Deutetrabenazine

12 August 2025 PureTech Health plc PureTech Announces the Launch of Celea Therapeutics with a Mission to Transform the Treatment of Respiratory Diseases Former Teva North America CEO Sven Dethlefs, PhD, to lead Celea PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced the launch of a new Founded Entity Celea Therapeutics ("Celea"). Celea's mission is to deliver therapies that transform the lives of people with serious respiratory diseases. Its lead program, deupirfenidone (LYT-100), is a Phase 3-ready therapeutic candidate that holds promise across multiple fibrotic and inflammatory lung conditions and is initially being advanced for the treatment of idiopathic pulmonary fibrosis (IPF), a rare, progressive, and fatal lung disease. Sven Dethlefs, PhD, has been appointed to lead Celea, bringing deep expertise and a clear vision to accelerate the program's advancement. The launch of Celea reflects PureTech's commitment to advancing differentiated programs through focused, capital-efficient structures with seasoned leadership. Dr. Dethlefs is a proven pharmaceutical executive with more than 25 years of experience in global commercialization, R&D strategy, business development, and operations. He has played a central role at PureTech, driving forward the deupirfenidone program for more than a year. Prior to joining PureTech, Dr. Dethlefs served as CEO of Teva North America, where he oversaw the company's $8 billion specialty branded and generic businesses across the U.S. and Canada. At Teva, he also held senior leadership roles as Global Head of Marketing and Portfolio, Head of Respiratory Medicines, and COO Operations. He played a key role in the successful launch of AUSTEDO®, Teva's blockbuster treatment for Tardive Dyskinesia and Huntington's Disease, which is a deuterated form of tetrabenazine. Prior to joining Teva, Dr. Dethlefs was a partner at McKinsey & Company. He holds a PhD in Biochemistry. Dr. Sven Dethlefs commented: "Bringing meaningful innovation to patients with serious diseases has been a consistent theme throughout my career, and I believe deupirfenidone has the potential to be a true turning point in the treatment of IPF. Our Phase 2b data demonstrated the potential for best-in-class efficacy with a favorable safety and tolerability profile-addressing two of the most critical limitations of current therapies. The strength of the clinical data, combined with the team and mission behind Celea, make this a uniquely compelling opportunity. I'm excited to lead the next phase of development as we work to deliver a new standard of care for people living with IPF and other debilitating lung conditions." PureTech completed a successful Phase 2b trial of deupirfenidone in December 2024. A meeting with the U.S. Food and Drug Administration to discuss these results and the proposed Phase 3 trial design is expected by the end of the third quarter of 2025. Consistent with its capital-efficient innovation model, PureTech is pursuing third-party funding for Celea to advance the program through Phase 3 and potential commercialization. Robert Lyne, PureTech's Interim Chief Executive Officer, added: "The launch of Celea is an important value driver for PureTech. Sven brings deep experience in respiratory medicine and a strong track record of commercial success, including having played a critical role in the growth of AUSTEDO®, a deuterated medicine developed using the same underlying chemistry approach as deupirfenidone. He is uniquely suited to lead Celea and advance this important program." About Deupirfenidone (LYT-100) Deupirfenidone (LYT-100) is in development as a potential new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF). It is a deuterated form of pirfenidone, which - along with nintedanib - is one of the two FDA-approved treatments for IPF. Both approved therapies offer only modest efficacy in slowing lung function decline, largely due to tolerability challenges that limit the ability to achieve higher doses that could significantly improve patient outcomes. These limitations have contributed to low treatment uptake and poor adherence, with approximately 25% of people with IPF in the U.S. ever receiving either drug. Despite this, combined peak global sales exceed $5 billion, representing a significant market opportunity in IPF and other fibrotic lung diseases. [1] Deupirfenidone may overcome these limitations. In the global Phase 2b ELEVATE IPF trial, deupirfenidone demonstrated the potential to stabilize lung function decline over at least 26 weeks as a monotherapy while maintaining a favorable safety and tolerability profile. Initial data from an ongoing open-label extension study suggest that this effect may be sustained through at least 52 weeks. These findings support the potential for deupirfenidone to offer a meaningful advance for people living with this progressive and deadly disease. Beyond IPF, deupirfenidone may also address multiple underserved fibrotic conditions, including progressive fibrosing interstitial lung diseases. About Idiopathic Pulmonary Fibrosis (IPF) Idiopathic pulmonary fibrosis (IPF) is a rare, progressive, and fatal lung disease characterized by irreversible scarring of lung tissue that leads to a steady decline in lung function. Median survival following diagnosis is estimated to be two to five years, and currently there is no cure.