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Executives

Michael W. Aguiar – Senior Vice President and Chief Financial Officer

Rick E Winningham – Chairman and Chief Executive Officer

Mathai Mammen – Senior Vice President, Research and Early Clinical Development

Analysts

Ronny Gal – Sanford C. Bernstein & Co. LLC

Steve Byrne – Bank of America Merrill Lynch

David Friedman – Morgan Stanley & Co. LLC

Tom Russo – Robert W. Baird & Co.

Howard Liang – Leerink Swann LLC

Luisa Hector – Credit Suisse Securities

Ian Somaiya – Piper Jaffray, Inc.

Stephen Willey – Stifel, Nicolaus & Co., Inc.

Theravance, Inc. (THRX) LAMA/LABA Phase 3a Results Conference Call July 2, 2012 8:00 AM ET

Operator

Ladies and gentlemen, good morning. At this time, I’d like to welcome everyone to the Theravance Conference Call. During the presentation, all participants will be in a listen-only mode. A question-and-answer session will follow the company’s formal remarks. (Operator Instructions) I will repeat these instructions after management completes their prepared remarks. Today’s conference call is being recorded.

And now, I’d like to turn the conference over to Mike Aguiar, Senior Vice President and Chief Financial Officer. Please go ahead, sir.

Michael W. Aguiar

Good morning, everyone, and thank you for joining us as we discuss the positive results from the first four Phase 3a studies in this LAMA/LABA program in chronic obstructive pulmonary disease or COPD. With me on the call today is Rick Winningham, our Chief Executive Officer and Mathai Mammen, Senior Vice President of Research and Early Clinical Development.

We’ve prepared a few brief remarks for today’s call, and then we’ll open it up for questions. A copy of the press release and slide presentation can be downloaded from our website 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 the 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 the information available to the company today, and Theravance assumes no obligation to update these statements as circumstances change.

Future events and actual results 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-Q filed with the SEC.

I’ll now turn the call over to Rick Winningham, our Chief Executive Officer. Rick?

Rick E. Winningham

Good morning, everyone. Thank you for joining us at this early hour. I’m very pleased that earlier this morning GSK and Theravance issued a release announcing the positive top line results from four of seven Phase 3a studies in the LAMA/LABA program. GSK and Theravance believe the results from these initial studies support the commencement of global regulatory filings starting at the end of 2012 ahead of schedule. Before reviewing the results of these studies, I’d like to review the significant unmet medical need we are trying to address with this program.

Now turning to slides on our website and starting with slide three, as a reminder, our investigational LAMA/LABA product is a combination of two bronchodilators. The long-acting muscarinic antagonist, or LAMA, is 719, or what we now refer to as umeclidinium bromide, or UMEC; and the long-acting beta 2 agonist or LABA is vilanterol or VI. The UMEC/VI combination is currently under development for patients suffering from COPD. We believe our LAMA/LABA combination will address the unmet medical need of COPD patients requiring improved bronchodilators.

A particularly important and widely prescribed maintenance bronchodilator therapy is tiotropium, and therefore, tiotropium was included as a comparator in two of the four studies being reported today. The over-arching goal with this program is to help COPD patients breathe better. Today, the global market opportunity for COPD agents like this LAMA/LABA combination is growing and exceeds $5 billion globally on an annual basis.

Now turning to slide four. The Phase 3a COPD program consists of seven studies that enrolled approximately 6,000 patients globally, including two 24-week efficacy studies that compared UMEC/VI, its components and placebo, and two 24-week studies that compared the combination with its components in tiotropium. The Phase 3a program also includes a 52-week study to evaluate the long-term safety of umeclidinium alone and in combination with vilanterol, and two studies to assess the effect of the combination on exercise endurance.

The Phase 3a program investigated UMEC at 62.5 micrograms and 125 micrograms, in combination with 25 micrograms of vilanterol. I’d like to note that these doses were selected based upon an extensive Phase 2 program and regulatory discussions that give GSK confidence in both of the doses selected and that UMEC is dosed once daily.

Today, we have reported positive top-line results from four of the seven studies. These four studies only contribute part of the data expected from the Phase 3a program. The program was designed to be evaluated in its entirety to formulate a complete view of the safety and effectiveness of UMEC/VI. Also, we’re only providing high level results from these studies at this time. GSK will be presenting full results from all of the Phase 3 studies at future scientific meetings.

