Regeneron Pharmaceuticals Announces Significant Scientific Developments and Improvements in Clinical Trials

Regeneron Pharmaceuticals, led by President and CEO Dr. Leonard S. Schleifer, made several notable announcements at the Robertson Stephens & Company 1995 Medical Conference in New York City. The company highlighted significant progress in its research and development programs, including the BDNF clinical trial for amyotrophic lateral sclerosis (ALS) and the development of an IL-6 antagonist. Additionally, Regeneron's collaboration with Amgen and Sumitomo Pharmaceuticals was emphasized, demonstrating the company's commitment to advancing novel therapeutics for various human medical conditions.

Key Takeaways:

  • The BDNF Phase III clinical trial for ALS has reached 90% enrollment, with patient enrollment beginning in July 1995 and a double-blind, placebo-controlled study involving over 1,000 patients.
  • Amgen is conducting a clinical trial testing the safety and tolerability of BDNF in diabetic patients with peripheral neuropathy, which is expected to commence in late 1995 or early 1996.
  • Regeneron has been granted a patent covering its proprietary IL-6 antagonist, which utilizes IL-6 specific receptor components to create a high affinity trap for IL-6.
  • The development of an IL-6 antagonist has potential broad clinical applications, particularly in reducing IL-6 levels in various human diseases, including multiple myeloma, certain solid tumors, AIDS, lymphomas, rheumatoid arthritis, osteoporosis, and sepsis.
  • Regeneron has a strong capital position, with approximately $60 million in cash and cash equivalents as of September 30, 1995, which will enable the company to proceed with its programs and plans from a position of strength.
  • The company is collaborating with Amgen-Regeneron Partners to develop BDNF and NT-3 in the United States, while also partnering with Sumitomo Pharmaceuticals to develop BDNF in Japan.

Statistics:

  • Over 1,000 patients are being treated in the BDNF Phase III clinical trial.
  • The trial is a double-blind, placebo-controlled study lasting nine months.
  • Approximately $60 million in cash and cash equivalents as of September 30, 1995.
  • 2.3 million newly-issued shares of Common Stock were sold in a public offering in November 1995 at $10.50 per share.

Sources:

  • Regeneron Pharmaceuticals Inc. press release, November 28, 1995
  • "Regeneron Pharmaceuticals Announces Significant Scientific Developments" by Business Wire, November 28, 1995