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Wyeth Breast Cancer 03 16
`
`3/16/06 AP Alert - Med. 22:07:58
`
`AP Alert - Medical
`Copyright © 2006 The Associated Press
`
`March 16, 2006
`
`Wyeth Breast Cancer 03 16
`
`bc-Wyeth-Breast-Cancer 03-16
`
`1/8STK 3/8 WYE
`
`1/8IN 3/8 BIO HEA MTC
`
`1/8SU 3/8 WOM TRI
`
`TO BUSINESS, HEALTH AND MEDICAL EDITORS:
`
`Wyeth Pharmaceuticals Announces Termination of Phase 3 Clinical Program with
`
`Oral Temsirolimus in Women with Metastatic Breast Cancer
`
`Ongoing Phase 3 Studies With I.V. Temsirolimus in Renal Cell Carcinoma and
`
`Mantle Cell Lymphoma Continue
`
`MADISON, N.J., March 16 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a
`
`division of Wyeth (NYSE: WYE), announced today its decision to discontinue the
`
`HORIZON phase 3 clinical trial program of Wyeth's investigational drug
`
`temsirolimus oral tablets in combination with letrozole (Femara(R)), a
`
`currently approved breast cancer therapy, for first-line use in postmenopausal
`
`women with hormone-receptor positive metastatic breast cancer. This decision
`
`was based upon the recommendation of an Independent Data Monitoring Committee
`
`(IDMC) after review of data from a planned interim analysis.
`
`The HORIZON study compared the combination of temsirolimus oral tablets
`
` © 2016 Thomson Reuters. No claim to original U.S. Government Works.
`
`1
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`NOVARTIS EXHIBIT 2009
`Roxane v. Novartis, 2016-01461
`Page 1 of 5
`
`

`
`Wyeth Breast Cancer 03 16
`
`and letrozole versus letrozole alone. The IDMC advised that continuation of
`
`the trial was unlikely to achieve the targeted level of efficacy for the
`
`combination therapy compared to letrozole alone. The IDMC concluded,
`
`therefore, that the risk/benefit ratio for treatment of metastatic breast
`
`cancer did not favor continuation and recommended that the trial be
`
`discontinued.
`
`"While not the anticipated outcome, it is unfortunately not unusual for
`
`cancer drugs to work in some tumor types and not others, or even work in only
`
`some specific subpopulations of cancer patients," says Gary L. Stiles, M.D.,
`
`FACC, Executive Vice President and Chief Medical Officer, Wyeth
`
`Pharmaceuticals. "We remain committed to studying temsirolimus in other cancer
`
`indications."
`
`While the phase 3 trial for women with hormone-receptor positive
`
`metastatic breast cancer involved an oral formulation of temsirolimus, two
`
`other phase 3 clinical trials studying temsirolimus in renal cell carcinoma
`
`and mantle cell lymphoma using an intravenous formulation are continuing.
`
`After a recent review of the data, the IDMC for the renal cancer study
`
`indicated that study continue as planned.
`
`About the IDMC and the Interim Analysis
`
`The IDMC consists of independent experts in medical oncology, statistics
`
`and medical ethics, who are not participating in the clinical trials, whose
`
`primary responsibility is to monitor, on a periodic basis, the data emerging
`
`from a clinical trial and to provide recommendations to the sponsor on whether
`
`a study should be modified or discontinued.
`
` © 2016 Thomson Reuters. No claim to original U.S. Government Works.
`
`2
`
`NOVARTIS EXHIBIT 2009
`Roxane v. Novartis, 2016-01461
`Page 2 of 5
`
`

`
`Wyeth Breast Cancer 03 16
`
`About Temsirolimus
`
`Temsirolimus is a targeted investigational drug that specifically inhibits
`
`mTOR (mammalian target of rapamycin) kinase, a protein critical for tumor
`
`growth and cell survival. Enrollment continues as planned with other ongoing
`
`clinical trials with temsirolimus in the oncology setting. In addition to
`
`Wyeth's ongoing renal cell carcinoma and mantle cell lymphoma phase 3 trials,
`
`independent investigators are evaluating temsirolimus in clinical trials in
`
`prostate cancer, and head and neck cancer. These and other early oncology
`
`trials with temsirolimus are being conducted through a cooperative research
`
`and development agreement with the National Cancer Institute. Anti-tumor
`
`activity with this agent has been previously reported in phase 1 and phase 2
`
`studies.
`
`Wyeth Pharmaceuticals
`
`Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the
`
`areas of women's health care, cardiovascular disease, central nervous system,
`
`inflammation, transplantation, hemophilia, oncology, vaccines and nutritional
`
`products. Wyeth is one of the world's largest research-driven pharmaceutical
`
`and health care products companies. It is a leader in the discovery,
`
`development, manufacturing, and marketing of pharmaceuticals, vaccines,
`
`biotechnology products and non-prescription medicines that improve the quality
`
`of life for people worldwide. The Company's major divisions include Wyeth
`
`Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
`
`The statements in this press release that are not historical facts are
`
`forward-looking statements based on current expectations of future events that
`
`involve risks and uncertainties including, without limitation, risks
`
` © 2016 Thomson Reuters. No claim to original U.S. Government Works.
`
`3
`
`NOVARTIS EXHIBIT 2009
`Roxane v. Novartis, 2016-01461
`Page 3 of 5
`
`