And now to review the results of these important studies, I will turn the call over to Mathai. Mathai?

Mathai Mammen

Thank you, Rick. Good morning, everyone. I’m pleased to discuss with you the data reported earlier today. I’ll discuss two pairs of studies. The first was a pair of placebo-controlled efficacy studies and the second a pair of efficacy studies that included the active comparator tiotropium.

Let’s please turn to slide five. The placebo-controlled efficacy studies were 24 weeks in duration and double-blind. They each enrolled approximately 1,500 patients with COPD with moderate to severe disease. Study 1 assessed the high dose UMEC/VI combinations and its components. Patients were randomized into four arms and received either 125/25 micrograms of UMEC/VI, 125 micrograms of UMEC alone, 25 micrograms of VI alone, or placebo.

Study 2 paralleled the first, but evaluated instead a 62.5 microgram dose of UMEC. The primary efficacy endpoint was trough FEV1 at the end of treatment period day 169 and evaluated the bronchodilatory effect of the combination as well as of the individual components.

In Study 1, the 125/25 microgram combination improved trough FEV1 by 238mL, which was statistically significant compared to placebo with a p-value less than 0.001. The combination also improved trough FEV1 more than each of the components and was statistically significant with a p-value less than 0.001 for each comparison.

In Study 2, the lower dose strength of 62.5/25 microgram combination improved trough FEV1 by 167mL, which is statistically significant compared to placebo with p-value of less than 0.001. The 62.5/25 combination also improved trough FEV1 relative to each of the components and was statistically significant with p-value less than or equal to 0.004.

In both of these placebo-controlled efficacy studies UMEC and VI as individual component, each demonstrated significant improvements in trough FEV1 relative to placebo with p-values less than 0.001. The first pair of positive placebo-controlled efficacy studies meets regulatory requirements for fixed-dose combinations, as the contributions of both VI and UMEC to the combination were demonstrated.

Let’s now please turn to slide six, which illustrates the second pair of studies. Each study included both strengths of UMEC/VI and the active comparator tiotropium. And in addition, Study 1 included VI and Study 2 included UMEC. These studies were also 24 weeks in duration and were double-blind. They each randomized approximately 850 patients with COPD. As with the first pair of studies, the majority of these patients had moderate to severe disease.

In the first study, patients were randomized into four groups and received either a 125/25 microgram or a 62.5/25 microgram of UMEC/VI, 25 micrograms of VI alone, or 18 micrograms of tiotropium. The second study followed an identical design, except that 125 micrograms of UMEC alone was substituted for the VI alone arm. The primary efficacy point was trough FEV1 at the end of the treatment period at day 169.

In Study 1, both doses of the combination provided 88mL to 99mL of improvement over tiotropium with p-values less than 0.001, versus vilanterol both doses of the combination provided trough FEV1 changes that were statistically significantly greater by 88mL to 90mL, again with p-values of less than 0.001.

In Study 2, UMEC/VI a 125/25 microgram showed a statistically significant improvement of 74mL compared with tiotropium with a p-value of 0.003. For the second comparison in the hierarchical analysis, the 125/25 microgram combination showed a numerical, but not statistically significant improvement of 37mL compared with UMAC 125 microgram, with a p-value of 0.142. The 62.5/25 microgram demonstrated a 60mL improvement over tiotropium, but no statistical inference was made because it fell behind the failed analysis in the hierarchy.

In summary, GSK and Theravance are very pleased with the efficacy of both dose strengths of UMEC/VI. The data are largely in line with what was expected based on the previous Phase 2b dose ranging studies on both components.

Now let me turn to safety, please refer here to slide seven. In these four studies, the most common adverse events across all treatment arms, including placebo, were headache, nasopharyngitis, upper respiratory tract infection, cough, or pharyngeal pain and back pain. Importantly, the incidence of cardiovascular adverse events across all treatment groups is similar, and finally, the incidence of serious adverse events across all treatment groups was also similar. GSK and Theravance are highly encouraged by the data from these four key efficacy studies in the Phase 3a LAMA/LABA program with GSK.

Let’s now turn to slide eight as I hand the call back to Rick for a few closing remarks. Rick?

Rick E. Winningham

Thanks, Mathai. In summary, we’ve reported positive results from these four important studies in the LAMA/LABA Phase 3a program with GSK. This is a significant achievement for the program in COPD as it supports the intension of GSK to commence global regulatory filings for the combination of UMEC/VI starting at the end of 2012.

