Proxy Statement 2021
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Pfizer's Bourla
No. 3985 December 13, 2019 line success and business development. “In the next two years, we need to see how the pipeline is delivering,” he said. Bourla has been outspoken that when it comes to business development, he doesn’t see a mega-merger on the hori- zon. Instead, he said he is looking to bring in mid-stage clinical development assets to complement the internal pipeline. It sounds like investors can expect the company to be active on the business development front within those guard- rails. “I want to double it,” he said of the pipeline, which includes 92 projects right now. “And, we are going to double it by bringing in a lot of innovation to comple- ment what we distribute.” The company is focusing business de- velopment on six core therapeutic areas Pfizer’s Bourla: “I Think We Forgot as well, but Bourla indicated the company will be actively building out those areas both through internal investment and What It Looks Like To Grow” external collaboration. “We’re going to be JESSICA MERRILL [email protected] active because Pfizer is a very big plane and it cannot fly with one engine,” he said. fizer Inc. CEO Albert Bourla took in July it will merge the Upjohn business Bourla highlighted Pfizer’s recent acqui- over the top leadership spot from with Mylan NV to form a new generic drug sition of the cancer specialist Array Bio- PIan Read a year ago, but has quickly company to be called Viatris GMBH. Pharma for $11.4bn as an example of the executed on big changes poised to make The resulting Pfizer will be significantly kinds of deals the company will be pursu- Pfizer significantly smaller and faster smaller, with a 2020 annual revenue base ing. -
Q1 Pharma Sector Snapshot
SPECIALTY & GENERIC PHARMA Q1 2021 Report Market Commentary – Debt Capital Markets Debt Markets ▪ 2020 saw increased amounts of debt used in buyouts across the board, resulting in the highest debt / EBITDA Median US Buyout Multiples levels since 2014 − The increased use of debt was driven by 2H20 back- end loaded lending activity (primarily 4Q20) as 16.0x 12.7x 14.1x 12.2x 12.0x 11.6x 11.5x certainty around the U.S. election and vaccination 11.1x 10.0x 9.8x 12.0x 9.7x expectations increased 9.4x 8.6x 8.3x 8.2x 7.5x 7.8x 5.2x 6.7x 5.7x 5.6x ▪ 8.0x 5.9x As the effects of COVID now begin to diminish, debt 5.4x 4.4x 4.1x 3.7x 4.6x 4.3x 3.8x markets have seemingly recovered, signaling that 3.6x lenders have become increasingly comfortable with 4.0x 4.3x 6.9x 6.5x 6.3x 6.0x 5.9x 5.7x 5.7x 5.7x 5.7x 5.6x 5.3x 4.5x 4.4x macroeconomic and company-specific fundamentals 4.3x 0.0x 3.2x − With increased confidence, lenders are currently looking to provide strong leverage for high-quality assets, particularly ones that have proven their Debt/EBITDA Equity/EBITDA EV/EBITDA stability through the recent market downturn Source: PitchBook ▪ The spread on U.S. high-yield debt has returned to pre- Historical US High Yield Debt Effective Yield COVID levels − 4.22% current effective yield compared with a 12.0% 11.4% 11.38% effective yield on March 23, 2020 (peak of the pandemic) 9.0% ▪ We expect increased activity by lenders in 2021 due to: 6.0% 4.2% − Pent-up demand in M&A activity driven by the impact of COVID 3.0% − Limited Partner agreements and investor -
Combination Medications
Combination Medications WHAT ARE COMBINATION MEDICATIONS? Combination medications are pills, tablets, or injections that contain more than one medication to treat HIV. They are listed in the tables below. Pharmaceutical companies have been working hard to make their medications easier to take. Part of this effort has been to combine more than one medication into a single pill. These combinations are referred to as fixed-dose combinations (FDCs). Combinationantiretroviral therapy (ART), sometimes called highly active antiretroviral therapy (HAART), has revolutionized the management of HIV infection and rendered it a chronic manageable disease. The first FDC to treat HIV wasCombivir , manufactured by ViiV Healthcare. Combivir contains two nucleoside reverse transcriptase inhibitors (NRTIs): lamivudine and zidovudine. This was followed byTrizivir , also manufactured by ViiV Healthcare. Trizivir includes three NRTIs:abacavir , lamivudine, and zidovudine. Both Combivir and Trizivir are no longer widely used in the U.S. due to the frequency and severity of side effects. Be sure that you do not take a combination medication along with any of its components!For example, do not take Truvada (which contains emtricitabine and tenofovir DF) with tenofovir DF (Viread) or emtricitabine (Emtriva). Your healthcare provider will help you decide which HAART regimen is best for you; take your medications exactly as your healthcare provider tells you to. TABLE OF COMBINATION HIV MEDICATIONS Brand name Year Approved Individual Components Also Known As Manufacturer -
How Jews Change the World - the Jerusalem Post
