TIDMREDX
RNS Number : 0520F
Redx Pharma plc
10 July 2019
THE INFORMATION CONTAINED WITHIN THIS ANNOUNCEMENT IS DEEMED BY
THE COMPANY TO CONSTITUTE INSIDE INFORMATION AS STIPULATED UNDER
THE EU MARKET ABUSE REGULATION (596/2014). UPON THE PUBLICATION OF
THE ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS
INFORMATION IS CONSIDERED TO BE IN THE PUBLIC DOMAIN
REDX PHARMA PLC
("Redx" or "the Company" or "the Group")
Redx announces sale of its pan-RAF inhibitor programme to Jazz
Pharmaceuticals
Redx to receive $3.5 million upfront, up to $203 million in
milestone payments and royalty payments
Redx will collaborate with Jazz to advance the programme through
IND-enabling studies
Alderley Park, 10 July 2019 Redx Pharma plc (AIM: REDX) today
announced that it has signed a definitive agreement with Jazz
Pharmaceuticals plc (Nasdaq: JAZZ; "Jazz") under which Jazz has
acquired Redx's pan-RAF inhibitor programme for the potential
treatment of RAF and RAS mutant tumours. Jazz will be responsible
for all future development, regulatory, manufacturing and
commercialisation activities.
Under the terms of the agreement, Jazz will pay Redx an upfront
payment of $3.5 million in cash for all rights, title and interest
relating to Redx's proprietary pan-RAF inhibitor programme,
including all related patents. Redx is eligible to receive up to
$203 million in development, regulatory and commercial milestone
payments from Jazz, with the next milestones being initiation of
IND enabling studies, followed by a further milestone at IND
submission to the FDA. Redx is also eligible for incremental tiered
royalties in mid-single digit percentage, based on any future net
sales.
As part of a separate collaboration agreement, signed in
parallel, Jazz will pay Redx to perform research and preclinical
development services with the goal of completing IND-enabling
studies.
Lisa Anson, Chief Executive Officer of Redx, commented: "We are
pleased to deliver on our previously announced intention to realise
value from our pan-RAF research programme through entering into
this strategic transaction with Jazz. Jazz has a growing
hematology/oncology portfolio and demonstrated success in
developing and commercialising treatments for patients worldwide.
This transaction validates Redx's excellence in drug design and
represents the company's second oncology deal in the last two
years, following the sale of our BTK inhibitor programme to Loxo
Oncology in 2017. We look forward to working with Jazz to advance
the pan-RAF inhibitor programme."
"We are excited to acquire Redx's pan-RAF inhibitor program. It
has the potential to work in RAF driven tumors where current
selective B-RAF inhibitors and their respective combinations are
ineffective due to acquired resistance mechanisms. In addition,
there is the potential to address RAS driven tumors," said Robert
Iannone, M.D., M.S.C.E., executive vice president, research and
development of Jazz Pharmaceuticals. "We look forward to advancing
the pan-RAF inhibitor program that is part of a novel class of next
generation precision oncology drugs and is highly complementary to
our growing R&D portfolio of early-stage, innovative,
hematology/oncology therapies."
The $3.5 million upfront payment received will be used for
working capital, extending the Group's cash runway through to 2020.
The Company will continue to execute its strategy and, in
particular, progress patient recruitment in the ongoing phase 1/2a
trial of RXC004, an oral porcupine inhibitor aimed at treating
cancer driven by the Wnt pathway. The Board continues to be in
active discussions with shareholders and third-party healthcare
specialist investors regarding longer-term funding of the Group.
The Company will provide further updates in due course.
About Pan-RAF Inhibitors(1,2,3)
Mutations leading to uncontrolled signalling via the
RAS-RAF-MAPK pathway are seen in more than one third of all
cancers. Redx's pan-RAF inhibitor program aims to overcome both
resistance mechanisms and safety concerns associated with
clinically approved BRAF selective drugs.
The RAF kinases (ARAF, BRAF and CRAF) are an integral part of
this pathway, with BRAF mutations commonly seen in the clinic.
Although most BRAF V600E mutant skin cancers are sensitive to
approved BRAF-selective drugs, BRAF V600E mutant colorectal cancers
are surprisingly insensitive to these agents as monotherapy due to
the functions of other RAF family members and require combination
therapy. Furthermore, BRAF-selective therapies fail to show
clinical benefit against the more prevalent RAS-mutated tumours.
