Pharmaceutical

  • Sera collected from participants 7 days after administration of a 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine showed a substantial increase in the Omicron BA.4/BA.5 neutralizing antibody response above pre-booster levels
  • Data suggest Omicron BA.4/BA.5-adapted bivalent booster is anticipated to provide better protection against Omicron BA.4/BA.5 sublineages than original vaccine across younger and older adults
  • Omicron BA.4/BA.5-adapted bivalent vaccine was well tolerated with early data showing a safety profile similar to that of the original vaccine
  • Additional data measuring responses at 1-month post-administration of the Omicron BA.4/BA.5-adapted bivalent vaccine booster are expected in the coming weeks

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced early data from a Phase 2/3 clinical trial ( NCT05472038 ) evaluating the safety, tolerability, and immunogenicity of the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221010005742/en/

A 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccine demonstrated a substantial increase in the Omicron BA.4/BA.5 neutralizing antibody response above pre-booster levels based on sera taken 7 days after administration, with similar responses seen across individuals aged 18 to 55 years of age and those older than 55 years of age (40 participants in each age group). When comparing responses in individuals older than 55 years of age who received either the bivalent vaccine, or the original vaccine, a 30-µg booster dose of the Original Pfizer-BioNTech COVID-19 Vaccine (also referred to as BNT162b2 Wild Type) elicited more limited increases in the neutralizing antibody response against the Omicron BA.4/BA.5 variants. COVID-19 vaccine responses to date have reliably shown consistent trends across age groups and are further supported by these early data on the bivalent vaccine. Together, these data suggest a 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccine is anticipated to provide better protection against the Omicron BA.4/BA.5 variants than the original vaccine for younger and older adults. The Omicron BA.4/BA.5-adapted bivalent vaccine was well tolerated with early data indicating a favorable safety profile, similar to that of the original vaccine.

"Since the earliest days of the pandemic, we have strived to transparently share data regarding our COVID-19 vaccines in the interest of public health," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "While we expect more mature immune response data from the clinical trial of our Omicron BA.4/BA.5-adapted bivalent vaccine in the coming weeks, we are pleased to see encouraging responses just one week after vaccination in younger and older adults. These early data suggest that our bivalent vaccine is anticipated to provide better protection against currently circulating variants than the original vaccine and potentially help to curb future surges in cases this winter."

"These preliminary findings are consistent with our preclinical data showing a substantial increase in the neutralizing antibody response against the Omicron sublineages BA.4 and BA.5," said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. "The current dominance of BA.4/BA.5 and related sublineages, underscores the importance of our data and science-based approach to develop a vaccine which is adapted to these prevalent strains of the virus and make it available in a timely manner."

Immunogenicity was evaluated using a SARS-CoV-2 live virus fluorescent focus reduction neutralization test (FFRNT) assay. Sera were collected 7 days post second booster dose from participants aged older than 55 (40 participants in each age group) and compared to 7-day post sera from 40 participants older than 55 years of age that had received three prior doses of BNT162b2 encoding the wild-type spike-protein of SARS-CoV-2 and a second booster with BNT162b2 Wild-Type. Sera were also collected at 7 days post second booster dose from participants 18 to 55 years of age who received the Omicron BA.4/BA.5-adapted bivalent booster (n=40) to compare bivalent vaccine responses in younger and older adults. The time between third and fourth doses for the bivalent vaccine recipients was approximately 11 months compared to approximately 6 months for the original vaccine. Despite this difference, baseline neutralizing antibody response was generally similar across groups. Among the participants, samples were equally stratified at baseline in each group between those who had a prior or current history of SARS-CoV-2 and those with no prior or current history of SARS-CoV-2.

Additional data measuring responses at one-month post-administration of the Omicron BA.4/BA.5 bivalent vaccine booster are expected in the coming weeks. These data will be used to support potential full licensure and global registration of the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. Additionally, the companies have initiated a similar Phase 1/2/3 trial ( NCT05543616 ) investigating the Omicron BA.4/BA.5-adapted bivalent vaccine among children 6 months through 11 years of age.

A 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccine has been authorized for emergency use by the U.S. Food and Drug Administration (FDA) for ages 12 years and older and has also been granted marketing authorization in the EU by the European Medicines Agency (EMA) for the same age group.

The Pfizer-BioNTech COVID-19 Vaccines (COMIRNATY®), which are based on BioNTech's proprietary mRNA technology, were developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 Wild Type and BNT162b2 Bivalent (WT/OMI BA.4/BA.5) in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

About the Phase 2/3 Study

This multicenter, randomized, controlled Phase 2/3 trial ( NCT05472038 ) has enrolled about 900 healthy volunteers 12 years of age and older in the U.S. who have received at least three doses of an authorized COVID-19 vaccine. During the trial, participants aged 18 and older received either a 30-µg or 60-µg booster dose of Pfizer and BioNTech's Omicron BA.4/BA.5-adapted COVID-19 vaccine and participants aged 12 through 17 years received a 30-µg booster of the same vaccine. Comparisons to support potential full licensure and registrations globally will be made with a control group who previously received a fourth dose with the original vaccine.

