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Nexvet Announces Opening of Manufacturing Facility and Production Milestone Achievement

DUBLIN, Ireland, June 03, 2016 (GLOBE NEWSWIRE) -- Nexvet Biopharma (Nasdaq:NVET), a veterinary biologic therapeutics developer, today announced the official opening of BioNua Limited, its veterinary biologics manufacturing facility in Tullamore, Ireland, as well as in-house production of its first clinical trial batch of NV-02 from a 200 liter production bioreactor. NV-02 is Nexvet’s monoclonal antibody (mAb) therapy in development for the control of pain associated with osteoarthritis in cats. This batch will supply the pivotal safety and efficacy study of NV-02 which is anticipated to commence in the second half of 2016.

Nexvet secured the 20,000 square foot facility, previously used to produce human biopharmaceuticals, in September 2015. A team of over 20 process scientists, quality assurance personnel and support staff has since been assembled. The Company has procured state-of-the-art large scale disposable bioreactors and other equipment in preparation for manufacture of veterinary mAbs in accordance with good manufacturing practices (GMP). BioNua has now fully transitioned the NV-02 processes from contract manufacturing organizations (CMOs). The team assembly, process development work and equipment procurement occurring at BioNua is supported by IDA Ireland, the Irish Government’s foreign investment agency.

Nexvet will host a site tour and Investor Symposium at the BioNua facility today. Irish Minister for Jobs, Enterprise & Innovation Mary Mitchell O’Connor TD will preside over an official opening ceremony for the facility.

On May 26, 2016, Nexvet announced the receipt of positive, statistically significant results from its pilot field study of NV-02, which evaluated monthly doses of NV-02 versus placebo in 126 cats with osteoarthritis.

“We are very pleased that within nine months of securement, we have delivered the major milestone of a fully operational state-of–the-art manufacturing and development facility producing drug substance for a pivotal clinical study of NV-02. We expect that our strategy to invest in and internalize manufacturing within Ireland will add significant value to Nexvet through improving process control, lowering our cost of goods, and enhancing security of clinical and commercial supply,” said Nexvet’s Chief Executive Officer, Dr. Mark Heffernan.

The presentations and audio of Nexvet’s company briefings given today will be made available in the Investor Relations section of the Nexvet website at http://ir.nexvet.com.

About Nexvet (www.nexvet.com)

Nexvet is a veterinary biologic therapeutics 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 design 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, which conducts drug discovery in Australia, conducts clinical development in the United States and Europe and conducts biomanufacturing in Ireland.

Forward looking statements

This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward looking statements consist of all statements other than statements of historical fact, including statements regarding our future results of operations and financial position, results of any current or future pivotal safety and efficacy study, future expenditures relating to our lead product candidates, time for completion of any of our studies or facilities upgrades, ability to develop our pipeline of product candidates, business strategy, prospective products, ability to successfully manufacture our own product candidates, ability to meet conditions for the receipt of government grants, time for regulatory submissions or ability to qualify for conditional licensure or obtain product approvals, research and development costs, timing and likelihood of success, plans and objectives of management for future operations, and future results of current and anticipated products. These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward looking statements. The words “anticipate,” “assume,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “plan,” “potential,” “predict,” “project,” “position,” “seek,” “should,” “target,” “will,” “would,” or the negative of these terms or other similar expressions are intended to identify forward looking statements, although not all forward looking statements contain these identifying words. These forward looking statements are based on current expectations, estimates, forecasts and projections about our business and the industry in which we operate, and management’s beliefs and assumptions are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors. Factors that could cause actual results to differ materially from our expectations expressed in this report include those summarized under Risk Factors in our reports on Forms 10-Q and 10-K and the other documents we file from time to time with the Securities and Exchange Commission. Given these risks and uncertainties, you should not place undue reliance on these forward looking statements. Also, forward looking statements represent management’s beliefs and assumptions only as of the date of this press release. Except as required by law, we do not intend, and undertake no obligation, to revise or update these forward looking statements, or to update the reasons actual results could differ materially from those anticipated in these forward looking statements, even if new information becomes available in the future.

Further information: Investors Candice Knoll Blueprint Life Science Group +1 415-375-3340 Ext. 4 cknoll@bplifescience.com Media Jessica Burns Berry & Company Public Relations +1 212-253-8881 jburns@berrypr.com

Source:Nexvet Biopharma plc