Latest news with #PfizerInc
Japan Today
5 days ago
- Health
- Japan Today
Japan discards state-acquired COVID-19 drugs worth ¥240 billion
The government discarded COVID-19 oral medicines believed to be worth around 240 billion yen in the fiscal year through March as they had passed their expiry dates, health ministry officials said Wednesday. While the exact purchase price remains unclear, the value was calculated in accordance with current prices. The amount is enough to treat some 2.5 million people. The government acquired the oral drugs at the height of the coronavirus pandemic and provided them free of charge to hospitals and clinics nationwide. But many of them were unused after COVID-19 was downgraded to the same category as seasonal influenza in May 2023, which required people to pay for COVID-19 treatment. Drugmakers had also started general distribution of COVID-19 medicine in Japan themselves. A Ministry of Health, Labor and Welfare official said offering the drugs to other countries was considered but legally difficult. Among the 2 million doses of Pfizer Inc's nirmatrelvir and 1.6 million doses of Merck & Co's molnupiravir procured by the government, about 1.75 million doses of nirmatrelvir and some 780,000 doses of molnupiravir were disposed of, according to the ministry. The government also secured 2 million doses of Shionogi & Co's ensitrelvir but about 1.77 million of them are unused, the ministry said. They are expected to be discarded after they reach their expiration dates starting next fiscal year. © KYODO
Mint
5 days ago
- Business
- Mint
Zohran Mamdani backs away from ‘globalize the intifada' slogan, reaffirms tax plan for NYC's wealthy
New York City mayoral candidate Zohran Mamdani told a group of prominent business leaders on Tuesday (July 15) that he would begin discouraging the use of the phrase 'globalize the intifada,' according to a report by Bloomberg, which cited people with knowledge of the meeting. The shift came after a pointed question from Pfizer Inc. CEO Albert Bourla, who moderated the meeting and personally raised concerns about the slogan, widely used in anti-Israel demonstrations. Bourla, who lost family members in the Holocaust and helped deliver Pfizer's COVID-19 vaccine to Israel in 2020 through an agreement with then-Prime Minister Benjamin Netanyahu, moderated the closed-door session. Mamdani, a 33-year-old democratic socialist, had been a long-time Palestinian rights activist, and the phrase 'globalize the intifada' is used in reference with the violent Palestinian uprisings against Israel. As per the news report, Mamdani 'appeared to relent', and committed to discouraging the slogan going forward, signaling his willingness to recalibrate some of his more contentious positions as he courts mainstream support. The meeting was held with about 100 members of the Partnership for New York City, a powerful coalition that includes executives from top banks, law firms, real estate developers, and media companies. The event marked part of Mamdani's broader effort this week to engage with the business community, following his upset victory over former Governor Andrew Cuomo in the Democratic primary. Mamdani's mayoral campaign centered on pledges to freeze rents on affordable housing and finance free bus services and government-run grocery stores by imposing new taxes on corporations and high-income earners. However, on other issues, the Queens assemblyman remained steadfast, reaffirming his goals and dismissing concerns over higher taxes, reportedly stating that wealthy New Yorkers would not leave the city because of them. On policing, Mamdani told the group he would consider retaining current NYPD Commissioner Jessica Tisch but stopped short of any commitments. Tisch's father, James Tisch, chairman of Loews Corp., was in attendance. Executives present included Uber CEO Dara Khosrowshahi, Hearst CEO Steve Swartz, Related Companies CEO Jeff Blau, and Centerview Partners co-founder Blair Effron, Bloomberg reported. Mamdani campaign spokesperson Jeffrey Lerner said the meeting was 'a constructive, honest discussion,' and added, 'Zohran continues to believe that working in partnership is the best way to deliver an affordable city for all New Yorkers.' During the meeting, Mamdani also said he would examine the city's Department of Education for inefficiencies and explore leveraging the upcoming FIFA World Cup to bolster New York's infrastructure, according to Bloomberg. Mamdani's meetings with business leaders come as he attempts to consolidate broader support in what could be a more competitive general election than usual for deep-blue New York City. He will face incumbent Mayor Eric Adams, Andrew Cuomo (running as an independent), Republican Curtis Sliwa, and attorney Jim Walden, also running as an independent.
