Mayne Pharma Group Limited (Mayne Pharma) is an ASX-listed specialty pharmaceutical company focused on applying its drug delivery expertise to commercialize branded and generic pharmaceuticals. Mayne Pharma also provides contract development and manufacturing services to more than 100 clients worldwide.
Mayne Pharma’s roots can be traced to FH Faulding and Co, for many years one of the largest and most prominent public companies headquartered in South Australia.
A technology driven company, Mayne Pharma has a significant product portfolio and pipeline, global reach through distribution partners in Australia, North America, Europe and Asia and two product development and manufacturing facilities based in Salisbury, Australia and Greenville, North Carolina, USA with expertise in formulating complex oral dose forms including highly potent compounds, controlled substances, modified release products and inherently unstable compounds. The business is supported by over 850 staff globally with more than 200 scientists employed.
ASX Code
MYX
Sector
Pharmaceuticals- Biotechnology & Life Sciences
Website
https://www.maynepharma.com/
Mayne Pharma Group received a complete response letter (CRL) from the US FDA regarding the application for a generic version of NuvaRing. Management is confident the issues raised by the FDA will be addressed in a timely matter.
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Script volume trends indicate competitors continue to take share in several of Mayne Pharma's categories, the broker notes, albeit at a slower pace than in FY19.
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Mayne Pharma has entered into a supply agreement with Chinese base manufacturer Novast Laboratories for 13 US generic oral contraceptive products, including five not previously marketed.
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Mayne Pharma has entered into a supply agreement with Chinese base manufacturer Novast Laboratories for 13 US generic oral contraceptive products, including five not previously marketed.
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Generic drugmaker, Mayne Pharma shares went for a little run yesterday after the company revealed a link up with a fellow generic maker from China to try and make deeper inroads into the US contraceptive market.
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Reported operating earnings (EBITDA) were below Macquarie's estimates. Generics revenue fell by -33% with underlying gross margins down -11%. Meanwhile, growth in specialty brands moderated.
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Mayne Pharma has completed its response to the US FDA regarding its generic NuvaRing application, although any approval is not anticipated before the second half of 2020.
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Mayne Pharma aspires to have more than 60% of its FY24 revenue from US specialty products, although significant challenges in generics are likely to beset the business in the interim.
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The company has indicated that gross revenue for the first four months of FY20 is down -16%. Key products in generics, liothyronine, and dofetilide, continue to lose share to competitors. Specialty revenue was broadly flat. Contract services revenue increased by 16%.
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Bad news Friday, at least for three ASX-listed companies. 7-Eleven's decision to walk away on a supply deal has left Metcash shares deep in the red while Gentrack and Mayne Pharma have disappointed investors with new profit warnings.
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DOWNLOAD RESEARCH REPORTSecures binding contract with Tier-1 OEMUS based anode active project gathers momentumMagnis Energy Technologies (MNS.ASX) – MNS is planning an anode active facility in the US and recently announced a binding, yet conditional, contract for the supply of anode active with Tesla. The contract is for a minimum 17.5kt/year with an option to purchase another 17.5t/year. Conditions precedent carry a tight development timeframe, with first production scheduled for February 2025. Site selection is underway and co-locating with an OEM on a brownfields site makes sense. Long lead items have been ordered and detailed engineering and design is expected to commence soon. |
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