1/7/2021 How Jews change the world - The Jerusalem Post Jerusalem Post > Opinion How Jews change the world It comes as no surprise that two Jews, Bourla and Zaks, are spearheading two COVID- 19 vaccines to which many may one day soon owe their lives. By SHLOMO MAITAL DECEMBER 22, 2020 12:28 8000 British author Norman Lebrecht faces the media holding his Whitbread Book of the Year Award entry, 'The Song of Names,' in London in 2003. (photo credit: REUTERS) Advertisement ~ Listen to this article now \l:V 09:18 Powered by Trinity Audio https://www.jpost.com/jerusalem-report/how-jews-change-the-world-652199 1/6 1/7/2021 How Jews change the world - The Jerusalem Post Report~ A Greek Jew, two Turkish-born Germans, a Lebanese Armenian and an Israeli walk into a bar. Actually - not a bar, but a research lab. And it's not a joke. It's about brilliant people, all of them emigres, some Jewish, whose vaccines will hopefully save countless lives in Israel and the world. And there is a back story - about a century of Jewish genius that changed the world. It is recounted brilliantly by Norman Lebrecht, a British journalist and novelist, and graduate of Bar-llan University, in his book Genius and Anxiety: HowJews Changed the World, 1847-1947. Let's begin with the vaccine. On Friday, November 13, Prime Minister Benjamin Netanyahu signed a deal with the giant US pharmaceutical company Pfizer to purchase millions of coronavirus vaccine doses. It was only days after Pfizer announced clinical trials showed the vaccine was 90% effective at preventing COVID-19. -
Big Pharma Freshens Up
April 09, 2021 Big pharma freshens up Amy Brown Reliance on established drugs lessened for most large drug makers last year, but staleness is creeping in at Merck and Bristol. All successful drug franchises must one day fade – the challenge comes in finding replacements. It is encouraging therefore to see that almost all major developers improved on the sales freshness index last year, versus 2019, with a couple of notable exceptions. This percentage measure is derived from the proportion of a company’s prescription drug sales that come from products more than 10 years old. Scores range widely within the cohort, showing that some groups have much more work to do than others. Take Abbvie, with 74% of 2020’s drug sales derived from drugs at least a decade old, compared with a much fresher Astrazeneca, at 44%. Abbvie is still very reliant on its mega-blockbuster Humira – the autoimmune antibody contributed 44% of the company’s drugs sales last year – and the big pharma group’s freshness score has not shifted from 2019, when Evaluate Vantage last ran these numbers (Sanofi's geriatric pipeline fails to freshen up, January 22, 2020). Astrazeneca was at the other end of the scale last time and its performance improved again in 2020. The previous laggard Sanofi, meanwhile, has the huge success of Dupixent to thank for its big shift towards the fresher end of the group. The French company’s departure from the top of the table leaves Abbvie, Pfizer and Roche as the stalest big pharma groups, and arguably under the most pressure to find new sales sources. -
Pfizer and Biontech Announce Collaboration with Biovac to Manufacture and Distribute COVID-19 Vaccine Doses Within Africa
Pfizer and BioNTech Announce Collaboration with Biovac to Manufacture and Distribute COVID-19 Vaccine Doses within Africa July 21, 2021 NEW YORK and MAINZ, GERMANY, July 21, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac”, a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 vaccine for distribution within the African Union. Biovac will perform manufacturing and distribution activities within Pfizer’s and BioNTech’s global COVID-19 vaccine supply chain and manufacturing network, which will now span three continents and include more than 20 manufacturing facilities. To facilitate Biovac’s involvement in the process, technical transfer, on-site development and equipment installation activities will begin immediately. Pfizer and BioNTech expect that Biovac’s Cape Town facility will be incorporated into the vaccine supply chain by the end of 2021. Biovac will obtain drug substance from facilities in Europe, and manufacturing of finished doses will commence in 2022. At full operational capacity, the annual production will exceed 100 million finished doses annually. All doses will exclusively be distributed within the 55 member states that make up the African Union. “From day one, our goal has been to provide fair and equitable access of the Pfizer-BioNTech COVID-19 vaccine to everyone, everywhere,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Our latest collaboration with Biovac is a shining example of the tireless work being done, in this instance to benefit Africa. We will continue to explore and pursue opportunities to bring new partners into our supply chain network, including in Latin America, to further accelerate access of COVID-19 vaccines.” “We aim to enable people on all continents to manufacture and distribute our vaccine while ensuring the quality of the manufacturing process and the doses,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. -
