Ischemic Heart Disease In the combined data of four randomized, placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients on the XTANDI arm compared to patients on the placebo arm (2.9% vs 1.3%). Discontinue XTANDI in patients who develop PRES. The forward-looking statements in the webcast speak only as of the original date of the webcast. Pfizer and Astellas’ Xtandi is already approved to treat nonmetastatic castration-resistant prostate cancer, thanks to data showing it can stop tumors from spreading. Permanent discontinuation due to AEs as the primary reason was reported in 5% of XTANDI patients and 4% of placebo patients. Key secondary endpoints of the trial included overall survival (OS), time to prostate-specific antigen (PSA) progression, and time to first antineoplastic therapy use. In 2018, the partners amended the protocols of the ARCHES and EMBARK registrational Phase III trials of Xtandi in hormone-sensitive prostate cancer (HSPC) patients. In PROSPER, the placebo-controlled study of non-metastatic CRPC (nmCRPC) patients, Grade 3 or higher ARs were reported in 31% of XTANDI patients and 23% of placebo patients. About AstellasAstellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. Pfizer and Astellas report positive results of Xtandi in cancer 12th February 2020 (Last Updated February 12th, 2020 10:41) Pfizer and Astellas Pharma have reported positive results from the Phase III PROSPER clinical trial of Xtandi (enzalutamide) in patients with non … Since its initial approval in 2012, XTANDI has been prescribed to more than 330,000 men worldwide. 1 Astellas and Pfizer Announce Positive Top-Line Results from Phase 3 ARCHES Trial of XTANDI ® (enzalutamide) in Men with Metastatic Hormone-Sensitive Prostate Cancer Effect of XTANDI on Other Drugs Avoid CYP3A4, CYP2C9, and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. As part of Pfizer and Astellas’ ongoing commitment to the clinical development of enzalutamide, XTANDI is also being evaluated in the EMBARK trial, in men with high-risk non-metastatic HSPC. TOKYO & Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide), following FDA Priority Review designation, based on results from the Phase 3 PROSPER trial. 2018;378(26):2465-2474. doi:10.1056/nejmoa1800536. New England Journal of Medicine. GlobalData's TMT Themes 2021 Report tells you everything you need to know about disruptive tech themes and which companies are best placed to help you digitally transform your business. Effect of Other Drugs on XTANDI Avoid strong CYP2C8 inhibitors, as they can increase the plasma exposure to XTANDI. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of XTANDI; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications for XTANDI may be filed in any other jurisdictions; whether and when regulatory authorities in any jurisdictions where applications may be pending or filed may approve any such applications, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether XTANDI will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of XTANDI; risks related to increasing competitive, reimbursement and economic challenges; dependence on the efforts and funding by Astellas Pharma Inc. for the development, manufacturing and commercialization of XTANDI; and competitive developments. We use cookies to ensure that we give you the best experience on our website. OCT West Coast: IQVIA’s Nagaraja Srivatsan talks decentralised trials and the future of clinical research. The companies jointly commercialize XTANDI in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States. Contact Contact. Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving XTANDI. 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Call XTANDI Support Solutions ® at 1-855-8XTANDI (1-855-898-2634). About the Pfizer/Astellas Collaboration In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE: PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. The modifications revised the planned analyses of the primary and secondary endpoints of the trials, as well as their scheduled primary completion date. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring. Discontinuations with an AE as the primary reason were reported for 9% of XTANDI patients and 6% of placebo patients. For Media: For more information, please visit our website at https://www.astellas.com/en. Advise patients of the risk of developing a seizure while taking XTANDI and of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. OCT West Coast: how can decentralisation help optimise rare disease trials? A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Fractures occurred in 10% of patients treated with XTANDI and in 4% of patients treated with placebo. Chris Goldrick As part of Pfizer and Astellas’ ongoing commitment to the clinical development of enzalutamide, XTANDI is also being evaluated in the EMBARK trial, in men with high-risk non-metastatic HSPC. In a preliminary analysis, adverse events were generally consistent with those previously reported from PROSPER. About the Pfizer/Astellas Collaboration In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE:PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. Hypertension: In the combined data from four randomized placebo-controlled clinical trials, hypertension was reported in 12% of XTANDI patients and 5% of placebo patients. On Monday, the U.S. Food and Drug Administration (FDA) greenlit the new indications for Xtandi (enzalutamide). Key secondary endpoints included overall survival, time to PSA progression and time to first use of antineoplastic therapy. Warnings and Precautions. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. There is troubling news for Pfizer and cancer med Xtandi, a shared asset it picked up in its $14 billion deal last year for Medivation. Discontinuations due to AEs were reported for 6% of XTANDI-treated patients. In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE:PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. Contract Research Organisation for Clinical Trials, 12th February 2020 (Last Updated February 12th, 2020 10:41). XTANDI (enzalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with castration-resistant prostate cancer. Dec 16 (Reuters) - The U.S. Food and Drug Administration has approved Pfizer Inc and Astellas Pharma Inc’s Xtandi to treat patients with a type of prostate cancer, the companies said on Monday. Today, Pfizer Oncology has an industry-leading portfolio of 22 approved innovative cancer medicines and biosimilars across more than 30 indications, including breast, prostate, kidney and lung cancers, as well as leukemia and melanoma. Characterising the castration-resistant prostate cancer population: a systematic review. Ischemic events led to death in 0.4% of patients on XTANDI compared to 0.1% on placebo. A description of these risks and uncertainties can be found in Pfizer’s most recent Annual Report on Form 10-K and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. 2 Kirby M, Hirst C, Crawford ED. Ryan.Crowe@pfizer.com, Astellas Contacts: For help with XOSPATA, please call 1-844-632-9272. ; The partnered companies had announced the success of the Phase 3 ARCHES study last December. Learn how the Astellas Patient Assistance Program can offer XTANDI® to eligible patients at no cost. XTANDI, Astellas, and the flying star logo are registered trademarks of Astellas Pharma Inc. XTANDI Support Solutions®, a component of Astellas Pharma Support SolutionsSM, is a registered trademark of Astellas Pharma US, Inc.© 2021 Astellas Pharma US, Inc. and Pfizer Inc. The trial met its primary endpoint of MFS in 2018. You can identify these statements by the fact that they use future dates or use words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim,” “seek” and other words and terms of similar meaning. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Int J Clin Pract 2011;65(11):1180-92. About XTANDI® (enzalutamide)XTANDI (enzalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with castration-resistant prostate cancer (CRPC) and metastatic castration-sensitive prostate cancer (mCSPC). In 2018, Astellas and Pfizer announced that the PROSPER trial met its primary endpoint of metastasis-free survival (MFS). Discontinuations with an AE as the primary reason were reported for 8% of XTANDI patients and 6% of bicalutamide patients. 3 Luo J, Beer T, Graff J. Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., 'Astellas') and Pfizer Inc. (NYSE: PFE) announced today results of the final overall survival (OS) analysis from the Phase 3 PROSPER trial, which evaluated XTANDI (enzalutamide) plus androgen deprivation therapy (ADT) versus placebo plus ADT in men with non-metastatic castration-resistant prostate cancer (nmCRPC). In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. As part of Pfizer and Astellas' ongoing commitment to the clinical development of enzalutamide, XTANDI is also being evaluated in the EMBARK trial, in men with high-risk non-metastatic HSPC. Getting to Know CPO Dara Richardson-Heron, M.D. Pfizer will add its much-vaunted marketing talents to Astellas' efforts, in a bid to make sure that happens. XTANDI® (enzalutamide) Demonstrates Significant Improvement in Overall Survival in Phase 3 PROSPER Trial