Company Announcements

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
All vigabatrin products including VIGAFYDE™, 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.

IMPORTANT SAFETY INFORMATION FOR VIGAFYDE™ (vigabatrin)

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

VIGAFYDE can cause serious side effects, including:

• Permanent vision loss: VIGAFYDE can damage the vision of anyone who takes it. Some babies can have severe loss, particularly to their ability to see to the side when they look straight ahead (peripheral vision). With severe vision loss, your baby may only be able to see things straight in front of them (sometimes called "tunnel vision"). Your baby also may have blurry vision. If this happens, it will not get better.

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.

• Parents or caregivers are not likely to recognize the symptoms of vision loss in babies until it is severe. Healthcare providers may not find vision loss in babies until it is severe.
• It is difficult to test vision in babies, but, to the extent possible, all babies should have their vision tested before starting VIGAFYDE or within 4 weeks after starting VIGAFYDE, and every 3 months after that until VIGAFYDE is stopped. Your baby also should have a vision test about 3 to 6 months after VIGAFYDE is stopped.
• Your healthcare provider will determine if your baby can be tested. If your baby cannot be tested, your healthcare provider may continue prescribing VIGAFYDE, but they will not be able to watch for any vision loss.

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:

• Are at risk for permanent vision loss with any amount of VIGAFYDE.
• The risk of vision loss may increase with higher doses of VIGAFYDE, and the longer it is taken.
• It is not possible for your healthcare provider to know when vision loss will happen. It could happen soon after starting VIGAFYDE or any time during treatment. It may even happen after treatment has stopped.

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.

• Magnetic resonance imaging (MRI) changes in babies with infantile spasms (IS): brain pictures taken by MRI show changes in some babies after they are given VIGAFYDE. It is not known if these changes are harmful.

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
Founded in 2007, Bora Pharmaceutical Co., Ltd. ("Bora" or "the Company", 6472.TW) now is the largest pharmaceutical manufacturer in Taiwan with well-connected global distribution to supply more than 100 countries around the world. Bora is dedicated to becoming a global leader in pharmaceutical manufacturing by offering its clients the best quality, efficiency and reliability. For more information, visit www.bora-corp.com. 

About Pyros
Pyros Pharmaceuticals is dedicated to developing enhanced specialty pharmaceuticals for rare diseases. Pyros's mission is to elevate the standard of care for infantile spasms, providing treatment options that significantly improve the lives of affected children. Through innovative therapies and comprehensive support, Pyros helps providers and caregivers navigate the complex patient journey. For more information, visit www.pyrospharma.com. 

Forward-Looking Statements
The Company has made statements throughout this press release which constitute forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors that may cause its actual results, levels of activity, performance or achievements to be materially different from any results, levels of activity, performance or achievements expressed or implied by any such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as "may," "will," "should," "could," "expect," "hopes," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "likely," "potential," or "continue" or the negative of these terms and similar words. Although management believe that the expectations reflected in these forward-looking statements are reasonable, management cannot guarantee future results, levels of activity, performance or achievements. Furthermore, management undertakes no obligation to update any forward-looking statements for any reason unless required to do so by law.

Contacts
Bora Pharmaceuticals Co., Ltd.
Elizabeth Likly
Kovak-Likly Communications, LLC
elikly@klcpr.com
203-762-8833

Jim Maahs
Head of Commercial
Upsher-Smith Laboratories, LLC
763-315-2000

Pyros Pharmaceuticals, Inc.
Edwin Urrutia
Chief Operating Officer
media@pyrospharma.com
201-743-9468

 

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SOURCE Bora Pharmaceuticals Co., Ltd.