U.S. INDICATION & AUTHORIZED USE

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original And Omicron BA.4/BA.5)

AUTHORIZED USE

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is FDA-authorized under Emergency Use Authorization (EUA) for use in individuals 12 years of age and older as a single booster dose administered at least 2 months after either:

  • completion of primary vaccination with any authorized or approved monovalent* COVID-19 vaccine; or
  • receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

*Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus

COMIRNATY ® (COVID-19 Vaccine, mRNA)

INDICATION

COMIRNATY ® (COVID-19 Vaccine, mRNA) is a vaccine approved for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

AUTHORIZED USE

Primary Series

  • a third primary series dose to individuals 12 years of age and older who have certain kinds of immunocompromise

Pfizer-BioNTech COVID-19 Vaccine

AUTHORIZED USES

Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for use in individuals 6 months and older to provide:

Primary Series

  • a 3-dose primary series to individuals 6 months through 4 years of age
  • a 2-dose primary series to individuals 5 years through 11 years of age
  • a third primary series dose to individuals 5 years through 11 years of age with certain kinds of immunocompromise
  • a single booster dose to individuals 5 through 11 years of age who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine

EMERGENCY USE AUTHORIZATION

Emergency uses of the vaccines have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older for the Pfizer-BioNTech COVID-19 Vaccine and 12 years and older for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

IMPORTANT SAFETY INFORMATION

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), COMIRNATY ® (COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine

Tell your vaccination provider about all of your medical conditions, including if you:

  • have any allergies
  • have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
  • have a fever
  • have a bleeding disorder or are on a blood thinner
  • are immunocompromised or are on a medicine that affects the immune system
  • are pregnant, plan to become pregnant, or are breastfeeding
  • have received another COVID-19 vaccine
  • have ever fainted in association with an injection
  • The vaccine may not protect everyone
  • You should not get COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent if you have had a severe allergic reaction after a previous dose of COMIRNATY or the Pfizer-BioNTech COVID-19 Vaccine or any ingredient in these vaccines
  • There is a remote chance that these vaccines could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination. If you experience a severe allergic reaction, call 9-1-1 or go to the nearest hospital

Seek medical attention right away if you have any of the following symptoms: difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness

  • Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received COMIRNATY® (COVID-19 vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine. The observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males, and the observed risk is highest in males 12 through 17 years of age. In most of these people, symptoms began within a few days following receipt of the second dose of vaccine. The chance of having this occur is very low

Side effects that have been reported with these vaccines include:

  • Severe allergic reactions
  • Non-severe allergic reactions such as rash, itching, hives, or swelling of the face
  • Myocarditis (inflammation of the heart muscle)
  • Pericarditis (inflammation of the lining outside the heart)
  • Injection site pain
  • Tiredness
  • Headache
  • Muscle pain
  • Chills
  • Joint pain
  • Fever
  • Injection site swelling
  • Injection site redness
  • Nausea
  • Feeling unwell
  • Swollen lymph nodes (lymphadenopathy)
  • Decreased appetite
  • Diarrhea
  • Vomiting
  • Arm pain
  • Fainting in association with injection of the vaccine
  • Unusual and persistent irritability
  • Unusual and persistent poor feeding
  • Unusual and persistent fatigue or lack of energy
  • Unusual and persistent cool, pale skin

These may not be all the possible side effects of the vaccine. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.

Individuals should always ask their healthcare providers for medical advice about adverse events. Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1‐800‐822‐7967 or report online to www.vaers.hhs.gov/reportevent.html . In addition, individuals can report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985

Click for Fact Sheets and Prescribing Information for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5):
EUA Fact Sheet for Recipients and Caregivers (12 years of age and older)
EUA Fact Sheet for Vaccination Providers (12 Years & Up), BIVALENT (Original and Omicron BA.4/BA.5), DO NOT DILUTE, Gray Cap

Click for Fact Sheets and Prescribing Information for individuals 6 months of age and older:
Recipients and Caregivers Fact Sheet (6 months through 4 years of age)
Recipients and Caregivers Fact Sheet (5 through 11 years of age)
Recipients and Caregivers Fact Sheet (12 years of age and older)
COMIRNATY® Full Prescribing Information (12 years of age and older), DILUTE BEFORE USE, Purple Cap
COMIRNATY® Full Prescribing Information (12 years of age and older), DO NOT DILUTE, Gray Cap
EUA Fact Sheet for Vaccination Providers (6 months through 4 years of age), DILUTE BEFORE USE, Maroon Cap
EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and older), DILUTE BEFORE USE, Purple Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and older), DO NOT DILUTE, Gray Cap

About Pfizer: Breakthroughs That Change Patients' Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com . In addition, to learn more, please visit us on and follow us on Twitter at @Pfizer and @Pfizer News , LinkedIn , YouTube and like us on Facebook at Facebook.com/Pfizer .

