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Jazz Pharmaceuticals Enters Into Agreement with TerSera Therapeutics LLC for Prialt

DUBLIN, June 29, 2018 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced a definitive agreement to sell its rights related to Prialt® (ziconotide) intrathecal infusion to TerSera Therapeutics LLC (TerSera) for $80 million in cash at closing.  The transaction is expected to close in the third quarter of 2018 and is subject to the satisfaction of customary closing conditions.  As part of the transaction, TerSera will offer employment positions to a majority of the Jazz employees dedicated to Prialt.

Prialt is the only FDA approved, non-opioid agent indicated for the management of severe chronic pain in adult patients for whom intrathecal therapy is warranted.  Jazz recorded $27 million in net product sales for Prialt in 2017. 

"This transaction allows us to focus resources on our core therapeutic areas of sleep medicine and hematology/oncology," said Daniel Swisher, President and Chief Operating Officer of Jazz Pharmaceuticals.  "Given TerSera's strong track record and focus on the business, we're confident they will continue to educate medical professionals about and ensure full access to this important medicine for patients."

"We are excited about acquiring Prialt and welcoming a team of seasoned professionals to support the future growth of this product as we continue to serve patients who can benefit from this therapy," said Ed Fiorentino, Chairman and Chief Executive Officer of TerSera. "It is vitally important to ensure non-opioid alternatives are available for patients for the management of their severe chronic pain."

Advisors
Jazz Pharmaceuticals' financial advisor for the transaction is MTS Health Partners, L.P.

About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs.  The company has a diverse portfolio of products and product candidates with a focus in the areas of sleep and hematology/oncology.  In these areas, Jazz Pharmaceuticals markets Xyrem® (sodium oxybate) oral solution, Erwinaze® (asparaginase Erwinia chrysanthemi), Defitelio® (defibrotide sodium) and Vyxeos® (daunorubicin and cytarabine) liposome for injection in the U.S. and markets Erwinase® and Defitelio® (defibrotide) in countries outside the U.S.  For country-specific product information, please visit http://www.jazzpharmaceuticals.com/products.  For more information, please visit http://www.jazzpharmaceuticals.com/ and follow us on Twitter at @JazzPharma.

About TerSera Therapeutics LLC
TerSera Therapeutics LLC acquires, develops and markets specialty pharmaceutical products with a focus on select therapeutic areas.  Its mission is to provide products which truly make a difference for patients.  For more information about TerSera Therapeutics, please visit www.tersera.com.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to the anticipated sale of Jazz Pharmaceuticals' rights related to Prialt and the timing thereof, Jazz Pharmaceuticals' strategy, and other statements that are not historical facts. These forward-looking statements are based on Jazz Pharmaceuticals' current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties.  Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: Jazz Pharmaceuticals' ability to close the transaction on the proposed terms and schedule, including risks and uncertainties related to the satisfaction of closing conditions; disruption to Jazz Pharmaceuticals' business as a result of the transaction; and other risks and uncertainties affecting the company, including those described from time to time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange Commission filings and reports (Commission File No. 001-33500), including the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2018 and future filings and reports by the company.  Other risks and uncertainties of which Jazz Pharmaceuticals is not currently aware may also affect the company's forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated.  The forward-looking statements herein are made only as of the date hereof or as of the dates indicated in the forward-looking statements, even if they are subsequently made available by Jazz Pharmaceuticals on its website or otherwise.  Jazz Pharmaceuticals undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations or other circumstances that exist after the date as of which the forward-looking statements were made.

About Prialt
Prialt received FDA approval in 2004, and is indicated for the management of severe chronic pain in adult patients for whom intrathecal (IT) therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or IT morphine.

IMPORTANT SAFETY INFORMATION:
Prialt is contraindicated in patients with a preexisting history of psychosis.  Severe psychiatric symptoms and neurological impairment may occur during treatment with Prialt.  Monitor all patients frequently for evidence of cognitive impairment, hallucinations, or changes in mood or consciousness.  Discontinue Prialt therapy in the event of serious neurological or psychiatric signs or symptoms.

WARNINGS AND PRECAUTIONS

  • Cognitive and neuropsychiatric adverse reactions – Cognitive impairment and severe neuropsychiatric symptoms may occur with Prialt use
  • Meningitis and other infections - Patients, caregivers, and healthcare providers must be aware of the signs and symptoms of meningitis, including but not limited to fever, headache, stiff neck, altered mental status (e.g., lethargy, confusion, disorientation), nausea or vomiting, and occasionally seizures.
  • Reduced level of consciousness - Patients may become unresponsive or stuporous while receiving Prialt
  • Elevation of serum creatine kinase – Patients taking Prialt may experience elevations in creatine kinase. Monitor serum CK in patients undergoing treatment with Prialt periodically
  • Withdrawal from opiates: Patients must not be abruptly withdrawn from opiates and must be gradually tapered over a few weeks and replaced with a pharmacologically equivalent dose of oral opiates

Please click here to see the full Prescribing Information for Prialt, including BOXED Warning. 

Jazz Pharmaceuticals Logo (PRNewsFoto/Jazz Pharmaceuticals plc) (PRNewsFoto/Jazz Pharmaceuticals plc)

 

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SOURCE Jazz Pharmaceuticals plc

Jazz Pharmaceuticals Contacts: Investors: Kathee Littrell, Vice President, Investor Relations, Ireland, +353 1 634 7887, U.S., +1 650 496 2717; Media: Jacqueline Kirby, Vice President, Corporate Affairs & Government Relations, Ireland, +353 1 697 2141, U.S., +1 215 867 4910; TerSera Therapeutics LLC Contact: Media: Mark Leonard, +1 847 651 9682 or mark@reachthenextlevel.com