License Agreement to Commercialize Breast Cancer Treatment

Puma Biotechnology Inc. recently entered a license agreement with Pint Pharma International SA to commercialize NERLYNX (neratinib), a breast cancer treatment, in Latin America. The drug is currently only available in the United States (US), but Pint Pharma has taken on the responsibility of getting approvals for the drug in Latin American countries such as Argentina, Brazil, Chile, Colombia, and Mexico. This is a positive step toward Puma Biotechnology’s goal to make its breast-cancer treatment available all over the world.

Agreements like this not only signify growth for the signing parties but can also be lucrative for the global biotechnology industry, which is expected reach $727.1 billion by 2025 according to Grandview Research.

Nasdaq reported that Puma Biotechnology stocks were on an upward rally, growing around 10.2% since it reported its earnings for the last quarter of 2017 in March 2018. The company earned total revenues of $21.6 million in the last quarter, of which $20.1 million was from the sales of NERLYNX. The expansion of NERLYNX into the rest of the world is only expected to increase these earnings and, in turn, help the biopharmaceutical market prosper.

The US Food and Drug Administration (FDA) approved oral neratinib – which Puma Biotechnology sells under the registered trademark of NERLYNX – in July 2017 for the treatment of adult patients with early-stage HER2 breast cancer following adjuvant trastuzumab-based therapy. Puma Biotechnology and Pint Pharma are not the only pharmaceutical companies that are working in the field of cancer care. Many other biopharma firms are working in the same capacity, which means more drugs are on their way to be approved by the FDA to cure debilitating diseases such as cancer and HIV.

As license agreements like this progress, biopharmaceutical products are expected to dominate the drug industry. Earlier in March, Pint Pharma entered a similar license agreement with Onconova Therapeutics Inc. to commercialize rigosertib in Latin America. Rigosertib is an innovative anti-cancer compound, which is currently in a Phase 3 study for the treatment of myelodysplastic syndromes (MDS) – rare disorders in which the bone marrow is not able to make enough healthy blood cells.

Analysts have also predicted growth in the biotech industry through a wave of merger and acquisition (M&A) deals in 2018 with pharmaceutical giants like Amgen, Johnson & Johnson, Gilead, Merck, and Pfizer expected to acquire small-cap biopharmaceutical companies to gain from their research and innovation.


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