December 2007 and May 2008 with respect to the NDAs. In view of the approval of Duavee (conjugated estrogens/bazedoxifene), we continue to assess next steps for Viviant.

  REGULATORY APPROVALS AND FILINGS IN THE EU AND JAPAN

  PRODUCT

Xalkori (Crizotinib)

Effexor SR (Venlafaxine HCl) Bosulif (Bosutinib)

Eliquis (Apixaban)(a)

DESCRIPTION OF EVENT

Application filed in the EU for first line treatment of ALK- positive non-small cell lung cancer

Application filed in Japan for treatment of depression/ depressed state

Approval in Japan for treatment of previously treated chronic myelogenous leukemia

Approval in the EU for treatment of DVT and PE, and prevention of recurrent DVT and PE in adults

DATE APPROVED

—

—

September 2014

July 2014

DATE FILED*

January 2015

December 2014 —

—

         Duavive (Conjugated Approval in the EU for treatment of estrogen deficiency December 2014 — Estrogens/Bazedoxifene) symptoms in postmenopausal women with a uterus (with at

least 12 months since the last menses) for whom treatment with progestin-containing therapy is not appropriate

                Prevenar 13 Adult Approval in Japan for prevention of pneumococcal disease June 2014 __ caused by Streptococcus pneumoniae serotypes (1, 3, 4, 5,

6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) in adults 65 years of age and older

*

(a) This indication for Eliquis (apixaban) was developed and is being commercialized in collaboration with BMS.

For applications in the EU, the dates set forth in this column are the dates on which the European Medicines Agency (EMA) validated our submissions.

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

INDICATION

First-line treatment for patients with chronic phase Philadelphia chromosome positive chronic myelogenous leukemia, which is being developed in collaboration with Avillion Group

Adjuvant treatment of renal cell carcinoma, which is being developed in collaboration with SFJ Pharmaceuticals Group

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

Adjuvant treatment of renal cell carcinoma

Treatment of psoriasis (ex-US), ulcerative colitis, psoriatic arthritis, and QD MR (once-a-day) dosing Adult symptomatic transthyretin cardiomyopathy

  PRODUCT

Bosulif (Bosutinib) Inlyta (Axitinib)

Lyrica (Pregabalin)

Sutent (Sunitinib)

Tofacitinib(a)

Vyndaqel (Tafamidis meglumine)

       Ibrance (Palbociclib) An oral and selective reversible inhibitor of the CDK 4 and 6 kinases for the first-line

treatment of patients with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2- negative (HER2-) advanced breast cancer (ex-U.S.), as well as for the treatment of recurrent advanced

breast cancer and, in collaboration with the German Breast Group, high-risk early breast cancer

           (a) Tofacitinib QD is currently conducting pivotal Phase 1 studies with registrational intent.

      CANDIDATE

Bococizumab (RN316) (PF-04950615)

Ertugliflozin (PF-04971729) Inotuzumab ozogamicin

PF-06836922

PF-06438179(a) PF-05280014(b) PF-05280586(c) Tanezumab(d)

NEW DRUG CANDIDATES IN LATE-STAGE DEVELOPMENT INDICATION

A monoclonal antibody