Clinuvel enters a joint venture with Biotech Lab Singapore Development of pediatric formulations for EPP and a topical melanocortin peptide [CUV9900] for dermatology
Baar, Switzerland and Melbourne, Australia, September 19 2014
Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that it has reached agreement on terms and conditions with Biotech Lab Singapore Pte Ltd (BLS) to enter a joint venture (to be called Vallaurix Pte Ltd) for the final development of formulations for paediatric use of afamelanotide, and CUV9900, a novel melanocortin peptide for topical application for skin care. Clinuvel retains a majority interest in the partnership. The financial terms have not been disclosed.
In the joint venture, Clinuvel will lead and oversee the scientific aspects including the regulatory development of the melanocortins whereas BLS will be managing chemistry and formulation development in Asia.
RATIONALE FOR FOLLOW-ON PRODUCTS The innovative clinical use of SCENESSE® (afamelanotide 16 mg - Clinuvel’s lead product, currently under European regulatory review) over the past decade has provided Clinuvel with specific knowledge of the clinical use and safety of melanocortins in dermatology.
The feedback received during the European Medicines Agency’s (EMA) regulatory review of SCENESSE® played an important role in the timing of the joint venture’s establishment. Vallaurix Pte Ltd will focus on the development of the paediatric formulations of afamelanotide for erythropoietic protoporphyria (EPP), as well as CUV9900, a melanocortin peptide intended to be used as a complementary therapy in photodermatoses and depigmentation disorders such as vitiligo.
INTELLECTUAL PROPERTY The paediatric formulations and CUV9900 will be part of the proprietary portfolio of the joint venture.
TIMELINES Subject to a positive regulatory outcome of SCENESSE® in Europe in October 2014, the formulations for paediatric use in EPP will be developed to stay within the timelines committed to the EMA.
The development of CUV9900 for topical use follows a strategic plan to evaluate its’ stability, clinical efficacy and safety.
“In view of the development progress of SCENESSE®, we identified this as the right time to advance new formulations for paediatric use in EPP and CUV9900 for the complementary treatment of skin disorders,” Clinuvel’s Acting Chief Scientific Officer, Dr Dennis Wright said.
“After months of negotiations, the Board has found a good commercial outcome with BLS, a local partner providing us with access to Asia and China and capable of proportionally sharing in the development costs and commercial upside of future products,” Clinuvel’s Chair, Mr Stan McLiesh said.
“SCENESSE® has been a central part of our business plan to catalyse further downstream development of complementary formulations and next products,” Mr McLiesh added. “For years the Board has strived to realise the vision of furthering the development of SCENESSE® into complementary treatments. This vision was shared by our recently departed and much respected Board member Jack Wood and I am excited to play a part in realising this vision”.
- End -