IntelGenx Technologies Corp. (TSX V:IGX)(OTCQX:IGXT) (the “Company” or “IntelGenx”), a leader in pharmaceutical films, today announced various initiatives aimed at helping the Company address, and satisfactorily respond to, the Complete Response Letter (“CRL”) that it recently received from the U.S. Food and Drug Administration (“FDA”) regarding its resubmitted 505(b)(2) New Drug Application for RIZAPORT® VersaFilm
SAINT LAURENT, Quebec, April 06, 2020 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSX V:IGX)(OTCQX:IGXT) (the “Company” or “IntelGenx”), a leader in pharmaceutical films, today announced various initiatives aimed at helping the Company address, and satisfactorily respond to, the Complete Response Letter (“CRL”) that it recently received from the U.S. Food and Drug Administration (“FDA”) regarding its resubmitted 505(b)(2) New Drug Application for RIZAPORT® VersaFilm®, as well as maintain IntelGenx’s financial stability in light of the current market environment and the challenges posed by the global COVID-19 pandemic.
“The decision by the FDA to issue a CRL for our RIZAPORT® NDA significantly reduces our internal revenue expectations for 2020. Additionally, the current COVID-19 crisis and its potential effect on the capital markets may make it more difficult to secure additional capital and the long-term financial stability of the Company,” commented Dr. Horst G. Zerbe, CEO of IntelGenx. “In order to address these issues, the Board and Management of the Company have decided to launch an aggressive performance improvement program that focusses on: (1) generating near-term revenue; (2) reducing staff headcount and implementing other measures to preserve the Company’s resources and extend its cash runway; (3) implementing organizational changes to strengthen various parts of IntelGenx’s business, including regulatory affairs and manufacturing operations; (4) comprehensively and satisfactorily responding to the CRL; (5) undertaking steps to accelerate the launch of RIZAPORT® in Spain and, subsequently, in other European countries; and (6), to the extent possible, working to mitigate the impact of the COVID-19 pandemic on the Company’s employees, customers and other stakeholders.”
Key components of the performance improvement program include:
Adjusted VersaFilm® Business Development Strategy
While IntelGenx’s business development strategy will continue to focus on partnering its current product pipeline, which includes 10 pharmaceutical oral film product candidates, and pursuing potential oral thin film manufacturing opportunities, in light of recent unforeseeable developments, the Company will also accelerate its focus to pursue short-term revenue generating opportunities by expanding its pipeline to include additional products for which there is not an FDA or Health Canada (“HC”) approval requirement. These include nutraceutical films, for which IntelGenx is already in active discussions with potential partners. Finally, the Company will continue to work with HC to finalize the review of its micro-processing license application. Once the micro-processing license is received, which IntelGenx currently expects to occur in April 2020, the Company will be able to commence commercial production of cannabis-infused VersaFilm® for its partner, Tilray®, with product sales anticipated to begin as soon as practicable thereafter.
“Rapidly disintegrating pharmaceutical oral film products provide tangible benefits for patients, such as improved efficacy due to better bioavailability, quicker onset of action and reduced side effects,” commented Dana Matzen, IntelGenx’s VP of Business and Corporate Development. “As many as 40% of American adults have experienced difficulty swallowing traditional tablets and capsules, making our VersaFilm® products an ideal solution, especially for pediatric and geriatric patients. Many of these attributes can be just as important in the nutraceutical space, which will now be an increased focus for the next few quarters, as we continue to build our product pipeline.”
Maintaining Financial Stability
As at December 31, 2019, IntelGenx had cash and short-term investments totalling $1.9 million, which the Company believes, together with the gross proceeds of C$8.2 million received from its February 2020 equity offering, are sufficient to fund planned operations into the fourth quarter of 2020. The Company has also taken immediate measures to reduce its burn rate by initially cutting 10% of its employee headcount, as well as decreasing non-essential expenses in all areas of its business. Additional cost reduction measures are being analysed in order to further extend the cash runway and may be implemented in the near future.
“While we deploy the funds received from our recent financing and anticipated near-term commercial activities, we will also work to further improve our overall cost structure, as well as pursue less dilutive funding opportunities to extend our cash runway,” commented Andre Godin, IntelGenx’s President and Chief Financial Officer. “We believe that these immediate measures will not affect our overall ability to execute on our business development strategy.”
