Jazz Pharmaceuticals Public Limited Company (NASDAQ:JAZZ) Q4 2015 Earnings Conference Call - Final Transcript

Feb 23, 2016 • 04:30 pm ET


Jazz Pharmaceuticals Public Limited Company (NASDAQ:JAZZ) Q4 2015 Earnings Conference Call - Final Transcript


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Bruce Cozadd

an opportunity to further penetrate our physician dates by targeting health care providers with high narcolepsy diagnoses and low utilization of Xyrem; educate health care providers on the early recognition, diagnosis and treatment of narcolepsy, including use of tools like the Swiss Narcolepsy Scale, help diagnose narcolepsy with cataplexy; enhance patient and health care provider office services in this increasingly complex reimbursement environment; and continue to provide unbranded, web-based disease awareness to increase the diagnosis of narcolepsy in the U.S.

Turning to a brief legal and intellectual property update on Xyrem. Patent litigation continues in the District Court in New Jersey. No trial dates have been set in any of the cases. We anticipate the trial of a portion of the case against the first filer, Roxane Laboratories, would not occur any earlier than the second quarter of 2016.

Activity on challenges to our patents with U.S. Patent and Trademark Office Patent Trial and Appeal Board, or PTAB, is continuing. In July 2015, PTAB instituted proceedings for inter partes review, or IPR, on six of our distribution patents listed in the Orange Book for Xyrem. And we expect the decision for PTAB on those petitions in mid-July 2016.

Additional IPR petitions challenging certain of our distribution, method of use and formulation of patents covering Xyrem have also been filed, but PTAB has not yet ruled on institution of those proceedings. For further details, please see our 2015 Form 10-K which we will file shortly.

Now turning to our development program for JZP-110. We are enrolling patients in the Phase III safety and efficacy studies, and we expect the preliminary efficacy results from the three of our Phase III studies in narcolepsy and in obstructive sleep apnea will be available at the end of 2016. Subject to these results, we anticipate submitting an NDA next year.

We plan to enroll other studies to support the NDA during 2016, including a planned study of driving performance in narcolepsy and OSA that we expect to begin this quarter.

Studying the effects of JZP-110 on driving performance will allow for assessment of potential impairments and improvement in patient populations where there are known increases in accident risks relative to people with the same age and gender who do not have a sleep disorder.

We also expect to present our human abuse liability results mid-year, and we'll provide more detail once the relevant meetings are confirmed.

Now on to Erwinaze. We continue to believe that Erwinaze has the potential to help more patients in the adolescent and young adult population with acute lymphoblastic leukemia, as more adult oncology centers are using pediatric-inspired asparaginase protocols for the treatment of some of their ALL patients. We also saw additional adult accounts for Erwinaze for the first time in 2015.

In 2016, the sales force will focus on educating new physicians who are treating adolescents and young adult patients with ALL to reinforce the impact of asparaginase-based protocols on patient outcomes. We continued our support in medical education