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Summary
- Mayne Pharma has entered in a long-term supply agreement with Novast Laboratories Limited for 13 US generic oral contraceptives.
- The latest announcement had a favourable impact on Mayne’s share price with the stock closing ~4% higher.
- During late June 2020, Mayne had announced that an NDA (New Drug Application) for E4/DRSP as a contraceptive had been acknowledged for review by the US FDA.
- The Company had extended license and supply agreement of E4/DRSP with Mithra Pharmaceuticals for the Australian market in May.
The Australian economy is on track to recovery following the recession induced by the COVID-19 pandemic. However, there will be an unemployment turnaround, and some experts suggest that the real wages are expected to drop. Meanwhile, according to media reports, the spike in cases of coronavirus in Victoria over several weeks has put the entire economic recovery of the country at risk.
Despite the crisis, several companies in the healthcare sector have remained focused on their set goals, and have attained some key achievements amid COVID-19. One such Company is Mayne Pharma Group Limited, which recently revealed a strategic partnership with China-based company Novast Laboratories for 13 US generic oral contraceptive products.
Let us delve deep and discuss three key things about Mayne Pharmaceuticals:
About Mayne Pharma
ASX-listed specialty pharmaceutical company Mayne Pharma Group Limited (ASX:MYX) is engaged in applying its drug delivery expertise for commercialisation of generic and branded pharmaceuticals and offers patients better and more accessible medicines. The Company has two facilities: one each in Salisbury, Australia and Greenville, the United States with expertise in the development of complex oral as well as topical dose forms comprising modified-release products, potent compounds, and poorly soluble compounds.
Furthermore, Mayne Pharma provides manufacturing services and contract development to over 100 clients across the world.
Mayne Pharma Reveals Strategic Partnership With Novast
After disclosing significant Novast Laboratories agreement on 6 July 2020, Mayne’s stock price rose by ~4%. MYX stock last quoted at A$0.425, climbing up by 3.659% on 6 July 2020. The market capitalisation of Mayne stood at A$688.42 million with ~1.68 billion outstanding shares trading on ASX. In the last three months, Mayne has delivered a positive return of 32.26%.
Novast Laboratories is a pharmaceutical company based in Nantong, China. The Company is into development and commercialisation of generic drugs for markets across the globe. Novast has been operating since 2006, and several products of Novast approved by the US FDA, including hormone products as well as sustained-release oral dosage forms.
The partnership between Novast Laboratories Limited and Mayne Pharma is for 13 US generic oral contraceptive products. Out of these 13, five products are new that are not previously marketed by Mayne.
The products include two of the most prescribed oral contraceptives in the US. Four of the additional five products have FDA approvals while one of the products is awaiting FDA approval. Four FDA approved products include- ORTHO CYCLEN®, ORTHO TRICYCLEN®, LOESTRIN®24 FE and DESOGEN®.
The Company sees a significant market opportunity in the United States market. Mayne observes that these five products generated annual sales worth approximately US$500 million, with over 1.3 billion tablets sold per year in the US.
Mr Richards also mentioned that Mayne’s women health portfolio includes 27 products, including marketed and pipeline products. The products include a novel oral contraceptive E4/DRSP and two generic contraceptive products that are targeting markets with nearly US$1.2 billion in sales and expected to launch in the fiscal year 2021.
The CEO added that the Company is a leading supplier of contraceptives in the United States, with its portfolio now encompassing higher than 85% of oral contraceptive prescription volumes.
Mayne Pharma Disclosed FDA filing approval of E4/DRSP NDA in the US
On 24 June 2020, Mayne Pharma announced that the NDA (New Drug Application) for E4/DRSP as a contraceptive had been acknowledged for review by the US FDA (Food and Drug Administration). The agency anticipates completing its review in the first half of CY21.
E4/DRSP is developed by Mithra Pharmaceuticals SA, which is a novel combined oral contraceptive pill comprising drospirenone (3 mg) and estetrol (15 mg).
Following over 20 years of R&D, Mithra can synthesise estetrol (E4) at scale through a complicated plant-based manufacturing process.
The submission of New Drug Application included findings from two Phase 3 clinical trials performed in over 3,725 women having age in between 16 to 50 years.
Once approved by the FDA, Mayne’s E4/DRSP would be the first contraceptive product including E4, and the first new estrogen introduced in the US for contraceptive use in approximately 50 years.
The Company noted that according to IQVIA, the sale of combined hormonal contraceptives in the US is more than US$4 billion yearly, with 10 million US women using a combination of estrogen and progestin oral pills, vaginal rings, or patches.
It is noteworthy to mention that recently Mayne Pharma extended its strategic partnership with Mithra to also bring E4/DRSP to the market of Australia as well as to plan filing of the product with the TGA (Therapeutic Goods Administration) during this calendar year.
Mayne Pharma Entered Extended License & Supply Agreement to Commercialise E4/DRSP in Australia
On 28 May 2020, Mayne Pharma revealed that the Company entered an exclusive long-term license and supply contract with Mithra Pharmaceuticals for commercialising its E4/DRSP in Australia.
The Company noted that as per IQVIA, the contraceptive market in Australia is valued at A$130 million with the short-acting combined (estrogen & progestin) hormonal oral contraceptives projected at A$70 million with nearly 14 million units sold per year.
E4/DRSP is anticipated to be filed with the TGA in 2020 with a potential launch in the H2 CY21. After approval, the product is likely to obtain 5-years of data exclusivity from the TGA as it is a new chemical entity.
Furthermore, the Company has an opportunity to obtain a license to register as well as launch E4/DRSP across New Zealand.
Bottomline
Amid the turmoil, Mayne Pharma is moving progressively to attain a strong product portfolio with its E4/DRSP contraceptive. With a significant opportunity in the US market as observed by the Company coupled with its recent partnership with Novast Laboratories, Mayne looks set to blossom in an otherwise gloomy environment.
