Hunter’s DiseaseWhat is Hunter’s Disease?
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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
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What Does Hunter’s Disease
Look Like?
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Genetically associated with lysosomal storage disorder
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The build-up in sugars causes damage that affects physical and mental development in
affected individuals
Affects the nervous system
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This is because of deficiency in IDS
X-Linked recessive disorder
Mostly males
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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
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Diagnosis and Treatment
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Urinary Glycosaminoglycan (GAG) Testing
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Patients with severe form of Hunter’s disease have cognitive impairment and typically die
10-12 years old.
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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
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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
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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.
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Primary Market Research
RN Nurse Instructors at Cypress College
Focus group of 8 nurses
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5 out of 8 nurses have heard about Hunter’s Disease
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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
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Secondary Market Research
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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
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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%
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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
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Societal, Humanistic, Economic Burden
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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.
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Impact on Quality of Life & Employment
Quality of Life:
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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:
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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.
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Treating Physician/
Specialists
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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
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Standard of Care
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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.
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Estimated Costs
Enzyme Replacement Therapy (ERT):
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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:
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Cost: Initial costs can exceed $100,000 (costs can vary widely depending on location, complications, and follow-up care
requirements)
Associated Costs:
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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).
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Measurements of GAG Levels
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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
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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).
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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.
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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).
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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
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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/
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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
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References
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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
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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
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Indication:
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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:
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■
■
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:
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■
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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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