Theravance Inc. (THRX) Q1 2010 Earnings Call April 21, 2010 5:00 PM ET
Ladies and gentlemen, good afternoon. At this time I would like to welcome everyone to the Theravance Conference Call to review results for the quarter ended March 31, 2010. (Operator Instructions). Today’s conference call is being recorded.
And now, I would like to turn the call over to Mr. Mike Aguiar, Senior Vice President and Chief Financial Officer. Please go ahead, sir.
Good afternoon everyone and thank you for joining us. With me on the call today is Rick Winningham, our Chief Executive Officer and Dr. Mathai Mammen, Senior Vice President of Research & Early Clinical Development.
Today's call will be in three parts. First, Rick will review highlights from the quarter and he and Dr. Mammen will provide an update on our clinical programs, and then I will review our financial results. And finally we will open up the call for questions.
Earlier today, Theravance issued a press release detailing fourth quarter and 2009 financial results and recent corporate developments. A copy of the press release can be downloaded from our web site or you can call Investor Relations at 650-808-4100, and we will be happy to assist you.
Before we get started, we would like to remind you that this conference call contains forward-looking statements regarding future events and the future performance of Theravance.
Forward-looking statements include anticipated results and other statements regarding Theravance's goals, expectations, strategies and beliefs. These statements are based upon information available to the company today and Theravance assumes no obligation to update these statements as circumstances change.
Future events, financial result could differ materially from those projected in the company's forward-looking statements. Additional information concerning factors that could cause results to differ materially from our forward-looking statements are described in greater detail in the company's form 10-K and in the perspective supplement filed with the SEC during the first quarter 2010.
I will now turn the call over to Rick Winningham, our Chief Executive officer.
Thanks Mike. Good afternoon everyone. I am very pleased with the progress we’ve made thus far in 2010. In particular in our long acting bid antagonist or LABA, collaboration GSK recently initiated a very large RELOVAIR Phase 3 program in asthma patients and complements the ongoing Phase 3 and COPD.
We also recently initiated a Phase 2 proof of concept study of a Theravance discovered compound TD-1211. This compound is an orally dosed peripherally restricted opioid antagonist for the treatment of Opioid-Induced Constipation.
And finally on the corporate front, we recently completed a public offering of approximately 80.6 million shares of common stock in March. Now, I will provide more details on RELOVAIR, VIBATIV and 5HT-4 program and Dr. Mathai Mammen will expand on the peripheral Mu-Opioid Antagonist and MARIN program for the treatment of pain.
Mike will walk you through the financials later on the call. Let me start with the RELOVAIR program. As I said, I'm pleased with the progress of the RELOVAIR programs in both asthma and COPD.
In March 2010, the first patient was dosed in a global Phase 3 asthma program. As a remainder, RELOVAIR is a next generation, once daily combination of an inhaled corticosteroid with fluticasone furoate also known as FF and a long acting beta-agonist ‘444 or vilanterol trifenatate for the treatment of patients suffering from asthma and COPD.
The asthma Phase 3 program consists of eight studies, designed to evaluate the potential benefit of RELOVAIR against a component products and existing treatments for asthma. These eight studies include a 2000 patient exacerbation study, a 12 month safety study and six additional studies including three comparator studies.
These studies are described in our press release. As a remainder, the 2000 patient exacerbation study is designed to evaluate the safety and the potential benefit of adding the LABA 2NICS with a primary end point of time to first exacerbation in patients who’s Asthma remains uncontrolled on current therapy
Turning to the RELOVAIR COPD program, enrolment in the pivotal Phase 3 studies is progressing. Phase 3program consists of a broad range of large scale Phase 3 studies to evaluate vilanterol in combination with FF for the treatment of COPD.
The overall program will study more than 6000 patients and includes 2, 12 month exacerbation studies, 2, 6 month efficacy and safety studies and a detailed long functioned profile study.
We believe RELOVAIR has the potential to be the best in class next generation treatment for the patient suffering from COPD and asthma and as a reminder Theravance is entitled to receive royalties of 15% on the first $3 billion of annual net sales and 5% on annual net sales above $3 billion for approved single agent long-acting beta agonists and combination long-acting beta agonists inhaled corticosteroid medicines.
