Sterile Injectable Drugs Segment Rises, Avadel Pharma Sells Portfolio

Avadel Pharmaceuticals, a global emerging biopharmaceutical company, sold its portfolio of sterile injectable drugs to Exela Sterile Medicines LLC for $42 million. The Avadel transaction closed on June 30, 2020. In accordance with the transaction terms, Avadel was paid $14.5 million on the closing date and the remaining $27.5 million will be paid to Avadel over the next 13 months.

Avadel’s Sterile Injectable Drugs

Avadel’s portfolio of sterile injectable drugs that it sold to Exela included three commercial products, Vazculep, Bloxiverz, and Akovaz. Vazculep and Akovaz are both used in the treatment of hypotension, or low blood pressure. Bloxiverz is used in the treatment of a muscle disease called myasthenia that causes muscle weakness and rapid fatigue. A fourth product, Nouress, is a cysteine hydrochloride injection that treats neonatal patients requiring total parental nutrition. Nouress received FDA approval in December 2019 and is being prepared for eventual commercial launch. By divesting its sterile injectable drugs portfolio, Avadel Pharmaceuticals can now focus more closely on its products to treat excessive daytime sleepiness.

Sterile Injectable Drugs Market Expected to Expand

According to many research estimates, the sterile injectable drugs market is expected to expand significantly in the future. Key drivers propelling the growth of the sterile injectables market include rising chronic disease rates and the shift to larger molecule drugs to treat diseases. In particular, an uptick in cancer and diabetes worldwide is likely to fuel demand. One research report projects an 11.25% compound annual growth rate (CAGR) of this pharmaceutical segment between 2018 and 2024.

Market Increasing in Value

The sterile injectable drugs market is projected to be valued at approximately $780 billion by 2024. Due to this fact, both pharmaceutical startups and large industry players alike are aiming to strategically position themselves with products that will meet future demand.

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FDA Approval Complicated

Although manufacturing generic sterile injectable drugs is highly lucrative if executed successfully, mishaps can result in FDA recalls such as the ones Fresenius was subject to for inadequate labeling and contamination issues. Heritage Pharmaceuticals, an industry competitor headquartered in New Jersey, likewise had a nationwide recall of injectables that purportedly caused sterility failures. The reality is that the manufacturing process involves a lot of complexity.

Ryan Carpenter serves as Attorney and Managing Director of Carpenter Wellington. Ryan advises clients across a broad set of corporate and commercial matters.

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