Pfizer: New Potential Billion-Dollar Drugs Under Development (NYSE:PFE)

Pfizer’s story of success

Pharmaceutical giant Pfizer (NYSE:PFE) is one of the world’s largest companies and is primarily known for its great capacity for innovation. Over the years, it has managed to bring dozens of revolutionary drugs to market, such as Viagra or Lyrica, while also developing Lipitor, a prescription for the treatment of hypercholesterolemia, which has achieved $125 billion in sales in 14.5 years. But what are the most promising drugs in Pfizer’s pipeline to date?

Pfizer’s long pipeline

Pfizer, according to the latest May quarterly report, currently has 96 drugs in development, divided between phase1 (30 drugs), phase2 (31 drugs), phase3 (29 drugs), and in registration (6 drugs).

The drugs are divided into six major sections, which are:

1. Inflammation and Immunology
2. Internal Medicine
3. Oncology
4. Rare Disease
5. Vaccines
6. Hospital (Anti-Infectives)

In Phase 3 are two of the most exciting drugs from which Pfizer could make billions of dollars:

• fordadistrogene movaparvovec (PF-06939926) for the treatment of Duchenne syndrome
• (PF-06928316) for the treatment of Respiratory Syncytial Virus Infection

Duchenne syndrome

Duchenne affects about 1 in 3,500-5,000 males born worldwide. An estimated 250,000 patients worldwide, about 10,000-15,000 in the United States. It predominantly affects males, but sometimes, more rarely, it can also affect females. Duchenne causes weakening and damage to the body’s muscles over time, leading to the patient’s death. Muscles begin to weaken between 3 and 5, and most patients use a wheelchair by age 12. During adolescence, heart and respiratory muscles weaken, leading to life-threatening complications. Genetic testing helps confirm the diagnosis and identify the dystrophin gene mutation that causes the disease.

The Duchenne syndrome market

Analysts expect the Duchenne syndrome market to be worth about $7 billion in 2027. To date, the main approved drugs are Sarepta’s Exondys 51, Amondys 45, and Vyondys 53, and PTC Therapeutics’ (PTCT) Translarna (approved in Europe) and Emflaza (approved in America). PTC Therapeutics made $423 million (Translarna is worth $236 million and Emflaza $187 million), while Sarepta made $612 million from its drugs in 2021.

Analysts expect the market to reach a value of about $4 billion in 2023, of which only $1.5 billion will be occupied by drugs to date. So, there is plenty of room for companies that, to date, are developing drugs for the treatment of Duchenne and are ahead in trials, such as Sarepta and Pfizer.

Other companies that are developing drugs

The Duchenne syndrome has been treated for several years with drugs that can reduce patients’ suffering without eliminating it. Pfizer’s main competitors are Sarepta (SRPT) and its SRP-9001 and Solid Biosciences (SLDB) with its SGT-001. Sarepta recently published updated data on SRP-9001 that continue to be very promising.

Pfizer, in late April, resumed the trial of (PF-06939926) after the latter was suspended twice: in August 2021 following three serious adverse events of muscle weakness (two of them with myocarditis) and in December after the death of a patient.

The other gene therapy candidate, Solid Bio SGT-001, lags behind its two rivals. Solid announced in late April that it had completed enrollment in Phase I/II IGNITE DMD study (NCT03368742) for SGT-001 and will continue to monitor dosed patients for five years after treatment. In March, Solid released some favorable two-year safety and efficacy data of the first three high-dose patients, who showed improvement in motor function two years after treatment.

Respiratory Syncytial Virus Infection

RSV is a common, highly contagious virus spread through contact with a contaminated surface or through sneezing and coughing. According to data from the Centers for Disease Control and Prevention, RSV causes an average of 58,000 hospitalizations per year in the United States, with 100-500 deaths among children under the age of five and 177,000 hospitalizations and 14,000 deaths among adults aged 65 and older. The cost of managing adult cases alone is estimated at $3 billion per year.

The Respiratory Syncytial Virus Market

Analysts expect the RSV market to reach $4 billion by 2027. However, in 2020, the RSV market dropped 48% due to the adoption of tools for protection and prevention from COVID-19 that significantly reduced transmission of the virus. The RSV market can be divided into a majority part related to prophylaxis and a minor part depending on hospital treatment. Pfizer and Glaxo’s launch of maternal vaccines could push the growth of the prophylaxis-related sector. Pfizer estimates that the entire portfolio of drugs in development acquired from ReViral for the treatment of RSV could generate or exceed $1.5 billion.

Competition with GlaxoSmithKline and other companies

Three other competitors for developing the first RSV vaccine are GlaxoSmithKline (GSK), Moderna (MRNA), and Johnson & Johnson (JNJ). While the vaccines developed by GlaxoSmithKline and Pfizer use the same technology, Johnson & Johnson’s vaccines use different technology. So instead, Moderna wants to create a jab to prevent the disease (RSV), Covid-19, and influenza.

At this time, GlaxoSmithKline is the company furthest along in vaccine development. The latest data released by the company show that the injection is the first to work in the vulnerable age group for the primary infectious disease. With this data, Glaxo plans to submit regulatory submissions in the second half of 2022.

Pros and cons of Pfizer’s two drugs

There are several pros and cons to Pfizer’s drugs that an investor should consider before putting their money on this stock.

• Pro: The drugs that Pfizer is developing go-to treat diseases that are little or not treated but afflict hundreds of thousands of people worldwide. The price of treatments for Duchenne syndrome is very high, hundreds of thousands of dollars (Exondys 51, the latest drug developed by Sarepta, is estimated to cost between $750,000 and $1.5 million per year). Pfizer is already far ahead in the trial, with both drugs in phase 3 providing encouraging results.
• Cons: For both Duchenne syndrome treatment and RSV treatment, Pfizer has to compete with companies that are ahead of it in trials. This delay could hurt it and cause it to lose market share. In addition, during the trial for Duchenne syndrome, there were severe adverse effects on three patients that slowed down the trial. Although Pfizer has received regulatory and ethical approvals to proceed with the movaparvovec fordadistrogene trial in the outpatient population, it continues to ponder restarting the trial in more advanced patients. However, Sarepta had also reported a case of muscle weakness in a phase 3 trial of SRP-9001 in October 2021

Conclusions

For the treatment of Duchenne and RSV, Pfizer is developing cutting-edge drugs that could generate billions in revenue for the company’s coffers. In both cases, however, some companies are slightly further in development, which could be a significant hurdle. In addition to the effectiveness of the drugs, what will make the difference will be the companies’ ability to manage pricing and relationships with health care providers.

Pfizer is a dominant company in its industry, and its extensive pipeline shows that it is a company still capable of innovating and staying on top of the game. Although fierce competition, Pfizer continues to be among the top biopharmaceutical companies in the world (having developed the most widely used covid vaccine is proof). Moreover, it is a company with enormous financial resources (increased by the resounding success of the coronavirus vaccine), able to sustain all the trials it is pursuing.