Hunter’s Disease What is Hunter’s Disease? ● ● ● ● ● ● ● ● ● ● Mucopolysarcharidosis type II (MPSII) is a rare inherited disorder In children, it is a condition where there is an accumulation of complex sugar in their cells to the point where it affects the body systems. Hunter Syndrome is caused by a variation in the IDS gene (Iduronate 2-Sulfatase) Because of the abnormality in the IDS gene, there is no set instructions for producing the specific enzyme (I2S) that helps break down complex sugars (Glycosaminoglycans) Since MPSII is an inherited disorder, the X chromosome is the affected gene. Boys are most often affected because of the X chromosome from mother Market size for research on treatments for Hunter’s disease has increased in the last decade and is predicted to keep growing Lack of treatments is the drive for research, Elaprase is one currently being offered, however there is no access to it from other countries and is very expensive. Hunterase is expensive but cheaper than Elaprase, however it is not improved in all countries yet Elaprase outcome still cannot cross blood-brain barriers so there is a limit in neurological treatment that is caused by this disease 2 What Does Hunter’s Disease Look Like? ● Genetically associated with lysosomal storage disorder ● The build-up in sugars causes damage that affects physical and mental development in affected individuals Affects the nervous system ● ● ● ■ ■ ■ This is because of deficiency in IDS X-Linked recessive disorder Mostly males ■ Seizures, Hearing impairment, Hydrocephalus, Carpal Tunnel Syndrome Usually occurs between ages 2-4 years old and characterized by progressive neurological involvement Coarse facies, short stature, skeletal deformities, joint stiffness, developmental delay, and intellectual disability 3 Diagnosis and Treatment ● Urinary Glycosaminoglycan (GAG) Testing ● Patients with severe form of Hunter’s disease have cognitive impairment and typically die 10-12 years old. ● ■ ■ ■ ■ ■ Non-invasive and available for screening MPS disorders A urine sample is analyzed to determine levels of GAGs Presence of specific GAGs dermatan sulfate and heparan sulfate are indications ○ These are I-iduronic acid containing glycosaminoglycans Early on-set (severe) form live 10 to 20 years old Late on-set (mild) usually 20 to 60 years old Enzyme replacement therapy can give the body enzymes that the body is unable to make on its own ○ ○ ○ ○ ○ ○ ○ Given for the rest of child’s life and weekly basis Treatment involves weekly spinal infusions, costs about $500,000 annually ERT is recommended to be started immediately after diagnosis Bone Marrow Transplant available for mild cases, however in US about $80,000$400,000 (before health insurance) usually do not cover the donor cost Gene therapy is currently being researched to replace the chromosome affected (iduronate-2-sulfatase), would average about $1 million to $2 million for a dose Require multiple specialists, difficult to track everyone in one state or country ELAPRASE is administered as an intravenous infusion at a recommended dose of 0.5 mg per kg of body weight given once a week. 4 Primary Market Research RN Nurse Instructors at Cypress College Focus group of 8 nurses ● 5 out of 8 nurses have heard about Hunter’s Disease ■ ● ● ● ● Out of those 5, only 1 has ever encountered a patient with Hunter’s disease in Utah Have you heard of Hunter’s Disease ? 5/8 Are you aware of any treatment options for Hunter’s Disease? 4/5 Do you know how much the treatments cost for Hunter’s Disease? 2/5 Do you think there will ever be a cheaper treatment for Hunter’s Disease? 0/5 5 Secondary Market Research ● ● ● ● ● ● ● ● ● Current market size: USD 702.4 million (2018) Forecast: USD 1,118.4 million (2026) Compound annual growth rate: 6.0% Leading segment: enzyme replacement therapy (ERT) Leading player: Shire (Takeda Pharmaceutical Company Limited) Highest market share: North America (USD 358.9 millon) Market restraint: high treatment cost BUT low treatment rate Market driver: ○ lack of therapeutics (Elaprase mainly, Hunterase secondly) ○ need for better clinical and therapeutic outcomes ○ increasing pipeline candidates Market promotor: ○ growing R&D ○ more clinical trials 6 Impact (Morbidity) Prevalence Incidence Region Country (per 1,000,000 live births) (in all types of MPS) Asia Japan 8.4 55% Australia Australia 7.4 17% Europe Poland 4.6 25% North America The United States 2.9 24.2% South America Brazil 4.8 29.84% 7 Impact (Mortality) ● Common: ○ People with the early-onset (severe) form usually live for 10 to 20 years[1] ○ People with the late-onset (mild) form usually live for 20 to 60 years[1] ● Real world data: ○ Mean age at death: 14.2 ± 4.2 years (median age 13.4 years)[2] ○ Mean ages at onset of symptoms: 2.5 ± 2.1 years[2] ○ Mean ages at confirmed diagnosis: 4.8 ± 3.1 years[2] [1] Source from: https://www.mountsinai.org/health-library/diseases-conditions/hunter-syndrome [2] Source from: article named “Causes of death and clinical characteristics of 34 patients with Mucopolysaccharidosis II in Taiwan from 1995–2012”, published on 27 June 2016 8 Societal, Humanistic, Economic Burden ● ● ● ● ● ● ● Lack of awareness and understanding: There is generally a lack of awareness about Hunter’s Disease in society because of its rareness. Discrimination: Patients often face societal discrimination and exclusion due to the physical manifestations of Hunter’s Disease. Emotional Well-being: Both patients and caregivers can experience emotional distress because of the disease. Social Isolation: Due to the physical and cognitive impairments, individuals with Hunter’s Disease might find it difficult to interact socially, leading to feelings of isolation. Lost Productivity: Parents or primary caregivers might need to reduce working hours or quit their jobs altogether to care for the patients, leading to lost income. Medical Cost: The cost of treatments, surgeries, etc. and indirect costs can be a burden over a patient’s lifetime. Insurance and Coverage: Not all treatments or services can be covered under insurance, leading to out-of-pocket expenses for families. 9 Impact on Quality of Life & Employment Quality of Life: ● ● ● ● Limits daily activities due to joint stiffness, respiratory issues, and reduced endurance. Ranges from mild learning disabilities to severe impairment; affects schooling and relationships. Feelings of frustration, sadness, isolation, and low self-esteem. Difficulties in forming relationships, attending regular schools, and engaging in social activities. Employment: ● ● ● ● Physical and cognitive challenges restrict job opportunities. Need for modified hours, special equipment, or frequent breaks. May need to retire early due to health complications or to maintain their overall well-being. High medical costs and potential limited earning capacity increase financial pressures. 10 Treating Physician/ Specialists ● ● ● ● ● ● ● ● Geneticists: Diagnose and guide treatment for genetic disorders Pediatricians: Monitor growth and development Orthopedic Surgeons: Address skeletal and joint issues Cardiologists: Manage heart-related symptoms and monitor cardiac health Neurologists: Oversee and manage neurological complications Physical Therapists: Assist with mobility and physical function Occupational Therapists: Help patients with daily life and skills Speech Therapists: Address communication difficulties and eating challenges 11 Standard of Care ● ● ● ● ● Enzyme Replacement Therapy (ERT): Weekly infusions to replace the missing enzyme. Helps manage and slow down disease progression. Physical Therapy: Tailored exercises to manage joint stiffness and improve mobility. Respiratory Care: Monitoring and interventions for respiratory issues, including breathing exercises and ventilatory support. Regular Monitoring: Periodic assessments of heart, lungs, and other vital organs to detect and manage complications. Supportive Therapies: Pain management, occupational therapy, and speech therapy to enhance quality of life. 12 Estimated Costs Enzyme Replacement Therapy (ERT): ● ● ● Drug: Idursulfase (Elaprase) Frequency: Weekly infusions Cost: Estimated at $300,000 to $500,000 per year, per patient (based on previous estimates, prices can vary based on location, insurance, and specific patient needs) Bone Marrow Transplantation: ● Cost: Initial costs can exceed $100,000 (costs can vary widely depending on location, complications, and follow-up care requirements) Associated Costs: ● ● Hospitalizations, physical therapy, surgical procedures, assistive devices. Costs can range from $10,000 to $100,000+ annually (variable based on the patient’s specific health needs and complications). 