Yahoo
5 days ago
- Business
- Yahoo
Mamdani Talks ‘Intifada', Taxes in Grilling by Business Leaders
(Bloomberg) -- New York City mayoral candidate Zohran Mamdani told business leaders that he would begin to discourage the use of the phrase 'globalize the intifada' after being pressed on his views by Pfizer Inc. Chief Executive Officer Albert Bourla, according to people with knowledge of the matter. The Dutch Intersection Is Coming to Save Your Life Advocates Fear US Agents Are Using 'Wellness Checks' on Children as a Prelude to Arrests LA Homelessness Drops for Second Year Manhattan, Chicago Murder Rates Drop in 2025, Officials Say Mamdani, the 33-year-old democratic socialist who shocked New York City's business and political establishment by beating Andrew Cuomo in last month's Democratic mayoral primary, met Tuesday with about 100 business leaders from the Partnership for New York City. The group is a 350-member coalition of the city's largest banks and media companies as well as investment, real estate and law firms. The meeting, which came at Mamdani's request, is one of several scheduled this week between the Democratic nominee and the business community, which is grappling with the potential impact of Mamdani's leadership on the city. Mamdani campaigned on promises to freeze the rent on affordable housing, and fund free buses and government-run grocery stores with new taxes on corporations and high-earners. JPMorgan Chase & Co. CEO Jamie Dimon last week criticized Mamdani and the Democratic reaction to his election, describing him as 'more of a Marxist than a socialist.' Bourla, whose grandparents perished at Auschwitz, moderated the event. Mamdani, an activist for Palestinian causes, has been criticized for refusing to denounce calls by anti-Israel protesters to 'globalize the intifada,' a reference to the armed Palestinian uprisings against Israel. Bourla in 2020 struck an agreement with Israeli Prime Minister Benjamin Netanyahu to use Israel as a test case for Pfizer's Covid-19 vaccine. In Tuesday's meeting, Mamdani appeared to relent on the matter, the people said, saying he would discourage such language going forward. But on other subjects the Queens assemblyman held firm, reiterating his goals and brushing off concerns about higher taxes by saying wealthy New Yorkers would stay put regardless, the people said. Mamdani also said he'd consider, but wouldn't commit, to keeping Police Commissioner Jessica Tisch, the people said. Her father, Loews Corp. Chairman James Tisch, was at the meeting. Other attendees included Uber Technologies Inc. CEO Dara Khosrowshahi, Hearst Corp. CEO Steve Swartz, Related Cos CEO Jeff Blau, and Centerview Partners' co-founder Blair Effron, the people said. 'Zohran appreciated the meeting today, and felt it was a constructive, honest discussion,' Jeffrey Lerner, a spokesman for Mamdani's campaign, said in a statement. 'We look forward to the opportunity to build on this conversation, even in navigating disagreement on fiscal policy. Zohran continues to believe that working in partnership is the best way to deliver an affordable city for all New Yorkers.' Business leaders who attended the Tuesday event thought Mamdani was 'the most impressive candidate they have seen in generations,' Kathy Wylde, CEO of the coalition, said in an interview on CNBC Wednesday. But Wylde said Mamdani is 'clearly, totally inexperienced' and that she doesn't think the candidate changed the minds of city business leaders. Mamdani also told attendees he would examine the New York City Department of Education for waste and duplication, and that he would look to use the World Cup as an opportunity to build up city infrastructure. Mamdani has been making efforts to consolidate traditional institutions behind his candidacy ahead of November's mayoral race, which could prove unusually competitive in a heavily blue city where the Democratic nominee has been all but assured of victory in recent elections. He will face off against four other candidates: incumbent Mayor Eric Adams, former governor Cuomo, and attorney Jim Walden — all of whom are running as independents — as well as Republican Curtis Sliwa. President Donald Trump, who has described Mamdani as a 'communist lunatic,' said this week that Cuomo should stay in the race, even after losing by more than 12 percentage points to Mamdani in the primary. --With assistance from Aysha Diallo. (Updates with comments by Partnership for New York City CEO in 10th paragraph) Forget DOGE. Musk Is Suddenly All In on AI How Starbucks Is Engineering a Turnaround With Warm Vibes and Cold Foams How Hims Became the King of Knockoff Weight-Loss Drugs Thailand's Changing Cannabis Rules Leave Farmers in a Tough Spot The New Third Rail in Silicon Valley: Investing in Chinese AI ©2025 Bloomberg L.P. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
