BW20021108002093 20021108T123009Z UTC
( BW)(ELI-LILLY-&-CO)(BC43) Lilly Outlines to Wall Street Its Strategy
To Realize Its Growth Opportunities and Deliver Superior Earnings
Growth Over the Long Term
Business Editors
UK REGULATORY NEWS
INDIANAPOLIS--(BUSINESS WIRE)--Nov. 8, 2002--
Lilly Also Announces Two Recent Submissions -- OFC for Bipolar
Depression and Duloxetine for Stress Urinary Incontinence
Eli Lilly and Company (NYSE: LLY) today will review with members of
the investment community its implementation plans for capitalizing on
its many growth opportunities, including its outstanding pipeline, and
delivering superior long-term growth.
Implementation of Lilly's Growth Strategy
"After four consecutive quarters of declining earnings due to the U.S.
Prozac(R) patent expiration, our earnings per share grew 3 percent in
the third quarter of 2002, excluding unusual items. We had expected to
emerge in a stronger growth mode, but we have been confronted with
some manufacturing and regulatory challenges that have delayed the
launch of some of our new products," said Sidney Taurel, Lilly
chairman, president and chief executive officer. "We are working very
hard to address these challenges and expect to start capitalizing on
our many growth opportunities next year. We could possibly launch as
many as eight new products by the end of 2004, which will lay the
foundation for sustained long-term growth. I believe Lilly's
innovation-driven approach that combines critical mass, speed and
excellence in our core business areas with flexibility through
partnering offers Lilly shareholders superior long-term value."
Regarding the outstanding manufacturing issues with the U.S. Food and
Drug Administration (FDA), Taurel commented, "We have been meeting
with senior FDA officials to discuss their priority issues and
expectations as well as Lilly's comprehensive action plan. We have
confirmed that our primary challenges involve two facilities in
Indianapolis, particularly the injectable plant. While we cannot speak
for the FDA, I believe that we are making progress and are on the
right path with the right leadership, expertise and resources to
implement our plan. We expect to hear from the FDA in the near future
regarding next steps."
Taurel continued, "However, manufacturing issues will not affect the
approval of Strattera(TM), and we expect that Cialis(TM) will not be
affected as its manufacturing is also planned for outside
Indianapolis. In addition, the FDA recently conducted a preapproval
inspection of Forteo(TM) at its bulk site in Indianapolis. I am
pleased to say that there were no observations from the inspection and
there are no longer any manufacturing-related barriers for approval of
this product. For the other two products for which we hold approvable
letters, final approval is contingent upon resolving the outstanding
manufacturing issues. We will be ready in the first half of next year
for a preapproval inspection for Cymbalta(TM) at our dry-products
facility in Indianapolis and a reinspection for Zyprexa(R)
IntraMuscular formulation at our injectable facility in Indianapolis.
However, these inspections have not yet been scheduled."
The company is taking a number of proactive steps to ensure it
maximizes the many new upcoming product launches. Taurel commented,
"To capitalize on our expanding product line, we are setting
priorities among our growth opportunities. We are also identifying
selling synergies among our new and current products, and we'll use
trigger points based on passing regulatory hurdles to ensure we get
the right resources behind our launches at the right time. To
appropriately fund those launches, we are cutting costs in noncore
areas. At the same time, we will create shareholder value through the
very selective use of partnerships that provide us with additional
resources and capacity and help us manage risks."
Major Product Growth Opportunities
"The product delays have provided us with additional time to further
strengthen our global launch plans. We are taking full advantage of
this time," said Gerhard N. Mayr, Lilly executive vice president,
pharmaceutical operations. "We are continuing to strengthen our sales
force through internal expansions and strategic partnerships. By the
end of 2004, we expect our global sales organization to top 17,500,
which is an increase of about 30 percent over a three-year period. At
the same time, we are continuing to strengthen our marketing
leadership, skills and processes. In addition, we are taking an
approach of prioritization, partnership, focus and flexibility that
will help ensure we optimize each of our new product launches and
deliver superior results to investors."
Mayr continued, "Overall, our marketing and sales investments to date
are paying off. In each of our top affiliates, the company's growth
has exceeded that of the overall pharmaceutical market. Fueling this
growth is our portfolio of best-in-class and first-in-class products,
effective marketing strategies and solid implementation. In the
year-to-date period ending September 30, 2002, the collective sales of
Zyprexa, Gemzar(R), Evista(R), Actos(R), Humalog(R) and Xigris(R) grew
23 percent. Indeed, we are winning head-to-head competitive battles as
we grow best-in-class products like Zyprexa and Actos. However, we
continue to have greater aspirations for Xigris and are taking
numerous actions to accelerate its sales growth and realize the full
commercial potential of this lifesaving product."
