[Note how this PR botches the discussion of the statistics for overall survival, making it sound as though the p-value pertains to the median values of the survival curves rather than the hazard ratio. This is a common error that investors should be aware of—even CEOs are often guilty of such a misstatement.]
- First mTOR Inhibitor to Be Submitted for Cancer Indication -
MADISON, N.J., Oct. 6 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE ), announced today that the Company has initiated its global filing strategy for Torisel(TM) (temsirolimus) with the simultaneous submissions of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMEA). The company is seeking an indication for the treatment of patients with advanced renal cell carcinoma (RCC).
The registration dossier contains interim data from a three-arm, phase 3 clinical trial of 626 patients who had received no prior systemic therapy. The primary end point of the study was overall survival. The results showed treatment with Torisel increased median overall survival time by 3.6 months, or 49 percent, compared with treatment with interferon-alpha (10.9 months vs. 7.3 months, p=0.0069). The final analysis will also be submitted to regulatory authorities at a future date.
Torisel is an investigational drug that specifically inhibits the mTOR (mammalian target of rapamycin) kinase, a protein that regulates cell proliferation, cell growth and cell survival. If approved, Torisel would be the first agent in this class indicated for the treatment of a cancer.
"This is an exciting milestone, as Torisel has the potential to help many patients who have advanced RCC, if it is approved by the FDA and EMEA," said Lee F. Allen, M.D., Ph.D., Vice President of Oncology Clinical Research at Wyeth. "These filings also represent an important contribution to oncologists and their patients, since Torisel may provide a new option for the treatment of RCC."
"The interim phase 3 data demonstrate that mTOR inhibition with Torisel could be a viable approach to treating advanced RCC patients with poor-risk features, and that is good news, as new treatment options are constantly needed for these patients," said Gary Hudes, M.D., Director, Genitourinary Malignancies Program, Fox Chase Cancer Center, Philadelphia, and lead investigator of the phase 3 trial of Torisel in RCC.
The NDA and MAA were submitted on October 5. In July 2004, the FDA granted fast track designation for Torisel for first-line poor prognosis subjects with advanced RCC, and in December 2004, the FDA granted orphan drug designation to investigational temsirolimus for the treatment of RCC. In March 2006, Torisel received Orphan Medicinal Product designation for the treatment of RCC in the European Union.
The most significant adverse events reported in arm 1 (interferon-alpha alone), arm 2 (Torisel alone) and arm 3 (Torisel in combination with interferon-alpha) included asthenia (27 percent, 12 percent and 30 percent, respectively), anemia (24 percent, 21 percent and 39 percent, respectively) and dyspnea (8 percent, 9 percent and 11 percent, respectively). Of the 626 patients enrolled in the study, 442 deaths occurred at the time of the interim analysis.
About Renal Cell Carcinoma
Renal cell carcinoma accounts for about 85 percent of all renal cancers. Globally, more than 208,000 new cases of kidney cancer were diagnosed in 2002 -- including about 36,700 in the U.S. and 85,700 in Europe -- according to estimates from the International Agency for Research on Cancer (IARC), part of the World Health Organization (WHO). The incidence of the disease is highest among people between the ages of 50 to 70, and it affects nearly twice as many men as women.
Approximately 25 percent of patients with RCC are initially diagnosed with advanced disease, including locally invasive or metastatic RCC. Patients with advanced kidney cancer have a five-year survival rate of approximately 20 percent.
About Torisel
Torisel is an investigational drug for the treatment of patients with advanced RCC. Wyeth continues to study Torisel in a phase 3 trial of patients with mantle cell lymphoma and is planning and conducting several additional studies in RCC and other solid tumor indications. Additional early oncology trials with Torisel are being conducted through a cooperative research and development agreement with the National Cancer Institute in several other tumor types. <<
[Pristiq is an isomer of WYE’s SNRI blockbuster, Effexor, which in its XR formulation is the largest-selling antidepressant drug from any company. Thus, Pristiq is the most important drug in WYE’s pipeline because it will allow WYE to switch patents from Effexor XR to Pristiq as Effexor XR nears the end of tits patent life. This PR cites the issues to be overcome for Pristiq to receive FDA approval, the most important of which appears to be clearance of the manufacturing site in Puerto Rico. Regardless of the regulatory status, WYE won’t launch Pristiq until obtaining the results of a study in progress that tests a lower dose to mitigate nausea.]
