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Pfizer at Cowen and Company Health Care Conference - Final
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| Copyright: | CCBN, Inc. and FDCH e-Media, Inc. | | Source: | FD (FAIR DISCLOSURE) WIRE | | Wordcount: | 6486 |
UNIDENTIFIED SPEAKER: Well, good morning, and welcome to the Pfizer
session this morning. We're very pleased to have with us Dr. Joe
Feczko, who is Senior Vice President and Chief Medical Officer of
Pfizer.
Pfizer has one of the broadest and deepest pipelines in the
pharmaceutical industry. Many of these products are novel and headed
into very large potential markets. Of course, their success is
critical to the future of Pfizer, so careful analysis of each of
these products is, of course, very important. And here to help us
with that analysis is Dr. Joe Feczko.
So, Dr. Feczko.
JOE FECZKO, SVP & CHIEF MEDICAL OFFICER, PFIZER: Thank you, and good
morning, everybody.
What I'm going to do today is review some of our strategies that we
rolled out a couple of weeks ago at our analyst meeting, hopefully
review a few of them in a little detail, and if we have time take
some questions, especially on the pipeline and our products that
we've got in the marketplace.
But first, the usual, I do want to just draw your attention to the
cautionary language on this slide about our discussion this morning.
I'll let you read it for a second. Thank you.
Okay, so we're pretty cognizant in Pfizer about the impact of many
changes going on in the healthcare industry. There's an information
explosion. There's tough questions being asked on affordability,
demands for evidence-based medicine and better quality care. Most
importantly we think is the changes on information and who owns the
information -- managed care companies and large insurers doing their
own analysis of data and relying more on their own analysis than they
are on -- even on clinical trials and regulatory documentation. We're
realistic about this, but we feel we're in a -- at a good position to
really deal with these changes as they go forward.
A couple weeks ago at the analyst meeting we laid out a five-point
strategy for our path forward. We know that we face some tough times
ahead. We're not being blase about the issue of Lipitor. But even
before Lipitor and after Lipitor we will be having loss of
exclusivity. But that loss of exclusivity is comparable to really
what we've had in recent years. But nothing really compares to the
scale of Lipitor loss of exclusivity, and we do want to talk about
how we're going to continue to generate revenues and how we're going
to deal with that as we go forward.
So what I'm going to do first is focus on three of the key
strategies. The first one I'd like to talk about is to focus on
optimizing our patent-protected portfolio. I'd like to focus on the
late-stage pipeline as well as the portfolio that we have that's
currently on the market. It's imperative that we -- like any
pharmaceutical industry -- that we deliver our late-phase pipeline.
This is really critical in Pfizer.
What we've done over the last year is gone through an exercise in
Pfizer of really trying to winnow down the large, large portfolio
that we had and take a long hard look at the areas we're operating in
-- the disease areas we're operating in. And I think it's true to say
that we, like a lot of companies, may have been spread a little bit
too thin. It's obvious that certain therapeutic areas and certain
disease areas are projected to have significant growth in the future.
The ones we've got up here -- the six I've got up here -- oncology,
pain, immunology, diabetes/obesity and Alzheimer's and schizophrenia
-- really are the ones that are viewed in the marketplace as being
key growth drivers over the next decade -- major areas of medical
need, major areas of market growth, and major areas, I think, because
of the science that is driving newer and better medicines in these
areas, and where we expect to have some breakthroughs.
So we've gone through a significant look at our portfolio and tried
to weed out, and we've actually dropped a number of programs over the
last year to maintain our focus in key areas, and these are the areas
that we're classifying as invest to win. We are in other areas, of
course, too. Anti-infectives is a big area for us. But these areas we
want to get broader and we want to get deeper in our portfolio and
use them also for licensing opportunities.
Just a snapshot of our current Phase 3 portfolio. We -- besides our
new chemical entities, we also want to explore new indications for
marketed products such as Sutent, Geodon, Lyrica, etc. We're putting
a lot of energy behind these late Phase 3 programs right now.
Axitinib for -- the first indication would be pancreatic cancer, but
it is a broad-based VEGF inhibitor that we'll be looking at a number
of different tumor types. Tremelimumab, initial filing would be for
melanoma. This is a CTLA4 antibody.
