Top 50 Pharma Companies 2021: The pandemic and beyond
— The pharmaceutical industry drew together in 2020 to fight the COVID-19 pandemic, and while the battle continues, pharma companies have even more going on
By Christiane Truelove • [email protected]
A year ago, there was a promise. A promise to the end of the pandemic, a promise that life would return to normal. And the pharmaceutical industry assured us we would get there.
In 2021, that promise began to come true, as Pfizer – Med Ad News’ Company of the Year – as well as AstraZeneca, Johnson & Johnson, and Moderna – started rolling out their vaccines around the world. By spring, many people were asking each other, “So, which one did you get?”
Even as variants to the original SARS-CoV-2 are still spreading, many of the companies profiled in this issue are not giving up. Whether it is researching new vaccine candidates (see AstraZeneca’s profile and Sanofi’s profile), continuing research into booster shots for already existing vaccines (see Pfizer’s profile), or therapies for COVID, there are many approaches being taken against the virus and COVID-19.
THE COVID-19 BATTLE
In August, Pfizer received FDA’s full approval for the vaccine it had developed with BioNTech. Now known as Comirnaty, it is the first COVID vaccine to be given full approval by FDA.
Comirnaty has been available in the United States under Emergency Use Authorization (EUA) since December 11, 2020 (as the Pfizer-BioNTech COVID-19 Vaccine). The EUA permitted essential rollout of vaccine doses across the United States.
While the full approval was for people 16 years and older, Pfizer and BioNTech continue to run trials for other age groups as well as investigating the need for boosters.
On Sept. 22, the FDA authorized for emergency use a booster dose of the Pfizer-BioNTech vaccine for individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19. According to the companies, the booster dose is to be administered at least six months after completion of the primary series, and is the same formulation and dosage strength as the doses in the primary series.
“This first FDA authorization of a COVID-19 vaccine booster is a critical milestone in the ongoing fight against this disease,” stated Chairman and CEO Albert Bourla. “Over the last year and a half, we have aimed to stay vigilant as the pandemic has evolved – including evaluating the impact of a booster dose. We believe boosters have an important role to play in addressing the continued threat of this disease, alongside efforts to increase global access and uptake among the unvaccinated. Today’s FDA action is an important step in helping the most vulnerable among us remain protected from COVID-19.”
Johnson & Johnson’s (see profile) single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of J&J, received Emergency Use Authorization from the Food and Drug Administration on Feb. 27, 2021, to prevent COVID-19 in individuals 18 years of age and older. This decision was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE trial that showed the vaccine was 85 percent effective in preventing severe disease across all regions studied, and demonstrated protection against COVID-19 related hospitalization and death, starting 28 days after vaccination.
New data reinforcing the strong and long-lasting protection of the company’s COVID-19 vaccine were reported in September 2021. Data additionally demonstrated that protection against COVID-19 increases when a booster shot of the J&J vaccine is administered. Company management says the safety profile of the vaccine remained consistent and was generally well-tolerated when administered as a booster.
AstraZeneca had teamed with the University of Oxford’s spinout company, Vaccitech, to produce a COVID-19 vaccine. In January the vaccine, now known as Vaxzevria, was recommended for conditional marketing authorization (CMA) in the European Union for active immunization to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older.
In February, the vaccine was authorized for emergency use by the World Health Organization. AstraZeneca committed to making the vaccine available to as many countries as possible and at no profit during the pandemic period. In June 2020, the company announced a sub-licensing agreement with the Serum Institute of India (SII) to manufacture and supply up to 1 billion doses of the vaccine to low and middle-income countries. The WHO approval was based on pooled analysis for efficacy from 11,636 participants aged 18 years and older, accruing 131 symptomatic COVID-19 infections from the UK and Brazil Phase III trials conducted by Oxford University.
By March, however, there were reports of blood clotting in some vaccine recipients two weeks after vaccination.
In April, EMA’s safety committee (PRAC) concluded that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria, and that the benefits of vaccination outweighed the risks.
The vaccine was further vindicated in July when in a large real-world study – data published as a pre-print on The Lancet server from more than 1 million individuals – assessed the incidence rates of blood clotting disorders of thromboembolism and thrombocytopenia, including the very rare thrombosis with thrombocytopenia (TTS) following vaccination with an mRNA vaccine or Vaxzevria, and compared them with expected rates in a general population and in people with COVID-19.
The study found that safety profiles of Vaxzevria, and the mRNA-based vaccine were similar and overall favorable. Although very rare clotting disorders (TTS) were observed with both vaccines, these were in line with what would be expected in the general population and lower than in those diagnosed with COVID-19.
AstraZeneca is also thinking beyond the pandemic. In September, the company announced that it had joined the European Respiratory Society (ERS), the Global Allergy and Airways Patient Platform (GAAPP), Amgen, and leading respiratory clinicians to launch the International Respiratory Coalition, a new partnership to transform post-pandemic respiratory healthcare.
The Coalition aims to support governments and healthcare systems in their recovery from COVID-19 by strengthening respiratory care, and will seek to improve outcomes for people living with respiratory diseases by supporting the creation of ambitious national-level respiratory strategies and by building resilience in managing pandemics.
GlaxoSmithKline (see profile) is contributing the company’s unique adjuvant technology to help develop multiple protein-based COVID-19 vaccines, while simultaneously developing preventative and therapeutic medicines and co-developing novel mRNA vaccine candidates. According to GSK, partnering with other leading healthcare companies and research institutions is central to this approach.
“We have several partnerships to develop COVID-19 vaccines where we are contributing our pandemic adjuvant technology,” management says. “The use of an adjuvant can be of particular importance in a pandemic as it may reduce the amount of vaccine protein required per dose, allowing additional doses to be produced and therefore protecting more people. It can also enable an enhanced immune response.”
SK bioscience and GSK during September initiated a Phase III study of an adjuvanted COVID-19 vaccine candidate. The worldwide study is testing the vaccine candidate GBP510 against the AstraZeneca/Oxford University COVID-19 vaccine. The advancement into Phase III development follows positive interim Phase I/II immunogenicity and safety data. The clinical trial is one of the first global Phase III studies to compare two different COVID-19 vaccine candidates. The adjuvanted COVID-19 vaccine collaboration with SK was announced in February 2021.
GSK and CureVac agreed during early February 2021 to develop next-generation mRNA COVID-19 vaccines. The companies plan to develop a multi-valent candidate vaccine to address emerging variants for pandemic and endemic use. Development started immediately targeting vaccine availability in 2022, subject to regulatory approval. GSK is additionally signed on to support manufacture of up to 100 million doses of CureVac’s first generation COVID-19 vaccine CVnCoV in 2021.
For companies not currently developing COVID vaccines or treatments, 2021 has still been very eventful for the industry.
At Merck & Co. (see profile), longtime CEO Kenneth C. Frazier announced his retirement in February 2021. His successor, Robert M. Davis, Merck’s executive VP, global services and chief financial officer, became CEO in April 2021 and a member of the board in July.
Johnson & Johnson announced in August 2021 that Alex Gorsky will serve as executive chairman and transition the CEO post to Joaquin Duato, who has served as vice chairman of the company’s executive committee, effective January 3, 2022. Following the transition of the CEO position, Duato will additionally be appointed as a member of the company’s board of directors.
AstraZeneca and Alexion Pharmaceuticals entered into a definitive acquisition agreement during December 2020. AstraZeneca received U.S. clearance for the acquisition during April, and shareholders voted in favor of the deal in May. The UK’s Competition and Markets Authority gave authorization in July, and the acquisition was completed during that month. The total consideration paid to Alexion’s shareholders was $13.3 billion in cash and 236,321,411 new AstraZeneca shares (94 percent of which will be represented by new AstraZeneca American Depositary Shares).
“Alexion has established itself as a leader in complement biology, bringing life-changing benefits to patients with rare diseases,” AstraZeneca CEO Pascal Soriot stated at the time of the transaction. “This acquisition allows us to enhance our presence in immunology.”
The Alexion acquisition will help AstraZeneca establish a presence in rare diseases, which represent a high-growth area with rapid innovation and significant unmet medical need.
In February 2021, Merck announced a deal to acquire Pandion Therapeutics, a clinical-stage biotechnology company developing novel therapeutics designed to address the unmet needs of patients living with autoimmune diseases. Pandion is advancing a pipeline of precision immune modulators targeting critical immune control nodes. The company’s lead candidate, PT101, is an engineered IL-2 mutein fused to a protein backbone designed to selectively activate and expand regulatory T cells (Tregs) for the potential treatment of ulcerative colitis and other autoimmune diseases. Earlier this year, Pandion announced that PT101 had completed a Phase Ia trial, which achieved its primary objective of safety and tolerability. The company’s pipeline also includes PD-1 agonists in development for numerous autoimmune diseases.
In March, Merck and Alydia Health entered into a definitive agreement pursuant to which, after the intended Merck spinoff of Organon, Organon would acquire Alydia Health. Alydia is a commercial-stage medical device company focused on preventing maternal morbidity and mortality caused by postpartum hemorrhage (PPH) or abnormal postpartum uterine bleeding. PPH is one of the most common complications of birth, resulting in pharmacologic treatment in up to 10 percent of mothers and potentially resulting in emergency intervention such as hysterectomy and blood transfusions, and, in some cases, maternal death. The transaction was expected to close after Organon was spun off from Merck as a standalone publicly traded company in early June 2021.
For AbbVie (see profile), one big story was the company’s integration of the acquisition of Allergan, which was completed in May 2020. Acquired in the Allergan transaction, the two types of Botox – Therapeutic and Cosmetic – each generated more than $1 billion for AbbVie in the last seven months of 2020, with Therapeutic generating $1.39 billion and Cosmetic with $1.11 billion. In first-half 2021, Botox Therapeutic sales were $1.14 billion and Botox Cosmetic sales reached $1.06 billion.
