The acquisition expands Amneal’s commercial institutional and specialty portfolio in neurology while adding commercial infrastructure in advance of its entry into the biosimilar institutional market.
Lioresal is an intrathecal baclofen product delivered through an implantable intrathecal pump for use in the management of severe spasticity of cerebral or spinal origin for the institutional market. It has approximately $25 million in annual net revenue.
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Lyvispah is a baclofen oral granules (5, 10 and 20 mg) specialty product recently approved by the Food and Drug Administration for the treatment of spasticity. The product is expected to launch in 2022 leveraging Amneal’s neurology commercial team. Together, Amneal expects these two products to generate between $40 and $50 million in combined annual net revenues by 2025.
As part of the transaction, Amneal is adding Saol’s experienced institutional commercial team for Lioresal that can be utilized to support future product launches, including three oncology biosimilar products, filgrastim (biosimilar for Neupogen), pegfilgrastim (biosimilar for Neulasta) and bevacizumab (biosimilar for Avastin). Amneal expects to launch all three biosimilars in 2022, subject to approval by the FDA.
“This acquisition is highly aligned with Amneal’s long-term growth strategy adding to our specialty and biosimilars businesses. In specialty, we see Lyvispah fitting well with our neurology portfolio and pipeline.
In addition, Lioresal is a durable product with a long-established presence in the institutional market that we look to leverage as we prepare to commercialize our biosimilars in 2022 and beyond,” said Chirag and Chintu Patel, Co-CEOs.
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“For over 5 years, the Saol team has worked to reinvigorate the Lioresal® brand and develop new treatment options, like Lyvispah, for patients struggling with spasticity. We are excited to see these products find their new home at Amneal along with many of our team members that have been critical to our success,” said David Penake, CEO of Saol Therapeutics.
Baclofen is a skeletal muscle relaxant used to treat muscle spasms caused by spinal cord injury, multiple sclerosis, and other conditions. It was first approved by the FDA in 1977.