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Cerbios-Pharma and Lipidor consolidate AKVANO® partnership

news-releasesCERBIOS-PHARMA SA
November 25th 2015

Lugano, Switzerland:- High-tech CDMO Cerbios-Pharma SA (Cerbios) has increased its stake in Lipidor AB as part of a deepening partnership focused on the innovative and versatile drug delivery technology, AKVANO®.

AKVANO offers a completely new topical dosage form that creates a lipid layer on the skin surface for effective delivery of drugs and skin care treatment. Lipidor is currently in clinical development of an initial sprayable product concept for treating plaque psoriasis.

Phase III clinical trials

Cerbios CEO Dr. Gabriel Haering commented: “We decided to boost our involvement as shareholder in Lipidor to support the company at this important stage as it takes on new industrial partners and Phase III clinical trials with Cerbios’ HPAI (High Potency Active Ingredient) Calcipotriol, combined with Lipidor’s AKVANO delivery system, in the treatment of psoriasis.”

“Dermatology is one of the key therapeutic areas in which Cerbios is active in the development and manufacturing of drug substances in Lugano since 1993,” said Dr. Haering.

“The partnership with Lipidor is bringing new pharma companies on board either because they are interested in the quick delivery of clinical batches (formulation and bottle filling) with their own supplied HPAI or because they are originator companies wanting their HPAI manufactured by Cerbios in a fully integrated process with the formulation. This is definitely of great value to them in speeding up the process,” Dr. Haering added.

Calcipotriol HPAI formulation

Lipidor CEO Dr. Anders Carlsson said: “We are very happy that Cerbios is showing confidence in Lipidor and our AKVANO technology, by increasing their involvement as a shareholder and by participating in the upcoming Phase III clinical trial.”
“This strengthens our possibilities for a successful completion of the Calcipotriol program and supports us in the commercialization of the AKVANO technology.”

“Cerbios’ strong industrial background and broad network means that projects with potential industrial partners interested in AKVANO, whether with their own generic API’s or NCE’s, can be implemented more easily and efficiently,” Dr. Carlsson added.

Lipidor has recently announced a series of significant milestones on the road to clinical or product launch of AKVANO:

  • Phase III Clinical Trial on the Calcipotriol formulation is predicted to start at the beginning of 2016.
  • Feasibility study with NCE of the topical spray form as a substitute for the originally developed oral dosage forms.
  • Skin Care and Cosmetic applications will be the first products launched on the market with Bag-on-valve technology in Nordic countries at the beginning of 2016. These products are available for licensing throughout the rest of the world.
  • Pharmaceutical applications (cGMP) based on the Bag-on-valve technology will be available from mid 2016.

About Cerbios-Pharma

Cerbios-Pharma SA 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. Active since almost 40 years, Cerbios specializes in the development and production of High Potency Active Ingredients (HPAIs) in the area of fine chemicals and biologicals.

Cerbios Chemical Division offers exclusive, third-party manufacturing services for HPAIs while Biological Division produces monoclonal antibodies, recombinant proteins and pharma probiotics.

Cerbios provides full CMC support to its worldwide 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.

About Lipidor

Lipidor AB is a Swedish drug delivery company established in 2009. The Company is focused on the development and commercialization of its AKVANO® technology, a new proprietary class of topical medication.

AKVANO offers “lipid layer” product opportunities across dermatology, wound & burn care and skin care markets.

Research and development is conducted at Karolinska Institutet and tockholm University.

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