News Article | May 5, 2017
DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "PharmSource - CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2017 Edition" report to their offering. The report examines 91 drugs approved by the FDA Center for Drug Evaluation and Research (CDER) in 2016 along with 1 therapeutic drug approved by the FDA Center for Biologics Evaluation and Research (CBER) under the BLA process. PharmSource's data-rich Trend Report, CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2017 Edition, has ascertained that 2016 was not a halcyon year for new drug approvals with only 25 NMEs being approved since 2010. Global bio/pharma companies received 22 approvals in 2016 (24% of all NDAs), 10% below their 2011-2015 average. Small commercial companies were responsible for 21 approvals (23% of the total), some 5% above their five-year average. There was a clear difference between outsourcing propensity of NME and Non-NME drugs. Only 13% of NMEs sponsored by global bio/pharma companies were outsourced compared with an average of 28% from 2011-2015. However, the largest companies increased their outsourcing of Non-NME drugs from an average of 32% in 2011-2015 to 57% in 2016. In 2016, the FDA approved 92 NDAs and BLAs including new molecular entities (NMEs), therapeutic drugs approved through CBER and new formulations of older drugs. This figure represents a 25% decrease from 2015 (122) and is also 5% less than the 2011-2015 average of 97. Furthermore, 48% of NMEs were outsourced compared to 64% of Non-NME NDA products. 28 dose CMOs garnered approvals in 2016 although two companies, Vetter and Patheon, won 7 out of the 12 NMEs that were outsourced. No other company secured more than a single NME approval for contract manufacturing, although Catalent and DPT were responsible for 7 Non-NME NDA drugs. The CMO landscape is dominated by the quartet of Patheon, Baxter, Vetter and Catalent, which collectively accounted for over 30% of all NDA approvals between 2007-2016. Parenteral NME outsourcing is dominated by the first three of these, which are responsible for manufacturing 47% of all drugs, with the remainder split between 28 other companies. In depth, this report provides the following: - Provides the detailed analysis of drugs examined by the European Medicines Agency (EMA). The centralized procedure is mandatory for all New Active Substances, as well as Biosimilar drugs and certain generics depending on their therapeutic category. - Analyzes propensity to outsource by dosage form, sponsor type, nature of API and special handling requirements. In addition, it includes information on product approvals, which have utilized formulation technologies such as amorphous solid dispersion (ASD), hot melt extrusion (HME) and jet milling. - Helps for CMO executives and strategic decision-makers who seriously follow the global CMO industry, including dose and API manufacturers. For more information about this report visit http://www.researchandmarkets.com/research/9b6jb9/pharmsource_cmo
News Article | April 24, 2017
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 1, 2017
NEW YORK, May 01, 2017 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq:AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, today announced the appointment of Emmanuel O. Fadiran, RPh, PhD, as Senior Vice President of Regulatory Affairs. Dr. Fadiran has 24 years of regulatory experience within the U.S. Food and Drug Administration (FDA), having held leadership positions at the FDA’s Center for Drug Evaluation and Research (CDER). “Dr. Fadiran has an accomplished track record of working within the FDA,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “His depth of experience makes him an excellent choice to manage the considerable number of regulatory filings that Anavex has planned.” Prior to joining Anavex, Dr. Fadiran served as a Clinical Pharmacology Team Leader at the FDA’s CDER. During his 24-year (1993-2017) tenure at the FDA, Dr. Fadiran reviewed hundreds of New Drug Applications (NDAs), supplemental New Drug Applications (sNDAs), Biologics License Application (BLAs), Abbreviated New Drug Applications (ANDAs) and Investigational New Drug applications (INDs) for approval and made strategic recommendations for the development of several products across many therapeutic categories. He was on review teams for several novel therapies including first-in-class approvals. Dr. Fadiran also led a cross-disciplinary NDA review team and authored the first Cross-Discipline Team Leader (CDTL) review for the Division of the Pulmonary and Allergy Products, Office of Drug Evaluation II, CDER. He was actively involved in the writing, internal/external training and implementation of the U.S. FDA Guidance for Industry for population pharmacokinetics. “I am very pleased to be joining Anavex at this important and exciting time for the company,” stated