MARLBOROUGH, Mass.—Sunovion Pharmaceuticals Inc. hasannounced the signing of a definitive agreement with Elevation Pharmaceuticals,Inc. under which it will acquire the privately held biopharmaceutical company.The acquisition includes EP-101, Elevation Pharmaceuticals' lead drugcandidate, an inhalation solution of a long-acting muscarinic antagonistbronchodilator. The compound is currently undergoing Phase IIb clinical trialsunder the indication of treating patients with moderate to severe chronic obstructivepulmonary disease (COPD).
"The acquisition of Elevation Pharmaceuticals willfurther strengthen and diversify our respiratory pipeline and portfolio, andenable Sunovion to continue to meet the needs of people living with respiratorydiseases and the healthcare providers who treat them," Hiroshi Nomura,vice chair of Sunovion Pharmaceuticals, said in a press release.
Per the terms of the agreement, Sunovion will pay $100million upfront to Elevation's shareholders upon closing of the acquisition ofits shares, after which it will also make developmental milestone payments forEP-101, up to $90 million. Upon attaining regulatory approval for the compound,Sunovion will make commercial milestone payments that could total up to $210million, will additional milestone payments that could total up to $30 millionbased on the successive development of additional programs. The transaction hasbeen approved by the boards of directors of both companies, and is subject tocustomary closing conditions.
EP-101 is a proprietary solution formulation ofglycopyrrolate, and is delivered by a customized eFlow Nebulizer System, whichis created by and licensed from PARI Pharma GmbH. The system is designed foreasier use as well as optimized delivery of the medication, and EP-101 isintended for patients whose conditions are not well controlled by the currentstandard of care or who prefer a nebulizer. The eFlow Nebulizer System offers areduced administration time, taking less than two minutes compared to the five to10 minutes of a standard jet nebulizer, with a more portable size and decreasednoise level than standard devices.
"EP-101 is currently the only LAMA in late stagedevelopment in nebulized form, providing a significant opportunity to addressthe needs of patients struggling with the control of their COPD using handheldinhalers," said Nomura in a statement. "With our extensive expertisein successfully launching and commercializing nebulized respiratory treatments,we have the knowledge and infrastructure necessary to complete the developmentof this important medication."
EP-101 has undergone two Phase II studies so far, withanother expected to take place this year to determine the product's efficacyand safety in patients suffering from moderate to severe COPD. Phase III trialsfor the treatment are expected to begin in the second half of 2013.
Elevation Pharmaceuticals has two other product candidatesin its development pipeline, including EP-102 (LAMA/LABA) and EP-103(LAMA/ICS). Both compounds are indicated for COPD, though EP-103 has asecondary indication for asthma. EP-102 is currently approaching the end ofPhase I development, and EP-103 is still undergoing formational development.
"Nebulized medicine is an important treatment optionfor older and sicker patients -- the fastest growing segment within COPD,"Bill Gerhart, founder and CEO of Elevation Pharmaceuticals, said in a pressrelease. "Sunovion is the ideal sponsor to realize our original vision tosignificantly elevate the standard of care for this underserved patientpopulation."
