Wyeth's TORISEL Receives European Commission Approval for the Treatment of Advanced Kidney Cancer

Collegeville, Pennsylvania, November 26 (ots/PRNewswire) -

- TORISEL Extends Median Overall Survival vs. Interferon-Alpha

Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced
today that the European Commission has approved TORISEL(TM)
(temsirolimus) for the first-line treatment of patients with advanced
renal cell carcinoma (RCC) who have at least three of six prognostic
risk factors. TORISEL is the only approved cancer therapy that
specifically inhibits the mTOR (mammalian target of rapamycin)
kinase, an important regulator of cell proliferation, cell growth and
cell survival. TORISEL was approved in the United States in May 2007
for the treatment of advanced RCC.

Renal cell carcinoma accounts for approximately 85 percent of the
estimated 85,000 new cases of kidney cancer diagnosed in Europe
annually. TORISEL is the only renal cancer therapy proved to extend
median overall survival compared with interferon-alpha in patients
with advanced RCC.

"Temsirolimus was studied in the most difficult-to-treat patients
with advanced renal cell carcinoma: those who have multiple risk
factors that have been associated with shortened survival," says
Bernard Escudier, M.D., Head of the Immunotherapy Unit, Department of
Medical Oncology, Institut Gustave Roussy, Villejuif, France, and an
investigator in the TORISEL phase 3 study. "The ability of
temsirolimus to provide an increase in overall survival in these
patients provides us with a much-needed new option for the treatment
of advanced kidney cancer."

TORISEL was studied in a three-arm, phase 3 clinical trial of 626
patients with advanced RCC and three or more of six preselected
prognostic risk factors who had received no prior systemic therapy.
In the study, TORISEL significantly increased median overall survival
by 49 percent compared with interferon-alpha (10.9 months vs. 7.3
months, P=0.0078). TORISEL also was associated with a statistically
significant improvement over interferon-alpha in the secondary
endpoint of progression-free survival (when the disease does not
worsen; 5.6 months vs. 3.2 months, P=0.0042). The combination of
TORISEL and interferon-alpha did not result in a significant increase
in overall survival when compared with interferon-alpha alone.

"The European Commission's approval of TORISEL underscores the
importance of this therapy for patients with advanced kidney cancer
and reinforces the potential of this mechanism of action as a new
approach in oncology," says Robert R. Ruffolo, Jr., Ph.D., President,
Wyeth Research, and Senior Vice President, Wyeth.

About TORISEL

TORISEL is an mTOR inhibitor indicated in the European Union for
the first-line treatment of patients with advanced RCC who have at
least three of six prognostic risk factors. These risk factors
include less than one year from time of initial RCC diagnosis to
randomization, Karnofsky performance status of 60 or 70, hemoglobin
less than the lower limit of normal, corrected calcium of greater
than 10 mg/dL, lactate dehydrogenase > 1.5 times the upper limit of
normal, and more than one metastatic organ site. In the United
States, TORISEL is indicated for the treatment of advanced RCC.

Inhibition of mTOR in treated cancer cells blocked the translation
of genes that regulate the cell cycle. In in vitro studies using
renal cancer cell lines, TORISEL inhibited the activity of mTOR and
resulted in reduced levels of certain cell growth factors involved in
the development of new blood vessels, such as vascular endothelial
growth factor.

In March 2007, the European Association of Urology published
guidelines recommending that TORISEL be considered as first-line
treatment in patients with advanced RCC with poor-risk features. In
August 2007, the National Comprehensive Cancer Network (NCCN) in the
United States added TORISEL to the NCCN Kidney Cancer Guidelines as
an option in first-line therapy for both predominant clear cell
histology and non-clear cell histology and as a subsequent therapy
option for patients with predominant clear cell histology.

TORISEL U.S. Important Safety Information

Hypersensitivity reactions manifested by symptoms, including, but
not limited to anaphylaxis, dyspnea, flushing, and chest pain have
been observed with TORISEL.

Serum glucose, serum cholesterol, and triglycerides should be
tested before and during treatment with TORISEL.

The use of TORISEL is likely to result in hyperglycemia and
hyperlipemia. This may result in the need for an increase in the dose
of, or initiation of, insulin and/or oral hypoglycemic agent therapy
and/or lipid-lowering agents, respectively.