Dr. Fadiran. “There are tremendous opportunities ahead, and I look forward to working with the Anavex team to deliver on the corporate objectives for 2017 and beyond.” Dr. Fadiran has been involved in the formulation of significant strategic FDA regulatory initiatives including serving as a member of the Senior Management Teams for the Data Standard (Janus) and Sentinel Initiatives. He was an active member of the FDA Senior Science Council working group for the creation and launching of the FDA’s Strategic Plan for Regulatory Science in 2012. Recently, he has played an active role in the development of the Comprehensive in vitro Proarrhythmia Assay (CiPA) for future replacement of the thorough QT studies. As a long-term member of the FDA Institutional Review Board (IRB), he actively contributed to the development of standard operating procedures (SOP) for the committee. Dr. Fadiran holds a BS (Pharmacy) and MS from Obafemi Awolowo University, Ile-Ife, Nigeria and a PhD in Pharmaceutical Sciences from the University of Strathclyde, Glasgow, UK. Dr. Fadiran is a recipient of the prestigious Fogarty International Fellowship of the National Institutes of Health (NIH) (1991-1993) as well as numerous awards from the FDA, among them the Commissioner’s Award of Excellence, in recognition of his outstanding contributions to regulatory review of applications and development of regulatory guidance and policies. About Anavex Life Sciences Corp. Anavex Life Sciences Corp. (Nasdaq:AVXL) is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, recently successfully completed a Phase 2a clinical trial for Alzheimer’s disease. ANAVEX 2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors and successfully completed Phase 1. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. ANAVEX 2-73 has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The Michael J. Fox Foundation for Parkinson’s Research has awarded Anavex a research grant to develop ANAVEX 2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX 2-73 into a Parkinson’s disease clinical trial. ANAVEX 3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions. Further information is available at www.anavex.com. You can also connect with the company on Twitter, Facebook and LinkedIn. Forward-Looking Statements Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
News Article | May 29, 2017
MediMergent announced today that its CEO, Sandra S. Garrett Ph.D., presented the company’s innovative “Voice of the Patient” software to the BigIdea CONNECTpreneur Forum. The sold-out event was attended by over 300 business leaders and investment groups . Dr. Garrett was among six corporate executives invited to present. “It was a great opportunity to present our platform to experts that could provide feedback on our product and services from multi-industry perspectives,” said Sandra S. Garrett, CEO MediMergent, LLC. “Our NMSOAP initiative enrolls patients at point of service, and creates a communication loop among patients, physicians and pharmacists that help track early warning signals related to medications. The majority of the audience is/was a patient and recognized how important it is for patients to know potential adverse effects of their medication and to be able to intervene before costly and dangerous events occur.” According to Sandra S. Garrett, the CONNECTpreneur Forum is the first of a series of industry events and private investor meetings that MediMergent plans to participate in over the next few months as it scales its business across thousands of pharmacies and physicians to enroll patients and collect real world evidence. About MediMergent, LLC MediMergent, LLC is a data collection, integration and analytics company co-founded by Sandra S. Garrett, CEO. or web-based devices, Under a Research Collaboration Agreement with the Center for Drug Evaluation Research (CDER) at the U.S. Food and Drug Administration (FDA), MediMergent established the National Medication Safety, Outcomes and Adherence Program (NMSOAP) to longitudinally assess safety, outcomes, and medication adherence using an innovative, prospective, evaluative approach towards recently approved drugs under real-world conditions. The result is the ability to collect health information directly from patients using the “Voice of the Patient” software without third party interpretation. This information is integrated with other sources of patient information including electronic medical records, pharmacy and claims data to create databases of real-world safety, clinical outcomes, medication compliance, REMS and comparative effectiveness data. About The BigIdea CONNECTpreneur Forum Big Idea CONNECTpreneur is a Community of over 3000 Business leaders, CEOs, Entrepreneurs, VCs and angels in the Mid-Atlantic Region. The Forum is a quarterly half-day event featuring networking, news-making speakers and a showcase of 7–8 exciting companies.