GSK is planning a number of presentations this year that will highlight the work completed to-date of a RELOVAIR program in both COPD and asthma. At the upcoming American Thoracic Society or ATS conference in New Orleans in May GSK will present data from pre-clinical Phase 1 and Phase 2-A data.
Phase 2-A studies on the components of RELOVAIR fluticasone furoate and vilanterol. 12 abstracts have been accepted for presentation at ATS. In addition, GSK has submitted two Phase 2-B data to the European Respiratory Society meeting scheduled for September in Barcelona.
Now I will turn to VIBATIV. VIBATIV an antibiotic discovered and developed by Theravance was launched by our partner in the U.S. for complicated skin and skin structure infections in the fourth quarter of 2009.
Since the launch we have achieved a number of formulary approvals including approval at leading institutions. And have now shipped VIBATIV to more than 500 accounts. As we expected, during the first quarter wholesalers primarily worked off initial launch inventories which were shift in the fourth quarter of 2009 and is expected we recognized minimum royalty revenues during the first quarter. Sales and marketing efforts remained focused on achieving access to hospital formularies and increasing physician experience with VIBATIV.
Recently, Astellas announced the VIBATIV price increase from $50 to $52 for each 250 milligram vial and from $150 to $155 for each 700 milligram vial. As a reminder under our Theravance in collaboration Astellas is responsible for the sales of the product including commercialization cost.
Theravance is entitled to receive royalties on VIBATIV net sales from the high teens to the upper 20s depending on sales volume with the highest tier for sales over $500 million.
We are continuing an active publication effort with Telavancin. We recently presented two oral presentations and two posters at the European Congress of Clinical Microbiology and Infectious Disease last week featuring in Vitro surveillance in VIVO and clinical PK/PD data on complicated skin and skin structure infections as well as, nosocomial pneumonia.
We are planning publication of the Phase 3 attain study for later this year. In addition, we continue to make progress on earlier stage clinical programs. In our 5HT-4 Alzheimer’s program, we've successfully completed the TD5-108 Phase 1 study assessing CNS penetration or the TD-8954 Phase 1 multiple ascending dose study assessing CNS penetration is ongoing. The result for the TD-5108 Phase 1 study data are encouraging as we achieved our targeted CNS penetration levels at doses for which we already have significant clinical experience, while this data is encouraging I might add we are still early in this program. In our oral peripherally selective Mu-Opioid receptor antagonist or PUMA program, for the treatment of Opioid induced constipation lastly if we announced that the first patient was dosed in a Proof of Concept Phase 2 Clinical Study with our lead compound TD-1211. To provide a little more background on the PUMA program and describe progress in our norepinephrine, serotonin reuptake inhibitor program for pain. I’ll turn the call over to Dr. Mathai Mammen, Senior Vice President of Research & Early Clinical Development. Mathai?
Dr. Mathai Mammen
Thanks very much Rick. We’re quite excited by the recent advancement to our lead peripheral Mu-opioid antagonists compound TD-1211 into a Proof of Concept Phase 2 study.
As many of you know, opioid comprised a large and effective class of medicine used for managing various pain conditions. Opioid is primarily exert there and lead exact by acting on regions of the brain and spinal cord inside of the central nervous system or CNS.
However, opioid also circulated outside the CNS compartment, which results in a wide range of side-effects, including constipations, nausea, pruritus or itching.
For many patients on opioid therapy, there’s a significant problem as there are currently no orally absorb medicines approved in the U.S. to help alleviate these side-effects. TD-1211 was selected as our lead compound for development to based on pre-clinical data to demonstrated excellent peripheral restrictions, that is, TD-1211 is a highly selected antagonist of a new receptor that is largely excluded from the CNS compartment, by developing a compound that is peripherally restricted, we believed that we can relieve gastrointestinal and potentially other undesirable and sometimes dose limiting side effects of opioid therapy without affecting analgesia. TD-1211 which is designed using our multivalency approach has excellent selectivity over non-opioid receptors by binding to both the primary and secondary binding site on the new opioid receptor.
