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`3/16/06 AP Alert - Med. 22:07:58
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`AP Alert - Medical
`Copyright © 2006 The Associated Press
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`March 16, 2006
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`Wyeth Breast Cancer 03 16
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`bc-Wyeth-Breast-Cancer 03-16
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`1/8STK 3/8 WYE
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`1/8IN 3/8 BIO HEA MTC
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`1/8SU 3/8 WOM TRI
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`TO BUSINESS, HEALTH AND MEDICAL EDITORS:
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`Wyeth Pharmaceuticals Announces Termination of Phase 3 Clinical Program with
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`Oral Temsirolimus in Women with Metastatic Breast Cancer
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`Ongoing Phase 3 Studies With I.V. Temsirolimus in Renal Cell Carcinoma and
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`Mantle Cell Lymphoma Continue
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`MADISON, N.J., March 16 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a
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`division of Wyeth (NYSE: WYE), announced today its decision to discontinue the
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`HORIZON phase 3 clinical trial program of Wyeth's investigational drug
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`temsirolimus oral tablets in combination with letrozole (Femara(R)), a
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`currently approved breast cancer therapy, for first-line use in postmenopausal
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`women with hormone-receptor positive metastatic breast cancer. This decision
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`was based upon the recommendation of an Independent Data Monitoring Committee
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`(IDMC) after review of data from a planned interim analysis.
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`The HORIZON study compared the combination of temsirolimus oral tablets
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` © 2016 Thomson Reuters. No claim to original U.S. Government Works.
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`Wyeth Breast Cancer 03 16
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`and letrozole versus letrozole alone. The IDMC advised that continuation of
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`the trial was unlikely to achieve the targeted level of efficacy for the
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`combination therapy compared to letrozole alone. The IDMC concluded,
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`therefore, that the risk/benefit ratio for treatment of metastatic breast
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`cancer did not favor continuation and recommended that the trial be
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`discontinued.
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`"While not the anticipated outcome, it is unfortunately not unusual for
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`cancer drugs to work in some tumor types and not others, or even work in only
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`some specific subpopulations of cancer patients," says Gary L. Stiles, M.D.,
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`FACC, Executive Vice President and Chief Medical Officer, Wyeth
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`Pharmaceuticals. "We remain committed to studying temsirolimus in other cancer
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`indications."
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`While the phase 3 trial for women with hormone-receptor positive
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`metastatic breast cancer involved an oral formulation of temsirolimus, two
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`other phase 3 clinical trials studying temsirolimus in renal cell carcinoma
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`and mantle cell lymphoma using an intravenous formulation are continuing.
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`After a recent review of the data, the IDMC for the renal cancer study
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`indicated that study continue as planned.
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`About the IDMC and the Interim Analysis
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`The IDMC consists of independent experts in medical oncology, statistics
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`and medical ethics, who are not participating in the clinical trials, whose
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`primary responsibility is to monitor, on a periodic basis, the data emerging
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`from a clinical trial and to provide recommendations to the sponsor on whether
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`a study should be modified or discontinued.
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` © 2016 Thomson Reuters. No claim to original U.S. Government Works.
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`Wyeth Breast Cancer 03 16
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`About Temsirolimus
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`Temsirolimus is a targeted investigational drug that specifically inhibits
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`mTOR (mammalian target of rapamycin) kinase, a protein critical for tumor
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`growth and cell survival. Enrollment continues as planned with other ongoing
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`clinical trials with temsirolimus in the oncology setting. In addition to
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`Wyeth's ongoing renal cell carcinoma and mantle cell lymphoma phase 3 trials,
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`independent investigators are evaluating temsirolimus in clinical trials in
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`prostate cancer, and head and neck cancer. These and other early oncology
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`trials with temsirolimus are being conducted through a cooperative research
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`and development agreement with the National Cancer Institute. Anti-tumor
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`activity with this agent has been previously reported in phase 1 and phase 2
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`studies.
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`Wyeth Pharmaceuticals
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`Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the
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`areas of women's health care, cardiovascular disease, central nervous system,
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`inflammation, transplantation, hemophilia, oncology, vaccines and nutritional
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`products. Wyeth is one of the world's largest research-driven pharmaceutical
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`and health care products companies. It is a leader in the discovery,
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`development, manufacturing, and marketing of pharmaceuticals, vaccines,
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`biotechnology products and non-prescription medicines that improve the quality
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`of life for people worldwide. The Company's major divisions include Wyeth
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`Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
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`The statements in this press release that are not historical facts are
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`forward-looking statements based on current expectations of future events that
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`involve risks and uncertainties including, without limitation, risks
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` © 2016 Thomson Reuters. No claim to original U.S. Government Works.
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`Wyeth Breast Cancer 03 16
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`associated with the inherent uncertainty of the timing and success of
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`pharmaceutical research, product development, manufacturing,
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`commercialization, economic conditions including interest and currency
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`exchange rate fluctuations, changes in generally accepted accounting
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`principles, the impact of competitive or generic products, trade-buying
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`patterns, wars or terrorist acts, product liability and other types of
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`lawsuits, the impact of legislation and regulatory compliance and obtaining
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`reimbursement, favorable drug pricing, access and other approvals,
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`environmental liabilities, and patent, and other risks and uncertainties,
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`including those detailed from time to time in the Company's periodic reports,
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`including current reports on Form 8-K, quarterly reports on Form 10-Q and the
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`annual report on Form 10-K, filed with the Securities and Exchange Commission.
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`Actual results may vary materially from the forward-looking statements. The
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`Company assumes no obligation to publicly update any forward-looking
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`statements, whether as a result of new information, future events or
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`otherwise.
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`SOURCE Wyeth
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`-0- 03/16/2006
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`/CONTACT: Media: Gerald V. Burr, +1-484-865-5138, or Natalie de Vane,
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`+1-484-865-5139; Investors: Justin Victoria, +1-973-660-5340, all of Wyeth/
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`/Web site: http://www.wyeth.com /
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`(WYE)
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`CO: Wyeth
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`ST: New Jersey
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` © 2016 Thomson Reuters. No claim to original U.S. Government Works.
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`Wyeth Breast Cancer 03 16
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`IN: BIO HEA MTC
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`SU: WOM TRI
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`LD
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`-- NYTH103A --
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`5036 03/16/2006 17:05 EST http://www.prnewswire.com
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`---- Index References ----
`
`Company: WYETH PHARMACEUTICALS; WYETH; HORIZON; NATIONAL CANCER INSTITUTE
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`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)
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`Keywords: (f); (Medical); (Business)
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`Word Count: 1130
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`End of Document
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`© 2016 Thomson Reuters. No claim to original U.S. Government Works.
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` © 2016 Thomson Reuters. No claim to original U.S. Government Works.
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