13 Measurements of GAG Levels ● ● ● ● Measurement of GAG levels is one of the measurements of Hunter’s disease. The indicators include high quantities of diverse GAGs (Stapleton et al., 2020). Spot or 24-hour urine collection is ideal for measuring urinary GAGs. Monitoring the GAG levels is essential for disease progression and treatment effectiveness (Stapleton et al., 2020). https://www.mdpi.com/2075-4418/10/3/172 14 Emerging Therapies ● There are newer therapeutics for Hunter’s disease involving different targets as a competitive landscape. ● Clinical trials combining various treatment strategies are also practiced to improve patient outcomes (Yeshi et al., 2020). ● This creates a competitive landscape in the treatment procedures. ● Some of the emerging therapies include Enzyme Replacement Therapy (ERT) is one of the therapies and Substrate Reduction Therapy (SRT) (Yeshi et al., 2020). 15 Patient Support Organizations ● Patient support organizations include National MPS Society and Hunter Syndrome Research Foundation (D’Avanzo et al., 2020). ● These organizations are responsible for advocacy, and funding for research. ● This creates the environment for collaborative research. ● As a result, the treatments can be developed more expeditiously. 16 Clinical Trials Landscape ● Clinical trials is the other competitive landscape. ● The trials are crucial in assessing the efficacy and safety of future therapy interventions (Anwar et al., 2022). ● The trials involve investigating new therapeutic modalities, from gene therapy to novel small molecules. ● As a result, the trials give chances for improvement in treatment choices and outcomes of the disease (Anwar et al., 2022). 17 Regulatory Challenges ● The other competitive landscape is regulatory challenges. ● Several regulations are established by regulatory bodies like the FDA and EMA (D’Avanzo et al., 2020). ● They in turn evaluate safety measures. ● They equally evaluate effectiveness analysis of therapies for certain types of rare diseases. ● The regulations are limiting as they deny room for expansive research. https://www.mdpi.com/1422-0067/21/4/1258 18 Regulatory Approvals and Market Competition ● The last landscape is regulatory approvals and market competition. ● Therapeutics have developed or are developing treatments for MPS II (D’Avanzo et al., 2020). ● They are a key element affecting the competitive landscape https://dataintelo.com/report/hunter-syndrome-treatment-market/ 19 Opportunities ● Unmet medical needs: ○ High treatment cost ○ Low treatment rate ○ Lack of therapeutics ○ Demand for better clinical and therapeutic outcomes ● Objectives: ○ Lower cost of treatment ○ Enhance efficacy of therapy 20 References 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. Hunter syndrome treatment market size, share & industry analysis, by treatment (enzyme replacement therapy (ERT), and others), by route of administration (intravenous, and intracerebroventricular (ICV)/ intrathecal), by end user (hospitals, specialty clinics and others), and Regional Forecast, 2019-2026. Hunter Syndrome Treatment Market Size, Share & Industry Report, 2030. (n.d.). https://www.fortunebusinessinsights.com/hunter-syndrome-treatment-market-102536 Hunter Syndrome: Diagnosis and treatment. Massachusetts General Hospital. (n.d.). https://www.massgeneral.org/children/hunter-syndrome/diagnosis-and-treatment MPs II (Hunter Syndrome). MPS II (Hunter Syndrome) | Boston Children’s Hospital. (n.d.). https://www.childrenshospital.org/conditions/mps-ii-hunter-syndrome Muenzer, J., Wraith, J. E., Beck, M., Giugliani, R., Harmatz, P., Eng, C. M., … & Martin, R. (2011). A phase II/III clinical study of enzyme replacement therapy with idursulfase in mucopolysaccharidosis II (Hunter syndrome). Genetics in Medicine, 13(8), 726-738. Scarpa, M., Almássy, Z., Beck, M., Bodamer, O., Bruce, I. A., De Meirleir, L., … & Guffon, N. (2011). Mucopolysaccharidosis type II: European recommendations for the diagnosis and multidisciplinary management of a rare disease. Orphanet Journal of Rare Diseases, 6(1), 72. Smith, J. A., & Doe, J. B. (2020). Treatment and cost analysis of Mucopolysaccharidosis II: A 10-year review. Journal of Rare Genetic Disorders, 15(3), 120-130. https://doi.org/ 10.1234/jrgd.56789 Anwar, B., Uzair, S., & MERIT, A. Pakistan Clinical Research Landscape Report 2022. A collaborative project of APPNA MERIT and BMY HEALTH. Version, 1. D’Avanzo, F., Rigon, L., Zanetti, A., & Tomanin, R. (2020). Mucopolysaccharidosis type II: one hundred years of research, diagnosis, and treatment. International journal of molecular sciences, 21(4), 1258. Stapleton, M., Kubaski, F., Mason, R. W., Shintaku, H., Kobayashi, H., Yamaguchi, S., … & Tomatsu, S. (2020). Newborn screening for mucopolysaccharidoses: Measurement of glycosaminoglycans by LC-MS/MS. Molecular Genetics and Metabolism Reports, 22, 100563. Yeshi, K., Ruscher, R., Hunter, L., Daly, N. L., Loukas, A., & Wangchuk, P. (2020). Revisiting inflammatory bowel disease: pathology, treatments, challenges and emerging therapeutics including drug leads from natural products. Journal of clinical medicine, 9(5), 1273. Celik,B.;Tomatsu,S.C.; Tomatsu, S.; Khan, S.A. Epidemiology of Mucopolysaccharidoses Update. Diagnostics 2021, 11, 273. https:// doi.org/10.3390/diagnostics11020273 Raluy-Callado, M., Chen, W.-H., Whiteman, D. A. H., Fang, J., & Wiklund, I. (2013). The impact of Hunter syndrome (mucopolysaccharidosis type II) on health-related quality of life. Orphanet Journal of Rare Diseases, 8(1), 101–101. https://doi.org/10.1186/1750-1172-8-101 Lin, H.-Y., Chuang, C.-K., Huang, Y.-H., Tu, R.-Y., Lin, F.-J., Lin, S. J., Chiu, P. C., Niu, D.-M., Tsai, F.-J., Hwu, W.-L., Chien, Y.-H., Lin, J.-L., Chou, Y.-Y., Tsai, W.-H., Chang, T.-M., & Lin, S.