Pfizer Disclosure Notice

The information contained in this release is as of October 13, 2022. 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's efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162b2 mRNA vaccine program, and the Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) (including the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine and early data from an ongoing phase 2/3 clinical trial, potential full licensure, a Phase 1/2/3 study in children aged 6 months through 11 years of age, qualitative assessments of available data, potential benefits, expectations for clinical trials, potential regulatory submissions, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply) involving 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, 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 risks associated with preclinical and clinical data (including Phase 1/2/3 or Phase 4 data), including the data discussed in this release for BNT162b2, any monovalent, bivalent or variant-adapted vaccine candidates or any other vaccine candidate in the BNT162 program in any of our studies in pediatrics, adolescents, or adults or real world evidence, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data, including the risk that additional data from the Phase 2/3 trial will differ from the early data discussed in this release; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies, in real world data studies or in larger, more diverse populations following commercialization; the ability of BNT162b2, any monovalent, bivalent or variant-adapted vaccine candidates or any future vaccine to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when submissions to request emergency use or conditional marketing authorizations for BNT162b2 in additional populations, for a potential booster dose for BNT162b2, any monovalent or bivalent vaccine candidates or any potential future vaccines (including potential future annual boosters or re-vaccination), and/or other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2, any monovalent or bivalent vaccine candidates or any other potential vaccines that may arise from the BNT162 program, including a potential variant-based, higher dose, or bivalent vaccine, and if obtained, whether or when such emergency use authorizations or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including any requested amendments to the emergency use or conditional marketing authorizations), any monovalent or bivalent vaccine candidates (including any potential submissions for an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine), or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine's benefits outweigh its known risks and determination of the vaccine's efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist which may lead to reduced revenues or excess inventory; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine's formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant-based or next generation vaccines; the risk that we may not be able to maintain or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; 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, 2021 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 .

About BioNTech

Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bispecific immune checkpoint modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.com .

BioNTech Forward-looking Statements

This press release contains "forward-looking statements" of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech's efforts to combat COVID-19; the collaboration between BioNTech and Pfizer including the program to develop a COVID-19 vaccine and COMIRNATY (COVID-19 vaccine, mRNA) (BNT162b2) (including early data regarding an Omicron-adapted COVID-19 bivalent vaccine based on the BA.4/BA.5 subvariant and its potential in adults 12 years of age and older and planned regulatory submissions, qualitative assessments of available data, potential benefits, expectations for clinical trials, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply); our expectations regarding the potential characteristics of BNT162b2, any monovalent or bivalent vaccine candidates or any future vaccine, in our clinical trials and/or in commercial use based on data observations to date; the ability of BNT162b2, any monovalent or bivalent vaccine candidates or any future vaccine, to prevent COVID-19 caused by emerging virus variants; 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 risks associated with preclinical and clinical data (including Phase 1/2/3 or Phase 4 data), including the data discussed in this release for BNT162b2, any monovalent or bivalent vaccine candidates or any other vaccine candidate in BNT162 program in any of our studies in pediatrics, adolescents, or adults or real world evidence, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the expected time point for additional readouts on efficacy data of BNT162b2, any monovalent or bivalent vaccine candidates or any future vaccine, in our clinical trials; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for, or receipt of, any marketing approval or Emergency Use Authorization; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures; the ability of BioNTech to supply the quantities of BNT162, any monovalent or bivalent vaccine candidates or any future vaccine, to support clinical development and market demand, including our production estimates for 2022; that demand for any products may be reduced or no longer exist which may lead to reduced revenues or excess inventory; the availability of raw materials to manufacture a vaccine; our vaccine's formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the ability to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant-based vaccines; the ability to maintain or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; and uncertainties regarding the impact of COVID-19 on BioNTech's trials, business and general operations. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; the ability to effectively scale our productions capabilities; and other potential difficulties.

