Center for Veterinary Medicine

Rockville, MD, United States

Center for Veterinary Medicine

Rockville, MD, United States
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This seminar on veterinary medicine regulations will provide attendees with a comprehensive understanding of FDA's veterinary drug approval process. The U.S. Food and Drug Administration's Center for Veterinary Medicine or CVM is responsible for the approval of veterinary drug products intended for both family pets and food-producing animals. FDA regulates not all products intended for animal use. Jurisdiction over animal products including licensed biologics such as vaccines is shared with a number of other federal agencies. For example, animal vaccines, animal disease diagnostic devices and some animal biologics are regulated by the U.S. Department of Agriculture's Animal and Plant Health Inspection Service or APHIS; and products such as flea and tick collars are regulated by the Environmental Protection Agency. This two day interactive course will cover: - Premarket approval process - Various sections of a New Animal Drug Application - Strategies for navigating the FDA approval process and for expending product approval - The nature of shared jurisdiction over veterinary products in certain cases. - Understand how the U.S. Food and Drug Administration regulates veterinary drug product. - Understand how FDA's Center for Veterinary Medicine is organized. - Discuss the process by which veterinary drug products are reviewed and approved. - Learn how to open an INAD File and request fee waivers. - Obtain a working knowledge of various sections included within an NADA. - Develop a deep understanding of what is needed to substantiate product characterization, target safety and effectiveness. - Analyze FDA's rules governing chemistry, manufacturing and controls or CMC. - Understand the various components of an animal field study to support product approval. - Discuss the difference between FDA's various user fees and fee waivers. - Identify the elements of an FDA compliant label. - Develop a corporate compliance strategy covering labeling, marketing and advertising. - Problem solving methods to mitigate regulatory enforcement risks. - Explain how jurisdiction is split between various Federal agencies in a certain cases. - Learn how animal feed, veterinary devices, OTC drug products and nutritional supplement are regulated in the U.S. Introduction to Veterinary Drug Approval process - FDA's jurisdiction and Center's relevant to Animal Health - Center for Food Safety and Applied Nutrition (CFSAN) - Center for Drug Evaluation and Research (CDER) - Center for Veterinary Medicine (CVM) - Specifics of CVM - Intro to the FDCA, AMDUCA, ADAA, MUMS, etc and guidance (GFI) - Overview of FDCA and regulations - Introduction to FDA GFI Overview of Veterinary Drug Development Discovery/Acquisition - Preliminary Patent Protection Concerns Submissions - Open INAD File - NADA (8 sections) - 5 Major Technical Sections - Chemistry, Manufacturing and Controls (CMC) - Safety (target animal safety study) - Efficacy (field study) - Human Food Safety (human food safety studies for food-producing animals) - Environmental Impact (EA/CE) - 3 Minor Technical Sections - All other information - Labeling - Freedom of Information Summary (FOI) Brief Description of cGxP (GMP, GLP, &GCP) CMC - API: name, structure, properties - API manufacturing - Clinical Trial material - Final Formulation Target Animal Safety - Content and format - Final Study Reports - Monitoring and Reporting Adverse Drug Events Human Food Safety - Analysis of Drug Residues - Toxicology - Residue Chemistry - Microbial Food Safety - Regulatory Method Relied Upon by Sponsor Effectiveness - Dosage Characterization - Substantial evidence (e.g. dose confirmation and clinical field studies) - All other information related to effectiveness - Proposed effectiveness-related labelling - Effectiveness Guidance Documents - The 7 Major Phases of Animal Field Studies - Planning - Study Initiation - In-life Activities - Site close-out - Data management - Biostatistical analysis - Report Writing Approval Process: Chemistry, Manufacturing Controls, Environmental Impact & Managing Clinical Trials - Environmental Impact - Categorical Exclusions - Environmental Assessments (EA) - Common EA Components - Environmental Impact Statements (EIS) - Labeling - FOI - AOI Animal Drug User Fees and Related Fee Waivers - Veterinary Drug User Fees and Fee Reductions and Waivers - Animal Drug User Fee Act (ADUFA) - Applies to Innovators Only - Animal Generic Drug User Fee Act (ADGUF) - Applies to Generic Manufacturers - ANADA sections - CMC - BE (Safety & Efficacy) - HFS - All others - Types of User Fees - Animal Drug Application and Supplement Fee - Animal Drug Product Fee - Animal Establishment Fee - Animal Drug Sponsor fee - Types of Fee Waivers and Reductions - Procedures, Timing and FDA Evaluation of Waivers or Reductions - FDA decision on approval Introduction to FDA's Regulation of Veterinary Feed, OTC Drugs and Supplements - Animal Feed - GRAS - Feed Labeling - AAFCO - Veterinary Feed Directive (VFD) - Veterinary OTC Drugs and Nutritional Supplements - Regulatory Agencies - CVM Compliance Policy - CPG 690.150 & CPG 690.100 - Veterinary Medical Devices CPG 655.100 USDA (CVB, APHIS, FSIS) & EPA - USDA's Animal and Plant Health Inspection Service - Virus Serum Toxin Act - Animal vaccines - Animal biologics - Animal disease diagnostic devices - EPA - Flea & Tick Products - Insect Repellants such as Equine Fly Sprays - State Registrations Non-Approval-Related Considerations - Extra-Label Drug Use - Compounding - Noncompliance and Enforcement - FDA Enforcement Authority over Development, Manufacture, Marketing, and Distribution - FDA's Office of Regulatory Affairs (ORA): Responsible for field activities, imports, inspections, and enforcement policy - Local, State, and Tribal governments - CVM's Office of Surveillance and Compliance - Types of Enforcement Actions Importance of Patent Protection: Right to Enforce For more information about this conference visit http://www.researchandmarkets.com/research/h6p6wc/the_veterinary To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/two-day-veterinary-drug-approval-process-and-fda-regulatory-oversight-course-kansas-city-missouri-united-states---june-13-14-2017---research-and-markets-300444055.html


