Allschwil, Switzerland, February 15, 2018
Polyphor to receive CHF6.5 million upfront and is eligible for additional
CHF121 million in future milestone payments plus tiered double-digit royalties
Polyphor announced today that it has entered into an exclusive, global license agreement with Santhera Pharmaceuticals to further develop and commercialize the inhaled neutrophil elastase inhibitor, POL6014, in Cystic Fibrosis (CF) and other neutrophilic lung diseases. POL6014, derived from Polyphor's proprietary macrocycle platform and advanced with the support of an award by the Cystic Fibrosis Foundation Therapeutics Inc., has already successfully completed a Phase Ib study in people with CF, confirming the safety, favorable pharmacokinetic profile, and strong elastase inhibition and confirming the previous data from preclinical studies, including animal models.
Under the terms of the agreement, Polyphor will receive an upfront payment of CHF6.5 million paid in the form of Santhera shares and could receive up to an additional CHF121 million in potential development, regulatory and sales milestones for the initial indication, as well as tiered double-digit royalties on sales. Santhera will have the exclusive worldwide rights to develop and commercialize POL6014, and assume full responsibility for its development within agreed timelines. If other indications are successfully developed, Polyphor would be entitled to additional undisclosed milestone payments and additional royalties.
"We are very excited to be licensing this program to Santhera, a specialty pharmaceutical company highly committed to the development and commercialization of orphan drugs with a strong and experienced team in the field of rare diseases and in respiratory trials," said Giacomo Di Nepi, Chief Executive Officer of Polyphor. "There is a high unmet medical need for the treatment of chronic neutrophilic lung inflammations."
"This collaboration is a further validation of the ability of our macrocycle platform to generate high-value, innovative new drug candidates. Our own efforts can now be further focused on advancing the Phase III program for our novel antibiotic, murepavadin, the first representative of a new class against Gram-negative bacteria to enter Phase III in several decades. We are also focusing on the development of our immuno-oncology asset, balixafortide, and generating further novel antibiotics from our OMPTA platform."
POL6014 is a highly potent and selective inhibitor of human neutrophil elastase (hNE). It is administered by inhalation via an optimized eFlow(R) nebulizer (PARI Pharma GmbH) and was shown to reach high concentrations in the lung while the systemic exposure remains low. A first-in-man Phase I study in healthy volunteers and a Single Ascending Dose (SAD) safety and tolerability Phase I study in CF patients have successfully been completed with POL6014. The drug candidate was well tolerated and safe with a favorable pharmacokinetic profile and strong elastase inhibition as previously shown in animal models. In addition, POL6014 may show therapeutic benefit for a range of neutrophilic pulmonary diseases with high medical need such as Non-Cystic Fibrosis Bronchiectasis, Alpha-1 Antitrypsin Deficiency or Primary Ciliary Dyskinesia.
Polyphor is a clinical stage, privately held Swiss specialty pharma company which has discovered and is developing the OMPTA (Outer Membrane Protein Targeting Antibiotics). The OMPTA are the first new class of antibiotics against Gram-negative bacteria to have reached phase III stage in the last 50 years. The company's lead product, murepavadin, (POL7080) is in Phase III development against Pseudomonas aeruginosa - recognized as a critical priority 1 pathogen by WHO. Polyphor is also developing an immuno-oncology candidate, balixafortide (POL6326), currently in Phase I / PoC for combination treatment in metastatic breast cancer, and a pipeline of further preclinical antibiotics based on its OMPTA platform. Polyphor is based in Allschwil near Basel. For more information, please visit www.polyphor.com
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Tel: +41 61 567 16 67
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