Synolyne Pharma, a biotech spin-off company of the University of Liège and spin-out of Kitozyme SA (Belgium), has recently been granted two new patents in both Europe and the United States in relation to its chitosan-based microbeads. Houtaï Choumane, Managing Director & CEO, gives us an insight of the company’s achievements and prospects.

Could you tell us more about Synolyne Pharma’s core Business?

HC – Synolyne Pharma is specialized in the development, manufacturing and commercialization of safer and exceptionally efficient therapeutic solutions to patients who suffer from high impact pathologies. We are developing a brand of “Vegetech inside™” medical devices and implants that integrate proprietary animal-free chitosan-based technologies. The chitosan-based hydrogel microbeads is a leading development in our pipeline, designed to protect the cartilage and promote joint repair in patients suffering from osteoarthritis.

How do we treat osteoarthritis?

HC – To date, there is no medicines able to cure osteoarthritis. Anti-inflammatory drugs only relieve pain and, when taken on the long run, may cause major side-effects on patients. Today, Intra-articular injections represent a promising alternative to anti-inflammatory drugs. The so-called “visco-supplementation” is a procedure that consists in injecting into the joint a gel product with viscoelastic properties to match synovial fluid properties. Chitosan microbeads are remarkably deformable and elastic. They act as shock absorbers and create a “ball bearing effect” between the joints.  This product does not only ease the pain, it slows down the progression of osteoarthritis and promotes cartilage repair.

A good news for the patients then?

HC – Yes indeed! Slowing down the progression of the disease means that patients can postpone the surgery for their joint replacement up- to 3 years! Consequently, in some categories of patients, this could result in abandoning this costly and potentially risky surgery, or at least avoid renewing this surgical act as prosthesis currently have a shelf life of around 10 years. The first generations of visco-supplement products required 3 to 5 injections a year. Our strategy is to develop an even more cost-effective and safer product to be administrated once a year. With this revolutionary product in hands, doctors will be able to decide which best treatment regimen to recommend to their patients.

What is your market?

HC – Osteoarthritis affects over 100 million patients worldwide, and brings upon additional costs of approximately 1-2% of global GDP. More and more young people suffer from this disease: global prevalence is estimated at 10% to 15%, and the rate keeps on increasing. On a global scale, the visco-supplementation market value is estimated to be $ 2 billion worldwide. In 2019, the European market should represent a value of EUR 400 million. 

Our objective with our new product is to take 5% of the European market shares within 2019, 3 years after commercial launch, and to generate an income of EUR 20 million.

How are you going to do this?

HC – Well, by developing a superior product compared to the existing visco-supplementation offer.  The first results we have in hand confirm the potential of our hydrogel microbeads technology as a significant boost of efficacy. The issuance of two patents in Europe and the United States is great news for us, and a key milestone as it secures the value we will generate on the European and American markets. Synolyne Pharma is now initiating the second phase of its development program, and aims at obtaining the CE mark of its product, which should pave the way for its commercial launch in Europe by 2017.

What about the US market?

HC – The US market is very attractive as it grows rapidly (up to 11% CAGR) and represents about 45% of the worldwide market. However access to the USA market will require additional investments to support clinical trials for the registration of the product by the FDA. We are committed to build a strong Rheumatology franchise in Europe first, and will go for the US in a second step. Of course our development plan takes into account the specificities of the US market in terms of regulations and practices.  A partnership with an American company would be a good way to accelerate the product introduction there. We are also considering the Middle-East region through a specialized distribution strategy.

Synolyne Pharma’s key milestones

• Exclusive worldwide license on the hydrogel microbeads technology since it was started up in June 2012.
• Raising of EUR 3,3 million to pursue the development of its treatment against degenerative osteoarthritis and secure animal-free ultrapure chitosan supply through the spin-out of the biomedical activities from KitoZyme in 2014.
• Signature of several development partnerships with leading players in the joint health  dermal repair areas in 2014.
• Registration of Vegetech inside, its trademark for the chitosan-based range of technologies
• Development partnership with a technological company that develops a revolutionary product for brain surgery in 2014.