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Press Release / Oct 19, 2015

Hovione acquires a Formulation Plant

Hovione announced today that it is investing in specialized formulation capabilities.

Loures, Portugal, October 19th, 2015 – Hovione announced today that it is investing in specialized formulation capabilities. The first step of the plan was the acquisition of a formulation facility adjacent to the current process chemistry and particle engineering facility in Loures, Portugal. This acquisition is a strategic investment to further boost development and manufacturing capabilities for both inhalation and oral dosage forms.

The facility will be engineered to enable to work with highly potent APIs and moisture sensitive compounds and will have dedicated rooms to allow for concurrent manufacture of these products. The facility will be capable to prepare a wide range of materials suitable for clinical trials as well as commercial batches meeting global regulatory requirements.

“Over the last decade we have built great knowledge in developing final dosage forms in the area of dry powder inhalation and oral dosage forms and have installed state-of-the-art formulation equipment to support these activities. Adding to our drug substance and particle engineering capabilities this new plant expands our integrated offer and technological capabilities to provide the best service to our customers”, said Filipe Gaspar, Hovione’s Vice-President R&D. “

“With this investment we will be able to expand our offerings and provide our clients with new services. I am sure our customers will value the option of not having to ship the material that comes out of our reactors and spray dryers to outside the walls of our site and away from our trusted quality culture.  This is also a great way to speed up the entire CMC development to meet the needs of the growing number of accelerated programs that our clients ask us to deliver on”, said Guy Villax, Hovione’s Chief Executive.

About Hovione

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 U.S., China, Ireland, and Portugal, 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, is able to support highly potent compounds and offers proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering such a broad range of services. Hovione is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.

 

 

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Integrated approach simplifies development, reduces risk, and supports scalable manufacturing. Hovione and Industrial Design Consultancy Ltd.’s (IDC) lead single-use nasal dry powder device is now available for commercial partnerships. Hovione and IDC have completed the device design and established initial device manufacturing and supply capability, enabling pharmaceutical partners to leverage existing capsule filling infrastructure. This approach simplifies development, reduces cost and risk, and helps shorten timelines to the clinic and commercialization. “This milestone marks an important step in the evolution of our collaboration with IDC — from device innovation to a fully integrated intranasal drug delivery platform,” said Márcio Temtem, Ph.D., Vice President, Strategic Business Management, Hovione. “As the industry looks for faster, more reliable ways to bring complex therapies to patients, integration becomes critical. By bringing together nasal particle engineering science, formulation manufacturing and filling, and device technologies into a single offering, we enable a more seamless and predictable development journey, accelerating the path to market for intranasal therapies.” The nasal delivery device enables broad and targeted nasal deposition flexibility while delivering maximum usability and reliability. With a patented design and manufacturing process established, the platform is available for partnering with pharmaceutical companies on an exclusive basis as part of Hovione’s integrated offering for inhalation and nasal drug development and manufacturing. Additionally, IDC’s Managing Director, Stephen Knowles Ph.D., said the companies are now “well-advanced” with the development of a multi-use device to support an even wider range of therapies and patient needs. Read the full article at ContractPharma.com    

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