Incyte Corp. (
Q2 2011 Earnings Call
July 28, 2011 8:30 am ET
Pamela Murphy – VP, IR & Communications
Paul Friedman – President & CEO
Dave Hastings – EVP and CFO
Rick Levy – EVP, Chief Drug Development & Medical Officer
Patty Andrews – EVP and Chief Commercial Officer
Rachel McMinn – Bank of America-Merrill Lynch
Thomas Wei – Jefferies & Co.
Lori [ph] – Collins Stewart
Cory Kasimov – JP Morgan
Tom Russo – Robert W. Baird
Brian Abrahams – Wells Fargo
Dave Friedman – Morgan Stanley
Josh Schimmer – Leerink Swann
Andrew [ph] – UBS
Ryan – Gleacher & Co.
Anton [ph] – Citigroup
Previous Statements by INCY
» Incyte Corporation's CEO Discusses Q1 2011 Results- Earnings Call Transcript
» Incyte CEO Discusses Q4 2010 Results - Earnings Call Transcript
» Incyte CEO Discusses Q3 2010 Results - Earnings Call Transcript
» Incyte Corporation Q2 2010 Earnings Call Transcript
Greetings, ladies and gentlemen, and welcome to the Incyte Corporation Second Quarter 2011 Financial Results. A brief question-and-answer session will follow the formal presentation. (Operator instructions) As a reminder, this conference is being recorded.
It is now my pleasure to introduce your host, Ms. Pamela Murphy, Vice President, Investor Relations and Communications. Thank you. Ms. Murphy, you may begin.
Good morning and thank you for joining us. On the call today are Paul Friedman, Incyte’s President and Chief Executive Officer; Dave Hastings, Executive Vice President, Chief Financial Officer; Rich Levy, Executive Vice President, Chief Drug Development and Medical Officer; Pat Andrews, Executive Vice President, Chief Commercial Officer. To begin, Paul will provide an overview of the second quarter and then Dave will follow with a brief discussion of the quarter’s financial results; we’ll then open up the call for Q&A.
Before beginning, we like to remind you that some of the statements made during the call today are forward-looking statements including statements regarding our plans and expectations for our drug development program, the timing of our clinical trials, regulatory submissions, anticipated product launch plans, potential safety and efficacy of our compounds as well as our expected financial results.
These forward-looking statements are subject to a number of risks and uncertainties that may cause our actual results to differ materially including those described in our Form 10-Q for the quarter-ended March 31, 2011 and from time-to-time in our SEC documents. Paul?
So good morning, everyone. Thanks for joining us. We’ve had an eventful couple of months here. The results from our two registration trials in myelofibrosis COMFORT-I and II represented in full at ASCO and at EHA and we submitted the NDA on June the 3rd.
While we wait the official NDA acceptance letter which is due within 60 days of the filing date, the agency has verbally confirmed on multiple occasions, the latest yesterday afternoon that we have been granted priority review and that our PDUFA date is December the 3rd. Novartis continues to make progress as well. They submitted the MAA in June.
The presentations at ASCO and EHA demonstrated that treatment with ruxolitinib gives very compelling results including significant reductions in spleen size, significant improvements in symptoms and an overall improvement in quality of life measures.
In contrast, and I think this is an important point, the patients who received placebo even in a six-month period and even or even the best available therapy, their disease worsened. Market research conducted over the past several years has consistently indicated that ruxolitinib’s ability to address these negative aspects of MF were expected to position the drug as a welcomed and important new treatment for both the patients and their treating physicians.
To support the anticipated launch of ruxolitinib later this year, we’re actively hiring the rest of the sales team focusing on the recruitment of approximately 60 sales professionals with substantial prior experience in promoting Hematology
Oncology products. And I can tell you that we are well along in bringing that sales group on board.
Other high priority commercial activities are far along. We are finalizing the specifics of a distribution network that will include a hub and a limited number of specialty pharmacies to ensure that our commercialization efforts meet the needs of all patients with MF we plan to implement a comprehensive patient assistance program.
Beyond myelofibrosis we’re also evaluating ruxolitinib patients with advanced Polycythemia Vera in a global Phase III trial called RESPONSE. We’ve been monitoring patient enrolment to raise over the past few months and while Novartis has over half its size up and running recruitment remains behind schedule. Both Novartis and we have concluded that the study needs to be amended to accelerate enrolment.
We’ve initiated discussions with the FDA and while I am not yet in a position to describe specific changes in the protocol to you and I won’t be until we’ve completed those discussions, I can’t tell you that we propose keeping the dual endpoint phlebotomy independence in screen size reduction the same. And because a study is currently highly overpowered for the end point we’re also proposing to reduce the study size.
Beyond that we’re proposing to alter some of the entry criteria, which we made more restrictive than necessary. In a manner that in no way compromises power of the study. Assuming these changes to eligibility are acceptable with a significant portion of patients who fail screening would then become eligible to enrol in the study. Again, once we have agreement with the FDA, we’ll be in a better position to describe the changes in appropriate detail.
In addition to MF and PV and as described in today’s press release we have a number of ongoing or plans studies for further developing ruxolitinib indication where there’s evidence that inhibiting the JAK pathway could lead deposit of clinical outcomes. One of these studies are randomized Phase II trial in patients with pancreatic cancer just initiated this month.