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Corporate News Blog - Novelion's Subsidiary Aegerion Pleads Guilty for Misbranding Juxtapid; Agrees to a Settlement of $40 Million

LONDON, UK / ACCESSWIRE / September 26, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Novelion Therapeutics Inc. (NASDAQ: NVLN) ("Novelion"), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=NVLN. On September 22, 2017, Aegerion Pharmaceuticals Inc. ("Aegerion"), a subsidiary of Novelion, agreed to plead guilty in the United States District Court for the District of Massachusetts on two counts of a misdemeanor with regards to misbranding its prescription drug, Juxtapid (lomitapide). The Company has entered into global civil, criminal, and administrative settlement and agreed to pay a fine of approximately $40.1 million. For immediate access to our complimentary reports, including today's coverage, register for free now at:

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Commenting on the matter, Chad A. Readler, Acting Assistant Attorney General of the Justice Department's Civil Division said:

"Today's settlement shows that the government will continue to hold accountable drug companies that violate laws designed to protect the health and safety of patients."

Scott Gottlieb, M.D, FDA Commissioner, added:

"By failing to follow the safety requirements that Aegerion had agreed to, the Company put patients' lives at risk and didn't honor the safety commitments they made as a condition of gaining approval for their drug. This is unacceptable. We will continue to pursue those who skirt the law, and flout patient safety and other post-market commitments, using all of the enforcement tools available to us."

The case

The case was a result of a lawsuit filed by three former employees of Aegerion - Michele Clarke, Tricia Mullins, and Kristi Winger Szudlo. The case deals with the promotion and distribution of Aegerion's Juxtapid during the period from December 2012 to December 2015.

Aegerion's Juxtapid was approved by the FDA in December 2012 as a drug used in the treatment of homozygous familial hypercholesterolemia (HoFH). HoFH is a very rare genetic condition wherein the affected patients are unable to lower their cholesterol using conventional treatments. The Federal Court found the Company guilty of violating the Federal Food, Drug, and Cosmetic Act (FDCA) as Juxtapid was being promoted and distributed wrongly for purposes other than that was approved by the FDA.

The criminal information filed points out that Aegerion managed to misbrand Juxtapid as the Company failed to comply with the requirements of the FDA's Risk Evaluation and Mitigation Strategy (REMS) program for Juxtapid. Due to this lapse, the labeling for Juxtapid remained vague and indefinite. This caused the extension of the product use to other patients. The REMS also mandated that Aegerion provide complete and accurate information to healthcare providers about HoFH its symptoms and diagnosis, which Aegerion failed to do.

Apart from this, Aegerion's management and sales personnel pushed Juxtapid for not just patients of HoFH but also as a drug used for the treatment of high cholesterol in general without providing adequate directions for such use.

Additionally, Aegerion filed a misleading REMS assessment report to the FDA. This assessment report did not mention that Aegerion was using a definition of HoFH while distributing Juxtapid, which was different from the definition of HoFH provided during the pre-approval filings with the FDA. It also did not match with any peer-reviewed clinical standard for diagnosing HoFH.

FDA's specific purpose of the Juxtapid REMS was to educate prescribers about the risks of liver toxicity and to restrict access to Juxtapid only to those patients with a clinical or laboratory diagnosis consistent with HoFH.

The prosecutors in the case also emphasized that the Company admitted to obtaining the personal health information of patients without their consent, and trying to use it "for commercial gain".

Details of the Settlement

As a part of the resolution on the matter, Aegerion has entered into a deferred prosecution agreement relating to criminal liability under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The Company has also agreed to settle the matter regarding the filing of misleading REMS assessment report to the FDA by paying more than $35 million to resolve any criminal and civil liability arising from these matters.

Aegerion has agreed to pay $28.8 million to the government over the next three years. This is a part of the civil false claims settlement to resolve federal and state civil liability for causing false claims for Juxtapid to be submitted to government health care programs (Medicare, Medicaid, and TRICARE) arising from its promotion of Juxtapid for patients not diagnosed with HoFH.

As per terms of the plea agreement, Aegerion has agreed to plead guilty of promoting Juxtapid to non-HoFH patients and has also agreed to pay a criminal fine and forfeiture of $7.2 million.

The Securities and Exchange Commission (SEC) has also claimed that Aegerion's conduct violated federal security statutes. To settle the matter the Company has agreed to pay $4 million to SEC as a part of a separate civil securities settlement.

Way Forward

Going forward, Aegerion has agreed to implement enhanced compliance provisions, including periodic certifications to the government concerning its implementation, as part of the deferred prosecution agreement. Aegerion has entered a separate civil consent decree to resolve civil liability under the FDCA for failing to comply with the requirements of the Juxtapid REMS program and mislabeling without proper directions about its uses. Aegerion also entered into a five-year Corporate Integrity Agreement (CIA) with the Office of Inspector General of the US Department of Health and Human Services (HHS-OIG), wherein the Company will ensure that its promotional activities and interactions with third-party patient assistance programs follow the law. The Company has agreed to keep the healthcare providers informed about the settlement and inform them that they can come forward to report any questionable practices by Aegerion's representatives. The complaints can be submitted to either the members of Aegerion's Compliance team or the FDA.

Once the Court enters the plea and consent decree, it will become part of a global resolution of the investigations initiated by various government agencies looking into Aegerion's marketing and distribution of Juxtapid.

About Aegerion Pharmaceuticals

Cambridge, Massachusetts based Aegerion Pharmaceuticals is an indirect subsidiary of Novelion Therapeutics. It is a biopharmaceutical Company dedicated to the development and commercialization of innovative therapies for patients with debilitating rare diseases.

Last Close Stock Review

At the close of trading session on Monday, September 25, 2017, Novelion Therapeutics' stock price rose 1.33% to end the day at $6.86. A total volume of 58.32 thousand shares were exchanged during the session. At Monday's closing price, the stock's net capitalization stands at $129.38 million.

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