Clinical Phase III to start during 2016 with the innovative dermatology spray delivery system AKVANO®
Cerbios-Pharma SA (from now on CERBIOS), the second largest investor in Lipidor AB in Stockholm, is proud to announce that Lipidor AB has entered into a collaboration agreement on the commercialization of a sprayable anti-psoriatic product consisting of the generic Vitamin D analogue, Calcipotriol, formulated with Lipidor´s patented lipid-based drug delivery technology, AKVANO®, with Cadila Pharmaceuticals Limited, one of the largest pharmaceutical manufacturing groups in India.
The product targets patients with mild to moderate psoriasis.
Under the collaboration agreement, Cadila Pharmaceuticals will conduct a Phase III program in India starting in 2016.
“We are very pleased with our collaboration with Cadila Pharmaceuticals which will enable us to bring this important psoriasis product to the market”, said Dr. Anders Carlsson, CEO of Lipidor AB.
CERBIOS will not only provide the HPAI (High Potency Active Ingredient) Calcipotriol, but also produce the finished dosage form with the formulation, bottle filling and labeling on its Lugano site.Several years ago, CERBIOS received (see also News 03/2012) the SWISSMEDIC authorization for the supply of spray finished dosage forms for clinical trials.
“I am very pleased that our partnership with Lipidor, started several years ago, is moving forward as expected”, confirms Dr. Gabriel Haering, CERBIOS’ CEO.”There are other open and ongoing projects where, in fact, there could even be a synergy between the latest investment made at CERBIOS in the manufacturing of nanoparticles and the AKVANO® technology for further improving the bioavailability and skin penetration of the Active Ingredient”.
CERBIOS has been active for more than 20 years in HPAI manufacturing and especially in dermatology applications. The integration with LIPIDOR’s patent protected AKVANO® technology for topical drug delivery is providing our partners with an option to have a single partner developing and manufacturing the active ingredient as well as providing the formulation and final packaging for the clinical trials of New Chemical Entities.
Cerbios is a privately held company located in Lugano, Switzerland, that specializes in the development and manufacture of both chemical and biological APIs for its partners world-wide.
Exclusive, third-party manufacturing services are offered by the Chemical Division for HPAIs and by the Biological Division for monoclonal antibodies, recombinant proteins and pharma probiotics.
Cerbios provides full CMC support to its world-wide partners, including the supply of cGMP clinical batches, registration/validation material and commercially manufactured APIs. Paramount to this is the ability to supply all of the technical documentation and support necessary for a successful registration. Cerbios’ commercial products are marketed worldwide but primarily in Europe, USA, Japan and India.