Xbrane signs deal with Helvetic BioPharma for its lead ranibizumab biosimilar, Xlucane

The deal is based on milestone payments during 2016 and royalty payments per sold dose. Product launch is expected during 2017.

Xlucane is a biosimilar version of Lucentis, containing the active substance ranibizumab, and is used primarily for treatment of the wet form of age-related macula degeneration, an eye disease that leads to impaired vision and in worst case blindness. Lucentis currently generates annual sales of approximately €3.8 billion globally. The deal is based on milestone payments during 2016 and royalty payments per sold dose. Product launch is expected during 2017.

"This agreement gives us a strong position as the first company on the Iranian market to sell a ranibizumab biosimilar. Helvetic BioPharma estimates that 70.000 people suffer from the disease in Iran, as the prevalence of the disease is similar to the rest of the world. Through this agreement we will be able to bring Xlucane to the market in Iran much earlier than previously planned and it also enables us to accelerate commercialization in other geographies," says Martin Åmark, CEO of Xbrane Biopharma.

Patents for Lucentis in the US and EU expire 2020 and 2022 respectively, while the drug lacks patent protection in many emerging markets including Iran. The world's first Ranibizumab biosimilar was recently introduced by Intas Pharmaceuticals in India. Treatment with Lucentis is based on monthly injections during up to 24 months, with an average list price per dosage of approximately €1.000 in the US and EU.

"We believe there is a high demand for a viable treatment of age related macula degeneration in Iran covered by the publicly funded social security system. We see great potential for launching a ranibizumab biosimilar in the Iranian market and we are delighted to have signed this important deal with Xbrane as their product, Xlucane, has very good in-vitro characterization data and has a very good production yield, which will be critical in the Iranian market," comments Mohsen Nayebpour, CEO of Helvetic BioPharma.

Production will be done in Pooyesh Darou's, a Helvetic BioPharma affiliate, facilities in Iran. Clinical studies will be conducted in Iran during the second half of 2016. Sales of the product can be initiated during 2017.

"We are pleased to have signed our second agreement for the Iranian market. Helvetic BioPharma affiliate, Pooyesh Darou, is one of the leading biotech companies in the Middle East and has an impressive track record of reaching near full penetration in Iran on all introduced biogeneric products. Iran is a very interesting market with a population of 80 million, of which more than 90 percent are covered by the publicly-funded health care and we see it as an ideal first market for our lead biosimilar product Xlucane," commented Martin Åmark, CEO of Xbrane