Pfizer Inc. PFE said today that the United States District Court for the District
of Delaware ruled that Pfizer's patent covering a method for using sirolimus,
the active ingredient in RAPAMUNE®, for the inhibition of organ transplant
rejection is valid and infringed. The company brought a patent infringement
action in April 2010 against the generic company Watson Laboratories,
Inc—Florida (now known as Actavis) and three other Watson entities after
Watson applied to the FDA to market a generic version of RAPAMUNE®. The
Court's decision prevents Watson from marketing its generic version of
RAPAMUNE® in the U.S. before Pfizer's patent expires, pending a possible
appeal by Watson.
The patent at issue in the lawsuit is U.S. Patent No. 5,100,899, which
including pediatric exclusivity, expires January 7, 2014. In response to the
decision, Amy Schulman, Executive Vice President and General Counsel for
Pfizer, said, “We are pleased with the Court's decision, recognizing the
validity of our patent."
In the United States, RAPAMUNE® is indicated for the prevention of organ
transplant rejection in kidney transplant patients aged 13 years and older.
Important Safety Information
* There is an increased risk of developing infections or certain cancers,
especially lymphoma and skin cancers. Rapamune has not been shown to be
safe and effective in people who have had liver or lung transplants.
Serious complications and death may happen in people who take Rapamune
after a liver or lung transplant. You should not take Rapamune if you have
had a liver or lung transplant without talking with your doctor.
* Do not take Rapamune if you know you are allergic to sirolimus or any of
the other ingredients in Rapamune. Symptoms of an allergic reaction
include swelling of your face, eyes, or mouth; trouble breathing or
wheezing; throat tightness; chest pain or tightness; feeling dizzy or
faint; and rash or peeling of your skin.
* Before taking Rapamune, tell your doctor if you have liver problems, skin
cancer or it runs in your family, high cholesterol or triglycerides, are
breastfeeding or plan to breastfeed, and are pregnant or plan to become
pregnant. Women of childbearing potential should use effective birth
control before therapy, during therapy, and for 12 weeks after Rapamune
therapy has been stopped. Rapamune may interact with other medicines. Make
sure that your doctor is aware of all prescription and over-the-counter
drugs that you are taking, including vitamins, herbs, and nutritional
supplements.
* Rapamune may cause swelling in your hands, feet, and in various tissues of
your body. Call your doctor if you have trouble breathing.
* Rapamune may cause your wounds to heal slowly or not heal well resulting
in redness, drainage, or opening of the wound.
* Rapamune may increase the levels of cholesterol and triglycerides (lipids
or fat) in your blood. Your doctor should do blood tests to check your
lipids during treatment with Rapamune. Your doctor may recommend treatment
if your lipid levels become too high. Your lipid levels may remain high
even if you follow your prescribed treatment plan.
* In patients taking Rapamune with cyclosporine, decreased kidney function
has been observed. Your doctor will regularly check your kidney function.
* Rapamune may increase protein in your urine. Your doctor may monitor you
for abnormal protein in your urine from time to time.
* Rapamune may increase your risk for viral infections. Certain viruses can
live in your body and cause active infections when your immune system is
weak. One of these viruses, BK virus, can affect how your kidney works and
cause your transplanted kidney to fail. A certain virus can cause a rare
serious brain infection called Progressive Multifocal Leukoencephalopathy
causing death or severe disability.
* Rapamune may cause potentially life-threatening lung or breathing
problems. Symptoms may include coughing, shortness of breath, or
difficulty breathing.
* When Rapamune is taken with cyclosporine or tacrolimus, you may develop a
blood clotting problem resulting in unexplained bleeding or bruising.
* Common side effects associated with Rapamune include high blood pressure,
pain (including stomach and joint pain), diarrhea, headache, fever,
urinary tract infection, low red blood cell count (anemia), nausea, and
low platelet count (cells that help blood to clot). If you experience any
side effects, contact your doctor.
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