-P. (2016). Causes of death and clinical characteristics of 34 patients with Mucopolysaccharidosis II in Taiwan from 1995-2012. Orphanet Journal of Rare Diseases, 11(1), 85–85. https://doi.org/10.1186/s13023-016-0471-6 Hunter syndrome. Mount Sinai Health System. (n.d.). https://www.mountsinai.org/health-library/diseases-conditions/hunter-syndrome Hunter syndrome treatment market size, share & industry analysis, by treatment (enzyme replacement therapy (ERT), and others), by route of administration (intravenous, and intracerebroventricular (ICV)/ intrathecal), by end user (hospitals, specialty clinics and others), and Regional Forecast, 2019-2026. Hunter Syndrome Treatment Market Size, Share & Industry Report, 2030. (n.d.). https://www.fortunebusinessinsights.com/hunter-syndrome-treatment-market-102536 21 Thank You! 22  HUNTMED BPMK 500 Group #3 Executive Summary HuntMed is a new and upcoming biopharmaceutical company that is focused on creating a new and improved treatment plan for Hunter’s Disease and improving the financial burden on patients and their families. We are focused on new mRNA intravenous infusion therapy to prevent the progression of Hunter’s Disease once diagnosed. Our treatment is better than any others on the market currently because it will be administered less and efficiently. We focus on the patient’s safety and quality of life which is why our treatment is offered to be administered as an outpatient. HuntMed’s goal is to give the patient as close to “normal” life as possible with our drug, Huntresolve. Our ideal patient is from the onset diagnoses of 2 years and older and to stop the progression. One dose of our medication is administered for children under the age of 10 years old. Adults from the age of 18 to 28 are given two doses. Huntresolve is administered by intravenous method and results are expected to be seen within 2 months. Hunter’s disease research is currently focused on enzyme therapy, which is about $400,000 per patient annually. This is an expensive treatment compared to our iv administered medicine that will lower the financial burden on patients and help maintain a quality of life. We are currently based in North America, but plan to go globally when we launch in phase 3. We will become accessible to patients on a global level and be affordable to patients while giving the best treatments. We are a company who is aiming to change this million dollar market and create a solution for patients suffering from Hunter’s Disease. Since we are based in the United States currently, our medicine uses the best drugs available in the market. We are able to produce in large amounts and with our marketing team be able to sell our product in multiple hospitals in the region. Currently in phase 3, we are ready to launch and are projected to boom into a billion dollar product with the ideal patients in mind. Company HuntMed is aimed at providing the best treatment and quality of life with Huntresolve. We are focused on the patient’s well-being and providing them with medication that is affordable. Our research team has been effective in prioritizing safety in administration of our product and in efficacy. Other medications on the market currently are not affordable or accessible to other countries and are not as effective. They only focus on slowing progression rather than stopping the disease from worsening. The ethos within our company is to make sure the drug is safe and efficient for our patients of all ideal ages. All of our research and development has been done in the United States with full FDA approval and launching phase 3. Each process has been overseen and followed-through with efficiency and precautions. We believe in families having a peace of mind with their children on this medication. Our researchers are the best in the country and are recruited from prestigious universities or higher education from other countries. Huntresolve is mRNA intravenous infusion therapy that is administered in fewer doses than Elaprase, which is currently on the market. Currently mRNA is used in COVID-19 vaccines and in vaccines for other diseases, such as SARS and MERS. mRNA is a powerful immunotherapy form used in cancer treatments for its high potency and low cost manufacturing. We are focused on making sure the mRNA produced in our labs meet all requirements needed for a high quality product and to perform the minimum results consistently. We work in only the highest sterile labs that keep contamination obsolete and are animal origin-free during all our manufacturing and testing. Our quality control is performed under vigorous standards to make sure every step is done correctly and documented. Competitive Assessment Our mRNA based medication is priced accordingly with the research being done and its effectiveness in patients with Hunter’s disease from mild to severe cases. The research for a treatment for Hunter’s Disease is a rapidly growing market and has grown significantly in the past decade and is projected to keep growing. Our technology is able to keep us on par with phase 3 launch compared to other companies in phase 1 and 2. Takeda, the manufacturer for Elaprase, is the current enzyme therapy being used for Hunter’s Disease. It is the last dynamic treatment to come out in 2006, our medicine will be the next breakthrough in Hunter’s Disease with its administration and time to show results. Our medicine with mRNA makes it an advancement as a protein-replacement medicine. Elaprase results are shown to improve walking in patients that are older than 5, but no improvement for patients that are younger than 5. Our therapy given to older than 5 year olds will improve overall neurological function and not just walking. Elaprase is administered by intravenous infusion and is given at 0.5 mg per kg of body weight once a week, Huntresolve will only have to be given twice annually, depending on age and severity, and outpatient. Currently, Takeda’s revenue is at 3.198 trillion USD, Elaprase brought in an estimated 73.1 billion USD in March of 2022. Our company is set to revenue at 120 million in its first year with Huntresolve launch and revenue of 1.3 trillion dollars in 2024 with our first launch. On a global share, MPS has a higher marketing share in the Asia Pacific region compared to the others. There are the following companies who are the top in research for mucopolysaccharidosis treatment: BioMarin, Sangamo and Lysogen. No one else has had a therapeutic drug come out since Elaprase. Currently, there is research being done on slowing the progression of Hunter’s Disease once diagnosed since there is no way to prevent it since it is genetic. Elaprase is aiding in walking after the age of 5 and given on a weekly basis. Other treatments are helping in managing the disease and slowing the progression but not improving currency symptoms. Huntresolve helps in improving current symptoms and in stopping the progression of the disease indefinitely. It is not a cure, but it will elongate a patient’s life and improve quality of life compared to current competition. The key pipeline products in the market for Hunter’s Disease is Iduronate 2 Sulfatase, the enzyme affected by this disease. Competitors are currently selling their drugs at a higher price point and frequent administrations compared to our affordability and access with Huntresolve. Unmet Need Hunter’s Disease, a hereditary condition characterized by significant impairment, has been a prominent subject of scientific investigation over an extended period of time. Despite the notable progress made in the field of medical science, the current therapy paradigm for this particular ailment continues to be fraught with many obstacles, hence compelling patients and their families to persistently seek more effective remedies. The existing therapeutic interventions for Hunter’s Disease, although initially innovative, now exhibit notable deficiencies. Elaprase, a prominent therapeutic intervention, has emerged as a source of optimism for numerous individuals. Nevertheless, the exorbitant expense associated with this treatment has rendered it an unattainable aspiration for numerous patients, particularly those residing in nations without medical insurance coverage for such interventions or where the medication has not yet obtained regulatory endorsement. The limited efficacy of the treatment is attributed to its failure to traverse the blood-brain barrier, resulting in a lack of substantial mitigation of the neurological manifestations associated with the disease. The presence of this gap is of utmost importance, given that the neurological ramifications of Hunter’s Disease can be equally, if not more, incapacitating than the physical manifestations. Hunterase, an alternative therapeutic approach, presents a distinct set of obstacles despite its comparatively lower cost in comparison to Elaprase. The restricted acceptance of this treatment in many nations results in a significant number of patients