Novelion Therapeutics Inc. (NASDAQ:NVLN) Files An 8-K Results of Operations and Financial Condition

On January 9, 2017, Novelion Therapeutics Inc. (the Company)
issued a press release reporting, among other things, its
preliminary, unaudited net product sales for the year ended
December 31, 2016, which is attached as Exhibit 99.1 to this
Current Report on Form 8-K.

This information in this Form 8-K and Exhibit 99.1 attached
hereto is intended to be furnished and shall not be deemed
“filed” for purposes of Section 18 of the Securities Exchange Act
of 1934, as amended (the “Exchange Act”), or otherwise subject to
the liabilities of that section, nor shall it be deemed
incorporated by reference in any filing under the Securities Act
of 1933, as amended, or the Exchange Act, except as expressly set
forth by specific reference in such filing.

On January 3, 2017, the U.S. Food and Drug Administration (FDA)
approved modifications to the JUXTAPID REMS Program (the REMS
Program). The REMS Program was a requirement of the original FDA
approval of JUXTAPID (lomitapide) capsules (JUXTAPID), a product
marketed and sold by Aegerion Pharmaceuticals, Inc. (Aegerion), a
subsidiary of the Company. The goal of the REMS Program, as
modified, is to mitigate the risk of hepatotoxicity associated
with the use of JUXTAPID by ensuring that: a) prescribers are
educated about the approved indication for JUXTAPID, the risk of
hepatotoxicity associated with the use of JUXTAPID, and the need
to monitor patients during treatment with JUXTAPID as per product
labeling; b) JUXTAPID is dispensed only to patients with a
clinical or laboratory diagnosis consistent with homozygous
familial hypercholesterolemia; and c) patients are informed about
the risk of hepatotoxicity associated with the use of JUXTAPID
and the need for baseline and periodic monitoring.

The originally approved REMS Program consisted of elements to
assure safe use (ETASU), an implementation system, a
communication plan and a timetable for submission of assessments
of the REMS Program. The ETASU require that healthcare providers
who prescribe JUXTAPID and pharmacies that dispense JUXTAPID must
be certified, and JUXTAPID must only be dispensed to patients
with evidence or other documentation of safe-use conditions. In
2016, the FDA communicated to Aegerion specific modifications the
FDA considered necessary to the REMS Program, including changes
to the REMS summary document, changes to the existing REMS
Program materials, and the following new REMS Program materials:
Fact sheet for Health Care Professionals, Patient Guide and
Patient-Prescriber Acknowledgment Form, Pharmacy Training Modules
and a Pharmacy Certification Form. Aegerion submitted its
response to the FDAs proposed modifications to the REMS Program
as a prior approval supplement in 2016, which the FDA approved on
January 3, 2017. The approved modifications to the REMS Program
must be implemented within 60 calendar days of January 3, 2017,
and healthcare professionals and pharmacies must complete the
recertification process within 180 calendar days of January 3,
2017 in order to continue prescribing and dispensing JUXTAPID,
respectively. The FDAs approval letter for the modified REMS
Program also specifies that an authorized generic drug under this
NDA must have an FDA-approved REMS program prior to marketing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.