Actelion Pharmaceuticals Ltd.

RICHMOND, Calif.--( BUSINESS WIRE )--BioAge Labs, Inc. (“BioAge”), a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases by targeting the biology of human aging, today announced the appointment of Jean-Pierre Garnier, PhD, as Chair of the company’s Board of Directors. Garnier will succeed current Board Chair James Healy, MD, PhD, managing partner of Sofinnova Investments, who will remain on the Board. “ We are excited to welcome JP to BioAge’s Board of Directors as Chair,” said Kristen Fortney, PhD, CEO and co-founder of BioAge Labs. “ His extensive experience in leading biotech and pharmaceutical companies through critical growth phases will be invaluable as we progress our lead compound, azelaprag, through clinical development for obesity and advance our pipeline of metabolic aging therapies. I would also like to express our deep gratitude to Jim, whose leadership as Chair has been pivotal during a crucial period of growth for BioAge. We are pleased that he will continue to contribute his expertise in clinical development and drug strategy as a key member of our Board.” “ It has been a privilege to serve as Chair of BioAge’s Board of Directors and lay the foundation for the company’s transformation as a late-stage clinical company. I look forward to continuing on BioAge’s Board as a Director while lending my full support to JP in his new role,” Healy said. “ JP brings exceptional operational and leadership experience as BioAge advances its pipeline for metabolic diseases.” Garnier served as the Chief Executive Officer of GlaxoSmithKline (GSK) from 2000 to 2008, overseeing the merger of Glaxo Wellcome and SmithKline Beecham. Prior to GSK, Garnier held executive positions at SmithKline Beecham and Schering-Plough. Garnier has extensive board experience, serving as Chairman of the Board of Actelion (acquired by Johnson & Johnson in 2017 for $30 billion) and as non-executive Chairman at Alzheon (2015-2018), Idorsia (2017-2020), and Carmat (2018-2022). He has also served on the Board of Directors of United Technology (1997-2020), Renault SA (2009-2016), and Radius Health (2015-2022). Garnier is currently Chairman of the Board of Cellectis SA and member of the Board of Directors of Carrier Global Corporation. He holds a PhD in pharmacology from Louis Pasteur University and an MBA from Stanford University. He is a Knight Commander of the Order of the British Empire and Officier de la Légion d’Honneur of France. “ This is a transformative era for the treatment of obesity and cardiometabolic diseases, and I’m excited to support BioAge as it leads the way with innovative approaches that could reshape the future of patient care,” said Garnier. “ I look forward to working alongside Kristen and BioAge’s talented leadership team to fully realize the potential of azelaprag and advance the company’s earlier stage pipeline to address diseases that limit healthspan for large patient populations.” About BioAge Labs, Inc. BioAge is a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases, such as obesity, by targeting the biology of human aging. BioAge’s lead product candidate, azelaprag, is an orally available small molecule agonist of APJ that was observed to promote metabolism and prevent muscle atrophy on bed rest in a Phase 1b clinical trial. In mid-2024, BioAge initiated a Phase 2 trial of azelaprag in combination with tirzepatide for the treatment of obesity in older adults. Azelaprag has potential as an oral regimen to amplify weight loss and improve body composition in patients on obesity therapy with incretin drugs. BioAge is also developing orally available small molecule brain penetrant NLRP3 inhibitors for the treatment of diseases driven by neuroinflammation. BioAge’s preclinical programs, based on novel insights from the company’s discovery platform built on human longevity data, address key pathways in metabolic aging.

