New Idiopathic Pulmonary Fibrosis Treatment May Open up Valuable Research Opportunity

Wednesday 17 April 2013, Amsterdam

Further research is a prerequisite to shine a light on Idiopathic Pulmonary Fibrosis (IPF) and offer therapeutic hope to these sufferers. With the approval of the initial IPF small molecule pharmaceutical this underserved market is set to change, allowing the better study of patients by extending survival time, states new analysis by research and consulting a firm.

For the last decade the IPF therapeutic field has been untapped and dominated by the off-label drug N- acetylcysteine provided for symptomatic relief and costly supportive palliative care. However, new research suggests that InterMune’s Esbriet (pirfenidone) – the sole therapeutic approved exclusively for the treatment of IPF – will work to slow the course of disease in IPF patients, if regulatory and financial barriers can be overcome. This may then allow for a closer epidemiological study of the disease, with patients able to survive longer periods of examination.

Idiopathic Pulmonary Fibrosis (IPF) is a fibrosing, interstitial form of chronic pneumonia, defined by irreversible and variable scarring, stiffening, and thickening of the lung tissues, which ultimately results in progressive worsening of pulmonary function. Little is understood about the fatal disease; the first international consensus statement defining the diagnosis, evaluation, and management of IPF patients only published in 2000. IPF also has the worst prognosis of any type of idiopathic interstitial pneumonia, with only three to five years of median survival. This poor survival rate, combined with IPF’s low incidence rate, makes studying the epidemiology of the
condition extremely difficult. Dr. Samantha Fernando, Analyst covering Immunology, discusses the difficulties faced in Esbriet launch and availability despite EU approval in 2011:

“The sole EU-approved IPF therapeutic, InterMune’s Esbriet has suffered delays in launching and availability within each EU market, due to complications regarding licensing, pricing, reimbursement and confidentiality, which has hindered market access to a much sought-after drug.

“Esbriet’s high price and minimal therapeutic effect also negatively affected its launch – prices exceed €30,000 $39,350 per annum per patient, and the drug only slows disease progression, rather than halting it completely.”

There was renewed hope for IPF sufferers in the UK on March 20, 2013 following the National Institute for Health and Clinical Excellence (NICE) overturning a previous decision to not recommend Esbriet. This due to InterMune’s provision of a Patient Access Scheme (PAS), details of which remain confidential but are sure to provide improved drug accessibility to patients.

Esbriet is also currently undergoing an additional Phase III trial in the US as requested by the FDA, owing to safety concerns regarding suitability of clinical trial endpoints used for this chronic disease. The US had 31,821 prevalent cases of IPF in 2012, and the nation’s large elderly population will ensure that this level of prevalence continues to 2022, making the FDA’s decision on Esbriet significant for the IPF therapeuticsmarket.

Epidemiologists forecast that there will be 45,718 incident cases of IPF across the US, France,  Germany,  Italy,  Spain,  and  UK  in  2022,  with  incidence  rates  and  prevalence  proportions remaining constant throughout the next decade (a slight projected increase in the IPF population due only to the growing and aging global population). Despite this, the IPF therapeutics market in these countries is projected to undergo exponential growth over 2012-2017, at a Compound Annual Growth Rate (CAGR) of87%, creating a fiercely competitive environment.

“InterMune is a one-drug company wholly reliant on Esbriet,” states Fernando, “and the company is currently filing a lawsuit against the EMA challenging the agency’s decision to disclose documentation on the company’s product, as InterMune will become vulnerable to competing companies if commerciallyconfidential information were made accessible. InterMune has also been plagued with acquisition deal speculation, which is anticipated to intensify after Esbriet completes its Phase III FDA trial in 2014.”