Sulopenem was licensed from Pfizer in late 2015 and under the license agreement, Pfizer received an initial equity interest and an upfront cash payment from Iterum. Pfizer is also eligible to receive additional equity, development and commercial event-driven cash milestone payments and royalties based upon global net sales of any potential sulopenem products.
In the initial indications of interest, it is estimated that there are more than 25 million infections annually in the U.S. alone, with approximately 80 percent of those occurring in uUTI. Resistance to fluoroquinolones, currently a main treatment in uUTI, has become an issue in many parts of the country and is expected to continue to rise. Additionally, there have been no new treatments approved for uUTI in the last 20 years. "With very limited products in late-stage development for uUTI, resistance rates to fluoroquinolones above 30 percent in some parts of the country and the strong profile of sulopenem, we believe that our new, unique oral agent will have a leading share of voice and be very well received in the marketplace," said Dr. Michael Dunne, Iterum's Chief Scientific Officer.
Sulopenem's global development efforts to date confirm its safety and efficacy, having been studied in more than 1,100 subjects in Japan with its IV formulation and a Phase 2a oral study in community-acquired pneumonia (CAP) in the U.S. Iterum anticipates commencing three Phase 3 studies under Special Protocol Assessment (SPA) with the United States Food and Drug Administration (FDA) and Scientific Advice from the European Medicines Agency (EMA) in the initial indications of uUTI, cUTI and cIAI by the end of 2017 and filing a new drug application (NDA) and marketing authorization application (MAA) in the second half of 2019.
As previously announced, Iterum secured a $40 million Series A financing in November 2015 from a syndicate of sophisticated life science investors. The round was led by Frazier Healthcare Partners and joined by Canaan Partners, Sofinnova Ventures and New Leaf Venture Partners. These investors also backed two previous companies (MedPointe Healthcare and Durata Therapeutics) that the Iterum team led, grew and successfully sold. "The Iterum team has made tremendous progress over the last 12 months since licensing this asset. We are very excited to continue development of this novel asset and ultimately bring a new, powerful agent to the marketplace that provides an effective option to treat both hospital and community infections," said Patrick Heron, managing general partner of Frazier Healthcare Partners.
Separately, the FDA has granted the QIDP designation to sulopenem for its oral and IV formulations for the treatment of uUTI, cUTI and cIAI. The QIDP designation will make sulopenem eligible to benefit from certain incentives for the development of new antibiotics provided under the Generating Antibiotic Incentives Now (GAIN) Act, which include priority review and fast-track status. Further, if approved, sulopenem would be eligible for an additional five-year extension of Hatch-Waxman exclusivity.
Iterum Therapeutics Limited
Iterum Therapeutics Limited is an Irish clinical-stage pharmaceutical company dedicated to developing differentiated anti-infectives aimed at combatting the global crisis of multi-drug resistant pathogens to significantly improve the lives of people affected by serious and life-threatening diseases around the world. Iterum is advancing its first compound, sulopenem, a novel penem anti-infective compound with oral and IV formulations in an IV only class of antibiotics that has demonstrated potent in-vitro activity against a wide variety of gram-negative, gram-positive and anaerobic bacteria resistant to other antibiotics. Iterum has received QIDP designations for its oral and IV formulations for the treatment of uUTI, cUTI and cIAI. Iterum is led by a highly experienced team and backed by a blue-chip venture capital syndicate including Canaan, Frazier, New Leaf and Sofinnova. For more information, please visit http://www.iterumtx.com.
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SOURCE Iterum Therapeutics Limited