Pharmaceutical

 Pfizer and BioNTech Receive Expanded U.S. Emergency Use Authorization for an Additional COVID-19 Vaccine Booster in Individuals Aged 50 Years and Older

  • FDA also authorizes second booster dose for individuals 12 years of age and older who have certain kinds of immunocompromise
  • Second booster dose is intended to offer increased protection against severe disease and hospitalization for individuals who are most vulnerable

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) has expanded the emergency use of their COVID-19 vaccine to include a second booster dose in adults ages 50 years and older who have previously received a first booster of any authorized COVID-19 vaccine. The FDA also has authorized a second booster dose for individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise and who have received a first booster dose of any authorized COVID-19 vaccine. The additional booster is to be administered at least four months after the first booster and is the same formulation and strength as prior Pfizer-BioNTech COVID-19 vaccine doses.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220328005745/en/

The expanded EUA is based on the totality of scientific evidence shared by the companies including immunogenicity data from an ongoing, open-label study in 154 healthcare workers 18 years of age and older at a single center in Israel who received two booster doses during a period when Omicron was the predominant variant. Among these individuals, approximately 11-fold increases in geometric mean neutralizing antibody titers against wild-type virus, and Delta and Omicron variants, respectively, were reported at two weeks after the second booster as compared to 5 months after the first booster dose. 1 No new safety concerns were noted among study participants. 1 The companies also shared with the FDA data from the U.S. and elsewhere showing a decline in vaccine effectiveness against COVID-19 3 to 6 months after the initial booster, 2-6 and evidence from Israel that an additional booster dose can improve protection against severe disease and death. 7-9

Together, these data demonstrate the public health need in the most vulnerable individuals and suggest that an additional booster dose of the Pfizer-BioNTech COVID-19 Vaccine administered at least four months after the initial booster may restore antibody levels, 1 improve protection in older people, 7-9 and provide a similar safety profile to that of previous doses. 1 These emerging data underscore the importance of considering an additional booster dose for all individuals included in this EUA.

The Pfizer-BioNTech COVID-19 Vaccine was previously authorized under EUA as a single booster administered to individuals aged 12 and older who have completed the primary vaccination series with the Pfizer-BioNTech COVID-19 Vaccine, as well as to individuals aged 18 and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The second booster authorized today for those age 50 years and older is meant to extend high levels of protection against COVID-19 for the most vulnerable populations in advance of potential future waves.

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech's proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada 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.

U.S. Indication & Authorized Use

HOW IS THE VACCINE GIVEN?

The vaccine will be given as an injection into the muscle.

Primary Series:

In individuals 5 years of age and older, the vaccine is administered as a 2-dose series, 3 weeks apart. In individuals 5 years of age and older, a third primary series dose may be administered at least 28 days after the second dose to individuals who are determined to have certain kinds of immunocompromise.

Booster Dose:

  • A first booster dose of the vaccine may be administered at least 5 months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) to individuals 12 years of age and older
  • A first booster dose of the vaccine may be administered to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. Individuals should check with their healthcare provider regarding timing of the booster dose
  • A second booster dose may be administered to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any of authorized COVID-19 vaccine.
  • A second booster dose of the vaccine may be administered at least 4 months after receipt of a first booster dose of any authorized COVID-19 vaccine to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise.

WHAT IS THE INDICATION AND AUTHORIZED USE?

The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably. Although they may be manufactured in different facilities, the products offer the same safety and effectiveness.

The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide:

  • a 2-dose primary series to individuals 5 years of age and older
  • a third primary series dose to individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise
  • a single booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
  • a single booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
  • a second booster dose may be administered to individuals 50 years of age and older who have received a first booster dose of any authorized COVID-19 vaccine; and
  • a second booster dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise and who have received a first booster dose of any authorized COVID-19 vaccine.

COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.

  • It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older
  • It is also authorized under EUA to provide:
    • a 2-dose primary series to individuals 12 through 15 years of age
    • a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
    • a single booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
    • a single booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
    • a second booster dose may be administered to individuals 50 years of age and older who have received a first booster dose of any authorized COVID-19 vaccine; and
    • a second booster dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise and who have received a first booster dose of any authorized COVID-19 vaccine.

