KRISANI BIO SCIENCES PVT. LTD.
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1 KRISANI BIO SCIENCES PVT. LTD. Flat B2, 2 nd Floor, Suryateja Apartments, Hindi Nagar, Punjagutta, Hyderabad, Telangana kkr@krisanibio.com. URL: Contact Number:
2 Overview: Krisani Biosciences is pioneering in rapidly and cost effectively design, develop, and commercialize best-in-class innovative therapies for the treatment of Copper toxicity (Wilson s disease), Non-Alcoholic Steatohepatitis (NASH), Neuropathic Pain, Cardiovascular Diseases, Cystinosis, Huntington's disease and Hepatic Disorders; which can provide multiple benefits to patients, caregivers, and consumers. Using our proprietary technologies was able to deliver unique therapeutic molecules with enhanced safety and efficacy. The resulting new molecular entities (NME) provide competitive advantage through product and technology driven multiple layers of intellectual property protection such as patents, trademarks and know-how; in addition to mitigating risks in various stages of development and lowering regulatory hurdles.
3 Business Model: KrisaniBio is an innovative biopharmaceutical company with a value driven sustainable business model with highly differentiated, potential best in class therapeutics to treat significant and life-threatening diseases. We are committed to developing therapeutic products that we elieve best- in-class with the potential to be more effective and safer products than the current standard of care or other products in development. Our strategic approach to drug development builds on internally and externally generated knowledge to identify and develop proprietary and highly differentiated products, as well as enables the company to limit development risks and costs. By applying our distinctive technologies and capabilities, and by utilizing an expeditious approach where possible to minimize development risk and costs, we believe that we can create substantial value while being very cost effective. Krisani Biosciences is focused to rapidly and cost-effectively design, develop and out-license or collaboratively develop products by strategic alliances or partnerships. Design, protection of the associated intellectual property and development work will be carried out in Krisani Biosciences Private Limited. After successful completion and validation of early stage proof-of-concept studies, Krisani Biosciences leverages its assets for strategic collaboration or partnering with multinational pharmaceutical companies to further develop and recognize value or out-license the clinical candidate and set royalties and milestones, thereby meeting projected revenues. By maintaining a lean infrastructure, and working collaboratively with others, including leading academic researchers, clinical centers, contract research organizations, and contract manufacturing organizations, we are able to efficiently and cost effectively advance multiple programs in parallel. As the product development programs at Krisanibio continues to advance and mature, the company intends to establish strategic alliances and collaborations in certain areas with leading pharmaceutical and medical device companies. The primary objective of such partnerships is to accelerate product development efforts, and to maximize stakeholder value.
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5 Research and Development: KrisaniBio's R&D has built one of the strongest and broadest pipelines of potential new candidates. We believe the pipeline has the potential to deliver value to patients and payers and improve rates of financial return on our R&D investment. The primary goal of our R&D function is to appropriately progress our pipeline products safely and efficiently to deliver innovative new medicines. KrisaniBio s has a portfolio of products in the pipeline. The company allocates its R&D investment with reference to the potential returns available from its target therapeutic markets and the technical and commercial aspects, those factors are reviewed at each phase of the development process and are central in the decision to proceed to the next stage. At the centre of this strategy, we will focus our molecules R&D and investments in Neuroscience Pain (Market potential: $29.8 Billion); Neurodegenerative Disorders ($19 Billion); Hepatology-($9 billion) and Cardiovascular Diseases ($116 Billion). KrisaniBio's pipeline is rich in Preclinical and first in human entries aimed at important unmet medical needs such as Copper toxicity, NASH, Neuropathic Pain; Liver Cirrhosis; Hypertriglyceridemia; Oncology, Cystinosis and Huntington's Disease. With biomedical science Advancing on all fronts, we are aiming to work more collaboratively with global clinical research and development organizations and other pharmaceutical and biotech companies in ways that allow us to share risk and gain access to new knowledge and technologies.
