Genzyme Corporation (NASDAQ: GENZ) today provided an extensive
briefing on the market potential of alemtuzumab for multiple
sclerosis at an event for investors and analysts in New York.
During the two-hour presentation, the company shared internal
market research and independent, third-party analysis defining the
unmet needs today in MS, key features of the alemtuzumab profile
that may address these needs and physician and payer perspectives
on the future positioning and uptake of alemtuzumab in the MS
market. This research supports forecasts for alemtuzumab adoption
and anticipated peak sales of $3-3.5 billion.
The event was part of a program, initiated in October by
Genzyme’s board and management, to communicate with shareholders
regarding the company’s value.
Market Research
Genzyme has conducted extensive market research related to the
market potential for alemtuzumab in MS, including interviews with
more than 2,500 prescribers and payers in major markets. This work
confirms that there is significant demand for new therapeutic
options with improved efficacy, tolerability and convenience over
existing therapies and that alemtuzumab has the potential to
address many of these unmet needs.
“There is still a significant unmet need in multiple sclerosis
and we desire new treatments,” said Edward Fox, M.D., Ph.D.,
Director of the Multiple Sclerosis Clinic of Central Texas, one of
the largest multiple sclerosis treatment centers in the U.S.
“Currently our goal is to slow disability progression and reduce
relapses. However, alemtuzumab has the potential to improve
function as well as to halt the accumulation of disability and
relapses, setting a new bar for MS treatment efficacy.”
Genzyme’s market research found that many respondents view
alemtuzumab as a potentially paradigm-shifting therapeutic option
that may specifically address limitations of current care, based on
the profile emerging from the phase 2 study.
Key findings from conjoint analyses, a statistical approach that
assigns value to product features against those of competing
products, show that:
- U.S. and European physicians strongly
associate alemtuzumab with best-in-class efficacy against other
disease modifying therapies, including natalizumab and emerging
oral options cladribine and fingolimod;
- The most important attribute driving
therapy choice in treatment-experienced patients, who comprise the
majority of the MS market today, is efficacy;
- With the convenience and compliance
advantage of annual dosing, a significant percentage of physicians
rate alemtuzumab’s administration schedule as outstanding;
- Based upon alemtuzumab’s profile,
physicians assign a higher preference share for alemtuzumab in
treatment-experienced patients (43 percent) than treatment-naïve
patients (11 percent), supporting the view that therapy switching
by patients is anticipated to be a strong growth driver; and
- Physicians score alemtuzumab
significantly higher than natalizumab on measures of safety and
efficacy.
To evaluate these findings further, Genzyme’s board commissioned
an independent market analysis completed in October 2010. This
research was based on existing phase 2 data and assumed the
approval of alemtuzumab and emerging oral therapies fingolimod and
cladribine. The analysis included interviews with over 100
neurologists and payers, and surveys from more than 200 physicians
across four major markets—the U.S., France, Germany and the United
Kingdom. Key findings from this work include the following:
- Efficacy was the primary prescribing
decision in all major markets;
- Alemtuzumab would be adopted across all
lines of use;
- Second- and third-line alemtuzumab use
is anticipated and held the greatest share in large markets;
- Physician adoption of alemtuzumab would
approach 5 percent in the first year after launch; 10-12 percent
two to three years after launch; and 18-20 percent five or more
years after launch.
Revenue Projections
The consistent findings from this and other research supports
market penetration launch assumptions and revenue growth models.
The company expects rapid adoption and peak sales of roughly $3-3.5
billion within 5 years of launch.
The company’s projected adoption rates for alemtuzumab compare
well against actual historical adoption rates for other innovative
therapies:
- Early phase adoption rate projections
for alemtuzumab are proportionate to the 2007-2009 adoption rates
for MS therapy natalizumab (in its second launch following a
post-marketing safety signal);
- Peak market share projections for
alemtuzumab are more conservative than the actual market share
levels achieved by current MS therapies, as well as therapies with
superior efficacy introduced in other disease areas, such as
rheumatoid arthritis.
Alemtuzumab MS Care Innovations and Pharmacoeconomic
Impact
Five-year follow-up data from the company’s completed phase 2
trial, a large randomized trial against an active MS comparator,
found that alemtuzumab-treated patients had significant reductions
in relapses and disability. For many alemtuzumab-treated patients,
these benefits were sustained several years after receiving their
last course of treatment. Over this period, the mean disability
score for patients receiving alemtuzumab improved, but worsened for
patients receiving the active comparator.
The precise mechanism of action of alemtuzumab in the treatment
of MS is unknown and remains an area of active study. Emerging data
suggest that the observed clinical effects of alemtuzumab in
relapsing MS may be the result of immunomodulation following the
repopulation of immune cells post-treatment. Specifically, research
conducted by Genzyme in collaboration with investigators at the
University of Cambridge suggests that:
- Depletion of CD52+ autoreactive
lymphocytes may induce re-setting of the immunological clock;
- Enrichment of T cells with regulatory
activity may result in a tolerogenic environment during
repopulation; and
- Increased lymphocyte production of
neurotrophic factors occurs post-treatment.