Apixaban is our joint venture with Bristol-Myers Squibb. That's going
along extremely well in the Factor Xx -- Factor Xa anticoagulant, and
we're very happy with this collaboration and this joint venture and
the way the program's progressing across a number of indications. And
new to this portfolio, this Phase 3 portfolio -- and also I just want
to mention we've had in there for a while now the CP-945598, which is
the CB-1 antagonist for obesity is in Phase 3. We've now brought into
play a new Alpha-2 Delta compound for generalized anxiety disorder
and S,S-reboxetine that we're looking at for fibromyalgia, still a
very unmet medical need.
Projected over the next year or two, we're projecting to add 15 to 20
Phase 3 starts in the 2008-2009 time period. We know that rebuilding
our pipeline is critical to our success, and by moving these
compounds into Phase 3 in this timeline we anticipate having some 24
to 28 products in Phase 3, with a good balance between new targets
and new chemical entities as well as new indications for existing
compounds.
Many of these are in our -- the previously mentioned sort of invest
to win category -- cancer, you'll see a number in cancer here;
diabetes; and inflammation. And I think this is a way of us showing
that we're trying to focus again on these areas for good balance. But
you also see here a number of anti-infectives, a novel IV and oral
sulopenem, a drug for broad-based bacterial infections, for hospital
infections, drugs for Hepatitis C and HIV. So we're maintaining our
expertise in the anti-infective area, as well. New indications -- as
I mentioned, apixaban has a number of indications we're looking at,
and other indications broadening out the cancer indications for
axitinib and tremelimumab.
Let me give you an example how we're trying to broaden out
indications. Sutent -- you're all familiar with Sutent. We have this
drug approved now for metastatic renal cell carcinoma as well as
gastrointestinal stromal cell carcinoma. But we know that those are
smaller markets for us, but they did get us early approval. We are
anticipating significant growth in the programs that are currently
running. We have large programs going on now in breast cancer,
non-small cell lung carcinoma and colorectal, and we're also in the
process of starting studies in hepatocellular carcinoma, which is
actually key in some developing markets in Asia. While hepatocellular
carcinoma is not a big tumor type, say, in Western Europe or the
U.S., it is a very significant -- has a very high prevalence in Asia,
especially in China. We're also looking at hormone-refractory
prostate cancer.
What will this portfolio project into? Well, hopefully, we anticipate
that this will project to 15 or 20 submissions in the 2010 to 2012
time frame. It's important that when you look at this, this does not
include necessarily new formulations or pediatric extensions
associated with some of our compounds. So this is either new chemical
entities or major new indications on our inline portfolio at that
time.
We know that we've had a gap in the past. We know that this gap has
been problematical for us, especially in light of our loss of
exclusivity over the last couple of years. We're hopeful, though,
that we're not only going to be filling this gap with substantial
number of new compounds coming through our Phase 3 and on to launch
but also that we have in place now a very large and robust Phase 2
pipeline so we can avoid having this gap problem in the future.
How are we going to do that? Well, one of the areas we've been
looking at -- and I think there's been a lot of folks (inaudible)
this in the pharmaceutical industry -- is how to identify the winners
early and identify the losers early and to maintain our focus on the
winners and get rid of the losers as quickly as possible. We do know
that many and most, actually, molecular entities right now declare
themselves very early. We lose very few compounds now in the early
phases of clinical research on toxicity or toxicology.
Where the problem really comes in is lack of efficacy. This has been
a major problem right now in Phase 2 programs. And it's critical that
we, through novel clinical trial designs and intensive work in
translation medicine, that we understand these winners and losers
very early on. And, looking back on our portfolio and looking back on
what we've done, we are seeing more and more that these do declare
themselves very early. So it's important when we do have a failure
that we understand its mechanism of action, understand why it failed
and move on, and feed that back to the research departments and move
on with the successes.
So we are -- have a very strong focus on this that we started putting
in place a few years ago looking at our Phase 2 pipeline. We also
have a strong focus now looking at our cycle times to try to improve
those cycle times through the development process. And we believe
it's starting to pay off with what appears to be at least the last
couple of years a much better survival rate in our Phase 2 portfolio.
Moving on to our patent-protected portfolio, we do have a large
number of compounds, as you're fully aware, in both primary care and
in specialty. I'll go through a few of the key ones.
Despite its intense competition, Lipitor continues to be a great
medicine and our largest product. Any of you who have heard Ian Read
talk about this, you know we're struggling and fighting hard, though,
against generic simvastatin. We'll continue to focus on the lack of
outcome data with key branded competition. We are trying to take
advantage of the results of our studies as they roll out and also the
competitors', especially when they don't show any improved efficacy
in their endpoint trials, such as what happened with ENHANCE.
While the U.S. is important, though, I do want to point out that
Lipitor is doing extremely well in the rest of the world. It's
holding its own in Europe and actually growing in high-single digits
in Canada and in the emerging markets. I think this is critical to
our emerging market strategy, because even in the emerging markets
currently we are already facing significant generic competition where
we either did not have patents or the patents are fairly weak. So we
are getting good growth in those markets even in the presence of
numerous brands of atorvastatin.
During 2008 we'll reinforce differentiation with our compelling
evidence -- clinical evidence and outcomes evidence. We'll drive
activities targeted at both new and continuing patients trying to get
new patients on, and we'll maintain our leverage and maintain our
access through appropriate negotiations with managed care.
Lyrica -- Lyrica is one of our anchors to our portfolio. It has a
very promising long-term outlook. In 2007 Lyrica was approved by the
FDA as the first compound for fibromyalgia. We had 53% of patients on
Lyrica experience rapid and sustained pain relief that continued
through the six months trial that we used for registration purposes.
This clinical evidence, we feel, will set Lyrica apart from its
competition. It's demonstrated a rapid and sustained uptake. In 2007
U.S. sales were up 46%, with international sales growing by 78%. In
international we had $781 million.
More importantly, we know that fibromyalgia patients are very
dissatisfied with their current treatments. About 90% said that they
are dissatisfied with the current mix of analgesics and various
neurotropic drugs that are used to treat fibromyalgia in the past, so
we think there's great opportunity here as we go forward.
We do still have a robust life cycle plan in place for Lyrica. As you
know, it was a stalwart in the area of neuropathic pain. We want to
continue to solidify the indications in pain, so we're doing work in
patients with spinal cord disorder and posttraumatic neuro pain.
We're also expanding our programs into post cancer pain, post stroke
pain and postoperative pain.
Celebrex -- Celebrex is a key inline component of our pain portfolio.
In 2007 we delivered 12% growth, to $2.3 billion in revenue. This is
up (technical difficulty) in the U.S. and 24% internationally. Our
strategy for Celebrex is to defend and preserve the brand near term
by doing three things. One, we're going to strengthen the
understanding of the efficacy and safety. We still have to have a lot
of effort put in this. We still have situations in the U.S. where
many people in the public still think that Celebrex was taken off the
market along with Vioxx and Bextra. So we're still pushing very hard
to make sure people understand the benefits of Celebrex. We are
working hard to repair the patient-physician dialog around this
compound, giving physicians the information they need to have
appropriate dialog with their patients, and then of course optimizing
execution with our field force.
We are having a number of studies reading out, both GI studies and
cardiovascular studies, in the next 24 to 36 months. CONDOR and
PRECISION are two of the key ones. CONDOR is a GI study and PRECISION
is the large cardiovascular study that we agreed with the FDA after
their advisory hearing in 2005. We also have another -- a couple
other GI studies as well as another cardiovascular safety study going
on concurrently in Europe. And we're hopeful that this new data will
renew the momentum for Celebrex.
Chantix, our key smoking cessation compound, is being rolled out
globally. I would like to comment on the recent changes in the FDA
label. Many of you are aware from the publicity around that that in
mid-January we did add a warning section to the label about patients
who -- that they should be observed for development of any serious
neuropsychiatric symptoms. This change was not due to any new data at
that time. We initially started this change in November with the FDA
when it was put into the clinical trials -- into the postmarketing
observation section. Subsequently, the FDA wanted this to be moved
into the warning section. So we worked with them over the holidays to
put the same information in the warning section right now.