`
`Wyeth Breast Cancer 03 16
`
`associated with the inherent uncertainty of the timing and success of
`
`pharmaceutical research, product development, manufacturing,
`
`commercialization, economic conditions including interest and currency
`
`exchange rate fluctuations, changes in generally accepted accounting
`
`principles, the impact of competitive or generic products, trade-buying
`
`patterns, wars or terrorist acts, product liability and other types of
`
`lawsuits, the impact of legislation and regulatory compliance and obtaining
`
`reimbursement, favorable drug pricing, access and other approvals,
`
`environmental liabilities, and patent, and other risks and uncertainties,
`
`including those detailed from time to time in the Company's periodic reports,
`
`including current reports on Form 8-K, quarterly reports on Form 10-Q and the
`
`annual report on Form 10-K, filed with the Securities and Exchange Commission.
`
`Actual results may vary materially from the forward-looking statements. The
`
`Company assumes no obligation to publicly update any forward-looking
`
`statements, whether as a result of new information, future events or
`
`otherwise.
`
`SOURCE Wyeth
`
`-0- 03/16/2006
`
`/CONTACT: Media: Gerald V. Burr, +1-484-865-5138, or Natalie de Vane,
`
`+1-484-865-5139; Investors: Justin Victoria, +1-973-660-5340, all of Wyeth/
`
`/Web site: http://www.wyeth.com /
`
`(WYE)
`
`CO: Wyeth
`
`ST: New Jersey
`
` © 2016 Thomson Reuters. No claim to original U.S. Government Works.
`
`4
`
`NOVARTIS EXHIBIT 2009
`Roxane v. Novartis, 2016-01461
`Page 4 of 5
`
`

`
`Wyeth Breast Cancer 03 16
`
`IN: BIO HEA MTC
`
`SU: WOM TRI
`
`LD
`
`-- NYTH103A --
`
`5036 03/16/2006 17:05 EST http://www.prnewswire.com
`
`---- Index References ----
`
`Company: WYETH PHARMACEUTICALS; WYETH; HORIZON; NATIONAL CANCER INSTITUTE
`
`News Subject: (Joint Ventures (1JO05); Health & Family (1HE30); Economics & Trade (1EC26); Major Corporations
`(1MA93); Economic Indicators (1EC19); Corporate Groups & Ownership (1XO09))
`
`Industry: (Pharmaceuticals Regulatory (1PH03); Pharmaceuticals & Biotechnology (1PH13); Manufacturing (1MA74);
`Urology (1UR82); Biopharmaceuticals (1BI13); Healthcare Regulatory (1HE04); Healthcare (1HE06); Nephrology
`(1NE51); Internal Medicine (1IN54); Healthcare Practice Specialties (1HE49); Pharmaceuticals Research &
`Development (1PH57); Cancer Drugs (1CA21); Oncology & Hematology (1ON95))
`
`Region: (Americas (1AM92); North America (1NO39); USA (1US73))
`
`Language: EN
`
`Other Indexing: (BREAST CANCER; CONTACT: MEDIA; FACC; HORIZON; IDMC; INDEPENDENT DATA
`MONITORING COMMITTEE; INTERIM ANALYSIS; LD; MANTLE CELL LYMPHOMA CONTINUE;
`METASTATIC BREAST CANCER; NATALIE DE VANE; NATIONAL CANCER INSTITUTE; NYSE:
`WYE; ONGOING PHASE 3; SECURITIES AND EXCHANGE COMMISSION; TEMSIROLIMUS; WYE;
`WYETH; WYETH BREAST CANCER; WYETH CONSUMER; WYETH PHARMACEUTICALS; WYETH
`PHARMACEUTICALS ANNOUNCES TERMINATION) (Cell Carcinoma; CO; Enrollment; Gary L. Stiles; Gerald
`V. Burr)
`
`Keywords: (f); (Medical); (Business)
`
`Word Count: 1130
`
`End of Document
`
`© 2016 Thomson Reuters. No claim to original U.S. Government Works.
`
` © 2016 Thomson Reuters. No claim to original U.S. Government Works.
`
`5
`
`NOVARTIS EXHIBIT 2009
`Roxane v. Novartis, 2016-01461
`Page 5 of 5

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