcement on 12 December 2018 stating that its New Drug Application (NDA) for Tolsura™ (SUBA®-itraconazole) has been approved by US Food and Drug Administration (FDA). Following this news, the share price of the company increased by 5 percent as on 12 December 2018 (AEST 12: 58 PM).
As per the announcement, Tolsura will be used to treat serious infections like blastomycosis and aspergillosis which are commonly in vulnerable or immunocompromised patients. According to the Mayne Pharma’s CEO Mr. Scott Richards, the management of the company is very pleased to receive this approval and they are proud to offer a new treatment option for patients which are having life-threatening infections. Mr. Scott further added that the physicians will appreciate having access to Tolsura, which is having increased bioavailability and significantly reduced variability as compared to conventional oral itraconazole capsules.
Mayne Pharma Group is planning to launch Tolsura in January 2019 with the help of a new institutional sales team which will be focused mainly on hospital-based infectious disease specialists. Currently, Tolsura is having four granted patents and the expiry dates of these patents are ranging from 2023 to 2033.
Recently, the company acquired Lexette® (halobetasol) foam which is used for the treatment of plaque psoriasis. Lexette® (halobetasol) foam is also expected to launch in January 2019. Currently, Mayne Pharma is directly marketing over 60 products in the US which include dermatology products like fabior® (tazarotene) foam, Sorilux® (calcipotriene) foam and Doryx® MPC (doxycycline) delayed-release tablets.
According to the consultant company IQVIA, US anti-fungal triazole market is currently having a value of around US$600 million and based on the clear unmet clinical need in serious systemic infections it is estimated that US is having an addressable market of around US$200 million.
In the recently held Annual General Meeting (AGM), the chairman of the company talked about the challenging market conditions in the US which the company has faced due to the aggressive contracting behavior from the major wholesaler/retail buying alliances as well as accelerated approvals through the US FDA. Due to all these reasons, the US generic industry faced a tough deflationary period in FY 2018.
Mayne Pharma Group reported revenue of $530 million in FY 2018. Further, the company incurred a net loss after tax of $134 million in FY 2018. The company’s results were affected due to several reasons which include non-cash intangible asset impairment cost, extraordinary stock obsolescence, abnormal Doryx® returns, and restructuring charge to decrease the cost base. As at 30 June 2018, the company was having a gearing ratio of 2.1x on a net debt to EBITDA basis. During FY 2018, the company also made significant investments to advance its product pipeline and expand its facilities.
Meanwhile, in the last six months, the share price of the company plunged by 1.10 percent as on 11 December 2018. MYX’s shares traded at $0.935 with a market capitalization of circa $1.41 billion as on 12 December 2018 (AEST 12:58 PM).