Therapeutic Class Report: Oral Mucositis
Oral Mucositis (OM) is a complication of aggressive chemotherapy and radiotherapy treatments in Head and neck cancer, Hematopoietic stem cell transplantation (HSCT) and multiple chemotherapies. Severe form of OM causes odynophagia and/or dysphagia leading to difficulty in eating/swallowing and can increase the cost of total cancer therapy. While the mechanism of OM is well established, there are very few targeted drugs or therapeutic options available to the patient. Untreated it can be life threatening (sepsis) and Palliative care offer temporary relief. Novel therapies could lead to a cut in this major cost burden along with improving the quality of life. There is a grave need for systematic management of oral mucositis triggered by anti-neoplastic protocols. Several products are marketed as palliative care for management of the OM that include anti-oxidant, anti-inflammatory agents, cryotherapy, oral rinse and ointments. However, there is high unmet medical need for systemic interventions.
Currently, ~800,000 worldwide patients per year suffer from mucositis during cancer therapy and the incidence is increasing. ~80-100% of Head and Neck cancer patients develop Ulcerative OM. The incidence of oral cancer in Asia, especially in India and China, is very high due to the lifestyle and tobacco consumption. Only drug Amgen/SOBI’s Kepivance (palifermin) is approved for oral mucositis in transplantation; but is contra-indicated for solid tumor patients. The safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies. Considering all these factors we expect the market to grow manifold from the existing ~$200mln (palliative and mouth wash) to $5,000mln in the next ~ten years. Mid-size and small companies are targeting this opportunity through in-house pipeline offers a good opportunity for In-licensing or M&A.
In the report, we have highlighted novel mechanism/targets which have obtained Fast Track designation from FDA and have advanced in the clinical trials. The report also indicates Drivers of M&A/Licensing Deals and Key Markets' potential.
RESEARCH METHODOLOGY
Research methodology is based on in-depth research and market study, scientific journals or technical literature, industry publications, company reports and published information, and statistical data from government agencies and other therapy foundation or associations. Forecasts and projections of market size and future market activity are derived using standard modelling and statistical techniques.
AUTHOR BIO
Sanjeev Mishra
ProGrow Pharma (PGP) Partners caters the full spectrum of services to Pharma companies (Pharma/Biotech, Generic, CRAMS, CROs, Start-ups) and its Investors (Private Equity, Fund Managers, HNI). With decades of experience in strategic advisory, regulatory aspects, technical publications, understanding complex drugs, identifying market potential and all related services, the team is widely approached by pharmaceutical companies and experts. Our team can support you from defining strategic programmes to providing expert guidance for tactical operations to transform your operational or market based challenges into growth aligned opportunities.
Currently, ~800,000 worldwide patients per year suffer from mucositis during cancer therapy and the incidence is increasing. ~80-100% of Head and Neck cancer patients develop Ulcerative OM. The incidence of oral cancer in Asia, especially in India and China, is very high due to the lifestyle and tobacco consumption. Only drug Amgen/SOBI’s Kepivance (palifermin) is approved for oral mucositis in transplantation; but is contra-indicated for solid tumor patients. The safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies. Considering all these factors we expect the market to grow manifold from the existing ~$200mln (palliative and mouth wash) to $5,000mln in the next ~ten years. Mid-size and small companies are targeting this opportunity through in-house pipeline offers a good opportunity for In-licensing or M&A.
In the report, we have highlighted novel mechanism/targets which have obtained Fast Track designation from FDA and have advanced in the clinical trials. The report also indicates Drivers of M&A/Licensing Deals and Key Markets' potential.
RESEARCH METHODOLOGY
Research methodology is based on in-depth research and market study, scientific journals or technical literature, industry publications, company reports and published information, and statistical data from government agencies and other therapy foundation or associations. Forecasts and projections of market size and future market activity are derived using standard modelling and statistical techniques.
AUTHOR BIO
Sanjeev Mishra
ProGrow Pharma (PGP) Partners caters the full spectrum of services to Pharma companies (Pharma/Biotech, Generic, CRAMS, CROs, Start-ups) and its Investors (Private Equity, Fund Managers, HNI). With decades of experience in strategic advisory, regulatory aspects, technical publications, understanding complex drugs, identifying market potential and all related services, the team is widely approached by pharmaceutical companies and experts. Our team can support you from defining strategic programmes to providing expert guidance for tactical operations to transform your operational or market based challenges into growth aligned opportunities.
