Agreement expanded to include a portfolio of novel isotretinoin products
New portfolio royalty extends through December 2024
MISSISSAUGA, ON, July 30, 2018 /CNW/ - Cipher Pharmaceuticals Inc. (TSX:CPH) ("Cipher" or "the Company") today announced that it has amended its distribution and supply agreement (the "Amendment") with Sun Pharmaceutical Industries, Inc. ("Sun") (previously Ranbaxy Laboratories Inc.) for Absorica®, an innovative formulation of the active ingredient isotretinoin, which is used in the treatment of severe acne. Under the original agreement, entered in August 2008, Cipher granted Sun the exclusive right to market, sell and distribute Absorica in the United States ("U.S."). Absorica was launched in the U.S. market in November 2012.
Key highlights of the Amendment include:
- Provides Sun with the ability to launch new isotretinoin products developed by or on behalf of Sun in the U.S. prior to the expiration of the agreement in November 2022;
- Expands the agreement to include a royalty payable to Cipher until December 2024 based on U.S. net sales from Sun's isotretinoin product porfolio; and
- Absorica New Drug Application (NDA) will be returned to Cipher on expiry of the agreement in November 2022.
"Sun has been a strong partner on Absorica and we're pleased to reach an agreement on changes aimed at achieving our shared objective of continuing the marketing of Absorica and bringing innovative new isotretinoin products to the U.S. market," said Robert Tessarolo, President and CEO of Cipher. "This is a significant milestone for Cipher, providing the opportunity to maximize our total cumulative revenues from Absorica and other isotretinoin products. At the same time, we continue to execute our strategy to aggressively grow our Canadian commercial business. Based on transaction activity to date, we expect to add five new products from our existing pipeline to the Canadian commercial portfolio in 2018 and 2019."
*Absorica® is a registered Trademark of Sun Pharmaceutical Industries, Inc.
Certain statements in this release constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements in this press release include, without limitation, statements relating to: the anticipated strategic and/or financial benefits of the distribution and supply agreement, as amended, (the "Agreement") to Cipher including the expected impact on Cipher's revenue; the launch of new products by Sun and Cipher's ability to realize royalty revenue thereon; the impact on Cipher of the launch of generic competitors to Absorica; and anticipated launch of new products by Cipher and the anticipated timing thereof. Words such as "may", "would", "could", "should", "will", "anticipate", "believe", "plan", "expect", "intend", "potential" and similar expressions may be used to identify these forward-looking statements although not all forward-looking statements contain such words.
Forward-looking statements involve significant risks, uncertainties and assumptions. Many factors could cause actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including the inability of Cipher to achieve the anticipated strategic and/or financial benefits from the Agreement or it may take longer than expected to achieve those benefits; reliance on Sun for the marketing of products under the Agreement; and the risk of unexpected costs or liabilities relating to the Agreement. Further, additional risk factors that could cause actual results to differ materially from expectations can be found in the "Risk Factors" section of Cipher's Annual Information Form and in Cipher's Management's Discussion and Analysis of Operating Results and Financial Position for the year ended December 31, 2017 and/or for the three months ended March 31, 2018, and elsewhere in Ciphers's filings with Canadian securities regulators.
Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by this press release. These factors should be considered carefully and reader should not place undue reliance on the forward-looking statements. These forward-looking statements are made as of the date of this press release and, other than as required by law, Cipher does not intend to or assume any obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.
About Cipher Pharmaceuticals Inc.
Cipher (TSX:CPH) is a specialty pharmaceutical company with a robust and diversified portfolio of commercial and early to late-stage products. Cipher acquires products that fulfill unmet medical needs, manages the required clinical development and regulatory approval process, and markets those products either directly in Canada or indirectly through partners in Canada, the U.S., and South America. Cipher is focused on a three-pronged growth strategy – including acquisitions, in-licensing, and selective investments in drug development – to assemble a broad portfolio of prescription products that serve unmet medical needs. For more information, visit www.cipherpharma.com.
SOURCE Cipher Pharmaceuticals Inc.
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