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Replies to post #121384 on Biotech Values
06/09/11 8:16 PM
Fondaparinux: Near-term revenue opportunity…soon?!
ACL’s manufacturing and marketing partner is Dr Reddy's Laboratories (NYSE: RDY). Dr Reddy’s
ANDA was filed with the FDA in March 2009 and was accepted for review in May 2009.
Based on the FDA's Generic Initiative for Value and Efficiency (GIVE) program announced in
2007, the FDA prioritises the review of first generics, like ACL's fondaparinux, with the aim of
completing the review within six months of filing. Given ACL’s experience, the FDA is not meeting
targeted approval timeframes and we instead shift our focus to average review times for non
prioritised generics. We continue to expect approval from the FDA at any time, with our
understanding that there are no outstanding questions from the regulatory body to be answered.
Without priority review the average review time for ANDA submissions in 2009 was 27 months
(see Charts 1 and 2). At a presentation at the February 2011 Generic Pharmaceutical Association
(GPhA) meeting, Debra Autor, Director of FDA’s Office of Compliance, commented that approvals
of ANDAs are slowing and surprisingly, as of January 25, there were 2,361 ANDAs awaiting
approval. During 2010, the median approval time slipped from 27 to over 30 months. We
understand that one of the key drivers of the delayed timelines is that there are 192 Pre-Approval
Inspections in the queue, affecting 354 ANDA submissions, but only 62 Pre-Approval Inspections
budgeted – with the Office of Generic Drugs (OGD) lacking the manpower to conduct inspections.
In a recent announcement, ACL noted that it was not aware of any outstanding items that could
stand in the way of approval being granted. As we have previously reported, multiple site
inspections were completed successfully with the most recent one completed in January this year.
That is, ACL has overcome one of the key hurdles highlighted above that are delaying the
approval of ANDAs. As a result, ACL expects there to be no further procedural impediments to
approval and anticipates the next communication from the FDA to be the product approval itself.
As we understand it, the review time for non prioritised ANDAs is calculated from the date on
which OGD receives an ANDA. While we acknowledge that ACL does actually have priority
review, with these timelines not being met we use the current median approval times for nonprioritised
generics to estimate a potential approval date. Based on the May 2009 FDA
acceptance for review of ACL’s ANDA and counting 27 – 30 months from this point, we estimate
approval of ACL’s fondaparinux ANDA between July and October 2011
AI
