Pfizer (PFE) has been a large solid pharma company for a long time and investors are contemplating the loss of income from Lipitor and how it will affect future income. What is coming down the pipe line that could help replace this lost income? For those of you who do not know much about Pfizer: Pfizer Inc., a biopharmaceutical company, offers prescription medicines for humans and animals worldwide. The company's Biopharmaceutical segment’s provides Lipitor for elevated LDL-cholesterol levels in the blood; ffexor XR for depressive, generalized anxiety, social anxiety, and panic disorders; Premarin for menopausal symptoms; and much more.
You might have read it in other articles or head it on the news. In 2010 Lipitor, the cholesterol drug that is losing its patent made Pfizer $10.7 billion dollars in revenue. That is coming to an end and will take a tough toll PFE's income. When other large pharma companies like Merck (MRK) and Bristol-Myers Squibb's (BMY) brand name drugs expired, they lost an average of 87.5% of income on generic alternatives. So they have quite a challenge ahead of them.
One of the drugs that could be a boondoggle for PFE is Apixaban. This is Pfizer's anticoagulation medication battling for a piece of the 10 billion dollar a year market of replacing Coumadin. It should be approved by the end of 2011 and may become the most widely used of these drugs because of what appears to be not just non-inferiority to warfarin but superiority in major outcomes.
As an alternative to warfarin, it will help prevent blood clotting in disorders like atrial fibrillation. For those of you who do not know what this is -- when the heart pumps in rhythm, the two upper chambers of the heart contract followed by the two lower chambers and blood is pumped out to the rest of their body. The heart's electrical system makes this happen. In fibrillation, the electrical impulses may begin at the same time instead of an orderly pattern. You have electrical impulses vying for a chance to pass through the AV node at the same time in a unorganized manner. This disorder makes the ventricles contract irregularly, leading to a rapid and irregular heartbeat.
In a study of over 18,000 patients with atrial fibrillation called the ARISTOTLE Study apixaban was the first of the drugs to show statistically significant superiority to warfarin in the key endpoints of incidence of bleeding complications (31% lower), risk of stroke (21% lower) and risk of death (11% lower). The show of superiority to warfarin will be very important because of the competition with generic warfarin. This is widely available and established in the marketplace already. To overcome the expense of the drug, apixaban will need to prove both safety and efficacy to warfarin.
The answer to this cost difference of a generic version of warfarin that may cost $4.00 to apixaban with a cost of $160.00 would be in cost basis analysis. Michael Ezekowitz, of Thomas Jefferson University Medical School in Philadelphia said: "It's clear to me, that on the basis of these trials, millions of patients worldwide with atrial fibrillation will benefit very significantly from stroke reduction." Preventing strokes and keeping patients out of the hospitals could be a major factor that allows the drug to be widely used.