6 Intellectual Property It is our policy to try to obtain patents on commercially important, protectable inventions discovered or developed through our R&D activities. Patent protection for new active ingredients is available in major markets and patents can also be obtained for new drug formulations, manufacturing processes, medical uses and devices for administering products. Krisani Biosciences applies its proprietary drug discovery platform to identify novel product candidates in a number of disease areas, including Wilson's disease, NASH, Cardiovascular Diseases, Neuropathic Pain and Neurodegenerative diseases. By applying our proprietary design platform, we have discovered and advanced into pre-clinical trials a portfolio of three product candidates targeting multiple diseases. To-date, the company is currently working on 5 therapeutic areas and had granted 12 international and national patents. To-date, the company has filed one patent application on the novel diagnostic technology and its applications in multiple disease areas with the United States Patent and Trademark Office (USPTO) and Indian Patent Office (IPO).
7 Application Number Title Patent No. / Status US US A1 US A ,6 Xylidine Derivatives for the treatment of Pain Compound, Composition and uses thereof for the treatment of Hypertriglyceridemia Compound, Composition and uses Thereof(Cystinosis) Compound, Compositions, Formulations and their uses thereof Compound, Compositions, Formulations and their uses thereof US B2 GRANTED US B1 GRANTED US B2 GRANTED Japan Israel Compound, Compositions, Formulations and their uses in the treatment diseases related to copper retention or Hepatic Disorders Compound, Compositions, Formulations and their uses thereof Australia European PO Cysteamine Derivatives and their use in the treatment of NASH (FR) derives Cysteamine ET LEUS utilisation DANS LE treatment DESTEATOPATHIES NON ALCOOLIQUES Japan Cysteamine Derivatives and their use in the treatment of NASH Australia Cysteamine Derivatives and their use in the treatment of NASH (FR) derives Cysteamine ET LEUS utilisation DANS LE treatment DESTEATOPATHIES NON ALCOOLIQUES European PO Cysteamine Derivatives and their use in the treatment of NASH Method and System for Prognosis and Treatment of Diseases using Portfolio of Genes Israel Singapore
8 Pipeline Profile: KB-HD-01: Wilson s disease: A novel prodrug and a novel Copper metal chelator with Significant Superior Pharmaceutical Profile compared to the marketed drugs. Potent Copper Chelator cum Antioxidant Lead and has better Drug Profile than D-Penicillamine with Neuroprotective Properties. Presently chemical synthesis completed and preclinical data is encouraging towards proof of concept studies. KB-GE-001:Non-Alcoholic Steatohepatitis (NASH): A novel Co- drug for liver cirosis and exhibits multiple fold activity than the marketed drugs. Chemical synthesis completed and preclinical work under progress KB-CN-01: Neuropathic Pain: A novel prodrug of a local anesthetic that alters signal conduction in neurons by blocking the fast voltage gated sodium (Na+) channels in the neuronal cell membrane; Longer duration of action with enhanced pharma cokinetics, safety and efficacy; Enhanced neural blood flow, conduction and glucose transport. Currently in the advanced Pre-clinical stage. The product portfolio has the potential for the treatment of Diabetic Neuropathy, Post-Herpetic neuralgia, Chronic Pain, Spinal Cord Injury and Peripheral Neuropathy. A US Patent has been granted US B2 in the Month of October KB-CV-001: Hypertriglyceridemia: A novel new molecular entity (NME) of Eicosapentaenoic acid. KB-CV-001 is an ULTRA-PURE form of EPA (Eicosapentaenoic acid) in an ESTER form and when compared to the US-FDA recently approved entity, Amarin Plc sepa ester (VASCEPA) product which claims to have above 96% pure EPA Ester only, whereas, KB-CV-001 EPA analytical purity was found to be 99% and has a greater potential. KB-CV-001is also a derivative of an endogenous compound, 2-aminoethanethiol and is a Chemically Highly Stable compound. KB-ND-01: Huntington s disease (Orphan category): A novel prodrug of Potent Trans glutamase inhibitor, Neuroprotection by increasing brain derived neurotrophic factor (BDNF) levels, Long duration of action with enhanced pharmacokinetics, tolerability, safety and efficacy, Potential to penetrate through Blood-Brain Barrier and stabilizes the neural membrane. Currently in the advanced Pre-clinical stage. The product portfolio has also the potential for the treatment of Nephropathic Cystinosis, Hypertriglyceridemia and Non- alcoholic Steatohepatitis (NASH).
9 Creating a successful and sustainable business is about more than financial results. We place great importance not just on what we achieve but on how we achieve it. Running a responsible, values-based business is embedded in our strategy.
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