News out of Greater Philadelphia's life sciences industry this week includes details on a multimillion-dollar acquisition and a multimillion-dollar licensing deal, plus updates on experimental drugs to treat cancer and seizures.
Here's the roundup:
Endo International
The Chester County specialty pharmaceutical company's subsidiary Endo Ventures Limited acquired six development-stage, ready-to-use injectable product candidates from Nevakar Injectables, a subsidiary of Nevakar Inc., for $35 million.
The acquisition is separate from Endo's previously announced exclusive licensing agreement with North Jersey-based Nevakar.
Scott Sims, Endo's senior vice president and general manager for injectable solutions and generics, said the six products are all designed to be used in critical care settings and will "meaningfully expand" Endo's ready-to-use injectable product pipeline.
The exact nature of the products, which are in various stages of development, is not being disclosed. The first of the products is expected to be launched in 2025.
Par Sterile Products, a New York-based subsidiary of Endo International (NASDAQ: ENDP), will commercialize the products in the United States.
Ready-to-use pharmaceuticals products are those designed to streamline hospital operations by eliminating the need for medical centers to prepare the products before giving then to patients.
NiKang Therapeutics
The Wilmington-based clinical stage biotech has entered into an exclusive collaboration and licensing agreement with Hansoh Pharmaceutical Group Co. Ltd that covers the development and commercialization of NKT2152, NiKang's experimental cancer therapy, in Greater China, including Mainland China, Hong Kong, Macau and Taiwan.
Under the terms of the deal, NiKang will receive an upfront cash payment of $15 million and be eligible to receive up to $203 million in potential development, regulatory and sales-based milestone payments, and tiered royalties.
Zhenhai Gao, co-founder and CEO of NiKang, said he believes the deal will accelerate the global development of NKT2152.
Galera
The Malvern-based clinical-stage biopharmaceutical company announced positive mid-stage clinical trial results for its new drug candidate avasopasem.
Avasopasem is being studied for its ability to reduce the incidence of severe acute radiation-induced esophagitis, an inflammation that damages the lining of the esophagus, in patients with lung cancer who are receiving concurrent chemoradiotherapy.
The study involved 39 patients with unresectable stage 3A/3B or post-operative stage 2B non-small cell or limited-stage small cell lung cancers. In the study, only two of the 29 patients experienced grade 3 esophagitis at any time, with neither of those patients experiencing grade 3 for more than one week. No patients experienced grade 4 or 5 esophagitis at any point during the trial.
Dr. Mel Sorensen, CEO of Galera (NASDAQ: GRTX), said the study results demonstrate avasopasem’s potential to meaningfully reduce severe radiotherapy-induced esophagitis — a condition for which there is no established drug therapies.
“Patients with lung cancer undergoing chemoradiotherapy are at high risk of severe, and potentially life-threatening esophagitis," Sorensen said, noting the condition can cause an inability to eat or swallow, severe pain, ulceration, infection, bleeding and weight loss.
About 50,000 lung cancer patients undergo standard-of-care chemoradiotherapy every year in the U.S. and are at risk of developing esophagitis.
Marinus Pharmaceuticals
The Radnor pharmaceutical company has resumed screening and recruitment of patients for its Phase 3 clinical trial testing its experimental IV ganaxolone product as a treatment for refractory status epilepticus.
Marinus (NASDAQ: MRNS) paused the recruitment in February after routine stability monitoring showed visible particulates of aluminum phosphate in the drug solution. An independent data monitoring committee for the trial reviewed the clinical safety data and determined no concerning safety events were identified in patients already treated with the batches of IV ganaxolone. The trial has resumed using new batches of the current IV formulation.
The company continues to expect to have study results in the second half of 2023.
In agreement with the Food and Drug Administration, ganaxolone clinical supplies will be stored under refrigerated conditions for the entire duration of clinical use.
Status epilepticus, a neurologic condition that afflicts as many as 150,000 people in the United States annually, is characterized by prolonged or repetitive seizures.
Quick hits
Fort Washington-based Nabriva Therapeutics (NASDAQ: NBRV) has agreed to extend, for three years, its exclusive agreement with Merck (NYSE: MRK) to promote and distribute Sivextro in the United States, Sivextro is Merck's antibiotic used to treat acute bacterial skin and skin structure infections caused by certain susceptible gram-positive microorganisms. Financial terms of the deal, which extends the agreement until Dec. 31, 2026, were not disclosed. … Malvern-based Neuronetics, Inc. (NASDAQ: STIM) is teaming up with a former major league baseball player, Drew Robinson, on a campaign to raise awareness about depression. Robinson will share his journey with depression and his successful experience with Neuronetics' NeuroStar advanced therapy system that uses transcranial magnetic stimulation to treat major depressive disorder. … Berwyn-based Virpax (NASDAQ: VRPX) entered into a cooperative research and development agreement with the U.S. Army Institute of Surgical Research to evaluate the company's experimental wound care anesthetic product Probudur. Probudur, an injectable hydrogel formulation of liposomal bupivacaine, is being developed to significantly reduce or eliminate the need for opioids after surgery in approved indications. … Foxx Life Sciences has entered into an online distribution agreement for its EZBio made-to-order medicine bottle assemblies with Thomas Scientific of Swedesboro, New Jersey. The products, select individual laboratory bottle assembly components, will be available for customization and ordering via a direct-to-consumer microsite hosted on the Thomas Scientific web site, ThomasSci.com. Terms of the deal were not disclosed.