of Patients with nmCRPC, MAINTAINING EMOITONAL WELLBEING DURING COVID-19, CORONAVIRUS DISEASE (COVID-19) SCIENTIFIC RESOURCES. The submission is based on results from the Phase 3 ARCHES trial presented at the 2019 Genitourinary Cancers Symposium (ASCO GU) in February and published in The Journal of Clinical Oncology in July 2019. Oncology 2016;30(4):336-44. OS was a key secondary endpoint of the trial. XTANDI is currently indicated in the U.S. for the treatment of patients with castration-resistant prostate cancer (CRPC). J Clin Oncol 2005;23(13):2918-25. Grade 3-4 ischemic events occurred in 1.4% of patients on XTANDI versus 0.7% on placebo. Jessica Smith PRES is a neurological disorder that can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. Permanently discontinue XTANDI for serious hypersensitivity reactions. The results demonstrated a statistically significant improvement in OS in patients with nmCRPC who were treated with XTANDI plus ADT. Pfizer and Astellas report OS data for Xtandi in non-metastatic CRPC Allie Nawrat 12 February 2020 (Last Updated February 12th, 2020 12:11) Japanese company Astellas and US-headquartered Pfizer have announced final overall survival (OS) for Xtandi (enzalutamide) in non-metastatic castration-resistant prostate cancer (nmCRPC). Shin Okubo In TERRAIN, the bicalutamide-controlled study of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were reported in 39% of XTANDI patients and 38% of bicalutamide patients. 4 Smith MR, Kabbinavar F, Saad F, et al. Important Safety Information. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Pfizer and Astellas Pharma have reported positive results from the Phase III PROSPER clinical trial of Xtandi (enzalutamide) in patients with non-metastatic castration-resistant prostate cancer (nmCRPC). Astellas Forward-Looking StatementIn this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. Xtandi is an androgen receptor inhibitor approved to treat castration-resistant prostate cancer (CRPC) and metastatic castration-sensitive prostate cancer (mCSPC). Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue XTANDI and promptly seek medical care. Hypersensitivity reactions, including edema of the face (0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI in seven randomized clinical trials. The randomised, double-blind, placebo-controlled, multi-national PROSPER study assessed a 160mg dose of the drug in combination with androgen deprivation therapy (ADT) in a total of around 1,400 nmCRPC patients in the US, Europe, Canada, South America and Asia-Pacific. In AFFIRM, the placebo-controlled study of metastatic CRPC (mCRPC) patients who previously received docetaxel, Grade 3 and higher ARs were reported among 47% of XTANDI-treated patients. Lab Abnormalities: Lab abnormalities that occurred in ≥ 5% of patients, and more frequently (> 2%) in the XTANDI arm compared to placebo in the pooled, randomized, placebo-controlled studies are neutrophil count decreased, white blood cell decreased, hyperglycemia, hypermagnesemia, hyponatremia, and hypercalcemia. 212-733-6213 If co-administration is necessary, increase the dose of XTANDI. These results were presented at the Genitourinary Cancers Symposium (ASCO GU) and later published in the New England Journal of Medicine.1. For Media: This release contains forward-looking information about XTANDI® (enzalutamide), including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Seizure occurred in 0.5% of patients receiving XTANDI in seven randomized clinical trials. Pfizer and its development partner Astellas Pharma released data late Monday showing the treatment efficacy in patients with non-metastatic Castration-Resistant Prostate Cancer (CRPC). Evaluate patients for fracture and fall risk. About the Pfizer/Astellas Collaboration. Pharyngeal edema has been reported in post-marketing cases. Editor's note: This story was updated to include Astellas' role as Pfizer's Xtandi partner. Pfizer Contacts: Discontinuations due to adverse events (AEs) were reported for 16% of XTANDI-treated patients. For help with PADCEV, please call 1-888-402-0627. PROSPER efficacy and safety data at the time of the MFS analysis are included in the XTANDI labels in the U.S., Europe and Japan and are currently under review in China. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. The trial evaluated enzalutamide at a dose of 160 mg taken orally once daily plus ADT, versus placebo plus ADT. Discontinue XTANDI for Grade 3-4 ischemic heart disease. Ryan Crowe In ARCHES, the placebo-controlled study of metastatic CSPC (mCSPC) patients, Grade 3 or higher AEs were reported in 24% of XTANDI-treated patients. Embryo-Fetal Toxicity The safety and efficacy of XTANDI have not been established in females. Creating Cures Through Facility Investments, Scaling Up to Supply a COVID-19 Vaccine, If Approved. 