Terms and Conditions

This website (the “Website”) is the website of Amryt Pharma plc (“Amryt”, “us” or “we”). The pages on the Website are published by Open Health (“OpenHealth”) on behalf of Amryt.

Please read these terms and conditions of use of the Website carefully as by using the Website you agree to be bound by them. We reserve the right to vary the conditions of use at any time and will post any variations here. You are advised to review the conditions of use on a regular basis as you will be deemed to have accepted variations if you continue to use the Website after they have been posted.

Your Responsibility

 

You assume all responsibility for your use of, or access to, this Website, including your access to any Amryt or other literature obtained through the Site, and waive all claims or causes of action against Amryt or their respective the officers, directors, employees, agents and affiliates in connection therewith. If you do not agree to abide by these conditions of use you should not use the Website in any way.

Third-Party Resources

 

This Website may contain links to websites operated by other parties. The linked sites are not under the control of Amryt or OpenHealth, and we are not responsible for the content available on any other Internet sites linked to this Website. Such links do not imply our endorsement of material on any other site, and Amryt and OpenHealth disclaim all liability with regard to your access to such linked websites. Amryt and OpenHealth may provide links to other Internet sites as a convenience to users, and access to any other Internet sites linked to this Website is at your own risk. Information published by Open Health on the Website is supplied by Amryt and, where indicated, by certain third parties. Open Health and Amryt take every care and precaution to ensure that information published on the Website is accurate when posted and regularly updated, but neither Open Health nor Amryt guarantees or can be held liable for its accuracy or timeliness and Open Health or Amryt may change the information at any time without notice. You must not rely on the information on the Website and you acknowledge that you must take appropriate steps to verify this information before acting on it.

Disclaimer

AMRYT AND OPEN HEALTH PUBLISH THE WEBSITE “AS IS” WITHOUT ANY WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, AS TO THE OPERATION OF THE WEBSITE, THE ACCURACY OF THE INFORMATION OR THE PRODUCTS OR SERVICES REFERRED TO ON THE WEBSITE (IN SO FAR AS SUCH WARRANTIES MAY BE EXCLUDED UNDER ANY RELEVANT LAW) AND TO THE EXTENT PERMITTED BY LAW, NEITHER AMRYT NOR OPENHEALTH SHALL BE LIABLE FOR ANY LOSSES OR DAMAGE WHETHER DIRECT OR INDIRECT (INCLUDING, WITHOUT LIMITATION DIRECT OR INDIRECT LOSS OF PROFITS), CONSEQUENTIAL, SPECIAL OR OTHERWISE INCIDENTAL THAT MAY RESULT FROM USE OF THE WEBSITE HOWSOEVER ARISING. WE FURTHER DISCLAIM ANY WARRANTY THAT THE INFORMATION ON THIS SITE WILL BE FREE OF INTERRUPTION, OR THAT THE SITE IS FREE OF VIRUSES, WORMS, TROJAN HORSES OR OTHER CODE THAT MANIFEST CONTAMINATING OR DESTRUCTIVE PROPERTIES

Indemnity

 

You agree to indemnify, defend and hold harmless Amryt and OpenHealth, and their respective officers, directors, employees, agents and affiliates from and against all losses, expenses, damages and costs, including reasonable attorneys’ fees, arising out of or relating to any violation of these Terms or any activity related to use of the Website (including but not limited to infringement of third parties’ worldwide intellectual property rights or negligent or wrongful conduct) by you or any other person accessing the Website on your behalf.

The information contained in the Website is not an invitation to invest in shares or other securities, or any other products or services or otherwise deal in these or enter into a contract with Amryt or any other company. The information provided should not be relied upon in connection with any investment decision. You should always seek appropriate professional advice in relation to such.

The past performance of Amryt or any other company referred to on the Website cannot be relied upon as a guide to its future performance. The price of shares and the income derived from them can go down as well as up and investors may not recoup the amount originally invested.

Any reference to any product or service which has been or may be provided by Amryt or any other company does not amount to a promise that such product or service will be available at any time. Changes to or improvements in such products or services may be made at any time without notice.

Copyright

Copyright in the design and architecture of the Website is owned by Open Health. Amryt owns the copyright and trademarks in the content published on the Website except where otherwise indicated by a third party’s proprietary notice. Images, trade-marks and brands are also protected by other intellectual property laws and may not be reproduced or appropriated in any manner without written permission of their respective owners. Unless specifically prohibited by a notice published on any page, you may make a print copy of such parts of the Website as you may reasonably require for your own personal use provided that any copy has attached to it any relevant proprietary notices and/or disclaimers. All other use is prohibited.

