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`FDA Approves Perjeta (Pertuzumab) for People
`With HER2-Positive Metastatic Breast Cancer
`
`New Personalized Medicine Gave People With
`Aggressive Form of Breast Cancer More Time Without
`Their Disease Worsening
`South San Francisco, Calif. -- June 8, 2012 -- Genentech, a member of the
`Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S.
`Food and Drug Administration (FDA) has approved Perjeta
`(pertuzumab). Perjeta
`TM
`is approved in combination with Herceptin (trastuzumab) and docetaxel
`®
`chemotherapy for the treatment of people with HER2-positive metastatic breast
`cancer (mBC) who have not received prior anti-HER2 therapy or chemotherapy for
`metastatic disease. This approval is based on data from a Phase III study which
`showed that people with previously untreated HER2-positive mBC who received the
`combination of Perjeta, Herceptin and docetaxel chemotherapy lived a median of
`6.1 months longer without their cancer getting worse (progression-free survival, or
`PFS) compared to Herceptin plus docetaxel chemotherapy (median PFS 18.5 vs.
`12.4 months).
`
`The combination of Perjeta, Herceptin and chemotherapy is the only regimen to
`have shown a significant improvement in PFS compared to Herceptin plus
`chemotherapy in people with previously untreated HER2-positive mBC.
`
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`Phigenix v. Immunogen
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`Perjeta is a personalized medicine that targets the HER2 receptor, a protein found
`in high quantities on the outside of cells in HER2-positive cancers. Perjeta is
`believed to work in a way that is complementary to Herceptin, as the two
`medicines target different regions on the HER2 receptor.
`
`"Today's approval of Perjeta is an important advance in the treatment of HER2-
`positive metastatic breast cancer," said Hal Barron, M.D., chief medical officer and
`head, Global Product Development. "Perjeta attacks HER2-positive tumors
`differently than Herceptin. Based on the way the two medicines work together, the
`combination plus chemotherapy can prolong the time before this aggressive cancer
`worsens compared to Herceptin and chemotherapy alone. We are very pleased to
`see our efforts in studying the science of HER2 translate into another personalized
`medicine."
`
`With the approval, Genentech has agreed to post-marketing commitments related
`to the manufacturing process for Perjeta. These include FDA review of data from
`the next several productions of the medicine.
`
`"We expect to meet demand for Perjeta following today's FDA approval. We
`recently identified a cell growth issue that might affect our future supply of the
`medicine," said Patrick Y. Yang, Ph.D., head, Pharma Global Technical
`Operations. "We take this very seriously and are working with the FDA to ensure a
`consistent manufacturing process that maintains drug supply for the people who
`need it."
`
`Perjeta will be available to people in the United States within two weeks.
`Genentech is committed to helping people who need Perjeta. Genentech Access
`Solutions is available to provide doctors and patients coverage and reimbursement
`support, patient assistance and information resources. Doctors can contact
`Genentech Access Solutions at http://www.GenentechAccessSolutions.com or
`1-888-249-4918.
`
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`Roche has also submitted a Marketing Authorization Application to the European
`Medicines Agency (EMA) for Perjeta in combination with Herceptin and docetaxel
`chemotherapy for the treatment of previously untreated HER2-positive mBC or
`locally recurrent, unresectable (inoperable) breast cancer, in people who have not
`received previous treatment or whose disease has returned after treatment in the
`early-stage setting. This application is currently under review by the EMA.
`
`Perjeta Efficacy in HER2-positive mBC
`The FDA approval of Perjeta is based on results from CLEOPATRA (CLinical
`Evaluation Of Pertuzumab And TRAstuzumab), an international, Phase III,
`randomized, double-blind, placebo-controlled study. The study evaluated the
`efficacy and safety profile of Perjeta combined with Herceptin and docetaxel
`chemotherapy compared to Herceptin and chemotherapy plus placebo in 808
`people with previously untreated HER2-positive mBC or that had recurred after
`prior therapy in the adjuvant or neoadjuvant setting. The study showed people who
`received Perjeta in combination with Herceptin and chemotherapy experienced a 38
`percent reduction in the risk of their disease worsening or death compared to
`people who received Herceptin and chemotherapy plus placebo (HR=0.62; p-value
`less than 0.0001, according to independent review). The study demonstrated a 6.1
`month improvement in median PFS for people who received Perjeta compared to
`those who received Herceptin and chemotherapy plus placebo (median PFS 18.5
`vs. 12.4 months).