News Article | May 5, 2017
Site: www.prnewswire.com

"It is the responsibility of feed manufacturers to have sufficient manufacturing controls in place to ensure the safety of their products," said Steven Solomon, D.V.M., director of the FDA's Center for Veterinary Medicine. "The FDA will take whatever steps are necessary to protect animal health when we find repeated violations that raise safety concerns." The consent decree prohibits Syfrett Feed from processing, manufacturing, preparing, packing and distributing the medicated animal feed it produces until the defendants hire an expert to ensure that they are following all cGMP regulations in the manufacture of medicated feed and until the FDA provides Syfrett Feed with written permission that they may resume the manufacture and distribution of their medicated feed. The complaint was filed by the U.S. Department of Justice on behalf of the FDA. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/fda-takes-action-against-florida-medicated-animal-feed-manufacturer-300452519.html


News Article | May 11, 2017
Site: globenewswire.com

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. 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. 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. As of March 31, 2017, Nexvet had cash of $14.5 million. For the three months ended March 31, 2017, Nexvet reported a net loss of $6.0 million which reflected one off items, namely $1.0 million to Pfizer for a patent license and $0.8 million in cost reduction costs, compared to $5.7 million for the three months ended March 31, 2016. Net loss per share attributable to ordinary shareholders (basic and diluted) for the three months ended March 31, 2017 was $0.51, compared to $0.50 for the three months ended March 31, 2016. The net loss of $6.0 million for the three months ended March 31, 2017 included operating expenses of $7.2 million, reflecting $5.6 million in research and development expenses and $1.6 million in general and administrative expenses. Other income of $1.1 million comprised research and development income of $0.6 million, government grant income of $0.4 million and an exchange gain of $0.1 million. The net loss of $5.7 million for the three months ended March 31, 2016 included operating expenses of $5.9 million, reflecting $4.3 million in research and development expenses and $1.7 million in general and administrative expenses. Other income of $0.2 million comprised research and development income of $0.4 million offset by an exchange loss of $0.2 million. For the nine months ended March 31, 2017, Nexvet reported a net loss of $16.5 million which reflected one off items, namely $1.0 million to Pfizer for a patent license and $0.8 million in cost reduction costs, compared to $15.4 million for the nine months ended March 31, 2016. Net loss per share attributable to ordinary shareholders (basic and diluted) for the nine months ended March 31, 2017 was $1.41, compared to $1.34 for the nine months ended March 31, 2016. The net loss of $16.5 million for the nine months ended March 31, 2017 included operating expenses of $18.0 million, reflecting $12.8 million in research and development expenses and $5.2 million in general and administrative expenses. Other income of $1.5 million comprised research and development income of $1.6 million, government grant income of $0.8 million and interest income of $0.1 million, offset by an exchange loss of $1.0 million. The net loss of $15.4 million for the nine months ended March 31, 2016 included operating expenses of $17.1 million, reflecting $11.8 million in research and development expenses and $5.3 million in general and administrative expenses. Other income of $1.7 million comprised research and development income of $1.4 million, interest income $0.1 million and an exchange gain of $0.2 million. 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 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 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 manufacturing in Ireland. 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 (the “Exchange Act”). Forward looking statements consist of all statements other than statements of historical fact, including statements regarding our future results of operations and financial position, potential acquisition by Zoetis, ability to access financing on acceptable terms or at all, results of any current or future pivotal 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.


