FDA Approves Sorilux for Adolescent Plaque Psoriasis

In continuation of my update on Sorilux(calcipotriene) 

 

Mayne Pharma Group Limited, announced that the US Food and Drug Administration (FDA) has approved Sorilux(calcipotriene) Foam, 0.005% in adolescents.

Sorilux is now approved for treating plaque psoriasis of the scalp and body in patients aged 12 years and older.

The FDA approved Sorilux in 2010 based on evidence from two 8-week placebo controlled clinical trials in patients with mild to moderate plaque psoriasis of the body and one 8-week placebo controlled clinical trial in patients with moderate plaque psoriasis of the scalp. Further data was obtained in a follow-on open label study in patients aged 12 to 17 years of age with psoriasis.

Sorilux Foam contains calcipotriene, a synthetic vitamin D analog that has a similar receptor binding affinity as natural vitamin D. The exact mechanism of action contributing to the clinical efficacy is unknown.

Psoriasis is a chronic disease of the immune system affecting approximately 7.5 million Americans each year[1]. The most common form, plaque psoriasis affects roughly 80 percent of people who have the condition.

Mayne Pharma's CEO, Mr Scott Richards, said "Sorilux is an elegant foam formulation that is marketed by Mayne Pharma's Specialty Brands sales team alongside recently launched LEXETTE™ (halobetasol propionate) Foam, a potent topical corticosteroid also used to treat plaque psoriasis in adult patients. Topical products are the mainstay of treatment for plaque psoriasis patients and the foam delivery platform has a well-established reputation with dermatologists due to ease of application and lack of greasiness and stickiness, especially in hair-bearing areas and under clothing."

Mayne Pharma directly markets more than 60 products in the US including four branded dermatology products FABIOR® (tazarotene) Foam, Sorilux Foam, DORYX® MPC (doxycycline hyclate) delayed-release tablets and LEXETTE Foam. The Company also markets TOLSURA® (SUBA®-itraconazole) capsules used to treat certain fungal infections which was recently approved and launched this year.

https://en.wikipedia.org/wiki/Calcipotriol

FDA Approves Tolsura (SUBA®-itraconazole capsules) for the Treatment of Certain Fungal Infections

In continuation of my update on Itraconazole

Mayne Pharma Group Limited (ASX: MYX) announced,  that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Tolsura™ (SUBA®-itraconazole) 65mg capsules. Tolsura is a new formulation of itraconazole indicated for the treatment of certain systemic fungal infections in adult patients.

Tolsura is indicated for the treatment of blastomycosis (pulmonary and extrapulmonary), histoplasmosis (including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis) and aspergillosis (pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy). These serious infections most commonly occur in vulnerable or immunocompromised patients, for example, those with a history of cancer, transplants (solid organ or bone marrow), HIV/AIDS, or chronic rheumatic disorders, and are often associated with high mortality rates or long-term health issues.

Mayne Pharma's CEO, Mr Scott Richards 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. Reformulation of existing drugs plays an important role in improving patient compliance and clinical outcomes. We are 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."

"After many years of research and development and working closely with key global opinion leaders in infectious disease management, Tolsura represents a major milestone in the SUBA (SUper-BioAvailable) drug delivery platform at Mayne Pharma."

The Company will directly commercialise Tolsura and plans to launch in January 2019 with a new institutional sales team focused primarily on hospital-based infectious disease specialists. Tolsura has four granted patents from the United States Patent and Trademark Office with expiry dates ranging from 2023 to 2033.

The US anti-fungal triazole market has a current value of US$600m according to IQVIA and based on the clear unmet clinical need in serious systemic infections, the addressable market is estimated at US$200m[1].

Mayne Pharma directly markets more than 60 products in the US including three patent protected dermatology products Fabior® (tazarotene) foam, Sorilux® (calcipotriene) foam and Doryx® MPC (doxycycline) delayed-release tablets. The Company recently acquired Lexette® (halobetasol) foam used to treat plaque psoriasis which it expects to also launch in January 2019. 

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FDA Approves Tolsura (SUBA®-itraconazole capsules) for the Treatment of Certain Fungal Infections