For a discussion of these and other risks and uncertainties, see BioNTech's Quarterly Report as Form 6-K for the quarter ended June 30, 2022, filed with the SEC on August 8, 2022, which is available on the SEC's website at www.sec.gov . All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

Pfizer:
Media Relations
+1 (212) 733-1226
PfizerMediaRelations@pfizer.com

Investor Relations
+1 (212) 733-4848
IR@pfizer.com

BioNTech:
Media Relations
Jasmina Alatovic
+49 (0)6131 9084 1513
Media@biontech.de

Investor Relations
Sylke Maas, Ph.D.
+49 (0)6131 9084 1074
Investors@biontech.de

News Provided by Business Wire via QuoteMedia

PFE
Love Pharma Initiates First Steps Towards a Strategic Alliance with Starton Therapeutics with Investment in this Biotech Leader

Love Pharma Initiates First Steps Towards a Strategic Alliance with Starton Therapeutics with Investment in this Biotech Leader

  • Starton Therapeutics is a leading clinical stage Biotechnology Company based in New Jersey led by CEO and Chairman, Mr. Pedro Lichtinger, Former President of Global Primary Care & President of Europe at Pfizer (PFE - NYSE)
  • Starton is focused on transforming standard of care therapies with proprietary continuous delivery technologies for selected approved drugs. The platform creates superiority regarding safety and side effect profiles over the original and can transform the drug into new indications for best-in-class oncology therapies allowing patients to live better longer lives
  • Through this initial investment, Love Pharma will be in position to imminently leverage Starton's advancements and clinical breakthroughs, helping to guide and accelerate the Company's current and prospective clinical pursuits
  • The investment establishes initial interest in Starton's ongoing growth and advancements and provides the framework to build a long-term strategic relationship

Love Pharma Co. ("LOVE" and or "The Company") (CSE:LUV)(FSE:G1Q0), the Company is pleased to announce that it has made a strategic investment in Starton Therapeutics Inc., a New Jersey based clinical stage biotechnology company focused on transforming standard of care therapies in oncology. This first investment in Starton establishes an initial position in the company and provides the starting point for a strategic relationship going forward whereby Love will leverage Starton's advancements and breakthroughs to guide the Company's clinical pursuits

"This investment provides our shareholders with exposure to a rapidly developing therapeutics business, which has just completed its phase 1 clinical trial for its STAR - LLD continuous delivery technology deploying lenalidomide (July 13 press release)," said Mr. Zach Stadnyk, Love Pharma President and CEO. "Starton is also entering a phase 2 trial with its STAR - OLZ transdermal five - day adhesive matrix patch deploying olanzapine, for which the FDA US Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for STAR-OLZ in Chemotherapy Induced Nausea and Vomiting (CINV) (press release). With this investment in Starton we are building our relationship, forming an alliance and will look to Starton's expert management team to reduce risk in our own portfolio of clinical pursuits and focus on the addiction space."

News Provided by ACCESSWIRE via QuoteMedia

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LYRICA (pregabalin) Oral Solution CV Phase 3 Trial in Pediatric Epilepsy Meets Primary Endpoint

Pfizer (NYSE: PFE) announced today positive top-line results of a Phase 3 study examining the use of LYRICA® (pregabalin) Oral Solution CV as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age.

As quoted in the press release:

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Oxis Acquires Pharma Company, Appoints New CEO

Oxis International (OTCQB:OXIS) appoints new CEO and Chief Medical Officer as it completes acquisition of  Georgetown Translational Pharmaceuticals, which will add new management and a class of close-to-market Central Nervous Systems products.
As quoted in the press release:

Oxis has agreed to pay 33 percent of its outstanding shares to GTP to complete the transaction, which is expected to close on or before 90 days as per the agreement.
Dr. Clarence-Smith will become Chief Executive Officer of Oxis as part of the acquisition and will be appointed to the Oxis Board of Directors. Also joining the company’s executive management team as part of the merger will be a Chief Medical Officer (name to be disclosed upon closing), who was formerly Vice President and Chief Medical Officer and Medical Director, Oncology Clinical R&D of Pfizer, Inc. (PFE).
Anthony J. Cataldo, who has served as Chief Executive Officer of Oxis since July 2014, will become Executive Chairman of the company. Steven Weldon will continue as Chief Financial Officer.
Prior to founding GTP, Dr. Clarence-Smith co-founded Chase Pharmaceuticals Corporation in Washington D.C. and served as Chairman of the company’s Board from 2008 to 2014. Chase Pharmaceuticals was acquired by Allergan, PLC (AGN) in 2016.
Under the deal, Allergan agreed to pay $125 million upfront along with potential Regulatory and commercial milestones of up to $875 million to the shareholders of Chase.

