Savara Appoints Braden Parker as Chief Commercial Officer, Effective Immediately

Rhea-AI Summary

Savara Inc. (Nasdaq: SVRA) has appointed Braden Parker as Chief Commercial Officer, effective immediately. Parker brings over 25 years of commercial leadership experience in healthcare and biotech, with expertise in launching rare disease products. He will oversee Savara's global commercial strategy for molgramostim inhalation solution in autoimmune Pulmonary Alveolar Proteinosis (aPAP).

Parker joins from Orchard Therapeutics, where he served as Chief Commercial Officer. His previous roles include Vice President and General Manager at PTC Therapeutics and commercial leadership positions at Celgene and NPS Pharma. Savara plans to complete submission of a Biologics License Application (BLA) for molgramostim to the FDA in the first half of 2025. If approved, it would be the first treatment for aPAP in the U.S. and Europe.

Positive

• Appointment of experienced Chief Commercial Officer with rare disease expertise
• Planned BLA submission for molgramostim in H1 2025
• Potential for first-to-market treatment for aPAP in U.S. and Europe
• Molgramostim has received multiple regulatory designations (Orphan Drug, Fast Track, Breakthrough Therapy)

Negative

• None.

Mr. Parker has More Than 25 Years of Commercial Leadership Experience and has Launched Multiple Rare Disease Products

LANGHORNE, Pa.--(BUSINESS WIRE)-- Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced the appointment of Braden Parker as Chief Commercial Officer, effective immediately. Mr. Parker is a seasoned global commercial leader with more than 25 years of experience in the healthcare and biotech industry. Throughout his career, he has developed and executed global commercial plans, including market expansion activities, built high-performance teams, and launched multiple successful rare disease products. Mr. Parker is responsible for overseeing Savara's global commercial strategy for molgramostim inhalation solution (molgramostim) in autoimmune Pulmonary Alveolar Proteinosis (aPAP).

“I am happy to welcome Braden to Savara, particularly as we approach a transformational milestone with the potential approval and launch of molgramostim,” said Matt Pauls, Chair and CEO of Savara. “Braden is an accomplished leader with a proven track record of building commercial teams, leading successful rare disease product launches and accelerating growth for companies as they transition to the commercial stage. We are thrilled to have him as part of our team and look forward to his contributions.”

Mr. Parker joins Savara from Orchard Therapeutics (Kyowa Kirin), where he served as Chief Commercial Officer. In this role, he was responsible for global commercial strategy and execution for the company’s unique ex-vivo autologous HSC gene therapy product portfolio, including overseeing Orchard Therapeutics' first product launch, Libmeldy, for the treatment of metachromatic leukodystrophy (MLD), a rare hereditary disease. Prior to joining Orchard Therapeutics, he served as Vice President and General Manager for the U.S. organization for PTC Therapeutics and led the company’s first U.S. product launch in Duchenne muscular dystrophy. Earlier in his career, Mr. Parker held commercial leadership roles at Celgene and NPS Pharma (Shire). Mr. Parker received his M.B.A. from New York University Stern School of Business and his B.B.A. from the University of Notre Dame.

“I am pleased to join Savara and work with a group of talented leaders who are deeply committed to developing and delivering transformative therapeutics for patients suffering from rare disease,” said Mr. Parker. “I believe molgramostim, if approved, is uniquely positioned to make a significant impact in the treatment of aPAP, and it is a privilege to be able to bring my experience and knowledge to Savara to support a product with such great potential.”

Savara plans to complete submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for molgramostim for the treatment of aPAP in the first half of 2025. If approved, molgramostim would be the first and only treatment for aPAP in the U.S. and Europe. Molgramostim has been granted Orphan Drug, Fast Track, and Breakthrough Therapy designation from the FDA, Orphan Drug designation from the European Medicines Agency and Innovative Passport and Promising Innovative Medicine designation from the UK's Medicines and Healthcare Products Regulatory Agency for the treatment of aPAP.

About Savara

Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, molgramostim inhalation solution, is a granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Molgramostim is delivered via an investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of a large molecule. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com. (X, formerly known as Twitter: @SavaraPharma, LinkedIn: www.linkedin.com/company/savara-pharmaceuticals/).

Forward-Looking Statements

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 related to the anticipated timing of our BLA submission, the potential impact of molgramostim on the treatment of aPAP, and molgramostim’s potential to be the first and only approved therapeutic for aPAP in the U.S. and Europe. 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 risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize molgramostim for aPAP; the actions and decisions of regulatory authorities; the risks and uncertainties related to the impact of widespread health concerns or changing economic or geopolitical conditions; 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; and the timing and ability of Savara to raise additional 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240924542532/en/

Savara Inc. IR & PR

Anne Erickson (anne.erickson@savarapharma.com)

(512) 851-1366

Source: Savara Inc.

FAQ

Who is the new Chief Commercial Officer of Savara (SVRA)?

Braden Parker has been appointed as the new Chief Commercial Officer of Savara (SVRA), effective immediately.

What is Savara's (SVRA) main product in development?

Savara's (SVRA) main product in development is molgramostim inhalation solution for the treatment of autoimmune Pulmonary Alveolar Proteinosis (aPAP).

When does Savara (SVRA) plan to submit the BLA for molgramostim?

Savara (SVRA) plans to complete the submission of a Biologics License Application (BLA) for molgramostim to the FDA in the first half of 2025.

What regulatory designations has molgramostim received from the FDA for Savara (SVRA)?

Molgramostim has been granted Orphan Drug, Fast Track, and Breakthrough Therapy designations from the FDA for Savara (SVRA).