EUA Statement

Emergency uses of the vaccine 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 5 years of age and older. 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. Please see EUA Fact Sheet at www.cvdvaccine-us.com .

IMPORTANT SAFETY INFORMATION

Individuals should not get the vaccine if they:

  • had a severe allergic reaction after a previous dose of this vaccine
  • had a severe allergic reaction to any ingredient of this vaccine

Individuals should tell the vaccination provider about all of their medical conditions, including if they:

  • 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.

Side effects reported with the vaccine include:

  • There is a remote chance that the vaccine 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, vaccination providers may ask individuals to stay at the place where they received the vaccine for monitoring after vaccination
    • Signs of a severe allergic reaction can include difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness
    • If an individual experiences a severe allergic reaction, they should call 9-1-1 or go to the nearest hospital
  • Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine, more commonly in males under 40 years of age than among females and older males. In most of these people, symptoms began within a few days following receipt of the second dose of the vaccine. The chance of having this occur is very low. Individuals should seek medical attention right away if they have any of the following symptoms after receiving the vaccine:
  • chest pain
  • shortness of breath
  • feelings of having a fast-beating, fluttering, or pounding heart
  • Additional side effects that have been reported with the vaccine 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
  • These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away

Data on administration of this vaccine at the same time as other vaccines have not yet been submitted to FDA. Individuals considering receiving this vaccine with other vaccines should discuss their options with their healthcare provider.

Patients should always ask their healthcare providers for medical advice about adverse events. Individuals are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit https://www.vaers.hhs.gov or call 1‐800‐ 822‐7967. In addition, side effects can be reported to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.

Click for

Fact Sheets and Prescribing Information for individuals 12 years of age and older

Full Prescribing Information (16 years of age and older) DILUTE BEFORE USE, purple cap

Full Prescribing Information (16 years of age and older) DO NOT DILUTE, gray cap

EUA Fact Sheet for Vaccination Providers (12 years of age and older), Purple Cap

EUA Fact Sheet for Vaccination Providers (12 years of age and older), Gray Cap

Recipients and Caregivers Fact Sheet (12 years of age and older)

Fact Sheets for individuals 5 through 11 years of age

EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), Orange Cap

Recipients and Caregivers Fact Sheet (5 through 11 years of age)

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 www.Pfizer.com 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 March 29, 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 emergency use authorization in the U.S. of a second booster dose in adults ages 50 and older who have previously received a booster of any authorized COVID-19 vaccine and a second booster dose for individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise and who have received a first booster dose of any authorized COVID-19 vaccine, 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) for BNT162b2 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; 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 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 or any potential future vaccines (including potential future annual boosters or re-vaccinations) 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 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) 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; 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 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, bi-specific checkpoint immuno-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, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de .

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 emergency use authorization in the U.S. of a second booster dose in adults ages 50 and older who have previously received a booster of any authorized COVID-19 vaccine and a second booster dose for individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise and who have received a first booster dose of any authorized COVID-19 vaccine, 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 in our clinical trials, real world data studies, and/or in commercial use based on data observations to date; the ability of BNT162b2 or a future vaccine to prevent COVID-19 caused by emerging virus variants; the expected time point for additional readouts on efficacy data of BNT162b2 in our clinical trials; 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 BNT162, or any future vaccine, in additional populations, or receipt of, any marketing approval or emergency use authorization or equivalent, including or amendments or variations to such authorizations; the development of other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant based vaccines; 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 to support clinical development and market demand, including our production estimates for 2022; challenges related to public vaccine confidence or awareness; 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; the availability of raw material to manufacture BNT162 or other vaccine formulation; 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; 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 Annual Report as Form 20-F for the Year Ended December 31, 2020, filed with the SEC on March 30, 2021, 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.

