`Trastuzumab Emtansine), the First Antibody-Drug
`Conjugate for Treating Her2-Positive Metastatic
`Breast Cancer
`
`New Personalized Medicine Helped People in Phase III
`Study Live Longer, Compared to Standard Treatment
`
`South San Francisco, Calif. February 22, 2013 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 Kadcyla (adotrastuzumab emtansine
`or TDM1) for the treatment of people with HER2positive metastatic breast cancer
`(mBC) who have received prior treatment with Herceptin (trastuzumab) and a
`®
`taxane chemotherapy. Kadcyla is the fourth medicine from Genentech to receive
`FDA approval for people with advanced cancers within the past two years.
`
`An antibodydrug conjugate (ADC) is a new kind of targeted cancer medicine that
`can attach to certain types of cancer cells and deliver chemotherapy directly to
`them. Kadcyla is the first FDAapproved ADC for treating HER2positive mBC, an
`aggressive form of the disease.
`
`"Kadcyla is an antibodydrug conjugate representing a completely new way to
`treat HER2positive metastatic breast cancer, and it helped people in the EMILIA
`study live nearly six months longer," said Hal Barron, M.D., chief medical officer
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`and head, Global Product Development. "We currently have more than 25
`antibodydrug conjugates in our pipeline and hope this promising approach will
`help us deliver more medicines to fight other cancers in the future."
`
`Kadcyla is made up of the antibody, trastuzumab, and the chemotherapy, DM1,
`joined together using a stable linker. Kadcyla combines the mechanisms of action
`of both trastuzumab and DM1, and it is the first Genentech ADC approved by the
`FDA. Genentech has studied ADC science for more than a decade and has eight
`ADCs in Phase I or Phase II studies for different types of cancer.
`
`Kadcyla will be available to people in the United States within two weeks. As part
`of this approval, Genentech plans to initiate patient assistance programs for
`people taking Kadcyla through Genentech Access Solutions. These programs help
`people who might not be able to afford this medicine. People who do not have
`health insurance, or who have reached the lifetime limit set by their insurance
`company, might qualify to receive Kadcyla free of charge. For people with
`insurance, Genentech Access Solutions offers copay assistance programs to help
`with the outofpocket costs of their medicine, including a copay card for those
`with private insurance. The card pays 80 percent of outofpocket costs for people
`who qualify (up to $9,000 or $24,000 per year, depending on the person's income).
`
`Doctors can contact Genentech Access Solutions at (888) 2494918. More
`information is also available at http://www.GenentechAccess.com.
`
`Roche has also submitted a Marketing Authorization Application to other
`regulatory authorities around the world, including the European Medicines Agency
`(EMA), for Kadcyla for the treatment of people with HER2positive mBC. This
`application is currently under review by the EMA.
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`Kadcyla Efficacy in HER2positive mBC
`The FDA approval of Kadcyla is based on results from EMILIA
`(TDM4370g/BO21977), an international, Phase III, randomized, openlabel study
`comparing Kadcyla alone to lapatinib in combination with Xeloda (capecitabine)
`®
`in 991 people with HER2positive locally advanced breast cancer or mBC who had
`previously been treated with Herceptin and a taxane chemotherapy. Results
`include:
`
`The study met both coprimary efficacy endpoints of overall survival and
`progressionfree survival (PFS; as assessed by an independent review
`committee).
`
`People who received Kadcyla lived a median of 5.8 months longer (overall
`survival) than those who received the combination of lapatinib and Xeloda,
`the standard of care in this setting (median overall survival: 30.9 months vs.
`25.1 months).
`
`People receiving Kadcyla experienced a 32 percent reduction in the risk of
`dying compared to people who received lapatinib and Xeloda (HR=0.68;
`p=0.0006).
`
`People who received Kadcyla lived significantly longer without their disease
`getting worse (PFS) compared to those who received lapatinib plus Xeloda
`(HR=0.65, 35 percent reduction in risk of disease worsening or death, p No
`new safety signals were observed and adverse events (AEs) were consistent
`with those seen in previous studies, with fewer people who received Kadcyla
`experiencing Grade 3 or higher (severe) AEs than those who received lapatinib
`plus Xeloda (43.1 percent vs. 59.2 percent).
`
`For people receiving Kadcyla, the most common (occurring in more than 2
`percent of participants) Grade 3 or higher AEs were low platelet count (14.5
`percent), increased levels of enzymes released by the liver and other organs
`(8.0 percent), low red blood cell count (4.1 percent), low levels of potassium
`in the blood (2.7 percent), nerve problems (2.2 percent) and tiredness (2.5
`percent).
`
`About Kadcyla (pronounced kad SIGH luh); adotrastuzumab emtansine
`(pronounced ADD oh traz TOO zuh mab em TAN zine)
`Kadcyla is an ADC being studied in HER2positive cancers. It is the first ADC to
`result from Genentech¿s 30 years of HER2 pathway research and the third
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`medicine Genentech has developed for the treatment of HER2positive breast
`cancer.