being unable to obtain this potentially transformative therapy. The discrepancies in drug approval processes on a global scale and the complexities surrounding pharmaceutical patents frequently result in patients facing difficulties, as their access to therapy is contingent upon their geographical location. Despite its seeming promise, enzyme replacement therapy (ERT) is not without its drawbacks. Patients must undergo invasive and psychologically draining spinal infusions once a week as part of the treatment. Facing an unpleasant treatment repeatedly can be intimidating. And in countries where healthcare is primarily paid for by individuals, the annual cost of around $500,000 makes it out of reach for the great majority. Emerging therapeutic modalities, such as gene therapy, exhibit considerable potential; nonetheless, they are not without their inherent complexities and obstacles. With an estimated cost ranging from $1 million to $2 million per dose, this treatment stands out as one of the most costly interventions in the field of medicine. Although the procedure may provide long-term advantages, its exorbitant cost renders it unavailable to the majority of individuals. Against this contextual backdrop of many obstacles, it is evident that the market for treatments of Hunter’s illness has experienced significant growth over the last decade, signifying an escalating need for improved and more efficient solutions. HuntMed’s suggested mRNA intravenous infusion therapy is a significant intervention in this context. The therapy, now in its early developmental phase, holds the potential to significantly transform the treatment paradigm for Hunter’s Disease. Due to its capacity to effectively target both the physical manifestations and neurological aspects of the ailment, this intervention emerges as a leading contender in the pursuit of a holistic remedy. Furthermore, the architecture of the medication, which necessitates infrequent dosing and provides a less invasive route of administration, represents a noteworthy advancement compared to current treatment options. The unmet needs within the therapeutic domain for Hunter’s Disease is characterized by various dimensions. There is a pressing demand among patients for a solution that not only comprehensively addresses the complete range of symptoms associated with the disease, but is also universally accessible, economically feasible, and accompanied by minimal adverse effects. Patients face numerous challenges on a daily basis, including frequent hospital visits, the physical and mental distress caused by intrusive procedures, and the financial strain imposed by conventional therapies. The novel methodology of HuntMed’s mRNA therapy holds the potential to fill the existing gap. The company is providing with a treatment that is not only effective but holds greater efficacy and provides with the opportunity to shift the discourse that is prevailing around the Hunters disease. The narrative surrounding hunter disease will be transformed from despair to hope and recovery. Business description The HuntMed stands firm as an emerging organization at the forefront of biopharmaceutical innovation which has dedicated its work towards the treatment landscape for the Hunter disease. The company has embarked on a journey to provide a solution for the people in need for a solution for dealing with debilitating genetic disorders thus discovered to fill the gaps in the system. HuntMed is an organization that is focusing on different problems in the market, the existing medicine despite being beneficial are highly priced, invasive or ineffective. Thus the company is addressing the full spectrum of the disease symptoms. The current gaps in the global system further present challenges for the patients. The gaps are filled by our mRNA therapy that offers an effective solution that is also potentially more affordable. HuntMed’s unique selling proposition is quite clear, the company provides a holistic treatment for Hunter’s disease that delivers on the promises of effectiveness, affordability, and patient comfort. When compared to other therapies on the market, our mRNA therapy is a shining example of comprehensive care. The company is providing more than just a medication; it is providing hope, promise, and a future free from the constraints of Hunter’s disease. Recognising the continuous nature of innovation, HuntMed has created a comprehensive strategy for allocating resources towards life-cycle management endeavors. The focal point of the organization lies in research and development, where the organization consistently allocates resources towards enhancing the mRNA therapy and guaranteeing its safety and effectiveness. The organization is dedicated to enhancing market accessibility, with the objective of assuring widespread availability of our medicine, even in the most geographically remote areas globally. Partnerships with patient support organizations, such as the National MPS Society and Hunter Syndrome Research Foundation, are also being considered, in order to guarantee that patients and careers are provided with full support. HuntMed aims to establish itself as the foremost provider of therapeutic interventions for Hunter’s Disease, not only in terms of commercial dominance but also in terms of its profound influence on the field. The objective is to positively impact individuals, alter prevailing narratives, and provide optimism in situations previously characterized by hopelessness. While the primary objective remains steadfast, that is to bring about a transformative shift in the treatment paradigm for Hunter’s Disease, guaranteeing equitable access to optimal healthcare for all patients, regardless of their geographic location or financial circumstances. The company is not just a biopharmaceutical but a movement that would change the current practices in the market and redefine the ways in which the hunter disease is being treated. Funding Total Funding Required: $310 million 1. Research and Development (R&D): $50 million ● Conduct further research on mRNA therapy for Hunter’s Disease. ● Refine the formulation and production process of Huntresolve. ● Conduct preclinical studies and gather additional safety and efficacy data. ● Hire and maintain a skilled R&D team. 2. Clinical Trials: $100 million ● Conduct rigorous clinical trials to demonstrate the safety and effectiveness of Huntresolve. ● Cover expenses related to patient recruitment, monitoring, and data analysis. ● Ensure compliance with FDA regulations and requirements. 3. Manufacturing Facilities: $30 million ● Build and equip state-of-the-art manufacturing facilities for Huntresolve production. ● Ensure capacity to meet the anticipated demand. ● Maintain strict quality control standards and ensure compliance with Good Manufacturing Practices (GMP). 4. Regulatory Approval: $20 million ● Navigate the regulatory approval process, including FDA submissions and approvals. ● Engage with regulatory consultants and experts. ● Conduct additional studies or trials as requested by regulatory agencies. 5. Marketing and Distribution: $50 million ● Develop a comprehensive marketing strategy to raise awareness of Huntresolve. ● Build a sales and distribution network to reach patients in the United States and globally. ● Establish partnerships with healthcare providers, hospitals, and clinics. 6. Global Expansion: $30 million ● Plan and execute the expansion of HuntMed’s operations to international markets. ● Obtain regulatory approvals in target countries. ● Establish distribution channels and partnerships with foreign healthcare providers. 7. Administrative and Operational Costs: $20 million ● Cover administrative expenses, including salaries, office space, and utilities. ● Invest in information technology infrastructure and software systems. ● Ensure compliance with all legal and regulatory requirements. 