Clinuvel Company News
Clinuvel files European MAA for SCENESSE® (afamelanotide)
Clinuvel has filed a marketing authorisation application (MAA) with the European Medicines Agency (EMA) for the orphan disease erythropoietic protoporphyria (EPP).
To read the company's full announcement, click here.
Read a blog post from Clinuvel's CEO, Dr Philippe Wolgen, on the MAA filing: MAA: a moment in Clinuvel's EPP story
Media coverage: Australian Life Scientist, Online Pharma Times
Analyst coverage from Nomura is available on our investor site.
To learn more about our EPP program, click here.
Updated: Clinuvel announces EU Phase III EPP results
Clinuvel has released results from its Phase III study of SCENESSE® (afamelanotide) in the orphan designated disease erythropoietic protoporphyria (EPP).This study (CUV029) was conducted in eight centres across Europe.
To read the results, click here.
Media coverage: Reuters, Australian Life Scientist, The Age
Analyst coverage from Nomura and Edison research is available on our investor site.
Q4 2011 media
Clinuvel has been the focus of articles in the Financial Times and Reuters in recent weeks. To read more, click the links below
| Date | Title | Link |
|---|---|---|
| 22/12/2011 |
Clinuvel Scenesse yields positive data in EPP |
Link |
| 21/12/2011 |
Clinuvel Filing for Scenesse In EU on Phase III Data in EPP |
Link |
| 21/12/2011 |
Drug helps the sun to shine for those with an allergy to light |
Link |
| 19/12/2011 | Clinuvel drug seen safe, effective in pivotal trial | Link |
| 15/12/2011 | Bringing the Online Investor Centre to Life | Link |
| 09/12/2011 | When a tan is good for your health | Link |
| 02/12/2011 | INTERVIEW-Tiny Clinuvel spurns tanning for medical need | Link |
| 08/11/2011 | Clinuvel Pharmaceuticals secures patent for melanin activating drugs | Link |
| 03/11/2011 | Clinuvel Analyses From U.S. Study Show ‘Dramatic Improvement’ | Link |
| 21/10/2011 | Clinuvel Pharmaceuticals’ U.S. trial shows positive results of accelerated repigmentation in people | Link |
| 21/10/2011 | Clinuvel Pharmaceuticals Announces First Positive Observations from Vitiligo Trial | Link |
Phase II US EPP results
In November Clinuvel released results from our first Phase II study of SCENESSE (afamelanotide) conducted in the USA. You can read the company's full release here along with comments from CEO, Dr Philippe Wolgen, on the blog.
Press coverage: Australian Life Scientist | Biospectrum Asia | Pharmaceutical Business Review
Clinuvel Annual General Meeting
Clinuvel hosted the company's 2011 Annual General Meeting (AGM) on Wednesday November 9 in Melbourne, Australia.
- View the CEO's AGM presentation (pdf)
- View the Results of Meeting ASX announcement (pdf)
- View the Notice of Meeting ASX announcement (pdf)
Clinuvel records first A$1 million in sales
Since commencing a special access 648/96 scheme 11 months ago Clinuvel's SCENESSE® (afamelanotide) has been distributed to approximately 40 patients in Italy to treat EPP, a severe genetic disorder designated as ‘orphan’ disease. During this period the company recorded approximately A$1 million worth of sales. Clinuvel is reimbursed for the drug by the Italian health system. Read the company's full announcement (pdf).
Press coverage: Business Spectator
