Friday, 20 February 2015
Sapien Biosciences, Partners with OncoStem Diagnostics to Develop Breast Cancer Recurrence Diagnostic Test
Sapien Biosciences, a niche biotech venture backed by Apollo Hospitals, has entered into a collaboration with a Bangalore-based diagnostic start-up, OncoStem Diagnostics, for the development and validation of a novel breast cancer recurrence prediction test.
Breast cancer is the most common cancer among women worldwide and accounts for 25% to 31% of all cancers. In India, breast cancer incidence rates are steadily increasing as awareness and screening improves, while the mortality rates in India are amongst the highest in the world. Recurrence or relapse of cancer, dreaded by both patients and oncologists, is often the cause of mortality in breast cancer and the cancer can recur at the original site, or spread to the bones, lungs, liver or brain, sometimes even after a period of dormancy. Given that more than 30% patients experience cancer recurrence within 5-10 years of the initial diagnosis, the identification of patients at high-risk for recurrence enables an optimal treatment plan that minimizes such recurrences significantly.
OncoStem has developed a unique panel of ‘prognostic and predictive’ proteomic markers that is indicative of the aggressiveness of the cancer and hence enables prediction of the risk of recurrence within the first five years of initial diagnosis. These markers are now being validated using retrospective tumor samples diagnosed with Stage 1, 2 or 3A breast cancer. OncoStem is collaborating with Sapien to validate this test using such annotated tumor samples with associated treatment and outcomes. Once the test is validated, OncoStem and Sapien will pilot and commercialize this test across the Apollo network.
Other recurrence prediction tests such as Oncotype DX (Genomic Health Inc.) and Mammaprint (Agendia Inc.) have been launched globally and have had significant impact in the industry even though these tests only apply to Stage 1 patients who are lymph node negative, hormone receptor positive. OncoStem’s test is a significant innovation in that it can predict recurrences in both lymph node and hormone receptors negative or positive patients and is applicable across all stages of cancer.
Announcing this partnership Dr. Jugnu Jain, CSO- Sapien Biosciences said: “Sapien Biosciences was set-up as a bio-repository that will enable the development of cutting-edge diagnostics & therapeutics. The samples and associated medical data that are being systematically collated & ethically banked at Sapien are a very rich resource for the development of such novel diagnostic tests. Recurrence diagnostics in cancer is particularly dependent on the availability of reliable retrospective information which is acutely lacking in India. I am glad that Sapien is filling this huge gap and we are excited to be part of this collaboration with OncoStem to develop such a test that will represent a paradigm shift in breast cancer treatment."
To highlight the importance of the diagnostic test that OncoStem is developing Dr. Manjiri Bakre, CEO, OncoStem Diagnostics said: “OncoStem was founded with the vision of developing novel diagnostic tests to predict cancer recurrence, an area of huge unmet medical need. This breast cancer recurrence diagnostic is the first of many such tests in development across several cancer types and is designed to predict the patients' risk of cancer recurrence within the first five years of their initial diagnosis, based on the characteristics of their tumor sample. This will in-turn allow optimal & personalized treatment planning for each patient so that risk of such recurrence is minimized. We are excited to be collaborating with Sapien to validate our test using such a valuable resource of samples & associated data which is otherwise extremely difficult to obtain. This partnership will help us realize the potential of our novel diagnostic test and impact millions of breast cancer patients worldwide.”
Commenting on the partnership, Ms. Sangita Reddy, Joint Managing Director, Apollo Hospitalssays, “Apollo has been at the forefront of recognizing personalized medicine as the future of healthcare delivery and has been adopting cutting edge diagnostic tests to deliver better patient care & improve outcomes. Sapien was set-up with the vision of enabling such personalized medicine approaches and we are very excited to see this crystallize through partnerships such as this one with OncoStem. Cancer recurrence space is largely unexplored especially in India and needs immediate attention. I look forward to Apollo & Sapien pioneering the introduction & adoption of this important innovation from OncoStem across our network for the benefit of our patients.”
