Pfizer 2011 Annual Report Download - page 25

Financial Review
Pfizer Inc. and Subsidiary Companies
This safety information was added at the FDA’s request following an observation of a small numeric increase in certain
cardiovascular events in patients treated with Chantix versus those taking a placebo in a study of 700 smokers with stable
cardiovascular disease. Approval of the EU labeling, revised at the European Medicine’s Agency’s (EMA’s) request to include a
similar cardiovascular-related warning/precaution, was received in late December 2011, with regulators reaffirming the positive
benefit/risk profile of the medication. Approval of the Japan labeling, which includes a similar precaution, occurred in late October
2011. In December 2011, Pfizer received a positive opinion from the EMA’s Committee for Medical Products for Human Use for
changes to the EU label regarding schizophrenia data.
•BeneFIX and ReFacto AF/Xyntha are hemophilia products using state-of-the-art manufacturing that assist patients with a lifelong
bleeding disorder. BeneFIX is the only available recombinant factor IX product for the treatment of hemophilia B, while ReFacto AF/
Xyntha are recombinant factor VIII products for the treatment of hemophilia A. Both products are indicated for the control and
prevention of bleeding in patients with these disorders and in some countries also are indicated for prophylaxis in certain situations,
such as surgery. BeneFIX recorded an increase in worldwide revenues of 8% in 2011, compared to 2010. ReFacto AF/Xyntha
recorded an increase in worldwide revenues of 25% in 2011, compared to 2010. The increases for all of these products were due to
strong operational performance and the favorable impact of foreign exchange.
•Effexor, an antidepressant for treating adult patients with major depressive disorder, generalized anxiety disorder, social anxiety
disorder and panic disorder, recorded a decrease in worldwide revenues of 61% in 2011, compared to 2010. Effexor and Effexor XR,
an extended-release formulation, face generic competition in most markets, including in the U.S., where Effexor XR lost exclusivity on
July 1, 2010. This generic competition had a negative impact in 2011, and will continue to have a significant adverse impact on our
revenues for Effexor and Effexor XR.
•Zosyn/Tazocin, our broad-spectrum intravenous antibiotic, faces generic global competition. U.S. exclusivity was lost in September
2009. Zosyn/Tazocin recorded a decrease in worldwide revenues of 33% in 2011, compared to 2010.
•Pristiq is approved for the treatment of major depressive disorder in the U.S. and in various other countries. Pristiq has also been
approved for treatment of moderate-to-severe vasomotor symptoms (VMS) associated with menopause in Thailand, Mexico, the
Philippines and Ecuador. Pristiq recorded an increase in worldwide revenues of 24% in 2011, compared to 2010, primarily driven by
promotional activities in the U.S., and targeted international markets where Pristiq was recently launched. The activities are designed to
educate physicians and pharmacists about the benefit-risk profile of Pristiq.
•Caduet is a single-pill therapy combining Lipitor and Norvasc for the prevention of cardiovascular events. Caduet worldwide revenues
increased 2% in 2011, compared to 2010, due to strong operational performance in international markets and the favorable impact of
foreign exchange, partially offset by the impact of increased generic competition, as well as an overall decline in U.S. hypertension
market volume. Caduet lost U.S. exclusivity in November 2011.
•Revatio, for the treatment of pulmonary arterial hypertension (PAH), had an increase in worldwide revenues of 11% in 2011, compared
to 2010, due in part to increased PAH awareness driving earlier diagnosis in the U.S. and EU and the favorable impact of foreign
exchange. In the U.S., Revatio tablet will lose exclusivity in September 2012, and Revatio IV injection will lose exclusivity in May 2013.
•Prevnar/Prevenar (7-valent), our 7-valent pneumococcal conjugate vaccine for preventing invasive, and, in certain international
markets, non-invasive pneumococcal disease in infants and young children, recorded a decrease in worldwide revenues of 61% in
2011, compared to 2010. Many markets have transitioned from the use of Prevnar/Prevenar (7-valent) to Prevnar 13/Prevenar 13 (see
discussion above), resulting in lower revenues for Prevnar/Prevenar (7-valent). We expect this trend to continue.
•Xalkori, the first-ever therapy targeting anaplastic lymphoma kinase (ALK), for the treatment of patients with locally advanced or
metastatic non-small cell lung cancer (NSCLC) that is ALK-positive as detected by an FDA-approved test, was approved by the FDA in
August 2011. In December 2011, Xalkori was approved in Korea for the treatment of ALK-positive locally advanced or metastatic
NSCLC.
•Inlyta was approved by the FDA in January 2012 for the treatment of patients with advance renal cell carcinoma after failure of one
prior systemic therapy.
•Alliance revenues worldwide decreased 11% in 2011, compared to 2010, mainly due to the loss of exclusivity for Aricept 5mg and
10mg tablets in the U.S. in November 2010, partially offset by the strong performance of Spiriva and Enbrel in the U.S. and Canada.
We expect that the Aricept 23mg tablet will have exclusivity in the U.S. until July 2013. See the “The Loss or Expiration of Intellectual
Property Rights” section of this Financial Review for a discussion regarding the expiration of various contract rights relating to Aricept,
Spiriva, Enbrel and Rebif. ELIQUIS (apixaban) is being jointly developed and commercialized by Pfizer and Bristol-Myers Squibb
(BMS). The two companies share with respect to the approved indication in the EU and, if and when indications for ELIQUIS are
approved in various markets, will share on a global basis commercialization expenses and profit/losses equally.
See Notes to Consolidated Financial Statements—Note 17. Commitments and Contingencies for a discussion of recent
developments concerning patent and product litigation relating to certain of the products discussed above.
Embeda—On February 23, 2011, we stopped distribution of our Embeda product due to failed specification tolerance related to
naltrexone degradation identified in post-manufacturing testing. On March 10, 2011, we initiated a voluntary recall to wholesale and
retail customers of all Embeda products. We are committed to returning this important product to the market as quickly as possible,
once the stability issue is resolved.
24 2011 Financial Report