TIDMIMM
RNS Number : 9181U
Immupharma PLC
28 November 2019
ImmuPharma PLC
("ImmuPharma" or the "Company")
ImmuPharma and Avion Pharmaceuticals sign exclusive licence and
development agreement and trademark agreement for Lupuzor(TM) with
Avion to fund new international Phase III trial and commercialise
in the US
ImmuPharma PLC (LSE:IMM), a specialist drug discovery and
development company, announces a licence and development agreement
with Avion Pharmaceuticals LLC, for the exclusive rights to
Lupuzor(TM) in North America (United States). Lupuzor(TM) is
ImmuPharma's lead compound, a peptide therapeutic and a first-in
class autophagy immunomodulator for systemic lupus erythematosus
(SLE or lupus) a potentially life-threatening auto-immune disease.
In addition, Lupuzor(TM) also has the potential for treating other
auto-immune diseases other than lupus. A trademark licence
agreement also has been signed to allow Avion the use of various
trademarks in connection with development, manufacture and
commercialisation of products under the Licence and Development
Agreement.
A summary of key highlights to both Agreements
-- Avion and ImmuPharma will co-develop Lupuzor(TM) to allow
registration for marketing in the US, Europe and elsewhere
-- Avion will commercialise Lupuzor(TM) exclusively for the US.
-- ImmuPharma retains all the rights to commercialise
Lupuzor(TM), outside of the US, either through distribution
partnerships or directly by ImmuPharma.
-- A new optimised international Phase III trial in lupus
patients (which is expected to include patients in the US, Europe
and elsewhere), is targeted to commence in 2020, following
agreement of the trial design between Avion, ImmuPharma and the US
Food & Drug Administration ("FDA").
-- 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.
Background
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 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.
Centre National de la Recherché Scientifique ("CNRS")
The CNRS is the French National Council for Scientific Research
and the largest basic research organisation in Europe. The CNRS is
ImmuPharma's longstanding collaboration partner and from which
Lupuzor(TM) was originally licensed. Through this partnership, CNRS
will be entitled to receive from ImmuPharma, low double-digit
royalty payments of monies received by ImmuPharma from Avion
through the Licence and Development Agreement.
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.
Commenting on the Agreements, Dimitri Dimitriou, ImmuPharma's
Chief Executive Officer and Robert Zimmer, President & Chief
Scientific Officer, said: "We are delighted to be entering into
this partnership with Avion, a company which has a strong track
record within late stage clinical development and commercialisation
of products within the US, the largest market for lupus patients.
Importantly, Avion's specialist sales team is well respected within
the rheumatologist community, whose focus is on prescribing safe
and efficacious treatments for auto-immune diseases such as lupus.
This makes it a perfect fit for Lupuzor(TM). We look forward to a
long and successful relationship with the Avion team and look
forward to sharing updates on progress with shareholders over the
next period."
Art Deas, Chief Executive Officer, Avion Pharmaceuticals added:
"Avion is extremely pleased to sign this partnership with
ImmuPharma. After in-depth due-diligence around Lupuzor(TM), its
mechanism of action and learnings within the initial Phase III
results, 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. With
approximately 1.5 million patients in the US suffering from lupus,
there is a significant unmet need for a safe and effective drug for
this debilitating disease that we believe Lupuzor(TM) can meet. We
look forward to forging a strong and successful 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 +44 (0) 203 368 8974
Vassil Kirtchev
Stanford Capital Partners (Joint Broker)
Patrick Claridge, John Howes +44 (0) 203 815 8880
SI Capital (Joint Broker)
Nick Emerson +44 (0) 1483 413500
Notes to Editors
About ImmuPharma PLC
ImmuPharma PLC (AIM: IMM) is a specialty biopharmaceutical
company that discovers and develops peptide-based therapeutics. The
company portfolio includes novel peptide therapeutics for
autoimmune diseases, metabolic diseases and cancer. The lead
program, Lupuzor(TM) , 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. For additional information about ImmuPharma please visit
www.immupharma.com.
About Avion Pharmaceuticals LLC
Avion Pharmaceuticals, LLC, is a specialty pharmaceutical
company formed to develop, acquire and market a portfolio of
innovative pharmaceutical products in the Women's Health and other
therapeutic categories aligned with its mission to improve the
quality of patient lives. Avion Pharmaceuticals focuses on
identifying opportunities to develop, acquire and enhance the
market potential of innovative, commercially available therapeutics
and late-stage development drugs to fulfil unmet medical needs. For
more information, visit www.avionrx.com.
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END
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