But what we're trying to emphasize and what we will continue to
emphasize is that this drug is one of the key mainstays to help with
smoking cessation. The real problem out there right now is smoking.
Smokers have, as we all know, have a significant impact on their
health, be it cancer, cardiovascular disease or contributing to
advancing and accelerating atherosclerosis. So the real issue here is
that it's important that smokers quit, but it's also important that
patients understand in -- smoking in patients who want to use Chantix
understand what they need to look for, what the physician needs to
look for. The syndromes still are very rare and do not occur on a
regular basis. However, we do want to alert people and that way they
can take the drug appropriately and gain the benefits from their
smoking cessation.
From a global perspective the U.S. is really just the tip of the
iceberg. There are about 1.3 billion smokers in the world. We are
gaining rapid approval throughout Europe. We've had recently approval
in Korea, and we're anticipating approval actually in China in the
not too distant future. So we're still -- we're extremely excited
about Chantix and about our partnering with various medical agencies
and governments around the world in their smoking cessation programs.
Sutent, as I mentioned earlier, is the bedrock of our oncology
portfolio. Global sales last year were just a shade under $600
million. It's the market leader in its core indications of metastatic
renal cell carcinoma and in second line GIST, and we're going to
continue to, in 2008, to drive its indication in first line renal
cell carcinoma and address any barriers to access that may exist
around the world. We do have a comprehensive life cycle plan, as I
mentioned, and we anticipate over the next couple of years to have
programs in breast cancer, colon cancer and non-small cell lung
carcinoma.
I'd like to now move to one of our other strategies, briefly --
opportunities for our established products.
You're all familiar with the life cycle of medicines. It begins with
its approval with regulators. It grows under patent protection and
declines, often very rapidly, when patent expires. This rapid
decline, though, is much more prominent in the U.S. than it is in
many other countries around the world. It's much more complicated
than what I just listed, and we want to take advantage of this in the
many markets where patent expiry is not as significant a problem as
it is in areas such as the U.S.
This is a picture of the established product segment in the
pharmaceutical market. This is a segment where medicines have either
lost their patent protection or are on the verge of doing so. This
segment is large and is growing fast. It was about $271 billion in
2006, and by 2012 it is expected to grow to about $525 billion.
There's two main drivers for this. About two-thirds of the growth in
this marketplace comes from products that are losing their
exclusivity in this time period. However, a third is really from pure
organic growth in this market, increasing use of these compounds in
the various markets around the world.
This will represent about $80 billion worth of growth. And we're
putting in a strategy by developing an established product business
unit with focus with a key senior manager from Pfizer in this area
and bringing together the resources for the established products
around the world under one leadership. The profitability of this
segment is still good, because the R&D investment has already
been done. So there is little advanced R&D to do in this area,
though it is a great opportunity -- does have great opportunities for
dosage form development for differentiation.
I wanted to spend a few minutes on the market. There really are three
markets. The green represents the branded emerging market segment.
The yellow represents the branded -- what we call branded traditional
markets. And the red represents the intellectual property-driven
markets. These markets behave very differently. We have seen the
traditional generic companies try to penetrate the markets for the
branded emerging markets, the ones in green, and have failed to do
so. They struggle. They struggle because these are physician,
pharmacy and patient-driven countries where payer influences are not
as pronounced as they are in, say, the U.S. or Australia or Canada.
Our model to attack these areas requires a significant commercial
footprint to succeed, and we have that in all these countries. In
many markets, we do compete very strongly and we have good growth,
even for those compounds that have multiple generic entrants already,
such as Lipitor, as I mentioned early. We're still growing at
high-single digits in many of these countries.
The second area we call is branded traditional markets, such as
Western Europe, Japan, South Korea. Here the pharmacy channel is
important and drives dispensing decisions. Physicians and payers
still retain some influence, but brand still matters here. So both in
the green and the yellow brand identification and brand loyalty are
still really critical drivers for use of products in these markets.