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ICU Medical Completes the Acquisition of Hospira Infusion Systems from Pfizer

ICU Medical Inc. (NASDAQ:ICUI) today announced that it has completed its acquisition of the Hospira Infusion Systems business from Pfizer Inc. (NYSE:PFE). The Hospira Infusion Systems business includes IV pumps, solutions, and devices that, when combined with the company’s existing businesses, makes ICU Medical one of the world’s leading pure-play infusion therapy companies.
“We are pleased that Hospira Infusion Systems is now part of ICU Medical and welcome our new Hospira colleagues to the ICU team. We look forward to working together to continue providing quality, innovation and value to our clinical customers worldwide,” said Vivek Jain, chairman and chief executive officer at ICU Medical.The Hospira Infusion Systems acquisition complements ICU Medical’s existing business to create a company with a complete IV therapy product portfolio from solutions to pumps to non-dedicated infusion sets. In addition, the acquisition gives ICU Medical a significantly enhanced global footprint and platform for continued competitiveness and long-term growth. With an integrated product offering, the company now holds industry-leading positions in key segments and has access to the full US infusion marketplace with a compelling product portfolio.The company plans to announce full FY 2017 guidance on its Q4 Earnings call in late February.Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements contain words such as ”will,” ”expect,” ”believe,” ”could,” ”would,” ”estimate,” ”continue,” ”build,” ”expand” or the negative thereof or comparable terminology, and may include (without limitation) information regarding the Company’s expectations, goals or intentions regarding the future, including our full year 2016 guidance and our acquisition of the Hospira infusion systems business. These forward-looking statements are based on management’s current expectations, estimates, forecasts and projections about the Company and assumptions management believes are reasonable, all of which are subject to risks and uncertainties that could cause actual results and events to differ materially from those stated in the forward-looking statements. These risks and uncertainties include, but are not limited to, decreased demand for the Company’s products, decreased free cash flow, the inability to recapture conversion delays or part/resource shortages on anticipated timing, or at all, changes in product mix, increased competition from competitors, lack of continued growth or improving efficiencies, unexpected changes in the Company’s arrangements with its largest customers and the Company’s ability to meet expectations regarding the timing, completion and integration of the Hospira infusion systems business. Future results are subject to risks and uncertainties, including the risk factors, and other risks and uncertainties, described in the Company’s filings with the Securities and Exchange Commission, which include those in the Annual Report on Form 10-K for the year ended December 31, 2015 and our subsequent filings. Forward-looking statements contained in this press release are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.ICU Medical Investor Contacts:
Scott Lamb, ICU Medical, Inc.
949-366-2183
slamb@icumed.com
John Mills, ICR, Inc
646-277-1254
John.Mills@icrinc.com
Media Contact:
Tom McCall, ICU Medical, Inc.
949-366-4368
tmccall@icumed.com

Transgene Announces Collaboration with Merck and Pfizer to Evaluate the Combination of TG4001 with Avelumab

Transgene (Paris:TNG), a company focused on designing and developing targeted immunotherapies for the treatment of cancer and infectious diseases, today announced it has entered a collaboration agreement with the science and technology company Merck KGaA, Darmstadt, Germany, and Pfizer (NYSE: PFE) under which Transgene will sponsor a Phase 1/2 study evaluating the potential of the therapeutic vaccine candidate TG4001 in combination with avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, for the treatment of human papilloma virus- (HPV-) positive head and neck squamous cell carcinoma (HNSCC), after failure of standard therapy.
Philippe Archinard, Chairman and CEO of Transgene, commented: “We are
pleased to enter this collaboration with Merck KGaA, Darmstadt, Germany,
and Pfizer to evaluate our therapeutic vaccine TG4001 in association
with avelumab. In previous clinical trials, TG4001 has demonstrated
promising activity in terms of HPV viral clearance and was well
tolerated. TG4001 is one of the few drugs targeting HPV-associated
cancers that can be combined with an immune checkpoint blocker such as
avelumab. The preclinical and clinical data that have been generated
with both TG4001 and avelumab individually suggest this combination
could potentially demonstrate a synergistic effect, delivering a step up
in therapy for HPV-positive HNSCC patients
.”
The combination of TG4001 and avelumab aims to target two distinct steps
in the immune response to target cancer cells. This is an exclusive
agreement between the parties to study the combination of these two
classes of investigational agents in HPV-positive HNSCC.
Prof. Christophe Le Tourneau, M.D., Head of the Early Phase Program at
Institut Curie, and a world expert in ENT cancers, will be the Principal
Investigator of the Phase 1/2 study. This trial is expected to begin in
France, with the first patient expected to be recruited in H1 2017. It
will seek to recruit patients with recurrent and/or metastatic
virus-positive oropharyngeal squamous cell carcinoma that have
progressed after definitive local treatment or chemotherapy, and cannot
be treated with surgical resection and/or re-irradiation.
Prof. Christophe Le Tourneau said: “HPV-induced head and neck cancers
are currently treated with the same regimen as non-HPV-positive HNSCC
tumors. However, their different etiology clearly suggests that
differentiated treatment approaches are needed for HPV-positive
patients. Immunotherapy, and in particular the therapeutic vaccine
TG4001 together with the PD-L1 blocker avelumab, by targeting two
distinct steps in the immune response, could deliver improved efficacy
for patients who have not responded to or have progressed after a first
line of treatment.”

