RedHill Biopharma Ltd.
RedHill Biopharma’s Co-Promotion Partner Concordia Announces U.S. District Court Grants Treble Damages Relating to Donnatal(R)
DGAP-News: RedHill Biopharma Ltd. / Key word(s): Miscellaneous RedHill Biopharma’s Co-Promotion Partner Concordia Announces U.S. District Court Grants Treble Damages Relating to Donnatal(R)
TEL-AVIV, Israel, March 7, 2017 RedHill Biopharma Ltd. (NASDAQ: RDHL) (TASE: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today updated that Concordia International Corp. (NASDAQ: CXRX) (TSX: CXR) (“Concordia”), RedHill’s co-promotion partner for the gastrointestinal drug Donnatal(R), announced that a U.S. district court granted a Concordia subsidiary treble damages related to false claims made by Method Pharmaceuticals, LLC (“Method”) and its principal owner. According to Concordia’s announcement, the court awarded Concordia treble damages of $2.2 million, an increase from the original damages award of $733,000, concluding that Method willfully engaged in false advertising under the Lanham Act by falsely listing the product on pharmaceutical databases, and asserting that its medication was a legal generic alternative to Concordia’s Donnatal(R) drug. In January 2017, RedHill announced an exclusive co-promotion agreement with a subsidiary[1] of Concordia, granting RedHill certain promotional rights in the U.S. for Donnatal(R). RedHill expects to initiate promotion of Donnatal(R) in the second quarter of 2017. Concordia stated that it believes that the treble damages awarded by the U.S. court further vindicates their marketing rights of the Donnatal(R) brand and should serve as notice to any other company marketing an illegal copy of Donnatal(R) that the judicial system in the U.S. will hold them financially accountable for such actions. Donnatal(R) (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) is a prescription oral drug used with other drugs in the treatment of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis (inflammation of the small bowel)[2]. About Donnatal(R): Donnatal(R) is contraindicated in patients who have glaucoma, obstructive uropathy, obstructive disease of the gastrointestinal tract, paralytic ileus, unstable cardiovascular status, severe ulcerative colitis, myasthenia gravis, hiatal hernia with reflux esophagitis, or known hypersensitivity to any of the ingredients. Patients who are pregnant or breast-feeding or who have autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac arrhythmias, tachycardia or hypertension should notify their doctor before taking Donnatal(R). Side effects may include: dryness of the mouth, urinary retention, blurred vision, dilation of pupils, rapid heartbeat, loss of sense of taste, headache, nervousness, drowsiness, weakness, dizziness, insomnia, nausea, vomiting and allergic reactions which may be severe. Further information, including prescribing information, can be found on www.donnatal.com. Please see the following website for important safety information about Donnatal(R): http://www.donnatal.com/professionals/important-safety-information/ This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’s ability to successfully market Donnatal(R), (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company’s ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and of the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; and (xii) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xiii) competitive companies and technologies within the Company’s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on February 23, 2017. All forward-looking statements included in this Press Release are made only as of the date of this Press Release. We assume no obligation to update any written or oral forward-looking statement unless required by law.
[1] Concordia Pharmaceuticals Inc.
07.03.2017 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG. |