On January 5, 2022 Amneal Pharmaceuticals, Inc. (NYSE: AMRX) ("Amneal") and Saol Therapeutics, a private specialty pharmaceutical company ("Saol"), reported a definitive agreement under which Amneal will acquire Saol’s Baclofen franchise, including Lioresal and LYVISPAHTM as well as a pipeline product under development (Press release, Amneal Pharmaceuticals, JAN 5, 2022, View Source [SID1234598270]). 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. The transaction is expected to be accretive to Amneal’s adjusted EBITDA and adjusted earnings per share results for 2022.
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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. LYVISPAHTM is a baclofen oral granules (5, 10 and 20 mg) specialty product recently approved by the U.S. Food and Drug Administration (FDA) 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 FDA.
"This acquisition is highly aligned with Amneal’s long-term growth strategy adding to our specialty and biosimilars businesses. In specialty, we see LYVISPAHTM 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-Chief Executive Officers.
"For over 5 years, the Saol team has worked to reinvigorate the Lioresal brand and develop new treatment options, like LYVISPAHTM, 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. Important Safety Information includes a boxed warning on abrupt discontinuation, which can result in sequalae and in rare cases, has advanced to multiple organ-system failure and death. Reported adverse drug reaction includes convulsion, hypotension, hypotonia, somnolence, dizziness, nausea and headache. Animal data indicates it may cause fetal harm.
See Package Insert (PI) for full prescribing information including boxed warning and complete safety information:
Lioresal: View Source
LYVISPAHTM: View Source
Terms of the Transaction
Under the terms of the transaction, Amneal will pay approximately $83.5 million of cash at close, and certain royalties (low double-digits) based on annual net sales for certain acquired products. The transaction will be financed with cash on hand and is expected to close in the first quarter of 2022, subject to the satisfaction of customary closing conditions, including clearance under the Hart-Scott Rodino Antitrust Improvements Act.
Advisors
Morgan Lewis & Bockius LLP served as legal counsel to Amneal. SVB Leerink served as exclusive financial advisor and Mayer Brown LLP served as legal counsel to Saol Therapeutics.