View:
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
8-K
Current
Report Pursuant
to
Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date
of
Report (Date of earliest event Reported): January 11, 2006
THERAVANCE,
INC.
(Exact
Name of Registrant as Specified in its Charter)
|
Delaware
(State
or Other Jurisdiction of Incorporation)
|
000-30319
(Commission
File Number)
|
94-3265960
(I.R.S.
Employer Identification Number)
|
901
Gateway Boulevard
South
San
Francisco,
California 94080
(650)
808-6000
(Addresses,
including zip code, and telephone numbers, including area code, of principal
executive offices)
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
|
o
|
Written
communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425)
|
|
o
|
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
|
o
|
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act
(17 CFR
240.14d-2(b))
|
|
o
|
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act
(17 CFR
240.13e-4(c))
|
|
Item
7.01
|
Regulation
FD Disclosure.
|
The
information contained in this Item 7.01 and in the accompanying exhibit
shall not be deemed filed for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by
reference in any filing under the Exchange Act or the Securities Act of
1933, as
amended, except as shall be expressly set forth by specific reference in
such
filing.
On
January 11, 2006, Rick E Winningham and Michael Aguiar, the Chief Executive
Officer and the Chief Financial Officer, respectively, of Theravance, Inc.
(the
“Company”), held a conference call regarding the Company’s January 10, 2006
press release that provided updated guidance relating to the Company’s LABA
collaboration with GlaxoSmithKline. A copy of the transcript of the conference
call is attached hereto as Exhibit 99.1 and is incorporated herein by
reference.
In
addition, Mr. Winningham made a presentation on January 11, 2006 at the
24th
Annual JP Morgan Healthcare Conference during which he discussed the Company’s
significant milestones expected in 2006, as follows:
|
Complete
Phase 3 complicated skin and skin structure infection (cSSSI)
enrollment
|
1st
half of 2006
|
|
Initiate
Beyond Advair (159797) Phase 2b
|
1st
half of 2006
|
|
File
an NDA for Csssi
|
2nd
half of 2006
|
|
Complete
Phase 3 hospital acquired pneumonia (HAP) enrollment
|
2nd
half of 2006
|
Copies
of
the slides shown at this presentation are available for viewing at the
“Investor
Relations” section of our website located at http://ir.theravance.com/medialist.cfm,
although we reserve the right to discontinue that availability at any
time.
This
report contains certain "forward-looking" statements as that term is defined
in
the Private Securities Litigation Reform Act of 1995 regarding, among other
things, statements relating to goals, plans, objectives and future events.
The
Company intends such forward-looking statements to be covered by the safe
harbor
provisions for forward-looking statements contained in Section 21E of the
Exchange Act and the Private Securities Litigation Reform Act of 1995.
Examples
of such statements include statements relating to the goals, timing and
expected
results of clinical and preclinical studies, statements regarding the potential
benefits and mechanisms of action of drug candidates, the enabling capabilities
of the Company’s approach to drug discovery and its proprietary insights,
statements concerning expectations for product candidates through development
and commercialization and projections of revenue and other financial items.
These statements are based on the current estimates and assumptions of
the
Company’s management as of the date of this report and are naturally subject to
risks, uncertainties, changes in circumstances, assumptions and other factors
that may cause the actual results of the Company to be materially different
from
those reflected in its forward-looking statements. Important factors that
could
cause actual results to differ materially from those indicated by such
forward-looking statements include, among others, risks related to delays
or
difficulties in commencing or completing clinical and preclinical studies,
the
potential that results of clinical or preclinical studies indicate product
candidates are unsafe, ineffective, inferior or not superior, and delays
or
failure to achieve regulatory approvals, and risks of collaborating with
a third
party to develop and commercialize products. These and other risks are
described
in greater detail under the heading "Factors Affecting Results, Including
Risks
and Uncertainties" contained in Item 2, "Management's Discussion and Analysis
of
Financial Condition and Results of Operations" in the Company’s Quarterly Report
on Form 10-Q filed with the Securities and Exchange Commission (SEC) on
November
14, 2005 and the risks discussed in our other filings with the SEC. Given
these
uncertainties, you should not place undue reliance on these forward-looking
statements. The Company assumes no obligation to update its forward-looking
statements.
|
ITEM
9.01
|
Financial
Statements and Exhibits.
|
|
(c)
|
Exhibits
|
|
Exhibit
|
|
Description
|
|
Exhibit 99.1
|
Transcript
of January 11, 2006 Conference Call
|
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
|
THERAVANCE,
INC
|
||
|
Date:
January 11, 2006
|
By:
|
/s/
Bradford J. Shafer
|
|
Bradford
J. Shafer
|
||
|
Senior
Vice President and General
Counsel
|
||
EXHIBIT
INDEX
|
Exhibit
No.
|
|
Exhibit
|
|
Transcript
of January 11, 2006 Conference
Call
|
Theravance,
Inc.
