Clinuvel Pharmaceuticals' (CUV: $12.29) second product expected to reach the market will be its ACTH generic, called NEURACTHEL Instant. The company intends to file its generic in Europe first, similar to the path taken for its first product, Scenesse.
This follows the successful manufacture and validation of three batches of the product by Clinuvel's European partner. Product is now available for clinical use, pending approval.
There are just two main products on the market. One is Cortrophin Gel, sold by ANI Pharmaceuticals. Sales are tracking at US$408 million a year, up 98% of the PCP.
The other main product on the market is Acthar Gel sold by Keenova Therapeutics. Sales are tracking at US$726 million a year, up 44% over PCP. Around 93% of sales are in the US.
This represents the current ACTH market at US$1.1 billion, and growing strongly with limited competition. Clinuvel's decision to develop a product for this market has shown very good foresight.
Building Drug Delivery Expertise
Clinuvel has also recently announced a five-year investment initiative to expand its R&D activities in Singapore in the sustained delivery of peptide drugs. Clinuvel's Scenesse is a peptide drug that is delivered as a depot injection for sustained two month activity in the body. Building its drug delivery platform in this area, which the company started in 2014, can be expected to become an increasingly important backbone to the company's core business for the next decade, particularly as it seeks to break into the billion dollar ACTH market.
US Management Team
With the current CEO of Clinuvel Philippe Wolgen to retire at the end of June next year, it appears that the company may be looking to form more of a US base, particularly given the large market opportunities ahead in Vitiligo and ACTH. The company has announced that it will be building up its US management team in the second and third quarters of next year.
In the Vitiligo application, the first Phase III study completed recruitment in May last year (210 subjects) with results expected in the second half of next year. The second Phase III study, also with around 200 subjects, is due to commence in the first quarter of next year.
Clinuvel believes revenue of around US$500 million a year is possible in the Vitiligo market, and around US$150 million from ACTH.
Clinuvel is well funded to invest in expanding its business; the company held cash of $224 million last year and generated a net profit after tax of $36 million. Clinuvel is capitalized at $615 million.
Bioshares recommendation: Buy
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