TG4001 is an active immunotherapeutic designed by Transgene to express
the coding sequences of the E6 & E7 tumor-associated antigens of HPV-16
and the cytokine, IL-2. This therapeutic vaccine, which is based on a
non-propagative, attenuated vaccinia vector (MVA), has already been
administered to more than 300 patients with high grade cervical
intra-epithelial neoplasia (CIN 2/3). It has demonstrated good safety, a
significant HPV clearance rate and promising efficacy results. Its
mechanism of action and good safety profile make TG4001 a particularly
appropriate candidate for combinations with other therapies, such as
avelumab.
Avelumab is an investigational, fully human antibody specific for a
protein found on tumor cells called PD-L1, or programmed death ligand-1.
As a checkpoint inhibitor, avelumab is thought to have a dual mechanism
of action that may potentially enable the immune system to find and
attack cancer cells. By binding to PD-L1, avelumab is thought to prevent
tumor cells from using PD-L1 for protection against white blood cells
such as T-cells, exposing them to anti-tumor responses. Avelumab is also
thought to help white blood cells such as natural killer (NK) cells find
and attack tumors in a process known as ADCC, or antibody-dependent
cell-mediated cytotoxicity. In 2014, the science and technology company
Merck KGaA, Darmstadt, Germany, and Pfizer signed a strategic alliance
to co-develop and co-commercialize avelumab.
Alise Reicin, M.D., Head of Global Clinical Development in the biopharma
business of Merck KGaA, Darmstadt, Germany, which in the US and Canada
operates as EMD Serono, commented: “We believe combination regimens
show significant promise in the development of novel and efficacious
immuno-oncology treatments. Through this study, we hope to discover the
potential of avelumab as a combination therapy with TG4001 for patients
fighting this recurring cancer.”

Chris Boshoff, M.D., Ph.D., Head of Immuno-Oncology, Early Development,
and Translational Oncology at Pfizer, said: “Through this
collaboration, we hope to better understand how therapeutic vaccines may
help support the clinical development program for avelumab as our end
goal is to find the best treatment options for patients.”

About HPV-mediated Head and Neck Cancer
Head and neck squamous cell carcinoma (HNSCC) is a heterogeneous group
of cancers that can affect the oral cavity, pharynx, and larynx. HPV-16
infection is recognized to participate in the development of a
substantial proportion of head and neck cancers and is associated with a
subset of HNSCC, especially those arising from the oropharynx (more than
80%), which are the most frequent, and the larynx (~70%).
The incidence of HPV-16-related head and neck cancer has significantly
increased in recent years. Although there are more than 100 subtypes of
HPV, HPV-16 accounts for 90% of all HPV-related head and neck cancers.
Global spending on head and neck cancer indications amounted to
$1 billion in 2010.
Current treatments include surgical resection with radiotherapy or
chemoradiotherapy. However, better options are needed for advanced and
metastatic HPV+ HNSCC. It is thought that immunotherapy combined with
immune checkpoint inhibitors could provide a promising potential
treatment option that would address this strong medical need.
About TG4001
TG4001 is an investigational therapeutic vaccine based on a
non-propagative, highly attenuated vaccinia vector (MVA), which is
engineered to express HPV-16 antigens (E6 & E7) and an adjuvant (IL-2).
It is one of the few therapies targeting HPV+ sub population. TG4001 is
designed to have a two-pronged antiviral approach: to alert the immune
system specifically to HPV-16-infected cells that have started to
undergo precancerous transformation (cells presenting the HPV-16 E6 and
E7 antigens) and to further stimulate the infection-clearing activity of
the immune system through interleukin 2 (IL-2). TG4001 has been
administered to more than 300 patients, demonstrating good safety,
significant HPV clearance rate and promising efficacy results. Its
mechanism of action and good safety profile make TG4001 an excellent
candidate for combinations with other therapies in solid tumors.
About Avelumab
Avelumab (also known as MSB0010718C) is an investigational, fully human
antibody specific for a protein found on tumor cells called PD-L1, or
programmed death ligand-1. Avelumab is thought to have a dual mechanism
of action which may enable the immune system to find and attack cancer
cells. By binding to PD-L1, avelumab is thought to prevent tumor cells
from using PD-L1 for protection against white blood cells such as
T-cells, exposing them to anti-tumor responses. Avelumab is also thought
to help white blood cells such as natural killer (NK) cells find and
attack tumors in a process known as ADCC, or antibody-dependent
cell-mediated cytotoxicity. In November 2014, Merck KGaA, Darmstadt,
Germany, and Pfizer announced a strategic alliance to co-develop and
co-commercialize avelumab.
About Transgene
Transgene S.A. (Euronext: TNG), part of Institut Mérieux, is a publicly
traded French biopharmaceutical company focused on designing and
developing targeted immunotherapies for the treatment of cancer and
infectious diseases. Transgene’s programs utilize viral vector
technology with the goal of indirectly or directly killing infected or
cancerous cells. The Company’s two lead clinical-stage programs are:
TG4010 for non-small cell lung cancer and Pexa-Vec for liver cancer. The
Company has several other programs in clinical and pre-clinical
development. Transgene is based in Strasbourg, France, and has
additional operations in Lyon, as well as a JV in China with Tasly
Group. Additional information about Transgene is available at www.transgene.fr.
Disclaimer
This press release contains forward-looking statements about the
future development of TG4001. Although the Company believes its
expectations are based on reasonable assumptions, these forward-looking
statements are subject to numerous risks and uncertainties, which could
cause actual results to differ materially from those anticipated. The
occurrence of any of these risks could have a significant negative
outcome for the Company’s activities, perspectives, financial situation,
results and development. The Company’s ability to commercialize its
products depends on but is not limited to the following factors:
positive pre-clinical data may not be predictive of human clinical
results, the success of clinical studies, the ability to obtain
financing and/or partnerships for product development and
commercialization, and marketing approval by government regulatory
authorities. For a discussion of risks and uncertainties which could
cause the Company’s actual results, financial condition, performance or
achievements to differ from those contained in the forward-looking
statements, please refer to the Risk Factors (“Facteurs de Risque”)
section of the Document de Référence, which is available on the AMF
website (
http://www.amf-france.org)
or on Transgene’s website (
www.transgene.fr).