LABA
Update Conference Call
January
11, 2006
TRANSCRIPT
THERAVANCE
Moderator:
Mike Aguiar
January
11, 2006
8:45
a.m. EST
|
Operator:
|
Ladies
and gentlemen, good morning, and thank you for standing by. At this
time,
I would like to welcome you to the Theravance Conference Call to
update
the development status of the Beyond Advair program.
|
During
the presentation, all participants will be in a listen-only mode. A
question-and-answer session will follow the company’s formal remarks. To ask a
question press the star key followed by the digit one on your touch-tone phone.
Once again, that’s star one to ask a question. I will repeat these instructions
after management completes their prepared remarks. Today’s 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.
|
Mike
Aguiar:
|
Good
morning everyone, and thank you for joining us. Yesterday, Theravance
issued a press release announcing a new timeline for the initiation
of
Phase 2b studies for compound ‘797 in our Beyond Advair collaboration with
GSK. A copy of the press release can be downloaded from our website,
or
you can call investor relations at (650) 808-4100, and we will be
happy to
assist you. Joining me on the call today is Rick Winningham, our
Chief
Executive Officer.
|
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, without limitation, statements
regarding anticipated results in 2006 and beyond, growth opportunities and
other
statements that refer to Theravance’s goals, prospects, expectations,
strategies, intentions, and beliefs. These forward-looking statements are based
on the information available to Theravance today.
Theravance
assumes no obligation to update these statements as circumstances change. Future
events and actual results could differ materially from those projected in
Theravance’s forward-looking statements. Additional information concerning risk
factors that could cause actual results to differ materially from our
forward-looking statements are contained under the heading “Factors Affecting
Results, Including Risks and Uncertainties” in item 2, “Management’s Discussion
and Analysis of Financial Condition and Results of Operations,” contained in the
Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2005
and the risk described in the Company’s other filings with the Securities and
Exchange Commission.
Page
1
Theravance,
Inc.
LABA
Update Conference Call
January
11, 2006
TRANSCRIPT
I
will
now turn the call over to Rick Winningham, Chief Executive Officer of
Theravance.
|
Rick
Winningham:
|
Thank
you, Mike.
|
Good
morning everyone, and thank you for joining us. I’m pleased to announce that
we’ve identified a plan for the continued development of ‘797, the currently
beta agonist in our Beyond Advair collaboration with GSK. A plan that minimizes
the impact of the previously disclosed formulation issue, and a plan which
is
intended to provide definitive safety and efficacy data coming out of the Phase
2b program. Today, I’d like to discuss some more specific details of this plan,
including our criteria used in evaluating various alternatives.
But
before discussing the specifics, I’d like to provide a brief review of the
Beyond Advair program.
The
goal
of the Beyond Advair collaboration is to develop a once-a-day replacement
medication for Advair by combining a beta agonist with an inhaled corticosteroid
in a dry powder inhaler that can be launched around the end of the decade.
We
currently have a development pool of eight beta agonists, five of which are
either in or have completed Phase 2a clinical studies. The three Phase 2a
compounds which are currently receiving a majority of the development effort
are
compounds ‘797 and ‘802 discovered by Theravance, and compound ‘444 discovered
by GSK. In October, we announced the formulation issue had been identified
with
‘797 that would delay the start of Phase 2b studies initially schedule to being
in late 2005. At that time, we believed the issue was confined to formulation,
not due to the active moiety, and this has been confirmed by our subsequent
analysis. While I cannot provide any additional detail on the specific nature
of
the earlier formulation issue or its resolution due to competitive concerns,
I’m
pleased to be able to provide you with a favorable update to this previous
announcement.
The
collaboration has identified a plan for ‘797 that we believe will resolve the
formulation issue and will enable GSK to initiate Phase 2b program for ‘797
during the first half of 2006. During the course of our analysis of this issue,
the team developed alternate scenarios, which were reviewed according to their
potential to maximize decision-making data, minimize the impact on overall
timing, and increase the probability of successfully developing a commercial
medicine.
Page
2
Theravance,
Inc.
LABA
Update Conference Call
January
11, 2006
TRANSCRIPT
The
Phase
2b studies will be designed to provide definitive safety and efficacy data.
These results will enable us to make a go/no go decision on ‘797 based on a
robust Phase 2b data set. We will not be going into the specific design criteria
of the studies at this point, except to comment that the Phase 2b will entail
larger numbers of patients dosed for longer periods of time than our Phase
2a
work with doses that have the potential to be the commercial dose.
Importantly,
given the current development status of ‘444 and ‘802, we believe there is the
potential to have definitive Phase 2b data for more than one compound prior
to
mid-2007 if the results of the ongoing Phase 2a work for these compounds are
positive. We will not be providing any update at this point regarding overall
program timing or the potential initiation of Phase 3 studies, as these plans
remain under discussion pending the completion of the Phase 2b programs.
While
we’re disappointed with the formulation issue that arose with ‘797 in late 2005,
we believe that the subsequent work done by the project team has resulted in
a
stronger overall program. The Beyond Advair collaboration between GSK and
Theravance continues to be very solid, and continues to operate as initially
envisioned, with multiple compounds advancing together through clinical
development to increase the likelihood of bringing one medicine to the market
around the end of the decade.
I’m
proud
of the work completed by the GSK and Theravance team in quickly identifying
a
resolution to this issue, and I believe that the new development plan will
enable us to reduce overall program risk and to provide definitive data on
multiple compounds in a timely manner.
I’d
now
like to turn the call over to the conference facilitator and open the call
for
questions.
|
Operator:
|
Thank
you. If you would like to ask a question, please do so by pressing
the
star key followed by the digit one on your touch-tone telephone.
If you
are using a speakerphone, please make sure your mute function is
turned
off to allow your signal to reach our equipment. Once again, star
one if
you have a question. We’ll take our first question from Dallas Webb with
Stanford Group.
|
|
Dallas
Webb:
|
Hey
guys. Just real quick, in the press release it says multi-day
administration. Is this an indication that the once-daily may not
be
possible with ‘797? And would GSK want to continue development of a
multi-day product?
|
Page
3
Theravance,
Inc.
LABA
Update Conference Call
January
11, 2006
TRANSCRIPT
|
Mike
Aguiar:
|
No,
no, no. Dallas, this is Mike Aguiar. The intention there is to infer
that
this is a trial that extends over multiple days, not multiple
administrations per day.
|
|
Dallas
Webb:
|
Oh,
okay.
|
|
Mike
Aguiar:
|
Yeah,
this is clearly still a once-a-day product that we are working on,
but it
will be a multiple-day trial.
|
|
Rick
Winningham:
|
Yeah.
Phase 2b, longer duration of study, larger numbers of patients,
multiple-doses.
|
|
Dallas
Webb:
|
Okay.
And with ‘444 and ‘802, you said that ‘797 is now the lead compound. But
where do those stand as far as moving into Phase
2b?
|
|
Rick
Winningham:
|
Well,
I think ‘797 was the lead compound in October when we said we were going
to have a delay. It’s the lead compound today. ‘444 is progressing through
multiple-day studies, currently in the Phase 2a study. And the ‘802 is
progressing through a single dose Phase 2a study. So, when we get
the data
from those studies, we’ll be able to update everyone on the status of
their progression into Phase 2b.
|
|
Dallas
Webb:
|
Okay.
And as far as the go/no go decision with ‘797, any indication of timing
there?
|
|
Rick
Winningham:
|
No.
I think what we’re communicating today that we plan to start the study in
the first half of 2006. When we initiate the study, that of course
will be
a significant event for the company, so we’ll come back with an
announcement on initiation. And I think the key point here that I
tried to
make in my comments was that the potential exists for having data
for
multiple 2b studies on multiple products by
mid-2007.
|
|
Dallas
Webb:
|
Okay,
great. Thank you.
|
|
Rick
Winningham:
|
Great.
Thanks, Dallas.
|
|
Operator:
|
We’ll
go next to Ian Somaiya with Thomas Weisel Partners. Your line is
open,
please go ahead.
|
|
Ian
Somaiya:
|
Can
you hear me?
|
|
Rick
Winningham:
|
We
can.
|
Page
4
Theravance,
Inc.