>> Wyeth Receives Approvable Letter From FDA for Pristiq (Desvenlafaxine Succinate) for the Treatment of Major Depressive Disorder
Tuesday January 23, 3:37 pm ET
MADISON, N.J., Jan. 23 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE ), announced today that the Company has received an approvable letter from the U.S. Food and Drug Administration (FDA) for Pristiq(TM) (desvenlafaxine succinate), a serotonin-norepinephrine reuptake inhibitor (SNRI) studied as a treatment for adult patients with major depressive disorder (MDD). The letter was received January 22.
"The approvable letter is in line with Wyeth's expectations and we remain on track with our plans for Pristiq," says Joseph Mahady, President, Wyeth Pharmaceuticals -- North America and Global Businesses. "We are working toward resolution of all outstanding issues at our manufacturing site in Guayama, Puerto Rico and have already made significant progress in meeting previously established commitments."
According to the approvable letter, FDA approval of Pristiq is subject to several conditions, including the following:
* A satisfactory FDA inspection of the Company's Guayama, Puerto Rico facility, which is where Pristiq will be manufactured
* Several post-marketing commitments, including submission of long-term relapse prevention, low dose and pediatric studies
* Additional clarity around the Company's product education plan for physicians and patients
* Confirmation by the FDA of the acceptability of the proprietary name, Pristiq
As the Company has already communicated, launch timing for the MDD indication is predicated on three elements -- final FDA approval for Pristiq as a treatment for adult patients with MDD, the results of ongoing MDD studies at lower dosage levels, and the progress of FDA review of Wyeth's separate New Drug Application (NDA) for vasomotor symptoms (VMS) associated with menopause. Importantly, while the approvable letter requires some post-marketing commitments, the FDA does not require that any additional clinical studies be submitted prior to the approval of Pristiq.
"Given the importance of Pristiq, we are committed to ensuring the most complete profile and product information is available to physicians and patients at the time of this product's launch," Mahady says.
About Pristiq
Pristiq is an SNRI studied as a potential treatment for adult men and women with MDD. Wyeth submitted a NDA for MDD on December 22, 2005. The Company has also filed a NDA for VMS associated with menopause and expects an FDA action letter in the second quarter of 2007. If approved, Pristiq will be the first and only non-hormonal medicine for the treatment of VMS associated with menopause. Wyeth is a leader in both neuroscience and women's health care.
Wyeth discovered and developed the first SNRI approved by the FDA, which is currently the most widely used antidepressant in the world. Pristiq represents Wyeth's latest efforts and continued commitment to developing therapies to help improve the lives of patients suffering from mental health disorders.
According to a large depression trial funded by the National Institute of Mental Health, only 28 percent of patients with depression achieved remission with initial antidepressant treatment. This leaves a large percentage of patients still suffering from depression. Clearly, additional medicines are needed for treating MDD.
About Antidepressants
Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with major depressive disorder and other psychiatric disorders. Anyone considering the use of any antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are on such therapy should be observed closely for clinical worsening, suicidality or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with their prescriber.
About Major Depressive Disorder
Major depressive disorder is a serious medical condition that is different from "feeling blue" and is not something that people just "get over." Criteria for major depressive disorder include five or more of the following symptoms that have been present for at least two weeks, and at least one of the symptoms must be either depressed mood or loss of interest or pleasure.
* Depressed mood
* Loss of interest or pleasure
* Changes in appetite or weight
* Changes in sleeping patterns
* Psychomotor agitation or retardation
* Fatigue or low energy
* Feeling worthless or guilty for no reason
* Difficulty thinking or concentrating
* Thoughts of death or suicide
Further, people with major depressive disorder may experience clinically significant distress or impairment in social, occupational or other important areas of functioning. If a person experiences these symptoms, he or she should speak with a health care professional.
Major depressive disorder is a common mental disorder, affecting about 121 million people worldwide. In the United States, it is estimated that depression affects about 19 million American adults each year. The lifetime risk of major depression has been assessed from 10 to 25 percent for women and five to 12 percent for men. Research has shown that hormonal changes, including estrogen decline, or life stressors experienced by women may contribute to a major depressive episode.
About 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, hemophilia, oncology and vaccines. 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 nonprescription 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. <<
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