We look forward to updating you on the remaining studies in the Phase 3a LAMA/LABA program in due course. I’d like to extend my thanks and congratulations to our partner, GSK for well-executed studies that completed ahead of schedule.

With the imminent RELOVAIR filings, we believe UMEC/VI would be approved after RELOVAIR if the regulatory process is successful for both programs. Theravance has the potential to receive royalties ranging from 6.5% up to 10% of net sales, if net sales exceed $2.5 billion per year. If the product is launched before RELOVAIR, as we’ve noted before, Theravance is entitled to receive royalties of 15% on the first $3 billion of annual sales, and 5% thereafter. Importantly, we don’t have any cost obligation for either program through U.S. and EU regulatory submissions.

GSK and Theravance are working on several respiratory programs together, including RELOVAIR, VI monotherapy, UMEC/VI and MABA. RELOVAIR remains on track, as I noted earlier, for midyear global filings, while the MABA evaluation is progressing. We believe that together, these programs have the potential to address the needs of a wide range of COPD and asthma patients suffering from these debilitating diseases.

In addition to our programs with GSK, Theravance has a significant pipeline of products being developed internally in a number of therapeutic areas. We’re very pleased with the significant progress of our programs, and look forward to providing you with further updates in the future.

And now I’d like to turn the call over to the conference facilitator and open the call for questions.

Question-and-Answer Session

Operator

Thank you, sir. (Operator Instructions) We’ll have our first question from Ronny Gal from Sanford Bernstein. Your line is open.

Ronny Gal – Sanford C. Bernstein & Co. LLC

Good morning, everybody, and congratulations on the results. Three quick questions, first, there’s been a lot of concern around the issue of dose response in the long-acting muscarinic antagonist arm. Could you just elaborate a little bit on the – if we are seeing a dose response in these two active comparator trials, it’s not clear from the results?

Rick E. Winningham

Well, I think the data that we’re releasing today are top line results from the Phase 3 studies. It’s early on in the evaluation of the overall totality of the data from these programs. The – I think that I can guide you back to the Phase 2b study – or Phase 2 dose ranging study that was presented at CHEST with regard to what – more or less what to expect. I think these were largely in line with our – with the evaluation that we undertook of umeclidinium in Phase 2 with GSK. I think that clearly the 125/25 dose of UMEC/VI performed extremely well in these studies, but so did the 62.5/25 dose of the combination.

So I think we’ll have to wait until a complete presentation of the scientific data to answer all of the questions. But I think right now, we believe we’ve got two great combination doses of umeclidinium and VI that provide an advantage over current therapy that address, as I mentioned, Ronny, the need that COPD patients have for additional bronchodilator. Mathai?

Mathai Mammen

I think that says it well, Rick. I don’t know that I’ve anything to add. I would just reiterate to go back to the Phase 2 presentation at CHEST and looking both at the primary and secondary endpoints there, and that gives a good idea of what the different doses of UMEC provide to patients.

Michael W. Aguiar

Ronny, this is Mike. Let me just make something, one quick comment here, which is I do want to point out, we believe we have the right dose here. So I want to make sure that is a fairly strong message out there, as well as the right dosing. So we’re pretty confident in our dose today and we’re pretty confident in the fact this is a once-a-day medicine. So we’re feeling extremely good about that particular metric here. We weren’t certainly expecting to see a giant dose response in this study, if you were to look back at the Phase 2b data. So I would say from that perspective, it is largely in line with what we were expecting to see coming out of these particular studies here. So overall, we are quite pleased with the data that came out today.

Ronny Gal – Sanford C. Bernstein & Co. LLC

Great. Thank you. Second one is around the safety issue, around the safety result. They look a little bit numerically higher in the treatments arm versus the placebo and the Spiriva arm. Could you just elaborate a little bit about what we should expect from a combination of the LABA/LAMA versus what you would see from the LAMA alone and placebo in similar trials?

Rick E. Winningham

Well, I think overall Ronny, looking across all of the – you’re looking across all of the treatment arms; you see quite similar adverse event profiles even relative to placebo. The ranges here are meant to describe the range of adverse events from all four studies. So I think the ranges really are on top of one another for all arms, including placebo. This is a patient population that, as Mathai mentioned, had moderate to severe COPD. So they’re struggling with a baseline set of health issues when they enter the trial. And I think that it was quite comforting that really we saw very well-tolerated medicine, both the single agents and combination across these four trials.

