RedHill Biopharma Strengthens Partnership with Cosmo Pharmaceuticals with Manufacturing Agreements for Movantik and RHB-204
"Movantik is currently our biggest commercial product. This agreement strengthens our qualified supply base and capacity moving forward and solidifies our ongoing strategic relationship with Cosmo," said
"We are happy to strengthen our partnership with RedHill with the manufacturing of these two important products and therefore to further expand Cosmo's production capacities and capabilities," said
Movantik is the leading prescribed oral peripherally acting mu-opioid receptor antagonist (PAMORA) in the
RHB-204 is an investigational proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin, and clofazimine, developed as a stand-alone first-line treatment for pulmonary NTM disease caused by Mycobacterium avium Complex (MAC). Although rare, the incidence and prevalence of pulmonary NTM disease are increasing in many areas of the world. There were an estimated 110,000 pulmonary NTM disease patients in the
About RedHill Biopharma
About Cosmo Pharmaceuticals
Cosmo is a specialty pharmaceutical company focused on developing and commercializing products to treat selected gastrointestinal disorders and improve endoscopy quality measures through aiding the detection of colonic lesions. Cosmo has also developed medical devices for endoscopy and has recently entered into a partnership with Medtronic for the global distribution of GI Genius™ its artificial intelligence device for use in coloscopies and GI procedures. Cosmo has licensed Aemcolo® to
Important Safety Information About Movantik
Movantik® (naloxegol) is contraindicated in:
- Patients with known or suspected gastrointestinal (GI) obstruction and patients at risk of recurrent obstruction, due to the potential for GI perforation.
- Patients receiving strong CYP3A4 inhibitors (eg, clarithromycin, ketoconazole) because these medications can significantly increase exposure to naloxegol which may precipitate opioid withdrawal symptoms.
- Patients with a known serious or severe hypersensitivity reaction to Movantik or any of its excipients.
Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning, occurred in patients treated with Movantik. Patients receiving methadone as therapy for their pain condition were observed in the clinical trials to have a higher frequency of GI adverse reactions that may have been related to opioid withdrawal than patients receiving other opioids. Patients with disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia. These patient (eg, multiple sclerosis, recent brain injury, Alzheimer's disease, and uncontrolled epilepsy) were not enrolled in the clinical studies. Take into account the overall risk-benefit profile when using Movantik in such patients. Monitor for symptoms of opioid withdrawal when using Movantik in such patients.
Severe abdominal pain and/or diarrhea have been reported, generally within a few days of initiation of Movantik. Monitor and discontinue if severe symptoms occur. Consider restarting Movantik at 12.5 mg once daily.
Cases of GI perforation have been reported with the use of peripherally acting opioid antagonists, including Movantik. Post marketing cases of GI perforation, including fatal cases, were reported when Movantik was used in patients at risk of GI perforation (eg, infiltrative gastrointestinal tract malignancy, recent gastrointestinal tract surgery, diverticular disease including diverticulitis, ischemic colitis, or concomitantly treated with bevacizumab). Monitor for severe, persistent, or worsening abdominal pain; discontinue if this symptom develops.
The most common adverse reactions with Movantik as compared to placebo in clinical trials were: Abdominal pain (21% vs 7%), diarrhea (9% vs 5%), nausea (8% vs 5%), flatulence (6% vs 3%), vomiting (5% vs 4%), headache (4% vs 3%), and hyperhidrosis (3% vs <1%).
Movantik® (naloxegol) is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g. weekly) opioid dosage escalation.
You are encouraged to report Adverse Reactions to
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, including without limitation, the risk that the agreement with Cosmo will not provide high-quality manufacturing capacity for Movantik® and RHB-204 or be sufficient to meet market demands, as well as other 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, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (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 and type 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 risk that the Company will not succeed to complete the patient recruitment; the risk that the Company will not receive the relevant data required for benefiting from the Fast Track designation; the risk that the
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 Crockett, Seth D., et al.
 Henkle E, et al. Population-based Incidence of Pulmonary Nontuberculous Mycobacterial Disease in
 Foster|Rosenblatt, 2017.
 Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.
 Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.
 Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.
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