TIDMIMM
RNS Number : 1295C
Immupharma PLC
06 February 2020
06 February 2020
ImmuPharma PLC
("ImmuPharma" or the "Company")
ImmuPharma provides an update on the Avion Agreement in relation
to
Lupuzor(TM)'s new international Phase III trial
ImmuPharma PLC (LSE AIM: IMM - Euronext Growth: ALIMM), a
specialist drug discovery and development company, announces an
update on activities with Avion Pharmaceuticals LLC ("Avion")
following the successful licence and development agreement signed
with Avion in November 2019 for the exclusive rights to Lupuzor(TM)
in North America (United States).
A summary of key activities completed since November 2019
-- First joint steering committee ("JSC") completed in December
2019 to identify and agree the optimised Phase III study design for
Lupuzor(TM) including a focus on those patients presenting with the
biomarker anti-dsDNA autoantibody positive
-- Confirmation that the JSC wish to progress Lupuzor(TM) into
its second international Phase III clinical trial as soon as
possible this year
-- Avion and ImmuPharma to meet with the FDA in Q1 2020 to
discuss guidance on a new optimised international Phase III trial
protocol
-- Positive discussions with a number of potential commercial
partners of Lupuzor(TM) outside of the US
Summary of the Avion Agreement
-- ImmuPharma retains all the rights to commercialise
Lupuzor(TM), outside of the US, either through distribution
partnerships or directly by ImmuPharma
-- Avion will fund the full expected costs of the new Phase III trial up to $25 million
-- ImmuPharma will receive milestone payments of up to $70
million. A $5 million milestone payment will be paid on regulatory
approval of Lupuzor(TM) in lupus, and $65 million will be based on
achievement of overall sales targets
-- ImmuPharma will also receive $5 million for each additional
approval, other than lupus, as Avion also has the rights, for the
US, to explore further opportunities within Lupuzor(TM)'s peptide
platform for other auto-immune indications outside of lupus
-- ImmuPharma will receive from Avion tiered double-digit
royalties up to 17 percent, according to pre-specified annual US
sales targets
-- Avion has the right to use relevant trademarks for the
development, manufacture and commercialisation of products
Commenting on the announcement, Dimitri Dimitriou, ImmuPharma's
Chief Executive Officer and Robert Zimmer, President & Chief
Scientific Officer, said: "We are delighted with the positive and
proactive progress made since entering into this partnership with
Avion in November last year. Both companies are focused on
expediting Lupuzor(TM) into a new optimised international Phase III
study as soon as possible this year after discussions with the FDA
over the next period. In parallel, we have entered into positive
discussions with a number of potential commercial partners for
Lupuzor(TM) outside of the US. We are in a new chapter within
ImmuPharma's history, with the investment thesis for the Company
and specifically Lupuzor(TM) being repositioned and we look forward
to providing further updates on progress with shareholders over the
next period."
Art Deas, Chief Executive Officer, Avion Pharmaceuticals added:
"Avion is extremely pleased with the partnership with ImmuPharma.
We believe that Lupuzor(TM) has a unique position within lupus that
sets it apart from competition, and we are delighted to be
extending our footprint within this therapeutic area. We are
committed on moving Lupuzor(TM) into a new Phase III trial as
quickly as possible this year. We look forward to continuing to
make successful strides in the relationship with ImmuPharma going
forward."
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014. ("MAR")
For further information please contact:
ImmuPharma PLC (www.immupharma.com)
Tim McCarthy, Chairman + 44 (0) 207 152 4080
Dimitri Dimitriou, Chief Executive Officer
Lisa Baderoon, Head of Investor Relations + 44 (0) 7721 413496
SPARK Advisory Partners Limited (NOMAD)
Neil Baldwin, Henry Todd +44 (0) 203 368 8974
Stanford Capital Partners (Joint Broker)
Patrick Claridge, John Howes +44 (0) 203 815 8880
SI Capital (Joint Broker)
Nick Emerson +44 (0) 1483 413500
4Reliance (Euronext Growth Listing Sponsor) +32 (0) 2 747 02 60
Jean-Charles Snoy
Degroof Petercam (Liquidity Provider) +32 (0) 2 287 95 34
Erik De Clippel
Backstage Communication
Olivier Duquaine +32 (0) 477 504 784
Jean-Louis Dubrule +32 (0) 497 50 84 03
Notes to Editors
About ImmuPharma PLC
ImmuPharma PLC (LSE AIM: IMM - Euronext Growth: ALIMM) is a
specialty biopharmaceutical company that discovers and develops
peptide-based therapeutics. The Company's portfolio includes novel
peptide therapeutics for autoimmune diseases, metabolic diseases
and cancer. The lead program, LupuzorTM, is a first-in class
autophagy immunomodulator which is in Phase III for the treatment
of lupus and preclinical analysis suggest therapeutic activity for
many other autoimmune diseases that share the same autophagy
mechanism of action. ImmuPharma and Avion Pharmaceuticals signed on
29 November 2019, an exclusive licence and development agreement
and trademark agreement for Lupuzor(TM) to fund a new international
Phase III trial for Lupuzor(TM) and commercialise in the US. For
additional information about ImmuPharma please visit
www.immupharma.com. ImmuPharma's LEI (Legal Entity Identifier)
code: 213800VZKGHXC7VUS895.