Ronny Gal – Sanford C. Bernstein & Co. LLC

Great. Thank you very much.

Michael W. Aguiar

And if there was an issue here that we were concerned about, we would have pointed it out to you. So I think our initial view of the data is there’s not a whole lot to talk about from a safety perspective.

Ronny Gal – Sanford C. Bernstein & Co. LLC

Great. Thank you.

Operator

Our next question is from Steve Byrne from Bank of America Merrill Lynch. Your line is open.

Steve Byrne – Bank of America Merrill Lynch

Hi. You have the comparison of the high dose LAMA/LABA versus the high of the 125 microgram UMEC in both, the placebo-controlled and the active comparator; one was statistically significant and the other one wasn’t. The patients, number of patients per arm looked like they were roughly half in the active comparator. Is that the difference in this statistical significance, or is the milliliter of bronchodilation improvement meaningfully different between those two comparisons as well?

Rick E. Winningham

Well, I think I’ll just make a couple comments and let Mathai add. I think in the comparators, in the active comparator study with tio, UMEC – in the second study, UMEC 125 as a single agent certainly performed quite well. But I would say that the purpose really of the active comparator was to measure the drug against – the combination against tiotropium, while the purpose of the placebo-controlled studies were to measure the active control, to measure the individual components against placebo, as well as the combination. And in that study, those two studies we demonstrated the contribution of each of the components to the combination. Therefore, satisfying the combination rule as Mathai, noted in his remarks. Mathai?

Mathai Mammen

I think that’s the most important point, is that both the components demonstrated their value to the combination in that first study and was recapitulated for the most part in the active comparator study. The direct answer to your question is, the numbers, of course, given the modest numbers in both these studies, vary a little bit, but we’re more or less in line with what we expected from the Phase 2 studies.

Steve Byrne – Bank of America Merrill Lynch

And so in the active comparator studies, the fact that this 125 microgram UMEC versus the high dose LAMA/LABA was considered hierarchically above the low dose combo versus tio, and that’s why that latter comparison, even though it fell below a p-value of 0.05, was considered not statistically interpretable. It seems a little illogical to me, because both comparisons, both active agents change from one to the next. And so I guess I wonder why did you need the UMEC and vilanterol comparisons in the active study, if it effectively diluted your ability to show statistically significance versus tio.

Rick E. Winningham

Well, I think what, the bottom line is here we achieved our objective in both the active comparator studies of showing that the UMEC/VI combination was better than tio, and it was particularly strong just because of the hierarchical method used with the 125/25 dose. So I don’t, we’re not at all concerned really by the second 62.5/25 combination and the results where it fell in the hierarchy, because the 125/25 dose was successful against tiotropium. And we view that as, I think, collectively GSK and Theravance, quite a significant achievement given the levels of bronchodilation that you’re seeing here.

You’re seeing 74mLs of additional bronchodilation in the 125/25 arm versus a very good medicine, which is tiotropium. And clearly, these patients on the 125/25 arm statistically, and even on the 62.5/25 arm, are able to breathe better with the dual bronchodilator therapy than they are with tiotropium. So Mathai?

Mathai Mammen

I would also add, if you look at the placebo-controlled studies, the absolute levels of bronchodilation of 167mLs and 238mLs is great and clinically meaningful, better FEV1 troughs than at baseline. And those are good numbers relative to what one normally looks at.

Steve Byrne – Bank of America Merrill Lynch

And just lastly, Rick, you mentioned how the economics would change depending on whether RELOVAIR is approved first or LAMA/LABA. Is that only in the U.S.? For example, what if the LAMA/LABA were approved first in the U.S. and RELOVAIR was approved ex-U.S. before the LAMA/LABA? How would that change?

Rick E. Winningham

This is global order of entry into the market. Given that the RELOVAIR filings are imminent, they’ll remain ahead of the UMEC/VI filings, which again GSK helps to commence at the end of 2012. So our operating assumption is right now that RELOVAIR reaches the market before – on a global basis before UMEC/VI.

Steve Byrne – Bank of America Merrill Lynch

Okay. Thank you.

Operator

Our next question comes from David Friedman for Morgan Stanley. Your line is open.

