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`Genentech Provides Update on Phase III Study of Avastin in Men With Late Stage Prostate Cancer | Business Wire
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`(4%
`Basswhet
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`A Berkshire Hathaway Company
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`Genentech
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`Genentech Provides Update on Phase III Study of Avastin in Men With
`Late Stage Prostate Cancer
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`March 12, 2010 01:02 AM Eastern Standard Time
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`SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, Inc., a wholly owned member ofthe Roche Group
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`(SIX: R0, ROG; OTCQX: RHHBY), announced today the topline results ofa Phase III trial led by the U.S. Cancer and
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`Leukemia Group B (CALGB) and sponsored by the National Cancer Institute (NCI) investigating the use ofAvastin®
`(bevacizumab) in combination with docetaxel chemotherapy and prednisone in men with late stage prostate cancer
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`(hormone-refractory / HRPC). The study, known as CALGB 90401, did not meet its primary objective of extending overall
`survival compared to chemotherapy and prednisone alone. A preliminary assessment of safety performed by CALGB
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`has shown adverse events that have been previously observed in pivotal trials with Avastin. Data from the study will be
`submitted by CALGB for presentation at the American Society of Clinical Oncology (ASCO) annual meeting, June 4 to 8,
`2010.
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`"Patients with hormone-refractory prostate cancer are in urgent need of new treatment options. It is unfortunate that the
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`study did not meet its primary objective, however, we look fonivard to sharing the data with the medical community,
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`including the secondary endpoints," said Hal Barron, M.D., head, Global Developmentand chief medical officer at
`Roche.
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`These findings do not impact Avastin's approved uses or its broad development program in othertumor types.
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`About Prostate Cancer
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`Among American men, prostate cancer is the most common form of cancer and the second leading cause of cancer
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`death. According to the American Cancer Society, in 2009 an estimated 192,000 men were diagnosed with prostate
`cancer and approximately 27,000 died from the disease in the United States.
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`About CALGB 90401
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`CALGB 90401 is a multicenter, randomized, double-blinded, placebo-controlled Phase III study designed to evaluate
`Avastin plus docetaxel chemotherapy and prednisone, compared to docetaxel chemotherapy and prednisone alone in
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`1,050 men with hormone-refractory prostate cancer. The trial is sponsored by the NCI under a Cooperative Research
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`http://www.businesswire.com/news/home/20100311007023IenlGenentech-Update-Phase-|l|-Study-Avastin-Men
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`AVENTIS EXHIBIT 2114
`Mylan v. Aventis, |PR2016-00712
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`AVENTIS EXHIBIT 2114
`Mylan v. Aventis, IPR2016-00712
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`
`
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`10/12/2016
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`Genentech Provides Update on Phase III Study of Avastin in Men With Late Stage Prostate Cancer | Business Wire
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`and Deve|opmentAgreement between the NCI and Genentech, and conducted by a network of researchers led by the
`CALGB.
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`The primary endpoint of the study is overall survival. Secondary endpoints of the study include progression-free survival,
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`prostate-specific antigen response rate and safety.
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`Detailed safety assessments are ongoing. A preliminary assessment of safety performed by CALGB has identified
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`severe adverse events that have been previously observed in pivotal trials with Avastin, including neutropenia and fatal
`infections.
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`About Avastin
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`Avastin is a solution for intravenous infusion and is a biologic antibody designed to specifically bind to a protein called
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`vascular endothelial growth factor (VEGF). VEGF plays an important role throughout the lifecycle of the tumor to develop
`and maintain blood vessels, a process known as angiogenesis. Avastin interferes with the tumor blood supply by directly
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`binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. Avastin does not bind to
`receptors on normal or cancer cells. The tumor blood supply is thought to be critical to a tumor's ability to grow and
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`spread in the body (metastasize). For more information aboutangiogenesis, visit http://www.gene.com.