Valeant Pharmaceuticals International, Inc. 2012 Annual Report Valeant Inc
Valeant Pharmaceuticals International, Inc. 2012 Annual Report Valeant Pharmaceuticals International, Inc. 2012 Annual Report Valeant Gathering Momentum Company Overview Valeant Pharmaceuticals International, Inc. (NYSE/TSX:VRX) is a multinational specialty pharmaceutical company that develops and markets prescription and non-prescription pharmaceutical products that make a meaningful difference in patients’ lives. Valeant’s primary focus is principally in the areas of dermatology and neurology. The Company’s growth strategy is to acquire, develop and commercialize new products through strategic partnerships, and build on the company’s strength in dermatology and neurology. Valeant plans to strategically expand its pipeline by adding new compounds or products through product or company acquisitions and will maximize its pipeline through strategic partnering to optimize its research and development assets and strengthen ongoing internal development capabilities. Valeant’s strategic markets are primarily in the United States, Canada, Central and Eastern Europe, Latin America, Australia and South East Asia. Headquartered in Montreal, Quebec, Valeant has approximately 7,000 employees worldwide. FORWARD-LOOKING Statements In addition to current and historical information, this Annual Report contains forward-looking statements, including, without limitation, statements regarding our strategy, expected future revenue, the prospects for approval of product candidates and the timing of regulatory approvals, and the growth and future development of the company, its business units and its products. Words such as “expects,” “anticipates,” “intends,” “plans,” “should,” “could,” “would,” “may,” “will,” “believes,” “estimates,” “potential,” or “continue” or similar language identify forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties. Our actual results may differ materially from those contemplated by the forward-looking statements. -
Pfizer and Biontech Receive First U.S. Authorization for Emergency Use of COVID-19 Vaccine in Adolescents
Pfizer and BioNTech Receive First U.S. Authorization for Emergency Use of COVID-19 Vaccine in Adolescents May 11, 2021 In a Phase 3 trial, the vaccine was 100% effective and generally well tolerated in participants aged 12 to 15 years Data also submitted to European Medicines Agency (EMA) and other global regulators, with additional authorizations expected in coming weeks NEW YORK and MAINZ, GERMANY, May 11, 2021 —Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for their COVID-19 vaccine to include individuals 12 to 15 years of age. This is the first COVID-19 vaccine authorized in the U.S. for use in this age group. “Today’s expansion of our EUA represents a significant step forward in helping the U.S. government broaden its vaccination program and help protect adolescents before the start of the next school year,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We are grateful to all of our clinical trial volunteers and their families, whose courage helped make this milestone possible. Together, we hope to help bring a sense of normalcy back to young people across the country and around the world.” The FDA based its decision on data from a pivotal Phase 3 clinical trial, which enrolled 2,260 participants aged 12 to 15 years. Topline results from this trial, announced on March 31, 2021, showed a vaccine efficacy of 100% in participants with or without prior SARS-CoV-2 infection and robust antibody responses. -
April 16, 2021
April 16, 2021 Dear <<First Name>>, Welcome to this week's issue of the California Pharmacists Association's CEO Message. IN THIS ISSUE Emerging Role of Pharmacists on the Front Line of Vaccine Administration Now that we have been at the front and center of this whole vaccine for COVID-19 and its protocols, the role of pharmacists as a frontline vaccinator and administration has really emerged with this pandemic. [Read Article] Burnout and the Challenges Facing Pharmacists during COVID-19: Results of a National Survey Background COVID-19 has impacted the psychological wellbeing of healthcare workers and has forced pharmacists to adapt their services. [Read Article] Joint CDC and FDA Statement on Johnson & Johnson COVID-19 Vaccine As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. [Read Article] How Pharmacists Can Protect Patients from Outdated COVID-19 Treatment Hydroxychloroquine is an ineffective and potentially dangerous treatment for COVID-19, yet prescriptions for patients with the virus continue. [Read Article] Pfizer CEO says Third Shot Likely Needed Within 12 Months People will probably need a third shot of the Pfizer/BioNTech within 12 months of being fully vaccinated, Pfizer CEO Albert Bourla told CNBC on Thursday. Annual shots may also be needed, Bourla said. [Read Article] Tabula Rasa HealthCare Expands COVID-19 Vaccine Support Services to Community Pharmacies Tabula Rasa HealthCare, Inc., a leading healthcare technology company advancing the safe use of medication, today announced an expansion of COVID-19 services for independent and chain pharmacies. -