David Friedman – Morgan Stanley & Co. LLC

Hi. Thanks for taking the question. Just around the filing, it says in the slide that you – that GSK plans to commence global filing from end of 2012. What exactly is the plan in terms of the filing strategy U.S. versus Europe? And then, do you need to have the 52-week safety study in order to file? And if so, when will we see that study? And, I guess, the exercise studies.

Michael W. Aguiar

Yeah, David, it’s Mike. We’re not going to disclose really detailed specifics around the filings of U.S. versus Europe. We do need the 12-month safety study, and the exercise studies have been noted previously as part of the overall Phase 3 program. So that data will be coming up a little later this year. But I think it’s pretty safe to interpret from our statement around starting in the – by the end of 2012 that that data is not coming in late December or something like that.

So I would just say, this is good news that certainly should be upside to everybody’s filing timelines that we will be filing this by the end of the year. But I really couldn’t get too much more specific around either the specifics of how we’re handling U.S. versus Europe or the exact timing of the other three studies coming in.

David Friedman – Morgan Stanley & Co. LLC

Okay. Thanks.

Michael W. Aguiar

Okay.

Operator

Our next question comes from Tom Russo from Baird. Your line is open.

Tom Russo – Robert W. Baird & Co.

Good morning and congrats on the data.

Michael W. Aguiar

Thank you.

Tom Russo – Robert W. Baird & Co.

Just wanted to circle back on safety. Were there any issues showing an apparent dose response on safety between the higher dose combo and the lower dose combo?

Mathai Mammen

No, there weren’t. All the treatment arms looked quite similar.

Tom Russo – Robert W. Baird & Co.

Okay. And then can I get your latest thoughts on pricing for the combo? Should we be thinking about it more like Spiriva, more like Spiriva plus Serevent? Because I think the market’s been growing, if I’m not mistaken, primarily on price rather than on underlying prevalence.

Rick E. Winningham

Yeah. I think, Tom, it’s too early to talk about the marketing strategy. I think critical to the overall plan for the LAMA/LABA program were these two active comparator studies, and I think we’re just very happy that UMEC/VI performed so well against tiotropium. It’s obvious in the studies that when you’re looking at the data, as in fact has been shown in publicly available marketing research work, that patients remain have a degree of breathlessness on tiotropium, which is why they use rescue medicines with tiotropium. And clearly, I think, we think this combination can provide an advantage versus tiotropium in addressing symptoms of breathlessness.

Tom Russo – Robert W. Baird & Co.

Okay. And then lastly, can you just recap the comments that you made earlier on how the royalty tiers from 6.5% to 10% with varying levels of end market sales?

Rick E. Winningham

Sure. The royalty rate for the combination starts at 6.5%, and then for annual sales greater than $2.5 billion, it’s 10%. So it’s a stair step-up. In royalties, we haven’t given all the stair steps, but it’s an ascending royalty rate with the highest rate being 10% for global sales above $2.5 billion.

Tom Russo – Robert W. Baird & Co.

Okay. But somewhere between zero and $2.5 billion, it steps up from 6.5% to something between that and 10%?

Rick E. Winningham

Yes. Yeah.

Tom Russo – Robert W. Baird & Co.

Okay. Thank you.

Operator

Our next question comes from Howard Liang from Leerink Swann, your line is open.

Howard Liang – Leerink Swann LLC

Thanks very much and congratulations. First, it’s a question on whether it is a regulatory requirement to show superiority over tiotropium? If not, what was the reason of comparing the 62.5 microgram UMEC, 25 microgram VI to tiotropium and to 125 UMEC?

Rick E. Winningham

No, it wasn’t a regulatory requirement to compare versus the tiotropium. Mathai – or I mean, Mike?

Michael W. Aguiar

Yeah, Howard, not in the U.S…

Rick E. Winningham

Yeah.

Michael W. Aguiar

Certainly Europe like to see that quite a bit just to differentiate between the two. The reason 62.5 is in there is that we think that 62.5 and 125, those are the most likely candidates to be optimal dose, and so we were looking at all the various combinations in there. I would have to say, we’re extremely pleased with the performance versus tio, and I think we have a heck of a medicine. But just we have to divide the world sort of in U.S and non-U.S. with regard to the specific question whether tio is a regulatory requirement on that one.

Howard Liang – Leerink Swann LLC

Okay. And I think you stated earlier that you don’t think that dose response of between 62.5 and 125. But the – if you look at the two placebo-controlled studies, Study 1 and 2, it seems to show a difference of higher, the 238 milliliters versus 157 milliliters whether it’s high dose or it’s a low dose, are the patients different if you look at the comparison of VI to placebo in the two studies?

Rick E. Winningham

Well, the – are there individual patients there, which I’m sure they are. But broadly, these are all patients with moderate to severe COPD. It does look like that the 125 provides a little bit better bronchodilation just on the point estimate, but these are both – whether you’re looking at 238mL or 167mLs, these are both significant levels of improvement of bronchodilation versus baseline that are really characteristic of dual bronchodilator therapy. Mathai?

Mathai Mammen

I think what Rick and we said earlier was that, on trough FEV1 there was not much of a dose response. But, yes, you’re right that on the placebo-controlled studies, the point estimates were different and both pretty attractive. In the head-to-head, they were closer together, but this is on trough FEV1. There is a lot of data that we’re still looking at to understand the doses and understand the full story of differences.

Howard Liang – Leerink Swann LLC

Great. And was there a formal statistical comparison of UMEC versus tiotropium in the active comparator study?

Mathai Mammen

I don’t believe so.

Howard Liang – Leerink Swann LLC

Okay. And I’d just ask one last question. I will – UMEC single agent will be filed at the same time?

Mathai Mammen

Well, I can’t comment on the specific filing timeline with that. UMEC monotherapy is a GSK compound. There was a mention of that in the press release that GSK is evaluating that. So you have to ask GSK the specific timing and what’s the specific status of that compound.

Howard Liang – Leerink Swann LLC

Thank you.

Operator

Our next question comes from Luisa Hector from Credit Suisse. Your line is open.

Luisa Hector – Credit Suisse Securities

Thank you. I have a question on timing of data, three different parts. So first of all, the data you’ve presented today, could we expect to see the details at the ATS next May? And then the final round of the Phase 3 data that’s due before the end of the year, would we expect to see the headline announcements by the end of this year? And the third part of the question on Phase 2 data, so specifically some of these dose ranging studies looking at the much lower dose, I think it’s 15.6. Will that data be available by year-end and does it form part of the filing for the combination?

Rick E. Winningham

Yeah. So the LAMA/LABA UMEC/VI Phase 3 data presentation, we haven’t made a decision with GSK on when that data will be presented. It’s unlikely to be presented at ERS, but beyond that, no decisions have been made. The 52-week data for the safety data will be in far in advance of the filings. So the filings will commence at the – targeted to commence at the end of 2012. So we’ll have the 52-week data far in advance of that to enable GSK to pull together both the filings for to support the LAMA/LABA program.

And then the dose ranging, the dose ranging study, that study is complete. It has been complete and the data, as GSK and Theravance both set are supportive of the doses selected to take into Phase 3. The timing of the presentation on those doses, I can’t comment because I just don’t know right now. But the data is done and will form a part of the submission to regulatory authorities at the end of 2012.

Luisa Hector – Credit Suisse Securities

Okay, thanks. So then, just the safety data that will be already well ahead of the filing, so we might expect to see a headline announcement from you in the not too distant future basically?

Rick E. Winningham

Yes. So there are three remaining studies in the Phase 3a program, two exercise endurance studies and the 52-week safety study. And well, as I said in the – my comments, we’ll be updating you in due course. But those will be in well in advance of the filings at the end of 2012. Mike?

Michael W. Aguiar

Yeah, just with regard of other studies, I just point you to ClinTrials. Certainly, tomorrow morning we’re not going to be having the data from the rest of it. ClinTrials has the best update I can give you at this point in time with the caveat that certainly it’s not updated to the minute, but that’s probably the best guidance I can give you with regard to timing around those.

Luisa Hector – Credit Suisse Securities

Great. Thank you.

Operator

Our next question comes from Ian Somaiya from Piper Jaffray. Your line is open.

Ian Somaiya – Piper Jaffray, Inc.

Thanks. Couple of questions. As far as the RELOVAIR Phase 3 data press release you had mentioned several cases of fatal pneumonia. I was wondering if there were any cases noted in these four Phase 3 studies.

Mathai Mammen

Yes. So we’re not going to answer specifics on that, but there were serious adverse events seen in this study which is entirely in line with the goal of Phase 2 and 3 severity – moderate to severe severity of these patients. But there were – as we said on the call, there were no differences among the different treatment arms.

