Nerlynx is not approved currently for commercialisation outside of the United States. Medison will be responsible for seeking the requisite regulatory approval and, once approved, for commercializing Nerlynx in Israel. Puma will receive upfront and milestone payments throughout the term of this agreement, as well as significant double digit royalties on Nerlynx sales in Israel.
Neratinib was approved by the US Food and Drug Administration in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and is marketed in the United States as Nerlynx (neratinib) tablets.
Puma biotechnology is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care.
Medison, backed by three generations of experience in the healthcare industry, has built and maintained long-standing relations with HMOs, local medical centers, and physicians.
It is uniquely qualified to provide the complete spectrum of integrated services for international companies looking to enter or expand their presence in the Israeli market.
Amneal announces launch of PEMRYDI RTU, a ready-to-use oncology injectable
Medivir and Vetbiolix report positive results from VBX-1000 Proof-of-Concept clinical study
Norgine submits first marketing authorisation application submissions for approval of eflornithine
Innovent Biologics names new Oncology CMO
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Precision Epigenomics partners with TruDiagnostic
Portage Biotech expands evaluation of strategic alternatives
Stamford Pharmaceuticals starts locally advanced basal cell carcinoma (laBCC) trial of SP-002
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
ELIAS Animal Health names new chief revenue officer
Innate Pharma reports preclinical efficacy of IPH45
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval