FREIENBACH, Switzerland (BUSINESS WIRE) – 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.
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
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