Ian Somaiya – Piper Jaffray, Inc.

Okay. Will we see or will you be able to quantify the cases of fatal pneumonia seen in RELOVAIR program, as well as better characterize the severe safety cases in this program at the ERS conference or are we waiting longer for that?

Mathai Mammen

For the LAMA/LABA program, the publication of the data at the medical congress, timing has not been determined. With regard to RELOVAIR, there will be additional data presented at ERS. Specifically on your question of pneumonia, actually I don’t know.

Ian Somaiya – Piper Jaffray, Inc.

All right. Okay.

Michael W. Aguiar

Just to give you a little clearer, pneumonia is not something you would typically see in a study like – I mean, clearly there are going to be cases, so it’s not a signal that you watch particularly keenly for like you would with a steroid on board. I’m just going to reiterate a comment we made a little bit earlier that, if there was something we were concerned about, specifically with regard to anything like serious adverse events or fatality, like that, we certainly would have called it out right now. So I think today we’re pretty comfortable, but again fatal pneumonia or something like that is not a signal that one would have expected to see in this study. And if we saw anything unexpected, we would have called it out.

Ian Somaiya – Piper Jaffray, Inc.

Okay. And thanks for that clarification, Mike. On the potential uses of this combo versus RELOVAIR, can we just walk through the patient population that we’re seeing data from today compared to the RELOVAIR Phase 3 program and how do you expect to position these two different combination therapies?

Rick E. Winningham

Well, this is Rick. I’ll start. I think the positioning and everything, I won’t comment on that. I’d say, if you look overall at patients with COPD and you look at our respective programs clearly the RELOVAIR program in COPD special emphasis was made on those patients who are at risk or who had experienced an exacerbation and therefore needed an anti-inflammatory medicine as part of their therapy. We focused in this study, and by using tiotropium as a comparator on patients who needed to breathe better. And I think within the COPD population, you do have patients who are at risk of an exacerbation or who have had an exacerbation, today who are on LABA/ICS therapy. And you have patients who simply need to breathe better that are on bronchodilator therapy. And I think the great news about today the studies that we’ve done is that, we’re very encouraged that we may be able to deliver a combination medicine to those patients who need to breathe better that in fact can enable them to improve their airway function. Mathai?

Mathai Mammen

Yeah. So overall it’s difficult at this point ahead of having these medicines available to patients to speak about strategy. So neither GSK nor Theravance will provide details of strategy. But to reiterate what Rick said, something can be made or inferred of the choice of comparator in this study and in the RELOVAIR study. In this study, we chose to use tiotropium in the comparator arms and so one can say that those are the patients that presumably benefit from excellent bronchodilation. And in the active comparator arms, we’ve shown that both combination strength provided damage versus that agent tiotropium. Similarly in the RELOVAIR study, we will eventually be comparing with other LABA/ICS combinations.

Ian Somaiya – Piper Jaffray, Inc.

Just so I can finish my modeling exercise. Can you give us a sense of the size of those two pockets of patient population those that need to breathe better versus those that are dealing with exacerbation?

Michael W. Aguiar

Yeah. I wouldn’t want to get too detailed on that side. I mean, we did make one note during the call where Rick said that the current market opportunity, they would be occupied by or that loosely categorize it as a single bronchodilator sales in and excess of $5 billion today as a proxy. I do not want to say that, the market we’re going after, but it’s certainly one piece of that. So it’s pretty substantial today, but I wouldn’t want to get too much more clear than that in terms of – or specific in that in terms of where we’re going with this.

Ian Somaiya – Piper Jaffray, Inc.

Okay. Thank you very much.

Operator

Our next question comes from Stephen Willey from Stifel, Nicolaus. Your line is open.

Stephen Willey – Stifel, Nicolaus & Co., Inc.

Yeah, hi. Good morning and congratulations on the data. Mathai, I know you just mentioned the selection of a compared arm across your studies. So I guess in contrast to that, how should we be thinking about GSK moving forward with a single agent LAMA filing? And whether you think there is actually room in the treatment paradigm to kind of create a sequential tiering of those patients maybe starting off on the LAMA first and then coming back with a double. I’m just kind of curious as to whether or not GSK precedes that market to exist in a couple of different segments. And then just lastly, I know you said that there was no formal statistical comparison made between UMEC and tio in the active comparator studies. But can you just make any color around the comparative efficacy on that front?