News Article | May 11, 2017
Site: globenewswire.com

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. 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. 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. As of March 31, 2017, Nexvet had cash of $14.5 million. For the three months ended March 31, 2017, Nexvet reported a net loss of $6.0 million which reflected one off items, namely $1.0 million to Pfizer for a patent license and $0.8 million in cost reduction costs, compared to $5.7 million for the three months ended March 31, 2016. Net loss per share attributable to ordinary shareholders (basic and diluted) for the three months ended March 31, 2017 was $0.51, compared to $0.50 for the three months ended March 31, 2016. The net loss of $6.0 million for the three months ended March 31, 2017 included operating expenses of $7.2 million, reflecting $5.6 million in research and development expenses and $1.6 million in general and administrative expenses. Other income of $1.1 million comprised research and development income of $0.6 million, government grant income of $0.4 million and an exchange gain of $0.1 million. The net loss of $5.7 million for the three months ended March 31, 2016 included operating expenses of $5.9 million, reflecting $4.3 million in research and development expenses and $1.7 million in general and administrative expenses. Other income of $0.2 million comprised research and development income of $0.4 million offset by an exchange loss of $0.2 million. For the nine months ended March 31, 2017, Nexvet reported a net loss of $16.5 million which reflected one off items, namely $1.0 million to Pfizer for a patent license and $0.8 million in cost reduction costs, compared to $15.4 million for the nine months ended March 31, 2016. Net loss per share attributable to ordinary shareholders (basic and diluted) for the nine months ended March 31, 2017 was $1.41, compared to $1.34 for the nine months ended March 31, 2016. The net loss of $16.5 million for the nine months ended March 31, 2017 included operating expenses of $18.0 million, reflecting $12.8 million in research and development expenses and $5.2 million in general and administrative expenses. Other income of $1.5 million comprised research and development income of $1.6 million, government grant income of $0.8 million and interest income of $0.1 million, offset by an exchange loss of $1.0 million. The net loss of $15.4 million for the nine months ended March 31, 2016 included operating expenses of $17.1 million, reflecting $11.8 million in research and development expenses and $5.3 million in general and administrative expenses. Other income of $1.7 million comprised research and development income of $1.4 million, interest income $0.1 million and an exchange gain of $0.2 million. 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 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 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 manufacturing in Ireland. 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 (the “Exchange Act”). Forward looking statements consist of all statements other than statements of historical fact, including statements regarding our future results of operations and financial position, potential acquisition by Zoetis, ability to access financing on acceptable terms or at all, results of any current or future pivotal 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.


