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ROCHE R&D DAY 2002
INNOVATION KEY TO SUCCESS: GOOD PROGRESS IN ROCHE'S R&D PIPELINE
AND STRONG MID-TERM FLOW OF NEW PRODUCTS
Nutley, NJ and Pleasanton, Calif. -- April 30, 2002
§ 138 projects in Pharma research and 74 projects in Pharma
development
§ 48 new molecular entities (NMEs) in pipeline
§ 35% increase in the number of NMEs in development portfolio
over the past 12 months
§ Filing of 17 new drug applications and several additional
indications for existing products planned in the next five years
§ Extending the leading position in in vitro diagnostics
with a broader portfolio in virology, blood screening and genomics
§ Uniquely placed to take advantage of Genomic Medicine
Broad Product Pipeline in Pharmaceuticals and Diagnostics
Last week in Penzberg, Germany, Roche held its annual R&D conference
to discuss the significant progress seen with the development of
its R&D pipeline over the last two years. With 138 projects
in research and 74 projects in development, including 48 new molecular
entities (NMEs), Roche's pharmaceutical pipeline has improved in
quantity, quality and value. Over the past 12 months, the number
of potential products in the development pipeline has increased
by 35%.
The higher hurdles Roche has put in place before moving compounds
to the next stage of development, have increased the quality of
pipeline projects. With the assignment of rigorous product profiles,
Roche expects that these medicines will bring value to patients,
physicians and payers.
Roche´s Pharmaceuticals division has diversified access to
innovation through its in-house R&D activities, with currently
33 NMEs in development. Including existing licensing agreements
and opt-in opportunities, Roche's Pharmaceutical pipeline contains
48 NMEs. Over the next five years, the Group expects to file seventeen
new drug applications (NDAs) for products in a variety of key disease
areas including oncology, HIV/AIDS, anxiety/depression, stress incontinence
and rheumatoid arthritis.
"Over the last five years, the Pharmaceutical division has
seen major changes in the organizational structure and the processes
that will deliver our pipeline," said Jonathan Knowles, head
of Global Research. "These changes are now delivering increased
productivity in terms of quantity, quality and value."
Broad Diagnostics Pipeline
Based on its broad product portfolio, Roche Diagnostics has outpaced
the competition with record double-digit sales and profit growth
for the last three years. The division is investing 9% of annual
sales revenues in R&D and spends more than any other company
in the diagnostics industry. The activities include in-house R&D
projects, independently run "venture companies", and a
number of alliances with technology leaders.
The range of diagnostic options is expected to broaden significantly
in the coming years, as advances in genomics and proteomics enable
industry to develop new tests to analyze risk factors at the gene-
or protein level early on and provide tests that improve efficacy
and safety of therapies. Roche Diagnostics is committed to use its
expertise in these fields to create new markets. The division aims
to provide healthcare professionals with tools to analyze the large
amount of data and to translate them into medical action.
The R&D pipeline ranges from projects focused on the search
for specific genetic variants of common, complex diseases as well
as pharmacogenetic testing for efficacy and adverse effects, disease
predisposition and patient stratification. The division has a genomics
portfolio, which includes development of a genetic test for the
analysis of Cystic Fibrosis and pharmacogenetic tests involving
the analysis of genes such as P450 to determine the effectiveness
and dosage of various drugs.
The launch of new cancer tests and an extended range
of assays for virology and blood screening will further diversify
and enrich Roche Diagnostics' portfolio. Analyzers such as COBAS
AmpliPrep™ System* and COBAS TaqMan™ Analyzer*, together
with the division's AmpliNat MPX™+ and COBAS AmpliScreen™++
tests, have a sales potential of more than CHF 500 million/year.
Innovative software and IT-based products will be an important part
of Roche Diagnostics' portfolio. New software will form an integral
part of analyzers such as the next-generation Modular system. This
will play a major role in helping healthcare professionals to analyze
large amounts of data and to translate information into medical
action.
Looking to the long term, Roche Diagnostics intends to continue
developing its molecular diagnostics business and expanding the
market for PCR-based products. Alliances with deCODE genetics and
Partners Health-Care System will yield genetic information on common
complex diseases such as hypertension, obesity and metabolic disorders.
The intelligent combination of this data with Roche Diagnostics'
know-how will lead to pioneering products and integrated health
care solutions.
Heino von Prondzynski, head of the Diagnostics Division said: "Roche
Diagnostics is not only ready to face the paradigm shift taking
place in the diagnostics industry today, but will actually shape
it. Especially in the field of genomics and proteomics we will lead
the industry in turning scientific knowledge into marketable products
and useful healthcare information."
