Tomahawk, WI 04/10/2014 (Basicsmedia) – The success of palbociclib in Phase II trials is a good news for Pfizer Inc. (NYSE:PFE) coming on the heels of the bad news of a U.S. court invalidating Pfizer’s patent for blockbuster drug Celebrex.

Breakthrough Therapy?

Pfizer Inc. (NYSE:PFE) announced in early February some positive results from a randomized Phase 2 trial of palbociclib in combination with letrozole (for blocking the synthesis of estrogen) in post-menopausal women with estrogen receptor (ER) positive recurring or metastatic breast cancer that is human epidermal growth factor receptor 2 (HER2) negative.

About 60 to 65 percent of breast cancers are of this type translating to about 50,000 American women a year who might benefit from palbociclib. It remains to be seen whether the Food and Drug Administration (FDA) will grant approval to the drug based on this study alone or a larger Phase 3 trial will be needed. Palbociclib has already received ‘Breakthrough Therapy’ designation in April 2013 based on interim data from this trial. Patient enrolment is currently on for a Phase 3 randomized global trial in this patient population.

Palbociclib is a new class of drugs that works by inhibiting the activity of two related enzymes — cyclin-dependent kinases 4 and 6 — in cell division. Pfizer Inc. (NYSE:PFE) is in the lead at this point to bring this new class of CDK 4/6 inhibitor drugs to the market but competitors — Novartis AG (ADR) (NYSE:NVS) and Eli Lilly and Co (NYSE:LLY) — are testing their own drugs.

Other Drugs

With its hugely successful statin therapy Lipitor (atorvastatin) now no longer being an exclusive Pfizer product, Pfizer needs to bring more blockbuster drugs to the market to make up for the loss in revenue from declining Lipitor sales. Its other blockbuster drug Viagra is also attracting generic manufacturers and the company recently sued a company, Torrent Pharmaceuticals, based in India.

Pfizer Inc. (NYSE:PFE) has reported success for its experimental Bococizumab in reducing LDL-C cholesterol in a Phase 2 trial involving patients who are at risk for cardiovascular events. This is a new drug formulation for patients whose high cholesterol level isn’t controllable with traditional statin therapy.

It has reported success in Phase 3 study of ALK-inhibitor Xalkori (crizotinib), in demonstrating progression-free survival in patients with advanced non-squamous non-small cell lung cancer (NSCLC).

Meanwhile, Pfizer has also got vaccines such as Prevnar-13, the company’s pneumococcal vaccine and a meningococcal B vaccine in Phase III clinical trial whose results are expected later in 2014.


So the long-term outlook for Pfizer looks good at this point.

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