News Article | May 11, 2017
Site: globenewswire.com

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. 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. 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. As of March 31, 2017, Nexvet had cash of $14.5 million. For the three months ended March 31, 2017, Nexvet reported a net loss of $6.0 million which reflected one off items, namely $1.0 million to Pfizer for a patent license and $0.8 million in cost reduction costs, compared to $5.7 million for the three months ended March 31, 2016. Net loss per share attributable to ordinary shareholders (basic and diluted) for the three months ended March 31, 2017 was $0.51, compared to $0.50 for the three months ended March 31, 2016. The net loss of $6.0 million for the three months ended March 31, 2017 included operating expenses of $7.2 million, reflecting $5.6 million in research and development expenses and $1.6 million in general and administrative expenses. Other income of $1.1 million comprised research and development income of $0.6 million, government grant income of $0.4 million and an exchange gain of $0.1 million. The net loss of $5.7 million for the three months ended March 31, 2016 included operating expenses of $5.9 million, reflecting $4.3 million in research and development expenses and $1.7 million in general and administrative expenses. Other income of $0.2 million comprised research and development income of $0.4 million offset by an exchange loss of $0.2 million. For the nine months ended March 31, 2017, Nexvet reported a net loss of $16.5 million which reflected one off items, namely $1.0 million to Pfizer for a patent license and $0.8 million in cost reduction costs, compared to $15.4 million for the nine months ended March 31, 2016. Net loss per share attributable to ordinary shareholders (basic and diluted) for the nine months ended March 31, 2017 was $1.41, compared to $1.34 for the nine months ended March 31, 2016. The net loss of $16.5 million for the nine months ended March 31, 2017 included operating expenses of $18.0 million, reflecting $12.8 million in research and development expenses and $5.2 million in general and administrative expenses. Other income of $1.5 million comprised research and development income of $1.6 million, government grant income of $0.8 million and interest income of $0.1 million, offset by an exchange loss of $1.0 million. The net loss of $15.4 million for the nine months ended March 31, 2016 included operating expenses of $17.1 million, reflecting $11.8 million in research and development expenses and $5.3 million in general and administrative expenses. Other income of $1.7 million comprised research and development income of $1.4 million, interest income $0.1 million and an exchange gain of $0.2 million. 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 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 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 manufacturing in Ireland. 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 (the “Exchange Act”). Forward looking statements consist of all statements other than statements of historical fact, including statements regarding our future results of operations and financial position, potential acquisition by Zoetis, ability to access financing on acceptable terms or at all, results of any current or future pivotal 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.