Adding to these innovations is a new dosing model. Unlike daily,
weekly, or monthly dosing of existing therapies, alemtuzumab
follows an annual course approach. The once-yearly schedule offers
substantial convenience and potential tolerability advantages for
patients, while avoiding some compliance issues that can occur with
more frequent dosing such as daily pills or injections required for
some current therapies.
Based on the phase 2 data, the company’s pharmacoeconomic
research shows a substantial positive impact on health system
resources:
- Reduction in the costs related to
chronic treatment;
- Potentially fewer hospitalizations and
associated costs due to relapses; and
- A potential decrease in expenses from
disability care.
The company has held more than 100 payer and regulatory
interviews across major markets, and alemtuzumab’s potential
innovations for MS care are recognized. Most large markets,
including the U.S., are likely to support value pricing if phase 3
data confirms earlier findings.
Phase 3 Program
Genzyme is conducting two pivotal phase 3 trials to evaluate
alemtuzumab in the treatment of MS. CARE-MS I, a randomized trial
comparing alemtuzumab to Rebif, is studying early, active
relapsing-remitting MS patients who have received no prior therapy.
CARE-MS II, which also compares alemtuzumab to Rebif, is studying
relapsing-remitting MS patients who experience disease activity
while on other MS therapies. Data from the phase 3 trials are
expected beginning in mid-2011. The company expects to file for
U.S. and E.U. approval in early 2012, and has been granted fast
track status by the FDA for this program.
Alemtuzumab is an investigational drug for the treatment of MS
and must not be used in MS patients outside of a formal, regulated
clinical trial setting in which appropriate patient monitoring
measures are in place.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is
dedicated to making a major positive impact on the lives of people
with serious diseases. Since 1981, the company has grown from a
small start-up to a diversified enterprise with approximately
10,000 employees in locations spanning the globe and 2009 revenues
of $4.5 billion. In 2010, Genzyme was named to the Fortune 500.
With many established products and services helping patients in
100 countries, Genzyme is a leader in the effort to develop and
apply the most advanced technologies in the life sciences. The
company's products and services are focused on rare inherited
disorders, kidney disease, orthopaedics, cancer, transplant, and
immune disease. Genzyme's commitment to innovation continues today
with a substantial development program focused on these fields, as
well as cardiovascular disease, neurodegenerative diseases, and
other areas of unmet medical need.
Important Information
Genzyme has filed with the Securities and Exchange Commission a
Solicitation/Recommendation Statement on Schedule 14D-9 relating to
the tender offer by Sanofi-Aventis. Genzyme shareholders are
advised to read the company's Solicitation/Recommendation Statement
on Schedule 14D-9 because it contains important information.
Shareholders may obtain a free copy of the
Solicitation/Recommendation Statement on Schedule 14D-9, as well as
any other documents filed by Genzyme in connection with the tender
offer, free of charge at the SEC's website at http://www.sec.gov.
In addition, investors can obtain free copies of these documents
from Genzyme by directing a request to Genzyme at 500 Kendall
Street, Cambridge, MA 02142, Attention: Shareholder Relations
Department, or by calling 617-252-7500 and asking for the
Shareholder Relations Department.
Safe-Harbor
This press release contains forward-looking statements,
including the statements regarding: expectations for peak sales of
alemtuzumab and related timing expectations; forecasts for adoption
of alemtuzumab by physicians and the marketplace; the ability of
alemtuzumab to meet patient needs in the treatment of MS; the
potential of alemtuzumab to halt accumulation of disability and
relapses and improve function; the potential of alemtuzumab to be a
paradigm-shifting treatment option for MS; the view that patients
switching to alemtuzumab will be a strong driver of growth; the
possible mechanism of action of alemtuzumab; the potential
tolerability advantages of alemtuzumab; the positive impact of
adoption on health care system resources; the likelihood of value
pricing being supported in large markets, including the U.S.; and
the expected timelines for results of the phase 3 clinical trials
and filing for regulatory approvals. These statements are subject
to risks and uncertainties that could cause actual results to
differ materially from those projected in these forward-looking
statements. These risks and uncertainties include: the possibility
that phase 3 trials will not support the same conclusions as the
phase 2 trials; the risk that alemtuzumab will not receive
regulatory approvals on the timeframes expected or at all; the risk
that the results of the phase 3 clinical trials may be delayed; the
possibility that peak sales of alemtuzumab will not achieve
projected levels as a result of the inaccuracy of underlying
assumptions or as a result of other risks and uncertainties not
contemplated or adequately accounted for by Genzyme’s market
research; the risks that alemtuzumab will not address the unmet
needs of MS patients or that physicians and the marketplace will
not adopt alemtuzumab to the extent expected; the risk that pricing
will not be supported at projected levels; the risk we will not be
able to implement our business plans for alemtuzumab successfully
or as expected; and the risks and uncertainties described in
Genzyme's SEC reports filed under the Securities Exchange Act of
1934, including the factors discussed under the caption "Risk
Factors" in Genzyme's Quarterly Report on Form 10-Q for the period
ended September 30, 2010. We caution investors not to place undue
reliance on the forward-looking statements contained in this press
release. These statements speak only as of the date of this press
release, and we undertake no obligation to update or revise these
statements.
Genzyme’s press releases and other company information are
available at www.genzyme.com and by calling Genzyme’s investor
information line at 1-800-905-4369 within the United States or
1-678-999-4572 outside the United States.
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