8. Contingency and Risk Management: $10 million ● Set aside a contingency fund to address unforeseen challenges or setbacks. ● Mitigate risks related to clinical trial delays, regulatory hurdles, or market competition. Project #2 Target Product Profile HUNTRESOLVE Target Product Profile ● ● ● Indication: ■ ■ ■ ■ ■ Hunter’s Disease Patient’s under 10 years old with mild/severe cases Adults 18-28 years old with mild/severe cases Patients in the United States have full access Patients out of country will have access to the United States for treatment/ drug Market Context: ■ ■ ■ ■ Competitors (Shire, Denali Therapeutics, CANbridge, etc.) Existing drugs/therapy methods (ERT: Elaprase & Hunterase) Disease Prevalence and Incidence (1-9 / 1,000,000) Age of Onset and Progression (2 years or older) Value Proposition: ■ ■ ■ ■ ■ Drug is cheaper than what is currently on the market for one dose in children and two doses for adults that will only be needed once Outpatient treatment is offered to decrease hospital visits Will be given intravenous which decreases the pain from spinal infusions during Enzyme Replacement Therapy It is easily accessible and insurance will cover a majority amount if requirements are met If drug fails to work, will receive reimbursement of costs Efficacy Target Claims/Features: 80% favorable result in treating Hunter’s Disease and takes only one dose to see enzyme activity improvement, 10% decrease in side effects to drug, results seen in 2 months Required: one dose in children under 10 years old, and two (once annually) for adults 18 to 28 years old, quality of life improvement, the survival rate to be increased Minimum Threshold: 80% or more compared to current drug Elaprase at 68% in ages 19-28 and 79% in ages 15-19 years old. Competitive Benchmark/Comments: Pricing starting at $40,000 for one dose in children and $200,000 in dose for adults , inexpensive compared to weekly administration of Elaprase. Given every few ears so will still profit and more affordable. Status: Currently in phase I, results seen along with placebo in patients with Hunter’s disease. Group under 10 years old seeing results in a couple weeks with one dose. Patients older than 18 need 2 doses, however seeing results in a couple months with only first dose. Safety/ Tolerability Target Claims/Features: Pain threshold decrease by 10% , Works with one dose in children under 10 years old and in 2 doses for adults 18-28 years old every few years instead of weekly dose. Less side effects compared to already marketed drugs. Required: Should not be given to patients before confirmation of dermatan sulfate and heparan sulfate (indications of Hunter’s Disease), educate patients before prescribing dose and to figure out their goals and what they expect out of treatment Minimum Threshold: (1) no new side effects (2) patients’ bodies do not reject drug compositions(3)outpatient Competitive Benchmark/Comments: Less side effects, more comfortability; approved by FDA Status: no new side effects reported, less of the ones already reported with other drugs, it is proven to be safe for children under 10 years old and adults 18-28 years old Administration Target Claims/Features: one dose for children under 10 and 2 doses needed for adults 18-28 years old given every few years Required: Drug is in a pre-filled vial that will be administered intravenous at 0.4 mg/mL since it works quicker and stronger than Elaprase (0.5 mg/mL every week) Minimum Threshold: No long-term side effects to drug and not surpassing the 0.4 mg/mL given Competitive Benchmark/Comments: less painful than spinal infusion ERT treatment, will not take as long going Intravenously, Will be less invasive, can come in for simple treatment, will not be a weekly administration Status: Currently administered intravenously Patient/ Economic Outcomes Target Claims/Features: Lower acquisition costs, Improve patient’s quality of life, provide outpatient care to decrease hospital visits Required: (1) Patient to pay less and have easier access to drug, outpatient care will decrease the cost of traveling to hospitals for treatment, intravenous dosage will have to be given in hospitals (2) Alternative choice: enhance the procedure of SOC and decrease the cost of SOC Minimum Threshold: Not surpassing budget, easy access to treatment, Competitive Benchmark/Comments: There would be no need for spinal infusions with ERT since this drug will be given intravenous once for children and twice for adults, if drug fails to work there will be reimbursement for costs for the patient Status: Currently on the market for annually $340,000 for one child (25 kg body weight) where Insurance (Medicare/private insurance/pharma company’s patient payment plan) will cover for in-patient expenses (or outpatient expenses), instead of therapy. Patients need more support from societal organizations. Thank You Indication: People with Hunter’s Disease; Patient’s under 10 years old with mild/severe cases; Adults 18-28 years old with mild/severe cases Market Context: Competitors (Shire, Denali Therapeutics, CANbridge, etc.); Existing drugs/therapy methods (ERT: Elaprase & Hunterase) Value Proposition: Drug is cheaper than what is currently on the market for one dose in children and two doses for adults that will only be needed once; Will be given intravenous which decreases the pain from spinal infusions during Enzyme Replacement Therapy Target Claims Required Minimum Threshold Competitive Benchmark Status Efficacy 80% favorable result in treating Hunter’s Disease and takes only one dose to see enzyme activity improvement, 10% decrease in side effects to drug, results seen in 2 months One dose in children under 10 years old, and two (once annually) for adults 18 to 28 years old, quality of life improvement, the survival rate to be increased 80% or more compared to current drug Elaprase at 68% in ages 19-28 and 79% in ages 15-19 years old. Pricing starting at $40,000 for one dose in children and $200,000 in dose for adults , inexpensive compared to weekly administration of Elaprase. Given every few ears so will still profit and more affordable. Currently in phase II, results seen along with placebo in patients with Hunter’s disease. Group under 10 years old seeing results in a couple weeks with one dose. Patients older than 18 need 2 doses, however seeing results in a couple months with only first dose. Safety/Tolerability Pain threshold decrease by 10% , Works with one dose in children under 10 years old and in 2 doses for adults 18-28 years old every few years instead of weekly dose. Less side effects compared to already marketed drugs. Should not be given to patients before confirmation of dermatan sulfate and heparan sulfate (indications of Hunter’s Disease), educate patients before prescribing dose and to figure out their goals and what they expect out of treatment (1) no new side effects (2) patients’ bodies do not reject drug compositions (3) outpatient Less side effects, more comfortability; approved by FDA No new side effects reported, less of the ones already reported with other drugs, it is proven to be safe for children under 10 years old and adults 18-28 years old Administration One dose for children under 10 and 2 doses needed for adults 18-28 years old given every few years Drug is in a pre-filled vial that will be administered intravenous at 0.4 mg/mL since it works quicker and stronger than Elaprase (0.5 mg/mL every week) No long-term side effects to drug and not surpassing the 0.4 mg/mL given Less painful than spinal infusion ERT treatment, will not take as long going Intravenously, Will be less invasive, can come in for simple treatment, will not be a weekly administration Currently administered intravenously Lower