  1. Regev-Yochay G, Gonen T, Gilboa M, et al. Efficacy of a Fourth Dose of Covid-19 mRNA Vaccine against Omicron. https://www.nejm.org/doi/full/10.1056/NEJMc2202542 . Published online March 16, 2022. doi: 10.1056/NEJMc2202542
  2. COVID-19 vaccine surveillance report – Week 9. UK Health Security Agency. Published March 17, 2022. Accessed March 16, 2022. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1058464/Vaccine-surveillance-report-week-9.pdf
  3. Andrews N, Stowe J, Kirsebom F, et al. Covid-19 Vaccine Effectiveness against the Omicron (B.1.1.529) Variant. https://doi.org/101056/NEJMoa2119451 . Published online March 2, 2022. doi:10.1056/NEJMOA2119451
  4. Tartof SY, Slezak JM, Puzniak L, et al. BNT162b2 (Pfizer–Biontech) mRNA COVID-19 Vaccine Against Omicron-Related Hospital and Emergency Department Admission in a Large US Health System: A Test-Negative Design. SSRN Electronic Journal . Published online January 20, 2022. doi:10.2139/SSRN.4011905
  5. Chemaitelly H, Ayoub HH, Almukdad S, et al. Duration of protection of BNT162b2 and mRNA-1273 COVID-19 vaccines against symptomatic SARS-CoV-2 Omicron infection in Qatar. medRxiv . Published online February 8, 2022:2022.02.07.22270568. doi:10.1101/2022.02.07.22270568
  6. Ferdinands JM, Rao S, Dixon BE, et al. Waning 2-Dose and 3-Dose Effectiveness of mRNA Vaccines Against COVID-19-Associated Emergency Department and Urgent Care Encounters and Hospitalizations Among Adults During Periods of Delta and Omicron Variant Predominance - VISION Network, 10 States, August 2021-January 2022. MMWR Morbidity and mortality weekly report . 2022;71(7):255-263. doi:10.15585/MMWR.MM7107E2
  7. Bar-On YM, Goldberg Y, Mandel M, et al. Protection by 4th dose of BNT162b2 against Omicron in Israel. medRxiv . Published online February 1, 2022:2022.02.01.22270232. doi:10.1101/2022.02.01.22270232
  8. Gazit S et al. Relative Effectiveness of Four Doses Compared to Three Doses of the BNT162b2 Vaccine in Israel. medRXiv. Published online March 24, 2022:2022.03.24.22272835. doi:10.1101/2022.03.24.22272835
  9. Arbel et al. Second Booster Vaccine and Covid-19 Mortality in Adults 60 to 100 Years Old \. 24514bba-2c9d-4add-9d8f-321f610ed199.pdf (researchsquare.com)

Pfizer:
Media Relations
+1 (212) 733-7410
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

Keep reading...Show less

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:

Keep reading...Show less

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.

Keep reading...Show less

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).

PFIZER REPORTS RECORD FULL-YEAR 2022 RESULTS AND PROVIDES FULL-YEAR 2023 FINANCIAL GUIDANCE

  • Full-Year 2022 Revenues of $100.3 Billion, An All-Time High for Pfizer, Reflecting 30% Operational Growth
    • Excluding Contributions from Paxlovid and Comirnaty (1) , Revenues Grew 2% Operationally
  • Strong Fourth-Quarter 2022 Revenues of $24.3 Billion, Reflecting 13% Operational Growth
    • Excluding Contributions from Paxlovid and Comirnaty (1) , Revenues Grew 5% Operationally
  • Full-Year 2022 Reported Diluted EPS (2) of $5.47, Up 42% Year-Over-Year, and Adjusted Diluted EPS (3) of $6.58, Up 62% Year-Over-Year, Both of Which Represent All-Time Highs for Pfizer
  • Fourth-Quarter 2022 Reported Diluted EPS (2) of $0.87, Up 48% Year-Over-Year, and Adjusted Diluted EPS (3) of $1.14, Up 45% Year-Over-Year
    • Includes a $0.32 Benefit from Lower Acquired IPR&D Expenses Compared to Fourth-Quarter 2021
  • Provides Full-Year 2023 Revenue Guidance (4) of $67.0 to $71.0 Billion and Adjusted Diluted EPS (3) Guidance of $3.25 to $3.45
    • Full-Year 2023 Revenues Excluding COVID-19 Products Expected to Grow 7% to 9% Operationally Compared to Full-Year 2022
    • Full-Year 2023 Revenue Guidance for Comirnaty (1) of ~$13.5 Billion and Paxlovid of ~$8 Billion
    • Revenues from COVID-19 Products Expected to Grow in 2024 After Reaching a Low Point in 2023 Due to Significant Government Supply on Hand to Start the Year
    • Company Plans to Make Significant Incremental Investments in 2023 to Support Launch Products and R&D Projects that are Expected to Drive its Long-Term Growth Ambitions
  • Continues to Make Progress on Pfizer's Unprecedented Number of Anticipated Launches of New Products and Indications, Including Recent Regulatory Filing Acceptances for Prevnar 20 Pediatric, its RSV Vaccine for Older Adults, Etrasimod, and its Pentavalent Meningococcal Vaccine

