DUBLIN, Ireland, May 11, 2017 (GLOBE NEWSWIRE) -- Nexvet Biopharma (Nasdaq:NVET) today announced its financial results for the three and nine month periods ended March 31, 2017.
Recent highlights:
- In April 2017, entered into a Transaction Agreement for Zoetis to acquire all Nexvet shares for $6.72 per ordinary share in cash, valuing Nexvet at approximately $85 million
- Advanced key clinical programs and implemented a cost reduction program
- Signed a licensing agreement with Pfizer regarding certain anti-NGF mAb patents
The Company is continuing a pivotal field efficacy and safety study for frunevetmab. This study is a placebo-controlled, randomized, double-blinded study with a target enrolment of 250 cats with osteoarthritis at approximately 20 clinical sites around the United States. As at March 31, 169 cats had been enrolled into the study. Enrolled cats are randomly assigned to receive frunevetmab or placebo at a 2:1 ratio. Each cat receives three doses, with each dose given 28 days apart. This study has received protocol concurrence from the Center for Veterinary Medicine (CVM) at the United States Food and Drug Administration (FDA) and will utilize a comparison of owner-assessed responses, before and after treatment, as its primary endpoint.
The pivotal target animal safety study, which commenced in late October 2016, is examining the safety of frunevetmab in cats according to standard International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) guidance and a protocol concurred with the CVM. The in-life phase of the pivotal target animal safety study is complete and Nexvet expects to report data from both studies in the fourth quarter of calendar 2017.
In support of the Company’s planned frunevetmab CMC technical section submission to the CVM, a third 200 liter batch of frunevetmab was successfully produced during the quarter at BioNua, the Company’s wholly-owned manufacturing facility, which is also being prepared for commercial manufacturing of Nexvet’s products. The first and second 200 liter batch of ranevetmab was also successfully produced during the quarter.
In February 2017, the Company entered into a license agreement with Pfizer Inc. (“Pfizer”), pursuant to which the Company received a non-exclusive license to certain patents in the Pfizer portfolio for anti-NGF antibodies. The Company paid Pfizer a $1.0 million upfront license fee, and may pay Pfizer (i) additional amounts based on regulatory and sales milestones and (ii) a low, single-digit royalty based on net sales of the Company’s anti-NGF product candidates for the life of the relevant patents.
In March 2017, the Company implemented a cost reduction program focused on early stage research programs and general and administrative activities, which resulted in a reduction of 11 employees. The net cost reflected in the quarter was $0.8 million.
Since March 31, 2017
In April 2017, Zoetis Inc., entered into an agreement to acquire the Company, by means of a “scheme of arrangement” under Irish law. The Transaction Agreement provides that shareholders of the Company will be entitled to receive $6.72 in cash per ordinary share of the Company and values the Company at approximately $85 million.
The Nexvet board has unanimously recommended this offer to shareholders in the absence of a superior offer. The Company is expecting completion of the transaction in the second half of 2017.
Financial Results