Pfizer’s Abrysvo demonstrated promising efficacy in a late-stage study, showing a 67% effectiveness rate against RSV symptoms among adults aged 60 and older with two or more symptoms. Moreover, the vaccine exhibited an 85.7% effectiveness in preventing severe illness characterized by three or more symptoms. Both Pfizer and GSK anticipate a substantial market for RSV vaccines, estimated to be worth billions of dollars.

Pfizer plans to release Abrysvo in the third quarter, anticipating the upcoming RSV season, as long as it receives approval from the U.S. Centers for Disease Control and Prevention (CDC). The CDC’s advisory committee is scheduled to convene in June to discuss the recommended usage and frequency of RSV vaccines, including Pfizer’s and GSK’s offerings.

Pricing details for Pfizer’s vaccine remain undisclosed, with the company emphasizing that it will be value-based to support routine vaccination in the recommended age group. In the event that the CDC endorses the vaccine for regular usage, the majority of senior Americans who are enrolled in the government Medicare health plan can obtain it without incurring any expenses from their own pockets.

RSV typically causes mild symptoms similar to a cold, but it can lead to severe illness and hospitalization, particularly among individuals aged 65 and older. Government data indicates that RSV is responsible for approximately 14,000 annual deaths in this age group in the United States.

In addition to focusing on the elderly population, Pfizer is also pursuing FDA approval for its RSV vaccine with the aim of safeguarding infants through the immunization of pregnant women. If approved, this vaccine would be the first of its kind to safeguard babies, who are at a heightened risk of severe RSV-related complications. The vaccine received support from the FDA’s panel of outside experts for use in pregnant women, paving the way for its launch in the United States and Europe later this year.

In addition to Pfizer and GSK, Moderna Inc. is expected to file for approval of its RSV vaccine for individuals aged 60 and older in the current quarter. Meanwhile, Sanofi and AstraZeneca are awaiting U.S. approval for their preventive antibody, nirsevimab, which targets RSV in newborns and infants. In Europe, nirsevimab has already gained marketing authorization under the name Beyfortus.

The RSV vaccine market is emerging as a significant battleground within the pharmaceutical industry, with analysts projecting a potential opportunity exceeding $10 billion. With positive phase 3 vaccine results from Pfizer, GSK, and Moderna, and the upcoming potential approval of Sanofi and AstraZeneca’s antibody, the race to provide effective protection against RSV is intensifying.

Aamir Malik will be giving his services through managing company’s portfolio, extending business development, prioritizing pipeline, initiating new business ventures and innovating access programs with the stakeholders and government.    

Young is leaving the company with some remarkable dealmaking achievements out of which the mRNA COVID-19 vaccine collaboration with BioNTech was the most prominent one, with which Pfizer is expecting to generate a whopping $33.5 billion through the sales, after signing up supply contracts by July.

The COVID-19 jab, branded as Comirnaty, has become the first vaccine to be fully approved by the FDA from its emergency use authorization (EUA). Its success has brought in a whopping amount of cash for the company to initiate further deals.

However, Pfizer’s CEO, Albert Bourla, has repeatedly asserted that the revenues generated through the COVID vaccine neither really influence company’s strategic direction, nor would help pulling off further M&A deals. He said, “Our strategy on capital allocation was not driven with how much capital we have; was driven with how much opportunity we have.” 

Other than Pfizer-BioNTech successful collaboration, Pfizer’s acquisition of the Arixa, the antibiotics maker, in 2020, was also credited to John Young.  Young also struck up Pfizer’s partnerships with Myovant Sciences, CStone Pharmaceuticals and Valneva, the previous year. In 2019, he also contributed in planning and coordinating the acquisition of cancer-specialist Array BioPharma for $11.4 billion.

The closing of two large-scale spinoffs, which parted with Pfizer with the intention to focus on innovative drugs, was carried out in Young’s supervision. Pfizer, in 2020, abandoned its Upjohn based medicine franchise in a deal with Mylan to form Viatris, which had been led by Young.

Pfizer’s recent acquisition of the immuno-oncology biotech, Trillium Therapeutics, for $2.3 billion, might be Young’s last dealmaking for the company.

Previously Young, and now Aamir Malik, in this Chief Business Officer role, will be leading a committee for managing and setting R&D priorities and strategies. According to securities filing in March, the committee, by its efforts, managed to get endorsements of five crucial and vital study starts, together with seven proof-of-concept readouts and prioritization of investments in six pivotal programs for the company.     

Other than leading the management committee, the title includes ensuring integration of value-based access solutions into the plans of all phase III programs initiated by Pfizer.

Malik, currently serving as managing partner for McKinsey’s U.S. based operations, will soon be dealing with all these tasks with twenty-five years of experience “developing innovative growth strategies, guiding mergers and acquisitions, and implementing high-impact programs” for life sciences companies, noted Bourla.