The third segment is the IP-driven market, and that's the one I think
you're all familiar with -- the United States, Canada, U.K.,
Australia. These are tough, and they're very commodity style. Payers,
really, and the pharmacy channel are really the drivers for use of
drugs when they go off -- lose their exclusivity. There's little or
no brand preference among generics when they lose their exclusivity.
And this is where branded sales really drop very significantly as
patent expires.
We believe we can compete very well in these markets for a variety of
reasons, starting with the strength of the Pfizer brand. The Pfizer
brand really does have a lot of weight in these countries. We've
partnered very well with the governments in these countries and with
the distribution channels in these countries, and we've been there
for a long time, in all of these developing countries that are now
showing significant GDP and pharmaceutical growth.
We are already a leading player in the established products market.
We have a large base from our various portfolios, from -- as we
brought together the various companies, Warner-Lambert pharmacy and
Pfizer -- we have a large portfolio to use to leverage in these
countries of established products. We've been in regions such as
Latin America, China and Eastern Europe for decades, and we believe
we can use that experience to our benefit.
We also have a very strong pharmaceutical science group, and, as I've
said, differentiation in dosage form development, novel dosage forms
that are uniquely used in those areas, as well as injectables, are
key for advancing this marketplace. And also our manufacturing is
state of the art, and our ability to leverage across the world in
various low-cost environments for manufacture of these compounds will
be also critical to this strategy.
We're going to apply our strength across four broad value creation
work streams. We're going to leverage our product portfolio to drive
cost reductions and promote selected products. Second, we're going to
become a world leader in product enhancements and reformulation,
using innovative packaging, delivery devices, combination therapies,
etc. to drive this area. We're going to fill niches. I think we have
a large enough portfolio to fill product niches in certain markets.
And, lastly, we can add value by identifying our efforts to navigate
our products through the transition from LOE -- during LOE to this
established product stage.
We expect this established product segment to grow substantially,
about 11% over coming years. Our goal is to outpace the overall
market and increase our share in this segment. As I said, we've now
created a unique business unit with a leader who has a lot of
experience throughout Eastern Europe and Russia in working in these
developing markets, where this product portfolio is extremely
important.
Next I'm going to talk a little bit about how this dovetails with our
emerging market, growth in emerging markets. We are very optimistic
about growth in the emerging markets. I'm going to use Asia as an
example, but what I'm talking about here also applies to the unique
strategies we're using in Latin America, Eastern Europe and other
parts of the world.
We currently have a strong foothold in the global marketplace in
particular in Asia, and when I talk about Asia, in this case it's
minus Australia, Japan and New Zealand I'll be talking about. So I'll
be talking about Asia minus those developed countries. As you can
see, we're number one in most parts of the world. We can do more to
leverage our size and scale, and we're going to do that. Our aim is
to increase market share and try to increase the market share in
these developing markets, so it's much more similar to the market
share we see in the U.S. and Europe, so, in other words, moving from
the 5% or so, 6% market share, up to the 7 to 9% market share areas.
We have a large portfolio of products that are well suited for these
markets, both branded and established. So it will be a mixed strategy
of emphasizing our patented products, where they fit uniquely into
the product mix needed for those countries, as well as using our
established products to drive market growth.
Again, taking Asia as an example, we have a market share in Asia now
of about 4%, and the total market is valued at about $47 billion.
That market is projected to grow in 2012 to about $80 billion, and
we're anticipating growing our market share to about 6% in that
period of time. And, as I've said, our aim is to have market share
similar to what we have in Europe and the U.S. in the 7 to 9% range
with this strategy.
We feel we're well positioned to grow, and we are investing in these
emerging markets. We are the number one pharmaceutical company right
now in Asia. We've created over the years a good footprint, and this
is important in Asia. We have key local leaders, nationals in most of
our countries throughout the developed world that we've been working
with and [trained] over the years. We also have a strong footprint in
Hong Kong right now to support the region -- regional support for
medical, sales, public affairs, marketing and finance.
Another -- as I mentioned earlier, and this cannot underestimated, is
Pfizer's reputation in the developing area. Relationships with
governments and physicians in these areas is critical. We have
developed our reputation over the years. We are key partners with
regulators in these areas, helping to train, helping to advise,
helping to work on drug development in a very substantial way.
