IntelGenx Announces Organizational Changes to Support Global Growth Strategy
IntelGenx Technologies Corp. (TSX:IGX)(OTCQB:IGXT) announced major changes to its management team following the retirement of founder and CEO Horst G. Zerbe. Dwight Gorham has been appointed as the new CEO, with previous roles at Pillar 5 Pharma and Pharmascience. The FDA has set a PDUFA goal date of April 17, 2023, for the review of IntelGenx's RIZAFILM® NDA, and an ANDA for the Buprenorphine Buccal Film due April 28, 2023. Other key appointments include Dr. David Kideckel as Head of Corporate Development and Tommy Kenny as Senior Vice President, General Counsel. These leadership changes are aimed at enhancing the company's growth and preparing for the potential commercialization of its proprietary oral film products.
- Appointment of Dwight Gorham as new CEO, expected to drive growth.
- FDA PDUFA goal date of April 17, 2023, for RIZAFILM® review.
- Potential commercialization of RIZAFILM® and Buprenorphine Buccal Film in 2023.
- None.
SAINT LAURENT, Quebec, April 13, 2023 (GLOBE NEWSWIRE) -- IntelGenx Technologies Corp. (TSX:IGX)(OTCQB:IGXT) (the "Company" or "IntelGenx") today announced various changes to its management team. Following the planned retirement of its founder and CEO, Horst G. Zerbe, PhD, the new executive leadership team is designed to support its continued global growth as a leading CDMO for oral films and transdermal products, and in particular, to further prepare it for the potential commercialization of RIZAFILM® VersaFilm®, a proprietary oral thin film formulation of rizatriptan benzoate (active ingredient in Merck & Co.'s Maxalt®), and Buprenorphine Buccal Film, a generic version of Belbuca® (buprenorphine buccal film), in the United States.
The U.S. Food and Drug Administration (“FDA”) has assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 17, 2023 for completion of the review of IntelGenx’s RIZAFILM® 505(b)(2) new drug application (NDA), as well as a Generic Drug User Fee Act (GDUFA) date of April 28, 2023 for the review of an abbreviated new drug application (ANDA) for Buprenorphine Buccal Film, filed by the product’s co-developer, Chemo Research SL, through its agent and affiliate, Xiromed LLC. IntelGenx is looking forward to the commercialization of both product candidates, pending positive FDA decisions, as soon as is practicable.
Dwight Gorham has been appointed as Chief Executive Officer, effective immediately. He succeeds Dr. Zerbe, who has retired from his position as CEO, but will continue to serve as Chairman of IntelGenx’s Board of Directors.
Mr. Gorham has an accomplished history of senior leadership success in the life sciences industry. In an executive management career spanning more than three decades, he most recently served as President and CEO of Pillar 5 Pharma Inc. (“Pillar 5”), a pharmaceutical contract manufacturing organization (“CMO”) with a specialty in sterile ophthalmic products. Before joining Pillar 5 in 2015, he served as Senior Vice President and General Manager Global Operations of Pharmascience Inc., a leading Canadian generic drug company with an international presence in over 60 countries. Prior to that, he held a variety of senior roles, including: President and CEO at Accucaps Industries Ltd., a leading North American Supplier of soft gelatin capsules to pharmaceutical, OTC, Nutritional, Health & Beauty, and Recreational markets; a variety of management assignments at the Burroughs Wellcome & Co. facility in Montreal, Quebec; President (Founding) of Draxis Pharma Inc., a CMO supplier of small volume parenteral and lyophilization products to the pharmaceutical industry; General Manager of Baker Cummings Ltd.; and Director of Operations at the Canadian arm of Glaxo plc (now GSK plc).
