Janssen, the pharmaceuticals division of Johnson & Johnson LLC, and the Russian biopharmaceutical company NANOLEK announce localization of Darzalex® (daratumumab), a medication used for the treatment of multiple myeloma, in the Russian Federation.

“The fight against hematological malignancies has been one of Janssen’s strategic focus areas for many years. Our team is working hard to find new molecules, launch these on the market and expand access to the treatment for such serious and difficult to treat diseases as multiple myeloma. This year, our innovative drug daratumumab was included in the high-cost nosologies program, which gives hope to many patients across the country. In order to support this valuable achievement, we also want to reaffirm our commitment to the local strategy in Russia, and are pleased to announce cooperation with one of the leading Russian manufacturers, the biopharmaceutical company NANOLEK, to localize Darzalex®. We believe that this kind of joint work helps to increase access of the Russian patients to innovative therapy,” says Katerina Pogodina, Managing Director for Russia and the CIS at the Janssen Pharmaceutical Companies, General Director of Johnson & Johnson LLC.

Localization of Darzalex® will be conducted at the facilities of the NANOLEK Biomedical Complex located in the Kirov region, in accordance with the GMP and ISO standards.

Vladimir Khristenko, President of NANOLEK, said:

Today we can talk about global innovations and enormous reserves to increase the life expectancy of the population, particularly in the area of cancer therapy. Our partnership with Janssen is of great social importance – by pooling together our efforts, we will be able to make a significant positive contribution to the life of Russian patients with hematological malignancies. Our joint localization project will increase patient access to modern and effective therapy for patients with a hard to treat form of cancer – multiple myeloma. I am pleased that this cooperation will help to solve one of the most difficult medical problems and significantly improve the duration and quality of life of the Russian patients.    
 

Oncology, along with vaccines, today is one of the focal areas for NANOLEK. The company is actively developing its portfolio of drugs for the treatment of cancer, both in cooperation with major international companies and through its own efforts.
In 2017, Darzalex® was approved in Russia and launched on the market for use as monotherapy in patients with recurrent or refractory multiple myeloma who were previously treated with protease inhibitors and immunomodulating drugs. In 2019, the instructions for use were amended due to a broadening of the indications for the product. Darzalex® is now also recommended for use in combination therapy for adult patients with multiple myeloma. Daratumumab is the first human anti-CD38 monoclonal antibody approved for the treatment of this disease.

Janssen has been contributing to the fight against hematological malignancies in Russia for over 10 years, studying molecular and cellular mechanisms of disease development and launching innovative drugs on the market. Thanks to Janssen, a breakthrough was achieved in the treatment of multiple myeloma in 2007, and the drug Darzalex® which appeared on the Russian market in 2017, was repeatedly recognized as a breakthrough therapy by global regulatory agencies. In September 2019, as part of the Make Blood Cancer Visible information campaign, a special project to raise awareness of malignant blood disorders was launched together with Glamour magazine.
   
Darzalex® is the first fully human monoclonal antibody to act on the CD38 surface protein, which is highly expressed on all myeloma cells regardless of the stage of the disease. The innovative mechanism of action of Darzalex® causes rapid death of tumor cells by several mechanisms. Darzalex® induces myeloma cell destruction due to CD38-mediated immune mechanisms (complement-dependent cytotoxicity, antibody-dependent cell-mediated cytotoxicity and antibody-dependent phagocytosis), apoptosis and CD385 enzymatic activity modulation.