January 9, 2014 – New York, NY– CereSpir™ Incorporated, a company developing CHF 5074, a first-in-class microglial modulator as a potential treatment for Alzheimer’s disease, today announced Chris Griffett, BSc (Hons), C.Biol., FTOPRA, will serve as the Company’s Vice President, Regulatory Affairs. Mr. Griffett will report directly to Daniel G. Chain, PhD, Chairman, President and Chief Executive Officer of CereSpir
“When I retired from Celgene in 2013, I did not expect to engage in another corporate position. However, when Daniel approached me about CHF 5074, I was intrigued by the molecule and the uniqueness of CereSpir as an organization,” stated Mr. Griffett. “After conducting some research and conversing with several Key Opinion Leaders in Alzheimer’s disease, I felt this opportunity has the potential to make a lasting impact on the disease and the people who are affected by it. I am looking forward to shaping the Company’s reputation amongst the key regulatory bodies in the U.S. and Europe and aiding the Company’s interactions with the other agencies who are interested in potential new treatments for Alzheimer’s disease.”
“I cannot be more pleased to welcome Chris to the CereSpir team,” stated Daniel Chain, PhD, Chairman and CEO of CereSpir. “Chris has one of the most successful track records in developing drugs that receive FDA and EMA approval. CHF 5074 will benefit from Chris’ knowledge of and insight into what the regulatory bodies are seeking from clinical trials and marketing approval applications.”
Mr. Griffett served as Celgene’s Vice President Regulatory Affairs (Americas) from 2009 to 2013, during which time he successfully achieved the NDA Approval for POMALYST® (pomalidomide) and filed NDAs for ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) and apremilast. In addition to leading Celgene’s U.S. regulatory affairs activities, Mr. Griffett supervised the company’s global regulatory strategy and operations. Previously, he served Schering-Plough as Head of Regulatory Affairs, Europe; Executive Director of Schering-Plough Europe Ltd. and Global Regulatory Channel Head for Specialty Products, supporting the oncology, CNS, and inflammatory/immunology therapeutic areas in the United States. In this role, his key NDA/MAA Approvals included BRIDION® (sugammadex), SAPHRIS® (asenapine), SIMPONI® (golimumab), and SUBOXONE® (buprenorphine and naloxone). Mr. Griffett also has held various regulatory affairs positions at Pfizer, AstraZeneca, and Aventis. In these positions, he provided the Regulatory Affairs oversight for important approvals including SEROQUEL® (quetiapine fumarate), ARIMIDEX® (anastrozole), NEXIUM® (esomeprazole magnesium), ciclesonide, SOMAVERT® (pegvisomant), EXUBRA® (inhaled insulin), and MACUGEN® (pegaptanib). Mr. Griffett received his Degree in Biology from The Hatfield Polytechnic (UK) and is also a Chartered Biologist. He has supported numerous pharmaceutical trade associations, including the EFPIA, ABPI, and PhRMA (as a member of the Regulatory Affairs Committee). Mr. Griffett is a Fellow of TOPRA.
About CHF 5074
CHF 5074 is a small molecule with a unique microglial modulating mechanism of action that selectively reduces their pro-inflammatory activity while increasing their ability to remove neurotoxic amyloid beta (“Aβ”) aggregates in the brain by phagocytosis. Microglia are small cells that travel through the brain to remove waste products, such as amyloid aggregates that cause inflammation and irreversible damage to nerve cells. Chronic microglia dysfunction is increasingly believed to play an important role at the very beginnings of Alzheimer’s disease.
The results from Chiesi Farmaceutici SpA’s human clinical studies corroborate a large body of data from published preclinical studies. In Alzheimer’s disease transgenic mouse models, CHF 5074 was shown to reduce neuroinflammation, inhibit brain amyloid β plaque deposits, reduce tau pathology, and reverse associated memory deficits. These findings indicate CHF 5074 acts simultaneously on several important therapeutic targets, and this neuroprotective multi-target approach may translate into preventing the memory loss that is the hallmark of Alzheimer’s disease.
About CereSpir Incorporated
CereSpir is dedicated to preserving the primary essence of each person, his or her memories. The Company is developing CHF 5074, a novel, first-in-class small molecule that is believed to act primarily as a microglial modulator, as a potential treatment for Mild Cognitive Impairment and Alzheimer’s disease. CereSpir anticipates initiating a Phase 3 clinical trial in 2014 to determine if CHF 5074 has the potential to become the first approved therapy for people with the ApoE4 genotype and Mild Cognitive Impairment (MCI). The Company’s ultimate goal is to obtain approval to treat patients with CHF 5074 before amyloid plaques develop as a prevention strategy for Alzheimer’s disease. CereSpir holds the exclusive worldwide development and commercialization rights to CHF 5074 from Chiesi Farmaceutici S.p.A.