Journal of Controlled Release | Year: 2016
Balloon-based drug delivery systems allow localized application of drugs to a vascular segment to reduce neointimal hyperplasia and restenosis. Drugs are coated onto balloons using excipients as drug carriers to facilitate adherence and release of drug during balloon inflation. Drug-coated balloon delivery system is characterized by a rapid drug transfer that achieves high drug concentration along the vessel wall surface, intended to correspond to the balloon dilation-induced vascular injury and healing processes. The balloon catheter system allows homogenous drug delivery to the vessel wall, such that the drug release per unit surface area is kept constant along balloons of different lengths. Optimization of the balloon coating matrix is essential for efficient drug transfer and tissue retention until the artery remodels to a normal set point. Challenges in the development of balloon-based drug delivery to the arterial wall include finding suitable excipients for drug formulation to enable drug release to a targeted lesion site effectively, maintain coating integrity during transit, prolong tissue retention and reduce particulate generation. This review highlights various factors involved in the successful design of balloon-based delivery systems, including drug release kinetics, matrix coating transfer, transmural drug partitioning, dissolution rate and release of unbound active drug. © 2016
News Article | March 2, 2017
CLARENCE, N.Y.--(BUSINESS WIRE)--22nd Century Group, Inc. (NYSE MKT: XXII), a plant biotechnology company that is focused on reducing the harm caused by smoking, announced today that the Company has been granted a guidance meeting with the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) to discuss “X-22,” which the Company is developing as its signature smoking cessation aid. At the meeting, which will take place this June, the Company will seek agreement from CDER/FDA on an appropriate path for X-22 to become a prescription-based cessation aid for smokers in the United States. The Company’s keystone technology is its ability to grow proprietary Very Low Nicotine tobacco that contains up to 95% less nicotine than conventional tobacco plants. Independent clinical studies have shown that 22nd Century’s Very Low Nicotine SPECTRUM® cigarettes sever the powerful connection between the act of smoking and the rapid delivery of nicotine to the body. 22nd Century believes that X-22 may ultimately prove to be the most effective tool in the fight against nicotine addiction. FDA approval must be obtained before a product can be marketed for smoking cessation. The Tobacco Control Act provides that, at the request of an applicant, the FDA shall consider designating products for smoking cessation as “fast track” research. The FDA’s “fast track” program is intended to facilitate development and to expedite review of drugs that, among other things, treat serious and life-threatening conditions so that an approved product can reach the market expeditiously. 22nd Century intends to seek “fast track” designation by the FDA for X-22. “We are looking forward to meeting with FDA’s CDER this June to discuss development of our X-22 smoking cessation aid,” explained Henry Sicignano, III, President and CEO of 22nd Century Group. “Given that 89% of smokers that we have surveyed report that X-22 would be their top or first choice to help them quit smoking, we believe that doctors and patients across the United States should have the choice of being able to utilize X-22 in their fight against nicotine addiction.” Mr. Sicignano continued, “Independent scientific researchers have indicated that cigarettes made from 22nd Century’s proprietary Very Low Nicotine tobacco could save millions of lives and billions of dollars in healthcare costs. We think the time for X-22 smoking cessation cigarettes has arrived.” 22nd Century is a plant biotechnology company focused on technology which allows it to increase or decrease the level of nicotine in tobacco plants and the level of cannabinoids in cannabis plants through genetic engineering and plant breeding. The Company’s primary mission is to reduce the harm caused by smoking. 22nd Century currently owns or exclusively controls more than 200 issued patents and more than 50 pending patent applications around the world. Visit www.xxiicentury.com for more information. Cautionary Note Regarding Forward-Looking Statements: This press release contains forward-looking information, including all statements that are not statements of historical fact regarding the intent, belief or current expectations of 22nd Century Group, Inc., its directors or its officers with respect to the contents of this press release, including but not limited to our future revenue expectations. The words “may,” “would,” “will,” “expect,” “estimate,” “anticipate,” “believe,” “intend” and similar expressions and variations thereof are intended to identify forward-looking statements. We cannot guarantee future results, levels of activity or performance. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that we may issue in the future. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances, or to reflect the occurrence of unanticipated events. You should carefully review and consider the various disclosures made by us in our annual report on Form 10-K for the fiscal year ended December 31, 2015, filed on February 18, 2016, including the section entitled “Risk Factors,” and our other reports filed with the U.S Securities and Exchange Commission which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, our actual results may vary materially from those expected or projected.