Mayr also noted the additional growth opportunities that the company's
major products will provide through several new indications,
formulations and expansions into additional markets, some of which are
highlighted below:
Line Extension - Approvable Letter
-- Zyprexa IntraMuscular formulation's final U.S. approval from the
FDA is contingent upon resolution of manufacturing issues at the
Indianapolis injectable facility.
Line Extensions and Major Market Expansion - Under Regulatory Review
by End of 2002
-- Zyprexa's bipolar maintenance indication submissions in the U.S.
and Europe are ahead of schedule and will be filed by the end of 2002.
-- Gemzar's breast cancer indication will be submitted in Europe by
the end of 2002.
-- Evista is under review in Japan for the treatment of osteoporosis
and is expected to receive approval next year.
Line Extensions - Select 2003-2006 Submissions
-- Gemzar's ovarian cancer European submission is planned for 2003.
-- Zyprexa's depot formulation submission is planned for 2005.
-- Evista's U.S. submission for prevention of breast cancer is planned
for 2005.
Late-Stage Pipeline Opportunities
"With no fall-out in the near-term product pipeline over the last two
years, Lilly is poised to launch numerous new products over the next
couple of years," said John C. Lechleiter, Lilly executive vice
president of pharmaceutical products and corporate development.
"Forteo, Strattera, Cialis and Cymbalta all hold approvable letters
from the FDA. In addition, we are announcing today that we recently
made U.S. submissions for olanzapine/fluoxetine combination (OFC) for
bipolar depression and duloxetine for stress urinary incontinence. We
have also recently commenced the rolling submission process for
Alimta(R) for mesothelioma, which should be completed next year. Thus,
our late-stage pipeline remains intact and, in fact, has only
strengthened as we gather additional clinical data. This is a pivotal
and exciting time for Lilly as we work to translate the promise of our
science into meaningful new therapies for patients."
Lechleiter will review several products in the company's late-stage
pipeline, some of which are highlighted below.
New Products - Approvable Letters
-- Forteo - Forteo is a novel biotech product under FDA review for the
treatment of patients with osteoporosis and high fracture risk, an
often painful disease that can affect a person's longevity and quality
of life. Unlike antiresorptive agents that work to reduce bone loss,
Forteo is an anabolic agent that increases skeletal mass and
significantly lowers vertebral and nonvertebral fracture risks. In
fact, new biomarker data show that Forteo works by enhancing the
natural bone remodeling process. The company holds an approvable
letter from the FDA for the use of Forteo in postmenopausal women and
men with osteoporosis who are at a high risk for fracture. As noted
above, approval is no longer contingent on manufacturing issues. The
company is currently working with the FDA to finalize the label for
Forteo. Final U.S. approval is expected early next year.
-- Strattera - Strattera, a highly specific norepinephrine reuptake
inhibitor, is under FDA review for the treatment of attention-deficit
hyperactivity disorder (ADHD) in children, adolescents and adults.
ADHD affects an estimated 3 to 7 percent of school-aged children in
the U.S., of which up to 60 percent will carry their ADHD symptoms
into adulthood. If approved, Strattera would be the only nonstimulant
agent indicated for the treatment of ADHD. In addition, with
once-a-day dosing in children, in clinical trials it has shown
effectiveness throughout the day without causing insomnia. The company
received an approvable letter from the FDA in August 2002. Final U.S.
approval is contingent upon labeling discussions and review of
additional analyses. As noted above, approval is not contingent on
manufacturing issues. Lilly plans for final approval by the spring of
2003.
-- Cymbalta - This potent, balanced dual reuptake inhibitor of both
serotonin and norepinephrine is under review by the FDA for the
treatment of depression. There are significant unmet medical needs in
the antidepressant market as more than two-thirds of patients using
current therapies will not fully recover and at least one in three
patients does not complete an appropriate course of therapy. Clinical
trials have shown Cymbalta demonstrates impressive remission rates and
is effective in addressing both the emotional and painful physical
symptoms of depression. In addition, the safety profile is favorable.
The company received an approvable letter from the FDA in September
2002. Final U.S. approval is contingent upon labeling discussions and
successful completion of a preapproval manufacturing inspection at the
Indianapolis dry-products facility.
