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Sunovion to acquire Elevation Pharmaceuticals
by Kelsey Kaustinen  |  Email the author


MARLBOROUGH, Mass.Sunovion Pharmaceuticals Inc. has announced 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 drug candidate, an inhalation solution of a long-acting muscarinic antagonist bronchodilator. The compound is currently undergoing Phase IIb clinical trials under the indication of treating patients with moderate to severe chronic obstructive pulmonary disease (COPD).
"The acquisition of Elevation Pharmaceuticals will further strengthen and diversify our respiratory pipeline and portfolio, and enable Sunovion to continue to meet the needs of people living with respiratory diseases 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 $100 million upfront to Elevation's shareholders upon closing of the acquisition of its shares, after which it will also make developmental milestone payments for EP-101, up to $90 million. Upon attaining regulatory approval for the compound, Sunovion will make commercial milestone payments that could total up to $210 million, will additional milestone payments that could total up to $30 million based on the successive development of additional programs. The transaction has been approved by the boards of directors of both companies, and is subject to customary closing conditions.
EP-101 is a proprietary solution formulation of glycopyrrolate, and is delivered by a customized eFlow Nebulizer System, which is created by and licensed from PARI Pharma GmbH. The system is designed for easier use as well as optimized delivery of the medication, and EP-101 is intended for patients whose conditions are not well controlled by the current standard of care or who prefer a nebulizer. The eFlow Nebulizer System offers a reduced administration time, taking less than two minutes compared to the five to 10 minutes of a standard jet nebulizer, with a more portable size and decreased noise level than standard devices.  
"EP-101 is currently the only LAMA in late stage development in nebulized form, providing a significant opportunity to address the needs of patients struggling with the control of their COPD using handheld inhalers," said Nomura in a statement. "With our extensive expertise in successfully launching and commercializing nebulized respiratory treatments, we have the knowledge and infrastructure necessary to complete the development of this important medication."  
EP-101 has undergone two Phase II studies so far, with another expected to take place this year to determine the product's efficacy and safety in patients suffering from moderate to severe COPD. Phase III trials for the treatment are expected to begin in the second half of 2013.  
Elevation Pharmaceuticals has two other product candidates in its development pipeline, including EP-102 (LAMA/LABA) and EP-103 (LAMA/ICS). Both compounds are indicated for COPD, though EP-103 has a secondary indication for asthma. EP-102 is currently approaching the end of Phase I development, and EP-103 is still undergoing formational development.  
"Nebulized medicine is an important treatment option for older and sicker patients -- the fastest growing segment within COPD," Bill Gerhart, founder and CEO of Elevation Pharmaceuticals, said in a press release. "Sunovion is the ideal sponsor to realize our original vision to significantly elevate the standard of care for this underserved patient population."
Code: E08291201



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