The Phase 1 single and multiple ascending-dose programs show that TD-1211 was generally well tolerated up to doses that significantly exceed anticipated therapeutic doses. The Phase 1 program also demonstrated predictable and linear pharmacokinetics with the 16 hour pharmacokinetics cast life supportive of oral once daily administration. The proof-of-concept Phase 2 study is a randomized double blind multiple-ascending dose studies designed to evaluate constipation relieving effects, safety and tolerability in approximately 50 patients experiencing constipation while receiving their chronic opioid therapy. These patients will be randomized to TD-1211 or placebo while being maintained on their base line opioid regimen.
Study treatment is administered orally once daily for 14 days. The primary efficacy end point of the study is the frequency of spontaneous bowel movements or SBMs. The study will compare the frequency of SBMs in patients receiving TD-1211 to those in patients receiving a placebo. We look forward to reporting the Phase 2 results from the study by the end of this year.
Now let’s turn to our pain program which we call MARIN, which recently initiated Phase 1. Our goal here is to make a best in class MonoAmine Reuptake Inhibitor outside for the treat of chronic pain conditions such neuropathic pain, osteoarthritis or fibromyalgia. We believe that there is an opportunity to create a better medicine with similar pain release and fewer mechanism-based side effects by appropriately balancing the Norepinephrine Serotonin selectivity of our compounds. For example, duloxetine also know as Cymbalta is approved currently for the treatment of two pain conditions, fibromyalgia and painful diabetic neuropathic pain and has also achieved positive Phase 3 results of the treatment of osteoarthritis.
Duloxetine is substantially more inactive as the Serotonin Reuptake transporter then at the Norepinephrine transporter. This results in Serotonin related side effects such as nausea that may prevent optimal dose. Our leading compound TD-9855 is modestly more selected as the Norepinephrine transporter than at the Serotonin transporter which we believe based on various at the pre-clinical data is optimized for the treatment of pain.
The Phase 1 single dose study of TD-9855 is designed to test safety tolerability and pharmacokinetics of a range of single oral dosage in healthy subjects. We anticipate having results of this Phase 1 study later this year. I'm excited by the progression of these two Theravance have started programs and we would now like to turn the call back to Rick.
Thank you Mathai. In summary, we’re pleased with the recent developments of Theravance since our last call. The RELOVAIR program continues to advance in both asthma and Phase 3 COPD programs like that it continues to progress in the U.S. market. We initiated the Phase 2 study with TD-1211 for the treatment if Opioid-Induced constipation. And we successfully completed the Phase 1 CNS penetration study with TD-5108 as well as initiating a Phase 1 study in our MARIN program. And finally, we strengthened our balance sheet with the completion of the recent public offering.
I’d now like to turn the call over to Mike Aguiar, our chief financial officer and Mike will review the financial results and discuss the recent secondary offering. Mike?
Thanks Rick. Today, I’ll review the results of the quarter ending March 31, 2010 and we will review our guidance for the full year 2010 expenses. For the quarter ended March 31, 2010 Theravance had a net loss of $22.5 million or $0.35 per share. Total research and development plus total general and administrative expense excluding stock-based compensation totaled $22.3 million for the first quarter which was largely in line with our expectations and guidance. Revenue was $5.7 million during the first quarter of 2010 and consisted almost entirely of the amortization of upfront and milestone payments received from the company’s partnerships with GSK and Astellas.
As expected we had very little royalty income from sales of VIBATIV during the first quarter as wholesalers worked off their initial launched inventories. Total R&D expenses for the first quarter of 2010 or $20.4 million which is slightly higher than last year
I would like to remind everyone that the result of the first quarter 2009 included a one time expense reimbursement from Astellas that reduced our total R&D expense by $2.6 million. Excluding this reimbursement, expenses were down year-over-year primarily to lower external expending. External R&D cost excluding reimbursements for $4.1 million compared to $5.3 million in the first quarter of 2009.