We are not responsible for the content of any other website from which you have accessed the Website or to which you may hyperlink from the website and cannot be held liable for any loss or damage you incur as a result thereof.

This Website Does Not Provide Medical or Professional Services Advice

 

The content on the Website is intended to be a general information resource in regard to the subject matter covered. Amryt does not directly or indirectly practice medicine, render medical advice, or dispense medical services via the Website, and nothing contained in the Website is intended to be instruction for medical diagnosis or treatment. Any information provided should not be considered complete, nor should it be relied on to suggest a course of treatment for a particular individual. Information received from the Website should not be relied upon for personal, medical, legal, technical, or financial decisions. It should not be used in place of a visit, call, consultation or the advice of your physician or other qualified healthcare provider. Should you have any healthcare related questions, please consult with your physician or other qualified healthcare provider promptly.

Forward-Looking Statements

 

The Website may contain express or implied forward-looking statements, which are based on current expectations of management. These statements relate to, among other things, our expectations regarding management's plans, objectives, and strategies. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. Amryt assumes no obligation to update any forward-looking statements contained in any press release in the event of changing circumstances or otherwise, and such statements are current only as of the date they are made.

Updates

 

Amryt may make improvements and/or changes to the Website at any time. Although we attempt to periodically update information on this Website, the information, materials and services provided on or through this Website may occasionally be inaccurate, incomplete or out of date. Amryt do not have a duty to update information contained in the Website, and we will not be liable for any failure to update such information. We make no representation as to the completeness, accuracy or currentness of any information on the Website, and we undertake no obligation to update or revise the information contained on the Website, whether as a result of new information, future events or circumstances or otherwise. It is your responsibility to verify any information contained in the Website before relying upon it.

Governing Law

 

These conditions of use are governed by the laws of England and Wales and you agree that the English courts shall have exclusive jurisdiction in any dispute.

To the extent that any part of these conditions of use is found to be invalid, unlawful or unenforceable by any court of competent jurisdiction such part shall to that extent be severed from the remaining terms all of which shall remain in full force and effect as permitted by law.

Important Safety Information

LIMITATIONS OF USE:

The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH, including those with heterozygous familial hypercholesterolemia (HeFH). The effect of JUXTAPID on cardiovascular morbidity and mortality has not been determined.

WARNING: RISK OF HEPATOTOXICITY

JUXTAPID can cause elevations in transaminases. In the JUXTAPID clinical trial, 10 (34%) of the 29 patients treated with JUXTAPID had at least one elevation in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3x upper limit of normal (ULN). There were no concomitant clinically meaningful elevations of total bilirubin, international normalized ratio (INR), or alkaline phosphatase.

JUXTAPID also increases hepatic fat, with or without concomitant increases in transaminases. The median absolute increase in hepatic fat was 6% after both 26 and 78 weeks of treatment, from 1% at baseline, measured by magnetic resonance spectroscopy. Hepatic steatosis associated with JUXTAPID treatment may be a risk factor for progressive liver disease, including steatohepatitis and cirrhosis.

Measure ALT, AST, alkaline phosphatase, and total bilirubin before initiating treatment and then ALT and AST regularly as recommended. During treatment, adjust the dose of JUXTAPID if the ALT or AST are ≥3x ULN. Discontinue JUXTAPID for clinically significant liver toxicity.

Because of the risk of hepatotoxicity, JUXTAPID is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the JUXTAPID REMS Program.

Prescribe JUXTAPID only to patients with a clinical or laboratory diagnosis consistent with HoFH. The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH.

CONTRAINDICATIONS:

  • Pregnancy
  • Concomitant administration of moderate or strong CYP3A4 inhibitors
  • Moderate or severe hepatic impairment or active liver disease including unexplained persistent elevations of serum transaminases

WARNINGS AND PRECAUTIONS

JUXTAPID can cause elevations in transaminases and hepatic steatosis. Although cases of hepatic failure have not been reported, there is concern that JUXTAPID could induce steatohepatitis, which can progress to cirrhosis over several years. Modify the dose of JUXTAPID if elevations of transaminases are observed and discontinue JUXTAPID for persistent or clinically significant elevations. If transaminase elevations are accompanied by clinical symptoms of liver injury, such as nausea, vomiting, abdominal pain, fever, jaundice, lethargy, flu-like-symptoms, increases in bilirubin ≥2x ULN, or active liver disease, discontinue treatment with JUXTAPID and identify the probable cause. Use JUXTAPID with caution when co-administered with agents known to be hepatotoxic. Alcohol may increase levels of hepatic fat and induce or exacerbate liver injury.

