REG-Arix Bioscience plc: Pharmaxis business update

Arix BioscienceAnnouncement

18/12/2019 10:05

Arix Bioscience plc

Pharmaxis business update

LONDON, 18 December 2019: Arix Bioscience plc (“Arix”, LSE: ARIX) a
global venture capital company focused on investing in and building
breakthrough biotech companies, today notes that its portfolio company,
Pharmaxis Ltd (“Pharmaxis”, ASX: PXS), has provided an update on its
business plan following a decision by Boehringer Ingelheim (“BI”) not to
progress studies of the AOC3 inhibitor acquired from Pharmaxis in 2015 for the
treatment of non-alcoholic steatohepatitis (NASH). The reason provided by BI
for the discontinuation, after a successful Phase 2a study that met its safety
and efficacy endpoints, was the potential for drug interactions in NASH
patients. This decision has no impact on Pharmaxis’ short term cash as the
next milestone payment for NASH was not scheduled until the commencement of a
Phase 3 study in several years’ time.

A second study of the drug in diabetic retinopathy with associated milestone
payments will continue, with future development to be decided by BI following
completion of the current Phase 2a study due to report in the second half of
2020.

Additionally, Pharmaxis provided an update on its wider pipeline including its
anti-fibrotic LOXL2 inhibitor programme, which it is currently seeking to
partner, and a pan LOX inhibitor targeting myelofibrosis that it plans to
advance into patients in 2020.

The announcement can be accessed on the Pharmaxis investor website
at http://www.pharmaxis.com.au/investor-centre/news/ and full text of the
announcement from Pharmaxis is contained below. A recording of the Pharmaxis
Investor conference call held 18 December 2019 at 9.15am AEDT is
available here
(https://linkprotect.cudasvc.com/url?a=https%3a%2f%2fservices.choruscall.com.au%2fwebcast%2fpharmaxis-191218.html&c=E,1,HCEenQpekGE_HzI891iL1xfSy6ufTOYNZwu2Fwf-pJQSCG-qIKSFUC79VHDEPpRSqT6jnpYzGJLa4tZ97MQgCO7ilwZCdi-e3MleAGu-lI4Yd-s2&typo=1).

 ENDS 

Enquiries

Arix Bioscience plc
Charlotte Parry, Head of Investor Relations
+44 (0)20 7290 1072
charlotte@arixbioscience.com  

Optimum Strategic Communications
Mary Clark, Supriya Mathur
+44 (0)203 714 1787
optimum.arix@optimumcomms.com

About Arix Bioscience plc

Arix Bioscience plc is a global venture capital company focused on investing
in and building breakthrough biotech companies around cutting edge advances in
life sciences. We collaborate with exceptional entrepreneurs and provide the
capital, expertise and global networks to help accelerate their ideas into
important new treatments for patients. As a listed company, we are able to
bring this exciting growth phase of our industry to a broader range of
investors.

Arix Bioscience plc is listed on the Main Market of the London Stock Exchange.
For further information, please visit www.arixbioscience.com

About NASH

Non-alcoholic fatty liver disease (NAFLD), the most common liver disease in
Western industrialized nations, and its more serious form non-alcoholic
steatohepatitis (NASH) are especially highly prevalent in patients with
metabolic disorders such as type 2 diabetes and obesity. NASH is a major cause
of liver fibrosis and cirrhosis and is an area of high unmet medical need with
no approved treatments currently available. The high prevalence of type 2
diabetes and obesity is expected to make NASH one of the most common causes of
advanced liver diseases in coming decades. 1 out of 4 adults is assumed to
have NAFLD, and the prevalence of NASH has been estimated to range from 1.5
per cent to 6.45 per cent in current research, a number twice as high as 20
years ago. 

PHARMAXIS BUSINESS PLAN RESOURCED TO COMPLETE PARTNERING AND CLINICAL
DEVELOPMENT MILESTONES

Media Release: 18 December 2019

Pharmaceutical research company Pharmaxis Ltd (ASX: PXS) today provided an
update on its business plan following a decision by Boehringer Ingelheim (BI)
not to progress studies of the AOC3 inhibitor acquired from Pharmaxis in 2015
for the treatment of NASH. The reason provided by BI for the discontinuation
after a successful phase 2a study that met its safety and efficacy endpoints
was the potential for drug interactions in NASH patients. A second study of
the drug in diabetic retinopathy with associated milestone payments will
continue with future development to be decided by BI following completion of
the current phase 2a study due to report 2H 2020.

Boehringer Ingelheim’s decision has no impact on short term cash as the next
milestone payment for NASH was not scheduled until the commencement of a phase
3 study in several years’ time.

Pharmaxis closed the September quarter with $23 million cash, and in October
received its 2019 R&D tax incentive of $6.2 million. In addition, Pharmaxis
anticipates receipt of a US$10 million milestone payment for Bronchitol® from
its US licensee Chiesi in Q3 2020 subject to FDA approval midyear.