-- Cialis - Cialis, a molecule codeveloped by Lilly and ICOS
Corporation through the Lilly ICOS LLC joint venture, is under review
by the FDA and European regulatory authorities for the treatment of
erectile dysfunction. Cialis is expected to fill a significant need in
the market. In clinical trials, Cialis has shown a consistent response
in men, rapid onset and a long period of responsiveness. Trials have
also shown that the absorption of Cialis is not affected by food. The
company received an approvable letter from the FDA in April 2002 with
final approval contingent upon successful completion of additional
clinical pharmacology studies and labeling discussions. As noted
above, the company expects that manufacturing is not a barrier to
approval since Cialis will be manufactured outside Indianapolis. Lilly
and ICOS anticipate final U.S. approval in the second half of 2003.
European approval is anticipated by the end of this year with launch
planned for the first half of 2003.
New Products - Under Regulatory Review by End of 2002
-- OFC (olanzapine/fluoxetine combination) - Lilly is studying its
combination of Zyprexa (olanzapine) and Prozac (fluoxetine) for
treatment of bipolar depression and other difficult-to-treat
depressive disorders. Bipolar depression is associated with
significant suffering, disability and mortality with up to 25 percent
of patients attempting suicide at least once in their lifetime. There
are no medications currently approved for the treatment of bipolar
depression. OFC has shown in trials a rapid onset of action, a 65
percent response rate and a sustained effect throughout the eight
weeks of treatment. As announced today, the company recently filed its
U.S. OFC submission for the treatment of bipolar depression.
-- Alimta - Alimta is a multitargeted antifolate and is the first
potential approved treatment of malignant pleural mesothelioma, a rare
lung cancer usually associated with exposure to asbestos. It is also
being studied as a treatment for a variety of other tumors, including
non-small-cell lung, pancreatic, metastatic breast, colorectal,
gastric and bladder cancers. Alimta is viewed as an important step in
helping Lilly achieve its goal of becoming the number-one oncology
company by 2010. In clinical trials for mesothelioma, Alimta appears
to provide a positive balance of efficacy and tolerability when
administered with folic acid and vitamin B12. The company is making a
rolling U.S. submission for mesothelioma in four separate stages,
beginning with the recent submission announced today and ending in
early fall of 2003. In Europe, submissions for mesothelioma and
non-small-cell lung cancer are planned for 2003.
-- Duloxetine for Stress Urinary Incontinence - Duloxetine is being
studied for the treatment of stress urinary incontinence (SUI).
Urinary incontinence is a disease that affects as many as 30 to 40
percent of women, which in the U.S. alone represents nearly 40 million
women. SUI is the most prevalent form of urinary incontinence among
women and there are no approved treatments. In clinical trials,
duloxetine demonstrated robust efficacy and a favorable side-effect
profile. As announced today, the company recently filed its duloxetine
U.S. submission for the treatment of SUI.
Other Select Pipeline Opportunities
"We believe our research productivity is the best in the industry as
evidenced by our pipeline," said August M. Watanabe, M.D., Lilly
executive vice president, science and technology. "This success is a
result of many important changes we've made in our R&D organization,
including hiring and developing top scientific talent and leveraging
our expertise in biotechnology. In addition, Lilly has invested
aggressively in R&D. Over the past five years, R&D expenses as a
percent of sales have been the highest in the industry, and we plan to
maintain that leadership. At the same time, we have not been
distracted by merger activity and that has enabled us to maintain
stability and focus our attention on drug discovery and development.
We have also collaborated with partners to further strengthen our
pipeline. As a result, from 2002 through 2006, we anticipate filing an
average of more than two new chemical entities per year in addition to
line extensions."
Watanabe also commented on several of the pipeline products in which
the company anticipates submitting a regulatory dossier in the
2003-to-2006 time frame. These products cross various therapeutic
areas, including diabetes, oncology, infectious diseases,
cardiovascular and neuroscience.
New Products - Select Anticipated 2003-2006 Submissions
-- PKC Beta Inhibitor - The company's PKC beta inhibitor is being
studied for the treatment of diabetic microvascular complications,
including those related to diseases of the eyes and nerves that affect
three of every four people with diabetes and may ultimately lead to
blindness or amputation. Currently, there are no effective
pharmacological therapies that directly target the mechanism of
chronic microvascular complications of diabetes. The company's oral
inhibitor of PKC beta is in Phase III trials for three separate
indications. The company is encouraged by early clinical data and
anticipates making European submissions for diabetic retinopathy and
diabetic macular edema in 2003 and a U.S. submission for symptoms of
diabetic peripheral neuropathy in 2004.
