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Spin out and launch
BOSTON—Acetylon Pharmaceuticals, which has entered into an agreement to be acquired by Celgene Corp., will in turn be spinning out a new company: Regenacy Pharmaceuticals LLC. Regenacy will focus on the development of novel drug candidates that selectively regenerate intracellular transport and upregulate gene expression to modify the course of disease.
Under the terms of the agreement, Celgene has acquired worldwide rights to Acetylon’s selective HDAC6 inhibitor programs and intellectual property in oncology, neurodegeneration and autoimmune disease. Additionally, Regenacy has received an exclusive, worldwide license from Celgene for Acetylon’s Phase 2 selective HDAC6 inhibitor ricolinostat (ACY-1215) for the treatment of neuropathies and other non-oncology disease indications, as well as Acetylon’s preclinical HDAC1, 2 and 3 programs. The acquisition will give Celgene worldwide rights to Acetylon’s selective HDAC6 inhibitor programs and intellectual property in oncology, neurodegeneration and autoimmune disease, including its lead drug candidates citarinostat (ACY-241) and ricolinostat (ACY-1215).
Histone deacetylases (HDACs) can induce structural changes in the DNA-histone complex to result in altered gene expression and protein synthesis. Inappropriate deacetylation can disrupt these processes and contribute to a wide range of diseases, whereas regeneration of acetylation selectively causes apoptosis (cell death) in cancer cells and also induces favorable immunomodulatory effects. Currently available HDAC drugs non-selectively affect the expression of numerous other genes in normal cells as well as disease-causing cells, which can result in side effects.
Financial terms of the acquisition are not being disclosed. Key members of the Acetylon executive team will join Regenacy, which will operate out of Acetylon’s former headquarters in Boston’s Seaport District, be owned by Acetylon shareholders (excluding Celgene) and receive net working capital in Acetylon to fund Regenacy operations.
“Acetylon has had a longstanding partnership with Celgene, and its acquisition of our HDAC6 inhibitor programs is a positive event for patients and a favorable outcome for our shareholders and employees,” explained Marc A. Cohen, chairman of Acetylon. “Celgene has both the resources and markets knowledge to complete clinical development and commercialization of citarinostat, for the likely benefit multiple myeloma patients worldwide.”
Walter C. Ogier, president and CEO of Regenacy, added, “Since its founding in 2008, Acetylon has made substantial progress in the development of selective HDAC inhibitors for enhanced therapeutic outcomes. We are excited to continue Acetylon’s legacy through the receipt of rights to many of Acetylon’s most promising compounds and the continued advancement of these clinical and preclinical programs in disease indications outside of Celgene’s areas of strategic focus, where we believe patients may especially benefit from selective HDAC inhibition.”
Celgene prioritized certain Acetylon assets that fit strategically into Celgene’s portfolio. The spinout is an opportunity for Acetylon management and shareholders to advance the balance of Acetylon’s compelling clinical and preclinical programs.
Regenacy’s mission will be to selectively regenerate intracellular transport and upregulate gene expression to modify the course of disease and enhance therapeutic outcomes in a broad range of indications. The new company will focus on certain non-cancer indications for the HDAC6 inhibitor ricolinostat in peripheral neuropathy where axonal transport mechanisms critical to the functioning of the longest neuronal cells in the body are damaged, as well as more broadly on selective inhibition of HDACs 1, 2 and/or 3 for the upregulation of fetal hemoglobin to treat sickle cell disease and beta-thalassemia, as well as other opportunities such as enhancing cognition. Celgene gains selective HDAC6 inhibitor assets which address Phase 2-proven opportunities in cancer in addition to neurodegeneration and autoimmune disease.
The current worldwide commercial market for pharmaceuticals indicated for the treatment of multiple myeloma is more than $10 billion, benefitting more than 200,000 patients per year worldwide. The median survival of patients post-diagnosis of disease has improved from less than one year in the 1970s to nearly 10 years, although the disease is still considered incurable.
Newer proprietary drugs Revlimid (Celgene), Pomalyst (Celgene), Darzalex (Johnson & Johnson), Kyprolis (Amgen), Velcade (Takeda), and Ninlaro (Takeda) are being increasingly utilized around the globe to realize optimal patient outcomes. The commercial potential for Acetylon’s drug candidates remains to be established, although their performance in Phase 1 and Phase 2 clinical trials in advanced multiple myeloma in combination with Celgene’s Revlimid or Pomalyst and with Takeda’s Velcade is quite promising, including their combination activity against myeloma and their favorable tolerability.