`
`In CLEOPATRA, the most common adverse reactions (rate greater than 30 percent)
`seen with Perjeta in combination with Herceptin and docetaxel were diarrhea, hair
`loss, low white blood cell count, nausea, fatigue, rash and peripheral neuropathy
`(numbness, tingling or burning sensation in the arms or legs). The most common
`Grade 3-4 adverse reactions (rate greater than 2 percent) were low white blood
`cell count, low white blood cell count with fever, decrease in a certain type of white
`blood cell, diarrhea, peripheral neuropathy, decrease in red blood cell count,
`weakness and fatigue.
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`About Perjeta (pronounced per JET uh); pertuzumab (pronounced per TOO zuh
`mab)
`Perjeta is designed specifically to prevent the HER2 receptor from pairing (or
`"dimerizing") with other HER receptors (EGFR/HER1, HER3 and HER4) on the
`surface of cells, a process that is believed to play a role in tumor growth and
`survival. Binding of Perjeta to HER2 may also signal the body's immune system to
`destroy the cancer cells. The mechanisms of action of Perjeta and Herceptin are
`believed to complement each other, as both bind to the HER2 receptor, but to
`different regions. The combination of Perjeta, Herceptin and chemotherapy is
`thought to provide a more comprehensive blockade of HER signaling pathways.
`
`Perjeta Indication Statement
`Perjeta
`(pertuzumab) is approved for use along with trastuzumab and docetaxel
`TM
`(chemotherapy) in people with HER2-positive breast cancer that has spread to
`different parts of the body (metastatic) and who have not received anti-HER2
`therapy or chemotherapy for metastatic breast cancer.
`
`Important Safety Information
`
`• Perjeta has been shown to work only in people with HER2-positive breast
`cancer. Patients must have a HER2 test to know if their breast cancer is HER2-
`positive before receiving an anti-HER2 treatment, such as Perjeta
`
`• Because side effects from this treatment are common, it is important to know
`what side effects may happen and what symptoms patients should watch for
`
`• A patient's doctor may stop treatment if serious side effects happen. Patients
`must contact their healthcare team right away if they have questions or are
`worried about any side effects
`
`Serious Side Effect of Perjeta
`Most Serious Side Effect: Receiving Perjeta during pregnancy can result in
`the death of an unborn baby and birth defects.
`
`• Birth control should be used while receiving Perjeta and for six months after a
`patient's last dose of Perjeta. Patients who are breastfeeding should talk with
`their doctor about either stopping breastfeeding or stopping Perjeta
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`• If a patient is exposed to Perjeta during pregnancy, they are encouraged to
`enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720
`
`Other Possible Side Effects
`
`• Heart problems:
`
`Perjeta can result in heart problems, including those without symptoms (such as
`reduced heart function) and those with symptoms (such as congestive heart
`failure). A patient's doctor may run tests to monitor the patient's heart function
`before and during treatment with Perjeta
`Infusion-related reactions: Perjeta is a medicine that is delivered into a vein
`through a needle. This process can cause reactions known as infusion-related
`reactions. The most common infusion-related reactions when receiving Perjeta,
`trastuzumab, and docetaxel were fatigue, loss of taste, allergic reactions, muscle
`pain and vomiting
`
`Severe allergic reactions: Some people receiving Perjeta may have severe
`allergic reactions, called hypersensitivity reactions or anaphylaxis. This reaction
`may be severe, may happen quickly, and may affect many areas of the body
`Most Common Side Effects
`The most common side effects of Perjeta when given with trastuzumab and
`docetaxel are diarrhea, hair loss, low levels of white blood cells with or without a
`fever, upset stomach, fatigue, rash and damage to the nerves (numbness, tingling,
`pain in hands/feet).
`
`Patients are encouraged to report negative side effects of prescription drugs to the
`FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.
`
`Please see Perjeta full Prescribing Information including Most Serious Side
`Effect for additional Important Safety Information. For more information
`about Perjeta, visit http://www.perjeta.com.
`
`About Herceptin
`Herceptin is a personalized medicine designed to specifically block the HER2 protein
`on the surface of some cancer cells. Based on preclinical studies, this biologic
`antibody is believed to work by attaching to HER2 receptors to stop signals that
`make the tumor cells grow and divide, and also by signaling the body's immune
`system to destroy the cancer cells.
