FREIENBACH, Switzerland–(BUSINESS WIRE)–#Bronchitol—EffRx Pharmaceuticals SA, a commercial-stage company that
commercializes niche and orphan medicines in Switzerland and Europe,
today announced it has entered into an exclusive license agreement with
Pharmaxis Ltd, a listed pharmaceutical research company in Australia,
for the registration and commercialization of Bronchitol®
(mannitol) for cystic fibrosis in Switzerland.
Under the terms of the agreement, EffRx will take responsibility for
registering, obtaining pricing and reimbursement as well as
commercializing Bronchitol® in Switzerland. Bronchitol®
works by rehydrating the airway/lung surface and promoting a productive
cough, hence improving mucus clearance and lung function. The product is
inhaled as dry powder twice daily using a small handheld device and it
is expected to be available on the Swiss market by 2021.
Cystic fibrosis is a hereditary rare disorder affecting the exocrine
glands. It causes the production of abnormally thick mucus, leading to
disease manifestations primarily in the lungs, but also in pancreas,
intestines, liver and kidneys. Cystic fibrosis patients often suffer
from frequent respiratory tract infections. According to the Swiss
Society for Cystic Fibrosis (CFCH), there are about 1,000 people
affected by cystic fibrosis in Switzerland. While there is no cure for
the disease, thanks to medical advances, a majority of cystic fibrosis
sufferers today reach adulthood.
“We are extremely pleased to announce this exclusive licensing agreement
for Bronchitol®. We look forward to making this novel
therapeutic option accessible to Swiss patients suffering from cystic
fibrosis”, commented Lorenzo Bosisio, CEO of EffRx Pharmaceuticals. “We
are encouraged by the clinical data and experience with Bronchitol®
which show that this convenient treatment is well-tolerated and can lead
to improvements in lung function.”
Gary Phillips, CEO of Pharmaxis said, “Our team is delighted to have
entered this collaboration with EffRx. We are keen to leverage the
go-to-market expertise of EffRx to bring Bronchitol®
to the Swiss market and are pleased to secure in EffRx an experienced
commercial partner.”
This licensing agreement underpins EffRx strategy to expand its
portfolio through licensing collaborations in Europe and Switzerland
with innovative biopharmaceutical companies developing promising niche
and orphan medicines.
Bronchitol® has been the subject of three large-scale,
global clinical trials conducted by Pharmaxis. It is approved and
marketed in Europe, Russia, Australia and several other countries. In
the United States, Bronchitol® has recently received a
positive recommendation from a Committee advising the US Food and Drug
Administration (FDA) on the use of Bronchitol® for
adult cystic fibrosis patients; with the FDA expected to advise its
decision within the next few weeks.
About EffRx Pharmaceuticals
EffRx
Pharmaceuticals is a commercial-stage pharmaceutical company focused
on the late stage development and commercialization of prescription
medications for niche and orphan indications. The business model is
centered around providing superior clinical and commercial value
propositions for physicians, payers and patients. EffRx aims to be the
preferred accelerator for late clinical and regulatory development,
approval, valorization of niche and orphan medicines in Switzerland and
Europe.
EffRx pro-actively seeks in-licensing opportunities for Europe in niche
therapeutic areas, with a primary interest for rare diseases, where
EffRx has received an orphan drug designation (ODD) from FDA for a
pipeline asset.
EffRx’s go-to-market competence is proven by the development, launch and
lucrative expansion of Binosto® in a highly
competitive European market. Our lead commercialized product, Binosto®
for the treatment of osteoporosis, is licensed in 50+ countries and
marketed in the US, Europe, selected MENA and Asian countries.
About Pharmaxis
Pharmaxis
(ACN 082 811 630) is an Australian pharmaceutical research company
focused on inflammation and fibrosis with a portfolio of products at
various stages of development and approval. Its product Bronchitol®
for cystic fibrosis is marketed in Europe, Russia and Australia. Its
product Aridol® for the assessment of asthma is sold
in the United States, Europe, Australia and Asia. The company’s
development pipeline is centered on its expertise in amine oxidase
chemistry and includes a series of Lysyl Oxidase Inhibitors under
clinical development targeting fibrotic diseases of the heart, kidney,
liver and lung. Pharmaxis is listed on the Australian Securities
Exchange (symbol PXS). The company’s head office, manufacturing and
research facilities are located in Sydney, Australia. For more
information about Pharmaxis, please see www.pharmaxis.com.au
Contacts
Pamela Saredi
psaredi@effrx.com