Genomics & Proteomics
Roche has established a variety of in-house initiatives and organizations
to capitalize more fully on the opportunities offered by genomics
and proteomics:
§ Joint Program in Applied Genomics
§ Integrated Cancer Care Unit
§ Roche Molecular Diagnostics
§ Proteomics Initiative
A network of over 30 R&D alliances worldwide, with companies
such as deCODE genetics Inc., (Reykjavik, Iceland) and Partners
Health-Care System, (Boston, USA), has strengthened Roche's access
to innovations.
deCODE genetics has identified 13 new genetic risk factors for
common diseases over the last three years. Identification of 10
genetic loci, associated with disease phenotypes, have provided
Roche with valuable information for developing new diagnostic tests,
in diseases such as hypertension, obesity and other metabolic diseases,
within the next three to five years. This research will also help
pharmaceutical researchers identify drug target pathways, which
may lead to new products for diabetes, stroke and schizophrenia,
within the next seven to 10 years.
Number 1 in Oncology
Roche will continue to develop innovative drugs like Xelodaâ
(capecitabine), Herceptinâ (Trastuzumab) and MabTheraâ/Rituxanâ
(rituximab), whose novel mechanisms of action offer survival benefits
for patients with cancer, the second leading cause of death in western
countries.
By combining their efforts, the Group's Pharmaceuticals and Diagnostics
divisions will deliver new products for early disease detection,
specific therapy and therapy monitoring, thus contributing to more
individualized patient management options. These new oncology medicines
include R1415 (Tarceva), R440 a cell cycle inhibitor, R1273 (rhu
Mab 2C4) for cancer treatment and R744 (next generation anemia treatment)
as well as R1124 (G Protein-Coupled Receptor modulator).
§ Tarceva (R1415), currently in Phase III development,
is a tyrosine kinase inhibitor for non-small cell lung cancer (NSCLC)
and other solid tumors. Clinical testing is focused on using the
drug as first-line therapy in NSCLC, with two Phase III trials under
way for this indication in the U.S. and European Union. Roche's
partnership with OSI Pharmaceuticals, includes a Phase II study
of the drug in pancreatic cancer and as a third-line treatment in
NSCLC.
§ Humanized monoclonal antibody, rhu MAB 2C4 (R1273).
This drug is in Phase I trials for the treatment of a significant
number of solid tumors. It blocks the growth of lung, breast, prostate
and colon cancer cell lines in vitro. The compound may sensitize
tumor cell lines to chemotherapy.
In addition to drugs interacting with the HER-2 receptor pathway
(R1415 and R1273), novel cytotoxic agents are in development to
treat cancer, notably the cell cycle inhibitor R440, now in Phase
II development.
§ Cell Cycle inhibitor (R440). This compound is being
developed for the treatment of NSCLC, breast and colon cancer. It
is a twice-daily oral formulation and offers dual action in arresting
the cell cycle in M phase and inducing apoptosis. R440 has also
demonstrated substantial activity in 15 of 16 tumor models. Phase
II monotherapy studies are ongoing in NSCLC, breast cancer and colon
cancer as well as Phase I combination studies.
Roche Diagnostics already markets the Elecsys line of instruments
and reagents for small to high-volume diagnostic laboratories, which
includes a broad menu of assays for oncology.
Roche Diagnostics has initiated a program within the Integrated
Cancer Care Unit (ICCU) to identify new diagnostic markers or
marker profiles to fill today's gaps in our ability to diagnose
cancer. The focus is on developing screening tests for early cancer
detection, which will enable early therapeutic intervention and
improve the probability of cure. ICCU efforts are also concentrating
on tests that will enable doctors to take an individualized treatment
approach based on molecular characterization of cancer cells and
the genetic background of patients. Roche is already developing
its first tests of this kind for use in combination with Xeloda
and Herceptin.
New Solutions to Challenges in Viral Diseases
Continuing more than 15 years of groundbreaking research and development
and a string of award-winning new drugs - including protease inhibitors
for effective treatment of HIV - Roche plans to further expand its
portfolio with new innovative treatments.
§ T-20, Fusion Inhibitor for HIV (R698). Current therapy
of HIV infection is usually based on prescribing a combination of
multiple drugs. This approach has proven highly effective, but now
drug-resistant strains of the virus are emerging, creating an urgent
and growing medical need for drugs with new mechanisms of action.
T-20 is an investigational agent in a new class of anti-HIV drugs,
called fusion inhibitors, developed in collaboration with Trimeris,
Inc., to help meet this need. It is a 36 amino acid synthetic peptide,
which mimics the gp41 domain of HIV, thereby disrupting the fusion
of the virus with the body's cells. In vitro, T-20 is active against
HIV-1 isolates resistant to protease inhibitors, nucleoside and
non-nucleoside reverse transcriptase inhibitors.
Recently, Roche announced positive 24-week results from the first
of two pivotal Phase III studies of T-20, the fusion inhibitor currently
furthest along in clinical development. In this study, T-20 significantly
enhanced the activity of combination therapy over 24 weeks. Once
final results from pivotal studies are received, Roche plans to
file an NDA during the second half of 2002.
In addition, Roche recently announced an alliance with Medivir,
a Swedish biotechnology company, to develop MV026048, an innovative
treatment in development for HIV. A novel non-nucleoside reverse
transcriptase inhibitor (nNRTI), MV026048 is currently in preclinical
development and is expected to enter Phase I clinical studies in
2003.
