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News Article | March 2, 2017
Site: www.businesswire.com

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
Site: www.prweb.com

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 | December 7, 2016
Site: www.marketwired.com

HOUSTON, TX--(Marketwired - Dec 7, 2016) - Panther Biotechnology, Inc. ( : PBYA) today announced that it has received positive feedback from the submission presented to the U.S. Food and Drug Administration ("FDA") pursuant to a Pre-IND (Investigational New Drug) meeting with the Division of Oncology Products 1 (DOP1) of the Center for Drug Evaluation and Research (CDER) of the FDA. The purpose of the requested meeting was to obtain FDA's input regarding Panther's plans for the development of TRF-DOX, Panther's novel transferrin-doxorubicin conjugate initially planned for the treatment of platinum-resistant ovarian cancer. In preparation for the meeting, Panther submitted a Pre-IND Package to FDA that described the information Panther intends on submitting in the TRF-DOX IND submission planned in 2017. The IND is the regulatory vehicle that will allow for the initiation of clinical trials with TRF-DOX initially for the treatment of ovarian cancer. Panther submitted the request to seek guidance on a Phase 2a Open Label Sequential Cohort, Ascending Dose, Blinded, DOXIL controlled Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of Multiple Doses of TRF-DOX Administered Intravenously every 4 weeks for up to 12 months to patients with Advanced Platinum-refractory or -resistant Ovarian Cancer. The primary objective will be to evaluate the safety and tolerability of TRF-DOX administered intravenously to subjects with advanced platinum-refractory or resistant ovarian cancer for up to 12 months. Secondary objectives are tumor response rate (complete and partial responses) assessed every 3 months for 12 months following treatment according to Response Evaluation Criteria in Solid Tumors version 1.1. (RESIST) criteria, progression-free survival at 6 and 12 months following first injection of TRF-DOX and overall survival at 6 and 12 months following first injection of TRF-DOX. FDA reviewed Panther's manufacturing, preclinical pharmacology and toxicology, and clinical plans for TRF-DOX and provided specific feedback. In general, FDA agreed with Panther's plans and offered further recommendations and comments. The manufacturing and nonclinical pharmacology and toxicology plans with TRF-DOX were deemed adequate pending review of actual data by FDA in the IND. In addition, FDA had input into the design of the Phase 2b clinical trial with TRF-DOX which will be considered in the protocol submitted with the IND. "This is a significant leap for Panther as we prepare to enter clinical trials in the US and we look forward to getting started," stated Evan Levine, Chief Executive Officer of Panther. "We are extremely pleased and thankful for not only the valuable feedback we received from FDA but also from the productive recommendations to manage TRF-DOX through the next stage of clinical development. Based on earlier encouraging clinical results, we believe we may have a greater opportunity for increasing clinical benefit for patients receiving treatment." TRF-DOX binds to transferrin receptors on tumor cells, inhibits cancer cell proliferation and causes cell death. TRF-DOX has been shown to exhibit increased cytotoxicity relative to unconjugated doxorubicin toward a variety of cancer cell lines and reduced cytotoxicity to normal cells. In addition to improvements in cytotoxicity and selectivity, TRF-DOX exhibits cytotoxic effects in many multidrug-resistant cells in vitro. Tumor targeting of doxorubicin to transferrin receptors on the cell membranes of tumor cells is intended to improve the therapeutic index of doxorubicin and to reduce the development of doxorubicin resistance. Panther Biotechnology, Inc. has, for the past two years, been an entity focused on the acquisition and development of enhanced therapeutics for the treatment of neoplastic, autoimmune and antiviral disorders. Panther has recently merged with Brown Technical Media Corp. to diversify its business. Panther will continue its regulatory effort with the goal of seeking a partner or financing for its anticipated phase 2a study of Transferrin Doxorubicin and will also focus its efforts on growing its revenues in the eLearning, standards and codes industries via both organic growth and acquisitions.


