AUSTIN, Texas–(BUSINESS WIRE)–Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, today announced the appointment of Badrul Chowdhury, M.D., Ph.D., to the newly created position of Chief Medical Officer (CMO), effective immediately. Dr. Chowdhury will be Savara’s senior physician overseeing the medical and regulatory strategy of the Company’s investigational programs from late-stage development through to approval. He will also provide oversight of medical affairs and patient safety across the portfolio.
Dr. Chowdhury joins Savara from AstraZeneca, where he was Senior Vice President, Chief Physician-Scientist for Respiratory, Inflammation, and Autoimmunity Late Stage Development, in Biopharmaceuticals R&D. For 16 years prior to that, Dr. Chowdhury served as Director, Division of Pulmonary, Allergy, and Rheumatology Products, Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) where he provided scientific and regulatory oversight of both common and rare diseases such as asthma, chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, rheumatoid arthritis, systemic lupus erythromatosis, and various autoimmune and inflammatory diseases. Dr. Chowdhury is a medical doctor, and also holds a Ph.D. in Immunology. He completed Internal Medicine residency training from the Wayne State University School of Medicine, Detroit, Michigan, and Fellowship training in Allergy and Immunology from the National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Bethesda, Maryland. He is double board certified in Internal Medicine and Allergy and Immunology.
Over the course of his career, Dr. Chowdhury has been a member of many committees within the FDA, NIH, World Health Organization (WHO), United Nations Environmental Programme (UNEP), and the American Academy of Allergy, Asthma, and Immunology (AAAAI). Additionally, he has published scientific articles in more than 60 peer-reviewed scientific and medical journals and has been bestowed numerous research, academic, and service awards/honors.
“It is with great enthusiasm that we welcome an accomplished regulatory strategist, Dr. Chowdhury, to the role of CMO,” said Rob Neville, Chief Executive Officer, Savara. “His appointment comes at a critical time as we continue discussions with the FDA and EMA on the best path forward for the Molgradex aPAP program. With two decades of regulatory leadership experience at the FDA’s Pulmonary Division, where he presided over numerous approvals of medicines for pulmonary and orphan diseases, Dr. Chowdhury brings a unique perspective to the Company and we believe he will be instrumental in helping us achieve our goals.”
“As a physician and researcher with a passion for addressing significant unmet needs in pulmonary diseases, I am excited to join the Savara team,” said Dr. Chowdhury. “I am inspired by the Company’s dedication to becoming THE orphan lung disease company, spearheaded by the Molgradex aPAP program. After reviewing the clinical data from the Phase 3 IMPALA study, I believe that Molgradex can provide a meaningful therapy for these patients. I look forward to working with the executive team to navigate the regulatory pathway for Molgradex in aPAP and the Company’s other pipeline programs.”
Savara is an orphan lung disease company. Savara’s pipeline comprises Molgradex, an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP), in Phase 2a development for nontuberculous mycobacterial (NTM) lung infection in both non-cystic fibrosis (CF) and CF-affected individuals with chronic NTM lung infection; and AeroVanc, a Phase 3-stage inhaled vancomycin for treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in CF. Savara’s strategy involves expanding its pipeline of potentially best-in-class products through indication expansion, strategic development partnerships and product acquisitions, with the goal of becoming a leading company in its field. Savara’s management team has significant experience in orphan drug development and pulmonary medicine, identifying unmet needs, developing and acquiring new product candidates, and effectively advancing them to approvals and commercialization. More information can be found at www.savarapharma.com. (Twitter: @SavaraPharma, LinkedIn: www.linkedin.com/company/savara-pharmaceuticals/).
Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Such statements include, but are not limited to, statements regarding that he will oversee the Company’s medical and regulatory strategy, that the appointment comes at a critical time as we continue discussions with the FDA and EMA on the best path forward for the Molgradex aPAP program, our belief that he will be instrumental in helping us achieve our goals, being excited to join the Savara team, being inspired by the Company’s dedication to becoming the orphan lung disease company, belief that Molgradex can provide a meaningful therapy for these patients, looking forward to working with the executive team to navigate the regulatory pathway for Molgradex in aPAP and the Company’s other pipeline programs and our strategy. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the outcome of our ongoing discussions with the FDA regarding our IMPALA data and the path forward, risks and uncertainties associated with the outcome of our ongoing and planned clinical trials for our product candidates, Dr. Chowdhury’s continued employment with Savara and his interaction with the other members of our management team, the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources for Savara’s operations and to conduct or continue planned clinical development programs, the ability to obtain the necessary patient enrollment for our product candidates in a timely manner, the ability to successfully identify product acquisition candidates, the ability to successfully develop our product candidates, the risks associated with the process of developing, obtaining regulatory approval for and commercializing drug candidates such as Molgradex and AeroVanc that are safe and effective for use as human therapeutics, and the timing and ability of Savara to raise additional equity capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.