Clinuvel Update: Regulatory Timeline, Expansion Plans For SCENESSE® (afamelanotide 16mg)

  • Jan 15, 2019 AEDT
  • Team Kalkine
Clinuvel Update: Regulatory Timeline, Expansion Plans For SCENESSE® (afamelanotide 16mg)

On 15 January 2019, Clinuvel Pharmaceuticals Limited (ASX: CUV) announced major timelines for the FDA approvals on the overall benefit-risk assessment of SCENESSE® (afamelanotide 16mg), company’s flagship photoprotective drug for the prevention of phototoxicity in adults with the erythropoietic protoporphyria (EPP) disease.

Below are the important dates for SCENESSE® US regulatory approval:

  • 9 January 2019- The US Food and Drug Administration (FDA) completed the review of the New Drug Application filed by the company in June 2018.
  • 8 April 2019- FDA will be sharing labelling and post-marketing requirements and commitments if needed
  • 8 July 2019 – Target review date under the Prescription Drug User Fee Act (PDUFA).

Clinuvel is anticipating increased interactions with FDA this year in terms of possible questions on the individual scientific modules submitted such as pre-clinical and clinical product data, quality aspects, manufacturing process and distribution activities of the product in the US.  The FDA has already examined the US manufacturing site of SCENESSE®. Further inspections of US clinical sites are ongoing to determine GCP compliance. The company understands that the regulatory approvals are time-consuming, however, it highlights the benefits its clinical teams have derived by adding more safety measures to SCENESSE® dossier.

Vitiligo Program

On December 2018, Clinuvel released the findings of CUV103 study in vitiligo patients which demonstrated that the combination of SCENESSE® with narrowband UVB (NB-UVB) results in a follicular pigmentary response among Asian vitiligo patients. As suggested by FDA, the company conducted a pre-clinical study to access the scope of this combination therapy and observed that NB-UVB directed thrice a week and SCENESSE® administered once in four weeks over six months, did not pose any safety concerns. The company is targeting further work for the future of SCENESSE in vitiligo treatment and would keep the medical community and patients informed of the developments.

Post the FDA’s review process in EPP, the vitiligo program will be conducted in North America. The company also plans to conduct a Type C meeting with the Division of Dermatology and Dental Products for the protocol design and advanced development roadmap for SCENESSE® establishment in the US market.

Variegate Porphyria

Clinuvel has announced an experimental study as part of the clinical expansion of SCENESSE® in Variegate Porphyria (VP) patients. VP belongs to the family of 9 porphyrias disabling patients with skin fragility, frequent ulcerations and blistering. The company has received the initial regulatory approvals for Phase II study - CUV040, first photoprotective clinical study in VP patients since 1970s. This will involve procedures conducted on six VP patients for eight months, with up to six SCENESSE® implants administered over a six-month period. The study is expected to begin soon this year.

Clinuvel is looking forward to unveiling further work from the VALLAURIX team later this year. The company is also keeping an eye on its UK market presence given uncertain UK’s Brexit plans.

Stock performance:

Clinuvel shares are trading in red today at the price of A$21.880, down by 1.63% (As at 2:03 PM, 15 January 2019). The company’s stock has demonstrated impressive performance over last six months, offering a return of 98.13% to investors.


Disclaimer

This website is a service of Kalkine Media Pty. Ltd. A.C.N. 629 651 672. The website has been prepared for informational purposes only and is not intended to be used as a complete source of information on any particular company. Kalkine Media does not in any way endorse or recommend individuals, products or services that may be discussed on this site. Our publications are NOT a solicitation or recommendation to buy, sell or hold. We are neither licensed nor qualified to provide investment advice.

 

All pictures are copyright to their respective owner(s).Kalkinemedia.com does not claim ownership of any of the pictures displayed on this website unless stated otherwise. Some of the images used on this website are taken from the web and are believed to be in public domain. We have used reasonable efforts to accredit the source (public domain/CC0 status) to where it was found and indicated it below the image.

 

There is no investor left unperturbed with the ongoing trade conflicts between US-China and the devastating bushfire in Australia.

Are you wondering if the year 2020 might not have taken the right start? Dividend stocks could be the answer to that question.

As interest rates in Australia are already at record low levels, find out which dividend stocks are viewed as the most attractive investment opportunity in the current scenario in our report.

CLICK HERE FOR YOUR FREE REPORT!
   
x
We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it. OK