1 Hussain M, Fizazi K, Saad F, et al. Pfizer and Astellas are committed to helping patients access XTANDI by providing them with access and reimbursement support resources, including information regarding patient healthcare coverage options and financial assistance options that may … Xtandi was added to Pfizer’s portfolio with the acquisition of Medivation in September 2016. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. PROSPER enrolled patients with prostate cancer that had progressed, based on a rising PSA level despite ADT, but who had no symptoms and no prior or present evidence of metastatic disease. Northbrook, IL: Astellas Pharma US, Inc. 2. XTANDI can cause fetal harm and loss of pregnancy when administered to a pregnant female. About Pfizer OncologyAt Pfizer Oncology, we are committed to advancing medicines wherever we believe we can make a meaningful difference in the lives of patients. Information about pharmaceutical products (including products currently in development), which is included in this press release is not intended to constitute an advertisement or medical advice. See data on XTANDI® & how it may treat 3 forms of prostate cancer, non-metastatic castration-resistant prostate cancer, metastatic CRPC, & metastatic castration-sensitive prostate cancer. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. The companies said the median time for the primary endpoint of metastasis-free survival (MFS), was 36.6 months for men who received Xtandi in comparison to 14.7 months for those who only had the ADT … In PREVAIL, the placebo-controlled study of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were reported in 44% of XTANDI patients and 37% of placebo patients. to speak with a dedicated access specialist who can help you find ways to pay for XTANDI. The information contained in this release is as of February 11, 2020. Treatment of nonmetastatic castration-resistant prostate cancer. Hypertension led to study discontinuation in < 1% of patients in each arm. Xtandi, the prostate cancer drug developed by Pfizer and Japan-based Astellas, won approval for a new indication as a treatment for patients with metastatic castration-sensitive prostate cancer (mCSPC). A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2018 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. Preliminary analysis showed an adverse event profile generally consistent with previous PROSPER data. Pfizer. Call Us. shin.ohkubo@astellas.com. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents. Data on File. 212-733-8160 Full Prescribing Information; Patient Information; XTANDI is a prescription medicine used to treat men with prostate cancer that: no longer responds to a hormone therapy or surgical treatment to lower testosterone; OR. Factors that could cause actual results to differ materially from past results and future plans and projected future results are described in our Form 8-K furnished with the U.S. Securities and Exchange Commission on January 12, 2021 and linked here, which also contains information regarding our use of preliminary financial guidance. Patients in the study had one or more of the following predisposing factors: use of medications that may lower the seizure threshold, history of traumatic brain or head injury, history of cerebrovascular accident or transient ischemic attack, and Alzheimer’s disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, history of seizure, presence of a space occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection. About Non-Metastatic Castration-Resistant Prostate Cancer, Castration-resistant prostate cancer (CRPC) refers to the subset of men whose prostate cancer progresses on androgen deprivation therapy (ADT) despite castrate levels of testosterone (i.e., less than 50 ng/dL).2 Non-metastatic CRPC means there is no clinically detectable evidence of the cancer spreading to other parts of the body (metastases), and there is a rising prostate-specific antigen (PSA) level.3 Many men with non-metastatic CRPC and a rapidly rising PSA level go on to develop metastatic CRPC.4. XTANDI (enzalutamide) sponsored by Astellas Pharma Inc. and Pfizer Inc. Add to Favorites . XTANDI (enzalutamide) is an androgen receptor inhibitor jointly developed by Astellas Pharma and Pfizer. Pfizer Oncology is striving to change the trajectory of cancer. For more information on the PROSPER trial, go to