The use of TORISEL may result in immunosuppression. Patients
should be carefully observed for the occurrence of infections,
including opportunistic infections.

Cases of interstitial lung disease, some resulting in death, have
occurred. Some patients were asymptomatic and others presented with
symptoms. Some patients required discontinuation of TORISEL and/or
treatment with corticosteroids and/or antibiotics.

Cases of fatal bowel perforation occurred with TORISEL. These
patients presented with fever, abdominal pain, metabolic acidosis,
bloody stools, diarrhea, and/or acute abdomen.

Cases of rapidly progressive and sometimes fatal acute renal
failure not clearly related to disease progression occurred in
patients who received TORISEL.

Due to abnormal wound healing, use TORISEL with caution in the
perioperative period.

Patients with central nervous system tumors (primary CNS tumor or
metastases) and/or receiving anticoagulation therapy may be at an
increased risk of developing intracerebral bleeding (including fatal
outcomes) while receiving TORISEL.

Live vaccinations and close contact with those who received live
vaccines should be avoided.

Patients and their partners should be advised to avoid pregnancy
throughout treatment and for 3 months after TORISEL therapy has
stopped.

The most common (incidence greater than or equal to 30%) adverse
reactions observed with TORISEL are: rash (47%), asthenia (51%),
mucositis (41%), nausea (37%), edema (35%), and anorexia (32%). The
most common laboratory abnormalities (incidence greater than or equal
to 30%) are anemia (94%), hyperglycemia (89%), hyperlipemia (87%),
hypertriglyceridemia (83%), elevated alkaline phosphatase (68%),
elevated serum creatinine (57%), lymphopenia (53%), hypophosphatemia
(49%), thrombocytopenia (40%), elevated AST (38%), and leukopenia
(32%).

Most common grades 3/4 adverse events included asthenia (11%),
dyspnea (9%), hemoglobin decreased (20%), lymphocytes decreased
(16%), glucose increased (16%), phosphorus decreased (18%), and
triglycerides increased (44%).

Strong inducers of CYP3A4/5 (eg, dexamethasone, rifampin) and
strong inhibitors of CYP3A4 (eg, ketoconazole, atazanavir) may
decrease and increase concentrations of the major metabolite of
TORISEL, respectively. If alternatives cannot be used, dose
modifications of TORISEL are recommended.

St. John's Wort may decrease TORISEL plasma concentrations, and
grapefruit juice may increase plasma concentrations of the major
metabolite of TORISEL, and therefore both should be avoided.

The combination of TORISEL and sunitinib resulted in dose-limiting
toxicity (Grade 3/4 erythematous maculopapular rash, and
gout/cellulitis requiring hospitalization).

Please see TORISEL full U.S. Prescribing Information at
http://www.TORISEL.com.

Wyeth Pharmaceuticals

Wyeth Pharmaceuticals, a division of Wyeth, has leading products
in the areas of women's health care, infectious disease,
gastrointestinal health, 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 pharmaceutical, 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 and are subject to risks and uncertainties that could
cause actual results to differ materially from those expressed or
implied by such statements. These risks and uncertainties include the
inherent uncertainty of the timing and success of, and expense
associated with, research, development, regulatory approval and
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pipeline products; government cost-containment initiatives;
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compliance; risks and uncertainties associated with global operations
and sales; and other risks and uncertainties, including those
detailed from time to time in our periodic reports filed with the
Securities and Exchange Commission, including our current reports on
Form 8-K, quarterly reports on Form 10-Q and annual report on Form
10-K, particularly the discussion under the caption "Item 1A, RISK
FACTORS." The forward-looking statements in this press release are
qualified by these risk factors. We assume no obligation to publicly
update any forward-looking statements, whether as a result of new
information, future developments or otherwise.

Web site: http://www.wyeth.com
http://www.TORISEL.com

ots Originaltext: Wyeth Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Media, Natalie de Vane of Wyeth Pharmaceuticals, +1-484-865-5139; or
Douglas Petkus, +1-973-660-5218, or Investors, Justin Victoria,
+1-973-660-5340, both of Wyeth


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