This week's life sciences industry news includes details on a multimillion-dollar product sale, a biosimilar update, a new Philadelphia member for a coalition created to ensure access to drugs in short supply, and more.
Here's the roundup:
Jazz Pharmaceuticals
The Irish biopharmaceuticals company that has U.S. offices in Philadelphia and California entered into a definitive agreement to sell the rights to its Sunosi sleep disorder medicine to Axsome Therapeutics (NASDAQ: AXSM) in a deal that includes a $53 million upfront payment.
Sunosi is a dual-acting dopamine and norepinephrine inhibitor used to improve wakefulness in adults living with excessive daytime sleepiness because of narcolepsy or obstructive sleep apnea.
Under the terms of the agreement, New York-based Axsome will receive the rights to Sunosi in all of the existing territories available to Jazz. In addition to the upfront payment, Jazz (NASDAQ: JAZZ) will also receive a high-single-digit royalty on Axsome's U.S. net sales of Sunosi in current indications and a mid-single-digit royalty on Axsome's U.S. net sales of Sunosi in future indications.
"Jazz will continue to be laser-focused on investing in our highest strategic priorities including our ongoing launches, advancing our pipeline, pursuing opportunistic corporate development and achieving margin expansion," said Bruce Cozadd, the company's chairman and CEO. "Jazz remains committed to developing new, innovative therapies in neuroscience and oncology for patients and delivering on our recently announced Vision 2025."
The companies expect the U.S. transaction, subject to regulatory approvals, to close in the second quarter of 2022 and the ex-U.S. transaction close to occur within 60 days following the close of the U.S. transaction.
Guggenheim Securities served as financial advisor to Jazz for the transaction and Cooley LLP served as its legal counsel.
Children's Hospital of Philadelphia
The West Philadelphia pediatric medical center has joined The Children’s Hospital Coalition, a group — which has grown to 14 children's hospitals — formed to ensure the availability of critical, hard-to-secure pediatric medications for American families.
The coalition was formed one year ago by 11 children's hospitals around the country and Phlow Corp., a Virginia-based pharmaceutical manufacturer.
The group has identified 25 essential drugs impacted by shortages. This quarter, coalition members are expected to have access to four drugs for which Phlow has secured three years of committed inventory and production.
“For many years, we have been an advocate for the production of safe, high-quality pediatric medications that families and providers have struggled to access,” said Madeline Bell, CHOP's CEO. “We are thrilled to join our peers in this coalition and Phlow in reimagining the essential medicine supply chain, and reducing the uncertainty created by this longstanding challenge.”
Lannett Co.
The Trevose-based pharmaceutical company has dosed the first patient in its pivotal clinical trial of biosimilar insulin glargine.
Results from the late-stage clinical trial are expected later this year, putting Lannett in position to potentially seek approval for the product in early 2023 — and if that approval is secured, launch it during the first half of 2024.
Lannett (NYSE: LCI) is co-developing the biosimilar with alliance partners within the HEC Group of companies.
“Biosimilar insulin glargine is by far the biggest and most important opportunity in our pipeline, and initiating the pivotal clinical trial is a major step forward in bringing a high-quality, more affordable insulin to the millions of patients in the U.S. with diabetes,” said Tim Crew, CEO of Lannett.
The product is being developed to be interchangeable with Sanofi's insulin glargine product Lantus Solostar.
Biosimilars are not the same as generic medicines. Biosimilars are products manufactured to be highly similar to another already approved biological medicine, both of which feature a living organism as a key ingredient. Generic medicines are copies of synthetic drugs. Most of Lannett's products are generic medicines.
Quick hits
Radnor-based Marinus Pharmaceuticals (NASDAQ: MRNS) received $30 million in funding under its existing Oaktree Capital Management credit agreement. The additional funding became available as a result of the Food and Drug Administration’s recent approval of Ztalmy, a treatment of seizures associated with CDKL5 deficiency disorder in patients two years of age and older. … Renovacor (NYSE: RCOR), a biotechnology company developing precision therapies for genetically driven cardiovascular diseases, appointed Fred Driscoll as its chief financial officer. He takes over the post from interim CFO Wendy DiCicco. Driscoll was previously CFO of Flexion Therapeutics. Renovacor, which was spun out of Temple University, went public last year through a merger with a special purpose acquisition company, or SPAC, sponsored by Chardan Healthcare Acquisition 2 Corp. of New York.
