LEIDEN, The Netherlands, June 1, 2023
/PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company")
(EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) announces that it has
entered into a definitive agreement with Novartis Pharma A.G.
("Novartis") to sell its Rare Pediatric Disease Priority Review
Voucher (PRV) to Novartis for a pre-agreed, one-time payment of
approximately US$21.1 million shortly
after closing.
Pharming was granted the PRV by the Food and Drug Administration
(FDA) in March 2023 in connection
with the approval of Joenja® (leniolisib); an oral, selective PI3Kδ
inhibitor, for activated phosphoinositide 3-kinase delta (PI3Kδ)
syndrome (APDS), a rare and progressive primary immunodeficiency,
in adult and pediatric patients 12 years of age and older.
Pursuant to the terms of the August
2019 exclusive license agreement between Pharming and
Novartis for leniolisib, Novartis has the right to purchase the PRV
from Pharming for a pre-agreed, contractually defined percentage of
the PRV value.
Jeroen Wakkerman, Chief Financial Officer of Pharming,
said:
"The sale of the PRV will further strengthen Pharming's
financial position and help fund pipeline developments, including
new indications for leniolisib. We remain committed to growing a
portfolio of medicines in rare diseases, which have the potential
to transform the lives of patients and working towards our goal of
becoming a leading global rare disease company dedicated to patient
communities with unmet medical needs."
About the Rare Pediatric Disease Priority Review Voucher
(PRV) Program
The program is intended to encourage development of new drug and
biological products for prevention and treatment of certain rare
pediatric diseases. A PRV may be issued to the sponsor of a rare
pediatric disease product application and entitles the holder to
priority review of a single New Drug Application or Biologics
License Application, which reduces the target review time and could
lead to an expedited approval. The sponsor receives the PRV upon
approval of the rare pediatric disease product application and it
can be sold without limitation, subject to applicable FDA
requirements for filing and use.
About Pharming Group N.V.
Pharming Group N.V. (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) is
a global biopharmaceutical company dedicated to transforming the
lives of patients with rare, debilitating, and life-threatening
diseases. Pharming is commercializing and developing an innovative
portfolio of protein replacement therapies and precision medicines,
including small molecules, biologics, and gene therapies that are
in early to late-stage development. Pharming is headquartered in
Leiden, Netherlands, and has
employees around the globe who serve patients in over 30 markets in
North America, Europe, the Middle
East, Africa, and
Asia-Pacific.
For more information, visit www.pharming.com and find us on
LinkedIn.
Forward-looking Statements
This press release may contain forward-looking statements.
Forward-looking statements are statements of future expectations
that are based on management's current expectations and assumptions
and involve known and unknown risks and uncertainties that could
cause actual results, performance, or events to differ materially
from those expressed or implied in these statements. These
forward-looking statements are identified by their use of terms and
phrases such as "aim", "ambition", ''anticipate'', ''believe'',
''could'', ''estimate'', ''expect'', ''goals'', ''intend'',
''may'', "milestones", ''objectives'', ''outlook'', ''plan'',
''probably'', ''project'', ''risks'', "schedule", ''seek'',
''should'', ''target'', ''will'' and similar terms and phrases.
Examples of forward-looking statements may include statements with
respect to timing and progress of Pharming's preclinical studies
and clinical trials of its product candidates, Pharming's clinical
and commercial prospects, and Pharming's expectations regarding its
projected working capital requirements and cash resources, which
statements are subject to a number of risks, uncertainties and
assumptions, including, but not limited to the scope, progress and
expansion of Pharming's clinical trials and ramifications for the
cost thereof; and clinical, scientific, regulatory and technical
developments. In light of these risks and uncertainties, and other
risks and uncertainties that are described in Pharming's 2022
Annual Report and the Annual Report on Form 20-F for the year ended
December 31, 2022, filed with the
U.S. Securities and Exchange Commission, the events and
circumstances discussed in such forward-looking statements may not
occur, and Pharming's actual results could differ materially and
adversely from those anticipated or implied thereby. All
forward-looking statements contained in this press release are
expressly qualified in their entirety by the cautionary statements
contained or referred to in this section. Readers should not place
undue reliance on forward-looking statements. Any forward-looking
statements speak only as of the date of this press release and are
based on information available to Pharming as of the date of this
release. Pharming does not undertake any obligation to publicly
update or revise any.
Inside Information
This press release relates to the disclosure of information that
qualifies, or may have qualified, as inside information within the
meaning of Article 7(1) of the EU Market Abuse Regulation.
For further public information, contact:
Pharming Group, Leiden, The
Netherlands
Michael Levitan, VP Investor Relations & Corporate
Communications
T: +1 (908) 705 1696
Heather Robertson, Investor
Relations & Corporate Communications Manager
E: investor@pharming.com
FTI Consulting, London,
UK
Victoria Foster
Mitchell/Alex Shaw/Amy
Byrne
T: +44 203 727 1000
LifeSpring Life Sciences Communication, Amsterdam, The Netherlands
Leon
Melens
T: +31 6 53 81 64 27
E: pharming@lifespring.nl
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SOURCE Pharming Group N.V.