MISSISSAUGA, ON, Jan. 27 /PRNewswire/ -- Anthony Giovinazzo, President & CEO of GB Therapeutics Ltd. (GBt), announced today that GBt has entered into an agreement with Chiesi Farmaceutici S.p.A. headquartered in Parma, Italy, for an exclusive license to Chiesi's CHF1512 molecule which will result in an equity investment by Chiesi in GBt. The compound is a methyl-ester of levodopa (LDME), melevodopa, combined with the decarboxylase inhibitor carbidopa. The phase 3 clinical development, for Parkinson's Disease patients was completed in Europe, leading to the registration in Italy. Additional Phase 3 trials to meet FDA and ICH guidelines targeting motor fluctuations are expected to commence in Q1, 2006.
"We are delighted to have been able to obtain the license to this molecule. There is a significant unmet medical need for a medication that would allow Parkinsonian patients, especially those with fluctuating response to treatment, to have an option to take an oral liquid therapy that might significantly improve the reliability and stability of levodopa absorption and plasma levels, thereby increasing the efficacy, safety and tolerability of levodopa treatment," said Mr. Giovinazzo. "We believe that CHF1512 is a safe, well tolerated and effective drug, resulting in a significantly faster onset of action, a significant decrease of the daily experience of disabling motor impairment and uncontrolled movements (dyskinesias) as well as a potential improvement in the functional ability, quality of life and non-motor symptoms associated with the disease."
The agreement referred to in this press release follows an agreement reached in August 2004 pursuant to which GBt acquired an exclusive license from Chiesi Farmaceutici with respect to CHF3381, a Phase II neuropathic pain molecule.
"We are pleased to have this second agreement with GB Therapeutics Ltd." said Dr. Alberto Chiesi, President & CEO of Chiesi Farmaceutici, "since GBt has significant experience in the area of Central Nervous System diseases. We will acquire an equity interest in GB Therapeutics as a result of this agreement."
CHF1512 (to be known in the future as GT1512) is a combination containing two known drug substances: melevodopa hydrochloride, a levodopa pro-drug (LDME), and carbidopa and was developed by Chiesi Farmaceutici of Parma, Italy. Melevodopa is 250 times more soluble in water than levodopa and forms a clear solution, leaving no residue. Therapeutic doses of GT1512 can be dissolved in a modest quantity of water that can be swallowed easily by Parkinsonian patients. GT1512 is thus completely transformed into levodopa and enters the blood stream ensuring the establishment of effective levodopa plasma levels. Therefore, it offers a more predictable and constant levodopa plasma level which may prevent motor complications.
GT1512 was developed as a possible replacement for the traditional Sinemet(R) or Madopar(R) treatment, with the therapeutic benefits of potentially continuous dopaminergic stimulation. The effervescent tablet is one of the most convenient forms for Parkinson's patients to prepare and swallow.
About Parkinson's Disease
Parkinson's Disease (PD) is a chronic and progressive disorder that results from the death of dopaminergic neurons in the substantia nigra of the brain, leading to progressively worsening motor disability. These neurons produce dopamine, a chemical messenger that plays an important role in motor control. Dopamine depletion results in a patient's impaired ability to initiate and control motor functions (brady- or a-kinesia), tremor of the limbs at rest, rigid limbs, a shuffling gait and a stooped posture.
Parkinson's Disease affects an estimated 1.5 million people in the US, 3 million people in Europe (current EU) and tens of millions worldwide. Medication therapy has made significant advances and improvements especially over the last 10 years. A number of new treatments and new strategies have emerged and the quality of life for the average sufferer has improved. Levodopa remains the foundation of standard treatment for the management of PD.
About Chiesi Farmaceutici S.p.A.
Chiesi Farmaceutici is one of the largest Italian-owned European pharmaceutical groups headquartered in Parma, Italy. The company is dedicated to the research, development and commercialization of ethical products, focusing on respiratory, cardiovascular, musculoskeletal / inflammation and neonatology therapeutic areas. Consolidated group turnover was about (euro) 515 mil in 2004. Chiesi has marketing and sales organizations in all the major European markets and product distribution in over 40 countries. Chiesi employs 2700 people world wide, including approximately 300 scientists in research facilities in Italy, France and the US.
About GB Therapeutics Ltd.
GB Therapeutics Ltd. (GBt) is a private, development-stage pharmaceutical company that focuses on neurology therapeutics, in particular neuropathic pain and neurodegenerative (e.g. Alzheimer's and Parkinson's) diseases.
GB Therapeutics is supported by venture capital with VenGrowth Capital Partners Inc. as its primary investor. The Company is focusing on building a portfolio of proprietary and in-licensed clinical drug candidates for diseases of the central nervous system. The Company's core competency is to identify innovative, cost-effective drugs that provide superior relief and fewer safety and tolerability issues for patients.
GB Therapeutics Ltd.