Jannsen and Nanolek are launching a project for localization of Darzalex®
Janssen, a pharmaceutical company owned by Johnson and Johnson, and a Russian biopharmaceutical company Nanolek have announced the localization of manufacturing of Darzalex®(daratumumab) in Russia, which is used in treatment of multiple myeloma.
The battle against malignant hematologic diseases has been a strategic direction that Janssen had been working towards for many years now. Our team is diligently working on the search of new molecules, marketing and increasing access to therapy for such debilitating and hard to treat disease as multiple myeloma. This year our innovative product daratumumab was included in a program of high cost nosologies, which gives hope to many patients around the country. In support of this important milestone, we would like to express our commitment to the local Russian strategy, and are delighted to announce a partnership in localization of Darzalex®with one of the progressive Russian producers- biopharmaceutical company Nanolek. We believe that this collaboration will lead to a higher availability of this innovative therapy to Russian patients”, stated Katerina Pogodina, Managing Director of “Janssen” Russia and CIS, Executive Director of “Johnson and Johnson”.
Darzalex®localization is planned at the site of “Nanolek” biomedical center, which is located in Kirovskaya Oblast, in compliance with GMP and ISO.
Vladimir Khrestenko,” Nanolek” president commented: “Today we can talk about global innovations and enormous reserves for extending the life expectancy of the population in terms of availability of treatment for oncologic diseases. Our partnership with Janssen has a large social significance: by joining forces, we can positively contribute to the life of Russian patients living with malignant blood diseases. Our joint localization project will widen the access of patients with multiple myeloma to modern and effective therapy. I’m glad that this collaboration will help to solve one of the most complex medical problems, and aid in improving life expectancy and quality of life of Russian patients”.
Both oncological and vaccination areas are of the primary focus for Nanolek at the moment. The company is actively developing its medication database for treatment of oncological diseases both in collaboration with international companies, and on their own.
In 2017, Darzalex®was registered in Russia and marketed as a monotherapy treatment in patients with relapsing or refractory multiple myeloma. Previous treatment included proteasome inhibitors and immunomodulating substances. In 2019 the drug had a new indication added to its description.
Now, Darzalex® is also recommended as a combination therapy for treatment of adult patients with multiple myeloma. Daratumumab is the first human monoclonal antibody to CD38 protein that has been approved for treating this disease.
Janssen has been contributing to the fight against malignant blood diseases in Russia for over 10 years, by studying molecular and cellular mechanisms of disease development, and by producing and marketing innovative drugs. In 2007, Janssen has made a breakthrough in treatment of multiple myeloma, and the Darzalex® which has appeared on the Russian market in 2017 was acknowledged to be a breakthrough therapy by worldwide regulatory agencies.
Link: gmpnews.ru
