The 23% rise in the HedgePath share price over the past couple of days won't be material to Mayne. The good part about the press release is that the regulatory approval burden for the NDA is lower than it could have been. The FDA also granted SUBA itraconazole orphaned drug status, which gives some benefits to any successful NDA applicant, like a period of marketing exclusivity. They do this to encourage pharmaceutical companies to invest in smaller markets that may otherwise be unattractive.
Mayne says that the oncology market for this, as a basal cell carcinoma treatment, has the potential to be in excess of $100m per year. HedgePath (53% owned by Mayne) also has a partnership with Mayne, and licenses its technology. Aside from the beneficial ownership of HedgePath, the Mayne top and bottom lines would benefit directly if the FDA approves this drug.
Other information:
http://www.prnewswire.com/news-rele...eatment-of-patients-with-bccns-300278327.html
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