On Oct 16, we issued an updated research report on Puma Biotechnology Inc. PBYI. The company’s top line mainly comprises contribution from its sole marketed product, Nerlynx.
Nerlynx was launched in the United States last July for treating early stage HER2-positive breast cancer in patients, previously treated with Roche’s RHHBY Herceptin-based adjuvant therapy.
Sales of Nerlynx have improved steadily since its launch last July. The drug generated sales figures of $86.8 million in the first half of 2018. It recorded sales of $50.8 million during the second quarter of 2018, up 41.1% sequentially. Following its approval by the European Commission, Puma expects to pick up sales during 2019.
In September 2018, the European regulatory body gave a marketing approval to Puma’s kinase inhibitor Nerlynx for the same indication.
Puma plans to commercialize Nerlynx in Europe during 2019, starting with its launch in Germany in the first half of 2019 followed by other European countries in the second half of 2019.
Earlier this month, Puma’s licensing partner CANbridge Pharmaceutical filed a new drug application (“NDA”) for Nerlynx to the National Medical Products Administration (NMPA) in China.
In July this year, Puma also filed a regulatory application for the approval of Nerlynx in Canada, which is currently under review. Moreover, in the same month, the company entered into a collaborative agreement with Strata Oncology to drive patient enrollment in the phase II SUMMIT study on Nerlynx.
Moreover, in the first quarter of 2018, the National Comprehensive Cancer Network (NCCN) guidelines were updated to include Nerlynx as a recommended combination treatment option for breast cancer patients with brain metastases. Most physicians use the NCCN parameters to determine the best course of regimen for their cancer patients. This in turn, should boost sales.
Several additional studies on Nerlynx targeting different types of breast cancer patient populations and in earlier-line settings are currently underway. Meanwhile, several phase II combination studies on Nerlynx for breast cancer are ongoing. Notably, Puma expects to present data from the phase III NALA program, evaluating Nerlynx in third-line HER2-positive metastatic breast cancer during the second half of 2018 or the first half of 2019.
Although Puma’s efforts to expand Nerlynx’s label looks encouraging, the drug faces intense competition from approved treatments such as Roche’s Herceptin, Perjeta and Kadcyla, Glaxo’s GSK Tykerb, Lilly’s LLY Verzenio and Novartis's Kisqali. Hence, any kind of regulatory setback for Nerlynx could affect the company’s growth prospects.
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