30 July 2011

Indian Pharma:: Filing trends Recent US FDA’s quarterly data on filings ::CLSA

Please Share:: Bookmark and Share India Equity Research Reports, IPO and Stock News
Visit http://indiaer.blogspot.com/ for complete details �� ��


Filing trends
Recent US FDA’s quarterly data on filings (DMFs) shows strong momentum in
number of filings by Indian pharmaceutical companies with noticeable exception
being Lupin. Dr Reddy’s has filed a number of niche DMFs during late 1Q and
2QCY11 with likes of bendamustine and two others. Some other smaller Indian
companies have also filed for complex generics which we believe will be the trend
in coming years as simple formulations will be mostly out of patent protection.
Such filings provide long term visibility to their earnings. Based on the pipeline of
near term launches, we prefer Dr Reddy’s as play on the US generics opportunity.
We see Sun Pharma, Lupin and Cadila as companies that can sustain growth over
medium to long term.
India maintains strong filing trend
q We have analysed recent quarterly data on DMF filings released by the US FDA. The
date shows a continued momentum in DMF filings by Indian pharmaceutical
companies that comprised more than 50% of total DMFs filed with the US FDA.
q During the quarter (2QCY11), IPCA, Dr Reddy’s and Ranbaxy have filed for a couple
of products though Lupin did not file any this quarter. Some of the filings done by
Dr Reddy’s in previous quarter were fairly interesting.
q Considering that the US market comprises a big proportion (20-40%) of total
revenues for most of the Indian pharmaceutical companies, we expect the pace of
filings to be maintained going forward as well.
Niche filings – long term earnings visibility
q We see a number of niche filings by Dr Reddy’s and expect that it could be one of
the early generic entrants in those products.
q Dr Reddy’s filing in bendamustine could be fairly lucrative as it is a US$1bn+
product in the US market. Other filings like lubiprostone, febuxostat could also be
potential early entries.
Strong upcoming quarters Dr. Reddy’s
q We see strong earnings growth in Dr Reddy’s over the near term led by
opportunities in the US generics space.
q Over the longer term, we expect strong prospects for Sun Pharma, Lupin, and
Cadila based on their filings in complex generics segment.
q Sun Pharma and Lupin have the highest pending ANDA pipeline among the Indian
pharma companies.

No comments:

Post a Comment