Hovione, the leader in spray drying and particle engineering, announced today an exclusive license agreement for a preclinical ophthalmology program, JX08, with Ji Xing Pharmaceuticals Limited (JIXING).
East Windsor, New Jersey, March 10, 2016 – Hovione today announced that it plans to host and operate a commercial-scale continuous manufacturing facility as part of an agreement with Vertex Pharmaceuticals. The state-of-the-art facility will be installed in Hovione’s New Jersey location, and Hovione expects the project to be complete by the end of 2017 to support the future manufacturing of Vertex’s approved medicines.
Continuous manufacturing represents an innovative shift from the traditional multi-step, multi-location batch production process, which can take up to four weeks or more to make commercial-ready medicines. With continuous manufacturing, raw materials used to produce oral medicines (tablets) are fed into a single, continuously running machine that includes real-time release testing and can create commercial-ready tablets in just one day. Continuous manufacturing is well suited for the production of precision medicines and those with breakthrough therapy designations where development timelines may be short and there are patients in urgent need of transformative new treatments.
“This agreement enables Hovione to be at the forefront of an important evolution toward the use of continuous manufacturing and positions us as a reliable and innovative source for the production of new medicines,” said Filipe Gaspar, VP R&D at Hovione. “Like Vertex, we view continuous manufacturing as an important scientific advance and an important advance for patients, as the technology will allow us to run manufacturing and process development in parallel with clinical studies to more rapidly bring new medicines to those who need them.”
“Hovione and Vertex have been strong collaborators for more than a decade and share a commitment to innovative science,” added Guy Villax, CEO of Hovione. “This agreement adds to a recently announced $24 million investment in our New Jersey facility. The entire expansion will double Hovione’s development and manufacturing capacity at that site.”
The new facility will include all facets of the continuous manufacturing process, including continuous blending, wet or dry granulation, fluid bed drying, tableting and coating operations. Spare capacity will be offered to third parties who are interested in manufacturing medicines through this process.
Hovione is an international company with over 50 years’ experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in the USA, China, Ireland, and Portugal, and development laboratories in Lisbon and New Jersey the company focuses on the most demanding customers in the most regulated markets. The company also offers branded pharmaceutical customers services for the development and compliant manufacture of innovative new drugs, and is able to support highly potent compounds. In the inhalation area Hovione is the only independent company offering a complete range of services.