Two Eliquis patents previously won, were upheld by the U.S Courts of Appeals for the Federal Circuit. This current appeal win sets the two partners up until 1st April 2028 in the U.S market exclusively.

Before this, the two partners were expecting generic formulations of the anticoagulant to appear in the U.S between 2026 and 2031. The partners settled with numerous generic drug companies, however, Sunshine Lake Pharma, Hec Pharm, Sigmapharm, and Unichem are taking their cases to court.

Two patent questions were found to be valid in a court ruling by the U.S District Court for the District of Delaware in the previous summer. This led to last week’s court ruling after the generic drug companies appealed.

Eliquis generated about $9 billion annually, being among the globe’s top-selling medicines. These extra years of U.S patent coverage will lead to revenue gains of billion for the companies.

The copied versions of FDA-approved Eliquis will not be able to reach the U.S market until the patent protection period ends, or until the settlement terms are adhered to.

In 2020, Eliquis was able to gain $9.17 billion which is a 16% higher revenue than 2019. The company stated that its belief is that Bristol Myers Squibb will continue increasing its share within its medicinal class. Bristol Myer’s CFO stated “growth outlook for Eliquis remains strong as we continue to grow the oral anticoagulant class.”

Bristol Myers Squibb first manufactured this anticoagulant drug and then approached Pfizer, which was picked due to its global reach in the medicinal landscape, with the offer of a partnership, and in 2007 this Pfizer BMS partnership materialized.

The injection has been approved for once a week dosage for children weighing no less than 11.5 kg, having insufficient growth largely because of inadequate secretion of endogenous growth hormone.   

The said deficiency, caused by anterior pituitary gland, is a rare disorder among children in United States with a ratio of occurrence to be 1 to 3,500.

The approval includes an auto-injector along with cartridges which can store the medicine for 6 months at room temperature after taking out of the refrigerator.

Paul Thornton, MB BCh, MRCPI, a clinical investigator and pediatric endocrinologist in Fort Worth, Texas, stated, “Today’s approval represents an important new choice for children with GH deficiency and their families, who will now have a weekly treatment option.” He further added, “In the pivotal head-to-head clinical trial, weekly Skytrofa demonstrated higher annualizedized height velocity at week 52 compared to somatropin. This weekly treatment could reduce treatment burden and potentially replace the daily somatropin therapies, which have been the standard of care for over 30 years.”  

A 52-weeks global phase III height trial was conducted for Skytrofa, the results of which led to the FDA’s approval for the drug. It was a randomized, open-label, parallel-group trial in which 161 treatment-naïve children with growth hormone deficiency were tested for weekly skytrofa against the daily somatropin formulation.

The principal endpoint of the study was the annualized height velocity of the weekly skytrofa group against the other group at completion of 52 weeks. Whereas, adverse events, injection-site reactions, change in height SDS and incidence of anti-human GH antibodies were among other included endpoints. 

At the 52^nd week, the annualized height velocity for Skytrofa was 11.2 cm/year and that for the daily somatropin was 10.3 cm/year, having a difference of 0.9 cm/year. Moreover, there seemed to have no serious adverse effects or no discontinuations for skytrofa were reported throughout. The commonly noted adverse reactions were infections like nausea and vomiting, diarrhea, arthralgia and arthritis, abdominal pain, cough and haemorrhage.  

The FDA, in a press release, said that the drug may interact with oral estrogen, glucocorticoid treatment, insulin and other antihyperglycemic agents.

The Competition and Markets Authority (CMA) said it had preliminarily considered that the two companies “exploited a loophole by de-branding the drug known as Epanutin prior to September 2012,” such that its price couldn’t be regulated like other branded drugs.

This provisional decision by the CMA came after the 2020 directive given by the U.K. Court of Appeal which said that the authority’s investigation, which it did earlier, was “insufficiently deep or intense.”  According to CMA, the re-investigation of the case started in June 2020 after court’s ruling, the previous year.

The Chief executive officer of CMA stated, ”Thousands of patients depend on this drug to prevent life-threatening seizures as a result of their epilepsy… This is a matter that is important for the government, for the public as patients and taxpayers, and for the pharmaceutical industry itself.”

In 2016, Pfizer was fined 84.2 million pound and Flynn 5.2 million pounds by the U.K. watchdog, for as much as 2600% rise in prices of the unbranded versions of anti-epilepsy drug, in September, 2012.

Prior to the adoption of final decision, Pfizer seems to have a possibility to respond to the CMA’s statement of objections. It said that it “continues to co-operate fully with the CMA’s ongoing investigation.”

