Fujifilm Diosynth Biotechnologies has added another licensed product to its list of commercial biopharmaceutical products, following the announcement that ThromboGenics' has received FDA approval for the launch of JETREA® (ocriplasmin) in the USA for the treatment of Symptomatic Vitreomacular Adhesion (VMA).
The two companies announced a long-term commercial supply agreement for manufacture of the bulk substance in September 2010 when the product had completed its Phase III trials and have worked together to complete validation and establish a well characterised process.
Fujifilm Diosynth Biotechnologies is one of the world's leading providers of contract process development and manufacturing services for biopharmaceuticals and the UK business has been working with ThromboGenics for over seven years as the drug progressed through its clinical trials. This illustrates the value of long-term deep collaboration in securing both cost effective and timely commercialisation of such complex new medicines.
Steve Bagshaw, Managing Director of Fujifilm Diosynth Biotechnologies' Billingham, UK, said "we are delighted that ThromboGenics has received FDA approval for the launch of JETREA® in the USA. It is very gratifying for our team to see that their hard work in developing and manufacturing the product over the years has resulted in a drug being available to people suffering from distressing ophthalmic conditions. This is fifth licensed biopharmaceutical manufactured by Fujifilm Diosynth Biotechnologies and the second made at our Billingham site, demonstrating our growing expertise in helping to transition biopharmaceuticals from the clinic to become marketed new drugs".
Dr. Patrik De Haes, CEO of ThromboGenics said "Fujifilm Diosynth Biotechnologies has been a key partner in helping to bring our first drug to market. Their team at Billingham have done an excellent job in developing and validating a robust process and manufacturing material to enable us to launch the product on schedule".
About Fujifilm Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies UK Limited is an industry leading biologics Contract Development and Manufacturing Organization. Fujifilm Diosynth Biotechnologies has extensive experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules expressed in a wide array of microbial, mammalian, and insect systems. The company offers a comprehensive list of services from cell line development, including its proprietary pAVEwayT system to process development, analytical development, clinical and commercial manufacturing. Fujifilm Diosynth Biotechnologies is also located in Research Triangle Park, NC, USA as FUJIFILM Diosynth Biotechnologies U.S.A., Inc. Both sites have been FDA-approved for the production of commercial biopharmaceutical products
About FUJIFILM Holdings Corporation
FUJIFILM Holdings Corporation, Tokyo, Japan, brings continuous innovation and leading-edge products to a broad spectrum of industries, including electronic imaging, digital printing equipment, medical systems, life sciences, graphic arts, flat panel display materials, and office products, based on a vast portfolio of digital, optical, fine chemical and thin film coating technologies. The company was among the top 17 companies around the world granted U.S. patents in 2011, and in the year ended March 31, 2012, had global revenues of $27.8 billion*. Fujifilm is committed to environmental stewardship and good corporate citizenship. For more information, please visit www.fujifilmholdings.com .
* At an exchange rate of 79 yen to the dollar.
ThromboGenics is an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines. The Company's lead product, JETREA® (ocriplasmin), has been approved by the FDA for the treatment of symptomatic VMA. ThromboGenics has successfully completed two Phase III clinical trials for the pharmacological treatment of symptomatic VMA, sometimes referred to as Vitreomacular Traction (VMT). The marketing Authorisation Application (MAA) for ocriplasmin is under review in Europe. ThromboGenics is headquartered in Leuven, Belgium, and has offices in Iselin, New Jersey (US) and Dublin, Ireland. The Company is listed on the NYSE Euronext Brussels exchange under the symbol THR. More information is available at www.thrombogenics.com .