U.S.-based biopharmaceutical firm, Puma Biotechnology, Inc., has recently revealed that Specialised Therapeutics Asia (STA), its licensing partner, has obtained approval from Health Sciences Authority (HSA) to market NERLYNX® (neratinib) in Singapore.
For the uninitiated, NERLYNX® is suggested for the extended adjuvant treatment of patients above 18 years of age who are suffering from early stage HER2- amplified/overexpressed breast cancer. The drug is a registered trademark of Puma Biotechnology.
Speaking on the development, Carlo Montagner, Chief Executive Officer, STA, said that the approval in Singapore marks as a major landmark for the firm. NERLYNX would become the firm’s first drug to have HSA clearance for commercialization in Singapore. Moreover, STA is looking forward to extending the reach of this medicine, with regulatory dossiers also filed in Brunei, the Philippines, and Malaysia.
As for Alan H. Auerbach, President and Chief Executive Officer, Puma, their firm was pleased to see STA’s strong commercial strategy in Australia and hopes to witness the same success in South East Asia. Additionally, Puma Biotechnology is committed towards expanding NERLYNX to patients suffering from breast cancer across the globe.
Reportedly, Puma Biotechnology has also recently announced plans to extend the terms of its license with Pierre Fabre. Earlier, Puma gave Pierre Fabre sole rights to create and market NERLYNX® in some parts of Africa and entire Europe. But in the new agreement, it extends NERLYNX’s commercial rights to South Africa, the Middle East, Turkey and Sudan.
According to reliable sources, Puma would get $4 million upfront and would get additional sales-based regulatory milestone payments that would reach $3 million. Moreover, sales milestones and royalties’ payments would include NERLYNX’s net sales from all the nations in this extension territory. This would continue on its original license agreement which they had signed earlier this year.