With the increasing competition amongst pharmaceutical companies being driven by a proliferation of generic brands, Mayne Pharma Group (ASX: MYX) has secured its position in the U.S as a leading oral contraceptives supplier by partnering with Novast Laboratories for 13 generic products.
Of the 13 products, four have been approved by the U.S Food and Drug Administration (FDA) and include generic equivalents for two of the nation’s most prescribed oral contraceptive products – Ortho Cyclen ® and Ortho Tricyclen ®. A fifth is in the process of an FDA application but between the five products, more than 1.3 billion tablets were sold annually, totaling around USD $500m. Of the other eight products, five have never been marketed before.
“We are very pleased to have partnered with Novast, who have an outstanding quality track record manufacturing and supplying oral contraceptives to the U.S market,” said Mayne Pharma CEO, Scott Richards.
“This transaction expands our women’s health portfolio and secures supply on more favourable terms of eight products previously acquired from Teva Pharmaceuticals to continue to drive growth of our women’s health franchise.”
Through supply of these products in partnership with Novast, a pharmaceutical company based in Nantong, China, Mayne is well positioned to recoup market share lost over recent years due to a rapid rise in generic products being made available to the market. Such was the impact, Mayne reported a 17% decline in revenue for half-year ending 31 December 2019 due to the increased competition.
Despite the decline in sales revenue, Mayne Pharma is still a leading supplier of contraceptives in the U.S where its portfolio covers more than 85% of oral contraceptive prescription volumes.
While generic products of the most popular oral contraceptives will play a key role in Mayne’s hopes of a revenue turnaround, the Company is deep in the commercialisation process of their novel E4/DRSP next-generation oral contraceptive.
Having completed two Phase III clinical trials, Mayne submitted their FDA application for E4 on 16 April 2020 with the FDA confirming their application was under review on 24 June 2020. The review is expected to be completed in the first half of CY21.
The trials were conducted on more than 3,725 women aged 16 to 50 years and if approved, E4/DRSP would be the first contraceptive product containing estetrol and the first new estrogen introduced in the U.S for contraceptive use in approximately 50 years.
In the United States, combined hormonal contraceptives are worth more than $4 billion in sales per annum