Arias Pharmaceuticals: A Case Study
In recent years, there has been an expansion of product development activities for colorectal cancer through a number of new public-private partnerships (PPPs). However, there is a lack of credible drug leads to feed the development pipeline of these PPPs and there is a great need for new drug discovery initiatives to produce such leads. There is a need to go beyond lead discovery and identify drug candidates that can be further developed.
Pharmaceutical companies often have relevant compounds that have not been assessed for their potential to treat colorectal cancer. The overall objective for this company, Arias Pharmaceuticals, is to help and support the discovery of new drug leads for colorectal cancer through networks and partnerships between pharmaceutical companies as well as academia. Specifically, the …show more content…
objective of Arias Pharmaceuticals is the identification of quality drug leads for colorectal cancer and the facilitation of the transfer of those leads to PPPs, industry, and other innovative partnerships for further development.
The discovery of quality drug leads against colorectal cancer will involve the establishment of a portfolio of prioritized targets, progressing validated targets through high throughput screening, in vitro and in vivo screening through the Arias Pharmaceuticals compound assessment and pharmacological networks, as well as iterative medicinal chemistry and exploratory toxicology on promising leads.
The primary objective of Arias Pharmaceuticals is to deliver new treatments by 2026 for colorectal cancer as well as to establish a strong R&D portfolio that addresses patient needs for treatment. Utilizing R&D networks, Arias Pharmaceuticals aims to bring medical innovation to the patients by developing:
- New drugs from novel compounds identified through screening and lead optimization
- Reformulations and combinations better adapted to field conditions (pediatric, long-acting, new route of administration, fixed-dose combinations, co-packaging, or co-administration);
- Existing drugs for target diseases (geographical extension of registration; completion of regulatory profiles of existing drug candidates).
Within 10 years, it is expected that there will
be:
- At least 10 leads discovered by 2026
- Open access database of drug targets by 2018
- 2 possible drug candidates for colorectal identified by 2022
- Coordinated drug discovery strategy, based on networks and partnership
- Open access high-impact publications and standard operating procedures for lead discovery
The Technology and Product
Colorectal cancer is cancer that starts in the colon or rectum, which are are parts of the large intestine, and the lower part of the body’s digestive system (1). Most colorectal cancers are adenocarcinomas, which are cancers that begin in cells that make and release mucus and other fluids (1). Colorectal cancer often begins as a growth called a polyp, which may form on the inner wall of the colon or rectum and some of these polyps become cancer over time (1). Because colorectal cancer is considered one of the major contributors to cancer death and illness, the researchers at Arias Pharmaceuticals, as well as many other pharmaceutical companies, have studied it extensively and tried to find potential ways to combat it.
At Arias Pharmaceuticals, we believe that we have found a possible drug target for the treatment of colorectal cancer. Because kinases are proteins on or near the surface of a cell that transmit important signals to the cell’s control center, blocking these proteins can help stop the growth of cancer cells. Also, kinase inhibitors are capable of doing that and can be useful in the treatment of colon adenosarcoma. PRKACB has been identified as a kinase inhibitor that will be a very good potential target for drug therapies in the treatment of colorectal cancer. The location of PRKACB is in the cell membrane, which means it is close to the surface and can be easily targeted by a drug. It is also found in the nucleus of the cell. If the nucleus, the “brain” of the cell, can be targeted by treatment, this would be the most ideal because without the brain, the cell would not be able to function. Treating the cancer this way can stop the proliferation of these cells from the beginning. Without the brain, there are no signaling pathways available and thus the cell cannot multiply and ultimately spread the cancer.
Summary of Patent Search
What is the IP (intellectual properties) status? Is it patentable? Do you have freedom to operate? How about licenses, do you need patents from other parties?
Provide the key words and IPC codes of you patent search. Patents: The used search terms match with the product properties, production and application strategy, the search codes correspond to the search strategy and valid conclusions are drawn from the found patent database entries with respect to your own strategy
For the patent search, the term “PRKACB” was used. On Google Patents, two patents were found which were then searched on Espacenet for a more complete profile. The IPC codes for the two patents are C12N15/113, A61K38/00, (IPC1-7): A61Band, and G06F19/20, G06F19/24. The first patent is titled “Method of Killing Cancer Cells” and the second “Use of Gene Signatures to Design Novel Cancer Treatment Regimens.”
In both patents, PRKACB is mentioned as a possible target for the treatment of cancer. Because it does not specify neither a formulation nor that is can be used specifically for colorectal cancer, a new patent can be issued. However, the original publishers of the patent would require either the buying of the rights or conclude licensing contracts. Also, because PRKACB will be used in experimental applications, the patent can be held off until it is decided to begin marketing for commercial use.
