Please Share:: 
India Equity Research Reports, IPO and Stock News
Visit http://indiaer.blogspot.com/ for complete details �� ��
Mylan sues USFDA to block Ranbaxy’s sale of Lipitor
Mylan has sued the USFDA to block Ranbaxy’s exclusive rights to sell generic version of
Pfizer‘s cholesterol pill Lipitor (US sales of US $7.27bn for the 12 months period ending
September 30, 2010 – IMS Health).
Ranbaxy had reached an agreement with Pfizer in 2008 to sell copies of Lipitor beginning
November 2011 and is entitled to a 180-day marketing exclusivity as a reward for being
the first to challenge the Lipitor patent. According to Mylan, the other generic-drug makers
should be allowed to enter the market as soon as the patent expires. In its complaint,
Mylan stated that Ranbaxy is not eligible for the marketing exclusivity because of ‘false and
unreliable data’ from its manufacturing site in Paonta Sahib, India, where Lipitor copies
would be produced and, thereby, wants the court to force the FDA to say publicly that
Ranbaxy’s application ‘is tainted by Ranbaxy’s misconduct’ and that, therefore, the
application must be denied and the 180-day reward be announced void.
Currently, Lipitor contributes around `67/share to our target price of `588. Even in the
worst-case scenario, assuming there is no contribution from Lipitor, it would be
`521/share. Thus, given the correction in the stock price and the valuation of around 2.5x
and 2.0x EV/sales (excl. FTF) for CY2011E and CY2012E, respectively, we believe the
stock currently discounts most of the negatives. Hence, we maintain Buy on the stock with a
target price of `588.
India Equity Research Reports, IPO and Stock News
Visit http://indiaer.blogspot.com/ for complete details �� ��
Mylan sues USFDA to block Ranbaxy’s sale of Lipitor
Mylan has sued the USFDA to block Ranbaxy’s exclusive rights to sell generic version of
Pfizer‘s cholesterol pill Lipitor (US sales of US $7.27bn for the 12 months period ending
September 30, 2010 – IMS Health).
Ranbaxy had reached an agreement with Pfizer in 2008 to sell copies of Lipitor beginning
November 2011 and is entitled to a 180-day marketing exclusivity as a reward for being
the first to challenge the Lipitor patent. According to Mylan, the other generic-drug makers
should be allowed to enter the market as soon as the patent expires. In its complaint,
Mylan stated that Ranbaxy is not eligible for the marketing exclusivity because of ‘false and
unreliable data’ from its manufacturing site in Paonta Sahib, India, where Lipitor copies
would be produced and, thereby, wants the court to force the FDA to say publicly that
Ranbaxy’s application ‘is tainted by Ranbaxy’s misconduct’ and that, therefore, the
application must be denied and the 180-day reward be announced void.
Currently, Lipitor contributes around `67/share to our target price of `588. Even in the
worst-case scenario, assuming there is no contribution from Lipitor, it would be
`521/share. Thus, given the correction in the stock price and the valuation of around 2.5x
and 2.0x EV/sales (excl. FTF) for CY2011E and CY2012E, respectively, we believe the
stock currently discounts most of the negatives. Hence, we maintain Buy on the stock with a
target price of `588.
No comments:
Post a Comment