The Ministry of Health of the Russian Federation has registered a new drug, Primapur®, a recombinant follicle-stimulating hormone (FSH), which has been designed to treat human infertility and is now produced at the Medsintez plant. A fully Russian drug; it went through all stages, from the development and creation of a pharmaceutical substance to the release of a finished dosage form, exclusively in the Russian Federation. In 2019, the Medsintez plant produced four series of the FSH pharmaceutical substance and released the first four commercial batches of Primapur® finished dosage forms, which will reach clinics in early 2020.
Primapur® is a medicine that can be used by patients on a prescription basis as part of an in-vitro fertilization (IVF) program to induce the follicle growth in the ovaries. The technology allows getting the required number of mature, fertilization-ready eggs for a successful IVF procedure.
Primapur® is made using a technology based on recombinant DNAs. Hormone-producing cells have been developed by the Russian company IVFarma.
The Medsintez plant produces the drug in the form of a handy disposable pen injector available in three different dosages: 300, 450, 900 International Units (IU). The syringe pen has been designed for maximum convenience for patients and accurate dosage selection by specialists. It allows adjusting the administered dose of the drug with the minimum known increments of 5 IU of its activity. The syringe pen used with Primapur® has been registered by Roszdravnadzor as a medical device. The Medsintez plant's maximum production capacity for the drug will be up to 30 grams of the substance per year (up to 1 million disposable syringe pens), which is 200-250% of the existing Russian market.
Primapur® successfully passed preclinical trials, a clinical investigation of its pharmacokinetics and safety involving healthy volunteers and a randomized multicenter clinical investigation of its therapeutic equivalence in accordance with the requirements of the Russian Ministry of Health and the European Medical Agency. According to Russian and international standards, clinical trials were conducted on a comparative basis, with an original drug by a foreign manufacturer used as a reference.
The Medsintez plant has been partnering with IVPharma in the Primapur® development and manufacture since 2014. So, in April 2017, during clinical trials of the drug, the first developing clinical pregnancy was received at the AltraVita human reproduction clinic, which successfully ended in the birth of a healthy baby. By the date, as a result of clinical trials where Primapur® was used, 14 children were born, and the number of such babies is growing every day. 'A domestic FSH drug is necessary for the modern Russian medicine, since the IVF procedure is more and more in demand by the country's citizens. We, in turn, are ready to secure 200% supply of FSH drugs,” said Alexander Petrov, Chairman of Medsintez Board of Directors.