Nordic pharmaceutical company Orion Pharma and Qilu Pharma Europe have entered into an agreement to commercialise an intravenous (IV) pembrolizumab biosimilar in Europe.
Pembrolizumab is an immune checkpoint inhibitor used to treat various types of cancer. Qilu is currently developing the IV pembrolizumab biosimilar.
Under the agreement, Orion Pharma will have the exclusive right to distribute, market and sell Qilu’s IV pembrolizumab biosimilar in Europe. Qilu will supply the product to Orion Pharma and will be entitled to receive a share of the profits generated by Orion Pharma, as well as certain development, regulatory and sales milestone payments.
Satu Ahomäki, EVP Generics and Consumer Health, Orion Pharma, said, “We are pleased to expand our strategic partnership with Qilu. With this agreement, we are one step closer to reaching our division’s long-term targets and strategic goals, and to creating broader access to affordable quality medicines.”
What is pembrolizumab?
Pembrolizumab, sold under the brand name Keytruda by Merck, is an immunotherapy used to treat several types of cancer, including certain forms of non-small cell lung cancer (NSCLC), breast cancer, melanoma, head and neck squamous cell carcinoma (HNSCC) and urothelial cancer, among others.
As described by Merck, the therapy works by helping the body’s immune system detect and fight tumour cells.
“KEYTRUDA is a humanised monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumour cells and healthy cells,” the company said.
Pembrolizumab is administered as an intravenous infusion. Depending on the type of cancer being treated, the treatment may be given once every three or six weeks.
Orion Pharma’s First Biologic Candidate Enters Clinical Trials
Orion Pharma has also announced that the first patient has been dosed in a Phase 1/2 clinical trial of ODM-216, the company’s first biologic candidate and its first immuno-oncology treatment to enter clinical testing in humans.
The BICIDES Phase 1/2 clinical trial is evaluating the safety, pharmacokinetics and preliminary anti-tumour activity of ODM-216, an investigational bispecific antibody designed to simultaneously target PVRIG and PD-L1 in patients with advanced solid tumours.
ODM-216 is a key component of Orion Pharma’s immuno-oncology portfolio, which includes several other assets in the preclinical pipeline.
“Treating the first patient in the ODM-216 BICIDES study is a significant achievement for Orion Pharma and an important moment in the evolution of our long-term global R&D strategy to expand our capabilities beyond small molecules and into biologics,” said Professor Outi Vaarala, executive vice president, Research & Development at Orion Pharma.