-- Resiquimod - Resiquimod represents a potential breakthrough
treatment that is currently in Phase III clinical trials for genital
herpes, the most prevalent sexually transmitted disease in the world.
Resiquimod is one of a new family of immune response modifiers
developed by 3M Pharmaceuticals that act in a novel way by stimulating
the human body's immune system to fight viral infections. Early
clinical trials suggest that resiquimod significantly increases the
interval between outbreaks without the need for continuous treatment.
Some investigators believe that the drug's effect may grow over
several courses of therapy and that for many patients a long-lasting
immune suppressive effect may be achieved. 3M and Lilly are targeting
submissions in the U.S. and Europe in 2004.
-- Affinitac(TM)- This antisense agent, licensed from Isis
Pharmaceuticals, Inc., is in Phase III trials and represents a
potential new approach to the treatment of non-small-cell lung cancer.
Studies of Affinitac in other cancers, including non-Hodgkin's
lymphoma, ovarian, breast and prostate cancers, are also planned. In a
Phase II trial for non-small-cell lung cancer, Affinitac in
combination with chemotherapy has shown a median patient survival of
nearly 16 months, about twice as long as the approximately 8- to
9-month survival achieved with standard chemotherapy alone.
Additionally, Affinitac was well tolerated with minimal side effects
attributable to the drug. The companies plan to submit a regulatory
application for non-small-cell lung cancer in 2004 or 2005 if two
Phase III trials are required for submission or as early as 2003 if
one Phase III trial is sufficient.
-- AC2993 (synthetic exendin-4) - This molecule from Amylin
Pharmaceuticals, Inc., is being codeveloped by Lilly and Amylin and is
in Phase III trials. AC2993 could represent the first of a new class
of compounds that have similar action to GLP-1 (glucagon-like
peptide-1). AC2993 could represent a significant advance in the
treatment of type 2 diabetes as this potent compound may effectively
control blood-glucose levels while reducing or eliminating the risk of
hypoglycemia and weight gain. It is expected to be administered as a
fixed-dose injection. The companies anticipate a U.S. submission to
the FDA as early as 2004. A long-acting release formulation is in
Phase II development utilizing Alkermes, Inc.'s, sustained-release
drug-delivery technology.
-- MGluR2/3 - For the past 15 years, Lilly has been conducting
pioneering research in the area of glutamate receptors. Glutamate is
the major excitatory neurotransmitter in the central nervous system.
Lilly's clinical candidates are agonists for mGLu2/3 receptors and
include potential treatments for migraine, Parkinson's disease,
cognition, schizophrenia, and generalized anxiety disorder. The
mGluR2/3 agonist for generalized anxiety disorder is the most advanced
in development. Early clinical data suggest solid efficacy and a
strong safety profile in generalized anxiety disorder. U.S. submission
to the FDA for this indication is estimated for as early as 2006.
-- Fasidotril - This oral, once-daily vasopeptidase (or ACE/NEP)
inhibitor, licensed from Bioprojet, is one of a potential new class of
compounds for the treatment of hypertension and congestive heart
failure. The companies are continuing to study fasidotril to determine
if fasidotril's balanced effect on ACE and NEP offers advantages over
other drugs that have been studied in this class. Phase II studies
will continue into 2003 with potential U.S. submission as early as
2006 for a hypertension indication and about two years later for
congestive heart failure.
-- CS-747 - This antiplatelet inhibitor was licensed from Sankyo
Company Ltd. and is being studied for the secondary prevention of
stroke and acute coronary syndromes (heart attack and unstable
angina). Early clinical data suggest this potent agent has the
potential to offer greater inhibition of platelet aggregation than
other agents in this class. The companies plan to begin Phase Ib and
II studies over the next three to six months with the potential to
file a New Drug Application with the FDA as early as 2006.
-- PPAR (peroxisome proliferator-activated receptor) modulators - PPAR
modulators, which currently include insulin sensitivity enhancers such
as Actos, have potential applications in diabetes and cardiovascular
diseases. Lilly is working with Ligand Pharmaceuticals, Inc., to
develop the next generation of PPAR modulators. The PPAR platform has
been especially productive with more than a dozen PPAR modulators in
Lilly's pipeline. Two of these are now in Phase I testing, and a third
is expected to enter Phase I by the end of this year. In addition, one
of the three PPAR modulators is preparing to enter Phase II trials
early next year. Modulating PPAR receptors, including PPAR gamma,
alpha and delta, may ultimately offer a variety of potential solutions
to normalizing blood sugar, lowing triglycerides and LDL cholesterol,
and raising HDL cholesterol.