News Article | February 15, 2017
Karen C. Corallo joins the Washington, D.C. office of global law firm Greenberg Traurig, LLP, as of counsel in its Health & FDA Business Practice. Corallo previously served as the Director of the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Division of Drug Imports, Exports, Recalls, and Shortages. Before that, she was Associate Chief Counsel in the FDA’s Office of Chief Counsel where she handled enforcement work across all FDA-regulated commodities. At Greenberg Traurig, she will represent industry clients on pharmaceutical, medical device, foods, cosmetic, biologics, and other FDA-related matters, as well as on a wide range of health care issues. “We are very excited to welcome Karen to Greenberg Traurig,” said Nancy E. Taylor, Co-Chair of the firm’s Health & FDA Business Practice. “Karen brings hands on experience in dealing with FDA issues, particularly concerning regulatory and enforcement actions, which is invaluable to our clients.” While with the FDA, Corallo authored and implemented the FDA’s global drug imports strategy, participated in rule-making, and spearheaded important drug policy initiatives for the agency. In addition to her recent government work, Corallo was a commercial litigation partner in a global law firm and in-house counsel at a Fortune 100 company. “Karen’s blend of government, private practice, and in-house experience further enhances the diverse experience our firm can bring to bear on client issues,” said Laura Klaus, Co-Managing Shareholder of Greenberg Traurig’s Washington, D.C. office. “Having previously worked with Greenberg Traurig attorneys for many years, I am thrilled to be joining this firm with such an incredible platform, both geographically and substantively across a number of practice areas,” Corallo said. “I am looking forward to serving the diversity of clients in the FDA space, and combining my skills and experience with the firm’s enforcement, regulatory, and litigation expertise to enhance the service I can offer clients.” Corallo received her J.D. with highest honors from South Texas College of Law in 1984 and her B.A., summa cum laude, Phi Beta Kappa in English Literature from the University of Texas at Austin in 1979. She is admitted to practice in Texas. Currently, her practice in the District of Columbia is limited to matters and proceedings before federal courts and agencies. Corallo joins Greenberg Traurig on the heels of another former federal director, Rebecca L. Caldwell-Harrigal, the first female Director of the Office of Tax Exempt Bonds at the Internal Revenue Service. Caldwell-Harrigal joined as a tax shareholder in the firm’s Northern Virginia office. Greenberg Traurig’s multidisciplinary Health & FDA Business Group provides strategic counsel to a diverse group of companies and other organizations, helping them to respond proactively to the rapidly changing healthcare marketplace. The group combines dedicated experience in health care regulatory compliance and operational matters with the firm’s capabilities in corporate & securities, finance, tax, antitrust, ERISA, commercial and governmental litigation, restructuring, intellectual property and biotechnology, in order to provide a wide range of legal services. For more information, click here. Greenberg Traurig, LLP (GTLaw) has more than 2,000 attorneys in 38 offices in the United States, Latin America, Europe, Asia and the Middle East and is celebrating its 50th anniversary. A single firm worldwide, GTLaw has been recognized for its philanthropic giving, was named the second largest firm in the U.S. by Law360 in 2016, and among the Top 20 on the 2016 Am Law Global 100. Web: http://www.gtlaw.com Twitter: @GT_Law.
News Article | February 22, 2017
NDA Partners Chairman Carl Peck, MD, announced today that Dr. Daniel Spyker, PhD, MD former Acting Deputy Director in the FDA CDRH Division of Cardiovascular, Respiratory, and Neurological Devices and Medical Officer in CDER’s Pilot Drug Evaluation Staff has joined the company as an Expert Consultant. In Dr. Spyker’s accomplished career, he held positions as Senior Director of Drug Safety and Pharmacovigilance at Alexza Pharmaceuticals; Director, Pharmacokinetics and Pharmacodynamic Sciences, Genentech, where he established the clinical pharmacology unit; and Senior Medical Director, Clinical Risk Assessment and Coordination Department at Purdue Pharma. Dr. Spyker was a member of the Internal Medicine faculty in the Division of Clinical Pharmacology at the University of Virginia for 10 years, where he fostered and nurtured the Blue Ridge Poison Center. He was also founder and CEO of a software company specializing in poison center data collection and Bayesian pharmacokinetic applications. “Dr. Daniel Spkyer’s knowledge and expertise of cardiovascular, respiratory, and neurological devices at FDA and in the Industry, in addition to his expertise in quantitative clinical pharmacology and toxicology, make him an excellent addition to NDA Partners. He will bring great value to our medical device clients and we are very pleased to welcome him,” said Dr. Feigal, who heads NDA Partners’ Medical Device Practice. Dr. Spyker earned his PhD from the University of Minnesota in Electrical Engineering and Mathematics, his MD from the University of Virginia, and MS from Purdue University. He is board certified in Internal Medicine, a diplomate of the American Board of Medical Toxicology, and diplomate of the American Board of Clinical Pharmacology. About NDA Partners NDA Partners is a strategy consulting firm specializing in expert product development and regulatory advice to the medical products industry and associated service industries such as law firms, investment funds and government research agencies. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and virtual product development teams.