6 days ago
- Business
- Yahoo
Morningstar Reduces Moat Rating For Pfizer (PFE) To Narrow
Pfizer Inc. (NYSE:PFE) is one of the Best Large Cap Value Stocks to Invest In. Morningstar reduced its moat rating for the company to narrow due to the portfolio setbacks as well as policy risk. That being said, the firm also added that Pfizer Inc. (NYSE:PFE)'s foundation is strong on the basis of steady cash flows coming from the basket of diverse drugs. Furthermore, its large size possesses strong competitive advantages in developing new drugs. These factors, along with a broad portfolio of patent-protected drugs, have supported Pfizer Inc. (NYS E:PFE) in building an economic moat around its business, opines Morningstar. A medical technician wearing protective gloves and a mask mixing a biopharmaceutical solution. The company's overall strong Q1 2025 performance reflects its continued emphasis on commercial execution. Its focus on operational efficiency and financial discipline continues to drive healthy results to its bottom line. Pfizer Inc. (NYSE:PFE) saw revenues of $13.7 billion in Q1 2025, while its adjusted diluted EPS came in at $0.92. The company's aggressive cost-saving initiatives can significantly improve Pfizer Inc. (NYSE:PFE)'s long-term profitability. Therefore, by improving operational efficiency, it can allocate more resources to high-potential areas, including pipeline development and strategic acquisitions. While we acknowledge the potential of PFE as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 13 Cheap AI Stocks to Buy According to Analysts and 11 Unstoppable Growth Stocks to Invest in Now Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
Yahoo
10-07-2025
- Business
- Yahoo
XTANDI® Plus Leuprolide Significantly Improves Survival Outcomes in Men with Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical Recurrence
XTANDI: the first and only androgen receptor inhibitor-based regimen to demonstrate overall survival benefit in non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR) NEW YORK & TOKYO, July 10, 2025--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced positive topline results from the overall survival (OS) analysis from the Phase 3 EMBARK study evaluating XTANDI® (enzalutamide), in combination with leuprolide and as a monotherapy, in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as nonmetastatic castration-sensitive prostate cancer or nmCSPC) with biochemical recurrence (BCR) at high risk for metastasis. For patients treated with XTANDI plus leuprolide versus placebo plus leuprolide, EMBARK met the key secondary endpoint with a statistically significant and clinically meaningful improvement in OS. Results also showed a favorable trend towards improved OS for patients treated with XTANDI monotherapy versus placebo plus leuprolide, however the difference did not reach statistical significance. No new safety signals were observed in the analysis, and the safety results were consistent with the demonstrated safety profile of XTANDI.1 "These data demonstrate that treatment with XTANDI can extend life for men with nmHSPC and high-risk BCR who have relapsed after initial curative-intent therapy with prostatectomy, radiation therapy or both, further validating EMBARK's metastasis-free survival (MFS) data," said Neal Shore, M.D., F.A.C.S, START Carolinas/Carolina Urologic Research Center. "While men with nmHSPC with high-risk BCR now have expanded treatment choices, these results demonstrate a clear clinical benefit, including both MFS and OS, supporting the clinical practice of initiating XTANDI for these patients." Among men who have undergone definitive prostate cancer treatment, including radical prostatectomy, radiotherapy, or both, an estimated 20-40% will experience BCR within 10 years.2 About nine out of 10 men with high-risk BCR will develop metastatic disease, and one in three will die as a result of their metastatic prostate cancer.3 "XTANDI is the only androgen receptor inhibitor-based regimen to demonstrate a survival benefit in metastatic HSPC and nmHSPC with high-risk BCR, as well as castration-resistant prostate cancer, highlighting its significant patient impact in advanced prostate cancer," said Johanna Bendell, M.D., Oncology Chief Development Officer, Pfizer. "These positive results add to the robust clinical support