ANN ARBOR, Mich., Dec. 19, 2016 (GLOBE NEWSWIRE) -- Zomedica Pharmaceuticals Corp. (TSX-V:ZOM), a veterinary pharmaceutical company, today announced that it opened its third Investigational New Animal Drug (INAD) application with the U.S. Food and Drug Administration Center for Veterinary Medicine (FDA-CVM) for ZM-007. ZM-007 and the previously announced ZM-012 are complementary oral formulations being developed for the treatment of diarrhea in dogs. The active pharmaceutical ingredient for both ZM-007 and ZM-012 is metronidazole, an anti-infective not yet approved by the FDA-CVM for veterinary use but commonly prescribed by veterinarians for their canine patients using human-approved products. The FDA-CVM requires the use of animal approved drugs when available over human-approved drugs in veterinary species. ZM-012 is a novel tablet formulation being developed to replace the large, bitter tasting human-approved generic tablet routinely prescribed by veterinarians. Zomedica’s canine-specific tablet aims to maximize patient compliance while keeping treatment regimens affordable. ZM-007 is an oral suspension formulation being developed to provide veterinarians with a means to accurately dose smaller dog breeds and puppies. With this oral suspension, Zomedica hopes to offset the veterinarian’s reliance on compounding pharmacies for medication supply and bring associated pharmacy revenue back into the veterinarian’s clinic. Metronidazole suspension is one of the most frequently compounded drugs for dogs. “It is commonly recognized that metronidazole is one of the clinical veterinarian’s most preferred anti-diarrheal treatments for dogs,” stated Zomedica’s Chief Medical Officer William MacArthur, MS, DVM. “Our goal with these formulations is to give veterinarians full confidence that the medication they are using to treat their canine patients is indeed safe and effective rather than relying on data from human trials.” By taking ZM-007 and ZM-012 through the rigorous FDA-CVM approval process, Zomedica intends to validate these drugs as safe and effective for veterinary use in dogs. Both formulations support Zomedica’s veterinary-focused mission by providing products specifically formulated for companion animals to positively impact patient care and practice management. About Zomedica With U.S. operations based in Ann Arbor, Michigan, Zomedica is a veterinary pharmaceutical company targeting health and wellness solutions for companion animals (canine, feline and equine) through a ground-breaking approach that focuses on the unmet needs of clinical veterinarians. Zomedica is building a diversified portfolio of products comprised of the discovery, development and commercialization of innovative drugs alongside novel drug delivery systems, devices and diagnostics. With multiple clinical veterinarians in executive management, it is Zomedica’s mission to give veterinarians the opportunity to lower costs, increase productivity, and grow revenue while better serving the animals in their care. For more information, visit www.ZOMEDICA.com. Reader Advisory Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of the release. Except for statements of historical fact, this news release contains certain "forward-looking information" within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as "plan", "expect", "project", "intend", "believe", "anticipate", "estimate" and other similar words, or statements that certain events or conditions "may" or "will" occur. Although we believe that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. We cannot guarantee future results, performance or achievements. Consequently, there is no representation that the actual results achieved will be the same, in whole or in part, as those set out in the forward-looking information. Forward-looking information is based on the opinions and estimates of management at the date the statements are made, and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking information. Some of the risks and other factors that could cause the results to differ materially from those expressed in the forward-looking information include, but are not limited to: uncertainty as to whether our strategies and business plans will yield the expected benefits; availability and cost of capital; the ability to identify and develop and achieve commercial success for new products and technologies; the level of expenditures necessary to maintain and improve the quality of products and services; changes in technology and changes in laws and regulations; our ability to secure and maintain strategic relationships; risks pertaining to permits and licensing, intellectual property infringement risks, risks relating to future clinical trials, regulatory approvals, safety and efficacy of our products, the use of our product, intellectual property protection and the other risk factors disclosed under our profile on SEDAR at www.sedar.com. Readers are cautioned that this list of risk factors should not be construed as exhaustive. The forward-looking information contained in this news release is expressly qualified by this cautionary statement. We undertake no duty to update any of the forward-looking information to conform such information to actual results or to changes in our expectations except as otherwise required by applicable securities legislation. Readers are cautioned not to place undue reliance on forward-looking information.


Dublin, Dec. 20, 2016 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of Jain PharmaBiotech's new report "Animal Biotechnology - Technologies, Markets and Companies" to their offering. This report describes and evaluates animal biotechnology and its application in veterinary medicine and pharmaceuticals as well as improvement in food production. Knowledge of animal genetics is important in the application of biotechnology to manage genetic disorders and improve animal breeding. Genomics, proteomics and bioinformatics are also being applied to animal biotechnology. Transgenic technologies are used for improving milk production and the meat in farm animals as well as for creating models of human diseases. Transgenic animals are used for the production of proteins for human medical use. Biotechnology is applied to facilitate xenotransplantation from animals to humans. Genetic engineering is done in farm animals and nuclear transfer technology has become an important and preferred method for cloning animals.There is discussion of in vitro meat production by culture Biotechnology has potential applications in the management of several animal diseases such as foot-and-mouth disease, classical swine fever, avian flu and bovine spongiform encephalopathy. The most important biotechnology-based products consist of vaccines, particularly genetically engineered or DNA vaccines. Gene therapy for diseases of pet animals is a fast developing area because many of the technologies used in clinical trials humans were developed in animals and many of the diseases of cats and dogs are similar to those in humans.RNA interference technology is now being applied for research in veterinary medicine Molecular diagnosis is assuming an important place in veterinary practice. Polymerase chain reaction and its modifications are considered to be important. Fluorescent in situ hybridization and enzyme-linked immunosorbent assays are also widely used. Newer biochip-based technologies and biosensors are also finding their way in veterinary diagnostics. Biotechnology products are approved by the Center for Veterinary Medicine of the FDA. Regulatory issues relevant to animal biotechnology are described. Approximately 124 companies have been identified to be involved in animal biotechnology and are profiled in the report. These are a mix of animal healthcare companies and biotechnology companies. Top companies in this area are identified and ranked. Information is given about the research activities of 11 veterinary and livestock research institutes. Important 108 collaborations in this area are shown. Share of biotechnology-based products and services in 2015 is analyzed and the market is projected to 2025. The text is supplemented with 35 tables and 5 figures.Selected 260 references from the literature are appended. Key Topics Covered: Executive Summary 1. Introduction to Animal Biotechnology 2. Application of Biotechnology in Animals 3. A Biotechnology Perspective of Animals Diseases 4. Molecular Diagnostics in Animals 5. Biotechnology-based Veterinary Medicine 6. Research in Animal Biotechnology 7. Animal Biotechnology Markets 8. Regulatory issues 9. Companies Involved in Animal Biotechnology 10. References For more information about this report visit http://www.researchandmarkets.com/research/bxkxgm/animal


