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

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

Item 2.02 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.
Item 8.01
Other Events
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.
Exhibit No.
Description
99.1
Press Release, dated January 9, 2017.

About Novelion Therapeutics Inc. (NASDAQ:NVLN)
Novelion Therapeutics Inc, formerly QLT Inc., is a Canada-based biopharmaceutical company. The Company is engaged in development of new standards of care for individuals living with rare diseases. The Company is focused on advancing its portfolio of rare disease therapies by investing in science and clinical development. The Company holds a portfolio of products through its subsidiary, Aegerion Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the development and commercialization of innovative therapies for patients with debilitating rare diseases. The Company’s portfolio of products include MYALEPT and JUXTAPID. The Company is also developing zuretinol acetate for the treatment of inherited retinal disease caused by underlying mutations in RPE65 or LRAT genes. Novelion Therapeutics Inc. (NASDAQ:NVLN) Recent Trading Information
Novelion Therapeutics Inc. (NASDAQ:NVLN) closed its last trading session up +0.66 at 8.97 with 116,159 shares trading hands.

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