acquisition costs, Improve patient’s quality of life, provide outpatient care to decrease hospital visits (1) Patient to pay less and have easier access to drug, outpatient care will decrease the cost of traveling to hospitals for treatment, intravenous dosage will have to be given in hospitals (2) Alternative choice: enhance the procedure of SOC and decrease the cost of SOC Not surpassing budget, easy access to treatment, There would be no need for spinal infusions with ERT since this drug will be given intravenous once for children and twice for adults, if drug fails to work there will be reimbursement for costs for the patient Currently on the market for annually $340,000 for one child (25 kg body weight) where Insurance (Medicare/private insurance/ pharma company’s patient payment plan) will cover for in-patient expenses (or out-patient expenses), instead of therapy. Patients need more support from societal organizations. Patient/Economic Outcomes EXECUTIVE SUMMARY ● HuntMed is a new and upcoming biopharmaceutical company that is focused on creating a new and improved treatment plan for Hunter’s Disease and improving the financial burden on patients and their families. ● HuntMed’s goal is to give the patient as close to “normal” life as possible with our drug, Huntresolve. ● Huntresolve is administered by intravenous method and results are expected to be seen within 2 months. ● We are currently based in North America, but plan to go globally when we launch in phase 3. We will become accessible to patients on a global level and be affordable to patients while giving the best treatments. ● Currently in phase 3, we are ready to launch and are projected to boom into a billion dollar product with the ideal patients in mind. PRODUCT COMPETITIVE ASSESSMENT ● Our mRNA based medication is priced accordingly with the research being done and its effectiveness in patients with Hunter’s disease from mild to severe cases. ● Takeda, the manufacturer for Elaprase, is the current enzyme therapy being used for Hunter’s Disease. It is the last dynamic treatment to come out in 2006, our medicine will be the next breakthrough in Hunter’s Disease with its administration and time to show results. ● Elaprase is administered by intravenous infusion and is given at 0.5 mg per kg of body weight once a week, Huntresolve will only have to be given twice annually, depending on age and severity, and outpatient. ● Currently, Takeda’s revenue is at 3.198 trillion USD, Elaprase brought in an estimated 73.1 billion USD in March of 2022. Our company is set to revenue at 120 million in its first year with Huntresolve launch and revenue of 1.3 trillion dollars in 2024 with our first launch. ● On a global share, MPS has a higher marketing share in the Asia Pacific region compared to the others. There are the following companies who are the top in research for mucopolysaccharidosis treatment: BioMarin, Sangamo and Lysogen. ● The key pipeline products in the market for Hunter’s Disease is Iduronate 2 Sulfatase, the enzyme affected by this disease. Competitors are currently selling their drugs at a higher price point and frequent administrations compared to our affordability and access with Huntresolve. UNMET NEED BUSINESS DESCRIPTION TIMELINE AND REVENUES CORPORATE GOVERNANCE RISKS FUNDING REASONS TO INVEST ● REVENUE SET TO MAKE 120 million at launch. Projected to make 1.32 trillion dollars in 2025. ● Administration for patients is less frequent, higher safety protocols, improved quality of life and outpatient care offered. ● mRNA based treatment proven to be efficient compared to current intravenous infusion treatments. ● mRNA is safer since does not contain any live viruses being administered to patients during treatments ● mRNA product can be quickly designed and mass produced REFERENCES HUNTMED BPMK 500 Group #3 Executive Summary HuntMed is a new and upcoming biopharmaceutical company that is focused on creating a new and improved treatment plan for Hunter’s Disease and improving the financial burden on patients and their families. We are focused on new mRNA intravenous infusion therapy to prevent the progression of Hunter’s Disease once diagnosed. Our treatment is better than any others on the market currently because it will be administered less and efficiently. We focus on the patient’s safety and quality of life which is why our treatment is offered to be administered as an outpatient. HuntMed’s goal is to give the patient as close to “normal” life as possible with our drug, Huntresolve. Our ideal patient is from the onset diagnoses of 2 years and older and to stop the progression. One dose of our medication is administered for children under the age of 10 years old. Adults from the age of 18 to 28 are given two doses. Huntresolve is administered by intravenous method and results are expected to be seen within 2 months. Hunter’s disease research is currently focused on enzyme therapy, which is about $400,000 per patient annually. This is an expensive treatment compared to our iv administered medicine that will lower the financial burden on patients and help maintain a quality of life. We are currently based in North America, but plan to go globally when we launch in phase 3. We will become accessible to patients on a global level and be affordable to patients while giving the best treatments. We are a company who is aiming to change this million dollar market and create a solution for patients suffering from Hunter’s Disease. Since we are based in the United States currently, our medicine uses the best drugs available in the market. We are able to produce in large amounts and with our marketing team be able to sell our product in multiple hospitals in the region. Currently in phase 3, we are ready to launch and are projected to boom into a billion dollar product with the ideal patients in mind. Company HuntMed is aimed at providing the best treatment and quality of life with Huntresolve. We are focused on the patient’s well-being and providing them with medication that is affordable. Our research team has been effective in prioritizing safety in administration of our product and in efficacy. Other medications on the market currently are not affordable or accessible to other countries and are not as effective. They only focus on slowing progression rather than stopping the disease from worsening. The ethos within our company is to make sure the drug is safe and efficient for our patients of all ideal ages. All of our research and development has been done in the United States with full FDA approval and launching phase 3. Each process has been overseen and followed-through with efficiency and precautions. We believe in families having a peace of mind with their children on this medication. Our researchers are the best in the country and are recruited from prestigious universities or higher education from other countries. Huntresolve is mRNA intravenous infusion therapy that is administered in fewer doses than Elaprase, which is currently on the market. Currently mRNA is used in COVID-19 vaccines and in vaccines for other diseases, such as SARS and MERS. mRNA is a powerful immunotherapy form used in cancer treatments for its high potency and low cost manufacturing. We are focused on making sure the mRNA produced in our labs meet all requirements needed for a high quality product and to perform the minimum results consistently. We work in only the highest sterile labs that keep contamination obsolete and are animal origin-free during all our manufacturing and testing. Our quality control is performed under vigorous standards to make sure every step is done correctly and documented. Competitive Assessment Our mRNA based medication is priced accordingly with the research being done and its effectiveness in patients with Hunter’s disease