[2] About Celea Therapeutics Celea Therapeutics is dedicated to delivering transformative treatments for people with serious respiratory diseases. The company's lead program, deupirfenidone (LYT-100), is a Phase 3-ready therapeutic candidate with the potential to set a new standard of care for idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases. Celea was founded by PureTech Health plc (Nasdaq: PRTC, LSE: PRTC), a biotherapeutics company dedicated to giving life to science. PureTech's innovative R&D model drives the creation of Founded Entities like Celea, enabling the advancement of highly promising medicines to patients in a capital-efficient manner. For more information, please visit www.celeatx.com and www.puretechhealth.com. About PureTech Health PureTech is a clinical-stage biotherapeutics company dedicated to giving life to new classes of medicine to change the lives of patients with devastating diseases. The Company has created a broad and deep portfolio through its experienced research and development team and its extensive network of scientists, clinicians, and industry leaders that is being advanced both internally and through its Founded Entities. PureTech's R&D engine has resulted in the development of 29 therapeutics and therapeutic candidates, including three that have been approved by the U.S. Food and Drug Administration. A number of these programs are being advanced by PureTech or its Founded Entities in various indications and stages of clinical development, including registration-enabling studies. All of the underlying programs and platforms that resulted in this portfolio of therapeutic candidates were initially identified or discovered and then advanced by the PureTech team through key validation points. For more information, visit www.puretechhealth.com or connect with us on X (formerly Twitter) @puretechh. Cautionary Note Regarding Forward-Looking Statements This press release contains statements that are or may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements that relate to continued development of and regulatory interactions related to deupirfenidone, the potential of deupirfenidone in IPF and other indications, our expectations around our therapeutic candidates and approach towards addressing major diseases, our plans to advance our programs and deliver on our milestones, our future plans, prospects, developments, and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks, uncertainties and other important factors described under the caption "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2024 filed with the SEC and in our other regulatory filings. These forward-looking statements are based on assumptions regarding the present and future business strategies of the Company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, we disclaim any obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise. Contact: PureTech Public Relations publicrelations@puretechhealth.com Investor Relations IR@puretechhealth.com UK/EU Media Ben Atwell, Rob Winder +44 (0) 20 3727 1000 puretech@fticonsulting.com US Media Justin Chen +1 609 578 7230 justin@tenbridgecommunications.com [1] Esbriet peak sales (2020) per Roche 2021 Financial Results & Ofev peak sales (2024) per Boehringer Ingelheim 2024 Financial Results. Ofev sales include those for all approved indications - IPF, PF-ILD, and systemic sclerosis-associated interstitial lung disease (SSc-ILD). [2] Fisher, M., Nathan, S. D., Hill, C., Marshall, J., Dejonckheere, F., Thuresson, P., & Maher, T. M. (2017). Predicting life expectancy for pirfenidone in idiopathic pulmonary fibrosis. Journal of Managed Care & Specialty Pharmacy, 23(3-b Suppl), S17-S24. https://doi-org.libproxy1.nus.edu.sg/10.18553/jmcp.2017.23.3-b.s17 END NRAGPUUPRUPAUUP

More than 50% of Teva’s U.S. products—including its lead drug Austedo—are manufactured locally across eight production sites, the company's CFO, Eli Kalif, said Wednesday. As more drugmakers begin to report second-quarter earnings against the backdrop of the first material pharmaceutical tariff reveal from the Trump administration, Teva Pharmaceuticals isn’t sweating the situation.The Israel-based generics and innovative medicines hybrid has “absorbed the already confirmed tariffs into our 2025 guidance,” Teva’s CFO, Eli Kalif, said on a call with analysts Wednesday.More than 50% of Teva’s U.S. products—including its lead drug Austedo—are manufactured locally across eight production sites, Kalif pointed out. Further, the company has “very limited exposures” in India and China, with Kalif attributing Teva’s lack of reliance on the latter country to the closure of its API business there four years back.“All in all, when we are looking at our supply chain, our ability to actually build inventory and to manage our manufacturing steps, we don’t see here, currently, any meaningful impact for the short term,” Kalif said. The CFO’s comments came after pharmaceutical import tariffs finally surfaced in a new trade deal struck between the U.S. and the European Union (EU) on Sunday. Under the current terms of the deal, the tariff rate stands at 15% for pharmaceutical imports—and those of many other goods—entering the U.S. from Europe.Many unknowns still surround the EU tariffs, including how the U.S.’ Section 232 investigation into the national security implications of pharmaceutical imports could influence the current rate, if at all. Further, in a potentially key carveout for Teva, certain generic drugs will be excluded from the tariffs, though it’s currently unclear which ones.Teva has “done very comprehensive work to understand how we can mitigate the impact [of tariffs] on our business,” the company’s CEO, Richard Francis, said on the call. He cautioned, however, that “there’s a lot of ambiguity about what really occurred with these tariffs,” referring to the 15% duties in the U.S.-EU accord.“I think the way we’ve always played this on tariffs is to be very conservative,” Francis added. “[W]e think about this comprehensively, and probably with a more glass-half-empty approach.”Francis noted that the company has several mitigation plans prepped that Teva can roll out once more details on the Trump administration’s pharmaceutical tariffs become clear.Teva has good reason to want to keep those tariffs from impacting its business as it continues a sales growth rebound and innovative medicines pivot under a multi-year turnaround strategy dubbed “Pivot to Growth.”While Teva is continuing to make good on many different aspects of its plan, the company’s performance in the second quarter was a bit more mixed than it has been in other recent earnings periods.All told, Teva’s revenue grew 1% at constant currencies to $4.2 billion after taking sales from the company’s generics joint venture with Takeda out of the mix. Late last year, Teva and Takeda decided to divest the Japan business to better focus on their own innovative medicine ambitions.When including the Japan JV sales, Teva’s total revenue for the period was flat year over year, according to a company earnings presentation (PDF).Nevertheless, Teva’s focus on its innovative portfolio continues to pay off, with the company now raising its full-year sales guidance for all three of its key marketed meds: Austedo, Uzedy and Ajovy.Teva’s chief drug, Austedo—approved in Huntington’s disease and tardive dyskinesia—grew sales 19% to $498 million for the quarter and is now expected to bring home sales between $2 billion and $2.05 billion for the year, compared to a previous range of $1.95 billion to $2.05 billion.Ajovy for migraine prevention, which delivered second-quarter sales growth of 31% to $155 million, is now pegged to reach sales between $630 million and $640 million, versus a prior projection of roughly $600 million.And Teva’s long-acting risperidone product for schizophrenia, Uzedy, is now in the running to secure $190 million to $200 million in 2025 sales after growing 120% in Q2 to $54 million.Uzedy has fared well in the risperidone and long-acting markets, but Teva now aims to “compete in the broader market of schizophrenia,” Francis said on the call. “So, we’ll be looking for patients to benefit from this on other molecules currently,” he explained.The CEO reiterated that Teva aims to launch the anticipated second half of its long-acting schizophrenia portfolio—long-acting olanzapine—in 2026. Together, the company estimates that the long-acting schizophrenia franchise can deliver combined peak sales of $1.5 billion to $2 billion.The consistent growth of Teva’s innovative drug trio helps affirm the company’s multiyear turnaround thesis, Francis said.When Teva first telegraphed its new growth strategy some two years back, “there was a question mark,” Francis said in an interview following the company’s earnings call. “Can Teva sell innovative drugs? And now we continue to show quarter on quarter we can.” He added that “there’s no secret sauce to this,” explaining that the company is simply hitting on commercialization fundamentals and doing them well. The company’s generics business, meanwhile, fell 2% for the period. Teva called the comparison “flat,” as Francis attributed it to both the timing of shipments of generic Revlimid and a tough comparison to Teva’s second quarter in 2024, when the company benefited from the launch of its Victoza GLP-1 copycat.The company’s biosimilars business, on the other hand, is booming.“We’ve seen some really good sales momentum in the U.S., and that’s been driven by our established brands, as well as our new launches with Selarsdi and generic Soliris that we launched in Q1 this year,” Francis said on Teva's earnings call. Selarsdi is Teva’s biosimilar to Johnson & Johnson’s Stelara.Teva is planning two more biosimilar launches before the year is out.  “I think the thing that I’m seeing people take away is the transition from Teva as pure play generics to a biopharma company seemed like it was fiction two years ago,” Francis said in the interview with Fierce.“How could it be done,” he continued. “What we’re seeing now, with our ability to handle a flat generics quarter, because of our innovative growth, shows we’re well on our way to doing that, and I think that’s really exciting.” Editor's note: This story was updated with additional comments from an interview with Teva's CEO at 1:38 pm ET on July 30.