Arvinas Announces ARV-471 Achieves a Clinical Benefit Rate of 38% in Evaluable Patients and Continues to Show a Favorable Tolerability Profile in its Phase 2 Expansion Trial

ARV-471 continues to show activity in heavily pre-treated patients with locally advanced or metastatic ER+/HER2- breast cancer

Median progression free survival of 3.7 months in all patients and 5.7 months in patients with ESR1 mutant tumors support the initiation of two Phase 3 registrational trials

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Merck Announces Phase 3 KEYNOTE-859 Trial Met Primary Endpoint of Overall Survival in Patients With HER2-Negative Gastric or Gastroesophageal Junction Adenocarcinoma

In KEYNOTE-859, KEYTRUDA ® (pembrolizumab) combined with chemotherapy demonstrated statistically significant overall survival, progression-free survival, and overall response rate for patients regardless of PD-L1 expression

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the pivotal Phase 3 KEYNOTE-859 trial investigating KEYTRUDA, Merck's anti-PD-1 therapy, in combination with chemotherapy for the first-line treatment of patients with human epidermal growth factor receptor 2 (HER2)-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. KEYTRUDA in combination with chemotherapy showed a statistically significant and clinically meaningful improvement in the trial's primary endpoint of overall survival (OS) versus chemotherapy alone in the all-randomized patient population at a pre-specified interim analysis conducted by an independent Data Monitoring Committee. Statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall response rate (ORR) were also observed in the all-randomized patient population.

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Merck to Present at the 5th Annual Evercore ISI HealthCONx Conference

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Dr. Eliav Barr, senior vice president and head of Global Clinical Development, chief medical officer, Merck Research Laboratories, is scheduled to participate in a virtual fireside chat at the 5th Annual Evercore ISI HealthCONx Conference on Thursday, Dec. 1, 2022 at 9:40 a.m. ET.

Investors, analysts, members of the media and the general public are invited to watch a live video webcast of the presentation at this weblink .

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Merck to Acquire Imago BioSciences, Inc.

Acquisition expands Merck's growing hematology portfolio

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Imago BioSciences, Inc. ("Imago") (Nasdaq: IMGO) today announced that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Imago for $36.00 per share in cash for an approximate total equity value of $1.35 billion.

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Albert Labs signs Letter of Intent  with iNGEN? CRO for First In-Human Clinical Studies

Albert Labs signs Letter of Intent with iNGEN? CRO for First In-Human Clinical Studies

Albert Labs International Corp. ( Albert Labs (CSE: ABRT) (FSE: VB50), the "Company"), a pharmaceutical drug development company focused on gaining regulatory approval for novel medicines to treat various mental health conditions, signs a Letter of Intent (LOI) with full-service Contract-Research Organisation (CRO), iNGENū, to carry out the Company's first in-human study of its primary drug target, KRN-101.

Albert Labs Inc. logo (CNW Group/Albert Labs International Corp.)

This randomised, double-blind study will evaluate the safety and tolerability of KRN-101 in study participants and determine its full pharmacokinetic characterization. As a unique, natural medicine containing a range of bioactives, KRN-101 is required to have its own pharmacokinetic profile despite an extensive background of safety data to support psilocybin-based medicines. Profiling KRN-101 through this study will allow the Company to reap the long-term potential of having a differentiated product through extensive opportunities for intellectual property protection.

