Bach Pharma Inc

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Platform Technology Overview The Company transferred drug-manufacturing technology to the United Kingdom in 2005, and created a manufacturing process to scale up production of the product. Bach also made substantial qualitative improvements on its pharmaceutical properties, some of which include enhanced purity, from 95% to 99.8%, increased stability and increased solubility. Significant commercial scale-up hurdles have been overcome under GMP conditions and qualifications. Bach has an exclusive arrangement with SAFC Pharmaceuticals (Sigma Aldrich) to manufacture all of the Company ’s active pharmaceutical ingredients. The Company ’s focus is on the development of this new drug platform ’s unique attributes. Bach ’s lead candidate MSL ® is a novel cytoprotective agent. MSL ® has powerful anti-oxidant and anti-inflammatory properties and scavenges free radicals. Research has shown that MSL ® is a redox buffering molecule, a heavy metal chelator, as well as a regulator of proteostasis and Nrf2. MSL ® has the ability to cross the blood-brain barrier and enter cells of the central nervous system, as well as to enter the immune system, thereby delivering therapeutic results to the gut, thymus, spleen and blood. It is also able to cross the retinal-brain barrier. The safety of Bach ’s compounds has been established by extensive human trials, as well as its use outside of the United States, that has proven non-toxic at therapeutic doses. Many independently reviewed and published articles in scientific journals have reported results of studies using Bach ’s compounds. These studies have linked pro-inflammatory responses, targeted by MSL ®, to the amelioration of medically important health conditions and diseases. At therapeutic dose levels, MSL ® exhibits no mutagenicity. GLP studies demonstrate the absence of lethal mutations in germinal cells as well as the absence of DNA alteration in differentiated cells. Evidence has also shown that these compounds are not teratogenic, allergenic or immunotoxic. Current Research The Company ’s primary focus is on the utilization of MSL ® and its derivatives for inflammatory conditions, oxidative stress (traumatic or genetic), and the diseases they cause. Oxidative stress occurs in cells when the production of reactive oxygen species exceeds intracellular antioxidant defenses. Research results show oxidative stress is involved in many diseases involving neurodegeneration. Potential target indications include adjunct therapy for the treatment of neurodegenerative conditions including ataxia-telangiectasia, Alzheimer ’s disease, amyotrophic lateral sclerosis, Friedreich ’s ataxia, multiple sclerosis and Parkinson ’s disease. Halting or slowing the progression of neurodegeneration in these diseases by Bach ’s compounds will provide a significant commercial opportunity for the development of the use of these phthalazinedione compounds. Other areas of interest also affected by oxidative stress include ophthalmic diseases, trauma, healing and immune-deficiency syndromes.

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