1. EXECUTIVE SUMMARY
Unmet Need
Market Opportunity in Various Geographies
Limited Treatment Alternatives and Drugs in the Pipeline
Drivers of M&A/Licensing Deals
2. DISEASE OVERVIEW
Management of Oral Mucositis Falls into Two Main Categories
Market Potential
Key Growth Drivers
Current Market & Unmet Medical Need
Challenges in Developing Drugs for Oral Mucositis
Etiology, Pathogenesis, Diagnosis, Prevention and Current Treatment
3. COMPANIES DEVELOPING NOVEL DRUGS FOR ORAL MUCOSITIS
1. SGX942 (Soligenix)
2. GC4419 (Galera therapeutics)
3. Brilacidin (Innovation Pharmaceuticals)
4. SP13004 (Spherium Biomed)
5. Validive (Onxeo)
6. AG103 (Oragenics/Intrexon)
7. Easyef (Daewoong pharmaceuticals)
8. 0.25% EISO mouth rinse (Santalis pharmaceuticals)
9. IZN-6N4 (Izun pharma corp)
10. Dentoxol (Ingalfarma SpA)
4. MARKET MODEL – US
5. MARKET MODEL – EU (TOP 5 COUNTRIES)
6. MARKET MODEL – INDIA
7. KEY MARKETS’ POTENTIAL (US + EU - TOP 5 COUNTRIES + INDIA + ROW)
Unmet Need
Market Opportunity in Various Geographies
Limited Treatment Alternatives and Drugs in the Pipeline
Drivers of M&A/Licensing Deals
2. DISEASE OVERVIEW
Management of Oral Mucositis Falls into Two Main Categories
Market Potential
Key Growth Drivers
Current Market & Unmet Medical Need
Challenges in Developing Drugs for Oral Mucositis
Etiology, Pathogenesis, Diagnosis, Prevention and Current Treatment
3. COMPANIES DEVELOPING NOVEL DRUGS FOR ORAL MUCOSITIS
1. SGX942 (Soligenix)
2. GC4419 (Galera therapeutics)
3. Brilacidin (Innovation Pharmaceuticals)
4. SP13004 (Spherium Biomed)
5. Validive (Onxeo)
6. AG103 (Oragenics/Intrexon)
7. Easyef (Daewoong pharmaceuticals)
8. 0.25% EISO mouth rinse (Santalis pharmaceuticals)
9. IZN-6N4 (Izun pharma corp)
10. Dentoxol (Ingalfarma SpA)
4. MARKET MODEL – US
5. MARKET MODEL – EU (TOP 5 COUNTRIES)
6. MARKET MODEL – INDIA
7. KEY MARKETS’ POTENTIAL (US + EU - TOP 5 COUNTRIES + INDIA + ROW)
LIST OF TABLES
Table 1 Key Drugs in Pipeline
Table 2 Select Deals in Field of Oral Mucositis
Table 3 Ongoing Clinical Trials in Oral Mucositis
Table 4 Therapy and Related Occurrence of Oral Mucositis
Table 5 Failed/Discontinued Drugs
Table 6 Current Treatment Options
Table 7 Approved Drugs and Limitations
Table 8 Market Model – US
Table 9 Market Model – EU (Top 5 Countries)
Table 10 Market Model – India
Table 1 Key Drugs in Pipeline
Table 2 Select Deals in Field of Oral Mucositis
Table 3 Ongoing Clinical Trials in Oral Mucositis
Table 4 Therapy and Related Occurrence of Oral Mucositis
Table 5 Failed/Discontinued Drugs
Table 6 Current Treatment Options
Table 7 Approved Drugs and Limitations
Table 8 Market Model – US
Table 9 Market Model – EU (Top 5 Countries)
Table 10 Market Model – India
LIST OF FIGURES
Figure 1 Anti-Cancer Agents Treatment and Incidence of Severe OM (WHO Scale Grade 3-4)
Figure 2 Head and Neck Cancer Incidence Across the World
Figure 3 Current Model of OM Patho-biogenesis
Figure 4 – 5 SGX942 - Data from Phase 2 study
Figure 6 Innate Regulatory System
Figure 7 SOD and Catalase MOA
Figure 8 – 9 Brilacidin – Pre-Clinical Study Results
Figure 10 Host-Defence Mimetic
Figure 11 Phase 1 clinical evaluation with respect to the markers
Figure 12 – 13 Validive – Pre-Clinical Study Results
Figure 14 Morbidity Rate Compared to Radiation Therapy Oncology Group Morbidity Scale
Figure 15 EASYEF – Pre-Clinical Study Results
COMPANIES MENTIONED FORMATS
Soligenix
Galera therapeutics
Innovation Pharmaceuticals
Spherium Biomed
Onxeo
Oragenics
Intrexon
Daewoong pharmaceuticals
Santalis pharmaceuticals
Izun pharma corp
Ingalfarma SpA
Amgen
SOBI Biopharma
Daewoong Pharma
Otsuka pharma
Figure 1 Anti-Cancer Agents Treatment and Incidence of Severe OM (WHO Scale Grade 3-4)
Figure 2 Head and Neck Cancer Incidence Across the World
Figure 3 Current Model of OM Patho-biogenesis
Figure 4 – 5 SGX942 - Data from Phase 2 study
Figure 6 Innate Regulatory System
Figure 7 SOD and Catalase MOA
Figure 8 – 9 Brilacidin – Pre-Clinical Study Results
Figure 10 Host-Defence Mimetic
Figure 11 Phase 1 clinical evaluation with respect to the markers
Figure 12 – 13 Validive – Pre-Clinical Study Results
Figure 14 Morbidity Rate Compared to Radiation Therapy Oncology Group Morbidity Scale
Figure 15 EASYEF – Pre-Clinical Study Results
COMPANIES MENTIONED FORMATS
Soligenix
Galera therapeutics
Innovation Pharmaceuticals
Spherium Biomed
Onxeo
Oragenics
Intrexon
Daewoong pharmaceuticals
Santalis pharmaceuticals
Izun pharma corp
Ingalfarma SpA
Amgen
SOBI Biopharma
Daewoong Pharma
Otsuka pharma
