November 8, 2013 – New York, NY, and Parma, Italy – CereSpir™ Incorporated and Chiesi Farmaceutici S.p.A. today announced CereSpir has acquired the worldwide development and commercialization rights to CHF 5074, a novel, first-in-class small molecule microglia modulator discovered and developed by Chiesi researchers. Chiesi has demonstrated CHF 5074 improves cognition and reduced brain inflammation in patients with mild cognitive impairment (MCI). CereSpir now assumes all development and commercialization activities for CHF 5074.
“In the past year, scientists, clinicians, and drug developers have gained a significant amount of knowledge about Alzheimer’s disease and MCI. CHF 5074 represents the right asset at the right time with the right team to move it into Phase 3 clinical trials,” stated Daniel Chain, PhD, Chairman and CEO of CereSpir. “The more we learn about its multi-target neuroprotective mechanism of action, which is supported by the latest discoveries from academia, the more excited we become about CHF 5074 as a potential game changer in the fight against Alzheimer’s.”
“The Chiesi Group has been investing in the development of CHF 5074 up to phase 2 completion, getting more and more confident of its potential in the treatment of MCI. CereSpir will now be able to leverage these early clinical findings and know how to advance the program,” underlined Paolo Chiesi, Chiesi Group Vice President and Research & Development Director. “We trust this agreement will expedite the clinical development of this new therapeutic agent to the benefit of patients and their families.”
Reflecting its confidence in CHF 5074 and in the partnership with CereSpir, the Chiesi Group has reserved the possibility to contribute to the future manufacturing and eventual commercialization of the drug that might derive from the development of the molecule.
Mintz Levin Cohn Ferris Glovsky and Popeo PC represented CereSpir in negotiating this transaction.
About CHF 5074
CHF 5074 is a small molecule with a unique microglial modulating mechanism of action capable of selectively reducing pro-inflammatory activities of microglial cells while increasing their ability to remove neurotoxic amyloid beta (“Aβ”) aggregates in the brain by phagocytosis. Microglia are small cells that migrate through the brain to remove waste products, such as amyloid aggregates that cause inflammation and irreversible damage to nerve cells. Chronic dysfunction of microglia is increasingly believed to play an important role at the very beginnings of Alzheimer’s disease. The results from Chiesi’s human clinical studies corroborate the 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 Alzheimer’s disease, ApoE4, and Mild Cognitive Impairment
Alzheimer’s disease (AD) is the most prevalent neurodegenerative disease and the leading cause of dementia among the elderly. More than 30 million people have been diagnosed with AD, and the associated costs of care estimates exceed $200 billion annually. Today, AD remains the largest unmet medical need in neurology, with the disease expected to afflict 100 million people globally by 2050.
Individuals who have the ApoE4 gene are three to eight times more likely to develop AD than those who do not carry ApoE4. People who have two copies of the ApoE4 gene are at even greater risk than those with a single copy of ApoE4 copy. The ApoE4 gene causes a more aggressive form of AD that is believed to involve a strong inflammatory response.
Mild Cognitive Impairment (MCI) causes cognitive changes that are serious enough to be noticed by the individuals experiencing them or to other people, but the changes are not severe enough to interfere with daily life or independent function; therefore they do not meet diagnostic guidelines for dementia. However, those with MCI, particularly if they also carry the ApoE4 gene, have an increased risk of eventually developing Alzheimer’s or another type of dementia.
About Chiesi Farmaceutici S.p.A.
Founded in 1935 in Parma (Italy), the Chiesi Group achieved in 2012 a turnover of € 1,107 million, an increase of 4.7% in comparison with the previous year. The Group, whose main areas of activity are in respiratory therapies and specialist medicine, currently has 25 branches worldwide and is present in over 60 countries with its products, produced at the plants in Parma, Blois (France) and Santana de Parnaíba (Brazil).
In 2012 investment in R&D reached € 198 million, accounting for 18% of sales, a level that the company intends to maintain in coming years. The R&D operations in Parma, Paris, Rockville (USA) and Chippenham (UK) integrate their efforts to advance the Group’s pre-clinical, clinical and registration programs. At the end of 2012, the Chiesi Group employed over 3,800 people and more than 350 of them were involved in R&D.
About CereSpir Incorporated
CereSpir is dedicated to preserving the primary essence of each person, his or her memories. The Company holds the exclusive worldwide development and commercialization rights to CHF 5074, a novel, first-in-class small molecule microglial modulator, from Chiesi Farmaceutici S.p.A. Upon receiving further input from the U.S. Food and Drug Administration, CereSpir anticipates initiating a Phase 3 clinical trial to determine if CHF 5074 has the potential to become the first therapy for people with ApoE4 genotype and amnestic Mild Cognitive Impairment (MCI). The Company’s ultimate goal is to start treating patients with CHF 5074 before amyloid plaques develop as a prevention strategy for Alzheimer’s disease.