The Mayne Pharma Group Ltd (ASX: MYX) share price has had a positive start to the day.
In morning trade the pharmaceutical company's shares are up over 1.5% to 91 cents.
Why is the Mayne Pharma share price on the rise?
Investors have responded positively to news that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for its Tolsura 65mg capsules.
According to the release, Tolsura is a new formulation of itraconazole indicated for the treatment of certain systemic fungal infections in adult patients.
This includes the treatment of blastomycosis, histoplasmosis, and aspergillosis. These are serious infections that most commonly occur in vulnerable or immunocompromised patients such as those with a history of cancer, transplants, HIV/AIDS, or chronic rheumatic disorders, and are often associated with high mortality rates or long-term health issues.
Mayne Pharma's CEO, Scott Richards, appeared to be pleased with the news and the potential for Tolsura.
He said: "We are very pleased to have received FDA approval of this patented formulation of itraconazole which incorporates Mayne Pharma's proprietary SUBA technology to improve the bioavailability of poorly soluble drugs."
Before adding that the company is "proud to offer a new treatment option for patients with these life-threatening infections. We believe physicians will appreciate having access to Tolsura, which has been shown in clinical studies to have increased bioavailability and significantly reduced variability when compared to conventional oral itraconazole capsules."
What now?
The company plans to launch the product in January 2019 with a new institutional sales team focused primarily on hospital-based infectious disease specialists.
Management advised that the US anti-fungal triazole market is currently valued at US$600 million according to IQVIA. And based on the clear unmet clinical need in serious systemic infections, its addressable market is estimated at US$200 million.
Should you invest?
I think Mayne Pharma is a great company and well worth considering. However, due to management failing to provide any guidance at its AGM last month, I intend to keep my powder dry until the release of its half year results early next year.
In the meantime, I think CSL Limited (ASX: CSL) and Telix Pharmaceuticals Ltd (ASX: TLX) could be worth a closer look.