For the target product profile, there are various things to keep in mind. These are drug-related, product-related, legal-related, and manufacture related. The drug- and product-related attributes will be determined during the preclinical trial. These are the indication, route of administration, dose range, dos frequency, expected duration of treatment, infusion or injection rate/duration, volume per doe, drug concentration, pharmacokinetic profile, drug products that may be mixed or co-infused with the products, pH, toxicity, excipients compendial, low levels of endotoxin, the need to dilute/reconstitute with what, single or multiuse container, packaging type, storage conditions, shelf-life, and shipping requirements. The legal-related attributes include freedom to operate and if the product is intellectual property, discussed above. The manufacturing-related attributes are described below. These include the costs of goods sold, equipment needed for manufacture, and product processing time. Once the PRKACB target has undergone preclinical testing, the exact attributes to fulfill the target product profile can be more completely understood and demonstrated. The quality will be that of industry standards for all attributes considered and the quantity will be based on the market value of the target.
The Market
Based on data collected in 2012, approximately 4.5 percent of men and women will be diagnosed with colon and rectal cancer at some point during their lifetime and an estimated 1,168,929 people were living with colon and rectum cancer in the United States (7). It is the third leading cause of cancer-related deaths in the United States for both men and women (2). The American Cancer Society estimates 143,460 new colon and rectal cancer cases were diagnosed in 2012, and approximately 51,690 people died from colorectal cancers, which accounts for about 9 percent of all cancer deaths (2). Colorectal cancer screening tests, however, can find polyps before they turn into cancer. Screening tests can also find colorectal cancer early, which is when treatment works best and the chances for a full recovery is very high (2). Screening programs and prevention efforts by state colorectal cancer control programs have reduced mortality rates in recent years, with funding from the Centers for Disease Control and Prevention in 2009 (2). These cancer control programs have funding to provide colorectal cancer screening and follow-up care to low-income men and women aged 50 to 64 who are either underinsured or uninsured for screening, or when no other payment option is available (2).
In 2007, the estimated average cost for each cancer episode was between $35,000 and $80,000 (8). When the cancer is found early, the cost is about $30,000 per patient, while when found late, the cost is $120,000 per patient (8). The total cost for treatment for anticipated new cases is about $8.3 billion (8).
Colorectal Cancer Therapeutics in Major Developed Markets states that the Colorectal Cancer treatment market value will increase at a moderate Compound Annual Growth Rate of to $9.4 billion by 2020 (3). The growth, however, will be slow due to market saturation and patent expiries of the key brands (6). The marketed colorectal cancer products landscape comprises a wide range of treatment options. These treatment options include targeted therapies, such as Avastin and Zaltrap, immunotherapies, and chemotherapies (3). The key brands will likely be the main competitors for the drug target.
From 2014 to 2019, it is thought that sales for Avastin will go from $3151 million to $3536 million and from 2019 to 2023, from $3536 million to $2513 million (6). The lower market forecast between 2019 to 2023 will be due to patent expiry and bio-similar competition from 2019 (6). The launches of the bio-similar drugs in 2019 will cause a decrease in growth for the two branded drugs, Avastin and Erbitux (6). Also, three pipeline drugs that will be used as second- and third-line treatments will be launched during the 2019-2023 period, which will also affect the revenues for the branded drugs (6). Because the branded drugs will have expiring patents, after 2023 is the perfect time in which the PRKACB target can be launched. There will be more than enough time from now until then for the successful testing of the target as well as the appropriate market for it.
With the creation and acceptance of New Drug Application (NDA), the target can then enter the market. The NDA would include the efficacy of the drug, the package insert, and the guarantee that it was manufactured in a GMP site.
Financials Background
In a 2007 analysis by PHRMA, it was determined that “preclinical stages” include the Discovery Stages and the Preclinical Development stage, which is almost as much as the money spent on large Phase 3 clinical trials. The Phase 3 costs are a function of “out of pocket” expenses, capital investment, stage length, attrition and numbers of projects per stage. The numbers for 2007 are shown below and have been adjusted for the inflation rate of 2016 to estimate the costs of testing and marketing PRKACB.
To fund all these future endeavors, there are many grants available for innovative new drug molecules, such as Grants4Leads, which is a subsidy of Bayer. Submissions can be made in July and through them, the funding necessary for this promising lead can be acquired. Another way to pay for this venture is to team up with either another small pharmaceutical company or a larger company, like Bayer or Pfizer.