Financial Expectations
The company continues to expect sales to slightly decline for the
full-year 2002 but grow in the mid-single digits in the fourth quarter
of 2002. The company also reaffirmed its earnings-per-share guidance
for full-year 2002 of $2.55 to $2.57 and for the fourth quarter of
2002 of $.68 to $.70, excluding unusual items.
For full-year 2003, the company continues to be cautious about its
financial assumptions. Assuming no significant financial penalties
imposed by the FDA related to the company's manufacturing issues or
other unusual items, the company's goal is to deliver some earnings
growth in 2003. The company's ability to deliver that growth depends
in part on the timing of the new product launches. The company will
invest appropriately in its new products, which is a top priority. As
the outlook for the company's new product launch timelines and
resolution of manufacturing issues becomes more certain, the company
will provide more specific financial guidance as appropriate.
Webcast of Investment Community Meeting
A live webcast of the Lilly Investment Community meeting, along with
presentation slides, is available through a link on Lilly's website at
www.lilly.com. The meeting begins today at 8:45 a.m. Eastern Time and
lasts approximately four hours and will be available for replay
through November 22, 2002.
Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of best-in-class pharmaceutical products by applying
the latest research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Ind., Lilly provides answers - through medicines and
information - for some of the world's most urgent medical needs.
Additional information about Lilly is available at www.lilly.com.
This press release contains forward-looking statements that are based
on management's current expectations but actual results may differ
materially due to various factors. There are significant risks and
uncertainties in pharmaceutical research and development. There can be
no guarantees with respect to pipeline products that the preliminary
clinical results reported in this release will be confirmed in later
trials. Also, there is no guarantee that the products will receive the
necessary clinical and manufacturing regulatory approvals or that they
will prove to be commercially successful. In particular, there is
substantial uncertainty surrounding the ultimate impact of the
company's manufacturing compliance issues on the timing of new product
launches and on the company's results. The failure to resolve these
issues to the FDA's satisfaction could result in delayed product
approvals, recalls, fines and penalties, and other sanctions. The
company's results may also be affected by such factors as the
continuing impact of generic fluoxetine on Prozac sales in the United
States, competitive developments affecting current growth products,
rate of growth of Xigris sales, the timing of anticipated regulatory
approvals and launches of new products, other regulatory developments
involving current and future products and manufacturing facilities,
the impact of governmental actions regarding coverage and
reimbursement for pharmaceuticals, and the impact of exchange rates.
For additional information about the factors that affect the company's
business, please see Exhibit 99 to the company's latest Form 10-Q
filed August 14, 2002. The company undertakes no duty to update
forward-looking statements.
-0-
*T
Actos(R) (pioglitazone hydrochloride, Takeda), Takeda
Affinitac(TM) (LY900003 and formerly ISIS 3521, Isis Pharmaceuticals),
Lilly
Alimta(R)(pemetrexed disodium, Lilly)
Cialis(TM)(tadalafil, ICOS), Lilly ICOS LLC
Cymbalta(TM)(duloxetine hydrochloride, Lilly)
Evista(R)(raloxifene hydrochloride, Lilly)
Forteo(TM)(teriparatide [injection of rDNA origin], Lilly)
Gemzar(R)(gemcitabine hydrochloride, Lilly)
Humalog(R)(insulin lispro, Lilly)
Prozac(R)(fluoxetine hydrochloride, Dista)
Strattera(TM)(atomoxetine hydrochloride, Lilly)
Xigris(R)(drotrecogin alfa (activated), Lilly)
Zyprexa(R)(olanzapine, Lilly)
Zyprexa(R)IntraMuscular (olanzapine, Lilly)
*T
Short Name: Lilly (Eli) & Co
Category Code: RES
Sequence Number: 00001175
Time of Receipt (offset from UTC): 20021108T110951+0000
--30--djl/cl* mh/uk
CONTACT: Eli Lilly and Company
Terra L. Fox, 317/276-5795
Robert L. Smith, 317/277-1302
KEYWORD: INDIANA UNITED KINGDOM INTERNATIONAL EUROPE
INDUSTRY KEYWORD: MEDICAL BIOTECHNOLOGY PHARMACEUTICAL PRODUCT
SOURCE: Eli Lilly and Company
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