CLINUVEL PHARMACEUTICALS’s Drug SCENESSE® Goal Date Extended By The US FDA

CLINUVEL PHARMACEUTICALS LTD (ASX: CUV) is a global biopharmaceutical player. It concentrates on developing and providing treatments for severe genetic and skin disorders. The company’s R&D has led to innovative treatments for patient groups, ranging from 5,000 to 45 million worldwide, with a clinical need for photoprotection and re-pigmentation.

Its lead compound is SCENESSE® and the European Commission, in 2014, had approved it, to prevent phototoxicity in patients suffering from erythropoietic protoporphyria.

On 3rd June 2019, the company announced that the US Food and Drug Administration’s Division of Dermatology and Dental Products had extended the goal date for its drug SCENESSE®. The new Prescription Drug User Fee Act date is now 6th October 2019. Besides this, the FDA also revised the expected date to comment on product labelling and the company’s post-marketing authorisation commitments, to 6th September 2019.

It can hence be inferred that the DDDP needs time to finish a full review of the submission of the drug’s new drug application scientific dossier. The company had submitted an NDA in 2018 for the drug’s usage to avert phototoxicity and anaphylactoid responses in patients suffering from EPP (erythropoietic protoporphyria).

Tracing back to history, the drug had received an orphan drug designation by the FDA in 2008. Later, in 2016, CUV was asked to submit the clinical data by DDDP. FDA notified in July 2016 that the NDA filing met the Fast Track Designation criteria. This was a path to regulatory reviews, which started in 2018. In October 2016, FDA held its first public workshop on EPP where 150 patients with families were invited to learn about the disorder. In November 2016, a pre-NDA meeting was held according to which CUV was ready to file its scientific dossier on the drug.

In January 2019, NDA was granted the product Priority Review by FDA after validation of NDA’s filing. With a scientific review of six months, the initial fee goal date was set as 8th July 2019.

Dr Dennis Wright, CUV’s Chief Scientific Officer, stated that the drug was being prescribed in the EU and Switzerland. Also, a few US patients have been travelling to Europe for treatment but many of the patients have no access. CUV would aid FDA staff in the review of the drug and conclude a final benefit-risk assessment.

Also, in its newsletter released on 2nd May 2019, the company stated that because of BREXIT and EU Distribution of SCENESSE®, CUV was forced to seek solutions for present EU batch testing and release, a requisite from EU regulators. The company has the requirement to adapt systems and personnel to remain in compliance with the situation.

Besides this, a Global Vitiligo Expert Consortium of clinical experts in hypopigmentary disorders and vitiligo had been formed. After a result is obtained for SCENESSE® in EPP, the company would move towards its program to conduct the next clinical trial in North America.

CUV’s details as per its newsletter (Source: Company’s report)

 

The below table has the highlights from the company’s cash flow statement, released on 30th April 2019:

Cash Flows Amount (A$’000)
Net cash from operating activities 2,516
Net cash used in investing activities 27
Cash and its equivalents at the quarter’s end 44,975
Estimated cash outflows for next quarter 4,000

Share Price Information: 

As on 3rd May 2019, the stock of the company last traded at A$31.000, down by 10.119% from its previous close. It has provided a YTD return of 91.61%.


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