FDA to AstraZeneca to small biotech: Badrul Chowdhury on the move again

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Lung disease biotech Savara has had a roller coaster few years. (Pixabay)

Less than two years after jumping ship from the FDA to AstraZeneca, Badrul Chowdhury, M.D., Ph.D., is joining a host of other former colleagues exiting the U.K. Big Pharma with a move into biotech.

Just last April, Chowdhury ended a massive career at the FDA (as director of the division of pulmonary, allergy and rheumatology products at CDER) with a big move to AstraZeneca as its senior vice president and chief physician-scientist for respiratory, inflammation and autoimmunity late-stage development in biopharmaceuticals R&D.

But just 18 months down the line and amid an ongoing exodus from the company and its biologics arm Medimmune via an R&D shake-up (and all with a heavier focus on oncology), Chowdhury is out the door, now arriving at Savara as its new chief medical officer.

The small, Austin, Texas-based biotech (with a market cap of less than $40 million) focuses on orphan lung diseases, with a series of mid- to late-stage respiratory meds in the pipeline.

These include Molgradex, an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) in phase 3 for autoimmune pulmonary alveolar proteinosis (aPAP) and 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.

Molgradex was taken under Savara’s wing after it acquired Denmark’s Serendex Pharma back in 2016.

There’s also AeroVanc, a phase 3-stage inhaled vancomycin for treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in CF. Chowdhury will now help lead these projects.

But this doesn’t include Aironite (AIR001)—an inhaled formulation of sodium nitrite—which was being tested to see whether it could provide symptomatic relief to patients suffering from heart failure with preserved ejection fraction (HFpEF).

This drug was canned last year after its failed phase 2 trial, sparking a fall in Savara's share price. This was a particularly disappointing turn of events for the biotech, as Aironite was the main asset behind its reverse merger with Mast Therapeutics in 2017—which was itself struggling to cope with the failure of sickle cell drug vepoloxamer and was running out of cash. The biotech is still harboring hopes that Molgradex can be the blockbuster it has previously stated it should be.

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“It is with great enthusiasm that we welcome an accomplished regulatory strategist, Dr. Chowdhury, to the role of CMO,” said Rob Neville, CEO at 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,” added Chowdhury.

“I am inspired by the company’s dedication to becoming THE [sic] 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.”