The company, in an emailed statement, said, “Ensuring a sustainable supply of our products to U.K. patients is of paramount importance to Pfizer and Flynn Pharma was at the heart of our decision to divest the product in 2012.”  However, no spokesperson from the other company responded to the request to express their stance.

Pfizer, Sanofi, and other healthcare companies are suing their rival companies for allegedly giving rebates to the insurance companies and Pharmacy benefit managers in exchange for their drugs being added to the preferred formulary list.

The FTC (Federal Trade Commission) told Congress in May that lawsuits contending that such exclusive discounts restrict competition and might create constitutional theories that the agency will follow.

According to Industry observers, these suits as well as FTC’s evaluation of them could set the tone for how pharmaceutical rebates are governed, potentially changing the means of reaching hundreds of pharmaceuticals to the consumers.

However, this intricate sector is based on treaties with precise terms and unique connections, and plaintiffs are finding it very hard to apply antitrust legislation to fact-specific cases, which could impact authorities’ decisions to enforce or impel changes.

“The FTC may use the losses in private cases as evidence that the current interpretations or applications of antitrust laws are inadequate, and maybe as an argument that the laws need to be changed,” said Barbara Sicalides, a partner at Troutman Pepper LLP. 
PBMs (Pharmacy Benefit Managers) are used by insurers to bargain with the drug makers for reduced prices. Pharmaceutical manufacturers pay kickbacks to be included on the PBM formulary list, which often includes the terms to exclude rival’s products from the list. Competitors who seek to promote their products to PBMs’ customers face a “rebate wall” as a result of the practice.

According to a 2020 report by Xcenda, AmerisourceBergen’s healthcare consultancy firm, this rebate practice has been unregulated even though the PBMs have unified in past years.

The three top PBMs CVS Caremark, a CVS Health Inc. subsidiary, OptumRX, a part of Optimum Inc., and Express Scripts, a company of Cigna group, now hold about 70% of the prescriptions in the United States, according to a report.

“With MYFEMBREE, we can offer women with uterine fibroids a non-invasive treatment that provides clinically meaningful symptom relief for heavy menstrual bleeding with one pill, once-a-day,” said Ayman Al-Hendy, M.D., Ph.D., Professor of Obstetrics and Gynecology, University of Chicago, and LIBERTY Program Steering Committee Member. “The FDA approval of MYFEMBREE represents a significant milestone in expanding treatment options for uterine fibroids, a chronic and debilitating disease for many women in the U.S.”
“Uterine fibroids affect millions of women in the U.S. and account for over 250,000 hysterectomies each year, with heavy menstrual bleeding being one of the most bothersome symptoms,” said David Marek, CEO of Myovant Sciences, Inc. “The approval of MYFEMBREE represents the second FDA product approval for Myovant in less than one year. This is an important step forward as we seek to redefine care for women and men, not only through new medicines but through continued collaboration with the community.”
“MYFEMBREE’s approval is a testament to the shared commitment between Myovant and Pfizer to support women living with uterine fibroids,” said Nick Lagunowich, Global President, Internal Medicine at Pfizer. “We are excited to offer this new treatment option which will help provide much-needed symptom relief with the convenience of an oral, once-daily tablet.”
The primary objectives of the phase-lll LIBERTY trials were fulfilled with 72.1% & 71.2% of females are meeting the respondent criteria at week 24, as compared to 16.8% & 14.7% of females in the placebo group, respectively (both p < 0.0001). The response of the treatment was stated as the monthly blood loss with a volume of 80ml or less, and a 50% or higher decline in volume of menstrual blood loss by employing the alkaline hematin technique over the last 35 days of therapy compared to baseline.
MYFEMBREE reduced menstrual blood loss by 82% and 84.3% in women who took MYFEMBREE compared to placebo ( for both p < 0.0001). ADRs such as Hot flushes, alopecia, irregular uterine bleeding, and decreased libido was reported in approximately 3% of the women who were taking MYFEMBREE and at a higher rate than placebo. In both studies, no pregnancies were detected in MYFEMBREE groups.
Pfizer and Myovant are dedicated to assisting the women in the United States who have been prescribed with MYFEMBREE. Insurance coverage verification, copay assistance for privately insured patients, prior authorization support, and patient support for eligible uninsured patients are all available through MYFEMBREE Support Program.

All Democrats, Senators Elizabeth Warren, Edward Markey, Tammy Baldwin, Jeff Merkley, and Christopher Murphy, wrote a letter to Pfizer on Wednesday stating that Sharing intellectual property, “such as vaccine recipes and manufacturing information… could drastically expand vaccine development and access.”

The senators questioned the pharmaceutical company, in the letter, if it has shared its patent skills with a community established for this purpose by WTO ( World Trade Organization), and more importantly, whether it has any intention to collaborate with any of the Indian companies to manufacture its potentially powerful mRNA vaccine.

