8-KOther Events

BRISTOL MYERS SQUIBB CO 8-K Report (May 26, 2004)

Filed May 26, 2004For Securities:BMYCELG-RIBMYMP

Summary

This 8-K filing from Bristol-Myers Squibb (BMY) on May 25, 2004, provides an update on the resolution of patent litigation concerning PARAPLATIN (carboplatin) and its implications for market exclusivity. The company announced an agreement with Pharmachemie B.V. (a Teva Pharmaceutical Industries subsidiary) to settle patent litigation, allowing Pharmachemie to distribute an unbranded version of carboplatin starting June 24, 2004, following FTC approval. Bristol-Myers Squibb will continue to distribute its branded PARAPLATIN and also supply product to Pharmachemie. Furthermore, the filing confirms that Bristol-Myers Squibb secured a six-month extension of marketing exclusivity for PARAPLATIN from the FDA, based on pediatric studies. This extension grants the company additional market protection beyond the primary patent's expiration on April 14, 2004. The FTC's clearance of the settlement agreement removes a significant hurdle, paving the way for the new market entrant as planned.

Key Highlights

  • 1BMY has reached an agreement to settle patent litigation concerning PARAPLATIN (carboplatin) with Pharmachemie B.V. (a Teva subsidiary).
  • 2Pharmachemie B.V. is expected to begin distributing an unbranded version of carboplatin on June 24, 2004, subject to conditions.
  • 3BMY will continue to distribute branded PARAPLATIN and will also supply product to Pharmachemie for its distribution.
  • 4The Federal Trade Commission (FTC) has issued advice that the settlement agreement does not raise issues under Section 5 of the FTC Act.
  • 5BMY obtained a six-month extension of marketing exclusivity for PARAPLATIN from the FDA.
  • 6This exclusivity extension is based on studies evaluating carboplatin's use in the pediatric population.
  • 7The primary patent for PARAPLATIN expired on April 14, 2004.

Frequently Asked Questions

This 8-K filing provides an update on the resolution of patent litigation for Bristol-Myers Squibb's drug PARAPLATIN (carboplatin) and confirms regulatory approvals related to market entry for a competitor and extended marketing exclusivity for BMY.

Pharmachemie B.V. is expected to commence selling an unbranded version of carboplatin on June 24, 2004, subject to certain conditions, including approval by the Federal Trade Commission (FTC). BMY will supply product to Pharmachemie.

While the primary patent for PARAPLATIN expired on April 14, 2004, Bristol-Myers Squibb has secured a six-month extension of marketing exclusivity from the FDA based on pediatric studies. This provides additional market protection beyond the patent's expiration date.

The FTC has issued advice stating that the settlement agreement between Bristol-Myers Squibb and Pharmachemie B.V. does not raise issues under Section 5 of the Federal Trade Commission Act.