Pfizer Inc. (NYSE: PFE) reported exceptional financial results for fourth-quarter and full-year 2022 and provided 2023 financial guidance (4) .

The fourth-quarter 2022 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to Pfizer's R&D pipeline can be found at www.pfizer.com .

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

FDA Approves KEYTRUDA® as Adjuvant Treatment Following Surgical Resection and Platinum-Based Chemotherapy for Patients With Stage IB , II, or IIIA Non-Small Cell Lung Cancer

Approval based on KEYNOTE-091 trial, which demonstrated a clinically meaningful improvement in disease-free survival with KEYTRUDA in these patients following surgical resection and platinum-based chemotherapy versus placebo

Approval marks fifth indication for KEYTRUDA-based regimens in NSCLC and 34th indication for KEYTRUDA in the US

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Merck Animal Health Receives U.S. FDA Approval of Expanded Indication for BRAVECTO Chews for Dogs

Portfolio expansion provides dogs broad-spectrum protection against Asian longhorned ticks

Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA (NYSE:MRK), today announced the U.S. Food and Drug Administration's approval of an expanded indication for BRAVECTO ® Chews for Dogs. The new indication treats and controls Asian longhorned ticks, which are an invasive Ixodid species located across more than one-third of the U.S 1,2 .

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

BetterLife Announces Engagement of Bloom Burton Securities Inc. and Provides Summary of 2022 Accomplishments

BetterLife Pharma Inc. ("BetterLife" or the "Company") (CSE: BETR  OTCQB: BETRF FRA: NPAU ), an emerging biotech company focused on the development and commercialization of cutting-edge treatments for mental disorders, is pleased to announce the engagement of Bloom Burton Securities Inc. ("Bloom Burton") for strategic advisory services to support BetterLife's growth and development initiatives towards clinical trials.

"We are very excited to be working with Bloom Burton, Canada's leading healthcare investment banking firm," said Ahmad Doroudian, CEO of BetterLife. "Bloom Burton has extensive understanding of the overall biotechnology and healthcare landscape and the emerging psychedelics space specifically, which will help advance our clinical trial initiatives and accomplish our financing needs."

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Merck Announces KEYNOTE-991 Trial Evaluating KEYTRUDA® Plus Enzalutamide and Androgen Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer to Stop for Futility

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that it will stop the Phase 3 KEYNOTE-991 trial investigating KEYTRUDA, Merck's anti-PD-1 therapy, in combination with enzalutamide and androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). Merck is discontinuing the study based on the recommendation of an independent Data Monitoring Committee which reviewed data from a planned interim analysis. At the interim analysis, KEYTRUDA in combination with enzalutamide and ADT did not demonstrate an improvement in overall survival (OS) or radiographic progression-free survival (rPFS), the trial's dual primary endpoints, compared to placebo plus enzalutamide and ADT. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. No new safety signals were identified; however, the combination was associated with a higher incidence of Grade 3-5 adverse events and serious adverse events compared to the control arm. Merck is informing study investigators of the decision and advises patients in the study to speak to their physician regarding treatment. Data from this study will be presented at an upcoming medical meeting.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Merck's KEYTRUDA® Plus Chemotherapy Significantly Improved Overall Survival Versus Chemotherapy in First-Line Advanced or Unresectable Biliary Tract Cancer in KEYNOTE-966 Trial

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive results from the Phase 3 KEYNOTE-966 trial. In the final analysis of this trial, KEYTRUDA, Merck's anti-PD-1 therapy, in combination with standard of care chemotherapy (gemcitabine and cisplatin) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus chemotherapy alone for the first-line treatment of patients with advanced or unresectable biliary tract cancer (BTC). The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. Results will be presented at an upcoming medical meeting and will be submitted to regulatory authorities.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×