Senators also wrote similar letters to both Moderna and Johnson&Johnson.

Crisis in India spurs calls for action

Due to inadequate vaccination and pathetic management of the situation by P.M. Narendra Modi’s government, a significant increase in Covid-19 cases has been witnessed in India, where the AstraZeneca vaccine is manufactured. In India, doctors have blamed Modi for becoming a “super spreader” of the disease by conducting large political protests in the weeks foregoing the sudden rise, resulting in 357,700 new cases. The government has also been criticized for not ensuring that the local hospitals have an adequate supply of emergency oxygen.

However, apart from the shortcomings of the government, it is uncertain that the enhanced production of the coronavirus vaccine will help to alleviate the pandemic and prevent the spread of more harmful strains of the virus.

President Joe Biden has been persuaded by developing countries, along with the previous global leaders and Noble prize winners, to approve a WTO disclaimer that might permit the countries such as South Africa and India to use the proprietary information of the U.S. without the fear of being retaliated. Industry organizations have suggested that such exemption should prevent private developments.

Modern has stated that it will not implement its vaccine patents, but this is not enough to persuade WTO associates to initiate illicit manufacturing.

Although sharing the proprietary information will not help in the current situation, but the company’s previous director of chemical, Suhaib Siddiqui, told the reporters that a new plant might start the production of the company’s vaccine within four months.

Like European Union, the Biden government has so far refused to endorse the petition for WTO disclaimer, but it has announced earlier this week that it will start distributing the AstraZeneca vaccine in India without any delay.

Meanwhile, the U.S. pharmaceutical firms have said that they would soon respond to senators’ concerns.

Lisa Cannellos, a spokesperson for Johnson & Johnson, told Insider, “We are committed to the health and safety of people worldwide and look forward to replying to the senators’ letter.”

Pfizer’s representative has confirmed that they received the letter but refused to comment further.

The senators’ have demanded the answers by May 11th.

Every year, invasive fungal infections affect over 1.5 million people globally, with death rates ranging from 30% to 80% based on the types of infection. With an innovative mechanism of action(MOA), Fosmanogepix can attack fungal strains that became resistant to conventional therapy. Anti-fungal resistance may greatly restrict treatment choices, since there are only 3 main classes of anti-fungal medications available, a possible new therapeutic class could be significant for both patients and doctors. In nearly two decades, the U.S. Food and Drug Administration has not approved a single new therapeutic class for anti-fungal treatment.

Angela Lukin, global president of Pfizer hospital said, “The COVID-19 pandemic has been a stark reminder of the devastating impact of infectious diseases, highlighting the continuous need for new anti-infective therapies to treat both emerging and difficult to treat bacterial, viral, and fungal infections.” She added, “We are deeply committed to helping patients suffering from infectious diseases, continuously seeking opportunities to build our portfolio of anti-infective therapies. We’ve already invested in assets that, if approved, could help address drug-resistant bacterial infections and critical viral infections; with this acquisition, we look forward to progressing the development of a novel anti-fungal as well.”
Fosmanogepix is currently undergoing phase-2 clinical trials to assess the safety and effectiveness of both oral and IV (intravenous) dosage form in treating patients that are affected by serious invasive fungal infections caused by yeasts, molds, and rare molds (e.g. Candida species including Candida Auris, Aspergillus species, Fusarium, and Scedosporium species). In-vitro studies of Fosmanogepix showed a wide range of activity and widespread distribution to several body tissues such as kidneys, lungs, brain, and eyes. Fosmanogepix, which is being developed in both oral and IV dosage forms, could allow the patients to switch from IV to oral formulation, eventually allowing them to continue their therapy outside the hospital.
Besides Fosmanogepix, Pfizer has also acquired Amplyx’s initial pipeline which contains anti-fungal (APX2039) and antiviral (MAU868) drugs.
Infectious Diseases are causing over 8.4 million deaths worldwide per year, ranking them second in the top 10 causes of casualties according to WHO. A variety of microbes, such as viruses, bacteria, fungi, and parasites cause infections that can be transmitted in the community or clinical settings, or hospitals.

Pfizer made an initial capital investment in Amplyx as a part of its series C financing in December 2019. Pfizer was a member of the world’s top-class biotechnology investors at that time, which included 3×5 Partners, Adage Capital Management, BioMed Ventures, Arix Biosciences, Lundbeckfonden, Pappas Capital, New Enterprise Associates, RiverVest Partners, and Sofinnova Investment.

The economic conditions of this acquisition weren’t publicized.

Pfizer’s legal consultant in this agreement was DLA Piper LLP (US), while Amalyx’s legal consultant was Cooley LLP and Evercore served as its financial adviser.