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Furiex Pharmaceuticals Inc (FURX)
Q3 2012 Earnings Call
November 2, 2012 9:00 am ET
June Almenoff – President and Chief Medical Officer
Marshall Woodworth – Chief Financial Officer, Treasurer and Assistant Secretary
Fredric N. Eshelman – Chairman of the Board
Sailash Patel – Vice President, Strategic Development
Matthew Kaplan – Ladenburg Thalmann & Co.
Brian Lian – Suntrust Robinson Humphrey
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I would now like to introduce your host, Mr. Sailash Patel, Vice President of Strategic Development. Please go ahead.
Good morning. Welcome to the Furiex Pharmaceuticals third quarter 2012 earnings conference call. Before we begin, I would like to remind everyone that our comments today contain forward-looking statements. All statements other than statements of historical facts are forward-looking statements including any statements concerning research and development, clinical development plans and timelines, regulatory approval timelines, revenue and financing expectations, and post financing of new or existing projects, proposed licensing or collaborative opportunities or agreements, any statement of assumptions underlying any of the foregoing.
Actual results could differ materially from those projected or assumed in the forward-looking statements. Our future financial conditions and results of operations, as well as any forward-looking statements, are subject to inherent risks and uncertainties, including the risk factors described in our Annual Report on Form 10-K and other SEC filings, copies of which are available from our investor desk and on our website www.furiex.com.
I will now turn the call over to our President and Chief Medical Officer, Dr. June Almenoff.
Thank you, Sailash. Good morning everyone. Great to our business updates. Starting with MuDelta, as you know, this is a novel or locally active new agonist delta antagonist in development for treatment of diarrhea predominant irritable bowel syndrome, IBS-D. We believe that the dual activity on both Mu and Delta receptors enables the management of both the diarrheal as well as the pain symptoms in this condition without the constipating effect and tolerance that can occur with unapproved mu receptor agonist activity.
Janssen scientists recently published a paper in the British Journal of pharmacology summarizing the preclinical biology studies conducted with MuDelta and comparing its effect to those of loperamide. These two drugs behave differently in these preclinical studies supporting our clinical hypothesis that MuDelta will treat the diarrhea associated with IBS-D without the constipation associated with a pure new agonist such as loperamide. Reference to this publication is posted on our website furiex.com.
In June 2012, we commenced dosing patients with two parallel phase III pivotal trials. These trials are focused on the U.S. endpoints around dual consistently and pain over 12 weeks, but they also capture data on European endpoints obtaining global symptoms at 26 weeks which at positive quick support in EU submission. We reached our target of about 600 active sites in North America and further we expect to have about 50 studying sites in the UK which should all be active by years end.
Our target enrollment is 2,250 IBS-D patients and we recruited slightly more than 30% of the patients needed to complete these pivotal trials. One study will run for 52 weeks and the other for 3 weeks. We will collect efficacy data in both studies for 26 weeks to 30 weeks and safety data for the full duration of the trial. With the caveats that recruitment rates can fluctuate and that were still early in the recruitment process, our best estimate is that we will be able to report top line results of our 30 week phase III study in early 2014. We continue to evaluate those partnering and funding options to support the phase III development of MuDelta and we will share additional information if and when appropriate.
Next, a brief update on JNJ-Q2. This is a novel fifth generation quinolone with broad antimicrobial coverage including MRSA. We believe the product is ready for Q3 in both the acute bacterial skin and skin structure infections and pneumonia indications. In 2012, there were a total of 10 papers of abstract published on this molecule out there primarily scientific collaborates describing as microbiology, its preclinical and clinical from profiles.
We are continuing to look to partner or out license this product with the help of an investment bank. We continue to find the environment for antibiotic partnering challenging. There is minimal spend on maintaining its asset and at this time, we don’t plan to progress development without a partner.
Moving now to our marketed portfolio, we’ll start with alogliptin, which is partnered with Takeda. Alogliptin is a DPP-4 inhibitor that’s indicated for the treatment of type 2 diabetes. Nearly 10,000 patients have been treated with alogliptin in clinical trials. Since mid 2010, alogliptin has been marketed in Japan under the trade name Nesina. This past quarter, royalties to Furiex associated with sales in Japan increased over 63% compared to the prior quarter.
On the regulatory front, we understand that Takeda continues to make progress with regulatory submissions for alogliptin in the U.S., Europe and rest of the world. We anticipate an FDA decision on the U.S. NDA by the end of January 2013 and for the European MAA in the later half of 2013.