From Tribulus terrestris to Tribestan real life collaboration between Academia and the Industry CASE REPORT
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1 From Tribulus terrestris to Tribestan real life collaboration between Academia and the Industry CASE REPORT Andrey Mladenov, MD, MBA Sopharma PLC Bulgaria
2 Tribulus terrestris Used for several thousands of years China, India, Africa, Australia, South European Countries Aphrodisiac, antihypertensive, hypolipemic, spasmolityc and diuretic actions
3 TRIBESTAN Plant medicinal product - film-coated tablets with active substance Tribulus terrestris herba extractum siccum 250 mg (content of furostanol saponins not less than 112,5 mg) First Marketing Authorization in 1981, Bulgaria MA all over the world: As a medicinal product -Russia, Malaysia, Singapore, Ukraine, Armenia, Azerbaidjan, Georgia, Kazakhstan, Kirgizia, Tajikistan, Uzbekistan Lithuania, Croatia, Turkey; As a food supplement - China, Czech Republic, Poland, Latvia, Slovakia, Croatia in combination with vitamins and Genseng.
4 Movie Just to get an idea
5 Why is Tribestan so important for us? Sopharma s best selling products are based on herbal APIs with unique therapeutic characteristics that are not found in the alternative competitive products as these were originally developed in-house The phyto products make up the first positions in the TOP5 best selling products, together accounting for more than 50% of Sopharma s revenues in 2010 (mainly due to the strong brand recognition in export markets) Spasmalgon 2% Methylprednisolone 2% Cidnofarm 3% Tribestan 3% Cinnarizine 3% Tabex 4% Other 18% Broncholitin 5% Tempalgin 16% Carsil 27% Sedal M 17% Phyto product TOP20 Treatment Carsil 1 Liver diseases Broncholytin 5 Cough Tabex 7 Tobacco addiction Tribestan 8 Impotence & infertility Nivalin 13 Neurological disorders
6 Manufacturing Produced at Balgarska Roza Sevtopolis ( Based on tribulus plant collection and extraction of the API The technology is invented in collaboration with pharmaceutical academic experts 30 years + of successful production and distribution
7 Current usage As medicinal product: Indications - low libido, impotence, infertility; dyslipoproteinemia; climacteric and postcastration syndrome Doses 1-2 tablets 3 times daily for 90 day Adverse drug reactions hypersensitivity, irritating effect on stomach mucous membrane is possible Favourable safety profile! As supplement: In fitness and wellness clubs for body building In cosmetics and beauty centers for skin and nail care As self medication
8 Further collaboration with Academia in product clinical development Regulatory requirements RA requested additional information on efficacy and safety Upcoming (EU) registrations more complete data on efficacy and safety from recently conducted clinical trials Marketing activities post-marketing efficacy and safety data
9 Our post-marketing clinical research program 1 clinical study in men with infertility to assess the influence of Tribestan on spermatogenesis 1 clinical study in women with infertility 1 clinical study in women with climacteric syndrome Estimated 600 patients to be enrolled!
10 First trial Phase IV, 16 weeks, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to assess the efficacy and safety of oral Tribulus terrestris (Tribestan ) in men with erectile dysfunction (mild to moderate) and/or secondary hypoactive sexual desire (low libido) 4 study sites in leading hospitals, working in the field of sexual health a centre for sexual disorders, urology and endocrinology clinics with expected high recruitment potential 180 men with mild to moderate erectile dysfunction to be enrolled
11 Objectives and endpoints Objectives Primary: to compare the efficacy of Tribestan vs placebo on erectile function and sexual desire Secondary: to evaluate the effect of Tribestan on the level of Total cholesterol, LDL, HDL, triglycerides; to monitor the safety profile of Tribestan Endpoints Primary Endpoint The change of erectile function score, evaluated by IIEF after 12 weeks treatment period with Tribestan Secondary Endpoints Overall estimation of sexual function by IIEF; Adverse Events monitoring; Laboratory measurements; Lipids profile; Blood pressure
12 Next opportunity for collaboration with academic structures Further 3 clinical trials to be conducted Imminent start of a study for efficacy and safety in infertile mail patients Possible collaboration in: Protocol development Biostatistics Study set-up Generation of the study report Scientific publication And beyond
13 Lessons learned Phase IV studies committed for post-registration phase should be supported with sufficient resources Protocol design should reflect the routine medical practice and should be developed in close collaboration with Academia Competent academic experts should be attracted for collaboration Further opportunities for collaboration in favor of the business should be exploited: Optimization of the extraction of API New pharmaceutical form New dosage regimen Development of specifically designed food supplement
14 Thank you for your attention! My contact details: 3 Blvd. Kliment Ohridski 1797 Sofia, BG
15 Brief history and key milestones Local pharmaceutical community starts construction of the first laboratory for production of medicinal products Privatization Sopharma becoming a privately held pharmaceutical company New modern pharmaceutical plant Vrabevo opened for production of medicinal products Licensed its production facilities according to the European GMP Increased production capacity through acquisition of Bulgarian Rose Sevtopolis AD Acquired a very active distributor Briz Ltd. in Latvia Briz acquiring a pharmacy chain in Belarus Sopharma nationalized Start of production: 1956 Nivalin 1964 Tabex 1981 Tribestan Sopharma listed on BSE Acquired five small producers: Unipharm AD Vramed AD Pharmachim Holding AD NIHFI AD Rostbalkanpharm Opened the state-of-theart logistics terminal for distribution of pharmaceutical products (European GDP certified) Construction of new high tech production facilities in Sofia and Serbia First successfull registration of Sopharma s product in old EU (Nivalin in Austria) Control stake acquisition in Unifarm AD Construction of a new high tech tablet factory for the production of solid forms with doubled capacity Penetrating into distribution business by acquiring Sopharma Trading 15 Modern history period of constant modernization and development
16 Sopharma AD Key markets Poland Ukraine Russia Kazakhstan Market size: EUR 5.0bn Sopharma: EUR 2.0m Market size: EUR 1.9bn Sopharma: EUR 16.1m Market size: USD 17.1bn Sopharma: EUR 42.0m Market size: EUR 0.9bn Sopharma: EUR 3.0m Belarus Market size: EUR x.xbn Sopharma: EUR 1.8m Bulgaria Market size: EUR 0.96bn Sopharma: EUR 32.5m PL EE LV LT BY RU Turkey UA KZ Market size: EUR x.xbn Sopharma: EUR x.xm SB BG TR 16 Sopharma s core markets Sopharma s other active markets
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