News Article | February 22, 2017
Site: www.prweb.com

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 | October 28, 2016
Site: www.marketwired.com

LA JOLLA, CA--(Marketwired - Oct 24, 2016) - Panther Biotechnology, Inc. ( : PBYA) today announced that a Pre-Investigational New Drug (Pre-IND) meeting with the Divison of Oncology Products 1 (DOP1) of the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) has been granted by FDA. The meeting with the Oncology Division of FDA will take the form of written responses to Panther's Pre-IND package and questions regarding the development of TRF-DOX, Panther's novel transferrin-doxorubicin conjugate for the treatment of platinum-resistant ovarian cancer. In preparation for FDA's feedback, Panther is preparing a Pre-IND Package to be submitted to FDA that describes the information Panther intends on submitting in the TRF-DOX IND planned for submission in 2017. The IND is the regulatory vehicle that will permit the initiation of clinical trials with TRF-DOX in the U.S. FDA will specifically review Panther's manufacturing, preclinical pharmacology and toxicology, and clinical plans for TRF-DOX and provide specific feedback to Panther by the end of the year. TRF-DOX binds to transferrin receptors on tumor cells, inhibits cancer cell proliferation and causes cell death. TRF-DOX has been shown to exhibit increased cytotoxicity relative to unconjugated doxorubicin toward a variety of cancer cell lines and reduced cytotoxicity to normal cells. In addition to improvements in cytotoxicity and selectivity, TRF-DOX exhibits cytotoxic effects in many multidrug-resistant cells in vitro. Tumor targeting of doxorubicin to transferrin receptors on the cell membranes of tumor cells is intended to improve the therapeutic index of doxorubicin and to reduce the development of doxorubicin resistance. Panther is proposing to conduct an open label Phase 2a, multiple ascending dose study to investigate the safety, pharmacokinetics and preliminary efficacy of TRF-DOX in patients with platinum-resistant ovarian cancer. Panther Biotechnology, Inc. has been an entity focused on the acquisition and development of enhanced therapeutics for the treatment of neoplastic, autoimmune and antiviral disorders. The Company has recently announced a letter of intent to acquire Brown Technical Media Corp. to diversify its business interests and adjust its investment risk profile.


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.


News Article | February 28, 2017
Site: www.marketwired.com

SEATTLE, WA--(Marketwired - Feb 28, 2017) - CFN Media Group ("CannabisFN"), the leading creative agency and digital media network dedicated to legal cannabis, announces publication of an article discussing the initiation of Tetra Bio-Pharma Inc.'s ( : GRPOF) ( : TBP) clinical trial in Canada and the company's goals in the United States, especially in light of recent comments by the White House press secretary. Tetra Bio-Pharma recently announced that the Therapeutic Products Directorate ("TPD") of Health Canada approved its Phase I clinical study of PPP001 covering smoked cannabis for the management of uncontrolled pain in cancer and AIDS patients. The announcement was followed one week later by the beginning of the trial, as Tetra was clearly ready to get going. The trial is a first study approved that could eventually lead to approval of the product as a prescription drug. The study assesses single and 7-day multiple daily ascending doses of smoked cannabis on the cognitive function in healthy adults. It is the first development program aiming to obtain prescription drug approval and government provided insurance coverage for medical marijuana patients. If successful, the approval would set Tetra apart from all other medical marijuana providers who cannot get government provided insurance coverage and reimbursement for their patients. This could prove to be a major value driver for the company, as the lack of reimbursement is a serious obstacle for many patients seeking treatment. Tetra Bio-Pharma also recently completed a pre-IND meeting with the United States Food & Drug Administration ("FDA") Division of Anesthesia, Analgesia, and Addiction Products ("DAAAP") Center for Drug Evaluation and Research ("CDER") in late-January. During the meeting, the FDA provided guidance on the design of Phase I clinical trials and the overall program, while validating that the company was on the right track. Last week, White House press secretary Sean Spicer indicated that the federal government could be expected to step up enforcement of federal recreational cannabis laws, presumably in the face of various state laws permitting recreational use. The comment caused widespread concern in the industry. Whether the comment results in action or not, investors should note that development of cannabinoid based drugs should not be affected as it has nothing to do with recreational legalization. Additionally, Mr. Spicer reinforced the idea that the current administration is supportive of medical marijuana use. Please follow the link to read the full article: http://www.cannabisfn.com/tetra-bio-pharma-begins-clinical-trials/ Learn how to become a CFN Media client company, brand or entrepreneur: http://www.cannabisfn.com/become-featured-company/ Download the CFN Media iOS mobile app to access the world of cannabis from the palm of your hand: https://itunes.apple.com/us/app/cannabisfn/id988009247?ls=1&mt=8 Or visit our homepage and enter your mobile number under the Apple App Store logo to receive a download link text on your iPhone: http://www.cannabisfn.com CFN Media (CannabisFN), the leading creative agency and media network dedicated to legal cannabis, helps marijuana businesses attract investors, customers (B2B, B2C), capital, and media visibility. Private and public marijuana companies and brands in the US and Canada rely on CFN Media to grow and succeed. CFN launched in June of 2013 to initially serve the growing universe of publicly traded marijuana companies across North America. Today, CFN Media is also the digital media choice for the emerging brands in the space. Except for the historical information presented herein, matters discussed in this release contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Emerging Growth LLC, which owns CFN Media and CannabisFN.com, is not registered with any financial or securities regulatory authority, and does not provide nor claims to provide investment advice or recommendations to readers of this release. Emerging Growth LLC may from time to time have a position in the securities mentioned herein and may increase or decrease such positions without notice. For making specific investment decisions, readers should seek their own advice. Emerging Growth LLC may be compensated for its services in the form of cash-based compensation or equity securities in the companies it writes about, or a combination of the two. For full disclosure please visit: http://www.cannabisfn.com/legal-disclaimer/.


