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 had been received from the FDA with regard to the resubmission of the NDA. Having achieved technical milestones related to manufacturing and following guidance received from the FDA earlier in 2013, we announced in October 2013 that we will proceed with the additional clinical studies and other actions required to address the "complete response" letter received in June 2011. These new clinical studies will include, in part, a pivotal bioequivalence study with the modified Remoxy formulation to bridge to the clinical data related to the original Remoxy formulation, and an abuse-potential study with the modified formulation. As previously disclosed, the "complete response" submission is not expected to occur prior to mid-2015.

(f) 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. 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 view of the recent approval of Duavee by the FDA, we are reassessing the next steps regarding our NDAs for Viviant. 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.

   REGULATORY APPROVALS AND FILINGS IN THE EU AND JAPAN

   PRODUCT

Bosulif (Bosutinib) Eliquis (Apixaban)(a)

DESCRIPTION OF EVENT

Application filed in Japan for treatment of previously treated chronic myelogenous leukemia

Application filed in the EU for treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE

Conditional marketing authorization in the EU for treatment of previously treated chronic myelogenous leukemia

Approval in Japan for treatment of rheumatoid arthritis with inadequate response to existing therapies

Approval in Japan for treatment of neuropathic pain

Application filed in the EU for treatment of symptoms associated with menopause and osteoporosis

     LATE-STAGE CLINICAL PROGRAMS FOR ADDITIONAL USES AND DOSAGE FORMS FOR IN-LINE AND IN-REGISTRATION PRODUCTS

INDICATION

Peripheral neuropathic pain; CR (once-a-day) dosing

Adjuvant treatment of renal cell carcinoma

A JAK kinase inhibitor for the treatment of psoriasis, ulcerative colitis and psoriatic arthritis

Adult symptomatic transthyretin cardiomyopathy

An oral ALK and c-Met inhibitor for the treatment of ALK-positive first-line non-small cell lung cancer

NEW DRUG CANDIDATES IN LATE-STAGE