Allarity Therapeutics Provides Update on Dovitinib Program

Press release      

Hørsholm, Denmark (23 October 2020) – Allarity Therapeutics A/S (“Allarity” or the “Company”) today announced several updates related to its planned filing of a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for dovitinib, a pan-tyrosine kinase inhibitor (TKI) that is one of Allarity’s priority programs.

The Company is announcing an update on timing for its originally planned first NDA filing for dovitinib as a treatment for renal cell carcinoma (RCC). This NDA is based on non-inferiority to the approved drug sorafenib. The Company’s preparation of the application itself is progressing as scheduled, however the third-party contract manufacturer of the registration batch of the drug is experiencing delays, in part as a result of the ongoing coronavirus pandemic. A registration batch is a mandatory component of the NDA filing. Due to this reported delay, Allarity is now expecting to file the NDA in 2021.

Separately, the Company remains on track to file its first pre-market approval (PMA) application with the U.S. FDA for the use of the dovitinib DRP companion diagnostic to select and treat likely responders to the drug. If regulatory authorities provide the expected PMA approval of the Dovitinib DRP and an NDA approval of dovitinib, the Company believes it can make the drug available to DRP-selected RCC patients as an effective new therapy to treat their disease.   

Dovitinib, originally developed by Novartis, addresses a significant unmet need for improved therapies for the treatment of RCC, and is a potential therapeutic alternative to sorafenib. Annual sales of sorafenib, under the trade name Nexavar, were approximately USD $715 million in 2018. The global RCC market is projected to grow to USD $6.3 billon by 2022. In addition to the RCC market, dovitinib has promising potential as a monotherapy in a number of other indications, including estrogen receptor (ER) positive metastatic breast cancer, hepatocellular cancer, endometrial cancer and gastrointestinal stromal tumors, as well as in combination therapy with other approved drugs, including immune checkpoint inhibitors.