Er-Kim, an international pharmaceutical company specializing in novel therapy commercialization, has entered into an exclusive distribution agreement with Puma Biotechnology to bring NERLYNX® (neratinib) to patients in Eastern Europe and Central Asia. The partnership, announced on April 30, 2025, aims to improve access to this targeted therapy for HER2-positive breast cancer patients in regions where treatment options have been limited.
Under the agreement, Er-Kim will serve as the distribution partner for NERLYNX across ten countries: Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, Turkmenistan, and Uzbekistan. This collaboration specifically targets areas where access to advanced cancer treatments has historically been challenging.
Addressing a Critical Global Health Burden
Breast cancer represents a significant global health challenge, with the International Agency for Research on Cancer (IARC) identifying it as the most common cancer among women worldwide and the second most common cancer overall. In 2022 alone, approximately 2.3 million new breast cancer cases were diagnosed globally, with 670,000 breast cancer-related deaths. However, the burden and access to treatment vary considerably across different regions.
"While breast cancer affects individuals globally, treatment availability varies considerably across regions," said Cem Zorlular, Chief Executive Officer of Er-Kim. "That is why we are pleased to be working with Puma Biotechnology to support access to NERLYNX in Russia and most of the Commonwealth of Independent States (CIS) for patients with early-stage breast cancer. Er-Kim has a long history of providing treatments in the EMEA region, particularly in women's health."
NERLYNX: Mechanism and Approved Indications
NERLYNX works by blocking the human epidermal growth factor receptor 2 (HER2), a protein that promotes cancer cell growth when overexpressed. By targeting this pathway, the medication helps treat and limit breast cancer metastasis.
The drug has received regulatory approval for two key indications:
- As monotherapy for adults with early-stage HER2-positive breast cancer who have previously received trastuzumab-based therapy
- In combination with capecitabine for adults with HER2-positive metastatic breast cancer who have received two or more prior anti-HER2 therapies
For early-stage patients, NERLYNX serves as an extended adjuvant treatment, helping to reduce the risk of cancer recurrence after initial therapy. This application is particularly important as recurrence remains a significant concern for breast cancer patients even after successful initial treatment.
About the Partner Companies
Er-Kim, established in 1981, has built a reputation for biopharmaceutical innovation and strategic partnerships. The company works with over 40 global pharmaceutical leaders and reaches more than 600 million patients through its network of affiliates. With a team exceeding 280 professionals worldwide and revenues over EUR 260 million, Er-Kim has established itself as a significant player in improving healthcare access across the EMEA region.
Puma Biotechnology, focused on developing and commercializing innovative cancer treatments, acquired the global rights to neratinib in 2011. The company received FDA approval for NERLYNX in 2017 for extended adjuvant treatment of early-stage HER2-positive breast cancer following trastuzumab-based therapy. In 2020, the FDA expanded this approval to include combination therapy with capecitabine for advanced or metastatic HER2-positive breast cancer patients who had received at least two prior anti-HER2 regimens.
The European Commission granted marketing authorization for NERLYNX in 2018 for extended adjuvant treatment of early-stage hormone receptor-positive HER2-positive breast cancer in patients less than one year from completing prior trastuzumab-based therapy.
Expanding Treatment Access
This partnership represents a significant step toward addressing regional disparities in cancer care. By bringing NERLYNX to these markets, Er-Kim and Puma Biotechnology aim to provide patients with access to therapies that can significantly impact disease outcomes, particularly in reducing recurrence risk for early-stage patients and offering additional options for those with metastatic disease.
The collaboration highlights the ongoing efforts to ensure that advances in cancer treatment reach patients globally, regardless of geographic location, addressing a critical aspect of healthcare equity in oncology.
