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Nexvet Reports Financial Results for Second Quarter of Fiscal Year 2017
DUBLIN, Ireland February 10, 2017 Nexvet Biopharma (Nasdaq: NVET) today announced its financial results for the three and six month periods ended December 31, 2016.
|||Initiated pivotal field efficacy and safety studies of frunevetmab, the Companys anti-nerve growth factor monoclonal antibody (anti-NGF mAb) in development for the control of pain associated with osteoarthritis in cats|
|||Entered into a research collaboration with Genentech|
|||Successfully completed preliminary in vivo immunogenicity, pharmacokinetic and safety studies for the Companys canine anti-PD-1 immuno-oncology program|
|||Delivered first clinical-scale production of ranevetmab, the Companys canine anti-NGF mAb candidate, at the Companys wholly-owned manufacturing facility (BioNua)|
|||Signed a licensing agreement with Pfizer regarding certain anti-NGF mAb patents|
This was an important period of progress for the Company as we initiated pivotal clinical studies for frunevetmab, continued to advance our chemistry, manufacturing and controls (CMC) activities, and entered into a collaboration with Genentech, our first such agreement with a dedicated human biotech company utilizing our PETization platform, commented Mark Heffernan, Chief Executive Officer of Nexvet.
In December 2016, the Company announced it had treated the first cat in the frunevetmab pivotal field efficacy and safety study. 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. Enrolled cats will be randomly assigned to receive frunevetmab or placebo at a 2:1 ratio. Each cat will receive 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. Nexvet expects to report data from both studies in the fourth quarter of calendar 2017.
In support of the Companys planned frunevetmab CMC technical section submission to the CVM, a third 200 liter batch of frunevetmab was produced during the quarter at BioNua, the Companys wholly-owned manufacturing facility, which is also being prepared for commercial manufacturing of Nexvets products. A first 200 liter batch of ranevetmab was also successfully produced during the quarter.
In November 2016, the Company entered into a research collaboration with Genentech, a member of the Roche Group, involving use of the Companys PETization platform.
During the quarter, Nexvet also successfully completed preliminary pharmacokinetic, immunogenicity and safety studies for its anti-PD-1 program in dogs. In human medicine, blocking the interactions of programmed cell death protein 1 (PD-1) and programmed cell death-ligand 1 (PD-L1) has resulted in approved therapies with attractive safety profiles that demonstrate efficacy against multiple tumor types.
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The following information was filed by Nexvet Biopharma Plc (NVET) on Friday, February 10, 2017 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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