General and administrative cost was $6.5 million during the first quarter of 2010 compared to $7.1 million from the same period last year. This decrease was primarily due to lower employee related expenses. Excluding stock-based compensations, non-GAAP G&A expense was $4.5 million during the first quarter 2010 compared to $5 million for the same period in 2009.
Cash, cash equivalent and marketable securities totaled $225.4 million as of March 31, 2010 an increase of $70 million during the quarter. This increase was primarily due to the net proceeds of approximately $93.5 million from our public offering of common stock in March partially offset by cash used in operations.
Now turning to our guidance regarding expenses for 2010, for the full year we are reiterating our previous guidance range of between $80 million to $85 million. As a reminder our guidance includes total Research and Development expense and total General and Administrative expense that excludes stock-based compensation and non-cash restructuring items. Total cash used would be offset by any other milestone payments earned or other cash inflows.
Now I am going to turn the call back to Rick for our final closing comments.
Thanks Mike. Throughout the remainder of the year we will remain focused on our joint collaboration with GSK on RELOVAIR and COPD on progressing our early and mid-stage clinical programs and remaining disciplined with our spending.
And now I would like to turn the call over to conference facilitator and open the call for questions.
Thank you, sir. (Operator Instructions) Our first question comes from (inaudible) from Credit Suisse.
Hi, thanks for taking my question. So, Mike you were saying essentially order revenue in this quarter came from amortization and can you quantify exactly like how much royalty you booked for this quarter?
Yes, the royalty was quite small this quarter as we mentioned. It was almost entirely revenue this quarter from our amortization. The total royalties received were under $100,000 this quarter. So it was relatively a small, and this is something we had to expected coming end of the quarter given the inventory loading that happened here during the fourth quarter.
And then have you guys seen any label use for VIBATIV in the pneumonia study at all?
I think the product is out there being marketed, sold by Astellas for the treatment of complicated skin and skin structure, infections. As I said I think the reception to the drug and physicians particularly those that are struggling lift infections by methicillin-resistant Staph aureus. Again those have been well received although we are only marketing the product for complicated skin and skin structure infections. Physicians maybe using it off label for other things but we can’t comment on that really because it is not we are wrongly promoting it for complicated skin, skin structure infection.
Our next question comes from Howard Liang from Leerink Swann
John Eckard - Leerink Swann
Hello this is John Eckard in for Howard, just with a couple of questions on the RELOVAIR program. Could you give us an idea of how or what studies for both the COPD and asthma will be needed for approval. Are all these studies going to be required for approval or there is only a few.
Well today this is the program that we put in place that we will serve as the back bone for the global registration needs or fault indications. So there are five studies today that are underway for COPD and eight studies that are under way for the treatment asthma, is it right now again this we believe satisfies the U.S. for COPD and Europe for both COPD and asthma and as we mentioned a few times there is still an ongoing discussion GSK has with the U.S. regarding what the final studies will look like for asthma, whether the ones we have going are sufficient or whether we could use something in addition.
So those are the programs that are going today and in total they compromise at a pretty substantial number of patients we have disclosed that the COPD program will be in excess of 6000 patients and the first two programs that are underway today in asthma comprise 2500 patients in total.
So that’s really how we are thinking about it today but in total again there are about 13 studies that are underway or soon to be underway in support of these two indications.
John Eckard - Leerink Swann
Do you anticipate these studies will all be needed for approval or only some of them may be needed?
Well again, this is Rick Winningham, just to complement what Mike has said that you know there are some studies that are needed in the U.S., there’s other studies that are needed in Europe, these are global studies as a global program that is really targeted to meet the regulatory requirements by and large around the world and I don’t want to get into exactly what studies will be used and what jurisdiction but its just safe to say that through these total of 13 studies we believe that as Mike said we’ve covered what the U.S. will need in COPD, what the U.S. and Europe will need for what the U.S. and Europe will need for COPD and then there’s some ongoing discussions with GSK on asthma in the United States.
