Press Release 03 Jun 2016

June 3rd 2016 –Tullamore - Minister for Jobs, Enterprise & Innovation Mary Mitchell O’Connor TD today officially opened Nexvet Biopharma’s (Nasdaq:NVET) new development and manufacturing facility in Tullamore, which has begun clinical and commercial-scale production of Nexvet’s advanced development candidates, a significant milestone towards preparations for commercialization.  

The veterinary biologics company secured the facility in September 2015. It was announced at that time that up to 30 new highly-specialised technical roles would be created there. The project is supported by the Department of Jobs, Enterprise & Innovation through IDA Ireland.

BioNua Limited, a wholly owned subsidiary of Nexvet Biopharma, runs business operations at the 20,000 sq. ft. premises, and has undertaken extensive refurbishment transforming it into a state-of-the-art facility dedicated to the emerging area of therapeutic veterinary biologics. BioNua has a 10-year lease on the facility with an option to purchase the building, located in the IDA Business & Technology Park in Tullamore.

Securing a significant development and manufacturing facility and building BioNua’s capabilities is a major step forward for Nexvet’s plan to assume full internal control of its manufacturing. Nexvet intends for BioNua to meet the Company’s anticipated future global clinical and commercial needs for drug substance production in the high growth area of veterinary therapeutics. The creation of BioNua has added to Nexvet’s vertical integration in animal health biopharmaceuticals, with research, drug development, manufacturing, clinical development and regulatory affairs now all managed internally.

Regarding the milestone represented by this official opening, Nexvet’s Chief Executive Officer Mark Heffernan said, “We are delighted with the rapid progress made by the dedicated BioNua team in internalizing our manufacturing and preparing to supply Nexvet’s clinical trials. We have sourced outstanding talent for the BioNua team and installed state-of-the-art infrastructure. The compelling advantages of biologic therapies for chronic conditions in companion animals underpin Nexvet’s long-term vision for transforming animal medicine. Therefore, excellence in manufacturing is an essential part of our business strategy, and working in partnership with the IDA has given us a unique opportunity to build a centre for veterinary biopharmaceutical validation and manufacturing in the Midlands of Ireland.”

We are delighted with the rapid progress made by the dedicated BioNua team in internalizing our manufacturing and preparing to supply Nexvet’s clinical trials. We have sourced outstanding talent for the BioNua team and installed state-of-the-art infrastructure. The compelling advantages of biologic therapies for chronic conditions in companion animals underpin Nexvet’s long-term vision for transforming animal medicine. Therefore, excellence in manufacturing is an essential part of our business strategy, and working in partnership with the IDA has given us a unique opportunity to build a centre for veterinary biopharmaceutical validation and manufacturing in the Midlands of Ireland.

Nexvet’s Chief Executive Officer Mark Heffernan

Speaking at the Tullamore facility Minister for Jobs, Enterprise and Innovation, Mary Mitchell O’Connor said, “The Biopharma sector is an important sector for Ireland and the work of Nexvet represents a very exciting development. This company is at the cutting edge of innovative biological products for veterinary use. High technology companies like Nexvet will help create and manufacture some of the next generation of biopharmaceutical products, thereby further enhancing Ireland's position in this sector. I want to encourage more companies to set up in our regions as there are many benefits to setting up in rural locations.  Companies setting up and creating jobs in our regions ensures that there are opportunities for positive knock-on effects in the surrounding areas. Only a strong economy supporting people at work can pay for the services needed to create a fair society.  I wish Mark and his team every success with this new facility.”

CEO of IDA Ireland Martin Shanahan said, “It’s great to see the official opening today of this dedicated veterinary biologics facility in Ireland.  IDA is delighted to have assisted in the creation of this high value Research Development & Innovation (RD & I) investment in a key regional location. This facility assists IDA market the Midlands region as a compelling location for foreign direct investment to potential client companies around the world.  I wish Mark and his team every success here.”

About Nexvet (www.nexvet.com)
Nexvet is a clinical-stage biopharmaceutical company focused on transforming the therapeutic market for companion animals, such as dogs and cats, by developing and commercializing novel, species-specific biologics. Nexvet’s proprietary PETization™ platform is designed to rapidly create monoclonal antibodies (“mAbs”) that are recognized as “self” or “native” by an animal’s immune system, a property Nexvet refers to as “100% species-specificity.” Nexvet’s product candidates also build upon the safety and efficacy data from clinically tested human therapies, thereby reducing clinical risk and development cost.

Nexvet is leveraging diverse global expertise and incentives to build a vertically integrated biopharmaceutical company, through conducting drug discovery in Australia, clinical development in the United States and Europe and biomanufacturing in Ireland.

About BioNua (www.bionua.ie)
BioNua is a wholly owned subsidiary of Nexvet Biopharma plc based in Tullamore, Ireland, operating a 20,000 square foot facility which will focus on the manufacture of biopharmaceutical drug substance for clinical trials and commercial products.   

Further information:    
 Ray O’Connor
Nexvet Vice President, Technical Operations
Irish office telephone: +353 (0) 5793 24522
ray.oconnor@nexvet.com

Nexvet Biopharma plc
Unit 5, Sragh Technology Park
Tullamore
Co. Offaly

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