Today's Information

Provided by: PharmaEssentia Corp.
SEQ_NO 2 Date of announcement 2022/01/23 Time of announcement 22:08:22
Subject 
 The Company's Seven Years of United States Market
Drug Exclusivity for Besremi for the Treatment of Adults
with Polycythemia Vera (PV)
Date of events 2022/01/21 To which item it meets paragraph 53
Statement 
1.Date of occurrence of the event:2022/01/21
2.Company name:PharmaEssentia Corp.
3.Relationship to the Company (please enter ��head office�� or
  ��subsidiaries��): head office
4.Reciprocal shareholding ratios:NA
5.Cause of occurrence:
Besremi (Ropeginterferon alfa-2b) was designated as orphan drug for
polycythemia vera (PV) on April 2, 2012 and approved for adults with
PV on November 12, 2021 by the U.S. FDA.
On January 21, 2022, the U.S. FDA informed the Company that as the
first sponsor of this drug to obtain marketing approval for this
indication, the Company is entitled to seven years of orphan-drug
exclusive approval for Ropeginterferon alfa-2b for adults with PV.
The seven-year exclusive approval began on November 12, 2021, the
date of marketing approval.
The Company will assure the availability of sufficient quantities
of this drug to meet the needs of patients as stipulated under 21
CFR 316.36(b).
6.Countermeasures:
The Company hereby provides this material information.
7.Any other matters that need to be specified:
(1)Ropeginterferon alfa-2b is the first FDA-approved option and
   medication for PV that patients can take regardless of their
   treatment history, and the first interferon therapy specifically
   approved for PV. Ropeginterferon alfa-2b is marketed and
   commercialized in the United States.
(2)The Company will assure the availability of sufficient quantities
   of this drug to meet the needs of patients as stipulated under
   21 CFR 316.36(b).
(3)Ropeginterferon alfa-2b is approved for PV in European Union,
   Taiwan, Switzerland, Israel, Korea and the United States.
(4)It takes a considerable time and expenses to develop a new drug.
   In addition, the success of such development cannot be guaranteed.
   Therefore, the investors will bear investment risk and should
   carefully consider investment decisions.

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PharmaEssentia Corporation published this content on 23 January 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 23 January 2022 14:23:00 UTC.