Santhera enters agreement with Polyphor to licence POL6014

Santhera Pharmaceuticals announced on Thursday that it has entered into a license agreement with Polyphor 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).

The Swiss drugmaker said it would assume the global development, regulatory filings and commercialization of POL6014.

It said the development programme had been advanced with financial support from Cystic Fibrosis Foundation Therapeutics in the US, to Polyphor.

With POL6014, Santhera said it was expanding its product pipeline in pulmonary diseases where it was already developing its lead product idebenone for respiratory complication in Duchenne muscular dystrophy.

Under the agreement, Santhera obtained the worldwide, exclusive rights to develop and commercialize POL6014 - an innovative macrocycle elastase inhibitor - and its analogues for an initial payment of CHF 6.5m, payable in Santhera shares at an agreed valuation of CHF 27.2053 per share, and additional cash payments of up to CHF 121m contingent on future development, regulatory and particularly sales milestones.

In addition, Polyphor would be entitled to tiered royalty payments from Santhera's future net sales of POL6014 and to undisclosed milestone payments and royalties provided that Santhera advanced the development and market entry of POL6014 in other pulmonary diseases.

Santhera said it expected to issue the 238,924 shares - 3.8% of its currently issued shares - required for the initial payment to Polyphor out of its existing authorised 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.”

As a first step, Meier said Santhera intended to execute a multiple ascending dose tolerability trial during the second half of 2018, which had already been planned by Polyphor.

“In parallel, we will initiate discussions with EU and US regulators around the development program for POL6014 in CF and other indications.”