AVANIR Pharmaceuticals (AVNR)
F2Q10 (Qtr End 03/31/10) Earnings Call
May 03, 2010 11:00 a.m. ET
Brenna Mullen - IR
Keith Katkin - President and CEO
Christine Ocampo - VP, Finance
Randall Kaye - CMO
Ritu Baral - Canaccord Adams
Mike King - Wedbush PacGrow Life Sciences
Carol Werther - Summer Street Research Partners
Previous Statements by AVNR
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Thank you and good morning everyone. Joining me on today's conference call is Keith Katkin, President and Chief Executive Officer, Christine Ocampo, Vice President of Finance and Dr. Randall Kaye, Chief Medical Officer. I will begin the call by addressing our forward-looking statements. Following the call, I'll turn it over to Keith.
As a reminder the statements made on this call represent our judgment as of today, May 3rd, 2010. Our remarks and responses to questions during this conference call may constitute forward-looking statements, including plans, expectations and financial projections, all of which involve certain assumptions, risks and uncertainties that are beyond our control and could cause actual results to differ materially from the expected results expressed in the forward-looking statements.
These forward-looking statements include among others, statements about our expectations, about likelihood of success in obtaining FDA approval for Zenvia as well as statements regarding anticipated expenditure levels, future cash balances, clinical development timelines and intellectual property protection. We encourage you to take the time to review our recent filings with the Securities and Exchange Commission which present matters in more detail as well as related risk factors. AVANIR disclaims any intent to update any forward-looking statements made during this call.
Now I will turn over to Keith Katkin.
Thank you Brenna. Good morning everyone. Thank you for joining us on our fiscal 2010 second quarter earnings call. I'll start today's call by providing a brief commentary on our overall business performance before turning the call over the Christine Ocampo who will review the financial results, followed by Dr. Randall Kaye who will discuss the submission that we announced on Friday of our complete response to the Zenvia approval level PBA.
The second quarter of 2010 was a productive and exciting time at AVANIR marked by shift from clinical development activities to preparing the regulatory submission of Zenvia for the treatment of PBA as well as market development activities in the receipt of a new patent for Zenvia in PBA. We are delighted that we now have filed for complete response to the October 30th 2006 NDA approvable letter with the FDA and we believe that we have provided the FDA with all of the information they need to access benefit risk profile of Zenvia.
We continue to expect a six month review of application from the agency and expect a PDUFA date in the fourth calendar quarter of this year. Dr. Kaye will provide additional details regarding the regulatory review process in his comments. In the second fiscal quarter we also strengthened our Zenvia intellectual property portfolio. In February the United States patent and trademark office issued a new patent that will extend the period of intellectual property protection in the United States through late 2025, considerably improving the period of patent protection for Zenvia.
With the planed commercial launch in early 2011, the new patent is expected to provide approximately 15 years of protected revenue generation in the United States, and greatly enhances the long-term value of Zenvia. In addition, subsequent to the end of the quarter, we presented detailed Zenvia safety and efficacy data from the double blind and open label extension of the Phase III confirmatory STAR trial in three data posters at the American Academy of Neurology annual meeting in Toronto Canada.
The efficacy and safety data demonstrated the that the new low dose 3010 formulation of Zenvia demonstrated durable long-term efficacy as well as a favorable safety and tolerability profile. Overall we are very pleased with the clinical profile of the new lower dose Zenvia formulations that emerged from the STAR trial.
Our team is also continuing to prepare for a U.S. commercial launch in early 2011. As we announced this morning we are very excited to have hired a Vice President of Sales and Managed Markets, Michael McFadden who will be joining the management team of AVANIR this week.
Michael is an exceptional sales leader and has a rare combination of sales leadership and managed health care expertise. Michael most recently served in leadership roles in sales and marketing and sales and managed markets at Amylin Pharmaceuticals. During the tenure Amylin's managed markets team has consistently been recognized as one of the leading account teams in the industry.
Michael also is responsible for building a special sales team of over 100 sales representatives and launching two first in class diabetes products for the company. Prior to Amylin, Michael held commercial roles at Pharmacia and Eli Lilly. With over 20 years of experience in the pharmaceutical industry, Michael has been involved in marketing some of the most successful blockbuster prescription products and we're very pleased to have Michael on the team.
In addition, we continue to focus on raising awareness of PBA among our target physician audience which manages the neurology patients suffering from PBA. We have started to build out a medical affairs organization by staffing up with medical science liaisons that will interact with key opinion leaders in neurology and psychiatry.