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`Boxed WARNINGS and Additional Important Safety Information
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`People treated with Avastin may experience side effects. In clinical trials, some people treated with Avastin experienced
`serious and sometimes fatal side effects, including:
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`Gastrointestinal (GI) perforation: Treatmentwith Avastin can result in the development ofa potentially serious side
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`effect called GI perforation, which is the development ofa hole in the stomach, small intestine or large intestine. In
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`clinical trials, this side effect occurred in more people who received Avastin than in the comparison group (0.3 percentto
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`2.4 percent). In some cases, GI perforation resulted in fatality.
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`Surgery and wound healing problems: Treatmentwith Avastin can lead to slow or incomplete wound healing (for
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`example, when a surgical incision has trouble healing or staying closed). In some cases, this event resulted in fatality.
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`Surgery and wound healing problems occurred more often in people who received Avastin than in the comparison
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`group. Avastin therapy should not be started for at least 28 days after surgery and until the surgical wound is fully
`healed. The length oftime between stopping Avastin and having voluntary surgery withoutthe risk ofhaving surgery and
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`wound healing problems following surgery has not been determined.
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`Severe bleeding: Treatmentwith Avastin can result in serious bleeding, including coughing up blood, bleeding in the
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`stomach, vomiting of blood, bleeding in the brain, nosebleeds and vaginal bleeding. These events occurred up to five
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`times more often in people who received Avastin. Across cancer types, 1.2 percent to 4.6 percent of people who
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`received Avastin experienced severe to fatal bleeding. People who have recently coughed up blood (greaterthan or
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`equal to a halfteaspoon of red blood) or have serious bleeding should not receive Avastin.
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`In clinical trials for different cancer types, there were additional serious and sometimes fatal side effects that occurred in
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`more people who received Avastin than in those in the comparison group. The formation ofan abnormal passage from
`parts of the body to another part (non-GI fistula formation) was seen in 0.3 percent or less of people. Severe to life-
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`threatening stroke or heart problems were seen in 2.4 percent of people. Too much protein in the urine, which led to
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`kidney problems, was seen in less than 1 percentof people. Additional serious side effects that occurred in more people
`who received Avastin than those in the comparison group included severe to life-threatening high blood pressure, which
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`was seen in 5 percentto 18 percentof people, and nervous system and vision disturbances (reversible posterior
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`Genentech Provides Update on Phase III Study of Avastin in Men With Late Stage Prostate Cancer | Business Wire
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`Ieukoencephalopathy syndrome), which was seen in less than 0.1 percent of people. Infusion reactions with the first
`dose ofAvastin were uncommon and occurred in less than 3 percent of people and severe reactions occurred in 0.2
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`percent of people.
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`Common side effects that occurred in more than 10 percentof people who received Avastin for different cancer types,
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`and at least twice the rate ofthe comparison group, were nosebleeds, headache, high blood pressure, inflammation of
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`the nose, too much protein in the urine, taste change, dry skin, rectal bleeding, tear production disorder, back pain and
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`inflammation of the skin (exfoliative dermatitis). Across all trials, treatmentwith Avastin was permanently stopped in 8.4
`percent to 21 percent of people because of side effects.
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`Avastin may impairfertility. Patients who are pregnantorthinking of becoming pregnant should talk with their doctor
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`about the potential risk of loss ofthe pregnancy or the potential risk of Avastin to the fetus during and following Avastin
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`therapy, and the need to continue an efiective birth control method for at least six months following the last dose of
`Avastin.
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`For full Prescribing Information and Boxed WARNINGS on Avastin please visit http://www.avastin.com.
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`About Genentech
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`Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops,
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`manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The
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`company, a wholly owned member of the Roche Group, has headquarters in South San Francisco, California. For
`additional information about the company, please visit httg:I/www.gene.com.
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`Contacts
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`Genentech, Inc.
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`Media Contact:
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`Charlotte Arnold, 650-467-6800
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`Advocacy Contact:
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`Kristin Reed, 650-467-9831
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`Investor Contacts:
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`Kathee Littrell, 650-225-1034
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`Karl Mahler, 011 41 61 687 85 03
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`http://www.businesswire.com/nevvs/home/20100311007023IenlGenentech-Update-Phase-Ill-Study-Avastin-Men