And John may be I should add just one final point which is related specifically to COPD, we are trying to do something a little unusual here with regard to our regulatory strategy which is to potentially have two indications and the COPD label one for safety and efficacy and that is really driven by the two six months studies that you will find in our COPD program but also to get an indication for a reduction in exacerbation which is principally supported by the twelve months studies.
So I wouldn’t go to the point to say that you can have one or the other sale and everything would be okay. But there are actually two different indications that are going forward in COPD which is an important aspect for us here because it shows lower exacerbation, we would certainly have a pretty interesting label coming through this. And if we’re able to do that at the same time as getting our safety and efficacy it would help our launch prognosis quite there.
So that is a little bit different then what’s been down historically.
John Eckard - Leerink Swann
That’s very helpful. And one quick question. Can you discuss what kind of patients, mono therapy LABA, trials being done where studying the new versus the old LABA?
Yes. Well, there is a short duration study assumed to be underway I think covers the once-a-day vilanterol versus salmeterol versus placebo. That’s highlighted in the press release. That a study for the asthma program although one would not pursue a single age of long acting beta-agonist alone for the treatment of asthma. The program does include single agent arms in the six month safety and efficacy studies in the COPD as well as the 12 month exacerbation study in COPD and that particular disease, area long acting beta antagonists are used as single agents.
John Eckard - Leerink Swann
Very helpful. Thank you very much.
Our next question comes from (Inaudible) Robert W. Baird.
Hey guys, thanks for taking the question. Going back to the decision to start Phase 3 for asthma, can you just state what gave you confidence with that program design could potentially satisfy up to your requirements?
As I mentioned a little bit earlier, Ryan that the program that we start to hear, we really believe we are going to be the backbone from global approval and porosity in particular we are focused on getting the asthma studies that are going to be submitted for the European approval started as quickly as possible, while we are continuing our discussions with the FDA and if we have to make some tweaks on the programs that are out there, you know we would have the ability to do that but with regard to the specifics around the timing, I never wanted is critically important to get the start to support European filings because we want to be able to file both the COPD and the asthma applications at the same time in the Europe.
And then number two, we have what we consider to be a pretty robust set of Phase 2B data that gives us a level of comfort going into these large studies here in and the basis for having some level of confidence at this point and so I think the European filing was critically important to get that done in time to have a joint application but also having 3000 patients completing a Phase 2B program with the results we did give us a fair amount of confidence. Rick you want to add anything to that?
No I would just add that you know the exacerbation study that’s being conducted as a part of the asthma Phase 3 program is a randomized double blind parallel group study conducted with sites in U.S., Europe and other international locations.
You know importantly that study will evaluate the safety and the potential benefit of the combination product of vilanterol and FF, versus FF alone and over 2000 patients who where, their asthma remains uncontrolled on current therapy and given that primary end point time to perceiver exacerbation that’s a pretty informative endpoint with regard to the current discussion that are ongoing.
So I think again as Mike said we got a very robust Phase 3 program here, in collaboration with GSK, a total of 13 studies really targeted for global registration. If certain things come out where designed have to be tweaked on the asthma program to satisfy the U.S. well I think we are more than capable of doing that and right now we are finished, we are really focused with our partners GSK in getting the studies underway rapidly accrued the peak enrollment and then getting the data out so that's where we are.
That's helpful and then on the COPD study, can you give us a rough idea of the percentage enrolled?
At this juncture we can't. GSK policy is not to disclose the enrollment status while the program are continuing to enroll and unfortunately can't give you a specific number or specific percentage at this particular juncture. My likely next communication point would be some but later in the year out when we reach the peak enrollment number, there is probably the next point we will be able to have an update on that.
But I would say it is under discussion. At this point with GSK regarding the next step for communication.
Okay and then just one last one since, hope your form has been sort or seen through reporting does go around, can you give us idea of, or do you an idea of the paramedics in COPD and that was not for Advair as sort of a proxy going forward for a role there?
I would defer any questions on Advair to GSK, so I wouldn't want to jump in front of that right now.
Our next question comes from John Stephenson from Summer Street Research.