Measure ALT, AST, alkaline phosphatase, and total bilirubin before initiating treatment. During the first year, measure liver-related tests (ALT and AST, at a minimum) prior to each increase in dose or monthly, whichever occurs first. After the first year, do these tests at least every 3 months and before any increase in dose.

JUXTAPID may cause fetal harm when administered to a pregnant woman. Females of reproductive potential should have a negative pregnancy test before starting JUXTAPID and should use effective contraception during therapy with JUXTAPID. The recommended maximum dosage of JUXTAPID is 40 mg daily when used concomitantly with oral contraceptives.

Given its mechanism of action in the small intestine, JUXTAPID may reduce the absorption of fat- soluble nutrients. Patients treated with JUXTAPID should take daily supplements that contain 400 international units vitamin E and at least 200 mg linoleic acid, 210 mg alpha-linolenic acid (ALA), 110 mg eicosapentaenoic acid (EPA), and 80 mg docosahexaenoic acid (DHA).

Gastrointestinal adverse reactions are common and may lead to treatment discontinuation. Instruct patients to stop JUXTAPID and contact their healthcare provider if severe diarrhea occurs, or if they experience symptoms of volume depletion such as lightheadedness, decreased urine output, or tiredness. In such cases, consider reducing the dose or suspending use of JUXTAPID. To reduce the risk of gastrointestinal adverse reactions, patients should adhere to a low-fat diet supplying less than 20% of energy from fat and the dosage of JUXTAPID should be increased gradually.

Weak CYP3A4 inhibitors can increase the exposure of lomitapide approximately 2-fold; therefore, when JUXTAPID is administered with weak CYP3A4 inhibitors, the dose of JUXTAPID should be decreased by half and the recommended maximum dosage of JUXTAPID is 30 mg daily. The recommended maximum dosage is 40 mg daily when used concomitantly with oral contraceptives. Strong and moderate CYP3A4 inhibitors should not be used with JUXTAPID. Patients taking JUXTAPID 5 mg daily may continue with the same dosage.

Due to risk of myopathy associated with simvastatin or lovastatin, doses of these agents should be limited when co-administered with JUXTAPID.

JUXTAPID increases the plasma concentrations of warfarin. Increases or decreases in the dose of JUXTAPID may lead to supra- or subtherapeutic anticoagulation, respectively. Patients taking warfarin should undergo regular monitoring of the INR, especially after any changes in JUXTAPID dosage.

Avoid use of JUXTAPID in patients with rare hereditary diseases of galactose intolerance.

ADVERSE REACTIONS:

The most common adverse reactions were gastrointestinal, reported by 27 (93%) of 29 patients. Adverse reactions reported by 8 (28%) or more patients in the HoFH clinical trial included diarrhea, nausea, vomiting, dyspepsia and abdominal pain. Other common adverse reactions, reported by 5 to 7 (17-24%) patients, included weight loss, abdominal discomfort, abdominal distension, constipation, flatulence, increased ALT, chest pain, influenza, nasopharyngitis, and fatigue.

REPORTING OF ADVERSE REACTIONS:

All healthcare professionals should report all suspected adverse reactions. Please contact Aegerion Pharmaceuticals, Inc. at 1-855-303-2347 or the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

Please see accompanying Prescribing Information including BOXED WARNING.

Important Safety Information

LIMITATIONS OF USE:

The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH, including those with heterozygous familial hypercholesterolemia (HeFH). The effect of JUXTAPID on cardiovascular morbidity and mortality has not been determined.

WARNING: RISK OF HEPATOTOXICITY

JUXTAPID can cause elevations in transaminases. In the JUXTAPID clinical trial, 10 (34%) of the 29 patients treated with JUXTAPID had at least one elevation in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3x upper limit of normal (ULN). There were no concomitant clinically meaningful elevations of total bilirubin, international normalized ratio (INR), or alkaline phosphatase.

JUXTAPID also increases hepatic fat, with or without concomitant increases in transaminases. The median absolute increase in hepatic fat was 6% after both 26 and 78 weeks of treatment, from 1% at baseline, measured by magnetic resonance spectroscopy. Hepatic steatosis associated with JUXTAPID treatment may be a risk factor for progressive liver disease, including steatohepatitis and cirrhosis.

Measure ALT, AST, alkaline phosphatase, and total bilirubin before initiating treatment and then ALT and AST regularly as recommended. During treatment, adjust the dose of JUXTAPID if the ALT or AST are ≥3x ULN. Discontinue JUXTAPID for clinically significant liver toxicity.

