Pfizer’s Vyndaqel sales highlight rare disease drug's patent life

Pfizer's rare disease drug Vyndaqel, though lesser-known compared to its COVID-19 vaccine, has emerged as a significant revenue generator for the pharmaceutical giant. During the first quarter of this year, Vyndaqel's sales notably exceeded Wall Street expectations, bringing in $1.1 billion—a figure 25% higher than the projected $900 million. This performance represents a considerable increase from last year's $686 million in the same period.

Vyndaqel, known as Vyndamax in the U.S., is used to treat transthyretin amyloidosis, a rare cardiac disease. In its latest earnings report, Pfizer credited the drug's growth to robust uptake in the U.S. and certain European markets. Analyst Salim Syed of Mizuho Securities highlighted that the Inflation Reduction Act, which caps out-of-pocket costs for Medicare Part D enrollees, may have contributed to this uptake. Syed predicted that the cap, effective from 2024, could reduce patients' out-of-pocket expenses by approximately $10,000.

The impressive sales of Vyndaqel have sparked inquiries regarding the drug's remaining patent life. Pfizer's basic product patent in the U.S. is set to expire at the end of this year, with the European patent expiring in 2026. Several generic drug manufacturers have already filed for U.S. approval of their versions, prompting Pfizer to sue for patent infringement. To safeguard its market share, Pfizer is seeking to extend Vyndaqel's exclusivity through 2028 with pending patent term extension requests. If approved, this extension could secure billions in annual sales, an important factor as Pfizer navigates declining revenue from its COVID-19 vaccine and antiviral drug.

Pfizer's total revenue for the first quarter was $14.9 billion, a 20% decrease from the previous year, largely due to declining COVID-19 related sales. However, excluding COVID products, the company's revenue saw an 11% operational increase. Vyndaqel's performance is particularly critical in this context, demonstrating its role in bolstering Pfizer's financial health during this transitional period.

The future of Vyndaqel's market presence is also of interest to competitors such as BridgeBio Pharma and Alnylam Pharmaceuticals. BridgeBio is awaiting an FDA decision on its drug acoramidis, which treats the same condition as Vyndaqel. A decision is expected by late November. Meanwhile, Alnylam is awaiting results from a key study of its drug vutrisiran, expected by mid-year. The outcome of this study will determine if vutrisiran can compete with Vyndaqel in the market.

Market reactions to these developments have been notable. Shares in BridgeBio rose nearly 5% in early Wednesday trading, while Alnylam's shares increased by around 2%. These movements reflect investor anticipation and the potential impact of these competitors on Vyndaqel's market position.

In summary, while Pfizer's well-known COVID-19 products face declining sales, Vyndaqel has emerged as a significant revenue driver. Its strong performance underscores the importance of the drug within Pfizer's portfolio, especially as the company seeks to maintain its market share amid patent expiration challenges and competitive pressures.