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LPRI – R&D Pharma Madrid, 9th March, 2015.

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Presentation on theme: "LPRI – R&D Pharma Madrid, 9th March, 2015."— Presentation transcript:

1 LPRI – R&D Pharma Madrid, 9th March, 2015

2 LPRI – R&D Pharma - Ladee Pharma Research Institute “LPRI” is dedicated to innovative Pharmaceutical products in the field of Woman Health. LPRI supports the R&D activities of Mundo Sano (non for profit organization dedicated to unmet medical needs) with two different programs in Chagas disease and Helmintiasis. LPRI scientists are located in Madrid (Headquarter) – Paris and New Jersey. In 2015 LPRI employs 25 full time scientists. LPRI is supported for technical development and manufacturing its innovative products by Leon Farma (Leon, Spain) & Liconsa SA (Azuqueca, Spain) LPRI has developed regulatory expertise for filing of new drug applications in Europe and USA LPRI investment in R&D: 25 million Euros in million Euros in 2016 and 50 million Euros between 2017 and 2019 ( > 10% of sales) LPRI protects its innovations with patents in all developed countries (USA, Europe and RoW) LPRI has 8 active programs for innovation under development in 2015

3 LPRI – R&D Pharma - Project list
LPRI 211”Olevia” : contraception product. Olevia is a vaginal ring made of polymers that release constant levels of a progestin hormone (levonorgestrel) during 28 days (One ring for one 28 days cycle). Olevia is the first vaginal ring for contraception that does NOT use Estradiol derivatives (progestin only contraception) Olevia is entering clinical trials (Phase I) in Total investment ( ) = 30 million Euros. Slinda: contraception product. A daily tablet during 24 days each 28 days cycle. Slinda does not use Estradiol (progestin only contraception) More than 2,200 patients have been treated up to one year in 15 clinical trials in 10 countries (Europe) Total investment: 30 million Euros. Slinda is under review in Europe. Final approval expected in Fall Slinda has received an IND from FDA and was allowed to enter into a Phase III. Slinda is currently tested in a large clinical trial in USA (750 patients during one year - cost : 9 million Euros)

4 LPRI – R&D Pharma - Project list
LPRI 1000: folic acid for prevention of spina bifida (neural tube defect). LPRI1000 is a tablet to be used in combination with contraceptives in order to raise folate levels. Territory: US only. Total investment ( ) = 8 million Euros LPRI 100: LPRI 100 is a vaginal ring that release constant levels of a estradiol during 90 days. Indication: vulvo-vaginal atrophia in menopausal patients LPRI 100 is a new generation of vaginal rings that aims to replace the existing “poor performing” product and grow the use of vaginal rings vs. vaginal creams and tablets LPRI100 will enter into clinical trials (Phase I) in Territory: US, Europe and RoW. Total investment ( ) = 10 million Euros

5 LPRI – R&D Pharma - Project list
LPRI 421: contraception. LPRI421 is a daily tablet for continuous 90 days contraception that looks for a reduction of breakthrough bleeding during the cycle. Patients are expected to bleed once every 3 months (4 days of hormone free interval). LPRI421 offers an alternative for patients who do NOT want to bleed each cycle. Territory: US + Europe + RoW. Total investment ( ) = 30 million Euros LPRI 022: topical (gel) vibramycine for the treatment of acne. Vibramycine is a reference oral antibiotic for acne. LPRI is developing a local alternative with the benefit of lower systemic exposure. Total investment ( ) = 10 million Euros. Territory: US + Europe + RoW.

6 LPRI – R&D Pharma - Project list:
MS 747: Chagas. MS747 is a Mundo Sano project that aims to develop an oral treatment for acute and chronic Chagas patients based on Benznidazole. LPRI has received an orphan drug designation from FDA for this indication. Territory: LatAM and developed countries with infected migrants including USA and Spain. Total investment: 3 million Euros in MS 842: helmintiasis. MS842 is a Mundo Sano project that aims to develop an oral treatment with ivermectine at a fixed dose and develop a combination with albendazole for synergistic effect on resisting parasites. Territory: LatAm. Total investment: 4 million Euros in

7 LPRI – R&D Pharma Madrid, 9th March, 2015


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