· Extended diagnostics portfolio in virology. Roche
Diagnostics intends to expand its already broad menu of PCR-based
AMPLICOR® tests for HCV, HBV*, HIV and CMV* by developing
fully automated PCR tests and tests utilizing chip technology.
Roche Diabetes Portfolio
The World Health Organization (WHO) is predicting that diabetes
will reach epidemic proportions. It is estimated that by 2025 there
will be 300 million of people with diabetes worldwide.
§ Diagnosing Diabetes. Roche, the industry leader in
diabetes diagnostics care, offers the broadest range of diabetes
products. The Accu-Chek® product family, Roche's top-selling
brand with more than CHF 2 billion in sales per year, is just one
example of the company's expertise in this area.
The current R&D activities in the diabetes area are focused
on developing cutting-edge technologies for integrated spot monitoring
and continuous glucose monitoring systems that will help make living
with diabetes easier.
§ New ways for Diabetes treatment. Despite the availability
of numerous therapeutic options, there is a great demand for drugs
that produce a durable effect on glycemic control. The insulin
sensitizer (R483) has been shown in trials to improve insulin
sensitivity and inhibit glucose production in addition to offering
superior efficacy.
New Areas of Interest for Roche
Osteoporosis
Bonviva (R484) is a highly potent bisphosphonate that is
under development to determine if it reduces the incidence of new
vertebral fractures in women with post-menopausal osteoporosis (PMO).
Currently in Phase III development, an NDA filing for Bonviva for
an oral formulation for treatment and prevention of PMO is expected
in the second half this year followed in 2004 by filings for a more
convenient oral formulation and an intravenous form.
Depression
§ R673, an NK-1 Receptor Antagonist, is in Phase II
development for depression. It could represent a new generation
of anti-depressant, offering patients the advantage of good efficacy
with fewer adverse effects than the previous generation of drugs.
Emphysema
· Emphysema is part of the tobacco-induced disease spectrum
of chronic obstructive lung disease (COPD), the fourth leading cause
of death in the US. R667, a selective retinoic acid agonist, is
in Phase II development for the treatment of emphysema. In animal
studies, it has demonstrated the ability to regenerate lung tissue
and restore lung function and it may address the underlying pathology
of emphysema.
Asthma
· A selective integrin antagonist VCAM (R411), now
in Phase II, will address an unmet medical need. Current asthma
therapies merely lower the risk of worsening the recurrence of asthmatic
episodes. This novel, non-steroidal treatment, which targets the
inflammatory process underlying asthma, has shown better efficacy
than leukotrienes in animal studies and does not show the side effect
liability of inhaled steroids.
Stress Urinary Incontinence (SUI)
· More than 48 million people (98% of them women) suffer
from urinary incontinence, which is associated with physical exertion.
The need for treatment options is great as there are no globally
approved drugs yet for SUI. R450, alpha 1 adrenoceptor agonist,
is in Phase II development for the treatment of patients with SUI.
R450 has been shown in Phase II trials to significantly decrease
frequency of incontinence episodes.
Outlook over the Next Five Years
"The links between diagnostics and the pharmaceuticals business
have given us a unique and strong position in the healthcare industry.
In the mid- to long-term, the prospects for Roche have never been
more exciting," said Franz B. Humer, CEO of Roche. "Within
the next five years we expect innovative products from both divisions,which
will allow us to create more individualized therapies, thus benefiting
patients and reducing healthcare costs."
The R&D conference was held in Penzberg, Germany. Penzberg
is the home of Roche's largest biotech site and hosts pharmaceuticals
and diagnostics research and development as well as production facilities.
More than 3,000 people are employed at this 'state-of-the-art' Roche
unit.
An archived webcast of the Roche R&D Media Day is available
on the Roche website at: http://www.roche.com/med-events-rdday.htm.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S.
prescription drug unit of the Roche Group, a leading research-based
health care enterprise that ranks among the world's leaders in pharmaceuticals,
diagnostics and vitamins. Roche discovers, develops, manufactures
and markets numerous important prescription drugs that enhance people's
health, well-being and quality of life. Among the company's areas
of therapeutic interest are: dermatology; genitourinary disease;
infectious diseases, including influenza; inflammation, including
arthritis and osteoporosis; metabolic diseases, including obesity
and diabetes; neurology; oncology; transplantation; vascular diseases;
and virology, including HIV/AIDS and hepatitis C.
Roche's Diagnostics Division, the world's number one diagnostics
company with a uniquely broad portfolio, supplies a wide array of
innovative testing products and services to researchers, physicians,
patients, hospitals and laboratories world-wide.
For more information on the Roche pharmaceuticals business in the
United States, visit the company's website at http://www.rocheusa.com.,
and the diagnostics business at
www.roche-diagnostics.com.
All trademarks used or mentioned in this release are legally protected.
* Available in the United States for Research Use Only.
+ Available in Japan only.
++ Available under an FDA approved Investigational New Drug IND
program in the U.S.
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