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Ranbaxy (RBXY)
OW: FDA asks court to deny Mylan request in Lipitor case
FDA asks court to deny Mylan’s request for a preliminary
injunction with reference to approval of other ANDAs
FDA says Mylan’s motion lacks merit and claims it has not
unreasonably delayed taking action
As the FDA has not decided on Ranbaxy’s exclusivity, we
view this as a positive development. Reiterate OW, TP INR690
FDA says Mylan’s suit lacks standing. The FDA yesterday issued a response to USbased Mylan Pharmaceutical’s suit in the case of generic Lipitor (refer to our note dated
21
st
March 2011, Ranbaxy: Mylan asks court to block Ranbaxy’s generic Lipitor) stating
that Mylan has failed to establish actual injury in relation to the FDA’s actions concerning
approval of ANDAs for generic Lipitor. In the absence of this, it argues there is no case
for Article III controversy and hence the court should deny Mylan’s request for a
preliminary injunction.
Mylan ANDA has not received tentative approval. The FDA further comments that
Mylan’s claim is not fit for review given that its own application has not yet received
tentative approval. Moreover, it is not the question of exclusivity period for Ranbaxy’s
ANDA that has stopped the FDA from approving Mylan’s ANDA, given that the FDA is
still undecided on Ranbaxy’s exclusivity, and hence it sees insufficient grounds for a
preliminary injunction.
Ranbaxy exclusivity is still undecided. Determination of Ranbaxy’s eligibility for
exclusivity will be intensely fact-driven. Mylan’s request that the process be expedited
and made public, if granted, would in future subject the FDA to a series of challenges
every time a manufacturer is suspicious of data in a competitor’s ANDA application. The
FDA also points out that Mylan is erroneous in its assumption that FDA refusal of
Ranbaxy’s ANDA would immediately wipe out any exclusivity to which Ranbaxy might
be entitled. Should such a situation arise, Ranbaxy can appeal against the decision.
Clarity on Ranbaxy’s ANDA status is unlikely to come soon. The FDA and Ranbaxy
are engaged in discussions to resolve the issues described in the letter invoking the AIP
(application integrity policy). Additionally, it is known that resolution of issues here
require factual determinations about reliability of the data. We keep our rating and target
price unchanged. We value Ranbaxy at 22x CY12e EPS and add INR94 for para-IV
opportunities. Risks to our call include denial of exclusivity or possible delays in
atorvastatin generic launch (which is due 30th November 2011).
India Equity Research Reports, IPO and Stock News
Visit http://indiaer.blogspot.com/ for complete details �� ��
Ranbaxy (RBXY)
OW: FDA asks court to deny Mylan request in Lipitor case
FDA asks court to deny Mylan’s request for a preliminary
injunction with reference to approval of other ANDAs
FDA says Mylan’s motion lacks merit and claims it has not
unreasonably delayed taking action
As the FDA has not decided on Ranbaxy’s exclusivity, we
view this as a positive development. Reiterate OW, TP INR690
FDA says Mylan’s suit lacks standing. The FDA yesterday issued a response to USbased Mylan Pharmaceutical’s suit in the case of generic Lipitor (refer to our note dated
21
st
March 2011, Ranbaxy: Mylan asks court to block Ranbaxy’s generic Lipitor) stating
that Mylan has failed to establish actual injury in relation to the FDA’s actions concerning
approval of ANDAs for generic Lipitor. In the absence of this, it argues there is no case
for Article III controversy and hence the court should deny Mylan’s request for a
preliminary injunction.
Mylan ANDA has not received tentative approval. The FDA further comments that
Mylan’s claim is not fit for review given that its own application has not yet received
tentative approval. Moreover, it is not the question of exclusivity period for Ranbaxy’s
ANDA that has stopped the FDA from approving Mylan’s ANDA, given that the FDA is
still undecided on Ranbaxy’s exclusivity, and hence it sees insufficient grounds for a
preliminary injunction.
Ranbaxy exclusivity is still undecided. Determination of Ranbaxy’s eligibility for
exclusivity will be intensely fact-driven. Mylan’s request that the process be expedited
and made public, if granted, would in future subject the FDA to a series of challenges
every time a manufacturer is suspicious of data in a competitor’s ANDA application. The
FDA also points out that Mylan is erroneous in its assumption that FDA refusal of
Ranbaxy’s ANDA would immediately wipe out any exclusivity to which Ranbaxy might
be entitled. Should such a situation arise, Ranbaxy can appeal against the decision.
Clarity on Ranbaxy’s ANDA status is unlikely to come soon. The FDA and Ranbaxy
are engaged in discussions to resolve the issues described in the letter invoking the AIP
(application integrity policy). Additionally, it is known that resolution of issues here
require factual determinations about reliability of the data. We keep our rating and target
price unchanged. We value Ranbaxy at 22x CY12e EPS and add INR94 for para-IV
opportunities. Risks to our call include denial of exclusivity or possible delays in
atorvastatin generic launch (which is due 30th November 2011).
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