www.clinicaltrials.gov. In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE: PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. Permanently discontinue XTANDI in patients who develop a seizure during treatment. The Phase 3 randomized, double-blind, placebo-controlled, multi-national trial enrolled approximately 1,400 patients with nmCRPC at sites in the United States, Canada, Europe, South America and the Asia-Pacific region. The primary endpoint was metastasis-free survival (MFS), defined as the time from patients enrolling in the trial until their cancer was found to have metastasised, or until death within 112 days after treatment discontinuation. This information is intended for US Healthcare professionals. Patients whose prostate cancer had progressed without any symptoms and no previous or current evidence of metastatic disease participated in the trial. In the data from the four randomized placebo-controlled trials, the most common ARs (≥ 10%) that occurred more frequently (≥ 2% over placebo) in XTANDI-treated patients were asthenia/fatigue, back pain, hot flush, constipation, arthralgia, decreased appetite, diarrhea, and hypertension. The following transcript contains forward-looking statements about our anticipated future financial performance that involve substantial risks and uncertainties. Please see Full Prescribing Information for additional safety information. Final analysis of OS data revealed a statistically significant improvement in the OS of patients treated with Xtandi plus ADT compared to the placebo and ADT combination. About the Pfizer/Astellas CollaborationIn October 2009, Medivation, Inc., which is now part of Pfizer (NYSE: PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. About the Pfizer/Astellas Collaboration In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE: PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. XTANDI, Astellas, and the flying star logo are registered trademarks of Astellas Pharma Inc. XTANDI Support Solutions®, a component of Astellas Pharma Support Solutions SM, is a registered trademark of Astellas Pharma US, Inc. QUICK START+® is a registered trademark of Astellas Pharma US, Inc. Seizure occurred in 0.5% of patients receiving XTANDI in seven randomized clinical trials. XTANDI. Falls and Fractures occurred in patients receiving XTANDI. Natural history of rising serum prostate-specific antigen in men with castrate nonmetastatic prostate cancer. Detailed efficacy and safety results from the final PROSPER OS analysis will be shared at a later date. In the combined data of four randomized, placebo-controlled clinical studies, falls occurred in 11% of patients treated with XTANDI compared to 4% of patients treated with placebo. See risks & benefits. Pfizer assumes no obligation to update forward-looking statements contained in the webcast as the result of new information or future events or developments. Find contact information for Astellas Pharma US, Inc. and Pfizer Inc. for XTANDI® (enzalutamide). The companies jointly commercialize XTANDI in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States. The primary endpoint of the PROSPER trial, metastasis-free survival (MFS), was measured as the time from patients entering the trial until their cancer was radiographically detected as having metastasized, or until death, within 112 days of treatment discontinuation. Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI. 847-224-3014 We can also answer questions about insurance coverage and your out-of-pocket costs. For help with XTANDI, please call 1-855-898-2634. About the Pfizer/Astellas Collaboration. chris.goldrick@astellas.com, For Investors: Jessica.M.Smith@pfizer.com, For Investors: This webcast may contain forward-looking statements about, among other things, our anticipated future operating and financial performance, business plans and prospects, in-line products and product candidates, strategic reviews, capital allocation, business-development plans, the benefits expected from the reorganization of our commercial operations into three businesses effective at the beginning of our 2019 fiscal year, our acquisitions and other business development activities, our proposed transaction with GSK to combine our respective consumer healthcare businesses into a new consumer healthcare joint venture, our ability to successfully capitalize on growth opportunities or prospects, manufacturing and product supply and plans relating to share repurchases and dividends, among other things, that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.
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