The company’s drug development pipeline includes two drug projects that can
be brought to significant valuation points with the current cash position:
* Partnering of best in class anti fibrotic LOXL2 inhibitor program
 The company confirms that it is engaged in discussions with potential
partners and that those discussions will continue into next year. A variety of
deal structures are being considered including global pharma and regional
pharma deals, all of which fund the future LOXL2 inhibitor development
program.
* Commencement of clinical proof of concept studies in myelofibrosis
 The company’s systemic pan-LOX inhibitor program has recently cleared
3-month tox studies and is anticipated to successfully conclude the final
stage of a phase 1 study in healthy volunteers in Q1 2020. The company will
shortly seek approval from the FDA on orphan status for the treatment of the
bone marrow cancer myelofibrosis and seek feedback via the IND process on
progressing to phase 2 trials in this disease where there is a high level of
unmet need and an existing market value in excess of US$1 billion per annum.
Pharmaxis CEO, Gary Phillips said, “We are obviously disappointed by BI’s
decision not to progress the compound acquired from Pharmaxis in NASH.  This
was unexpected.  We understand the significant hurdles to overcome in the
early stages of drug development. That is why the company has pursued a
strategy of generating multiple research pipeline opportunities underpinned by
our cash position and a partnering strategy which offlays development risk
where appropriate.”

The company also has a topical pan LOX inhibitor program that has potential in
scar revision. This program is currently completing late stage pre-clinical
testing and is anticipated to enter a phase 1 clinical trial in healthy
volunteers in 2020.

Mr Phillips commented, “The topical LOX inhibitor has significant market
potential in both post-surgical and cosmetic indications. The company will
carefully consider the optimal development plan based on the financial
resources required and the level of interest from pharma companies with an
interest in dermatology.”

#ENDS#

SOURCE: Pharmaxis Ltd, Sydney, Australia

AUTHORISED FOR RELEASE TO ASX BY:

Pharmaxis Ltd Disclosure Committee. Contact: David McGarvey, Chief Financial
Officer and Company Secretary: T +61 2 9454 7203, E
david.mcgarvey@pharmaxis.com.au

CONTACT:

Media: Felicity Moffatt: T +61 418 677 701, E
felicity.moffatt@pharmaxis.com.au

Investor relations: Rudi Michelson (Monsoon Communications) T +61 411 402 737,

E rudim@monsoon.com.au

About Pharmaxis

Pharmaxis Limited is an Australian pharmaceutical research company and a
global leader in drug development for inflammation and fibrotic diseases. The
company has a highly productive drug discovery engine, drug candidates in
clinical trials and significant future cash flows from partnering deals.

Leveraging its small-molecule expertise and proprietary amine oxidase
chemistry platform, Pharmaxis has taken four in-house compounds to Phase 1
trials in just five years. Boehringer Ingelheim acquired the Pharmaxis
anti-inflammatory AOC3 inhibitor in 2015 to develop it (BI 1467335) for two
diseases: the liver condition Non?alcoholic Steatohepatitis (NASH) and
diabetic retinopathy (DR).

The company’s successor amine oxidase program has developed an oral
anti-fibrotic LOXL2 inhibitor, aimed at NASH, pulmonary fibrosis (IPF) and
other high-value fibrotic heart and kidney diseases, with a commercial
partnering process underway. Two further new drugs from the same program are
expected to begin proof-of-efficacy trials in 2020. Pharmaxis’ Mannitol
platform has yielded the products Bronchitol® for cystic fibrosis, which is
marketed in Europe, Russia and Australia, with United States FDA approval
pending; and Aridol® for the assessment of asthma, which is sold in the
United States, Europe, Australia and Asia.

Pharmaxis is listed on the Australian Securities Exchange (PXS). Its head
office, manufacturing and research facilities are in Sydney, Australia.
http://www.pharmaxis.com.au/

Forward-Looking Statements

Forward?looking statements in this media release include statements regarding
our expectations, beliefs, hopes, goals, intentions, initiatives or
strategies, including statements regarding the potential of products and drug
candidates. All forward-looking statements included in this media release are
based upon information available to us as of the date hereof. Actual results,
performance or achievements could be significantly different from those
expressed in, or implied by, these forward-looking statements. These
forward-looking statements are not guarantees or predictions of future
results, levels of performance, and involve known and unknown risks,
uncertainties and other factors, many of which are beyond our control, and
which may cause actual results to differ materially from those expressed in
the statements contained in this document. For example, despite our efforts
there is no certainty that we will be successful in partnering our LOXL2
program or any of the other products in our pipeline on commercially
acceptable terms, in a timely fashion or at all. Except as required by law we
undertake no obligation to update these forward-looking statements as a result
of new information, future events or otherwise.



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