Conclusion
The market need for a drug for one of the highest mortality rate cancers is ever increasing. With the expiry of the brand name drugs coming within the next 5 years, newer, more viable options are necessary. This can be accomplished through Arias Pharmaceuticals with the development of a drug for PRKACB. Through grants and possible contracts with other companies, the target can be formulated and marketed by 2026.
Pharmaceutical companies often have relevant compounds that have not been assessed for their potential to treat colorectal cancer. The overall objective for this company, Arias Pharmaceuticals, is to help and support the discovery of new drug leads for colorectal cancer through networks and partnerships between pharmaceutical companies as well as academia. Specifically, the …show more content…
objective of Arias Pharmaceuticals is the identification of quality drug leads for colorectal cancer and the facilitation of the transfer of those leads to PPPs, industry, and other innovative partnerships for further development.
The discovery of quality drug leads against colorectal cancer will involve the establishment of a portfolio of prioritized targets, progressing validated targets through high throughput screening, in vitro and in vivo screening through the Arias Pharmaceuticals compound assessment and pharmacological networks, as well as iterative medicinal chemistry and exploratory toxicology on promising leads.
The primary objective of Arias Pharmaceuticals is to deliver new treatments by 2026 for colorectal cancer as well as to establish a strong R&D portfolio that addresses patient needs for treatment. Utilizing R&D networks, Arias Pharmaceuticals aims to bring medical innovation to the patients by developing:
- New drugs from novel compounds identified through screening and lead optimization
- Reformulations and combinations better adapted to field conditions (pediatric, long-acting, new route of administration, fixed-dose combinations, co-packaging, or co-administration);
- Existing drugs for target diseases (geographical extension of registration; completion of regulatory profiles of existing drug candidates).
Within 10 years, it is expected that there will
be:
- At least 10 leads discovered by 2026
- Open access database of drug targets by 2018
- 2 possible drug candidates for colorectal identified by 2022
- Coordinated drug discovery strategy, based on networks and partnership
- Open access high-impact publications and standard operating procedures for lead discovery
The Technology and Product
Colorectal cancer is cancer that starts in the colon or rectum, which are are parts of the large intestine, and the lower part of the body’s digestive system (1). Most colorectal cancers are adenocarcinomas, which are cancers that begin in cells that make and release mucus and other fluids (1). Colorectal cancer often begins as a growth called a polyp, which may form on the inner wall of the colon or rectum and some of these polyps become cancer over time (1). Because colorectal cancer is considered one of the major contributors to cancer death and illness, the researchers at Arias Pharmaceuticals, as well as many other pharmaceutical companies, have studied it extensively and tried to find potential ways to combat it.
At Arias Pharmaceuticals, we believe that we have found a possible drug target for the treatment of colorectal cancer. Because kinases are proteins on or near the surface of a cell that transmit important signals to the cell’s control center, blocking these proteins can help stop the growth of cancer cells. Also, kinase inhibitors are capable of doing that and can be useful in the treatment of colon adenosarcoma. PRKACB has been identified as a kinase inhibitor that will be a very good potential target for drug therapies in the treatment of colorectal cancer. The location of PRKACB is in the cell membrane, which means it is close to the surface and can be easily targeted by a drug. It is also found in the nucleus of the cell. If the nucleus, the “brain” of the cell, can be targeted by treatment, this would be the most ideal because without the brain, the cell would not be able to function. Treating the cancer this way can stop the proliferation of these cells from the beginning. Without the brain, there are no signaling pathways available and thus the cell cannot multiply and ultimately spread the cancer.
Summary of Patent Search
What is the IP (intellectual properties) status? Is it patentable? Do you have freedom to operate? How about licenses, do you need patents from other parties?
Provide the key words and IPC codes of you patent search. Patents: The used search terms match with the product properties, production and application strategy, the search codes correspond to the search strategy and valid conclusions are drawn from the found patent database entries with respect to your own strategy
For the patent search, the term “PRKACB” was used. On Google Patents, two patents were found which were then searched on Espacenet for a more complete profile. The IPC codes for the two patents are C12N15/113, A61K38/00, (IPC1-7): A61Band, and G06F19/20, G06F19/24. The first patent is titled “Method of Killing Cancer Cells” and the second “Use of Gene Signatures to Design Novel Cancer Treatment Regimens.”
In both patents, PRKACB is mentioned as a possible target for the treatment of cancer. Because it does not specify neither a formulation nor that is can be used specifically for colorectal cancer, a new patent can be issued. However, the original publishers of the patent would require either the buying of the rights or conclude licensing contracts. Also, because PRKACB will be used in experimental applications, the patent can be held off until it is decided to begin marketing for commercial use.