We're going to leverage our (inaudible) there in our relationships
through three main areas, three main focus areas. One is in research
and development. And, just to give you a few examples, we've
committed to investing $300 million Korea over the next -- South
Korea over the next (inaudible) years. We have just opened up some
clinical core -- clinical research centers in Korea, a joint venture
between us and several of the academic institutions in Seoul, to do
early Phase 2 translational medicine research as well as some work
that we've now -- a memorandum of understanding we've signed with the
Korean Research Institute for Biotechnology and Biosciences looking
at cancer targets. We continue to invest in our research and
development facilities in China and leveraging our capabilities there
and putting in place key researchers to look at strategic alliances
with academics and startups in the Asian environment.
We want to expand our incubator initiatives. We talked in the past a
little bit at different meetings about our incubator initiative in La
Jolla, California, where we're bringing in small biotech companies
and startups to actually work side by side on our campus in La Jolla
with our researchers there. We're looking at expanding the same model
in Europe and in Asia.
In manufacturing, we have experience throughout Asia, with plants in
China, Singapore, Indonesia and Pakistan. We will leverage our
partnership opportunities in Asia to lower our costs of sales and to
help our medicines become more affordable in these markets. We will
also improve our skills in speed of execution at reformulations to
customize these for the local environment.
Business development, we see great opportunities for business
development activities in Asia. Again, to supplement our portfolio
we're moving from looking exclusively at worldwide deals to also
looking at reasonably specific deals so that we can advance the needs
of the region. This is critical to capture the various opportunities.
This is also critical really in our R&D environment. So there are
unique diseases and unique issues that we're having to deal with.
As I said, the number one killer of -- in Western Europe and the U.S.
is cardiovascular disease. The number one killer in most of Asia is
cancer. The cancer portfolio has to be not only what we usually see
for the West, such as for lung cancer, breast cancer, but they also
have some unique situations that where we need to develop our drugs
for gastric cancer, for hepatic cancer -- primary hepatocellular
cancer and nasopharyngeal cancer. So these are cancers that we don't
see that much of in the West but they have a huge incidence in Asia
and need specific programs. And we have in place now centers,
programs and strategies to deal with that.
So our goals are considerable. We want to grow our market share from
4% today to 6% in 2012 and between 7 and 9 by 2017, grow our share in
China, take Korea to a $1 billion business by 2012, become a top
three oncology company -- and we think our portfolio is well
positioned to do that -- and we want to capture a global advantage by
leveraging low-cost infrastructure in manufacturing and R&D. We
believe we have a good plan right now for this. We're going to use
the example in Asia again to leverage it in Latin America and Eastern
Europe.
So just in summary I just want to say that I feel that our portfolio
right now is developing the right products in the right therapeutic
areas. We are well poised in key areas that are going to show high
market growth and high medical need in the near term. This is both
for inline and -- for our R&D portfolio and continuing to develop
our inline with new indications. We're putting in place, we feel, the
right business models, by moving towards specific business units
where certain segments of the business need specific focus and
increased focus. And we want to assure that we will take advantage of
geographic expansion, to be in the right geographies and expand those
geographies as needed.
So I touched on three of the five, and I think we have a few minutes
for questions, if you want to take them, Steve.
Thank you.
UNIDENTIFIED AUDIENCE MEMBER: Can you update us on the status of the
Lipitor study (inaudible) and also can you help us with any maybe
basic research that would support the use of (inaudible) in
Alzheimer's Disease, and then why (inaudible)? Is there any basic
reason (inaudible)?
JOE FECZKO: Well, a lot -- well, (inaudible) was a study that was put
in place because of mainly (inaudible) because of epidemiological
observations, that patients with Alzheimer's Disease were felt to be
doing better if they had also been having concomitant statin therapy.
This had been seen in some large databases over the years. There was
some evidence that some of the neurofibrils associated with
Alzheimer's had a heavy cholesterol content in some of the early
basic work. But it was still unclear how you would really examine a
statin.