John Stephenson - Summer Street Research
Thanks for taking my question. Just a general topic, in terms of long-term spending outlook, I know you guys have some programs internally ongoing at this point with the TD-5108 etcetera. I assume we are going to bring these some of these forward to certain stage but what’s the outlook for R&D on a I mean subjectively long-term in terms of number of compounds you might seek to be putting into clinics going-forward, or is it something that you see a long-term investment in or do you think that overtime you might pay for down year investment on the R&D side and let the royalties flow through more strongly into the P&L?
I think that’s a good question, John, I would say. Let me kind of just quickly about where we’ve given and then I’ll turn it over to Rick and he’ll walk into a little bit of the strategy of how many compounds you kind of think through things.
Where we are today, we have the guidance of $80 million to $85 million for this year and that really is predicated upon the three studies we were running during the first quarter and then some and I tell you, will slowly be tapering off, through the rest of the year. I don’t generally get into quarter-by-quarter forecast but there’s would certainly be a little bit of non-linearity of our quarter’s spending this year.
Beyond this, I don’t provide any forecast into 2011 or beyond other than we did mention at the last call that we had at the time more than two years worth of cash on the books at that point given our current operating assumption and well, I am going to turn it over to Rick here and have him talk you through kind of the strategy of how we think about compounds.
I just think I just have to add to what Mike finished on there that projection was part of the offering that we did in mid March. And you know, a key piece of our, a key part of our strategy is we’ve done historically as to enter in the business development partnering relationships with other companies, you know, we continue to have ongoing partnering discussions on in both GI Motility as well as Alzheimer’s disease and the 5HT-4 area so I think that really is a core part of our strategy going forward as a way to manage the financial risk around the company, we do continue to invest if that’s really within the $80 million to $85 million guidance continue to invest in these programs as we talked about PUMA program, the MARIN program, small investments in 5-HT4. We have completed the BAL study for 1792 and 1792 did demonstrate special lung penetration there to be a potential candidate for the treatment of nosocomial pneumonia. So the investments that we are making really in the clinic are meant to strengthen the amount of data and the confidence really around these projects prior to eventually partnering them with other companies.
One final point and then I will make sure we’ve covered it for you, when we restructured the company back in early 2008 the vision at the time was generically to have two compounds at all time and sort of an exploratory phase, two compounds and full development -- and we seen a full discovery and two compounds in the early stages of the clinic. So in the Phase 1, Phase 2 area obviously you think about any particular quarter it might be plus or minus on that but that was really the structure we put in place at that time and at the structure we have today and plan on continuing at least into our current operating assumptions.
John Stephenson - Summer Street Research
Okay great and then moving over to the asthma program I just wanted to understand a little bit better about the monotherapy studies, what are you doing about, I guess how easy is that going to be to get it through IRB approval in light of these theoretical safety concerns with administering just the monotherapy LABA and what types of design aspects you add in the study to mitigate that risk for the physicians and the patients.
Well these, the one the studies that we described are short-term duration studies, 12-week studies and those should not be an issue for enrolment so.
John Stephenson - Summer Street Research
We’ll provide some more detail on the rest of the study in the asthma program as they begin. So what is probably going to happen is upon enrolment a very shortly after enrolment began, you’ll see that folks can grow upon ClinicalTrials.gov and end of that point we will be able to talk about the specifics a little more freely.
John Stephenson - Summer Street Research
But then, just to be clear that those short-term studies will be necessary for proof (Inaudible) for asthma?
Well, we’re not going to disclose even European or the U.S. strategies specifically but other than to say that the 13 Phase 3 studies that we are either out of the wire that we have planned are really targeted to satisfy U.S. and European regulatory meetings.
John Stephenson - Summer Street Research
Okay. The last question that I had, what’s the next step on MABA? Any specific data points we have coming upon that?
