Croma-Pharma GmbH Stockerauerstrasse Korneuburg Tel.: +43 / (0)2262 / Fax: +43 / (0)2262 /

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1 Artikelnr.: AUSTRIA Headquarter Croma-Pharma GmbH Stockerauerstrasse Korneuburg Tel.: +43 / (0)2262 / Fax: +43 / (0)2262 / office@croma.at Subsidiaries Germany, France, Poland, Romania, Spain, Switzerland, Hungary

2 Synocrom forte Innovations With Synocrom forte, Croma-Pharma introduces an innovative intra-articular viscosupplementation therapy which combines traditional therapeutic benefits of hyaluronic acid substitution with an accelerated mode of action and fewer injections. 2% hyaluronic acid of biofermentative origin Significant pain reduction 120 mg hyaluronic acid per treatment cycle Rapid therapeutic effect Only 3 injections For all synovial joints

3 Synocrom forte biochemical characteristics 2% hyaluronic acid Biofermentative origin Patented stabilization process Improved thermo stability High viscosity 2.1 million dalton Synocrom forte technical properties Pre-filled syringe 2 ml filling volume Hard-cover blister Luer lock Terminal steam sterilization

4 Indications Synocrom forte is an intra-articular viscosupplementation 3) product intended for the treatment of osteoarthritis of all synovial joints. Approved therapeutic indications include: Gonarthritis Coxarthritis Omarthritis Ankle arthritis Arthritis of the elbow

5 Rapid and long-lasting therapeutic effect A post-market surveillance study 4) assessing 115 patients showed that one Synocrom forte treatment cycle provides pain relief for up to 12 months. Synocrom forte contains 2% hyaluronic acid of biofermentative origin, which is stabilized in a patented procedure. VAS long-lasting therapeutic Effect Thanks to its high concentration of hyaluronic acid and the creation of a three-dimensional HA network, Synocrom forte ensures rapid pain relief which lasts up to 12 months. 4) 1. injection 2. injection 3. injection 1 month 2 months 3 months 4 months 5 months 6 months pain during therapy pain at follow-up 7 months 8 months 9 months 10 months 11 months 12 months Synocrom forte is particularly well suited for the treatment of of osteoarthritis grade III. Even in severe cases a long-lasting VAS reduction of more than 30 mm is achieved, which can last for up to 12 months.

6 Excellent patient satisfaction A post-market surveillance study 4) assessing 115 patients revealed excellent patient satisfaction. 80% of all patients treated with Synocrom forte confirm its excellent efficacy within the first 6 months after therapy completion. % ratings assessment of patient satisfaction % of all patients treated with Synocrom forte still confirm its excellent efficacy 12 months after therapy completion SYNOCROM forte months after last injection 80% of all surgeons confirm the excellent efficacy of Synocrom forte throughout the entire therapy. 4) 10

7 2% hyaluronic acid of biofermentative origin Synocrom forte pre-filled syringes contain 2% hyaluronic acid of biofermentative origin. Thus, Synocrom forte contains twice as much active substance compared to main competitive products. 5) Brand name Synocrom forte Synvisc Hyalgan Suplasyn Manufacturer Croma-Pharma Genzyme Fidia Bioniche Source Biofermentative Rooster combs Rooster combs Biofermentative Concentration 2% Hyaluronic acid 0.8% Hylan 1% Hyaluronic acid 1% Hyaluronic acid Amount of hyaluronic acid/treatment cycle 120 mg 48 mg 100 mg 100 mg Molecular weight 2.1m. Da. 6 m. Da. (average) kda kda. Number of injections

8 Improved stability in the joint Due to its hyaluronic acid stabilization process and the slower enzymatic degradation, Synocrom forte shows higher thermo stability at 40 C in vitro 4) and better stability in the synovial joint than native 2% hyaluronic acid. viscosity mpa. s effect of cross-linkage 100,000 80,000 60,000 40,000 20, weeks SYNOCROM forte native 2% hyaluronic acid 15

9 Viscosity Synocrom forte has outstanding shock-absorbing and friction reducing properties due to its excellent viscosity, which is 10 times higher than in conventional 1% non-stabilized hyaluronic acid products. mpa. s viscosity 80,000 70,000 77,250 60,000 50,000 40,000 30,000 20,000 10,000 0 SYNOCROM forte 6,060 1% HA 16

10 Croma-Pharma quality characteristics Hyaluronic acid of biofermentative origin Croma-Pharma places great emphasis on the safety and purity of its products. We carefully select our raw materials, choosing only hyaluronic acid of biofermentative origin which does not contain any traces of animal proteins or prions. Our products are manufactured according to strict safety guidelines at our high-tech production site in Austria. In this way we provide our customers with pure, sterile and pyrogen-free viscoelastic solutions of highest quality. 18

11 Croma-Pharma quality characteristics Sterilization Terminal steam sterilization of the product guarantees inner and outer sterility of the syringe. This special sterilization method guarantees a sterility grade of the syringe which is 1,000 times higher compared to conventional methods, e.g. aseptic filling. Thus, terminal steam sterilization is an essential part of our commitment to safety. All Croma-Pharma products are steam- and heat- sterilized and offer a sterility assurance level (SAL) of 10-6, i.e. all of our products are suitable for surgery. 19

12 Croma-Pharma quality characteristics Transparent quality control process All of our products are manufactured according to GMP guidelines and ISO standards. The sterility and quality of our hyaluronic acid products are tested on a regular basis by an accredited microbiologic institute (Austrian Agency for Health and Nutrition, Graz). 20