SAINT-LAURENT, QUEBEC--(Marketwired - Feb. 9, 2017) - IntelGenx Corp. ("IntelGenx"), (TSX VENTURE:IGX)(OTCQX:IGXT) and Tetra Bio-Pharma Inc. ("Tetra") (CSE:TBP)(OTC PINK:GRPOF), 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. Tetra Bio-Pharma is a multi subsidiary publicly traded company (CSE:TBP)(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. IntelGenx is a leading oral drug delivery company primarily focused on the development and manufacturing of innovative pharmaceutical oral films based on its proprietary VersaFilm™ 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 VersaFilm™ 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. This document may contain forward-looking information about IntelGenx' operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx' plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words "may," "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates," "could," "would," and similar expressions. All forward looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx' actual results could differ materially from those expressed or implied by these forward looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading "Risk Factors" in IntelGenx' annual report on Form 10-K, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities and www.sedar.com. IntelGenx assumes no obligation to update any such forward-looking statements. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange), nor the OTCQX accepts responsibility for the adequacy or accuracy of this release. Source: IntelGenx Technologies Corp.


News Article | November 22, 2016
Site: www.prweb.com

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) is establishing a public docket to collect comments related to a proposed Study Data Standardization Plan (SDSP) template. As part of the FDA’s on going collaboration with PhUSE, an independent, non-profit consortium addressing computational science issues, the SDSP template was developed by a PhUSE computational science working group. The purpose of the review is to evaluate the template and determine whether the FDA will recommend its use, either as it is, or in a modified form, for regulatory submissions of study data. The FDA invites public comment on all aspects of the SDSP template. To ensure all comments are considered as part of the review, they should be submitted before 9th January 2017. The FDA is a participating member of PhUSE. As part of this collaboration, PhUSE Working Groups develop and periodically publish proposals for enhancing the review and analysis of human and animal study data submitted to regulatory agencies. To find out more about PhUSE CS Working Groups visit http://www.phuse.eu/cs-working-groups.aspx. The CS Working Groups meet annually at the PhUSE Computational Science Symposium (CSS) in Silver Spring, MA. The 6th annual CSS, to be held 19th to 21st March 2017, will once again bring together FDA, PhUSE and industry in this unique collaborative event, to address computational science needs in support of regulatory review and ultimately bring safe and effective products to those who need them. This work will continue, later in the year, at the PhUSE European CSS to be held in London from 19th to 20th June 2017. Previous work has included the creation of a Nonclinical Study Data Reviewer’s Guide Template and the formation of a Statistical Computing Environment project to align industry requirements. Learn more about the CSS conferences at http://www.phuse.eu/CSS.aspx. PhUSE is a non-profit, volunteer-supported community of professionals, passionate about the advancement of clinical data science. It provides the industry with the premier platform for creating and sharing ideas, tools and standards around data and statistical reporting technologies. Since its inception, PhUSE has expanded from a single conference for European Statistical Programmers to a global platform for the discussion of topics encompassing the work of data managers, biostatisticians, statistical programmers and clinical data scientists.

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