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RedHill Biopharma's Game-Changer: RHB-102 Licensing Deal with Hyloris

$RDHL
Form 6-K
Filed on: 2025-02-25
Source
RedHill Biopharma's Game-Changer: RHB-102 Licensing Deal with Hyloris

Here are the key points and insights extracted from the financial report of RedHill Biopharma Ltd., as detailed in the Form 6-K:

Company Overview

  • Name: RedHill Biopharma Ltd.
  • Type: Specialty biopharmaceutical company.
  • Location: 21 Ha'arba'a Street, Tel Aviv, Israel.
  • Commission File Number: 001-35773.

Key Financial Information

  • Licensing Agreement: RedHill has entered into an exclusive licensing agreement with Hyloris Pharmaceuticals for the commercialization of its drug RHB-102 (Bekinda) worldwide, excluding North America.
  • Financial Terms of the Agreement:
  • Upfront payment to RedHill.
  • Up to $60 million in potential milestone payments.
  • Royalties in the mid-20% range on revenues, subject to certain cost recoupments.
  • Minimum annual payments guaranteed to RedHill.

Product Details

  • Product Name: RHB-102 (Bekinda).
  • Description: A once-daily, bimodal extended-release oral tablet formulation of ondansetron, used for treating chemotherapy-induced nausea and vomiting (CINV), acute gastroenteritis, gastritis, and diarrhea-predominant irritable bowel syndrome (IBS-D).
  • Dosage Strengths: 12 mg and 24 mg.

Market Insights

  • Antiemetics Market Value: Valued at approximately $7.5 billion in 2023, with an expected compound annual growth rate (CAGR) of around 6% from 2024 to 2030.
  • Development Status: Recent positive advice from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has provided a potential pathway for a Marketing Authorization Application (MAA) for RHB-102 in the UK.

Recent Developments

  • Clinical Trials:
  • Positive results from U.S. Phase 2 study for IBS-D (RHB-102 12 mg) and Phase 3 GUARD gastroenteritis study (RHB-102 24 mg) were published in reputable journals.
  • Hyloris will handle all development, regulatory, and commercialization activities for RHB-102 in its territories, while RedHill will pursue FDA approval in the U.S.

Leadership

  • CEO of RedHill: Dror Ben-Asher, who emphasized the potential of RHB-102 as a significant addition to supportive care in oncology and other settings.

Forward-Looking Statements

  • The report includes forward-looking statements regarding the company's expectations and potential risks associated with their development pipeline and market conditions.

Conclusion

This agreement with Hyloris represents a strategic move for RedHill Biopharma, providing them with a significant potential revenue stream from milestone payments and royalties, while also allowing them to focus on FDA approval for their product in the U.S. The successful development and commercialization of RHB-102 could enhance their market position within the growing antiemetics market.