News Article | February 15, 2017
OTTAWA, ONTARIO--(Marketwired - Feb. 9, 2017) - Tetra Bio-Pharma Inc. ("Tetra") (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GRPOF) and IntelGenx Corp. ("IntelGenx"), (TSX VENTURE:IGX)(OTCQX:IGXT), today announced the signing of a binding term sheet for the development and commercialization of a drug product containing dronabinol. Under the binding term sheet, Tetra will have exclusive rights to sell the product in North America with a right of first negotiation for outside the U.S. and Canada. The U.S. cancer pain market is expected to reach $5 billion in 2018. Per the Binding Term Sheet, Tetra will make a non-refundable exclusive negotiation payment to IntelGenx, an upfront payment along with set milestone payments based on the completion of an efficacy study, approvals from FDA and Health Canada and launching of the product. IntelGenx will be responsible for the research and development of the product, including clinical studies and will develop the product as an oral mucoadhesive tablet based on its proprietary AdVersa® controlled-release technology. Tetra will be responsible for funding the product development, and will own and control all regulatory approvals, including the application and any other marketing authorizations. Tetra will also be responsible for all aspects of commercializing the drug product. "We are pleased to partner with Tetra Bio-Pharma to enter the lucrative cannabis market," said Dr. Horst G. Zerbe, President and CEO of IntelGenx. "We will work with Tetra to bring this much needed THC product to North American patients suffering from anorexia and cancer chemotherapy-related pain. This announcement is a further testament to the strength of IntelGenx' scientists who continue to execute the development of innovative products using our advanced oral delivery platforms." PhytoPain Pharma Inc., a subsidiary of Tetra will be submitting a request for a Type B pre-IND meeting with the Division of Anesthesia, Analgesia, and Addiction Products (DAAAP), Center for Drug Evaluation and Research (CDER), USA Food and Drug Administration (FDA) to discuss the marketing requirements for Dronabinol AdVersa® Mucoadhesive tablet product. Tetra intends on developing Dronabinol AdVersa® Mucoadhesive tablet as an analgesic for the management of Breakthrough Cancer Pain. Once the safety and efficacy is demonstrated in patients, this drug product will be eligible for approval under the 505(b)(2) New Drug Application (NDA) path commented Dr. Guy Chamberland, Chief Scientific Officer and Regulatory Affairs. The 505(b)(2) pathway represents a significant reduction in time and cost to market commented Dr. Chamberland. He added that the company will also be meeting with the Therapeutic Product Directorate, Health Canada to discuss the clinical development and marketing requirements. Dr. Chamberland further commented that there are many clinical problems associated with the use of currently available form of Dronabinol in patients with anorexia and cancer chemotherapy. It has been demonstrated that psychoactive drugs exert their euphoria, and other psychoactive effects, when the blood levels of the drug rapidly increase. The pharmacokinetic profile of THC and its metabolite significantly affect the abuse potential of Dronabinol. The significant advantage of the Mucoadhesive technology is the controlled-release of THC resulting in a longer time release of the drug avoiding a rapid increase in the blood. There is also an improved bioavailability and potentially reduced gastro-intestinal side effects making the sustained-release THC product a promising alternative in the battle for the reduction of opioids in patients with chronic pain. IntelGenx is a leading oral drug delivery company primarily focused on the development and manufacturing of innovative pharmaceutical oral films based on its proprietary VersaFilmTM technology platform. Established in 2003, the Montreal-based company is listed on the TSX-V and OTC-QX. IntelGenx highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx state-of-the art manufacturing facility, established for the VersaFilmTM technology platform, supports lab-scale to pilot and commercial-scale production, offering full service capabilities to our clients. More information is available about the company at: www.intelgenx.com. Tetra Bio-Pharma is a multi subsidiary publicly traded company (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GRPOF) engaged in the development of Bio Pharmaceuticals and Natural Health Products containing Cannabis and other medicinal plant based elements. Tetra Bio Pharma is focused on combining the traditional methods of medicinal cannabis use with the supporting scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators physicians and insurance companies. More information is available about the company at: www.tetrabiopharma.com. The Canadian Securities Exchange ("CSE") has not reviewed this news release and does not accept responsibility for its adequacy or accuracy. Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words "may", "will", "should", "continue", "expect", "anticipate", "estimate", "believe", "intend", "plan" or "project" or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company's ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a licence for the production of medical marijuana; failure to obtain sufficient financing to execute the Company's business plan; competition; regulation and anticipated and unanticipated costs and delays, and other risks disclosed in the Company's public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.