Pfizer Wins RAPAMUNE® Patent Case in Delaware District Court

  Pfizer Wins RAPAMUNE® Patent Case in Delaware District Court

Business Wire

NEW YORK -- January 31, 2013

Pfizer Inc. 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.

Indications and Usage

RAPAMUNE® (sirolimus) is indicated for the prevention of organ rejection in
kidney transplant patients aged 13 years or older. Blood levels of sirolimus
should be checked in all patients taking Rapamune.

  *In patients at low to moderate risk of acute rejection, it is recommended
    that Rapamune be used initially in combination with cyclosporine and
    corticosteroids; cyclosporine should be withdrawn approximately 3 months
    after transplantation. Cyclosporine withdrawal has not been studied in
    patients who have had severe acute rejection prior to cyclosporine
    withdrawal, those who require dialysis or have a high serum creatinine,
    Black patients, patients receiving a repeat kidney transplant, patients
    receiving other transplanted organs besides the kidney transplant, or
    patients with antibodies that may be directed against the kidney
    transplant.
  *In patients at high risk of acute rejection (defined as Black patients
    and/or patients receiving a repeat kidney transplant who lost a previous
    kidney transplant from rejection and/or patients with high levels of
    antibodies that may be directed against the kidney transplant), it is
    recommended that Rapamune be used in combination with cyclosporine and
    corticosteroids for the first year following transplantation. The safety
    and efficacy of this combination in high-risk patients have not been
    studied beyond one year; therefore, after the first year, adjustments to
    the immunosuppressive regimen may be considered by your doctor.

In pediatric patients, the safety and efficacy of Rapamune have not been
established in kidney transplant patients less than 13 years old, or in
patients less than 18 years old who are considered at high risk of acute
rejection.

  *The safety and efficacy of Rapamune without cyclosporine in newly
    transplanted kidney patients have not been established.

  *The safety and efficacy of changing from either cyclosporine or tacrolimus
    to Rapamune in maintenance kidney transplant patients have not been
    established.

Please see full Prescribing Information for Rapamune, including Boxed Warning
and Medication Guide here.

Contact:

Pfizer Inc.
Media Relations
Steve Danehy, 212-733-1538
Cell:978-273-3946
or
Investor Relations
Suzanne Harnett, 212-733-8009
 
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