Because of the risk of hepatotoxicity, JUXTAPID is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the JUXTAPID REMS Program.

Prescribe JUXTAPID only to patients with a clinical or laboratory diagnosis consistent with HoFH. The safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH.

CONTRAINDICATIONS:

  • Pregnancy
  • Concomitant administration of moderate or strong CYP3A4 inhibitors
  • Moderate or severe hepatic impairment or active liver disease including unexplained persistent elevations of serum transaminases

WARNINGS AND PRECAUTIONS

JUXTAPID can cause elevations in transaminases and hepatic steatosis. Although cases of hepatic failure have not been reported, there is concern that JUXTAPID could induce steatohepatitis, which can progress to cirrhosis over several years. Modify the dose of JUXTAPID if elevations of transaminases are observed and discontinue JUXTAPID for persistent or clinically significant elevations. If transaminase elevations are accompanied by clinical symptoms of liver injury, such as nausea, vomiting, abdominal pain, fever, jaundice, lethargy, flu-like-symptoms, increases in bilirubin ≥2x ULN, or active liver disease, discontinue treatment with JUXTAPID and identify the probable cause. Use JUXTAPID with caution when co-administered with agents known to be hepatotoxic. Alcohol may increase levels of hepatic fat and induce or exacerbate liver injury.

Measure ALT, AST, alkaline phosphatase, and total bilirubin before initiating treatment. During the first year, measure liver-related tests (ALT and AST, at a minimum) prior to each increase in dose or monthly, whichever occurs first. After the first year, do these tests at least every 3 months and before any increase in dose.

JUXTAPID may cause fetal harm when administered to a pregnant woman. Females of reproductive potential should have a negative pregnancy test before starting JUXTAPID and should use effective contraception during therapy with JUXTAPID. The recommended maximum dosage of JUXTAPID is 40 mg daily when used concomitantly with oral contraceptives.

Given its mechanism of action in the small intestine, JUXTAPID may reduce the absorption of fat- soluble nutrients. Patients treated with JUXTAPID should take daily supplements that contain 400 international units vitamin E and at least 200 mg linoleic acid, 210 mg alpha-linolenic acid (ALA), 110 mg eicosapentaenoic acid (EPA), and 80 mg docosahexaenoic acid (DHA).

Gastrointestinal adverse reactions are common and may lead to treatment discontinuation. Instruct patients to stop JUXTAPID and contact their healthcare provider if severe diarrhea occurs, or if they experience symptoms of volume depletion such as lightheadedness, decreased urine output, or tiredness. In such cases, consider reducing the dose or suspending use of JUXTAPID. To reduce the risk of gastrointestinal adverse reactions, patients should adhere to a low-fat diet supplying less than 20% of energy from fat and the dosage of JUXTAPID should be increased gradually.

Weak CYP3A4 inhibitors can increase the exposure of lomitapide approximately 2-fold; therefore, when JUXTAPID is administered with weak CYP3A4 inhibitors, the dose of JUXTAPID should be decreased by half and the recommended maximum dosage of JUXTAPID is 30 mg daily. The recommended maximum dosage is 40 mg daily when used concomitantly with oral contraceptives. Strong and moderate CYP3A4 inhibitors should not be used with JUXTAPID. Patients taking JUXTAPID 5 mg daily may continue with the same dosage.

Due to risk of myopathy associated with simvastatin or lovastatin, doses of these agents should be limited when co-administered with JUXTAPID.

JUXTAPID increases the plasma concentrations of warfarin. Increases or decreases in the dose of JUXTAPID may lead to supra- or subtherapeutic anticoagulation, respectively. Patients taking warfarin should undergo regular monitoring of the INR, especially after any changes in JUXTAPID dosage.

Avoid use of JUXTAPID in patients with rare hereditary diseases of galactose intolerance.

ADVERSE REACTIONS:

The most common adverse reactions were gastrointestinal, reported by 27 (93%) of 29 patients. Adverse reactions reported by 8 (28%) or more patients in the HoFH clinical trial included diarrhea, nausea, vomiting, dyspepsia and abdominal pain. Other common adverse reactions, reported by 5 to 7 (17-24%) patients, included weight loss, abdominal discomfort, abdominal distension, constipation, flatulence, increased ALT, chest pain, influenza, nasopharyngitis, and fatigue.

REPORTING OF ADVERSE REACTIONS:

All healthcare professionals should report all suspected adverse reactions. Please contact Aegerion Pharmaceuticals, Inc. at 1-855-303-2347 or the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

Please see accompanying Prescribing Information including BOXED WARNING.