from mild to severe cases. The research for a treatment for Hunter’s Disease is a rapidly growing market and has grown significantly in the past decade and is projected to keep growing. Our technology is able to keep us on par with phase 3 launch compared to other companies in phase 1 and 2. Takeda, the manufacturer for Elaprase, is the current enzyme therapy being used for Hunter’s Disease. It is the last dynamic treatment to come out in 2006, our medicine will be the next breakthrough in Hunter’s Disease with its administration and time to show results. Our medicine with mRNA makes it an advancement as a protein-replacement medicine. Elaprase results are shown to improve walking in patients that are older than 5, but no improvement for patients that are younger than 5. Our therapy given to older than 5 year olds will improve overall neurological function and not just walking. Elaprase is administered by intravenous infusion and is given at 0.5 mg per kg of body weight once a week, Huntresolve will only have to be given twice annually, depending on age and severity, and outpatient. Currently, Takeda’s revenue is at 3.198 trillion USD, Elaprase brought in an estimated 73.1 billion USD in March of 2022 (Takeda Securities Report). Our company is set to revenue at 120 million in its first year with Huntresolve launch and revenue of 1.3 trillion dollars in 2024 with our first launch. On a global share, MPS has a higher marketing share in the Asia Pacific region compared to the others. There are the following companies who are the top in research for mucopolysaccharidosis treatment: BioMarin, Sangamo and Lysogen. No one else has had a therapeutic drug come out since Elaprase. Currently, there is research being done on slowing the progression of Hunter’s Disease once diagnosed since there is no way to prevent it since it is genetic. Elaprase is aiding in walking after the age of 5 and given on a weekly basis. Other treatments are helping in managing the disease and slowing the progression but not improving currency symptoms. Huntresolve helps in improving current symptoms and in stopping the progression of the disease indefinitely. It is not a cure, but it will elongate a patient’s life and improve quality of life compared to current competition. The key pipeline products in the market for Hunter’s Disease is Iduronate 2 Sulfatase, the enzyme affected by this disease. Competitors are currently selling their drugs at a higher price point and frequent administrations compared to our affordability and access with Huntresolve. Unmet Need Hunter’s Disease, a hereditary condition characterized by significant impairment, has been a prominent subject of scientific investigation over an extended period of time. Despite the notable progress made in the field of medical science, the current therapy paradigm for this particular ailment continues to be fraught with many obstacles, hence compelling patients and their families to persistently seek more effective remedies. The existing therapeutic interventions for Hunter’s Disease, although initially innovative, now exhibit notable deficiencies. Elaprase, a prominent therapeutic intervention, has emerged as a source of optimism for numerous individuals. Nevertheless, the exorbitant expense associated with this treatment has rendered it an unattainable aspiration for numerous patients, particularly those residing in nations without medical insurance coverage for such interventions or where the medication has not yet obtained regulatory endorsement. The limited efficacy of the treatment is attributed to its failure to traverse the blood-brain barrier, resulting in a lack of substantial mitigation of the neurological manifestations associated with the disease. The presence of this gap is of utmost importance, given that the neurological ramifications of Hunter’s Disease can be equally, if not more, incapacitating than the physical manifestations. Hunterase, an alternative therapeutic approach, presents a distinct set of obstacles despite its comparatively lower cost in comparison to Elaprase(Elaprase Prices, Coupons, and Patient Assistance Programs). The restricted acceptance of this treatment in many nations results in a significant number of patients being unable to obtain this potentially transformative therapy. The discrepancies in drug approval processes on a global scale and the complexities surrounding pharmaceutical patents frequently result in patients facing difficulties, as their access to therapy is contingent upon their geographical location. Despite its seeming promise, enzyme replacement therapy (ERT) is not without its drawbacks. Patients must undergo invasive and psychologically draining spinal infusions once a week as part of the treatment. Facing an unpleasant treatment repeatedly can be intimidating. And in countries where healthcare is primarily paid for by individuals, the annual cost of around $500,000 makes it out of reach for the great majority. Emerging therapeutic modalities, such as gene therapy, exhibit considerable potential; nonetheless, they are not without their inherent complexities and obstacles. With an estimated cost ranging from $1 million to $2 million per dose, this treatment stands out as one of the most costly interventions in the field of medicine. Although the procedure may provide long-term advantages, its exorbitant cost renders it unavailable to the majority of individuals. Against this contextual backdrop of many obstacles, it is evident that the market for treatments of Hunter’s illness has experienced significant growth over the last decade, signifying an escalating need for improved and more efficient solutions. HuntMed’s suggested mRNA intravenous infusion therapy is a significant intervention in this context. The therapy, now in its early developmental phase, holds the potential to significantly transform the treatment paradigm for Hunter’s Disease. Due to its capacity to effectively target both the physical manifestations and neurological aspects of the ailment, this intervention emerges as a leading contender in the pursuit of a holistic remedy. Furthermore, the architecture of the medication, which necessitates infrequent dosing and provides a less invasive route of administration, represents a noteworthy advancement compared to current treatment options. The unmet needs within the therapeutic domain for Hunter’s Disease is characterized by various dimensions. There is a pressing demand among patients for a solution that not only comprehensively addresses the complete range of symptoms associated with the disease, but is also universally accessible, economically feasible, and accompanied by minimal adverse effects. Patients face numerous challenges on a daily basis, including frequent hospital visits, the physical and mental distress caused by intrusive procedures, and the financial strain imposed by conventional therapies. The novel methodology of HuntMed’s mRNA therapy holds the potential to fill the existing gap. The company is providing with a treatment that is not only effective but holds greater efficacy and provides with the opportunity to shift the discourse that is prevailing around the Hunters disease. The narrative surrounding hunter disease will be transformed from despair to hope and recovery. Business description The HuntMed stands firm as an emerging organization at the forefront of biopharmaceutical innovation which has dedicated its work towards the treatment landscape for the Hunter disease. The company has embarked on a journey to provide a solution for the people in need for a solution for dealing with debilitating genetic disorders thus discovered to fill the gaps in the system. HuntMed is an organization that is focusing on different problems in the market, the existing medicine despite being beneficial