Pfizer 2008 Annual Report Download - page 27

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Financial Review
Pfizer Inc and Subsidiary Companies
In September 2007, we received an "approvable" letter from the FDA for Zmax that sets forth requirements to obtain approval for the
pediatric AOM indication based on pharmacokinetic data. A supplemental filing for pediatric AOM and sinusitis remains under
review.
In December 2005, we received an "approvable" letter from the FDA for our Vfend pediatric filing, which sets forth the additional
requirements for approval. We have been systematically working through these requirements and addressing the FDA's concerns,
including initiating an additional pharmacokinetics study in November 2008.
In June 2008, we completed the acquisition of Encysive, whose main product is Thelin. In June 2007, Encysive received a third
"approvable" letter from the FDA for Thelin for the treatment of PAH. We began an additional Phase 3 clinical trial in patients with
PAH during the fourth quarter of 2008 to address the concerns of the FDA regarding efficacy as reflected in that letter.
In September 2008, we announced that we would globally withdraw all dalbavancin marketing applications for the treatment of
complicated skin and skin structure gram-positive bacterial infections in adults, including the U.S. NDA and the European marketing
authorization application. We plan to conduct an additional Phase 3 clinical trial to support planned future regulatory submissions. A
pediatric program with dalbavancin is also planned.
Regulatory approvals and filings in the E.U. and Japan:
PRODUCT DESCRIPTION OF EVENT
DATE
APPROVED
DATE
SUBMITTED
Zithromac Approval in Japan for bacterial infections January 2009 —
Celsentri (maraviroc) Application submitted in the E.U. for HIV in treatment-naïve patients — January 2009
Approval in Japan for HIV in treatment-experienced patients December 2008 —
Genotropin Approval in Japan for treatment of short stature/growth problems December 2008 —
Geodon Application submitted in the E.U. for pediatric bipolar disorders — October 2008
rifabutin Approval in Japan for mycobacterium infection July 2008 —
Macugen Approval in Japan for treatment of age-related macular degeneration July 2008 —
Lyrica Application submitted in Japan for the treatment of pain associated
with post-herpetic neuralgia
— May 2008
Application submitted in the E.U. for the treatment of fibromyalgia — March 2008
Sutent Approval in Japan for treatment of mRCC and GIST April 2008 —
Xalacom Application submitted in Japan for the treatment of glaucoma — February 2008
sildenafil Approval in Japan for treatment of PAH January 2008 —
Fablyn (lasofoxifene)(a) Application submitted in the E.U. for the treatment of osteoporosis — January 2008
Chantix/Champix Approval in Japan as an aid to smoking cessation January 2008 —
Caduet Application submitted in Japan for hypertension — November 2007
Celebrex Application submitted in Japan for treatment of lower-back pain — February 2007
(a) In December 2008, the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending that the European
Commission grant marketing authorization for Fablyn (lasofoxifene) as a treatment for osteoporosis in post-menopausal women at increased risk of
fracture in Europe.
Ongoing or planned clinical trials for additional uses and dosage forms for our in-line products include:
PRODUCT INDICATION
Celebrex Acute gouty arthritis
Eraxis/Vfend Combination Aspergillosis fungal infections
Lyrica Epilepsy monotherapy; post-operative pain; GAD; restless legs syndrome
Macugen Diabetic macular edema
Revatio Pediatric pulmonary arterial hypertension
Sutent Breast cancer; colorectal cancer; non-small cell lung cancer; prostate cancer; liver cancer
Zithromax/chloroquine Malaria
New drug candidates in late-stage development include: axitinib, a multi-targeted kinase inhibitor for the treatment of renal cell
carcinoma; Dimebon, a novel mitochondrial protectant and enhancer being developed in partnership with Medivation for the
treatment of Alzheimer's disease; CP-751871, an anti-insulin-like growth factor receptor 1 (IGF1R) human monoclonal antibody for
the treatment of non-small cell lung cancer; dalbavancin, for the treatment of skin and skin structure infections; tanezumab, an anti-
nerve growth factor monoclonal antibody for the treatment of pain; and apixaban, for the prevention and treatment of venous
thromboembolism and the prevention of stroke in patients with atrial fibrillation, which is being developed in collaboration with BMS.
2008 Financial Report 25