“I believe Dwight is exceptionally well-qualified to lead IntelGenx as we continue to advance our portfolio of innovative film products and product candidates,” said Dr. Zerbe. “He is a seasoned leader with an exceptional track record and reputation, who has helped nurture and build great product franchises and businesses. His experience brings not only a relevant depth of knowledge of pharmaceutical product development and commercialization, but also the leadership skills necessary to build upon IntelGenx’s market-leading position. While it has been a pleasure steering the Company to this pivotal stage, and I look forward to continuing to contribute to its success as Chairman, I am confident that I am passing the CEO torch into the right hands.”
"I am honored to succeed Horst, and energized by the opportunity to lead IntelGenx going forward,” commented Mr. Gorham. “As IntelGenx’s founding CEO, Horst led the Company with passion and integrity for 20 years, which has resulted in the great people, technologies and assets now in place. There is a unique opportunity to leverage the elegance, precision and clinical advantages of IntelGenx’s proprietary drug delivery platform. I look forward to working with the team to continue to develop and expand the product pipeline, accelerate commercial growth, and enhance value for our shareholders.”
Andre Godin, IntelGenx’s President and Chief Financial Officer, will continue in his current position, with overall responsibility for day-to-day operations, financial reporting and budgeting, as well as managing the Company's relationships and interactions with the investment community. He will now report to Mr. Gorham.
IntelGenx also welcomed David Kideckel, PhD, MBA, to its team in the newly created position of Head of Corporate Development and Strategic Alliances of IntelGenx Corp., the Company’s operating subsidiary. Dr. Kideckel brings over 15 years of business development, advisory, and capital markets experience to the Company. In 2021 he founded the Kideckel Advisory Group Inc., where he advised growth-oriented companies on business and corporate development, capital markets and overall strategic initiatives. Prior to that and in 2017, Dr. Kideckel was recruited from industry to capital markets to build healthcare and life sciences equity research franchises, most recently serving as Managing Director, Senior Institutional Equity Research Analyst at ATB Capital Markets Inc. His industry and business development experience spans several senior healthcare and biotechnology roles, including at Alexion Pharmaceuticals, Inc. (acquired by AstraZeneca plc), the world leader in rare diseases.
"At this important stage of our clinical, commercial and corporate development, we are thrilled to have attracted a candidate of David’s calibre to this key position,” said Mr. Godin. “His unique combination of industry, capital markets and finance experience should help drive shareholder value for IntelGenx as he spearheads an initiative to look for new business development opportunities, helps advance our existing portfolio, and assists with our investor relations program.”
Another organizational change announced today was the promotion of Tommy Kenny to the position of Senior Vice President, General Counsel of IntelGenx Corp. Since joining the Company in 2016, Mr. Kenny has held a number of progressive management positions; most recently serving as Vice President, Intellectual Property and Legal Affairs, General Counsel of IntelGenx Corp.
Finally, Karen Kalayajian, CPA, who was previously IntelGenx’s Senior Director, Corporate Services and Corporate Controller, has now taken on additional responsibilities as Vice President, Finance of IntelGenx Corp. Reporting to Mr. Godin, she will be responsible for financial reporting, planning, treasury and taxation. Prior to joining IntelGenx, Ms. Kalayajian was Director of Finance of Neptune Technologies & Bioresources Inc. Previously, she held a series of progressive audit manager positions at Raymond Chabot Grant Thornton and WSBG.
"Assuming positive FDA decisions in the near-future, we will be entering a stage of anticipated rapid growth," concluded Dr. Zerbe. "Importantly, with these management changes following my retirement as CEO, we have a leadership team that is optimally structured to support both our current business and the successful execution of our long-term strategy.”
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®, DisinteQ™, VetaFilm™ and transdermal VevaDerm™, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offers 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 Information and 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. 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. IntelGenx assumes no obligation to update any such forward-looking statements.
Source: IntelGenx Technologies Corp.
For IntelGenx:
Stephen Kilmer
Investor Relations
(647) 872-4849
stephen@kilmerlucas.com
Or
Andre Godin, CPA, CA
President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
andre@intelgenx.com
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