For the target product profile, there are various things to keep in mind. These are drug-related, product-related, legal-related, and manufacture related. The drug- and product-related attributes will be determined during the preclinical trial. These are the indication, route of administration, dose range, dos frequency, expected duration of treatment, infusion or injection rate/duration, volume per doe, drug concentration, pharmacokinetic profile, drug products that may be mixed or co-infused with the products, pH, toxicity, excipients compendial, low levels of endotoxin, the need to dilute/reconstitute with what, single or multiuse container, packaging type, storage conditions, shelf-life, and shipping requirements. The legal-related attributes include freedom to operate and if the product is intellectual property, discussed above. The manufacturing-related attributes are described below. These include the costs of goods sold, equipment needed for manufacture, and product processing time. Once the PRKACB target has undergone preclinical testing, the exact attributes to fulfill the target product profile can be more completely understood and demonstrated. The quality will be that of industry standards for all attributes considered and the quantity will be based on the market value of the target.
The Market
Based on data collected in 2012, approximately 4.5 percent of men and women will be diagnosed with colon and rectal cancer at some point during their lifetime and an estimated 1,168,929 people were living with colon and rectum cancer in the United States (7). It is the third leading cause of cancer-related deaths in the United States for both men and women (2). The American Cancer Society estimates 143,460 new colon and rectal cancer cases were diagnosed in 2012, and approximately 51,690 people died from colorectal cancers, which accounts for about 9 percent of all cancer deaths (2). Colorectal cancer screening tests, however, can find polyps before they turn into cancer. Screening tests can also find colorectal cancer early, which is when treatment works best and the chances for a full recovery is very high (2). Screening programs and prevention efforts by state colorectal cancer control programs have reduced mortality rates in recent years, with funding from the Centers for Disease Control and Prevention in 2009 (2). These cancer control programs have funding to provide colorectal cancer screening and follow-up care to low-income men and women aged 50 to 64 who are either underinsured or uninsured for screening, or when no other payment option is available (2).
In 2007, the estimated average cost for each cancer episode was between $35,000 and $80,000 (8). When the cancer is found early, the cost is about $30,000 per patient, while when found late, the cost is $120,000 per patient (8). The total cost for treatment for anticipated new cases is about $8.3 billion (8).
Colorectal Cancer Therapeutics in Major Developed Markets states that the Colorectal Cancer treatment market value will increase at a moderate Compound Annual Growth Rate of to $9.4 billion by 2020 (3). The growth, however, will be slow due to market saturation and patent expiries of the key brands (6). The marketed colorectal cancer products landscape comprises a wide range of treatment options. These treatment options include targeted therapies, such as Avastin and Zaltrap, immunotherapies, and chemotherapies (3). The key brands will likely be the main competitors for the drug target.
From 2014 to 2019, it is thought that sales for Avastin will go from $3151 million to $3536 million and from 2019 to 2023, from $3536 million to $2513 million (6). The lower market forecast between 2019 to 2023 will be due to patent expiry and bio-similar competition from 2019 (6). The launches of the bio-similar drugs in 2019 will cause a decrease in growth for the two branded drugs, Avastin and Erbitux (6). Also, three pipeline drugs that will be used as second- and third-line treatments will be launched during the 2019-2023 period, which will also affect the revenues for the branded drugs (6). Because the branded drugs will have expiring patents, after 2023 is the perfect time in which the PRKACB target can be launched. There will be more than enough time from now until then for the successful testing of the target as well as the appropriate market for it.
With the creation and acceptance of New Drug Application (NDA), the target can then enter the market. The NDA would include the efficacy of the drug, the package insert, and the guarantee that it was manufactured in a GMP site.
Financials Background
In a 2007 analysis by PHRMA, it was determined that “preclinical stages” include the Discovery Stages and the Preclinical Development stage, which is almost as much as the money spent on large Phase 3 clinical trials. The Phase 3 costs are a function of “out of pocket” expenses, capital investment, stage length, attrition and numbers of projects per stage. The numbers for 2007 are shown below and have been adjusted for the inflation rate of 2016 to estimate the costs of testing and marketing PRKACB.
To fund all these future endeavors, there are many grants available for innovative new drug molecules, such as Grants4Leads, which is a subsidy of Bayer. Submissions can be made in July and through them, the funding necessary for this promising lead can be acquired. Another way to pay for this venture is to team up with either another small pharmaceutical company or a larger company, like Bayer or Pfizer.
Conclusion
The market need for a drug for one of the highest mortality rate cancers is ever increasing. With the expiry of the brand name drugs coming within the next 5 years, newer, more viable options are necessary. This can be accomplished through Arias Pharmaceuticals with the development of a drug for PRKACB. Through grants and possible contracts with other companies, the target can be formulated and marketed by 2026.