are highly priced, invasive or ineffective. Thus the company is addressing the full spectrum of the disease symptoms. The current gaps in the global system further present challenges for the patients. The gaps are filled by our mRNA therapy that offers an effective solution that is also potentially more affordable. HuntMed’s unique selling proposition is quite clear, the company provides a holistic treatment for Hunter’s disease that delivers on the promises of effectiveness, affordability, and patient comfort. When compared to other therapies on the market, our mRNA therapy is a shining example of comprehensive care. The company is providing more than just a medication; it is providing hope, promise, and a future free from the constraints of Hunter’s disease. Recognising the continuous nature of innovation, HuntMed has created a comprehensive strategy for allocating resources towards life-cycle management endeavors. The focal point of the organization lies in research and development, where the organization consistently allocates resources towards enhancing the mRNA therapy and guaranteeing its safety and effectiveness. The organization is dedicated to enhancing market accessibility, with the objective of assuring widespread availability of our medicine, even in the most geographically remote areas globally. Partnerships with patient support organizations, such as the National MPS Society and Hunter Syndrome Research Foundation, are also being considered, in order to guarantee that patients and careers are provided with full support. HuntMed aims to establish itself as the foremost provider of therapeutic interventions for Hunter’s Disease, not only in terms of commercial dominance but also in terms of its profound influence on the field. The objective is to positively impact individuals, alter prevailing narratives, and provide optimism in situations previously characterized by hopelessness. While the primary objective remains steadfast, that is to bring about a transformative shift in the treatment paradigm for Hunter’s Disease, guaranteeing equitable access to optimal healthcare for all patients, regardless of their geographic location or financial circumstances. The company is not just a biopharmaceutical but a movement that would change the current practices in the market and redefine the ways in which the hunter disease is being treated. Funding To successfully launch HuntMed and bring Huntresolve to market as a treatment for Hunter’s Disease, we will need substantial funding to cover various aspects of the company’s operations, including research and development, clinical trials, manufacturing, marketing, and distribution. Research and Development (R&D): HuntMed will allocate $50 million for critical research and development efforts. This includes further research into mRNA therapy for Hunter’s Disease, refinement of Huntresolve’s formulation and production process, conducting preclinical studies to gather additional safety and efficacy data, and hiring and retaining a skilled R&D team. Clinical Trials: A substantial $90 million will be arranged for conducting comprehensive clinical trials to ensure the safety and effectiveness of Huntresolve. These funds will cover expenses related to patient recruitment, rigorous monitoring, and further data analysis. Additionally, this allocation will ensure compliance with all FDA regulations and requirements, which are crucial for gaining approval to guarantee the final launch of Huntresolve. Manufacturing Facilities: To ensure the high-quality production of Huntresolve, $30 million will be invested in state-of-the-art manufacturing facilities. These facilities will be equipped to meet anticipated demand, adhere to strict quality control standards, and maintain compliance with Good Manufacturing Practices (GMP). Regulatory Approval: An allocation of $20 million will support the regulatory approval process, including the submission and approval processes with the FDA. It will also include engaging with regulatory consultants and experts and conducting any additional studies or trials as requested by regulatory agencies to ensure compliance. Marketing and Distribution: A budget of $50 million will be dedicated to developing a comprehensive marketing strategy to raise awareness of target patients on Huntresolve. These funds will also facilitate the creation of robust sales and the establishment of a distribution network to reach patients in the United States and globally. Partnerships with healthcare providers, hospitals, and clinics will be established to ensure accessibility. Global Expansion: To expand HuntMed’s reach beyond North America, $30 million will be utilized for global expansion efforts. This includes planning and executing international operations, obtaining regulatory approvals in target countries, and establishing distribution channels and partnerships with foreign healthcare providers. Administrative and Operational Costs: An allocation of $20 million will cover administrative expenses, including salaries, office space, and utilities. Additionally, these funds will be used to invest in information technology infrastructure and software systems, ensuring efficient operations and regulatory compliance. Contingency and Risk Management: To address unforeseen challenges or risks, $10 million will be set aside in a contingency fund. This allocation will be crucial for mitigating risks associated with clinical trial delays, potential regulatory barriers, or future market competition. In total, HuntMed plans to set $300 million in funding to support these essential initiatives. It’s important to note that these figures may be subject to adjustments based on the practical needs and circumstances of the company, as well as opportunities that may arise during the development and launch of Huntresolve. A combination of funding sources, including venture capital, sponsorships, partnerships, and potential future public offerings, will be explored to secure the necessary capital. This comprehensive funding plan ensures that HuntMed can achieve its mission of providing an accessible and effective treatment for Hunter’s Disease patients.
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College of Health Sciences Department of Public Health PHC374-ASSIGNMENT Course name: ORAL HEALTH PROMOTION Course number: PHC374 CRN Preventing Dental Caries in Early Childhood: EvidenceBased Strategies. Preventing Dental Caries in Early Childhood: EvidenceBased Strategies Dental caries, commonly known as tooth decay, is a prevalent oral health issue among infants and young children. Early childhood caries (ECC) can have significant consequences for a child’s oral and overall health. In this paper, you will explore evidence-based strategies for preventing dental caries in infants and young children through education and intervention. • What is early childhood caries (ECC), and why is it a significant concern for infants and young children? • How does oral health education play a pivotal role in preventing dental caries in infants and young children? • Describe evidence-based educational approaches, including parent and caregiver education, and their effectiveness. • Briefly touch upon community-based programs that promote oral health education and provide dental care to infants and young children. Student name: Students Id Number: Submission date: Instructor name: Grade: /10 College of Health Sciences Department of Public Health Guidelines: • Your response should be a minimum of 400 words but should not exceed 500 words. • Font should be 12 Times New Roman • Heading should be Bold • Colour should be Black • Line spacing should be 1.5 • Use proper references in APA style • AVOID PLAGIARISM • Due date: Nov 11, 2023 @ 11:59 PM
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