LABA
Update Conference Call
January
11, 2006
TRANSCRIPT
|
Ian
Somaiya:
|
All
right. Great. Good morning. Just a couple of questions. Just to be
clear,
formulation issue has been resolved? You’re not still working on
addressing the formulation in any
way?
|
|
Rick
Winningham:
|
The
formulation has been resolved in the progression of the compound
to Phase
2b.
|
|
Ian
Somaiya:
|
Okay.
|
|
Rick
Winningham:
|
So,
we’re very pleased right now with where we are with the formulation.
And I
think that’s the message today.
|
|
Ian
Somaiya:
|
And
your level of confidence in ‘797 today versus prior to the issue
arising?
|
|
Rick
Winningham:
|
Is
unchanged.
|
|
Ian
Somaiya:
|
Unchanged,
okay. And just one last question. I think back when you made the
initial
announcement that the Phase 2b trials were delayed, and you had
characterized the time lag between ‘797 and the two backup compounds as
approximately one year. May we assume that the, that ‘797 starts Phase 2b
studies in the second quarter, what would you say is the time lag
between
the ‘797 and two backup compounds?
|
|
Rick
Winningham:
|
Well,
I think we’re currently working on that, currently working to shorten,
we’re always working to shorten the development time of the compounds
in
this program. I think I will stay with the statement that I made
to
Dallas, is once we get the data from the ongoing ‘444 study and the data
from the ongoing ‘802 study, then we’ll be back to people with the timing
on the initiation of the Phase 2b studies for those two compounds.
There’s
been nothing that’s happened in the last two months that has lengthened
the time of ‘444 and ‘802 relative to ‘797. If anything, it’s shortened a
little bit.
|
|
Ian
Somaiya:
|
Well,
when can we expect data from those two Phase 2
studies?
|
|
Rick
Winningham:
|
Well,
I think we could expect a decision on the progression of those compounds
into Phase 2b sometime in 2006.
|
|
Ian
Somaiya:
|
Okay.
Thank you.
|
|
Rick
Winningham:
|
Great.
Thanks Ian.
|
|
Operator:
|
We’ll
take our next question from Gene Mack with
HSBC.
|
Page
5
Theravance,
Inc.
LABA
Update Conference Call
January
11, 2006
TRANSCRIPT
|
Gene
Mack:
|
Hi.
Thanks for taking my question. In thinking about the go/no go decisions
and given the fact that I guess the overall goal of the program is
to take
the best compound forward. What is the current thinking around the
go/no
go decision? In other words, are you, does it make sense to maybe,
given
the fact that the gap between the compounds has maybe shrunk a bit
does it
make sense to maybe hold on to some of this data, wait until you
have
definitive efficacy and safety data in Phase 2 from each of the compounds
before you start thinking about approval
trial?
|
|
Rick
Winningham:
|
Well,
I think to answer that definitively we would have to see what the
data
looked like coming out of the ‘797 study, which will be the first compound
to go in Phase 2b. The collaboration has been set up from the very
beginning to work to pick the best compound to go into Phase 3. That’s
clearly, that’s the overall guidance to the project team from the joint
steering committee, and that’s clearly the guidance today. And we’ll have
to depend on the strength of the data coming out with ‘797 and where ‘444
and ‘802 are when that data comes out.
|
|
Gene
Mack:
|
Okay.
Here, let me put it a different way, a little bit more directly.
Assuming
the data for ‘797 is as you expect in house, and assuming that the other
two compounds generate maybe more promising data earlier days, would
it be
possible to begin a trial with ‘797 maybe slow, I don’t want to say slow
boat the enrollment, but in an effort to sort of if you see something
more
promising earlier stage is there a way that you can adjust things
in order
to accelerate one of those compounds beyond
‘797?
|
|
Rick
Winningham:
|
Yes.