Organizational Changes to Support Future Growth
Pursuant to IntelGenx’s revised business strategy, effective immediately, all product development and manufacturing functions, including R&D, regulatory affairs and operations, will be led by Dr. Zerbe, while Mr. Godin will have overall responsibility for all business functions, including finance and business development. In addition, the Company’s Board and management will immediately conduct a comprehensive review of all functions and reporting relationships in order to determine what, if any, management structural and personnel changes or additions are necessary to help ensure the Company’s future success in these new circumstances.
“It is vital that our Company is optimally staffed and structured to support both our current business and the successful execution of key new initiatives,” concluded Dr. Zerbe. “Indeed, we are determined to build a stronger and more nimble organization.”
Planned RIZAPORT® CRL Response
As previously announced, the March 2020 CRL states that the FDA could not approve the application in its present form. The Agency requested additional information, but no new bioequivalence study. IntelGenx plans to request a meeting with the FDA to discuss the CRL comments, with the goal of obtaining needed clarification and determining next steps.
“We believe that we adequately addressed the questions and concerns outlined in the FDA’s April 2019 CRL in our NDA resubmission. This most recent CRL contains questions and concerns that are sufficiently different from those raised in the April 2019 CRL, such that we could not have reasonably anticipated the FDA’s most recent decision,” said Dr. Zerbe. “That said, we remain committed to working closely with the FDA to get the application approved as soon as possible. We will continue to inform our shareholders in a timely manner of any new developments in this important program.”
Planned Launch of RIZAPORT® in Spain
As previously announced, the Company has established a partnership with Exeltis Healthcare for the commercialization of RIZAPORT® in Spain and potentially other European countries. While IntelGenx was initially pursuing a manufacturing site change with the intent to supply the product from its Canadian manufacturing facility, it is now, together with Exeltis Healthcare, in advanced discussions with the originally listed contract manufacturing organization, which the Spanish marketing authorization lists as the approved manufacturer of the product, to leave the commercial production at its site.
“This should result in a much earlier product launch in Spain and, potentially, other countries in Europe,” commented Dr. Zerbe. “Manufacturing for the U.S. and certain other markets, however, will continue to be performed at the Company’s GMP compliant production facility in Montreal.”
Impact of COVID-19
IntelGenx has informed its employees, business partners and key stakeholders about immediate steps it has taken to manage potential health and business risks. These include proactive, precautionary measures, such as working from home when possible, freezing all non-essential travel, and switching to virtual sales and business meetings only, with the goal of keeping everyone safe. To help protect the well-being of its shareholders, Board and Management, the Company is also exploring the possibility of hosting its Annual General Meeting, which is scheduled to take place on Tuesday, May 12, 2020, via a virtual meeting instead of in-person.
With respect to the impact of the COVID-19 pandemic on IntelGenx’s product development programs, the most immediate change will be to subject enrolment in the ongoing Montelukast VersaFilm® Phase 2a (“BUENA”) clinical trial in patients with mild to moderate Alzheimer’s Disease (“AD”). Because the target study population in the BUENA study is considered to be a higher risk group for severe illness from COVID-19, and out of concern for the health and safety of clinical trial staff, IntelGenx has informed HC that the study is on a temporary recruitment hold.
“We are closely monitoring the situation and will resume enrolment under our amended protocol, which enables us to continue the BUENA trial at an increased daily dose, as soon as practicable,” said Dr. Zerbe. “We also continue to evaluate the trial’s expansion to the United States via a potential IND filing with the FDA at the appropriate time.”
About IntelGenx
IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.
IntelGenx’s superior film technologies, including VersaFilm®, VetaFilm™ and transdermal, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offer significant benefits to patients and physicians for many therapeutic conditions.
IntelGenx’s highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx’s state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit www.intelgenx.com.
Forward Looking Statements:
This document may contain forward-looking information about IntelGenx’s 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’s 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, including, without limitation, anticipated commencement of commercial production of cannabis-infused VersaFilm® and how long operations can be funded based on current assets. 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’s 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’s 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 at www.sedar.com. In addition, there is uncertainty about the spread of the COVID-19 virus and the impact it will have on IntelGenx’s operations, the demand for its products, global supply chains and economic activity in general. IntelGenx assumes no obligation to update any such forward-looking statements.
Each of the TSX Venture Exchange and OTCQX has neither approved nor disapproved the contents of this press release. 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 this release.
Source: IntelGenx Technologies Corp.
For IntelGenx:
Stephen Kilmer
Investor Relations
(514) 331-7440 ext 232
stephen@intelgenx.com
Or
Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
andre@intelgenx.com
