FRENCHS FOREST, Australia and
INGELHEIM, Germany, May 18, 2015 /PRNewswire/ --
- Boehringer Ingelheim exercises option and acquires global
ownership of Pharmaxis' investigational anti-inflammatory drug
candidate PXS4728A, including associated intellectual property
rights.
- PXS4728A is a highly selective oral small molecule inhibitor of
vascular adhesion protein-1 that has shown activity in pre-clinical
investigation in non-alcoholic steatohepatitis (NASH).
- Drug candidate will be investigated for the treatment of NASH
and has further potential in chronic obstructive pulmonary disease
(COPD) and other diseases with high medical need.
- The acquisition of this investigational anti-inflammatory
drug-candidate adds a highly innovative approach to Boehringer
Ingelheim's clinical development portfolio.
- Pharmaxis is transformed by significant deal size and
recognition of its drug discovery expertise.
Boehringer Ingelheim and pharmaceutical company Pharmaxis (ASX:
PXS) announce that Boehringer Ingelheim has exercised its option
and acquired the investigational drug PXS4728A, to develop it
for the treatment of the liver-related condition NASH and to
prevent its consequences. PXS4728A is a Semicarbazide-Sensitive
Amine Oxidase/Vascular Adhesion Protein-1 (SSAO/VAP-1) Inhibitor
discovered by Pharmaxis that works by blocking leucocyte adhesion
and tissue infiltration in inflammatory processes. Pharmaxis has
developed it through to phase 1 clinical studies, demonstrating
oral bioavailability, long-lasting target inhibition and good
tolerability and safety.
NASH is the progressive form of non-alcoholic fatty liver
disease (NAFLD), the most common liver disorder in Western
industrialized nations. It is regarded as a major cause
of fibrosis and cirrhosis of the liver and is an area of
high unmet clinical need. The high prevalence of type 2 diabetes
and obesity, which can lead to NASH and its long term consequences,
is considered to make NASH one of the most common causes of
advanced liver disorders in coming decades.
Pharmaxis CEO Mr Gary Phillips
said, "This is a transformational event for Pharmaxis. With a total
potential value in excess of $A750
million, it is a globally competitive deal and significant
for the Australian biotech sector. We are delighted that Boehringer
Ingelheim, a leader in cardiometabolic research and development,
has acquired PXS4728A. Boehringer Ingelheim's clinical expertise
will now be applied to the development of this drug which has the
potential to make a real difference in the treatment of diseases
with high unmet clinical need."
Glyn Parkin, Corporate SVP and Metabolism Head at Boehringer
Ingelheim commented, "We have ambitious strategic goals in diabetes
and metabolism and this Phase 1 asset acquisition fits well into
our development portfolio. We are pleased to have achieved access
to Pharmaxis' research excellence and innovative approach to
treatments for NASH. We will continue to build our portfolio
through both internal and external innovation so that we are able
to bring much needed medications to the patients we serve."
Pharmaxis will receive an upfront payment of EUR27.5 million (approximately A$39m) and, subject to the continuing successful
development and commercialisation of the PXS4728A program, the
following payments:
- up to a total of EUR55 million
in development milestone payments tied to the commencement of phase
2 and 3 clinical trials
- up to a total of EUR140 million
in regulatory milestone payments upon filing of applications for
marketing approval and receipt of regulatory and pricing approvals
for a PXS4728A program product in the major pharmaceutical markets
(i.e., USA, EU, and
China or Japan) for the first indication
- additional milestone payments similar in total to those set
forth above upon achievement of the same development and regulatory
milestone events by a PXS4728A program product for a second
indication
- earn-out payments on annual net sales of PXS4728A program
products at tiered percentages starting in the high single
digits
- commercialisation milestone payments upon achievement of
specified levels of annual net sales of PXS4728A program
products
Boehringer will be responsible for all development, regulatory,
manufacturing and commercialisation activities. Under the
agreement, Boehringer has also acquired other SSAO/VAP-1 inhibitor
molecules related to PXS4728A and associated patents.
Contact:
Pharmaxis
Felicity
Moffatt
Phone: +61-418-677-701
felicity.moffatt@pharmaxis.com.au
|
Contact:
Boehringer Ingelheim
Dr. Reinhard Malin
Director Corporate Communications - Oncology and Pipeline
Phone: +49 (6132) 77-90815
reinhard.malin@boehringer-ingelheim.com
|
About Pharmaxis
Pharmaxis (ACN 082 811 630) is a specialist pharmaceutical
company with a portfolio of products at various stages of
development and approval. Its product Bronchitol® for cystic
fibrosis is marketed in Europe and
Australia and a phase 3 trial to
enable completion of an NDA for the US market is underway. Its
product Aridol® for the assessment of asthma is sold in
Europe, Australia and Asia. The company's development pipeline is
centred around its expertise in amine oxidase chemistry and
includes Semicarbazide-Sensitive Amine Oxidase Inhibitors (SSAO)
for Non-alcoholic Steatohepatitis (NASH) and inflammatory
diseases including Chronic Obstructive Pulmonary Disease (COPD),
and Lysyl Oxidase Inhibitors (LOX) targeting fibrotic diseases
including pulmonary fibrosis and some cancers. Pharmaxis is listed
on the Australian Securities Exchange (symbol PXS). The company's
head office, research and manufacturing facilities are located in
Sydney, Australia.
About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading
pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates
globally with 146 affiliates and a total of more than 47,700
employees. The focus of the family-owned company, founded in 1885,
is researching, developing, manufacturing and marketing new
medications of high therapeutic value for human and veterinary
medicine.
Social responsibility is an important element of the corporate
culture at Boehringer Ingelheim. This includes worldwide
involvement in social projects, such as the initiative "Making more
Health" and caring for the employees. Respect, equal opportunities
and reconciling career and family form the foundation of the mutual
cooperation. In everything it does, the company focuses on
environmental protection and sustainability.
In 2014, Boehringer Ingelheim achieved net sales of about
13.3 billion euros. R&D
expenditure corresponds to 19.9 per cent of its net sales.
About NASH
NASH is the progressive form of non-alcoholic fatty liver
disease (NAFLD) which is the most common liver disorder in Western
industrialized nations with an estimated 30% prevalence in
the United States for NAFLD and
3-5% for NASH. NASH is regarded as a major cause
of cirrhosis of the liver and is an area of high unmet
clinical need. The high prevalence of type 2 diabetes and obesity,
which can lead to NASH and other non-alcoholic fatty liver
diseases, is expected to make NASH potentially the most
common cause of advanced liver conditions in coming decades and the
market has been estimated to exceed $3.5billion by 2025.
Forward-Looking Statements
Forwardlooking statements in this media release include
statements regarding our expectations, beliefs, hopes, goals,
intentions, initiatives or strategies, including statements
regarding the potential of PXS4728A. All forward-looking statements
included in this media release are based upon information available
to us as of the date hereof, and we assume no obligation to update
any such forwardlooking statement as a result of new information,
future events or otherwise. We cannot guarantee that any product
candidate will receive regulatory approval or that we will seek any
such approval.
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SOURCE Pharmaxis Ltd