So what we did was we actually ran a study that started several years
ago with Aricept, which is our drug that we co-promote with Eisai, so
it was Lipitor added onto Aricept versus Aricept alone, looking at
cognitive function in the usual manner that we do for -- in mild to
moderate Alzheimer's Disease, looking at cognitive function as you
would in any Alzheimer's study as well as a substudy with doing
specific magnetic resonance imaging to look at brain volume and other
changes in the brain associated with Alzheimer's Disease.
So anyway, (technical difficulty) last year. It did take a little bit
longer time than usual to finish and analyze the data, mainly because
of the MRI scanning needing to be read. But I can't really discuss
the results right now, but it is being presented at the American
Academy of Neurology this April. So we have locked down the database
and now we'll be presenting it.
UNIDENTIFIED AUDIENCE MEMBER: (Inaudible question - microphone
inaccessible)
JOE FECZKO: Parkinson's -- we don't have specific work in
Parkinson's. We are doing a lot of work, though, in the whole area of
neurosciences associated with Alzheimer's and schizophrenia. And many
times those drugs associated with that, especially when you're
looking at drugs that may have a side effect of movement disorder and
with the movement disorder as well as dementia associated with
Parkinsonism, these drugs may be used in that area. But right now we
don't have a specific program in Parkinson's. Our programs really are
focusing more on Alzheimer's and schizophrenia. If there's
opportunities there that we see based on the mechanisms and our --
we'd be willing to explore. We don't have a specific program in that
right now, though.
UNIDENTIFIED AUDIENCE MEMBER: (Inaudible question - microphone
inaccessible)
JOE FECZKO: The Greenstone -- the Greenstone is a tougher business,
of course, because it is the U.S., so you're reliant really on the
generic models, as I understand it, and I'm going to start getting
way out of my comfort zone here in about two seconds. But the -- but
of course the generic model in the U.S. is all based on that first
180-day exclusivity. And we have opportunities there, especially with
our own products, as they lose exclusivity, to be able to compete in
that area. But all generic companies really make their growth through
that area.
So there are opportunities. I mean, we do have a good portfolio. We
hope we can leverage the Greenstone portfolio with managed care,
looking at low-cost options. I think our biggest opportunity, though,
for growth in established products is really outside the U.S., in
areas where it's less of an IP-driven market, as I said, in those
areas that I had up there in green, where brand reputation and
physician and patient loyalty to brands are much more significant
than they are here in the U.S.
UNIDENTIFIED AUDIENCE MEMBER: (Inaudible question - microphone
inaccessible)
JOE FECZKO: Well, I think the -- well, like I said, the biggest
problem that the companies have had over the years in early phase
research had been in losing drugs because of side effects and
toxicity, and it's been gradually changing. So over the years, I'd
say beginning about six, seven years ago, I think with the different
targeting based on genomics and the Human Genome Project, when we
identified so many more targets associated with disease processes and
so many more opportunities to find druggable targets, what we started
losing then was -- because we were able to screen a lot for toxicity
-- now we're starting to lose for efficacy, because while there are a
tremendous number of targets identified associated with diseases,
they're not necessarily pathological for those diseases, and we don't
have enough science to know for sure that by impacting those targets
we actually impact the disease process.
And so what you find in many companies over the last sort of five to
seven years is that their Phase 2 attrition was lack of efficacy. And
so you have to really focus in on that, in developing specific
biomarkers, understanding mechanism of action. And we do post our
Phase 2 pipeline now along with our Phase 3, so I think it is a good
--- I think looking at that transition between Phase 2 to Phase 3 is
a good marker for us right now in looking at how well we're
succeeding. The success rate on that was pretty low in the past, and
like I said, knock on wood, two years don't make a trend,
necessarily, but it's better than a one-year trend. But we've been
doing pretty well over the last couple of years in moving our drugs
through Phase 2.
UNIDENTIFIED AUDIENCE MEMBER: (Inaudible question - microphone
inaccessible)
JOE FECZKO: That may be part of it, but we do have more biologics,
and I think we're also seeing that in our small molecules. I think
the biologics by their very nature are more targeted for a biological
target that has an impact on a disease process. But we're also seeing
that in our small molecules.
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