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`Herceptin has two approved uses in metastatic breast cancer (mBC):
`
`• Herceptin in combination with the chemotherapy drug paclitaxel is approved
`for the first-line treatment of HER2-positive mBC.
`
`• Herceptin alone is approved for the treatment of HER2-positive mBC in
`patients who have received one or more chemotherapy regimens for
`metastatic disease.
`
`Important Safety Information
`Herceptin treatment can result in heart problems, including for those
`patients without symptoms (such as reduced heart function) and those
`patients with symptoms (such as congestive heart failure). One patient
`died in an adjuvant breast cancer trial from significantly weakened heart
`muscle. The risk and seriousness of these heart problems were highest in
`patients who received both Herceptin and a certain type of chemotherapy
`(anthracycline).
`
`Before taking the first dose of Herceptin and during treatment, a patient's doctor
`should check to see if there are any health conditions that may increase the
`patient's chance of having serious heart problems. This includes a review of the
`patient's health history and tests to see how well the heart muscle is working.
`These tests may include an echocardiogram or a multigated acquisition (MUGA)
`scan. Some early-stage breast cancer patients may also need to have a test done
`after they have finished taking Herceptin to see how well their heart muscle is
`working.
`
`Some patients have had serious infusion reactions and lung problems;
`fatal infusion reactions have been reported. These reactions usually occur
`during or within 24 hours of receiving Herceptin.
`
`The patient's doctor may need to completely stop Herceptin treatment if
`the patient has a severe allergic reaction, swelling, lung problems,
`inflammation of the lung or severe shortness of breath.
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`Herceptin can cause harm to the fetus (unborn baby), and in some cases
`death to the fetus, when taken by a pregnant woman.
`
`Women who could become pregnant need to use effective birth control methods
`during Herceptin treatment and for at least six months after treatment with
`Herceptin. Nursing mothers treated with Herceptin should discontinue nursing or
`discontinue Herceptin.
`
`Worsening of low white blood cell counts associated with chemotherapy has also
`occurred.
`
`Patients must have a HER2 test to determine if their breast cancer is HER2-positive
`before using Herceptin, as benefit has only been shown in patients who are HER2-
`positive.
`
`The most common side effects associated with Herceptin in patients with breast
`cancer are fever, nausea, vomiting, infusion reactions, diarrhea, infections,
`increased cough, headache, fatigue, shortness of breath, rash, low white and red
`blood cells and muscle pain.
`
`Because everyone is different, it is not possible to predict what side effects any one
`patient will have. Patients with questions or concerns about side effects should talk
`to their doctor.
`
`Patients should read the Herceptin full Prescribing Information including Boxed
`WARNINGS, at http://www.herceptin.com.
`
`About Breast Cancer
`Breast cancer is the most common cancer among women worldwide. According to
`the American Cancer Society, approximately 229,000 people will be diagnosed with
`breast cancer, and 40,000 will die from the disease in 2012. In HER2-positive
`
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`breast cancer, increased quantities of the Human Epidermal growth factor
`Receptor 2 (HER2) are present on the surface of the tumor cells. This is known as
`"HER2 positivity" and affects approximately 25 percent of people with breast
`cancer. HER2-positive cancer is a particularly aggressive form of breast cancer.
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`Page 8 of 8
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`About Genentech Access Solutions
`Genentech is committed to people having access to our medicines. Genentech
`Access Solutions is a team of more than 350 Genentech employees who help those
`who need our medicines. Our knowledgeable and experienced Specialists can help
`patients and medical practices navigate the access and reimbursement process and
`provide assistance to eligible patients in the United States who do not have
`insurance coverage or who cannot afford their out-of-pocket co-pay costs. For
`more information, please visit http://www.GenentechAccessSolutions.com.
`
`About Genentech
`Founded more than 30 years ago, Genentech is a leading biotechnology company
`that discovers, develops, manufactures and commercializes medicines to treat
`patients with serious or life-threatening medical conditions. The company, a
`member of the Roche Group, has headquarters in South San Francisco, California.
`For additional information about the company, please visit http://www.gene.com.
`
`# # #
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`IMMUNOGEN 2209, pg. 8
`Phigenix v. Immunogen
`IPR2014-00676
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