EDITOR: | November 22nd, 2016 | 4 Comments

IntelGenX changing delivery of famous erectile dysfunction drug

| November 22, 2016 | 4 Comments
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intelgenxIntelGenX Technologies Corp. (TSXV: IGX | OTCQX: IGXT) announced the signing of a binding term sheet for a license to use Tadafil ED, which IntelGenX is integrating into its roster of VersaFilm™ products.

Like taking a Listerine film to freshen your breath.

Investors should take notice. VersaFilm™ is a drug delivery platform technology that enables the development of oral thin films, improving product performance:

  • Rapid disintegration without the need for water
  • Quicker buccal or sublingual absorption
  • Potential for faster onset of action and increased bioavailability
  • Potential for reduced adverse effects by bypassing first-pass metabolism
  • Easy administration for patients who have problems in swallowing: pediatric, geriatric, fear choking and/or suffering from nausea (e.g., nausea resulting from chemotherapy, radiotherapy or any surgical treatment)
  • Pleasant taste
  • Small and thin size, making it convenient for consumers
  • Can be used for veterinary applications

Subject to U.S. Food and Drug Administration (FDA) approval, this license allows IntelGenx to commercialize its Tadalafil ED VersaFilm™ product in the U.S.

IntelGenx has developed a proprietary process and formulation for manufacturing the Tadalafil ED VersaFilm™ product and plans to manufacture the product for multiple markets around the world.

IntelGenx plans to file Tadalafil VersaFilm™ 505(b)(2) NDA with the U.S. FDA in the second quarter of 2017 and expects a U.S. launch of the Tadafil ED product upon approval, in the second quarter of 2018.

The IntelGenx delivery system should trigger some excitement among ED patients who suffer upset stomach and diarrhea after buccal Tadafil as
sublingual delivery using IntelGenX’s film should eliminate these symptoms.

IntelGenx Tadalafil film formulations have been tested in various clinical trials to improve the pharmacokinetics and optimize the formulation. The latest formulation successfully demonstrated bioequivalence to Tadafil brand tablet in a pilot study.

Tadalafil VersaFilm™ now has the potential to be the first generic competitor to the Tadafil brand tablet and the only film delivery product of the blockbuster ED drug product.

On November 11, IntelGenX reported on Q3 financials. Total revenues for the three-month period ended September 30, 2016 amounted to $1.8 million, representing a decrease of $564 thousand or 24% compared to $2.4 million for the three-month period ended September 30, 2015. The decrease for the three-month period ended September 30, 2016 compared to the last year’s corresponding period is mainly attributable to a decrease in royalties of $248 thousand as well as a decrease in milestone revenues of $1.7 million and a decrease in deferred license revenues of $409 thousand, offset by an increase in upfront and deferred revenue on monetization of $1.8 million. Going forward, the royalty revenue should diminish due to the Company’s strategic decision to monetize the royalty on future sales of Forfivo XL®.

Operating costs and expenses were $1.7 million for the three-month period ended September 30, 2016 compared to $1 million for the corresponding period of 2015. The increase for the three-month period ended September 30, 2016 is mainly attributable to an increase in Research and Development expenses of $114 thousand and Selling, General and Administrative of $519 thousand. The increase in expenses relates to the investment into additional hiring’s to strengthen IntelGenx’s team as it executes its strategic plan to establish its state-of-the-art manufacturing facility.

For the third quarter of 2016, the Company generated operating income of $88 thousand compared to operating income of $1.4 million for the comparable period of 2015.


Dr. Luc Duchesne

Editor:

Dr. Luc C. Duchesne is a Speaker and Author with a PhD in Biochemistry. With three decades of scientific and business experience, he has published ... <Read more about Dr. Luc Duchesne>


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Comments

  • Tracy Weslosky

    Great column Dr. D.! Note however that I was scratching my head on “What is tadalafil?” After all – ED meds are not in my cabinet, having the luxury of being a woman…

    So here it is…drum role…”Tadalafil relaxes muscles found in the walls of blood vessels and increases blood flow to particular areas of the body.

    Tadalafil under the name of Cialis is used to treat erectile dysfunction (impotence) and symptoms of benign prostatic hypertrophy (enlarged prostate). Another brand of tadalafil is Adcirca, which is used to treat pulmonary arterial hypertension and improve exercise capacity in men and women.

    Do not take Cialis while also taking Adcirca, unless your doctor tells you to.”

    Well this is certainly exciting for IntelGenX as this must be a substantial market! Congrats to IntelGenX and their team….I have interviews scheduled with management tomorrow!

    November 22, 2016 - 4:58 PM

  • Dan

    “Tadalafil VersaFilm™ now has the potential to be the first generic competitor to the Tadafil brand tablet and the only film delivery product of the blockbuster ED drug product.”

    The above is incorrect as MonoSol RX has Tadalafil in a thin film as well that is late stage clinical trials

    November 22, 2016 - 8:52 PM

  • Edward Miller

    Dear Dan, the statement above claiming we have the potential to be the first is most accurate. The Tadalafilm VersaFilm has achieved bioequivalence and has been granted the first and only license by Lilly. How can you not see the real competitive advantages IntelGenx has compared to other competitors?
    Regards,
    Edward Miller, Director IR, IntelGenx.

    November 23, 2016 - 9:24 AM

  • Myron Zalucky,DDS

    Perhaps wouldn’t it be more appropriate to have a mans face in the picture “IntelGenX changing delivery of famous erectile dysfunction drug”

    Just a thought ?

    November 24, 2016 - 10:02 AM

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