Oslo, August 21, 2017 - Navamedic ASA (OSE: NAVA), the Norwegian medtech and pharmaceutical products company, today announced it has entered into a long term agreement with bene-Arznemittel GmbH (bene) for the Nordic launch and commercialisation of ELMIRON®, the only EU approved oral medication used to treat adults with bladder pain syndrome.
"We are very pleased to announce the partnership with bene-Arzneimittel for distribution of the prescription medicine, ELMIRON (pentosan polysulfate sodium), in the Nordics. ELMIRON is used to treat adults with moderate to severe pain related to bladder pain syndrome and Interstitial Cystitis and is the only oral prescription medicine of its kind to be approved by the EU. We believe the partnership opens up a significant market opportunity and revenue potential, as we can leverage a well-established position the Nordic market and a proven track record within the field of urology. The ten-year agreement is also in line with our strategic approach of further strengthening our pharmaceutical products portfolio and entering solid, long-term partnerships," says Tom Rönnlund, Chief Executive Officer of Navamedic.
ELMIRON® (pentosane polysulfate sodium) is used to treat adults with bladder pain syndrome or discomfort associated with Interstitial Cystitis (IC), a condition which causes pain in the pelvic area and a frequent, urgent need to pass urine. Bladder pain and IC is estimated to affect 18 for every 100,000 in the European Union, with 90% of patients being women over the age of 40. In patients with small bleeds and lesions in the bladder wall, treatment with ELMIRON® led to a significantly greater number of patients having an overall improvement in symptoms.
The medication, which is already well-established in the US market, is the only oral medication approved by the European Medicines Agency (EMA) to treat bladder pain syndrome. Under the agreement, Navamedic will have long term exclusive licensing-, supply- and distribution rights in Sweden, Denmark, Norway, Finland and Iceland. Navamedic expects to introduce the product during the first half of 2018.
"Bladder pain syndrome is a distressing condition for which no medicines have previously been approved in the EU. Treated with ELMIRON, more patients will have an overall symptoms improvement and the risk of bleeding can be minimised with appropriate precautions. We believe this long-term agreement with bene is a great opportunity for Navamedic to expand our pharmaceutical products portfolio with a product with significant market potential," says Rönnlund.
For further information, please contact:
Tom Rönnlund, CEO, Navamedic ASA
Telephone: +46 727 320 321
ABOUT Bladder Pain Syndrome (BPS)
Bladder pain syndrome is characterized by either glomerulations or Hunner's lesions is a severe chronic bladder disease that substantially reduces quality of life. For those affected by the condition, it means very frequent and painful urination, as well as severe pain in the lower abdomen. Affecting less than two patients per 10,000 people on average and being associated with a large degree of suffering, the condition has been officially recognised as an orphan disease.
The causes of this chronic disease include damage to the bladder lining, affecting the glycosaminoglycan (GAG) layer in particular. As a result, the protective effect of this layer is reduced, and toxic constituents of urine are able to penetrate into underlying tissue layers and cause tissue irritation or inflammation.
ABOUT Pentosan Polysulfate (PPS) / ELMIRON®
In European guidelines, pentosan polysulfate (PPS) is specified as a standard drug for the treatment of bladder pain syndrome. Due to its structural similarity to glycosaminoglycans, PPS is able to rebuild the damaged GAG layer of the bladder, thus preventing harmful substances from penetrating into the underlying tissue layers. In addition, PPS also promotes the inhibition of the release of the tissue hormone histamine, thereby reducing the accompanying symptom of inflammation caused by the disease.
ABOUT NAVAMEDIC:
Navamedic ASA is a Norwegian medtech and pharmaceutical products company, delivering products to patients, hospitals and pharmacies in the Nordic and Benelux markets. The Group's Medtech business has developed and is currently introducing the next generation of digital urine meter Sippi®. Navamedic's Pharma and Healthcare business is a distributor of products supplied by a number of pharmaceutical manufacturers. Navamedic is listed on the Oslo Stock Exchange (ticker: NAVA).
ABOUT bene-Arnzeimittel
bene-Arzneimittel GmbH is a medium-sized pharmaceutical company focused on analgesic, paediatric and urological medicines. As the pioneer of paracetamol in Germany, bene has a long lasting competence in treating children and other sensitive patient groups. Beyond that, bene offers unique and innovative pharmaceuticals e.g. with pentosan polysulfate. bene-Arzneimittel GmbH develops, produces and sells a balanced range of medicinal products and medical devices in Europe and selected countries worldwide.