for the use of XTANDI and broaden clinical confidence, offering men with high-risk BCR evidence that they might live longer when they start XTANDI early." In the EMBARK study, patients were randomized to one of three study arms: XTANDI plus leuprolide, placebo plus leuprolide, or XTANDI monotherapy. An initial analysis was previously reported in The New England Journal of Medicine in 2023, demonstrating that the study met its primary endpoint with a statistically significant and clinically meaningful improvement in MFS for patients treated with XTANDI plus leuprolide versus placebo plus leuprolide.4 The most common adverse events (occurring in ≥10% of patients) in the combination group and the leuprolide-alone group were hot flashes and fatigue. The most common adverse events in the monotherapy group were gynecomastia, hot flashes, and fatigue.4 XTANDI is currently approved in more than 80 countries, including in the United States, European Union, and Japan. "Over 1.5 million men with advanced prostate cancer around the world have benefited from treatment with XTANDI since its initial approval in 2012,"5 said Shontelle Dodson, Executive Vice President, Head of Medical Affairs, Astellas. "The scope and rigor of the EMBARK trial exemplify Astellas' and Pfizer's longstanding commitment to the prostate cancer community, and we look forward to sharing detailed findings in a future scientific forum." Detailed OS results from EMBARK will be presented at a future medical meeting. About EMBARK4The Phase 3, randomized, double-blind, placebo-controlled, multi-national trial enrolled 1,068 patients with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR) at sites in the United States, Canada, Europe, South America, and the Asia-Pacific region. Patients who were considered high-risk BCR had a prostate-specific antigen (PSA) doubling time ≤ 9 months, serum testosterone ≥ 150 ng/dL (5.2 nmol/L), and screening PSA by the central laboratory ≥ 1 ng/mL if they had a radical prostatectomy (with or without radiotherapy) as primary treatment for prostate cancer or at least 2 ng/mL above the nadir if they had radiotherapy only as primary treatment for prostate cancer. Patients in the EMBARK trial were randomized to receive enzalutamide 160 mg daily plus leuprolide, enzalutamide 160 mg as monotherapy, or placebo plus leuprolide. The primary results from the EMBARK trial were published in The New England Journal of Medicine in 2023. The primary endpoint of the trial was metastasis-free survival (MFS) for enzalutamide plus leuprolide versus placebo plus leuprolide. MFS is defined as the duration of time in months between randomization and the earliest objective evidence of radiographic progression by central imaging or death. For more information on the EMBARK (NCT02319837) trial go to About Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk Biochemical RecurrenceNon-metastatic hormone- (or castration-) sensitive prostate cancer (nmHSPC or nmCSPC) means there is no detectable evidence of the cancer spreading to distant parts of the body (metastases) with conventional radiological methods (CT/MRI) and the cancer still responds to medical or surgical treatment to lower testosterone levels.6,7 Of men who have undergone definitive prostate cancer treatment, including radical prostatectomy, radiotherapy, or both, an estimated 20-40% will experience a biochemical recurrence (BCR) within 10 years.8 About 9 out of 10 men with high-risk BCR will develop metastatic disease, and 1 in 3 will die as a result of the recurrence.8 The EMBARK trial focused on men with high-risk BCR. Per the EMBARK protocol, patients with nmHSPC with high-risk BCR are those initially treated by radical prostatectomy or radiotherapy, or both, with a PSA doubling time ≤ 9 months. Patients with nmCSPC who experience BCR after local therapy may be at a higher risk of metastases and death if their PSA doubling time is ≤ 9 months.9 About XTANDI® (enzalutamide)XTANDI (enzalutamide) is an androgen receptor signaling inhibitor. XTANDI is a standard of care and has received regulatory approvals in one or more countries around the world for use in men with metastatic hormone-sensitive prostate cancer (mHSPC), metastatic castration-resistant prostate cancer (mCRPC), non-metastatic castration-resistant prostate cancer (nmCRPC) and non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR). XTANDI is currently approved for one or more of these indications in more than 80 countries, including in the United States, European Union and Japan. Over 1.5 million patients have been treated with XTANDI globally.5 About XTANDI (enzalutamide) and U.S. Important Safety InformationXTANDI (enzalutamide) is indicated for the treatment of patients with: castration-resistant prostate cancer (CRPC) metastatic castration-sensitive prostate cancer (mCSPC) nonmetastatic castration sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR) Important Safety Information Warnings and Precautions Seizure occurred in 0.6% of patients receiving XTANDI in eight randomized clinical trials. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. 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. 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. Permanently discontinue XTANDI in patients who develop a seizure during treatment. Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving XTANDI. 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. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES. Hypersensitivity reactions, including edema of the face (0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI in eight randomized clinical trials. Pharyngeal edema has been reported in post-marketing cases. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue XTANDI and promptly seek medical care. Permanently discontinue XTANDI for serious hypersensitivity reactions. Ischemic Heart Disease In the combined data of five randomized, placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients on the XTANDI arm compared to patients on the placebo arm (3.5% vs 2%). Grade 3-4 ischemic events occurred in 1.8% of patients on XTANDI versus 1.1% on placebo. Ischemic events led to death in 0.4% of patients on XTANDI compared to 0.1% on placebo. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue XTANDI for Grade 3-4 ischemic heart disease. Falls and Fractures occurred in patients receiving XTANDI. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents. In the combined data of five randomized, placebo-controlled clinical studies, falls occurred in 12% of patients treated with XTANDI compared to 6% of patients treated with placebo. Fractures occurred in 13% of patients treated with XTANDI and in 6% of patients treated with placebo. Embryo-Fetal Toxicity The safety and efficacy of XTANDI have not been established in females. XTANDI can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment with XTANDI and for 3 months after the last dose of XTANDI. Dysphagia or Choking Severe dysphagia or choking, including events that could be life-threatening requiring medical intervention or fatal, can occur due to XTANDI product size. Advise patients to take each capsule or tablet whole with a sufficient amount of water to ensure that all medication is successfully swallowed. Consider use of a smaller tablet size of XTANDI in patients who have difficulty swallowing. Discontinue XTANDI for patients who cannot swallow capsules or tablets. Adverse Reactions (ARs)In the data from the five randomized placebo-controlled trials, the most common ARs (≥ 10%) that occurred more frequently (≥ 2% over placebo) in XTANDI-treated patients were musculoskeletal pain, fatigue, hot flush, constipation, decreased appetite, diarrhea, hypertension, hemorrhage, fall, fracture, and headache. In the bicalutamide-controlled study, the most common ARs (≥ 10%) reported in XTANDI-treated patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, diarrhea, upper respiratory tract infection, and weight loss. In EMBARK, the placebo-controlled study of nonmetastatic CSPC (nmCSPC) with high-risk biochemical recurrence (BCR) patients, Grade 3 or higher adverse reactions during the total duration of treatment were reported in 46% of patients treated with XTANDI plus leuprolide, 50% of patients receiving XTANDI as a single agent, and 43% of patients receiving placebo plus leuprolide. Permanent treatment discontinuation due to adverse reactions during the total duration of treatment as the primary reason was reported in 21% of patients treated with XTANDI plus leuprolide, 18% of patients receiving XTANDI as a single agent, and 10% of patients receiving placebo plus leuprolide. 