TARRYTOWN, N.Y. - Regeneron (NASDAQ:REGN) Pharmaceuticals, Inc. (NASDAQ: REGN) and its partner Sanofi (NASDAQ:SNY) have received approval from China's National Medical Products Administration (NMPA) for Dupixent® (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) with raised blood eosinophils. This approval is for patients who are on a specific combination of inhaled therapies and marks a significant advancement in targeted therapy for COPD in China.
COPD is a leading chronic respiratory disease in China, affecting a substantial portion of the population. The approval of Dupixent is seen as a critical development in the management of the disease, which aligns with the Healthy China 2030 public health initiative aimed at improving the quality of life for patients with chronic respiratory diseases.
The approval is based on the outcomes of the BOREAS and NOTUS Phase 3 trials, which demonstrated that Dupixent significantly reduced COPD exacerbations and improved lung function and health-related quality of life compared to placebo. The trials' results, which have been published in The New England Journal of Medicine, indicate a 30% and 34% reduction in exacerbations in the BOREAS and NOTUS trials, respectively.
Safety results from these trials were generally consistent with the known safety profile of Dupixent, with the most common side effects being injection site reactions, conjunctivitis, arthralgia, oral herpes, and eosinophilia.
Dupixent, which is now approved for four indications across respiratory and dermatological diseases in China, is a monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways. It is administered as a subcutaneous injection every other week and can be given at home by self-administration after training by a healthcare professional.
This approval of Dupixent in China for COPD offers a novel treatment option for a disease that has been notoriously difficult to manage. With the largest population of COPD patients globally, China's approval represents a significant step in addressing the unmet medical needs of these patients. Further submissions for Dupixent in COPD are currently under review with regulatory authorities around the world, including in the U.S. and Japan.
The information reported is based on a press release statement.
In other recent news, Regeneron Pharmaceuticals has been actively engaged in a legal battle to protect its Eylea product from biosimilar competition by rival firm Amgen (NASDAQ:AMGN). The Federal Circuit Court has issued a temporary injunction, halting Amgen's biosimilar launch until further notice. In response to these developments, Morgan Stanley reiterated its Overweight rating on Regeneron, while Leerink Partners downgraded the company's stock from Outperform to Market Perform. Goldman Sachs, however, maintained its Buy rating.
Regeneron has reported an increase in total revenues by 12% to $3.55 billion, with a significant surge in Dupixent global revenues by 29% to $3.56 billion. The company's Eylea HD sales in the U.S. held a 45% market share, generating $304 million in earnings. Amid these developments, Regeneron's drug Dupixent received expanded approval from the U.S. Food and Drug Administration and the European Medicines Agency's Committee for Medicinal Products for Human Use.
Despite the ongoing legal challenges, Piper Sandler, Truist Securities, and Baird have maintained positive and neutral stances on Regeneron, respectively. These recent developments highlight the company's continued commitment to advancing its drug development pipeline and maintaining its market position. Regeneron has also adjusted its full-year 2024 financial guidance, now expecting a gross margin of approximately 89%.
InvestingPro Insights
Regeneron Pharmaceuticals (NASDAQ: REGN) has recently achieved a milestone with the approval of Dupixent for COPD treatment in China, a development that could potentially bolster its market position. As investors evaluate the implications of this advancement, several key metrics and insights from InvestingPro can provide a clearer picture of the company's financial health and market performance.
According to InvestingPro data, Regeneron boasts a robust market capitalization of $112.25 billion, reflecting investor confidence in the company's growth prospects. This is further supported by a Price/Earnings (P/E) ratio of 25.7, indicating that investors are willing to pay a premium for Regeneron's earnings compared to the industry average. The company's revenue has also shown a healthy growth, with a 6.46% increase over the last twelve months as of Q2 2024. Additionally, Regeneron's gross profit margin stands at an impressive 53.27%, underscoring its ability to maintain profitability despite costs.
An InvestingPro Tip highlights Regeneron's aggressive share buyback strategy, a move that often signals management's confidence in the company's future performance and a potential increase in shareholder value. Furthermore, the company's liquid assets exceed its short-term obligations, providing financial flexibility and stability. This is particularly relevant as the company continues to invest in research and development for treatments like Dupixent.
Despite a recent drop in stock price over the last week, analysts remain optimistic, predicting profitability for the company this year. Regeneron has also maintained a strong return over the last five years, which could reassure long-term investors of the company's resilience and potential for growth. For those interested in more detailed analyses, InvestingPro provides additional tips, with a total of 11 insights available for Regeneron, offering a comprehensive evaluation of the company's financial and market position.
As Regeneron continues to expand its treatment portfolio and reach in international markets, these financial metrics and insights can help investors make informed decisions. The approval of Dupixent in China is not only a win for COPD patients but also a strategic achievement for Regeneron, potentially paving the way for further growth and success in the global pharmaceutical industry.
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