Mathai Mammen

Yeah. So, on the UMEC alone strategy, we’re not going to comment and you’ll need to check with GSK on how they imagine positioning that single agent. On the differences among the UMEC alone versus tiotropium, the best data that’s out there is what was published, and the presentation given at CHEST is particularly informative. And there one can compare each of these dose strengths versus tiotropium. We’re not able to say right now what the treatment differences were between UMEC and tiotropium in this study.

Rick E. Winningham

Yeah. And I think relative to single bronchodilator therapy, I think the guidelines that exist today were largely written before the advent of dual bronchodilator therapy. So we’ll have to see how the eventual publishing and presentation of this data, as well as data from others may affect the guidelines. In single bronchodilator therapy, I think for us now we’ve got four studies where VI monotherapy has shown to be effective as a single agent between the two studies here and then the two studies from the RELOVAIR program. So this is a very, very significant market segment in respiratory disease. There’s a terrific opportunity to improve therapy of these patients and I think both combination of bronchodilator with an inhaled corticosteroid and two bronchodilators, both have the potential upon approval to occupy significant segments of the overall respiratory market by really delivering additional benefits to patients that need the benefits.

Stephen Willey – Stifel, Nicolaus & Co., Inc.

All right. Thanks.

Operator

(Operator Instructions) Our next question is a follow-up from Howard Liang from Leerink Swann. Your line is open.

Howard Liang – Leerink Swann LLC

Hello. Thanks very much for taking the follow-up. For the safety trauma and safety study, I think only 125/25 dose, it is the plan to file both doses of UMEC/VI an issue, or should we assume that the higher dose of safety will cover the lower dose? And also, has there been an interim analysis of this safety study?

Rick E. Winningham

So the 52-week safety study is at the higher dose. But higher dose would cover a plan to file the 62.5. We haven’t made the decision yet on precisely the filing strategy of 125 and 62.5, although both doses look good here. And there was one other question there I think, Howard?

Howard Liang – Leerink Swann LLC

Interim.

Rick E. Winningham

The interim analysis? No, there’s no interim analysis on the 52-week safety study. I think we take some comfort from now having unblinded four Phase 3 studies, and really saw an adverse event profile that was similar across all treatment groups including placebo.

Howard Liang – Leerink Swann LLC

Thanks very much.

Operator

Our next question is a follow-up from Ronny Gal from Sanford Bernstein. Your line is open.

Ronny Gal – Sanford C. Bernstein & Co. LLC

Thank you very much for taking the follow-up. Actually, two of them, the first one is on the LABA/LAMA, which is, can you just give us a little bit more details about what the requirements are from Europe to do an active comparison? I don’t believe the requirements is to actually show superiority to existing drug, but if you can elaborate exactly what the requirements are for approval in Europe. And second, you haven’t mentioned it today, but obviously we are still waiting for the results from your PµMA program which is supposed to be reported right about now. And I was wondering if you can give us an update on when you expect those results to be available.

Rick E. Winningham

So sure. Just on the European requirements, I think between the this two sets of studies that we have talked about today and the 52-week safety study together with the complementary exercise endurance study, I believe we have a sufficient data package to file in Europe. Relative to PµMA, I’d say stay tuned because it’s coming soon.

Ronny Gal – Sanford C. Bernstein & Co. LLC

Okay. Just specifically on the issue of the active comparator. I’m just asking you, what are the requirements in Europe for having an active comparator trial? What does the European – what does the EMA want to see in terms of the results of the drug versus of the – I guess experimental results versus the established drug in order to deem a drug approvable?

Rick E. Winningham

Well, I think Europe likes to see active comparator study, superiority is not required in those active comparator studies. Again, I think we’ve got a pretty strong platform here with the two active comparator with tiotropium.

Ronny Gal – Sanford C. Bernstein & Co. LLC

Great. Thanks very much. Congratulations again.

Michael W. Aguiar

Thanks, Ronny.

Operator

Thank you. It appears we have no further questions on the phone. I’d now like to turn the conference back to Mr. Winningham. Please go ahead, sir.

Rick E. Winningham

Thank you very much, operator. I’d like to thank everyone for joining us this morning on what is a very exciting announcement for both GSK and Theravance. And I’d also thank you for your many questions today and have a great day.

Operator

Thank you. Ladies and gentlemen, that does conclude today’s conference. You may all disconnect and have a wonderful day.

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