Sure. We’re finishing up the Phase 2 be enabling program with MABA and as you sort of look at what we got with in the respiratory area with GSK off course, we have the very large RELOVAIR Phase 3A program that we’ve just discussed. We have the Phase 3B program which we’ll probably be talking about before the end of the year. We also versus, when you note on clintrials.gov, the combination of philanteral of 444 with long acting muscarinic Antagonist or 719 as well as a 719 Phase 2B study. So RELOVAIR saw the first LABA programs, second to then MABA is third and all right now we’re receiving recourses and moving forward but there is quite a bit of work right now going on in the respiratory group with GSK and Theravance and we are just trying to sequence the studies into the clinic and out of the clinic in a way that makes really the best sense for us but hopefully will be initiating the Phase 2B study on MABA later this year.
John Stephenson - Summer Street Research
And then the LABA combination study was, that’s what the second Glaxo compound which is (Inaudible) dropped? I think it was down.
Yeah this is compound 719.
And as Rick mentioned there are two studies to combine on ClinicalTrials.gov a monotheraphy that the Phase 2B and then a combination with FF which is a Phase 2 study, we haven’t spoken about this program down much as you probably were one today LABA were a challenging class and it turned out we’re successful at the year-end and these studies and are able to progress it and you are probably here a little bit more a bit. We really haven’t spoken too much about that particular combination today just because of the challenge about getting one today compound that are long-acting muscarinic antagonists.
(Operator Instructions) Our next question comes from Michael Olson, Piper Jaffray.
Michael Olson - Piper Jaffray
Hi guys thanks for taking the question just want to maybe shift back to RELOVAIR and in particular what impact the recent FDA panel on LABA use in asthma had on the Phase 3 trial design and maybe if you’d be willing to share any feedback you have done from the FDA since then?
You know as we said GSK is on ongoing discussions over the asthma program with the FDA. I think relative to coming out of the advisory committee meeting in March, it was in a terrific amount of really insight to be gained there. Other than, I think the exacerbation study that we’ve kicked off really addresses some of the issues that were raised and I think probably importantly for us if you look over the February-March time frame the message was pretty strong that long-acting beta agonists their combined with inhaled corticosteroids have a role in the treatment of asthma patients and that was still supported fairly strongly by the advisory committee. So that are takeaway.
Michael Olson - Piper Jaffray
That’s helpful. I am going to ask maybe another question. Just curious about your assumptions on potential generic Advair launch in the US and Europe and at last week’s FDA panel on equivalence had any impact on those assumptions?
Well I don’t know, if I want to get [tuned] into patent that stayed around Advair, I think they are probably a reasonable assumption that Europe is a little bit closer than the US but I think that would push that one back to GSK to have any further discussions around the potential timeline on that but again my guess is there probably a little more likely that you’ll see something in Europe before you would see it in the US.
Michael Olson - Piper Jaffray
And if I can just ask a last question. In terms of what that is in any kind of updates, you decide to start a Phase 3 trial or do you have an alternative strategy at this point or what?
No. we are not going to be providing interim updates on the hospital required the pneumonia program. The regulatory standard for approval and those coming off pneumonia is not clear as of today. We believe quite strongly in our, in the data that we’ve submitted. And if something material were to happen with regard to the half NDA. We’ve certainly, we’d certainly talk about it but I think right now the sort of the take away is extremely unclear what the standards are for approval and those coming on pneumonia in the United States.
And I would just add I think the chance for those running at additional Phase 3 study here. Certainly based on what you know today is we are essentially zero on this. We’ve run the largest study, set of studies done to gauge in this [indication] there, 3.5 or 4 times larger than the last set of studies that was running for a drug that was proven as indication. We’ve met what is the current guidelines that are out there. It was certainly understood for a period of time. These little guidelines might be changing, but I do not know today what could potentially give me enough comfort to go on running in other set large studies given the uncertainty out here. So I think that the chance for this running in (Inaudible) Phase 3 studies and support of this application is extremely low right now.
It appears that there no more questions in que. I would now like to send the conference over to Mr. Winningham, please sir proceed.
Okay thank you very much operator and I’d like to thank everyone for participating in our conference call and please enjoy the rest of your day.
This concludes our conference call for today. We thank you for you participation. You may all disconnect, have a wonderful day.
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