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 hemoglobin decrease, neutrophil count decreased, white blood cell decreased, hyperglycemia, hypermagnesemia, hyponatremia, hypophosphatemia, and hypercalcemia. Hypertension: In the combined data from five randomized placebo-controlled clinical trials, hypertension was reported in 14.2% of XTANDI patients and 7.4% of placebo patients. Hypertension led to study discontinuation in < 1% of patients in each arm. Drug Interactions Effect of Other Drugs on XTANDI Avoid coadministration with strong CYP2C8 inhibitors. If coadministration cannot be avoided, reduce the dosage of coadministration with strong CYP3A4 inducers. If coadministration cannot be avoided, increase the dosage of XTANDI. Effect of XTANDI on Other Drugs Avoid coadministration with certain CYP3A4, CYP2C9, and CYP2C19 substrates for which minimal decrease in concentration may lead to therapeutic failure of the substrate. If coadministration cannot be avoided, increase the dosage of these substrates in accordance with their Prescribing Information. In cases where active metabolites are formed, there may be increased exposure to the active metabolites. Please see Full Prescribing Information for additional safety information. About AstellasAstellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands at the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at About Pfizer OncologyAt Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and bispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world's most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives. 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 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. 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. 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. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. 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. 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. Pfizer Disclosure NoticeThe information contained in this release is as of July 10, 2025. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer Oncology, XTANDI (enzalutamide) and an overall survival analysis from the Phase 3 EMBARK study evaluating XTANDI in combination with leuprolide and as a monotherapy, in men with non-metastatic hormone-sensitive prostate cancer with biochemical recurrence at high risk for metastasis, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. 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 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 the clinical studies; whether and when drug applications for XTANDI may be filed in particular jurisdictions for any potential indications; whether and when regulatory authorities in any jurisdictions may approve any such applications that may be pending or filed for XTANDI, which will depend on a myriad of 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 for any potential indication 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; dependence on the efforts and funding by Astellas Pharma Inc. for the development, manufacturing and commercialization of XTANDI; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; and competitive developments. 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, 2024, 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 and Astellas Cautionary NotesIn 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. 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. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. 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. 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. References 1 Astellas and Pfizer. Data on File, EMBARK results, July 2025. 2 Ward JF, Moul JW. Rising prostate-specific antigen after primary prostate cancer therapy. Nat Clin Pract Urol. 2005 Apr;2(4):174-82. doi: 10.1038/ncpuro0145. PMID: 16474760. 3Antonarakis, Emmanuel S et al. The natural history of metastatic progression in men with prostate-specific antigen recurrence after radical prostatectomy: long-term follow-up. BJU international vol. 109,1 (2012): 32-9. doi:10.1111/j.1464-410X.2011.10422 4Freedland, Stephen J. et al. "Improved Outcomes with Enzalutamide in Biochemically Recurrent Prostate Cancer." N Engl J Med 2023;389:1453-1465. DOI: 10.1056/NEJMoa2303974 5Astellas. Data on File. XTANDI patient. June 2025. Prostate Cancer: Types of Treatment (12-2022). Accessed June 16, 2025. 7 American Society of Clinical Oncology. ASCO Answers: Prostate Cancer (2023). 8 Ward JF, Moul JW. Rising prostate-specific antigen after primary prostate cancer therapy. Nat Clin Pract Urol. 2005 Apr;2(4):174-82. doi: 10.1038/ncpuro0145. PMID: 16474760. 9 Paller, Channing J et al. "Management of patients with biochemical recurrence after local therapy for prostate cancer." Hematology/oncology clinics of North America vol. 27,6 (2013): 1205-19, viii. doi:10.1016/ Category: Medicines View source version on Contacts Pfizer Media Contact: +1 (212) 733-1225PfizerMediaRelations@ Pfizer Investor Contact: +1 (212) 733-4848IR@ Astellas Contact: +1 (847) Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
