Er-Kim to Exclusively Distribute Puma Biotechnology's NERLYNX for Breast Cancer

In a strategic move to expand access to cancer treatments, Er-Kim, a global pharmaceutical company, has entered into a collaboration with Puma Biotechnology, Inc. This partnership focuses on the commercialization of NERLYNX® (neratinib) in designated countries across Eastern Europe and Central Asia, including Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, Turkmenistan, and Uzbekistan. The targeted therapy, NERLYNX, is designed to inhibit the human epidermal growth factor receptor 2 (HER2), which plays a crucial role in the progression and spread of breast cancer.

NERLYNX, a prescription medication, is tailored for adults with early-stage HER2-positive breast cancer who have undergone prior treatment with trastuzumab-based therapy. Additionally, NERLYNX, when used in conjunction with capecitabine, is approved for treating adults with metastatic HER2-positive breast cancer who have previously received two or more anti-HER2 therapeutic regimens. The International Agency for Research on Cancer (IARC) indicates that breast cancer ranks as the most prevalent cancer among women globally, with 2.3 million new cases and 670,000 related fatalities reported in 2022. However, there is a significant discrepancy in the availability of treatments across different regions.

Cem Zorlular, CEO of Er-Kim, emphasizes the importance of this partnership, stating, "While breast cancer impacts individuals worldwide, access to treatment greatly varies by region. We are excited to join forces with Puma Biotechnology to facilitate access to NERLYNX in Russia and many CIS countries for patients dealing with early-stage breast cancer." Er-Kim has an established legacy in the realm of women's health within the EMEA region, with a focus on delivering essential treatments.

Founded in 1981, Er-Kim has established itself as a leader in biopharmaceutical innovation, collaborating with over 40 global leaders to enhance patient care in international markets. The company's innovative business strategies emphasize sustainability and flexibility, allowing it to serve over 600 million patients through its fully owned affiliates. Er-Kim's workforce of over 280 professionals worldwide has contributed to its revenue surpassing EUR 260 million, marking it as a trailblazer in healthcare standards, commercialization, and patient accessibility.

Puma Biotechnology, Inc., a prominent biopharmaceutical company, is dedicated to advancing cancer care through the development and commercialization of innovative products. Since acquiring the global rights to PB272 (neratinib) in 2011, Puma has made significant strides in oncology. The U.S. FDA granted approval for neratinib in 2017 for extended adjuvant treatment in adults with early-stage HER2-positive breast cancer, following trastuzumab-based therapy, and it is marketed as NERLYNX® in the U.S. In 2020, the FDA also approved NERLYNX for use with capecitabine in the management of advanced or metastatic HER2-positive breast cancer in patients previously treated with two or more anti-HER2-based regimens. The European Commission approved NERLYNX in 2018 for extended adjuvant treatment in hormone receptor-positive HER2-overexpressed/amplified breast cancer within a year of completing trastuzumab-based therapy.

In addition to NERLYNX, Puma is actively developing alisertib, an anti-cancer drug targeting aurora kinase A. The company is focusing on alisertib for small cell lung cancer and breast cancer treatment. Recent clinical trials include ALISCA™-Lung1 for extensive-stage small cell lung cancer and ALISCA™-Breast1, exploring alisertib combined with endocrine therapy for HER2-negative, HR-positive metastatic breast cancer.