Investor Update
Basel, 16 September 2004
Roche
and Protein Design Labs to jointly develop Zenapax for Asthma
Roche
and Protein Design Labs (PDL) today announced a worldwide agreement to co-develop and commercialize
Zenapax (daclizumab) for asthma and related respiratory diseases, based on recent positive phase II
data in patients with moderate to severe asthma.
“This new agreement
will strengthen our pipeline in asthma, where we are currently in phase II development of a novel oral
treatment,” said William Burns, Head of Roche’s Pharmaceuticals Division. “We believe that daclizumab
will offer patients a significant improvement over today’s current therapy. Our long-standing relationship
with PDL continues to grow as we develop daclizumab further.”
Mark McDade,
Chief Executive Officer, PDL, said, “The continued development of daclizumab in asthma is among PDL’s
highest clinical development priorities. With Roche as our ongoing partner in this indication, we believe
daclizumab will obtain the resources needed to develop the full potential of this humanized antibody
in asthma.”
Under terms of the agreement, PDL will receive a $17.5 million
upfront payment as well as up to $187.5 million in development and commercialization milestones for
successful further development of daclizumab. Roche and PDL will globally co-develop daclizumab in asthma,
share development expenses and co-promote the product in the US. Outside the US, PDL will receive royalties
on net sales of the product in asthma.
About the Roche
- PDL partnership
In 1989, Roche acquired the worldwide rights to daclizumab, a
product that has since gained an important position within Roche’s transplantation portfolio. In September
2003, Roche resold to PDL all rights to daclizumab, except in transplantation, until 2007 when PDL will
have the option to re-acquire the transplantation rights as well. In 2004, PDL approached Roche with
compelling phase II data for daclizumab in asthma, leading to today’s announcement for the continued
co-development of daclizumab in respiratory disorders by Roche and PDL.
Zenapax
in Asthma
In March 2004, PDL reported positive results from the initial clinical
study of daclizumab in patients with chronic, persistent asthma whose disease is not well controlled
with high doses of inhaled corticosteroid therapy. The primary endpoint, percent change in FEV1 from
baseline to 12 weeks (day 84), met statistical significance (p=0.05). FEV1, or forced expiratory volume
at one second, is a measure of pulmonary function. Secondary clinical endpoints also supported these
findings.
The Phase II randomized, double-blind, placebo-controlled clinical
trial was conducted at 24 centers in the United States and treated a total of 114 patients. In the assessment
of the primary endpoint, patients receiving daclizumab experienced a mean increase in FEV1 of 4.4% of
baseline, compared to placebo patients who experienced a mean decrease of 1.5% (p=0.05). Other spirometric
measures (FEV1/FVC, FEF25-75%) were consistent with these results. Patients receiving daclizumab also
demonstrated a statistically significant increase in the time to asthma exacerbation requiring oral
corticosteroid rescue (p=0.024). Peripheral eosinophil levels were significantly reduced in the daclizumab
treatment group compared to the placebo group (p=0.04). Statistically significant (p≤0.007) within-group
changes in the daclizumab group revealed improvements from baseline in diary symptom scores, as well
as morning and night time peak expiratory flow rates. There were no significant within-group changes
seen in the placebo group.
Treatment with Zenapax was generally well
tolerated. The overall frequency of adverse events was comparable between daclizumab and placebo groups.
About
Asthma
Asthma is among the most common chronic medical conditions in the United
States and worldwide, affecting more than 20 million people in the United States, according to the American
Lung Association (ALA) and the American Academy of Allergy, Asthma & Immunology (AAAAI). According
to a recent report on the global burden of asthma published by the NIH, WHO and the Global Initiative
for Asthma, asthma is one of the most common chronic diseases in the world and it is estimated that
around 300 million people in the world currently have asthma. The rate of asthma continues to increase
and it is estimated that there may be an additional 100 million persons suffering from asthma by 2025.
Asthma accounts for 1 in every 250 deaths worldwide.
About
Protein Design Labs
In September 2003, PDL acquired all rights to Zenapax, excluding
transplantation indications but with the option to gain such indication rights by 2007. PDL retains
this right in accordance with the terms of the September 2003 agreement.
Protein Design
Labs is a leader in the development of humanized antibodies to prevent or treat various disease conditions.
PDL currently has antibodies under development for autoimmune and inflammatory conditions, asthma and
cancer. PDL holds fundamental patents for its antibody humanization technology.
Further
information on PDL is available at www.pdl.com.
About
Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading
innovation-driven
healthcare groups. Its core businesses are pharmaceuticals and diagnostics. As a supplier of products
and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad
range of fronts to improving people’s health and quality of life. Roche is number one in the global
diagnostics market, a leading supplier of pharmaceuticals for cancer and transplantation and a market
leader in virology. In 2003 prescription drug sales by the Pharmaceuticals Division totalled 19.8 billion
Swiss francs, while the Diagnostics Division posted sales of 7.4 billion Swiss francs. Roche employs
roughly 65,000 people in 150 countries and has alliances and R&D agreements with numerous partners,
including majority ownership interests in Genentech and Chugai.
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