This study will take place in Melbourne, Australia , and including the collection of all clinical outputs, will be carried out over 8 weeks with an expected completion in Q3 2023. Upon completion, KRN-101 will be available for use in late-stage clinical trials, allowing the Company to proceed with its Real World Evidence trial in the United Kingdom , which will establish the efficacy of the treatment for cancer-related distress. This first in-human study also allows the Company to collect valuable data which will enable a future Investigational New Drug (IND) Application to be filed with the FDA, thus taking KRN-101 to the largest pharmaceutical market in the world.

The Company will also benefit from the Australian Federal Government's Research & Development incentive programme which will provide cash rebates for 43.5% of all eligible costs relating to the study.

The study will be carried out by iNGENū, a full-service CRO specialising in clinical trials for psychoactive pharmaceuticals, who work with a network of specialist consultants and research facilities across the South-East Pacific region to facilitate high quality and cost-effective research.

Dr. Sud Agarwal , CEO of iNGENū: "It's a privilege to have been selected as the CRO by Albert Labs' team of highly credentialed research experts to take the KRN-101 investigational product into first-in-human studies in Australia ."

"This study will be conducted by iNGENū CRO at a globally renowned research unit in Melbourne , and will yield critical data to help characterise the pharmacokinetics of KRN-101 and establish a recommended late-stage dose for future clinical trials."

Dr. Michael Raymont , CEO of Albert Labs : "We have carefully considered a range of partners for our first in-human study and are delighted to come to this agreement with iNGENū. We have been impressed by their capabilities and see a strong alignment with our core values as a company. We also greatly appreciate the assistance of the Australian Government for carrying out this research.  Through this partnership we will provide the highest standard of clinical due diligence, and risk mitigation for planned late-stage trials in the UK through expansion into the United States . We feel that this is a significant step forward in value creation for our shareholders."

Business of Albert Labs International Corp.

Albert Labs is a pharmaceutical drug development company, focused on gaining regulatory approval for novel medicines for the treatment of mental health, and providing rapid access to effective prescription medicines for people suffering from mental health disorders. Its team of experts leverage advanced culture technology and natural extraction, coupled with a comprehensive regulatory approach, to accelerate the development of mental health drugs, for which the needs are both urgent and unmet. Albert Labs looks to develop solutions through an approved, fast track clinical pathway focusing on Real World Evidence (RWE). RWE studies are an increasingly recognized clinical route, heavily used in oncology and recently, in the successful development of COVID-19 vaccines.

Through collaborations with research institutions, hospital centres and government agencies, Albert Labs uses existing clinical infrastructure to deliver and improve patient access to its treatment. Albert Labs' first drug target, KRN-101, is a potential solution for cancer-related anxiety, a market of over 15 million people with roughly 1 million new sufferers each year. From this initial focus, Albert Labs will address broader mental health concerns, reported to affect over a billion people worldwide.

Albert Labs (CSE: ABRT) (FSE: VB50) is publicly listed on the Canadian Securities Exchange (CSE) .

You can find more details about Albert Labs on our website here .

ON BEHALF OF THE BOARD OF DIRECTORS

Albert Labs International Corp.

Dr. Michael Raymont

Chief Executive Officer & Chairman

Cautionary Statement

This news release includes forward-looking statements that are subject to assumptions, risks, and uncertainties. Statements in this news release that are not purely historical are forward-looking statements, including without limitation any statements concerning the Company's intentions, plans, estimates, beliefs, or expectations regarding the future. Although the Company believes that any such intentions, plans, estimates, beliefs, and expectations in this news release are reasonable, there can be no assurance that any such intentions, plans, beliefs, and expectations will prove to be accurate.

The Company cautions readers that all forward-looking statements, including without limitation those relating to the Company's future operations and business prospects, are based on assumptions none of which can be assured, and are subject to certain risks and uncertainties that could cause actual events or results to differ materially from those indicated in the forward-looking statements. Readers are advised to rely on their evaluation of such risks and uncertainties and should not place undue reliance on forward-looking statements.

Any forward-looking statements are made as of the date of this news release, and the Company assumes no obligation to update the forward-looking statements or to update the reasons why actual events or results could or do differ from those projected in the forward-looking statements. The Company assumes no obligations to update any forward-looking statements, whether as a result of new information, future events, or otherwise unless required by the applicable securities laws.

SOURCE Albert Labs International Corp.

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/November2022/17/c3259.html

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LYNPARZA® in Combination With Abiraterone and Prednisone or Prednisolone Receives Positive Opinion From EU CHMP as Treatment for Certain Patients With Metastatic Castration-Resistant Prostate Cancer

First PARP inhibitor to demonstrate clinical benefit in radiographic progression-free survival in combination with a new hormonal agent with or without homologous recombination repair gene mutations

AstraZeneca and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of LYNPARZA in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated.

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