Pfizer 2009 Annual Report Download - page 27

Financial Review
Pfizer Inc. and Subsidiary Companies
On April 16, 2009, we announced that we entered into an agreement with GSK to create a new company focused solely on
research, development and commercialization of HIV medicines. The transaction closed on October 30, 2009 and the new
company, ViiV, began operations on November 2, 2009. We have contributed Selzentry/Celsentri (maraviroc), among other
HIV-related assets, to ViiV (see further discussion in the “Our Strategic Initiatives––Strategy and Recent Transactions: Acquisitions,
Dispositions, Licensing and Collaborations” section of this Financial Review). In November 2009, we received approval from the
FDA for Selzentry (maraviroc) tablets for use in treatment-naïve adult patients with CCR5-tropic HIV-1 virus as part of combination
therapy.
Pending U.S. new drug applications (NDA) and supplemental filings:
PRODUCT INDICATION DATE SUBMITTED
Taliglucerase alfa Treatment of Gaucher’s disease December 2009
Sutent Pancreatic neuroendocrine tumor December 2009
Genotropin Adult growth hormone deficiency (Mark VII multidose disposable device) October 2009
Celebrex Chronic pain August 2009
Lyrica Generalized anxiety disorder––monotherapy June 2009
Geodon Treatment of bipolar disorder––pediatric filing October 2008
Fablyn (lasofoxifene) Treatment of osteoporosis December 2007
Spiriva Respimat device for chronic obstructive pulmonary disease November 2007
Zmax Treatment of bacterial infections—sustained release—acute otitis media (AOM) and
sinusitis—pediatric filing
November 2006
Viviant Osteoporosis treatment and prevention June 2006
Pristiq Vasomotor symptoms of menopause June 2006
Vfend Treatment of fungal infections—pediatric filing June 2005
Thelin Treatment of pulmonary arterial hypertension (PAH) May 2005
In December 2009, our co-promotion partner, Protalix BioTherapeutics, submitted an NDA with the FDA for taliglucerase alfa.
Taliglucerase alfa was granted orphan drug designation and fast track designation by the FDA. In November 2009, we entered into
a license and supply agreement with Protalix BioTherapeutics, which provides us exclusive worldwide rights to develop and
commercialize taliglucerase alfa for the treatment of Gaucher’s disease except in Israel.
In June 2009, we resubmitted a data package to the FDA for Lyrica for the treatment of GAD monotherapy in response to a “not-
approvable” letter issued by the FDA in August 2004. On December 23, 2009, we received a “complete response” letter from the
FDA with respect to this NDA. We are working with the FDA to determine next steps. On January 27, 2010, we announced the
withdrawal of the adjunctive treatment for GAD submission.
In June 2009, an FDA advisory committee concluded that Geodon is effective for the treatment of bipolar mania in children ages 10
to 17. Eight members of the committee also concluded that Geodon is acceptably safe for that indication, with one committee
member disagreeing and nine additional committee members abstaining. On October 30, 2009, we received a “complete response”
letter from the FDA with respect to this NDA. The FDA is seeking additional information and is requesting that we take certain
actions with regard to the submission. We are working with the FDA to address its requests and recommendations.
We received “not-approvable” letters from the FDA for Fablyn (lasofoxifene) for the prevention of post-menopausal osteoporosis in
September 2005 and for the treatment of vaginal atrophy in January 2006. We submitted a second NDA for the treatment of
osteoporosis in post-menopausal women in December 2007, including the three-year interim data from the Post-menopausal
Evaluation And Risk-reduction with Lasofoxifene (PEARL) study in support of the new NDA. In September 2008, nine of the 13
members of an FDA advisory committee concluded that there is a population of women with post-menopausal osteoporosis for
which the benefit of treatment with Fablyn is likely to outweigh the risks. We received a “complete response” letter from the FDA in
January 2009. Subsequently, following a strategic review, we decided to explore strategic options for Fablyn, including out-licensing
or sale.
BI, our alliance partner, holds the U.S. NDA for Spiriva. 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.
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