Eden Biologics, Inc.

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.”

Michael Vi/Shutterstock Genentech’s Hemlibra® (emicizumab-kxwh) showed no new safety signals and continued to deliver consistent bleeding control in the final analysis of a long-term, late-stage hemophilia A study. Hemlibra, a bispecific factor IXa- and factor X-directed antibody, is approved in more than 100 countries to treat hemophilia A with factor VIII inhibitors. Individuals with hemophilia A who develop factor VIII inhibitors have an increased risk of more frequent bleeding and have greater day-to-day challenges than patients with hemophilia without factor VIII inhibitors. The drug is also approved in over 80 countries for hemophilia A without factor VIII inhibitors. Researchers performed a final analysis of the Phase IIIb STASEY study, which included 193 patients with hemophilia A with factor VIII inhibitors who were treated with prophylactic once-weekly Hemlibra for up to two years. Overall, the median duration of treatment was 103.1 weeks. In the analysis, there were no new cases of thrombotic microangiopathy or serious thrombotic events associated with the study drug. The most frequent adverse events (AEs) which occurred in 10 percent or more study participants included joint pain (17.1 percent), common cold symptoms (15.5 percent), headache (15.0 percent), injection site reaction (11.4 percent), and fever (pyrexia; 10.9 percent). Approximately 35 percent of patients experienced a drug-related AE, the most common being injection site reactions (9.8 percent). Only 5.2 percent (n=10) of participants were positive for anti-drug antibodies (ADAs), suggesting Hemlibra is associated with a low incidence of ADA development. A total of five of the patients positive for ADAs had neutralizing ADAs in vitro. The development of ADAs in the 10 participants demonstrated no effect on the efficacy or safety of the study drug. The ADAs all dissipated over time, with all participants testing negative at the last study visit. Treatment with Hemlibra over the long-term follow-up also effectively controlled bleeding – approximately 82.6 percent of patients had no bleeding episodes over the treatment period that required management. According to a statement made by the company, the annual bleeding rates were consistent with those reported in the pivotal HAVEN trials. “As the treatment landscape evolves, determining the long-term benefit/risk profile of medicines for people living with hemophilia A remains a top priority for the community,” said Genentech’s Chief Medical Officer and Head of Global Product Development, Levi Garraway, M.D., Ph.D. “These results provide further confidence in Hemlibra’s favorable safety profile in people with hemophilia A with factor VIII inhibitors, who have historically faced significant treatment challenges.” The positive study findings come soon after the recent indictment of prior Genentech staffers who recently pleaded guilty to orchestrating the theft of trade secrets. The U.S. government also charged the former Chief Executive Officer and Chief Operating Officer with wire fraud and money laundering exceeding $101 million. These indictments follow similar charges three years ago against former company employees who allegedly stole trade secrets from Roche subsidiary to establish JHL Biotech. In the most recent controversy, former Genentech principal scientist Xanthe Lam and husband Allen Lam pleaded guilty to orchestrating the theft of trade secrets from the subsidiary to assist competitors. The former company employees reportedly stole confidential intellectual property related to cancer drugs Avastin, Herceptin and Rituxan, in addition to cystic fibrosis drug Pulmozyme.