Bora Pharmaceuticals to Acquire Pyros Pharmaceuticals to Expand Rare Disease Portfolio

TAIPEI, Taiwan, Oct. 25, 2024 – Bora Pharmaceuticals Co., Ltd. (Bora) announced the approval of its Board of Directors to acquire Pyros Pharmaceuticals, Inc., a US-based company specializing in treatments for rare diseases. This acquisition signifies Bora's ongoing expansion in the pharmaceutical industry.

Established in 2017 by Michael Smith and Edwin Urrutia, Pyros Pharmaceuticals recently introduced VIGAFYDE™ (vigabatrin) oral solution. This medication is specifically designed as a monotherapy for treating infantile spasms (IS) in pediatric patients aged 1 month to 2 years, where the potential benefits outweigh the potential risk of vision loss. Infantile spasms, a severe form of epilepsy, present significant challenges for those affected and their families.

VIGAFYDE™ stands out as the first and only ready-to-use vigabatrin oral solution, marking significant progress in IS treatment as the first new product approved for the condition in 15 years. Its premixed form simplifies the dosing process, enhancing the likelihood of accurate dosage administration. The U.S. Food and Drug Administration (FDA) approved VIGAFYDE™ on June 17, 2024, and it became available to patients in September 2024.

This acquisition is part of Bora's strategic growth, following its recent purchase of Upsher-Smith Laboratories, LLC earlier this year and TWi Pharmaceuticals in 2022. These acquisitions are part of Bora’s strategy to establish itself as a global competitor in both the contract development and manufacturing (CDMO) and commercial prescription (Rx) sectors.

Bobby Sheng, Chairman and CEO of Bora Group, commented, "The synergies between Upsher-Smith and Pyros are remarkable. Pyros' innovative research and development, coupled with Upsher-Smith's expertise in the pediatric CNS space, create a formidable alliance that will enhance treatment satisfaction and patient outcomes with vigabatrin."

Michael Smith, co-founder and CEO of Pyros, expressed enthusiasm about the agreement with Bora. He emphasized Bora's shared commitment to supporting families dealing with the complexities of rare diseases and aligning with Pyros' mission to improve care standards for these underserved patient communities.

Sheng added that the combined team is dedicated to educating healthcare providers about the unique benefits of VIGAFYDE™ for both caregivers and patients.

In this transaction, Bora is advised by Stifel as its exclusive financial advisor and Gibson, Dunn & Crutcher LLP as its legal advisor. Pyros is advised by Piper Sandler as its exclusive financial advisor and Cooley LLP as its legal advisor.

All vigabatrin products, including VIGAFYDE™, are regulated under a Risk Evaluation and Mitigation Strategy (REMS) mandated by the FDA. This REMS ensures informed risk-benefit decisions regarding its use by patients and healthcare providers. To prescribe these products, healthcare providers must be enrolled in the Vigabatrin REMS, and patients must be enrolled to receive them.

IMPORTANT SAFETY INFORMATION FOR VIGAFYDE™ (vigabatrin)

VIGAFYDE™ can lead to serious side effects, including:

Permanent vision loss: VIGAFYDE™ can cause significant vision damage, particularly affecting peripheral vision. Some children may only retain tunnel vision, and such damage is irreversible. Parents and healthcare providers should monitor for signs of vision loss closely.

Health providers should assess the vision of babies before starting VIGAFYDE™ treatment and regularly during and after treatment. Even with regular vision tests, vision damage may not be detected until it is severe and permanent.

All babies taking VIGAFYDE™ are at risk of permanent vision loss, which can occur at any stage during or after the treatment. Because of this risk, VIGAFYDE™ is only available under the special Vigabatrin REMS program.

MRI changes: Brain MRIs in some babies show changes after taking VIGAFYDE™, though the implications of these changes are not yet understood.

Side Effects: VIGAFYDE™ can cause side effects such as sleepiness, weight gain without swelling, and ear infection. Serious side effects observed in adults include low red blood cell counts and nerve problems. Parents should report any worsening of seizures or other adverse effects to their healthcare provider.

Patients should not discontinue VIGAFYDE™ abruptly and should seek guidance from healthcare providers for safe discontinuation.

Before starting VIGAFYDE™, inform healthcare providers about all medical conditions and medicines, as interactions with other substances could lead to adverse effects. Report side effects to the FDA or Pyros.

About Bora: Founded in 2007, Bora Pharmaceutical Co., Ltd. is Taiwan's largest pharmaceutical manufacturer, supplying over 100 countries globally. Bora aims to be a global leader in pharmaceutical manufacturing, prioritizing quality, efficiency, and reliability.

About Pyros: Pyros Pharmaceuticals is dedicated to developing specialty pharmaceuticals for rare diseases, with a mission to enhance the standard of care for infantile spasms and improve the lives of affected children through innovative therapies and comprehensive support.