STEVENSON, Md.--(BUSINESS WIRE)--The securities litigation law firm of Brower Piven, A Professional Corporation, announces that a class action lawsuit has been commenced in the United States District Court for the Southern District of New York on behalf of purchasers of Aratana Therapeutics, Inc. (Nasdaq: PETX) (“Aratana” or the “Company”) securities during the period between March 16, 2015 and February 3, 2017, inclusive (the “Class Period”). Investors who wish to become proactively involved in the litigation have until April 7, 2017 to seek appointment as lead plaintiff. If you wish to choose counsel to represent you and the Class, you must apply to be appointed lead plaintiff and be selected by the Court. The lead plaintiff will direct the litigation and participate in important decisions including whether to accept a settlement for the Class in the action. The lead plaintiff will be selected from among applicants claiming the largest loss from investment in Aratana securities during the Class Period. Members of the Class will be represented by the lead plaintiff and counsel chosen by the lead plaintiff. No class has yet been certified in the above action. The complaint accuses the defendants of violations of the Securities Exchange Act of 1934 by virtue of the defendants’ failure to disclose during the Class Period that Aratana did not have manufacturing contracts in place sufficient to support manufacturing of ENTYCE at a commercial scale, and ENTYCE was not likely to be commercially available until late 2017. According to the complaint, following a February 6, 2017 announcement that the Center for Veterinary Medicine (“CVM”) had requested more information about ENTYCE in connection with the Company’s post-approval supplement request to transfer the manufacturing of ENTYCE to a new vendor in order to produce ENTYCE at a commercial scale and that the Company now anticipates that ENTYCE will be commercially available by late 2017, the value of Aratana shares declined significantly. If you have suffered a loss in excess of $100,000 from investment in Aratana securities purchased on or after March 16, 2015 and held through the revelation of negative information during and/or at the end of the Class Period and would like to learn more about this lawsuit and your ability to participate as a lead plaintiff, without cost or obligation to you, please visit our website at http://www.browerpiven.com/currentsecuritiescases.html. You may also request more information by contacting Brower Piven either by email at hoffman@browerpiven.com or by telephone at (410) 415-6616. Brower Piven also encourages anyone with information regarding the Company’s conduct during the period in question to contact the firm, including whistleblowers, former employees, shareholders and others. Attorneys at Brower Piven have extensive experience in litigating securities and other class action cases and have been advocating for the rights of shareholders since the 1980s. If you choose to retain counsel, you may retain Brower Piven without financial obligation or cost to you, or you may retain other counsel of your choice. You need take no action at this time to be a member of the class.