`
`Like Herceptin, Kadcyla binds to HER2positive cells and is thought to block out
`ofcontrol signals that make the cancer grow while also calling on the body's
`immune system to attack the cancer cells. Once Kadcyla is taken up by those
`cells, it is designed to destroy them by releasing the DM1 inside the cells.
`
`Genentech licenses technology for Kadcyla under an agreement with ImmunoGen,
`Inc.
`
`Kadcyla Indication Statement
`Kadcyla (adotrastuzumab emtansine) is approved as a single medicine for the
`treatment of people with HER2positive metastatic breast cancer (mBC) who have
`received prior treatment with Herceptin (trastuzumab) and a taxane
`®
`chemotherapy. People should either:
`
`Have already been treated for their metastatic cancer, or
`
`Have had their earlystage cancer come back during or within six months after
`they completed a course of treatment following surgery.
`
`Important Safety Information
`Kadcyla is not the same medicine as Herceptin.
`There are possible serious side effects of Kadcyla. Patients must contact their
`doctor right away if they experience any of these symptoms. The patient's doctor
`may do tests before starting Kadcyla and before each dose to monitor for these
`side effects. Kadcyla treatment may be stopped or the dose may be lowered if the
`patient experiences any of these side effects.
`
`Liver Problems
`
`Kadcyla may cause severe liver problems that can be lifethreatening.
`Symptoms of liver problems may include vomiting, nausea, stomach pain,
`dark urine or itching.
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`Heart Problems
`Kadcyla may cause heart problems, including those without symptoms (such
`as reduced heart function) and those with symptoms (such as congestive
`heart failure). Symptoms may include swelling of the ankles or legs,
`shortness of breath, cough or rapid weight gain of greater than five pounds in
`less than 24 hours.
`
`Pregnancy
`Receiving Kadcyla during pregnancy can result in the death of an unborn baby
`and birth defects. Birth control should be used while patients receive Kadcyla
`and for six months after their last dose of Kadcyla.
`
`If patients are exposed to Kadcyla during pregnancy, they must contact their
`healthcare provider right away; they are also encouraged to enroll in the
`MotHER Pregnancy Registry by contacting (800) 6906720.
`
`If patients are mothers who are breastfeeding, they should talk with their
`doctor about either stopping breastfeeding or stopping treatment with
`Kadcyla.
`
`Additional Possible Serious Side Effects of Kadcyla
`Lung Problems
`Kadcyla may cause lung problems, including inflammation of the lung tissue,
`which can be lifethreatening. Signs of lung problems may include trouble
`breathing, cough, tiredness and fluid in the lungs.
`
`InfusionRelated Reactions
`Symptoms of an infusionrelated reaction may include one or more of the
`following: the skin getting hot or red (flushing), chills, fever, trouble
`breathing, low blood pressure, wheezing, tightening of the muscles in the
`chest around the airways or a fast heartbeat. The patient's doctor will
`monitor the patient for infusionrelated reactions.
`
`Low Platelet Count
`Low platelet count may happen during treatment with Kadcyla. Platelets are
`cells in the blood that help the blood clot.
`
`Nerve Damage
`Symptoms may include numbness and tingling, burning or sharp pain,
`sensitivity to touch, lack of coordination, or muscle weakness or loss of
`muscle function.
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`Skin Reactions Around the Infusion Site
`Kadcyla may leak from the vein or needle and cause reactions such as
`redness, tenderness, skin irritation, or pain or swelling at the infusion site. If
`this happens, it is more likely to happen within 24 hours of the infusion.
`
`HER2 Testing and Kadcyla
`Patients must have a HER2 test to determine if their cancer is HER2positive
`before taking Kadcyla, as benefit has only been shown in patients whose tumors
`are HER2positive.
`
`Most Common Side Effects of Kadcyla
`In clinical studies, the most common side effects seen in people taking Kadcyla
`were tiredness, nausea, pain that affects the bones, muscles, ligaments and
`tendons, low platelet count, headache, liver problems and constipation.
`
`The most common severe side effects of Kadcyla were low platelet count, liver
`problems, low levels of red blood cells, nerve problems, low levels of potassium in
`the blood and tiredness.
`
`Report side effects to the FDA at (800) FDA1088 or
`http://www.fda.gov/medwatch. Patients and caregivers may also report side
`effects to Genentech at (888) 8352555.
`
`For full Prescribing Information and Boxed WARNINGS on Kadcyla, please visit
`http://www.gene.com.
`
`About Breast Cancer
`Breast cancer is the most common cancer among women worldwide. According to
`the American Cancer Society, approximately 235,000 people in the United States
`will be diagnosed with breast cancer, and 40,000 will die from the disease in 2013.
`In HER2positive breast cancer, increased quantities of the Human Epidermal
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`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. HER2positive cancer is a particularly aggressive form of breast
`cancer.
`
`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 outofpocket copay costs. For more
`information, please visit http://www.GenentechAccess.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 lifethreatening 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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