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www.ndareg.com/casestudies | July 2012
Get in touch | Paula Warmer, Communications Manager | [email protected] Page 1
InterMune is a small yet rapidly growing publicly traded (NASDAQ) biotechnology company
focused on developing and commercialising innovative therapies in pulmonology and fibrosis.
Previously, InterMune had limited experience in the submission of Market Authorisation
Application’s (MAA’s) for EU registration and was seeking to partner with a CRO
(contract research organisation) that had a proven track record of EU registration successes.
In early 2009 InterMune retained the NDA Group to consult on the processes, policies and
procedures required to gain marketing authorisation in Europe for Esbriet.
“A year prior to our initial start phase for applying for marketing authorisation in Europe, we
were working with a different regulatory consultant group and did not see effective progress
being made. We had shared a positive relationship with NDA Group in the past, so we
approached them to see if they could assist us in our application,” said Dr Marianne Porter,
Senior Vice President, Chief Regulatory and Drug Safety Officer at InterMune. “From our first
meeting we were very impressed with the NDA Group team. Their regulatory expertise,
professionalism, collaborative style and proven track record were readily apparent. Importantly,
we found our corporate values to be strongly aligned, resulting in a positive cultural fit.”
“Thanks to the support of NDA Group, we achieved our first approval from the European
Commission to market Esbriet® (pirfenidone), the only medicine approved for the
treatment of IPF (idiopathic pulmonary fibrosis) in Europe. Esbriet is indicated in adults
for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF), a progressive
and fatal lung disease. The approval authorises marketing of Esbriet in all 27 EU
member states, and marks a significant turning point in the treatment of IPF patients.
A large part of our successful application and registration process can be attributed to
the expertise, dedication and passion of the NDA Group team. Together we worked
side-by-side, as a collaborative team, to provide the EMA with a well written and
comprehensive application.”
intermune.com
InterMune Case Study
Challenge
Dr Marianne Porter,
Senior Vice President,
Chief Regulatory and
Drug Safety Officer
at InterMune
NDA Group quickly assembled a senior, dedicated team, comprised of regulatory experts, writers
and experienced quality, nonclinical and medical advisors, who together with NDA’s scientific
Advisory Board, reviewed all aspects of InterMune’s marketing authorisation application (MAA).
“We were impressed at how quickly NDA Group integrated with our regulatory, clinical, non-clinical,
quality and project management team members to review the relevant data,” continued Dr Porter.
“They evaluated the various aspects of our application, from the clinical to the quality requirements,
and were direct and forthcoming regarding their perceptions of how the EMA would view our data.
This initial assessment contributed to the establishment of appropriate expectations.”
After receipt of all of the existing application details, NDA Group began an extensive detailed
review, resulting in strategic advice on the application and MAA pre-submission planning.
Additionally, they conducted an in depth gap analysis of the data to identify any potential
deficiencies, with the support of the NDA Advisory Board, who provided key strategic input, in
addition to a thorough key documentation review. NDA Group assisted in the writing of the key
regulatory documents required to gain approval from the EMA, which included the quality,
nonclinical and clinical overviews and risk management plan. They were closely involved in all
key aspects, from full regulatory project management and strategic support, PIL user testing,
pharmacovigilance services and finally planning to post approval.
Solution
NDA Group’s knowledge of the European regulatory process, coupled with a successful
InterMune/NDA Group team dynamic resulted in the compilation of a MAA in under year. On 28th
February 2011, InterMune was granted marketing authorisation for Esbriet® (pirfenidone) by the
European Commission, making Esbriet the first and only medicine approved for the treatment of IPF
in Europe. Esbriet is approved for marketing in all 27 EU member states.
“With the assistance of the NDA Group team, we achieved our goal in record speed,” said Dr Porter.
“Our MAA approval of Esbriet signifies a historic moment in the treatment of IPF patients, and an
exciting new chapter for our company. It is very gratifying t to know that the patients in Europe
suffering from IPF will now have an approved therapeutic option to assist them in combating this
debilitating disease.”
Based on anticipated EU country reimbursement timelines, Esbriet will launch in Germany in
September of 2011; France, Spain and Italy in the first half of 2012 and in the United Kingdom in
mid-2012. InterMune also plans to launch Esbriet in all or substantially all of the 10 most important
pharmaceutical markets in the EU by approximately mid-2012.
Following the success in Europe, NDA Group is now supporting InterMune with submissions in
Canada and Switzerland, as well as post approval activities in Europe.
MAA and European marketing
authorisation achieved in under a year
Get in touch | Paula Warmer, Communications Manager | [email protected] Page 2
www.ndareg.com/casestudies | July 2012
InterMune Case Study
NDA SwedenJohanneslundsvägen 2
Oxfordhuset
SE-194 81 Upplands Väsby
Sweden
T +46 (0)8 590 77800
F +46 (0)8 590 71440
NDA UKPrime House
Challenge Court
Barnett Wood Lane
Leatherhead
Surrey KT22 7DE
T +44 (0) 1372 860 610
F +44 (0) 1372 860 611
NDA GermanyWeihenstephaner Straße 28
D-81673 München
Germany
T +49 (0)89 3585 4000
F +49 (0)89 3585 4010
• With the assistance of the NDA Group, InterMune Inc. obtained its first marketing authorisation
in Europe for Esbriet® (pirfenidone) on 28th February 2011, making Esbriet the first and only
medicine currently approved for the treatment of IPF in Europe.
• Adult patients in Europe diagnosed with mild to moderate IPF will now have access to a new
drug to treat this fatal disease, which on diagnosis usually has a 3-5 year prognosis, worse than
many cancers.
• Esbriet has been granted Orphan Drug designation in Europe, which provides 10 years of
marketing exclusivity lasting until 2021. In addition, InterMune has a number of granted, allowed
and pending patent applications in Europe relating to Esbriet’s formulation and use in IPF
patients, particularly related to the safe and efficacious usage of the product. This collection of
patents is currently expected to provide patent protection in Europe until 2030.
Benefits
Get in touch | Paula Warmer, Communications Manager | [email protected] Page 3
www.ndareg.com/casestudies | July 2012
InterMune Case Study
NDA SwedenJohanneslundsvägen 2
Oxfordhuset
SE-194 81 Upplands Väsby
Sweden
T +46 (0)8 590 77800
F +46 (0)8 590 71440
NDA UKPrime House
Challenge Court
Barnett Wood Lane
Leatherhead
Surrey KT22 7DE
T +44 (0) 1372 860 610
F +44 (0) 1372 860 611
NDA GermanyWeihenstephaner Straße 28
D-81673 München
Germany
T +49 (0)89 3585 4000
F +49 (0)89 3585 4010
