TWi Pharmaceuticals, Inc.

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) WARNING: PERMANENT VISION LOSS 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 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.

Bora Pharmaceuticals continued its global expansion push by buying a stake in Taiwanese drugmaker Tanvex Biopharma. Bora Pharmaceuticals extended its expansion tear by taking a 30.5% stake in fellow Taiwanese drugmaker Tanvex BioPharma, boosting the CDMO’s biomanufacturing capabilities.The deal, which is expected to be completed in the first quarter of 2025, will make Bora the largest shareholder in Tanvex. It also gives Bora access to Tanvex's commercial-scale production facility in San Diego, the CDMO said in an Aug. 27 press release.Tanvex boasts more than 100,000 square feet of biomanufacturing space and operates 1,000- liter bioreactors, which will complement Bora’s 500-liter bioreactors, Bora added. The companies "will combine their biomanufacturing facilities to create a global solution for biologics development and supply," according to Bora's release.Bobby Sheng, Bora Group’s chairman and CEO, will become chair of the merged organization.“This partnership will enable the combined entity to rapidly respond to evolving industry demands and policy developments, such as the BIOSECURE Act in the US, and capitalize on new opportunities in onshoring, friendshoring, and the growing CDMO demands driven by these policy changes,” Sheng said in the release. The investment in Tanvex is the latest move in Bora’s global expansion march.In June, Bora shelled out $30 million to snap up Emergent’s fill-finish drug product facility in Baltimore that offers clinical and commercial nonviral aseptic fill-finish services on four fill lines, including lyophilization, formulation development and support services.That acquisition followed January’s $210 million acquisition of Minnesota generics manufacturer Upsher-Smith Laboratories that gave Bora a foothold in the U.S.In 2022, Bora purchased fellow Taiwanese company TWi Pharmaceuticals, gaining two manufacturing facilities and some niche technologies, and it also bought Eden Biologics' CDMO business.

The sale represents one piece in Emergent’s plan to deprioritize its CDMO business. The asset sale portion of Emergent BioSolutions’ sweeping restructuring plan is taking shape. In a $30 million deal, Emergent has agreed to sell its fill-finish drug product facility in Baltimore to growing Taiwanese CDMO Bora Pharmaceuticals, the two companies said Thursday. The 87,000-square-feet Camden facility offers clinical and commercial non-viral aseptic fill-finish services on four fill lines, including lyophilization, formulation development and support services. About 350 Emergent employees are expected to join Bora as part of the transaction, which is expected to close in the third quarter of 2024, according to Emergent. Bora, through a media aide, confirmed to Fierce Pharma via email that the company plans to keep all existing employees at the plant. “The decision to sell our Camden manufacturing facility is aligned with our multi-year plan to create a customer focused, leaner and more flexible organization, while we improve overall profitability and raise capital to reduce our debt,” newly minted Emergent CEO Joe Papa said in a statement Thursday. The Camden site doesn’t have the most pristine track record. Following an FDA Form 483, the plant was slapped with an FDA warning letter in 2022 that detailed problems related to equipment cleaning, aseptic sterilization techniques and procedures, and quality systems. The problems were deemed adequately addressed and the warning letter closed following another FDA inspection last summer. The sale represents one piece in Emergent’s plan to deprioritize its CDMO business. About two months into his CEO role, Papa in May unveiled a restructuring initiative to reduce the company’s workforce by about 300 employees and to shut down two manufacturing facilities, while exploring strategic alternatives for some other plants. The two facilities being closed are located in Baltimore-Bayview and Rockville, Maryland. The Camden facility belongs to the group of sites for which Emergent has been weighing its options. Besides sites in Winnipeg, Canada, and Lansing, Michigan, which Emergent said it will keep, the company also owns about 122,500 square feet of manufacturing and warehouse space in Canton, Massachusetts, where Emergent has scaled back operations. In contrast to Emergent’s shrinking interest in the CDMO field, Bora has been on an expansion spree. The Taiwanese company just established a U.S. footprint earlier this year with a $210 million acquisition of Minnesota generics manufacturer Upsher-Smith Laboratories. The Upsher-Smith buy followed two acquisitions by Bora in 2022. Through the purchase of fellow Taiwanese company TWi Pharmaceuticals, Bora gained two manufacturing facilities and some niche technologies. The same year, Bora beefed up its biologics capabilities by acquiring Eden Biologic’s CDMO business. Buying the Camden sterile injectable fill-finish plant “not only demonstrates our commitment to our growth strategy and plans for expansion in North America, but also enables us to expand our offering for our biologics customers,” Bora CEO Bobby Sheng said in a statement Thursday. Without offering further details, Bora said it has “ambitious plans to enhance the newly acquired facility.” And the company is “always considering sites that are available,” Bora told Fierce Pharma. “We are planning to expand our operations across the US market to significantly enhance Bora’s position as a global competitor,” the company said. “As part of our growth strategy, we are constantly listening to our customer's needs to spot opportunities to provide the best possible service.”