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Er-Kim Announces Exclusive Distribution Agreement with Puma Biotechnology to Commercialize NERLYNX® (neratinib) for Breast Cancer Patients

1. PBYI partners with Er-Kim to commercialize NERLYNX in Eastern Europe. 2. NERLYNX treats HER2-positive breast cancer, expanding PBYI's market presence. 3. Er-Kim will distribute NERLYNX in several CIS countries including Russia. 4. Breast cancer remains prevalent, increasing potential demand for NERLYNX. 5. Er-Kim's established network could enhance PBYI's sales in new markets.

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Why Bullish?

This agreement could significantly expand PBYI's revenue streams. Historical partnerships often lead to increased market penetration and sales.

How important is it?

The agreement directly affects PBYI's market reach and potential sales, making it highly relevant. Expansion in emerging markets is crucial for growth in the biopharmaceutical sector.

Why Long Term?

Expanding into new regions with a growing cancer patient demographic suggests sustained revenue growth. Past notable partnerships have shown long-term benefits for companies like PBYI.

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AMGNGENVS
ATHENS, Greece and LOS ANGELES, April 30, 2025 (GLOBE NEWSWIRE) -- Er-Kim, an international pharmaceutical company specializing in the commercialization of novel therapies in the EMEA region, today announced that it has signed an agreement with Puma Biotechnology, Inc. (NASDAQ: PBYI) to commercialize NERLYNX® (neratinib) in select countries in Eastern Europe and Central Asia. NERLYNX is designed to block human epidermal growth factor receptor 2 (HER2) in order to treat and limit breast cancer metastasis. Under the agreement, Er-Kim is appointed as the distribution partner for NERLYNX in Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, Turkmenistan, and Uzbekistan. NERLYNX is a prescription medicine used alone to treat adults with early-stage HER2-positive breast cancer and who have previously been treated with trastuzumab-based therapy. NERLYNX is also approved for use with a medicine called capecitabine to treat adults with HER2-positive breast cancer that has spread to other parts of the body (metastatic) and who have received 2 or more anti-HER2 therapy medicines for metastatic breast cancer. According to the International Agency for Research on Cancer (IARC), globally, breast cancer is the most common cancer type among women and the second most common cancer type overall. An estimated 2.3 million new breast cancer cases and 670,000 breast cancer-related deaths occurred worldwide in 2022. However, the burden of breast cancer is not evenly distributed across different world 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.” About Er-Kim Established in 1981, Er-Kim stands at the forefront of biopharmaceutical innovation, partnering with over 40 global leaders to revolutionize patient care in key international markets. Our pioneering business models, tailored for sustainability and flexibility, have positioned us as a full-service solution, extending our reach to over 600 million patients through our fully owned affiliates. With a dedicated team of over 280 professionals worldwide and revenues exceeding EUR 260M, Er-Kim is not just a partner but a trailblazer in healthcare, continually setting new standards in commercialization and patient access. For more information, please visit http://www.er-kim.com/. About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral) in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early- stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX® is a registered trademark of Puma Biotechnology, Inc. Further information about Puma Biotechnology may be found at https://www.pumabiotechnology.com. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA™-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. In November 2024, Puma initiated ALISCA™-Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR-positive metastatic breast cancer. Media contact: Rosalia ScampoliMarketcom PRTel: (914) 815-1465rscampoli@marketcompr.com

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