Bayer (see profile) in August announced the acquisition of Vividion Therapeutics. “Vividion’s unique technologies and special expertise will significantly strengthen our drug discovery capabilities,” Baumann says.
Vividion is a U.S.-based biopharmaceutical company utilizing novel discovery technologies to unlock high value, traditionally undruggable targets with precision therapeutics. Company executives say Vividion’s platform is able to produce a variety of small-molecule therapies across indications, with initial focus on targets relevant to oncology and immunology. Vividion’s lead programs include multiple precision oncology targets and precision immunology targets, with ongoing efforts on a transcription factor NRF2 antagonist for the potential treatment of NRF2 mutant cancers, as well as NRF2 activators for various inflammatory diseases such as irritable bowel disease – among other pre-clinical programs.
“This acquisition is a cornerstone of our strategy to fuel our pipeline with breakthrough innovation,” says Stefan Oelrich, member of the board of management at Bayer and president of Bayer’s Pharmaceuticals Division. “Vividion’s technology is the most advanced in the industry, and it has demonstrated its ability to identify drug candidates that can target challenging proteins. Together with Bayer’s existing know-how, we will be able to develop first-in-class drug candidates, increasing the value of our pipeline. We want to provide innovative therapies for patients whose medical needs are not yet met by today’s treatment options.”
To preserve Vividion’s entrepreneurial culture as an essential pillar for nurturing successful innovation, management says the company will continue to operate as an independent organization on an arm’s length basis.
Bayer recently formed its own cell and gene therapy platform as part of its transformation strategy for the Pharmaceuticals division. The platform already has potentially groundbreaking medical innovations in clinical development, such as a therapy for the treatment of Parkinson’s.
In June 2021, Bayer announced an agreement to acquire Noria Therapeutics. (Noria) and PSMA Therapeutics. Company executives say through this acquisition Bayer will obtain exclusive rights to a differentiated alpha radionuclide therapy based on actinium-225 and a small molecule targeting prostate-specific membrane antigen (PSMA). The acquisition broadens Bayer’s existing oncology portfolio of targeted alpha therapies (TAT), which includes Xofigo and the proprietary platform of investigational TATs based on thorium-227. The pre-IND program focuses on treating prostate cancer, the second most commonly diagnosed cancer in men.
Researchers believe that based on its unique design, this therapy could provide a differentiated efficacy and safety profile and offer significant potential to address a high unmet medical need for men with prostate cancer.
“Bayer is focused on addressing the various medical needs of cancer patients, providing treatments that improve patient outcomes throughout the different stages of the disease,” says Robert LaCaze, member of the executive committee of the Pharmaceuticals Division and head of the Oncology Strategic Business Unit at Bayer. “This acquisition is another important milestone in enhancing Bayer’s oncology portfolio through both in-house expertise and strategic collaborations and agreements.”
Pfizer was also in on the acquisition trend. In August, Pfizer acquired Trillium Therapeutics, a clinical-stage immuno-oncology company developing innovative therapies for treating cancer. Under the terms of the agreement, Pfizer is acquiring all outstanding shares of Trillium not already owned by Pfizer for an implied equity value of $2.26 billion, or $18.50 per share, in cash. This represents a 118 percent premium to the 60-day weighted average price for Trillium.
Trillium’s portfolio includes biologics that are designed to enhance the ability of patients’ innate immune system to detect and destroy cancer cells. Trillium’s two lead molecules, TTI-622 and TTI-621, block the signal-regulatory protein α (SIRPα)–CD47 axis, which is emerging as a key immune checkpoint in hematological malignancies. TTI-622 and TTI-621 are novel, potentially best-in-class SIRPα-Fc fusion proteins that are in Phase Ib/II development across several indications, with a focus on hematological malignancies.
“Today’s announcement reinforces our commitment to pursue scientific breakthroughs with the addition of potentially best-in-class molecules to our innovative pipeline,” says Andy Schmeltz, global president and general manager, Pfizer Oncology.
“The proposed acquisition of Trillium builds on our strong track record of leadership in oncology, enhancing our hematology portfolio as we strive to improve outcomes for people living with blood cancers around the globe. Our deep experience in understanding the science of blood cancers, along with the diverse knowledge base we have developed across our growing hematology portfolio of eight approved and investigational therapies, provide us with a foundation to advance these important potential medicines to patients who need them.”
In another 2021 acquisition for Pfizer, during April the company purchased Amplyx Pharmaceuticals. A privately held company, Amplyx is dedicated to the development of therapies for debilitating and life-threatening diseases that affect people with compromised immune systems. The company’s lead compound, fosmanogepix (APX001), is a novel investigational asset under development for treating invasive fungal infections.
In addition to fosmanogepix, Pfizer has secured ownership of the early-stage pipeline portfolio of Amplyx that includes potential antiviral (MAU868) and antifungal (APX2039) therapies.