DUBLIN, Ireland—Specialty biopharmaceutical company Jazz Pharmaceuticals plc has announced the signing of a definitive agreement with Sigma-Tau Pharmaceuticals, Inc., under which a Jazz Pharmaceuticals subsidiary will acquire from Sigma-Tau the rights to defibrotide in the United States and all other countries in the Americas. Sigma-Tau holds the rights to market the product in the Americas thanks to an agreement with Gentium S.p.A., which Jazz acquired earlier this year. Jazz currently markets defibrotide in the European Union under the name Defitelio as a treatment for severe hepatic veno-occlusive disease (VOD) in patients over one month of age who are undergoing hematopoietic stem cell transplantation therapy.
Hepatic VOD is an early complication risk in patients receiving hematopoietic stem cell transplantation therapy, and in its severe form, it can be life-threatening, leading to multi-organ failure and proving fatal in 80 percent of patients. it is estimated that some 5 percent to 15 percent of patients receiving hematopoietic stem cell transplantation therapy develop VOD.
“The acquisition of the remaining worldwide rights to defibrotide is a strong strategic fit with our specialty focus and would continue the momentum of our recent launch of Defitelio in the EU, further leveraging our global clinical and commercial expertise in hematology/oncology,” Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals, commented in a statement. “This transaction supports our mission to improve care for patients with serious medical conditions, and we remain committed to making targeted investments to develop and bring to market differentiated treatments for patients.”
Under the terms of the agreement, Jazz will pay Sigma-Tau $75 million up front once the transaction closes. In addition, Jazz is currently working with the U.S. Food and Drug Administration (FDA) on a regulatory pathway for submitting a New Drug Application (NDA) for the potential approval of defibrotide to treat patients with severe VOD, and Sigma-Tau will also be eligible to receive milestone payments of $25 million should the FDA accept the first NDA for defibrotide for VOD and up to an additional $150 million based on the timing of its potential FDA approval.
“This transaction would not only strengthen our global presence, but also demonstrate our commitment to diversify and expand our U.S. commercial portfolio with meaningful new therapies,” Russell Cox, executive vice president and chief operating officer of Jazz Pharmaceuticals, said in a press release. “We look forward to ongoing discussions with the FDA as we continue our efforts toward submission of an NDA for defibrotide in the U.S. Patients in the U.S. with severe VOD have a critical unmet medical need, and we believe that defibrotide has the potential to become an important treatment option for these patients.”
The transaction is expected to close in the third quarter of 2014 and is subject to customary closing conditions, including the expiration or termination of the Hart-Scott-Rodino Act waiting period.
SOURCE: Jazz Pharmaceuticals plc press release