I think that there are, given the timeframes that we’re talking about,
there are always opportunities to accelerate, or the term you used
was
adjust, timelines. And I think clearly if we saw something with the
earlier compounds that we thought gave them more promise and it wouldn’t
mean a significant delay, we would have to evaluate that in the context
of
the data that we were looking at. Because again, the objective of
this
program is to pick the best beta agonist in terms of meeting the
overall
timeline goals for the program. Now, '797 is ahead of the two, if
the data
looks great on ‘797 in 2b we’ll keep marching forward with ‘797. But I
think clearly what we’re, what the group is always trying to do is trying
to reduce the timelines and shrink the timelines for all of the compounds
for the program without compromising the data that’s available at the time
that we need to make specific decisions.
|
|
Mike
Aguiar:
|
Yeah
Gene, I think I would just add on one thing, which is right now the
intention of the program is to advance all the compounds through
as
quickly as possible. So there is no adjustment going on to manage
one a
little slower and one a little faster. The goal right now is to advance
all of the products and compounds through the collaboration as quickly
as
possible. And fortunately, today we’re in the very enviable position of
having three terrific-looking compounds. Now, we’ll continue to see how
those look as the data rolls in. But as of today, we feel very, very
confident about all three, and are pushing all three very
aggressively.
|
Page
6
Theravance,
Inc.
LABA
Update Conference Call
January
11, 2006
TRANSCRIPT
|
Gene
Mack:
|
Okay,
so you would say the chief priority at this point would be timing
in
getting these things as advanced as possible as quickly as possible,
rather than getting pools of data where you could sort of cherry
pick.
|
|
Mike
Aguiar:
|
Yeah,
timing and quality of data, yes.
|
|
Gene
Mack:
|
Okay.
Thanks.
|
|
Rick
Aguiar:
|
Thanks
Gene.
|
|
Operator:
|
We’ll
go next to Jim Birchenough with Lehman
Brothers.
|
|
Jim
Birchenough:
|
Hi
guys. Just wanted to follow up on I guess the purpose of the Phase
2b, and
as it pertains to the formulation. Just want to make sure that this
formulation that arose is fully put to rest, you don’t anticipate that
there are new metrics that you’re looking at in the Phase 2b that could
highlight further limitations of the formulation. I just want to
make sure
that the decision to move forward is because of confidence that there
are
no limitations that would affect the Phase 2b
outcome.
|
|
Rick
Winningham:
|
Yes,
that is the decision that’s been made is that we’ve got confidence in the
data that will come out of the Phase 2b program.
|
|
Jim
Birchenough:
|
And
just on that data, in terms of safety metrics you’re looking at here,
could you maybe just review some of the ones that make sense for
this
class of drug and if there’s anything else that you’re looking for that is
atypical for this class of drug.
|
|
Rick
Winningham:
|
There
isn’t any, without commenting specifically on the design; there isn’t
anything that we’re looking for that’s atypical for this class of drug.
So, it’s more or less what we’ve been working on through the entire
program for all the compounds, which in terms of safety, really changes
in
heart rate, in glucose, potassium, everything that you want to monitor
when you’re studying beta agonists.
|
|
Jim
Birchenough:
|
And
then just finally on the two follow on compounds, have you reached
the
point where you would have identified if there’s a formulation issue with
either of those compounds? And what’s the level of confidence on the
adequacy of the formulation for those
two?
|
Page
7
Theravance,
Inc.
LABA
Update Conference Call
January
11, 2006
TRANSCRIPT
|
Rick
Winningham:
|
I
think where we are right now is that our focus is primarily on getting
the
existing Phase 2a studies done for both of those compounds and evaluating
the data, and then progressing those into 2b studies as quickly as
possible. So I think given that that is our focus, right now we’re
comfortable, right now we’re comfortable relative to the progression of
those compounds into Phase 2b, assuming that the Phase 2a data, data
from
the ongoing 2a studies, supports the progression to
2b.
|
|
Jim
Birchenough:
|
Great.
Thanks for taking the questions.
|
|
Rick
Winningham:
|
Yeah.
Great. Thank you, Jim.
|
|
Operator:
|
And
as a reminder, star one if you do have a question. We’ll go next to Eric
Ende with Merrill Lynch.
|
|
Eric
Ende:
|
Thanks.
Hey guys. I know you don’t really want to talk about the specific problem
for competitive reasons, but if it’s fixed, what needs to be done at this
point with ‘797 in order for the Phase 2 to be started? What needs to be
accomplished? What are your kind of goals in the near
term?
|
|
Rick
Winningham:
|
Well,
for the Phase 2b to be initiated, I mean we’re basically working along
sites, site selection and just lining up all of the details to initiate
the program.
|
|
Eric
Ende:
|
So
there’s no additional studies that need to be done with ‘797 at this
point? You’re that confident, it’s just site
selection?
|
|
Rick
Winningham:
|
Well,
at this point in time, yes. Based on what we know, we are, the majority
of
the work that is ongoing, the majority of the work, not the only
work, is
really related to clinical
operations.
|
|
Eric
Ende:
|
Now
you are also going to have to manufacture a new batch I’m assuming of
Phase 2b material?
|
|
Rick
Winningham:
|
Well,
I wouldn’t want to comment on that.
|
|
Eric
Ende:
|
Hmm…okay.
