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Oct 29, 2024

Bora Pharmaceuticals to Expand Rare Disease Portfolio with Acquisition of US-Based Pyros Pharmaceuticals - BioSpace

TAIPEI, Taiwan, Oct. 25, 2024 /PRNewswire/ -- Bora Pharmaceuticals Co., Ltd. (“Bora” or “the Company”, TWSE: 6472), today announced that its Board of Directors has approved the acquisition of US-based

TAIPEI, Taiwan, Oct. 25, 2024 /PRNewswire/ -- 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 VIGAFYDE™ (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

Healthcare providers must be enrolled in the Vigabatrin REMS to prescribe these products, and patients must be enrolled to receive them.

IMPORTANT SAFETY INFORMATION FOR VIGAFYDE™ (vigabatrin)

WARNING: PERMANENT VISION LOSS

See full prescribing information for complete boxed warning.

• VIGAFYDE can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, VIGAFYDE may also decrease visual acuity (5.1).

• Risk increases with increasing dose and cumulative exposure, but there is no dose or exposure to VIGAFYDE known to be free of risk of vision loss (5.1).

• Risk of new and worsening vision loss continues as long as VIGAFYDE is used, and possibly after discontinuing VIGAFYDE (5.1).

• Baseline and periodic vision assessment is recommended for patients on VIGAFYDE. However, this assessment cannot always prevent vision damage (5.1).

• VIGAFYDE is available only through a restricted program called the Vigabatrin REMS (5.2).

What is the most important information I should know about VIGAFYDE?

VIGAFYDE can cause serious side effects, including:

Tell your healthcare provider right away if your baby might not be seeing as well as before starting VIGAFYDE or is acting differently than normal.

Vision loss in babies: Because of the risk of vision loss, VIGAFYDE is used in babies 1 month to 2 years of age with infantile spasms only when you and your healthcare provider decide that the possible benefits of VIGAFYDE are more important than the risks.

Even if your baby’s vision seems fine, it is important to get regular vision tests because damage can happen before your baby acts differently. Even these regular vision exams may not show the damage to your baby’s vision before it is severe and permanent.

All babies who take VIGAFYDE:

Because VIGAFYDE might cause permanent vision loss, it is available to healthcare providers and patients only under a special program called Vigabatrin Risk Evaluation and Mitigation Strategy (REMS). Your healthcare provider will explain the details of the Vigabatrin REMS to you. For more information, go to or call 1-866-244-8175.

What are the possible side effects of VIGAFYDE?

VIGAFYDE can cause serious side effects, including sleepiness (sleepy babies may have a harder time suckling and feeding or may be irritable) and weight gain without swelling. Serious side effects that happen in adults who take vigabatrin and are not known if they will happen in babies are low red blood cell counts, nerve problems, and swelling.

Tell your baby’s healthcare provider right away if your baby’s seizures get worse.

The most common side effects of VIGAFYDE in babies include sleepiness, ear infection, swelling of the bronchial tubes, and irritability.

Tell your healthcare provider if your baby has any side effect that bothers them or that does not go away. These are not all the possible side effects of VIGAFYDE.

Do not stop taking VIGAFYDE suddenly. This can cause serious problems. Talk to your healthcare provider for directions on how to stop treatment.

What should I tell my healthcare provider before starting VIGAFYDE?

Before giving VIGAFYDE to your baby for IS, inform your healthcare provider about all your baby’s medical conditions. This includes whether your baby has ever had an allergic reaction to vigabatrin, such as hives, itching, or trouble breathing, as well as any history of vision problems, or kidney issues. Tell your healthcare provider about all the medicines your baby takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Interactions between VIGAFYDE and other medicines could lead to side effects.

You may report side effects to the FDA at http://www.fda.gov/medwatch or call 1-800-FDA-1088 or Pyros at 1-855-406-1010.

Please see full Prescribing Information, including BOXED WARNING, Medication Guide, and Instructions for Use for additional Important Safety Information.

About Bora

About Pyros

Forward-Looking Statements

Contacts

Bora Pharmaceuticals Co., Ltd.

Kovak-Likly Communications, LLC

[email protected]

203-762-8833

Jim Maahs

Head of Commercial

Upsher-Smith Laboratories, LLC

763-315-2000

Pyros Pharmaceuticals, Inc.

Chief Operating Officer

[email protected]

201-743-9468

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SOURCE Bora Pharmaceuticals Co., Ltd.