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`Bum:/11125-5Wnei
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`A Berkshire Hathaway Company
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`{3enen_tech
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`Genentech Provides Update on Phase III Study of Avastin in Men With
`Late Stage Prostate Cancer
`
`March 12, 2010 01:02 AM Eastern Standard Time
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`SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, |nc., a wholly owned member of the Roche Group
`(SIX: R0, ROG; OTCQX: RHHBY), announced today the topline results ofa Phase III trial led by the U.S. Cancer and
`
`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
`(hormone-refractory / HRPC). The study, known as CALGB 90401, did not meet its primary objective of extending overall
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`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 ofClinical Oncology (ASCO) annual meeting, June 4 to 8,
`2010.
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`“Patients with hormone-refractory prostate cancer are in urgent need ofnew treatment options. It is unfortunate thatthe
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`study did not meet its primary objective, however, we look forward 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 other tumor types.
`
`About Prostate Cancer
`
`Among American men, prostate cancer is the most common form of cancer and the second leading cause of cancer
`death. According to the American Cancer Society, in 2009 an estimated 192,000 men were diagnosed with prostate
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`cancer and approximately 27,000 died from the disease in the United States.
`
`About CALGB 90401
`
`CALGB 90401 is a multicenter, randomized, double-blinded, placebo-controlled Phase III study designed to evaluate
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`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
`
`and DevelopmentAgreement 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 ofthe study include progression-free survival,
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`prostate-specific antigen response rate and safety.
`
`JANSSEN EXHIBIT 2081
`Mylan v. Janssen IPR2016-01332
`
`

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`Detailed safety assessments are ongoing. A preliminary assessment of safety performed by CALGB has identified
`severe adverse events that have been previously observed in pivotal trials with Avastin, including neutropenia and fatal
`infections.
`
`About Avastin
`
`Avastin is a solution for intravenous infusion and is a biologic antibody designed to specifically bind to a protein called
`vascular endothelial growth factor (VEGF). VEGF plays an important role throughoutthe lifecycle of the tumor to develop
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`and maintain blood vessels, a process known as angiogenesis. Avastin interferes with the tumor blood supply by directly
`
`binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. Avastin does not bind to
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`receptors on normal or cancer cells. The tumor blood supply is thoughtto be critical to a tumor's ability to grow and
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`spread in the body (metastasize). For more information about angiogenesis, visit httgzl/www.gene.com.
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`Boxed WARN IN GS and Additional Important Safety Information
`
`People treated with Avastin may experience side effects. In clinical trials, some people treated with Avastin experienced
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`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 developmentofa hole in the stomach, small intestine or large intestine. In
`clinical trials, this side effectoccurred 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 least28 days after surgery and until the surgical wound is fully
`healed. The length of time between stopping Avastin and having voluntary surgery withoutthe risk of having 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 ofblood, bleeding in the brain, nosebleeds and vaginal bleeding. These events occurred up to five
`
`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 (greater than or
`equal to a halfteaspoon of red blood) or have serious bleeding should not receive Avastin.
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`In clinical trials for different cancertypes, 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
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`parts of the body to another part (non-GI fistula formation) was seen in 0.3 percentor 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 percent of peop|e.Additiona| serious side effects that occurred in more people
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`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 percent to 18 percent of people, and nervous system and vision disturbances (reversible posterior
`leukoencephalopathy syndrome), which was seen in less than 0.1 percent of people. Infusion reactions with the first
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`dose ofAvastin were uncommon and occurred in less than 3 percent of people and severe reactions occurred in 0.2
`
`percent of people.
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`Common side effects that occurred in more than 10 percent of people who received Avastin for different cancer types,
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`and at leastt\Nice the rate of the comparison group, were nosebleeds, headache, high blood pressure, inflammation of
`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
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`percent to 21 percent of people because of side effects.
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`Avastin may impair fertility. Patients who are pregnant or thinking of becoming pregnant should talk with their doctor
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`aboutthe potential risk of loss of the pregnancy or the potential risk ofAvastin to the fetus during and following Avastin
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`therapy, and the need to continue an effective birth control method for at least six months following the last dose of
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`

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`Ava sti n .
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`Forfull Prescribing Information and Boxed WARNINGS on Avastin please visit httpz//www.avastin.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
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`company, a wholly owned member ofthe Roche Group, has headquarters in South San Francisco, California. For
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`additional information aboutthe company, please visit httg://www.gene.com.
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`Contacts
`
`Genentech, Inc.
`
`Media Contact:
`
`Charlotte Arnold, 650-467-6800
`
`Advocacy Contact:
`
`Kristin Reed, 650-467-9831
`
`Investor Contacts:
`
`Kathee Littrell, 650-225-1034
`
`Karl Mahler, 011 41 61 687 85 03
`
`