Zacks_Analysts' Blog : European Watchdog OKs Pfizer Drugs - Analyst Blog

It has been an eventful week at Pfizer Inc. (PFE) with the European Medicines Agency (EMA) accepting the company’s regulatory submissions of two pipeline candidates – crizotinib, being evaluated for the treatment of patients with previously treated ALK-positive advanced non-small cell lung cancer (NSCLC); and bosutinib being investigated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML).

For crizotinib, Pfizer plans to conduct two randomized late-stage trials (PROFILE 1007 and PROFILE 1014) in patients with ALK-positive NSCLC. The first study will compare the safety and efficacy of crizotinib to standard-of-care chemotherapy as a first-line therapy, while the second will compare the candidate as a second-line therapy to chemotherapy.

Recently, Pfizer entered an agreement with Qiagen NV (QGEN) to develop a companion molecular diagnostic test for use with an investigational compound of Pfizer for treating NSCLC. The proposed test will use the same core assay component as Qiagen’s proprietary KRAS assay technology, which detects mutations of the KRAS gene, frequently found in human colorectal cancers.

Also, this week, Pfizer received a favorable ruling in its patent infringement case against Teva Pharmaceutical Industries Ltd. (TEVA). Teva had filed an abbreviated new drug application with the US Food and Drug Administration (FDA) seeking approval for its generic version of Viagra.

Teva had challenged the validity of the Viagra use patent, which expires in 2019. The United States District Court for the Eastern District of Virginia ruled that the Viagra patent for the treatment of erectile dysfunction is valid and enforceable.

We note that several other generic companies are also seeking approval for their generic versions of Viagra. Pfizer currently has no trials scheduled for these cases.

The court’s decision comes as a relief for Pfizer, which is facing a major patent cliff. Pfizer’s biggest drug, Lipitor (used for reducing cholesterol) is slated to lose exclusivity in the US later this year.

We currently have a Neutral recommendation on Pfizer. The stock carries a Zacks #3 Rank (Hold rating) in the short-run.