About Avion Pharmaceuticals LLC
Established in 2007, Avion is a US-based speciality
pharmaceutical company formed to develop, acquire and market a
portfolio of innovative pharmaceutical products in Women's Health
and other therapeutic categories. Avion has a deep in-house
expertise within medical and regulatory affairs and late-stage
clinical development, together with a strong marketing and
commercialisation operation. Avion's sales team reaches throughout
North America with more than 100 sales representatives with
significant specialist therapeutic experience. Since 2012, Avion
has launched more than 55 New Drug Candidates (NDCs) and 20+
generic product extensions. Avion's launch earlier this year of a
new gout product (Gloperba(R)) for adults is an excellent sales and
marketing fit for the future commercialisation of Lupuzor(TM), as
rheumatologists are the core prescribers and therapeutic
influencers in both gout and lupus. For more information, visit
www.avionrx.com.
Background to Lupuzor(TM) and Agreement with Avion
ImmuPharma announced top-line trial results from its pivotal
Phase III trial of Lupuzor(TM) in lupus patients on 17 April 2018.
Further data analysis, reported on 29 May 2018 demonstrated that in
the European cohort (130 patients) Lupuzor(TM) plus standard of
care ("Active Group") showed statistically significant reductions
(71.1 percent vs 48.8 percent, p=0.0218) in disease activity
compared to placebo plus standard of care ("Comparator Group") in
79 patients (60.8 percent) who were anti-dsDNA autoantibody
positive ("Antibody Positive").
With important insights gained from this pivotal Phase III
Lupuzor(TM) trial, a new Phase III clinical trial design has been
identified. The ability to select the most responsive patients by
biomarker profile has enabled Avion and ImmuPharma to agree the
most robust way forward for Lupuzor(TM) in lupus patients. The
Licence and Development Agreement allows completion of this new
optimised international Phase III trial. Avion and ImmuPharma have
assessed and agreed an expected level of funding required to
complete the Phase III trial, which Avion has agreed to fund in
full, in return for full licensing rights over the drug within the
US. ImmuPharma will receive milestone payments upon achievement of
certain milestones, and tiered double-digit royalties on future
revenues generated by Avion.
Outside of lupus, the Licence and Development Agreement also
includes the option for Avion to explore the peptide's potential in
other auto-immune diseases for the US market.
Terms of the Avion Agreements
Licence and Development Agreement
The Licence and Development Agreement is between Avion and
ImmuPharma (France) S.A, a subsidiary of the Company.
Avion Pharmaceuticals has licensed the exclusive rights to
co-develop, with ImmuPharma, Lupuzor(TM) and the molecule
forigerimod, to allow registration for marketing in the US, Europe
and elsewhere and for Avion to commercialise Lupuzor(TM) for US
territories. ImmuPharma retains all rights to commercialise
Lupuzor(TM) outside of the US, either through distribution
partnerships or directly by ImmuPharma. All existing clinical data
and any future joint Intellectual Property will be shared between
the two parties for their respective regions.
Avion has agreed to fund the full costs of the new optimised
international Phase III trial for Lupuzor(TM) in lupus patients,
based on an agreed level of expected costs up to $25 million. It is
anticipated that this new Phase III trial will commence in 2020,
following agreement of the trial design between Avion, ImmuPharma
and the FDA. Following recruitment of patients (to include US,
Europe and elsewhere), it is envisaged that this will be a 52-week
trial. Both companies will jointly steer the clinical program.
ImmuPharma will receive milestone payments of up to $70 million.
A $5 million milestone payment will be paid on regulatory approval
of Lupuzor(TM) in lupus, and $65 million will be based on
achievement of overall sales targets. ImmuPharma will also receive
tiered double-digit royalties up to 17 percent according to
pre-specified annual US sales targets.
Avion will also have the right to explore clinical development
for other auto-immune indications within US territories. Additional
milestone payments of $5 million will be paid to ImmuPharma for
each disease indication, outside of lupus, receiving regulatory
approval.
Trademark Agreement
The Trademark Agreement is between Avion and ImmuPharma AG, a
subsidiary of the Company.
The Trademark Agreement allows Avion to use various trademarks
in connection with development, manufacture and commercialisation
of products under the Licence and Development Agreement.
This information is provided by RNS, the news service of the
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END
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