Pratteln, Switzerland, February 15, 2018 - Santhera Pharmaceuticals (SIX: SANN) announces that it has entered into a license agreement with Polyphor Ltd. for POL6014, a clinical stage selective inhibitor of human neutrophil elastase with the potential to treat cystic fibrosis (CF) and other neutrophilic pulmonary diseases such as non-cystic fibrosis bronchiectasis (NCFB), alpha-1 antitrypsin deficiency (AATD) and primary ciliary dyskinesia (PCD).
Santhera will assume the global development, regulatory filings and commercialization of POL6014. The development program has been advanced with financial support by the Cystic Fibrosis Foundation Therapeutics Inc. (CFFT), USA, to Polyphor. With POL6014, Santhera is expanding its product pipeline in pulmonary diseases where the Company is already developing its lead product idebenone for respiratory complication in Duchenne muscular dystrophy.
Under the agreement, Santhera obtains the worldwide, exclusive rights to develop and commercialize POL6014, an innovative macrocycle elastase inhibitor, and analogs for an initial payment of CHF 6.5 million, payable in Santhera shares at an agreed valuation of CHF 27.2053 per share and additional cash payments of up to CHF 121 million contingent to future development, regulatory and particularly sales milestones. In addition, Polyphor is entitled to tiered royalty payments from Santhera's future net sales of POL6014 and to undisclosed milestone payments and royalties provided that Santhera advances the development and market entry of POL6014 in other pulmonary diseases. Santhera expects to issue the 238,924 shares (3.8% of its currently issued shares) required for the initial payment to Polyphor out of its existing authorized share capital.
"With the licensing of POL6014 Santhera is broadening its clinical stage pipeline in rare diseases with the option to address multiple pulmonary indications," said Thomas Meier, PhD, CEO of Santhera. "There is still a high unmet medical need in treating the chronic inflammation in patients with cystic fibrosis and other neutrophilic pulmonary diseases. In a first step, we intend to execute a multiple ascending dose (MAD) tolerability trial during the second half of 2018 which has already been planned by Polyphor. In parallel, we will initiate discussions with EU and U.S. regulators around the development program for POL6014 in CF and other indications."