SAINT LAURENT, Quebec, April 13, 2023 (GLOBE NEWSWIRE) — IntelGenx Applied sciences Corp. (TSX:IGX)(OTCQB:IGXT) (the “Firm” or “IntelGenx”) at present introduced a number of modifications to its administration crew. Following the deliberate retirement of its founder and CEO, Horst G. Zerbe, PhD, the brand new government management crew is designed to help its continued world development as a number one CDMO for oral movies and transdermal merchandise and, specifically, additional put together it for the potential commercialization of RIZAFILM® VersaFilm®, a proprietary thin-film oral formulation of rizatriptan benzoate (energetic ingredient in Merck & Co.’s Maxalt®), and Buprenorphine Buccal Movie, a generic model of Belbuca® (buccal movie buprenorphine), in the USA.
The US Meals and Drug Administration (“FDA”) has assigned a Prescription Drug Person Payment Act (PDUFA) goal date of April 17, 2023 for completion of the RIZAFILM® 505(b)(2) New Drug Utility overview by IntelGenx (NDA), in addition to a Generic Drug Person Payment Act (GDUFA) date of April 28, 2023 for overview of an Abbreviated New Drug Utility (ANDA) for Buprenorphine Buccal Movie, submitted by product co-developer, Chemo Analysis SL, by its agent and affiliate, Xiromed LLC. IntelGenx appears ahead to commercialization of each product candidates, pending constructive choices from the FDA, as quickly as potential.
Dwight Gorham has been named chief government officer, efficient instantly. He succeeds Dr. Zerbe, who retired from his place as CEO, however will proceed to function chairman of the board of IntelGenx.
Mr. Gorham has an extended and profitable historical past of senior management within the life sciences business. In an government management profession spanning greater than three a long time, he most lately served as President and CEO of Pillar 5 Pharma Inc. (“Pillar 5”), a pharmaceutical contract manufacturing group (“CMO”) with a specialty in sterile ophthalmic merchandise. Previous to becoming a member of Pillar 5 in 2015, he served as Senior Vice President and Common Supervisor International Operations of Pharmascience Inc., a number one Canadian generics firm with a global presence in over 60 international locations. Beforehand, he held a wide range of senior roles, together with: President and CEO at Accucaps Industries Ltd., a number one North American provider of sentimental gelatin capsules to the pharmaceutical, OTC, dietary, well being and sweetness, and leisure markets; a sequence of administration positions at Burroughs Wellcome & Co. in Montreal, Quebec; President (founder) of Draxis Pharma Inc., a CMO provider of small volumes of parenteral and lyophilization merchandise to the pharmaceutical business; Common Supervisor of Baker Cummings Ltd.; and Director of Operations on the Canadian division of Glaxo plc (now GSK plc).
“I imagine Dwight is exceptionally properly certified to guide IntelGenx as we proceed to advance our portfolio of modern movement image merchandise and product candidates,” mentioned Dr. Zerbe. “He’s a seasoned chief with an impressive monitor file and repute, who has helped nurture and construct giant product franchises and companies. His expertise brings not solely in-depth data of pharmaceutical product improvement and commercialization, but in addition the management expertise wanted to develop IntelGenx’s market-leading place. Whereas it has been a pleasure to guide the Firm by this pivotal part and I stay up for persevering with to contribute to his success as President, I’m assured that we are going to go the CEO torch into the fitting arms.”
“I’m honored to succeed Horst and energized by the chance to guide IntelGenx going ahead,” Gorham commented. , applied sciences and sources now in place. There’s a distinctive alternative to leverage the magnificence, precision, and scientific advantages of IntelGenx’s proprietary drug supply platform. I stay up for working with the crew to proceed to develop and increase the product pipeline, speed up business development and enhance worth for our shareholders.”
Andre Godin, President and Chief Monetary Officer of IntelGenx, will proceed in his present place, with general duty for day-to-day operations, monetary reporting and budgeting, in addition to managing the Firm’s relationship and interactions with the funding group. He’ll now he’ll report back to Mr. Gorham.
