- RedHill and Concordia recently entered into an exclusive co-promotion agreement, granting RedHill certain promotion
rights in the U.S. for Donnatal®
- RedHill expects to initiate promotion of Donnatal® in the second quarter of 2017
TEL-AVIV, Israel, March 07, 2017 (GLOBE NEWSWIRE) -- 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®, 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® drug.
In January 2017, RedHill announced an exclusive co-promotion agreement with a subsidiary1 of
Concordia, granting RedHill certain promotional rights in the U.S. for Donnatal®. RedHill expects to initiate promotion
of Donnatal® 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® brand and should serve as notice to any other company marketing an illegal copy of
Donnatal® that the judicial system in the U.S. will hold them financially accountable for such actions.
Donnatal® (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®:
Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide), a prescription
drug, is classified as possibly effective as an adjunctive therapy in the treatment of irritable bowel syndrome (irritable
colon, spastic colon, mucous colitis) and acute enterocolitis. Donnatal® slows the natural movements of the gut by
relaxing the muscles in the stomach and intestines and acts on the brain to produce a calming effect. Donnatal® comes in
two formulations: immediate release Donnatal® Tablets and immediate release Donnatal® Elixir, a
fast-acting liquid.
Donnatal® 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®. 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®: http://www.donnatal.com/professionals/important-safety-information/
About Concordia:
Concordia is a diverse, international specialty pharmaceutical company focused on generic and legacy pharmaceutical products. The
company has an international footprint with sales in more than 90 countries, and has a diversified portfolio of more than 200
established, off-patent products. Concordia also markets orphan drugs through its Orphan Drugs Division, consisting of
Photofrin® for the treatment of certain rare forms of cancer. Concordia operates out of facilities
in Oakville, Ontario and, through its subsidiaries, operates out of facilities in Bridgetown, Barbados; London,
England and Mumbai, India.
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) is a specialty biopharmaceutical company headquartered in Israel, primarily
focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for
the treatment of gastrointestinal and inflammatory diseases and cancer. RedHill has a U.S. co-promotion agreement with Concordia
for Donnatal®, a prescription oral adjunctive drug used in the treatment of IBS and acute
enterocolitis. RedHill’s clinical-stage pipeline includes: (i) RHB-105 - an oral combination
therapy for the treatment of Helicobacter pylori infection with successful results from a first Phase III study; (ii)
RHB-104 - an oral combination therapy for the treatment of Crohn's disease with an ongoing first
Phase III study, a completed proof-of-concept Phase IIa study for multiple sclerosis and QIDP status for nontuberculous
mycobacteria (NTM) infections; (iii) BEKINDA® (RHB-102) - a
once-daily oral pill formulation of ondansetron with an ongoing Phase III study for acute gastroenteritis and gastritis and an
ongoing Phase II study for IBS-D; (iv) RHB-106 - an encapsulated bowel preparation licensed to
Salix Pharmaceuticals, Ltd.; (v) YELIVA® (ABC294640) - a Phase II-stage,
orally-administered, first-in-class SK2 selective inhibitor targeting multiple oncology, inflammatory and gastrointestinal
indications; (vi) MESUPRON - a Phase II-stage first-in-class, orally-administered protease inhibitor, targeting
pancreatic cancer and other solid tumors and (vii) RIZAPORT® (RHB-103) - an oral thin film formulation
of rizatriptan for acute migraines, with a U.S. NDA currently under discussion with the FDA and marketing authorization received in
Germany in October 2015. More information about the Company is available at: www.redhillbio.com.
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®, (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.
2 Donnatal® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate,
Scopolamine Hydrobromide) is a prescription drug, classified as possibly effective as an adjunctive therapy in the treatment
of irritable bowel syndrome (irritable colon, spastic colon, mucous colitis) and acute enterocolitis. For more information,
please see the prescribing information: http://www.donnatal.com/wp-content/uploads/2015/02/2015-02-18-Risk-Benefit-information-DTC-REV.-SE.pdf.
Company contact: Adi Frish Senior VP Business Development & Licensing RedHill Biopharma +972-54-6543-112 adi@redhillbio.com IR contact (U.S.): Marcy Nanus Senior Vice President The Trout Group +1-646-378-2927 Mnanus@troutgroup.com
