ROVI will present positive results of Risperidone ISM® and Bemiparin at the 12th EACPT Congress

For more information: Marta Campos Martínez [email protected] Phone: +34 91 244 44 22 ROVI will present positive results of Risperidone ISM® and Bemiparin 1 ROVI will present positive results of Risperidone ISM® and Bemiparin at the 12th EACPT Congress The Company will be present in one of the most prestigious international Pharmacology Congresses. Madrid – June 26, 2015– Laboratorios Farmacéuticos Rovi, S.A. (www.rovi.es) today announced that the last clinical data on Risperidone ISM® and Bemiparin, both drugs belonging to the Company, are scheduled to be presented at the 12th European Association for Clinical Pharmacology and Therapeutics (EACPT) Congress in Madrid during next June 27-30th, 2015. In the area of long-acting injectable antipsychotics, the results obtained in one of the studies presented at the congress “Phase I Clinical Trial to evaluate the pharmacokinetic, safety, and tolerability of one intramuscular injections of Risperidone ISM® at different dose strengths in subjects with schizophrenia or schizoaffective disorder (PRISMA-1)”, confirm the expectations placed on Risperidone ISM®, which provides a sustained release of risperidone that achieved monthly therapeutic plasma levels within the first day without oral supplementation. Thus, the pharmacological profile of Risperidone ISM® not only facilitate better compliance of schizophrenic patients, but may also arise as a suitable medication to treat acute exacerbations of the disease. These results will be presented on Saturday, June 27. Besides, to predict the steady-state Pharmacokinetic (PK) exposure of Risperidone ISM® active moiety after drug administration, it was developed a population PK model (“Population pharmacokinetic modeling and simulations of long-acting ROVI will present positive results of Risperidone ISM® and Bemiparin 2 intramuscular Risperidone ISM®”)which will be presented on Tuesday, June 30 at the congress as an oral communication. This model can be further used for simulations aiding to provide a dosing rationale for Risperidone ISM®. Furthermore, within the field of antithrombotic drugs, the analysis of the aggregated data from several clinical trials, do not show an increase of bleeding in elderly and patients with renal impairment, after receiving Bemiparin in comparison with placebo. This data corroborate the safety profile of Bemiparin, a second-generation low molecular weight heparin, in the sub-populations analyzed. “Aggregated data of clinical trials: Bemiparin bleeding risk in elderly and patients with renal impairment”will be presented on Monday, June 29. About ISM® technology ISM® is a technology platform for the prolonged release of drugs that has been patented by ROVI, and is based on the in situ formation of biodegradable matrices following the administration of a liquid carrier. The product is presented in a Kit of two syringes, one of which contains the polymer and the active ingredient in solid state, and the second which contains the solvent needed for reconstitution, which is carried out unseasonably. The ISM technology design leads to a major improvement in the stability of the composition and allows for controlled and reproducible release profiles after subcutaneous or intramuscular administration. About Bemiparin Bemiparin is a second generation low molecular weight heparin patented and developed by Laboratorios Farmacéuticos Rovi, S.A. Currently, Bemiparin is marketed in 53 countries for the prevention and treatment of venous thromboembolic disease (VTD) both in surgical and medical patients and the treatment of acute long term patients that have undergone a VTD process. ROVI will present positive results of Risperidone ISM® and Bemiparin 3 About ROVI ROVI is a fully integrated Spanish specialty pharmaceutical company engaged in the research, development, in-licensing, manufacturing and marketing of small molecule and specialty biologic drugs. The Company has a diversified portfolio of products that it markets in Spain through its specialized sales force, calling on specialist physicians, hospitals and pharmacies. ROVI’s portfolio of 30 principal marketed products is currently anchored by the internally-developed, second generation low molecular weight heparin, Bemiparin. ROVI’s research and development pipeline is focused primarily on the expansion of applications, indications and alternative mechanisms of action for the heparin-derived products and other glycosaminoglycans and on the development of new controlled release mechanisms based on ISM® technology, with the aim of obtaining new pharmaceutical products that enable the regular administration of formulations which are administered daily in chronic and prolonged treatments. ROVI manufactures the active biological ingredient (Bemiparin) for its principal proprietary products and for injectable pharmaceutical products developed by its in-house research team, and utilizes its state-of-the-art filling and packaging capabilities to provide a broad array of toll manufacturing services to leading international pharmaceutical companies, primarily in the area of pre-filled syringes. In addition, ROVI provides contract manufacturing and packaging services of solid oral pharmaceutical dosage forms, using the most enhanced technology, Roller Compaction. Additional information about ROVI is available on the company’s website: www.rovi.es.

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