IntelGenx additionally welcomed David Kideckel, PhD, MBA, to its crew within the newly created place of Head of Company Improvement and Strategic Alliances at IntelGenx Corp., the corporate’s working subsidiary. Dr. Kideckel brings greater than 15 years of expertise in enterprise improvement, consulting and capital markets to the corporate. In 2021, he based Kideckel Advisory Group Inc., the place he suggested growth-oriented corporations on enterprise and company improvement, capital markets, and general strategic initiatives. Beforehand and in 2017, Dr. Kideckel was recruited by business to capital markets to construct healthcare and life sciences fairness analysis franchises, most lately as managing director, senior institutional fairness analysis analyst at ATB Capital Markets Inc. His industrial and business improvement expertise spans a number of senior roles in healthcare and biotechnology, together with at Alexion Prescribed drugs, Inc. (acquired by AstraZeneca plc), a world chief in uncommon illnesses.
“At this essential stage in our scientific, business and company improvement, we’re thrilled to have attracted a candidate of David’s caliber to this key place,” mentioned Godin. drive shareholder worth for IntelGenx as he leads an initiative to hunt new enterprise improvement alternatives, assist advance our present portfolio, and help with our investor relations program.”
One other organizational change introduced at present was the promotion of Tommy Kenny to the place of Senior Vice President, Common Counsel of IntelGenx Corp. Since becoming a member of the Firm in 2016, Kenny has held a wide range of progressive administration positions; most lately as vice chairman, mental property and authorized affairs, common counsel of IntelGenx Corp.
Lastly, Karen Kalayajian, CPA, who beforehand served as Senior Director, Company Providers and Company Controller of IntelGenx, has now assumed extra duties as Vice President, Finance of IntelGenx Corp. Reporting to Godin, she will probably be accountable for monetary reporting, planning, treasury and taxation. Previous to becoming a member of IntelGenx, Ms. Kalayajian was the director of finance at Neptune Applied sciences & Bioresources Inc. Beforehand, she held a wide range of progressive audit supervisor positions at Raymond Chabot Grant Thornton and WSBG.
“Assuming constructive FDA choices within the close to future, we’ll enter a part of anticipated fast development,” concluded Dr. Zerbe. “Importantly, with these administration modifications following my retirement as CEO, we now have an optimally structured management crew to help each our present enterprise and the profitable execution of our long-term technique.”
IntelGenx is a number one drug distribution firm centered on the event and manufacturing of pharmaceutical movies.
IntelGenx’s superior movie applied sciences, together with VersaFilm®, DisinteQ™, VetaFilm™, and transdermal VevaDerm™, allow next-generation pharmaceutical merchandise that tackle unmet medical wants. The modern IntelGenx product pipeline delivers vital advantages to sufferers and physicians for a lot of therapeutic situations.
IntelGenx’s extremely expert crew offers complete pharmaceutical providers to pharmaceutical companions, together with analysis and improvement, analytical methodology improvement, scientific monitoring, mental property, and regulatory providers. IntelGenx’s state-of-the-art manufacturing facility affords full service by offering lab, pilot and business scale manufacturing. For extra data, go to www.intelgenx.com.
Ahead-Trying Info and Statements
This doc could comprise forward-looking details about IntelGenx’s working outcomes and enterprise prospects that contain substantial dangers and uncertainties. Statements that aren’t purely historic are forward-looking statements throughout the which means of Part 21E of the Securities Alternate Act of 1934, as amended, and Part 27A of the Securities Act of 1933, as amended. These statements embody, however will not be restricted to, statements about IntelGenx’s plans, targets, expectations, methods, intentions, or different characterizations of future occasions or circumstances and are typically recognized by the phrases “could”, “expects”, “anticipates”, ” intends “, ” plans “, ” believes “, ” seeks “, ” estimates “, ” may “, ” would really like ” and related expressions. All forward-looking statements are expressly certified of their entirety by this cautionary assertion. As a result of these forward-looking statements are topic to a lot of dangers and uncertainties, IntelGenx’s precise outcomes may differ materially from these expressed or implied by such forward-looking statements. Components that would trigger or contribute to such variations embody, however will not be restricted to, these mentioned beneath the heading “Danger Components” in IntelGenx’s annual report on Kind 10-Ok, filed with the U.S. Securities and Alternate Fee, and out there at www. sec.gov, and likewise filed with Canadian securities regulators at www.sedar.com. IntelGenx undertakes no obligation to replace any such forward-looking statements.
Supply: IntelGenx Applied sciences Corp.
Andre Godin, CPA, CA
President and CFO
Intel Genx Corp.
(514) 331-7440 ext. 203