NEW YORK, Feb. 24, 2017 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Aratana Therapeutics, Inc. (“Aratana” or the “Company”) (NASDAQ:PETX) and certain of its officers. The class action, filed in United States District Court, Southern District of New York, is on behalf of a class consisting of investors who purchased or otherwise acquired Aratana securities, seeking to recover compensable damages caused by defendants’ violations of the Securities Exchange Act of 1934. If you are a shareholder who purchased Aratana securities between March 16, 2015 and February 3, 2017, both dates inclusive, you have until April 7, 2017 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at rswilloughby@pomlaw.com or 888.476.6529 (or 888.4-POMLAW), toll free, ext. 9980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and number of shares purchased. [Click here to join this class action] Aratana Therapeutics, Inc. is a development-stage biopharmaceutical company that develops biomedical therapeutics for animals. The Company offers various products to treat pain and inflammation associated with serious medical conditions in pets. One of the Company’s key products is ENTYCE, also known as AT-002 (capromorelin oral solution), an appetite stimulant for dogs. The Complaint alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) Aratana did not have manufacturing contracts in place sufficient to support manufacturing of ENTYCE at a commercial scale; (ii) consequently, ENTYCE was not likely to be commercially available until late 2017; (iii) accordingly, Aratana had misled investors with respect to the likely timeline for a commercial launch of ENTYCE; and (iv) as a result of the foregoing, Aratana’s public statements were materially false and misleading at all relevant times. On February 6, 2017, Aratana disclosed that the Center for Veterinary Medicine (“CVM”) had requested more information about ENTYCE. Aratana advised investors that the CVM’s request was “in connection with the Company’s post-approval supplement request to transfer the manufacturing of ENTYCE to a new vendor in order to produce ENTYCE at a commercial scale” and that the Company “now anticipates that ENTYCE . . . will be commercially available by late 2017.” On this news, Aratana’s share price fell $1.44, or 17.93%, to close at $6.59 on February 6, 2017. The Pomerantz Firm, with offices in New York, Chicago, Florida, and Los Angeles, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com


News Article | February 21, 2017
Site: www.prweb.com

VetStem Biopharma, Inc., announced the opening of its GMP cell therapy manufacturing facility at its headquarters laboratory in Poway, California. Based upon 12 years of knowledge gained by following GTP laboratory guidelines and utilizing the experience of both in-house personnel and consultants, VetStem constructed and validated a state-of-the-art GMP stem cell manufacturing plant. This clean room facility has already produced three registration batches of stem cell product and those batches have been officially released for use in pivotal FDA studies of safety and efficacy. Carolyn Wrightson, Ph.D., VP of Operations, stated, “This facility is the culmination of six years of planning and research, supported by over 12 years of commercial stem cell laboratory operations by VetStem’s experienced cell therapy team. We believe this is the first dedicated veterinary-specific cell therapy facility in the United States. It will provide all the stem cell products for use in VetStem FDA product development programs.” The facility operates under FDA GMP guidelines and is designed to produce commercial products, once approved by the FDA. “Quality is a critical element necessary to bring stem cell therapy into mainstream veterinary practice. VetStem has been committed to quality since its founding and has worked directly with the FDA Center for Veterinary Medicine since 2003 to assure our products and services adhere to the strictest guidelines for safety and efficacy,” said Bob Harman, DVM, MPVM, CEO of VetStem. “VetStem offers tours of this unique facility via large viewing windows in an exterior corridor and veterinarians are amazed at the high tech approach to veterinary cell therapy including the specialized approach to donor selection, disease screening, clean room cell culture and final packaging of the product in specialized cell product vials.” “Stem cell therapy is a truly novel and natural approach to treatment of acute and chronic diseases in animals that have few or less efficacious therapeutic options. Using donor derived allogeneic stem cells provides cell therapy in a “ready to use” format without the need for tissue collection, or processing thus expanding the availability to more animals. VetStem is dedicated to providing affordable stem cell therapy for diseases of dogs, cats and horses, especially in areas of unmet needs,” according to Harman. VetStem Biopharma is a veterinarian-lead company that was formed in 2002 to bring regenerative medicine to the profession. This privately held biopharmaceutical enterprise, based near San Diego (California), currently offers veterinarians an autologous stem cell processing service (from patients’ own fat tissue) among other regenerative modalities. With a unique expertise acquired over the past 14 years and 12,000 patients treated by veterinarians for joint, tendon or ligament issues, VetStem has made regenerative medicine applications a therapeutic reality beyond the realm of research. The VetStem team is focused on developing new clinically practical and affordable veterinary solutions that leverage the natural restorative abilities present in all living creatures. The company’s stated mission is “to extend and enhance the lives of animals by improving the quality of recovery in acute conditions, but also by unlocking ways to slow, stop and ultimately revert the course of chronic diseases.” In addition to its own portfolio of patents, VetStem holds exclusive global veterinary licenses to a portfolio of over 70 issued patents in the field of regenerative medicine.

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