Taipei, Taiwan, October 25, 2024 – Bora Pharmaceuticals Co., Ltd. (“Bora” or “the Company”, TWSE: 6472), today announced that its Board of Directors has approved the acquisition of US-based Pyros Pharmaceuticals, Inc. (“Pyros”), a specialty pharmaceutical company developing treatments for rare diseases.
Founded in 2017 by Michael Smith and Edwin Urrutia, Pyros recently launched VIGAFYDETM (vigabatrin) oral solution, which is indicated as monotherapy for the treatment of infantile spasms (IS) in pediatric patients 1 month to 2 years, where the potential benefits outweigh the potential risk of vision loss. Infantile spasms, a rare but severe form of epilepsy, pose significant challenges for patients and their families.
VIGAFYDE is the first and only ready-to-use vigabatrin oral solution and represents a significant advancement in the treatment of infantile spasms as the first new product approved for this condition in 15 years. As the only premixed, ready-to-use vigabatrin formulation, VIGAFYDE offers patients and caregivers a simpler dosing process and enhances the likelihood of accurate dosing. VIGAFYDE was approved by the U.S. Food and Drug Administration (FDA) on June 17, 2024 and became available to patients in September 2024.
This acquisition follows Bora’s recent purchase of Upsher-Smith Laboratories, LLC earlier this year and TWi Pharmaceuticals in 2022. These moves mark Bora’s rapid growth into a global competitor in both the contract development and manufacturing (CDMO) and commercial prescription (Rx) sectors.
“We see incredible synergies between Upsher-Smith and Pyros,” stated Bobby Sheng, Chairman and CEO of Bora Group. “Pyros’ innovative R&D and deep understanding of the unmet needs of the market, combined with Upsher-Smith’s reputation in the pediatric CNS space, create a powerful alliance that will enhance treatment satisfaction and patient outcomes with vigabatrin.”
Michael Smith, co-founder and CEO of Pyros commented, “We are excited to reach this agreement with Bora, a company that shares our commitment to supporting families navigating the unique challenges of rare diseases and aligns with our mission of elevating the standard of care for these often overlooked and under-supported patient communities.”
Sheng added, “Our combined team is committed to educating healthcare providers on the unparalleled value of VIGAFYDE and its unique benefits for both caregivers and patients alike.”
For Bora, Stifel is acting as exclusive financial advisor and Gibson, Dunn & Crutcher LLP is acting as legal advisor in this transaction. For Pyros, Piper Sandler is acting as exclusive financial advisor and Cooley LLP is acting as legal advisor.
Vigabatrin REMS
All vigabatrin products including VIGAFYDTM, are governed by a Risk Evaluation and Mitigation Strategy (REMS) mandated by the FDA. The Vigabatrin REMS ensures that patients and healthcare providers make informed risk-benefit decisions about its use.
Healthcare providers must be enrolled in the Vigabatrin REMS to prescribe these products, and patients must be enrolled to receive them.
