Type of information: Company acquisition
Acquired company: Celenex
Acquiring company: Amicus Therapeutics (USA - NJ)
Amount: $100 million in an upfront cash payment and up to $15 million in development milestones and $262 million in BLA/MAA submission and approval milestones
- • On September 20, 2018, Amicus Therapeutics announced the signing of a definitive agreement in which Amicus Therapeutics will receive worldwide development and commercial rights for ten gene therapy programs developed at The Center for Gene Therapy at The Research Institute at Nationwide Children’s Hospital and The Ohio State University. The ten programs are licensed to Amicus from Nationwide Children’s Hospital through the acquisition of Celenex, a private, clinical stage gene therapy company.
- Under the terms of the agreement, Amicus will pay $100 million in an upfront cash payment to acquire all of these assets. Celenex shareholders are also eligible for up to $15 million in development milestones and $262 million in BLA/MAA submission and approval milestones across multiple programs. Amicus expects to pay no more than $75 million over the next 4 years in these milestones. No royalties are owed to Celenex for any of these programs. Celenex shareholders may also be eligible for up to $75 million in tiered sales ($500 million/$750 million) milestone payments. The acquisition and several years of related development costs for all of these programs will be financed through a new $150 million debt facility provided by BioPharma Credit PLC, an investment fund managed by Pharmakon Advisors.
- Amicus Therapeutics also announced it has closed a five-year, senior credit facility with BioPharma Credit. The new credit facility consists of a $150 million non-dilutive term loan, which requires interest-only payments through 2022 and matures in 2023. Interest will accrue at a floating rate of LIBOR plus 7.5%, subject to a floor and ceiling on the rate. There are no warrants or any equity conversion features associated with the loan. The proceeds from this financing will be used to support the cost of the acquisition and several years of related development costs.
- The ten programs are licensed to Amicus from Nationwide Children’s Hospital. The lead programs in CLN6, CLN3, and CLN8 Batten disease are potential first-to-market curative therapies for these rare, devastating diseases. Batten disease, also known as Neuronal Ceroid Lipofuscinosis (NCL), is a family of rare disorders that can be life-threatening and debilitating, with high unmet medical need. The CLN6 and CLN3 program are clinical stage; CLN8 has definitive preclinical efficacy data in a mouse model of disease.
- All acquired programs leverage intrathecal delivery, using the same AAV vector approach utilized successfully in clinical trials across other rare CNS indications, such as SMA. This approach and technology are considered to be a clinically validated gene delivery platform for diseases of the central nervous system (CNS). Brian Kaspar, Ph.D., co-founder of Celenex, and Kathrin Meyer, Ph.D., a Principal Investigator at Nationwide Children’s Hospital Center for Gene Therapy, will continue to support these programs as scientific advisors to Amicus Therapeutics.
Related: Gene Therapy - Rare diseases - CNS diseases
Is general: Yes