The National Institute for Health and Clinical Excellence
(NICE), the health technology appraisal body in England and
Wales, recently issued a positive Final Appraisal Determination
(FAD) for the approval of
) Esbriet (pirfenidone). Esbriet is approved for the treatment of
mild to moderate idiopathic pulmonary fibrosis (IPF).
Following the positive recommendation from NICE, InterMune now
plans to launch Esbriet in these areas by the end of June this
year. The company stated that around 6,100 to 9,500 patients
suffer from IPF in England and Wales.
The list price of Esbriet as per the National Health Services
(NHS) is around $39,350 per patient per year. The FAD is expected
to be published in Apr 2013, and will be implemented within the
next 90 days.
InterMune is working on the pricing and reimbursement process
for Esbriet in the remaining EU countries. We believe that the
company is on track to launch Esbriet in six more EU countries by
mid-year, as notified earlier. The company has plans to complete
pricing and reimbursement in Italy, Spain and other mid-sized
countries by mid-2013.
Moreover, the company recently received encouraging news as
the health authorities of the Pharmaceutical Pricing Board of
Finland (HILA) agreed to price and reimburse Esbriet in
We note that Esbriet was launched in Germany for the treatment
of IPF in Sep 2011. Esbriet is the sole contributor to
InterMune's total revenues for the last few quarters. As of 2012,
Esbriet was priced and launched in nine European countries,
namely, Austria, Belgium, Denmark, France, Germany, Iceland,
Luxembourg, Norway and Sweden.
In Oct 2012, Esbriet was approved in Canada for the treatment
of adults suffering from IPF. InterMune is running the ASCEND
trial to support pirfenidone in the US for the treatment of IPF.
In Jan 2013, the company completed enrolment for the phase III
study in the US and some additional territories. Result from the
ASCEND trial are expected in the second quarter of 2014.
InterMune recorded Esbriet sales of $26.2 million in the year
2012. The company expects Esbriet sales of $40-$70 million in
2013. The guidance includes $40-$55 million from countries where
the product is currently launched and the rest from the countries
where the drug is yet to be launched.
Though Esbriet is the only approved medicine for IPF,
) are developing candidates for IPF. We remain concerned about
the fact that InterMune is dependent on a single product for
growth. Meanwhile, we expect investor focus to remain on the
pricing and reimbursement in the remaining EU countries.
InterMune carries a Zacks Rank #3 (Hold). Other biotech stocks
) currently look more attractive carrying a Zacks Rank #1 (Strong
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