February 2021 EPS Pipeline Report
Pipeline Report February 2021 Pipeline Report February 2021 © 2021 Envolve. All rights reserved. Page 1 This quarterly at-a-glance publication is developed by our Clinical Pharmacy Drug Information team to increase your understanding of the drug pipeline, Table of Contents ensuring you’re equipped with insights to prepare for shifts in pharmacy benefit management. In this issue, you’ll learn more about key themes and notable drugs referenced in the following points. COVID-19 1 > Veklury is currently the only agent that is FDA-approved for the treatment of COVID-19. Three additional therapeutics and two vaccines have been granted Emergency Use Authorization (EUA), and at least three more vaccines are Recent Specialty Drug Approvals1 4 expected to receive an EUA in the relatively near future. > The previous quarter noted the approval of several breakthrough therapies for rare or ultra-rare conditions, which previously had no available FDA-approved Recent Non-Specialty Drug Approvals 9 treatments — Zokinvy for Hutchinson-Gilford progeria syndrome and progeroid laminopathies, Oxlumo for primary hyperoxaluria type 1, and Imcivree for genetically mediated obesity. Upcoming Specialty Products 10 > Other notable approvals include: Lupkynis — the first oral therapy approved for lupus nephritis; Orladeyo — the first oral therapy approved as prophylaxis of hereditary angioedema attacks;Cabenuva – the first long-acting injectable antiretroviral therapy intended as maintenance treatment of HIV; and Breyanzi — Upcoming Non-Specialty Products 18 the -
FDA Listing of Authorized Generics As of July 1, 2021
FDA Listing of Authorized Generics as of July 1, 2021 Note: This list of authorized generic drugs (AGs) was created from a manual review of FDA’s database of annual reports submitted to the FDA since January 1, 1999 by sponsors of new drug applications (NDAs). Because the annual reports seldom indicate the date an AG initially entered the market, the column headed “Date Authorized Generic Entered Market” reflects the period covered by the annual report in which the AG was first reported. Subsequent marketing dates by the same firm or other firms are not included in this listing. As noted, in many cases FDA does not have information on whether the AG is still marketed and, if not still marketed, the date marketing ceased. Although attempts have been made to ensure that this list is as accurate as possible, given the volume of d ata reviewed and the possibility of database limitations or errors, users of this list are cautioned to independently verify the information on the list. We welcome comments on and suggested changes (e.g., additions and deletions) to the list, but the list may include only information that is included in an annual report. Please send suggested changes to the list, along with any supporting documentation to: [email protected] A B C D E F G H I J K L M N O P Q R S T U V X Y Z NDA Applicant Date Authorized Generic Proprietary Name Dosage Form Strength Name Entered the Market 1 ACANYA Gel 1.2% / 2.5% Bausch Health 07/2018 Americas, Inc. -
Drugs@FDA) for Information on All FDA Approved Drug Products, Including Labeling and Review Information
Welcome Disclaimer Organizations may not re-use material presented at this AMCP webinar for commercial purposes without the written consent of the presenter, the person or organization holding copyright to the material (if applicable), and AMCP. Commercial purposes include but are not limited to symposia, educational programs, and other forms of presentation, whether developed or offered by for-profit or not-for-profit entities, and that involve funding from for-profit firms or a registration fee that is other than nominal. In addition, organizations may not widely redistribute or re-use this webinar material without the written consent of the presenter, the person or organization holding copyright to the material (if applicable), Cate Lockhart, PharmD, PhD and AMCP. This includes large quantity redistribution of the Executive Director, BBCIC material or storage of the material on electronic systems for other than personal use. How to Ask Questions AMCP Partnership Forums Collaboration for Optimization The live, hands-on AMCP Partnership Forums bring key decision makers in managed care, integrated care, the pharmaceutical industry, and others together to discuss and collaborate on tactics and strategies to drive efficiencies and outcomes in integrated care and managed care. Partnership Forums 2020 2021 1. Helping Patients Anticipate and 1. Racial Health Disparities: A Closer Look at Manage Drug Costs Benefit Design 2. Preparing for and Managing Rare 2. Digital Therapeutics Diseases 3. Addressing Evidence Gaps in the 3. Biosimilars: Policy, Practice, and Post Expedited Approval Process: Payer Marketing Surveillance to Support Perspectives Treatment and Coverage Decisions Forum Objective Key Deliverables Identify key actions that 1. Identify challenges with biosimilar adoption within the U.S.