Thank you.
|
|
Rick
Winningham:
|
Okay.
Thanks, Eric.
|
|
Eric
Ende:
|
All
right.
|
|
Operator:
|
We’ll
go next to Michael Aberman with Morgan
Stanley.
|
Page
8
Theravance,
Inc.
LABA
Update Conference Call
January
11, 2006
TRANSCRIPT
|
Michael
Aberman:
|
Hey
guys. Congratulations.
|
|
Rick
Winningham:
|
Thank
you, Michael.
|
|
Michael
Aberman:
|
Getting
back on track, actually all my questions were previously
answered.
|
|
Rick
Winningham:
|
Okay.
|
|
Michael
Aberman:
|
I
guess I could probably do one to clarify. The potential here is that
you
have three compounds with Phase 2b data prior to the call date for
Glaxo
to choose one of those to move forward into Phase
3.
|
|
Rick
Winningham:
|
Okay,
what I said was that we had the potential to have multiple compounds
with
Phase 2b data prior to mid 2007. Multiple means more than one. Now,
is the
potential to have three? I guess the potential exists to have three,
but
what my statement was was multiple.
|
|
Michael
Aberman:
|
Right.
|
|
Rick
Winningham:
|
Importantly,
GSK doesn’t make the decision with regard to progression. The joint
steering committee makes the decision with regard to progression
of the
compounds. So, again, what we’ll do as we’ve done to date, is we’ll make
the decision based on the data that we have in front of us and the
members
of the joint steering committee will come to an agreement of the
progression of the compounds based on the evaluation of the data.
|
|
Michael
Aberman:
|
Okay.
Great. Thanks guys.
|
|
Rick
Winningham:
|
Okay.
Thanks, Michael.
|
|
Mike
Aguiar:
|
Thanks,
Michael.
|
|
Operator:
|
We’ll
go next to David Blaustein with Sutton
Brook(?)
|
|
David
Blaustein:
|
Thanks
for the call. Congratulations. The question that I have is I know
this is
a little uncomfortable, but there was some information that came
out of
the New England Journal I guess a month or two ago about some of
the
issues with beta agonists. And I guess my question is is the trial
designed with an increased end and longer time duration, is that
input
from the FDA because maybe there’s a _____ with beta agonists? Or is the
increase end with extended time more just a function of current studies
with the formulation? I just want to see if there’s an input because of
some of the new things with beta
agonists.
|
Page
9
Theravance,
Inc.
LABA
Update Conference Call
January
11, 2006
TRANSCRIPT
|
Rick
Winningham:
|
No.
The longer duration of the study, the increase in terms of going
into 2b,
a greater number of patients studying multiple doses is just really
your
classic, just a classic Phase 2b study design. It is not related
to the
ongoing issue around beta agonists. So, I think importantly what
the NIH
guidelines around beta agonists and guidelines in Europe really have
remained unchanged. And I know there’s quite a bit of work going on right
now relative to the resolution of the FDA concerns and specifically
the
beta agonists that are currently on the
market.
|
|
David
Blaustein:
|
Is
that, is there any impact or is there any guidance coming out of
the FDA
with respect to some of that information from last quarter? Or is
it
pretty much unchanged at this
point?
|
|
Rick
Winningham:
|
No,
I think it’s unchanged.
|
|
David
Blaustein:
|
Okay.
Thank you very much.
|
|
Rick
Winningham:
|
Yes.
|
|
Mike
Aguiar:
|
Great.
Thank you, David.
|
|
Operator:
|
It
appears we have no further questions from the phone. I’d like to turn the
conference back over to Mr. Winningham for any closing
remarks.
|
|
Rick
Winningham:
|
All
right. Thank you very much for your questions, and I thank you all
for
participating in today’s call. Have a great day.
|
|
Operator:
|
Thank
you, everyone. That concludes today’s conference, and you may now
disconnect.
|
End
Page
10