Johnson & Johnson’s (J&J) Yuvanci (macitentan and tadalafil) has been recommended by the European Medicines Agency’s human medicines committee as a single tablet combination therapy (STCT) for adults with pulmonary arterial hypertension (PAH). The combination therapy has specifically been recommended by the Committee for Medicinal Products for Human Use (CHMP) as a substitution therapy for the long-term treatment of PAH in adult patients of World Health Organization (WHO) functional class (FC) two or three who are already receiving a combination of Actelion Pharmaceuticals endothelin receptor antagonist (ERA), Opsumit (macitentan) and Eli Lilly’s phosphodiesterase 5 inhibitor (PDE5i), Cialis (tadalafil) as separate tablets. Affecting around 30,000 people in the EU, PAH is a rare, progressive and life-threatening form of pulmonary hypertension in which the blood vessels in the lungs thicken and narrow and elevate blood pressure, which can lead to heart failure and death. The CHMP’s recommendation was based on positive results from the phase 3 A DUE study, which compared the efficacy and safety of Yuvanci STCT of macitentan 10mg and tadalafil 40mg (M/T STCT) to each monotherapy in 187 adult patients with WHO FC two or three PAH. The study met its primary endpoint after Yuvanci demonstrated a 29% and 28% reduction, respectively, in pulmonary vascular resistance (PVR) at week 16 to baseline in patients with PAH versus the individual monotherapies. In addition, M/T STCT demonstrated consistent efficacy in patients who were either treatment-naïve or previously exposed to an ERA or PDE5i. James List, global therapeutic area head, cardiopulmonary, J&J Innovative Medicine, commented: “[This] positive opinion represents a significant step forward and underlines our commitment to providing solutions for patients in the PAH community [and]… we look forward to working with health authorities to bring our [STCT] to adult patients in need across the region as soon as possible.” If approved by the European Commission, Yuvanci will be the first and only STCT in the EU to treat patients living with PAH and expand J&J’s PAH portfolio to cover all guideline-recommended treatment pathways. The recommendation comes after the US Food and Drug Administration approved Opsynvi (macitentan and tadalafil) in March 2024 for the treatment of patients with PAH.

WASHINGTON, May 30, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that ownership of the U.S. New Drug Application and Investigational New Drug Applications for PONVORY® (ponesimod) has been transferred to Vanda from a Johnson & Johnson Company, which now fully allows Vanda to commercialize PONVORY® in the U.S. "This milestone completes the transfer of the FDA marketing authorization to Vanda and allows Vanda to commence full commercialization efforts and begin clinical development programs as we seek to maximize the potential of Ponvory in the treatment of a host of inflammatory disorders," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. Vanda acquired U.S. and Canadian rights to PONVORY® from a Johnson & Johnson Company on December 7, 2023. PONVORY® is approved by the U.S. Food and Drug Administration (FDA) and Health Canada to treat adults with relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease (RMS). In anticipation of the commercial launch of PONVORY® for RMS in the third quarter of 2024, Vanda is initiating a host of commercial activities including the creation of a specialty sales force, a prescriber awareness program and a comprehensive marketing program. About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit and follow us on X @vandapharma. About PONVORY® Vanda acquired U.S. and Canadian rights to PONVORY® from Actelion Pharmaceuticals Ltd., a Johnson & Johnson Company on December 7, 2023. PONVORY® (ponesimod) is a daily oral selective sphingosine-1-phosphate receptor 1 (S1P1R) modulator, indicated to treat adults with relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. PONVORY® blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. PONVORY® does not require genetic testing or first-dose cardiac monitoring for most patients. Because initiation of PONVORY® treatment results in a decrease in heart rate, first-dose monitoring is recommended in patients with certain preexisting cardiac conditions. For full U.S. Prescribing Information for PONVORY®, including Important Safety Information, visit . The PONVORY® Orange Book listed patent with the latest expiry date is set to expire in October 2042. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS Various statements in this press release, including, but not limited to, statements regarding Vanda's commercial and clinical development plans for PONVORY® and the initiation of commercial activities are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to execute the commercial launch of PONVORY® in the U.S. in the third quarter of 2024 and initiate its clinical development program for PONVORY® in the treatment of inflammatory disorders other than RMS, the results of any clinical trials conducted for PONVORY® in the treatment of such disorders, and Vanda's ability to obtain regulatory approval of PONVORY® for any such disorders and Vanda's ability to successfully create a specialty sales force, a prescriber awareness program and a comprehensive marketing program for PONVORY®. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at . All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] SOURCE Vanda Pharmaceuticals Inc.