Pfizer 2011 Annual Report Download - page 28

Financial Review
Pfizer Inc. and Subsidiary Companies
(c) In April 2010, we received a “complete response” letter from the FDA for the Genotropin Mark VII multidose disposable device submission. In
August 2010, we submitted our response to address the requests and recommendations included in the FDA letter. In April 2011, we received a
second “complete response” letter from the FDA, requesting additional information. We are assessing the requests and recommendations included
in the FDA’s letter.
(d) In June 2010, we received a “complete response” letter from the FDA for the Celebrex chronic pain supplemental NDA. The supplemental NDA
remains pending while we await the completion of ongoing studies to determine next steps.
(e) In October 2009, we received a “complete response” letter from the FDA with respect to the supplemental NDA for Geodon for the treatment of
acute bipolar mania in children and adolescents aged 10 to 17 years. In October 2010, we submitted our response. In April 2010, we received a
“warning letter” from the FDA with respect to the clinical trial in support of this supplemental NDA. We are working to address the issues raised in
the letter. In April 2011, we received a second “complete response” letter from the FDA in which the FDA indicated that, in its view, the reliability of
the data supporting the filing had not yet been demonstrated. We are working to better understand the issues raised in the letter.
(f) In 2005, King entered into an agreement with Pain Therapeutics, Inc. (PT) to develop and commercialize Remoxy. In August 2008, the FDA
accepted the NDA for Remoxy that had been submitted by King and PT. In December 2008, the FDA issued a “complete response” letter. In March
2009, King exercised its right under the agreement with PT to assume sole control and responsibility for the development of Remoxy. In December
2010, King resubmitted the NDA for Remoxy with the FDA. In June 2011, we and PT announced that a “complete response” letter was received
from the FDA with regard to the resubmission of the NDA. We are working to address the issues raised in the letter, which primarily relate to
manufacturing. There are several key decision points over the next several months that will determine the timing and the nature of our response to
the FDA’s “complete response” letter.
(g) Boehringer Ingelheim (BI), our alliance partner, holds the NDAs for Spiriva Handihaler and Spiriva Respimat. In September 2008, BI received a
“complete response” letter from the FDA for the Spiriva Respimat submission. The FDA is seeking additional data, and we are coordinating with BI,
which is working with the FDA to provide the additional information. A full response will be submitted to the FDA upon the completion of planned and
ongoing studies.
(h) In September 2007, we received an “approvable” letter from the FDA for Zmax that set forth requirements to obtain approval for the pediatric acute
otitis media (AOM) indication based on pharmacokinetic data. In January 2010, we filed a supplemental NDA, which proposed the inclusion of the
new indications for AOM and acute bacterial sinusitis in pediatric patients. In May 2011, we received a “complete response” letter from the FDA with
respect to the supplemental NDA. We are working to determine the next steps.
(i) Two “approvable” letters were received by Wyeth in April and December 2007 from the FDA for Viviant (bazedoxifene), for the prevention of post-
menopausal osteoporosis, that set forth the additional requirements for approval. In May 2008, Wyeth received an “approvable” letter from the FDA
for the treatment of post-menopausal osteoporosis. The FDA is seeking additional data, and we have been systematically working through these
requirements and seeking to address the FDA’s concerns. A full response will be provided to the FDA. In February 2008, the FDA advised Wyeth
that it expects to convene an advisory committee to review the pending NDAs for both the treatment and prevention indications after we submit our
response to the “approvable” letters. In April 2009, Wyeth received approval in the EU for CONBRIZA (the EU trade name for Viviant) for the
treatment of post-menopausal osteoporosis in women at increased risk of fracture. Viviant was also approved in Japan in July 2010 for the
treatment of post-menopausal osteoporosis and in Korea in November 2011 for the treatment and prevention of post-menopausal osteoporosis.
(j) In December 2005, we received an “approvable” letter from the FDA for our Vfend pediatric filing that set forth the additional requirements for
approval to extend Vfend exclusivity in the U.S. for an additional six months. In April 2010, based on data from a new pharmacokinetics study, we
and the FDA agreed on a pediatric dosing regimen, which was subsequently incorporated into the three ongoing pediatric trials. Depending on the
results of those trials, we may pursue a pediatric indication for Vfend; however, this would not extend Vfend exclusivity for an additional six months
because we lost exclusivity for Vfend tablets in the U.S. in February 2011.
In July 2007, Wyeth received an “approvable” letter from the FDA with respect to its supplemental NDA for the use of Pristiq in the
treatment of moderate-to-severe vasomotor symptoms (VMS) associated with menopause. The FDA requested an additional
one-year study of the safety of Pristiq for this indication. This study was completed, and the results were provided to the FDA in
December 2010. In September 2011, we received a “complete response” letter from the FDA regarding our supplemental NDA. In
February 2012, we decided to withdraw our supplemental NDA for Pristiq for the treatment of moderate-to-severe VMS associated
with menopause. Pristiq continues to be available in the U.S. for the treatment of major depressive disorder (MDD) in appropriate
adult patients, and around the world, for the respective indications approved in each market.
2011 Financial Report 27