RedHill Biopharma Completes Acquisition of Movantik® from AstraZeneca
“We are expanding the promotion of Movantik® with our current sales force of approximately 100 sales representatives. Given the excellent work that AstraZeneca has done to date, we expect a smooth transition of all commercial activities. We are excited for the opportunity to grow the call points for Movantik® and offer more patients this preferred treatment for opioid-induced constipation,” said
Movantik® is the first oral peripherally acting mu-opioid receptor antagonist (PAMORA) approved in the
SVB Leerink acted as exclusive financial advisor and
Movantik® is a proprietary once-daily oral PAMORA approved by the
About Opioid-Induced Constipation (OIC)
OIC is a condition caused by prescription opioid pain medicines. Opioids play an important role in chronic pain relief and work by binding to mu-receptors in the central nervous system, but they can also bind to mu-receptors in the bowel, which can result in patients suffering from OIC. OIC is the most prevalent and disabling adverse effect associated with opioid therapy, estimated to affect between 40-80% of the millions of patients taking chronic opioid therapy each year4.
About RedHill Biopharma Ltd.
IMPORTANT SAFETY INFORMATION ABOUT MOVANTIK®
- Movantik® may cause serious side effects, including:
- Opioid withdrawal. You may have symptoms of opioid withdrawal during treatment with Movantik®, including sweating, chills, diarrhea, stomach pain, anxiety, irritability, and yawning. Patients taking methadone to treat their pain may be more likely to experience stomach pain and diarrhea. Tell your doctor if you have any of these symptoms
- Severe Stomach Pain and/or Diarrhea. This can happen within a few days of starting Movantik® and can lead to hospitalization. If either of these side effects occurs, stop taking Movantik® and call your doctor immediately
- Tear in your stomach or intestinal wall (perforation). Stomach pain that is severe can be a sign of a serious medical condition. If you get stomach pain that gets worse or does not go away, stop taking Movantik® and get emergency medical help right away
- Do not take Movantik® if you:
- Have a bowel blockage (intestinal obstruction) or have a history of bowel blockage
- Are allergic to Movantik® or any of the ingredients in Movantik®
- Movantik® can interact with other medicines and cause side effects, including opioid withdrawal symptoms (see symptoms above). Tell your doctor or pharmacist before you start or stop any medicines during treatment with Movantik®
- Before you take Movantik®, tell your doctor about all of your medical conditions, including if you:
- Have any stomach, bowel (intestines), kidney, or liver problems
- Are pregnant or plan to become pregnant. Taking Movantik® during pregnancy may cause opioid withdrawal symptoms in you or your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with Movantik®
- Are breastfeeding or plan to breastfeed. It is not known if Movantik® passes into your breast milk. Taking Movantik® while you are breastfeeding may cause opioid withdrawal in your baby. You and your healthcare provider should decide if you will take Movantik® or breastfeed. You should not breastfeed if you take Movantik®
- Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect the way Movantik® works
- If you stop taking your opioid pain medicine, stop taking Movantik® and tell your doctor
- Avoid eating grapefruit or drinking grapefruit juice during treatment with Movantik®
- The most common side effects of Movantik® include: Stomach (abdomen) pain, diarrhea, nausea, gas, vomiting, headache, and excessive sweating
APPROVED USE FOR MOVANTIK®
Movantik® is a prescription medicine used to treat constipation that is caused by prescription pain medicines called opioids, in adults with long-lasting (chronic) pain that is not caused by active cancer.
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 related to the transition of all commercial activities from AstraZeneca and the timing of hiring sales representatives as well as 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 therapeutic candidates and its FDA-approved products; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (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 and Talicia®; (v) the Company’s ability to successfully commercialize and promote Talicia®, Aemcolo® and Movantik®; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the
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Managing Director, Relationship Manager
1 Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.
2 Movantik® is a peripherally acting mu-opioid receptor antagonist (PAMORA) indicated for the treatment of opioid-induced constipation (OIC) in adults 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.
3 Crockett, Seth D., et al. "
4 Crockett, Seth D., et al.
6 Crockett, Seth D., et al.
7 Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.
8 Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.
Source: RedHill Biopharma Ltd.