Preclinical study results of Redx's lead chemical series have
demonstrated in vivo efficacy in BRAFV600E mutant driven colorectal
cancer xenograft models as a single agent, where approved
BRAF-selective drugs are ineffective clinically. It has also shown
promising activity in RAS-mutated cancer cells.
About Redx Pharma plc
Redx is a UK-based biotechnology company whose shares are traded
on AIM (AIM:REDX). Redx's vision is to become a leading biotech
focused on the development of novel precision medicines that have
the potential to transform treatment in oncology and fibrotic
diseases.
For more information, please visit www.redxpharma.com. If you
would like to sign up to regular alerts from Redx Pharma, please
follow this link
https://www.redxpharma.com/investors/email-alerts/
About Jazz Pharmaceuticals plc
Jazz Pharmaceuticals plc (Nasdaq: JAZZ), a global
biopharmaceutical company, is dedicated to developing life-changing
medicines for people with limited or no options. As a leader in
sleep medicine and with a growing hematology/oncology portfolio,
Jazz has a diverse portfolio of products and product candidates in
development, and is focused on transforming biopharmaceutical
discoveries into novel medicines. Jazz Pharmaceuticals markets
Sunosi(TM) (solriamfetol), Xyrem(R) (sodium oxybate) oral solution,
Defitelio(R) (defibrotide sodium), Erwinaze(R) (asparaginase
Erwinia chrysanthemi) and Vyxeos(R) (daunorubicin and cytarabine)
liposome for injection in the U.S. and markets Defitelio(R)
(defibrotide), Erwinase(R) and Vyxeos(R) 44 mg/100 mg powder for
concentrate for solution for infusion in countries outside the U.S.
For country-specific product information, please visit www.
jazzpharmaceuticals.com/medicines. For more information, please
visit www.jazzpharmaceuticals.com and follow us on Twitter at
@JazzPharma.
For further information, please contact:
Redx Pharma Plc Lisa Anson, Chief Executive Officer T: +44 1625 469920
Cantor Fitzgerald Europe (Nominated Advisor & T: +44 20 7894
Joint Broker) 7000
Phil Davies
WG Partners LLP (Joint Broker) Claes Spång/ T: +44 20 3705
Chris Lee/ David Wilson 9330
FTI Consulting Simon Conway/Ciara Martin T: +44 20 3727
1000
References:
1. Knight T, Irving JA. Ras/Raf/MEK/ERK pathway activation in
childhood acute lymphoblastic leukemia and its therapeutic
targeting. Front Oncol. 2014; 4:160.
2. Santarpia L, Lippman SL, El-Naggar AK. Targeting the
mitogen-activated protein kinase RAS-RAF signaling pathway in
cancer therapy. Expert Opin Ther Targets. 2012; 16:103-119.
3. Hertzman Johansson C. & Egyhazi Brage S. BRAF inhibitors
in cancer therapy, Pharmacology & Therapeutics. 2014;
142:176-182.
Jazz Pharmaceuticals plc "Safe Harbor" Statement under the
Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements by Jazz,
including, but not limited to, statements related to the potential
of the pan-RAF inhibitor program to work in RAF driven tumors and
to address RAS driven tumors; Jazz's plans to advance the pan-RAF
inhibitor program; and other statements that are not historical
facts. These forward-looking statements are based on the Jazz's
current plans, objectives, estimates, expectations and intentions
and inherently involve significant risks and uncertainties. Actual
results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of these
risks and uncertainties, which include, without limitation, risks
and uncertainties associated with: pharmaceutical product
development and clinical success thereof; the regulatory approval
process; and effectively commercializing any product candidates;
and other risks and uncertainties affecting Jazz, including those
described from time to time under the caption "Risk Factors" and
elsewhere in Jazz's Securities and Exchange Commission filings and
reports (Commission File No. 001-33500), including Jazz's Quarterly
Report on Form 10-Q for the quarter ended March 31, 2019 and future
filings and reports by Jazz. Other risks and uncertainties of which
Jazz is not currently aware may also affect its forward-looking
statements and may cause actual results and the timing of events to
differ materially from those anticipated. The forward-looking
statements herein are made only as of the date hereof or as of the
dates indicated in the forward-looking statements, even if they are
subsequently made available by Jazz on its website or otherwise.
Jazz undertakes no obligation to update or supplement any
forward-looking statements to reflect actual results, new
information, future events, changes in its expectations or other
circumstances that exist after the date as of which the
forward-looking statements were made.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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