Hikma Pharmaceuticals, a renowned UK based biopharmaceutical company, and Arecor, a biopharmaceutical firm advancing today’s treatments to enable healthier lives, have reportedly signed a new strategic agreement to develop a novel injectable medicine in the U.S. from Hikma’s subsidiary, Hikma Pharmaceuticals USA Inc.
The new product, which would be unveiled before launch, is being developed utilizing Arestat™, a proprietary drug formulation technology platform of Arecor. Arestat improves the characteristics of authorized therapeutic peptides and proteins to provide new reformulations of complex, existing products.
Hikma would seek authorization for this product under the U.S. FDA’s (Food and Drug Administration) 505(b)(2) regulatory pathway. The filing is expected to take place in 2021.
President of Hikma Injectables, Riad Mishlawi stated that the company is thrilled to enter this collaboration with Arecor. This is one more vital step ahead for Hikma in developing and marketing complex medicines as well as delivery systems that help patients and position the company’s business for seamless long-term growth.
Mishlawi further added that the company is confident that this innovative development platform of Arecor, together with Hikma’s robust production capabilities and outstanding commercial team, with its strong connections across US hospital systems, would bring a vital new therapy option to healthcare providers and patients.
Chief Executive Officer of Arecor, Sarah Howell stated that the company is proud to be operating with Hikma. The company has an outstanding track record in developing RTU (ready-to-use) and RTA (ready-to-administer) medicines. These medicines have become increasingly important in order to enable safe, fast and effective therapy of patients.
Howell further added that Hikma has a respected and robust US hospital industry presence. The company is also focused at providing cost-effective treatments that advance the delivery of medication and enhance patient care. The company now looks forward to the combined development of this initial product as a part of the wide collaboration with Hikma.