The Salisbury-South pharmaceutical maker announced on ASX last week that its short-acting estrogen and progestogen birth control pill, Nextstellis, has received final TGA approval and is expected to enter on the Australian market by mid-2022.
The ‘first of its kind’ drug was developed by Belgian women’s health company Mithra Pharmaceuticals and contains 14.2 milligrams of estetrol, a natural estrogen during pregnancy, and 3 mg of the progestin drospirenone.
Nextstellis has already received approval from the United States Food and Drug Administration and regulators in Europe and Canada. The pill was launched in the US market in June.
The Australian regulator’s approval came faster than Mayne Pharma previously expected, with the company saying earlier this year that it expected TGA approval to come in early 2022.
“It’s been 10 years since Australians haven’t had a new contraceptive hormone to discuss with their doctor,” Mayne Pharma CEO Scott Richards told ASX on Tuesday.
“Nextstellis offers an effective, safe and well-tolerated pill with excellent cycle control and has been shown to have low impact on certain parts of the body.”
Mayne Pharma has a 20-year license and supply agreement for the drug in the United States and Australia, as well as five-year market exclusivity for the Nextstellis brand as the drug contains a new chemical entity.
The company said two Phase 3 clinical trials of Nextstellis in 3,632 women showed that the drug achieved its primary goal of preventing pregnancy and “positive results” in cycle control, bleeding, safety and health. tolerability and rates of adverse reactions.
Mithra Pharmaceuticals CEO Leon Van Rompay said the TGA approval paved the way for the drug’s commercial launch in a third continent.
âThis fourth major approval obtained this year is perfectly in line with our schedule, allowing us to cover more than 80% of the targeted territory,â he said.
The launch of Nextstellis in the US and Australian markets was a hot topic at Mayne Pharma’s annual general meeting on November 23, where company executives attempted to chart a course for a net loss of $ 201 million after tax in fiscal 21.
It comes after reporting a net loss of $ 92.8 million in the prior year and a loss of $ 280 million in fiscal 19.
The company’s revenue in FY21 fell to $ 401 million from $ 525.2 million two years ago, with revenues down 13 and 12 percent in consecutive years.
Mayne Pharma US President Frank Condella, who was appointed to the post in August, attributed the most recent results to increased competition and the weakening US dollar.
âFiscal 21 was another difficult year impacted by a number of external factors, including the global pandemic, continued competitive pressure in the generic retail market and increasing demands from payers for insurance coverage in the global market. ‘our entire brand portfolio,’ he told shareholders at last month’s AGM.
âWe also saw the USD weaken which impacted our results as they are reported in AUD.
“[The] The board of directors and the management team are very disappointed with the financial performance of the Group and are committed to improving performance and seeking the best opportunities to maximize shareholder value.
Condella said the launch of Nexstllis in the US market was the âbiggest business opportunityâ for the company in the near term.
âNextstellis competes in the US $ 3.4 billion combined hormonal contraceptive (CHC) market, with nearly 10 million US women using CHCs for their contraceptive needs,â he said.
Australia’s contraceptive market, meanwhile, is valued at A $ 125 million, with the short-acting, progestin-only oral contraceptive market valued at over A $ 65 million, according to Mayne Pharma.
CEO Scott Richards said the company will continue to invest in its âcore areas of focusâ of women’s health, dermatology and contract services, but noted that factors beyond his control would impact future results.
âThe success and performance of Mayne Pharma will be strongly influenced by the execution of our strategic priorities and will depend on market factors, including the timing of FDA approvals, payor coverage and reimbursement, and competitive intensity in our main product areas, âhe told shareholders.
âThe main growth drivers in the short to medium term are expected to be the successful commercialization of Nextstellis in the United States, the launch of more than 10 dermatological products during this fiscal yearâ¦ and the continued optimization of our cost base. “
Richards said as of November 23, more than 7,000 prescriptions have been written for Nextstellis in the United States, of which 300 have been issued.
The Mayne Pharma share price hit $ 1.30 in October 2018, before falling steadily following a series of poor results to hit $ 0.19 on March 19, 2020, during the market’s sharp decline. of COVID-19.
Its shares peaked at $ 0.51 in April this year, but are now trading at $ 0.26.
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