The OncoStem breast cancer recurrence diagnostic test is planned to be launched first within the Apollo network in India, followed by a worldwide launch in a phased manner starting late 2015-early 2016 and is steadily expected to garner market share in the highly lucrative breast cancer recurrence diagnostic space which is currently valued at $ 3 B globally and is expected to grow at 18% CAGR. Sapien's agreement with OncoStem includes a preferential launch of the OncoStem test across the Apollo Hospitals network through Sapien. Beside breast cancer, the Sapien-OncoStem collaboration also anticipates development of several such cutting-edge recurrence diagnostic tests across other cancer types.
About Apollo Hospitals Enterprise Ltd. (AHEL)
It was in 1983, that Dr. Prathap Reddy made a pioneering endeavor by launching India’s first corporate hospital - Apollo Hospital in Chennai. Now, as Asia largest and most trusted healthcare group, its presence includes over 8,600 beds across 50 Hospitals, 1,632 Pharmacies, 92 Primary Care and Diagnostic Clinics, 100 Telemedicine units across 10 countries. Health Insurance services, Global Projects Consultancy, 15 colleges of Nursing and Hospital Management, a Research Foundation with a focus on global Clinical Trials, epidemiological studies, genetic research and the upcoming first Proton Therapy Center across Asia, Africa and Australia.
In a rare honor, the Government of India issued a commemorative stamp in recognition of Apollo's contribution, the first for a healthcare organization. Apollo Hospitals Chairman, Dr. Prathap C Reddy, was conferred with the prestigious Padma Vibhushan in 2010. For more than 30 years, the Apollo Hospitals Group has continuously excelled and maintained leadership in medical innovation, world-class clinical services and cutting-edge technology. Our hospitals are consistently ranked amongst the best hospitals globally for advanced medical services and research.
About Sapien Biosciences Pvt. Ltd.
Sapien Biosciences is a joint venture between Apollo Hospitals & Saarum Innovations to create a world-class bio-bank and personalized medicine company that leverages Apollo’s leadership position in healthcare and Saarum’s cutting-edge life sciences research expertise for novel clinical and R&D applications. Sapien’s primary objective is to build a high-quality bio-repository that integrates ethically consented human samples with associated medical, pathological & treatment data and leverage this resource to develop & deliver high-end diagnostic applications. Further Sapien has entered into an alliance with Apollo Hospitals that allows Sapien to front-end Apollo’s personalized medicine initiatives. This allows Sapien to bring novel cutting-edge diagnostics to Apollo, either on its own or in collaboration with best-of-breed global institutions world-wide thereby enabling world-class healthcare to improve patient outcomes. Sapien has fully functional labs located within the Apollo Health City Campus in Hyderabad. For more information about Sapien Biosciences, visit www.sapienbio.com.
About OncoStem Diagnostics Pvt. Ltd.
OncoStem is a start-up diagnostic oncology company. It is founded by a Cell Biology veteran with significant experience in US, Singapore and India in cancer biology and cancer drug discovery. It is funded by Artiman, an early-stage Silicon Valley-based venture fund that INVESTS
in white space companies that create or disrupt multi-billion dollar markets. OncoStem is primarily focused on developing novel diagnostic tests which will predict ‘risk of disease recurrence’ and thus enable physicians to prescribe targeted drugs to prevent cancer recurrence. OncoStem’s initial focus is breast cancer as it is the most common cancer in women across the globe but it also plans to develop similar tests for other cancers such as oral, glioma, lung and colon.
Source: http://www.moneylife.in/business-wire-news/sapien-biosciences-partners-with-oncostem-diagnostics-to-develop-breast-cancer-recurrence-diagnostic-test/42686.html
Breast cancer is the most common cancer among women worldwide and accounts for 25% to 31% of all cancers. In India, breast cancer incidence rates are steadily increasing as awareness and screening improves, while the mortality rates in India are amongst the highest in the world. Recurrence or relapse of cancer, dreaded by both patients and oncologists, is often the cause of mortality in breast cancer and the cancer can recur at the original site, or spread to the bones, lungs, liver or brain, sometimes even after a period of dormancy. Given that more than 30% patients experience cancer recurrence within 5-10 years of the initial diagnosis, the identification of patients at high-risk for recurrence enables an optimal treatment plan that minimizes such recurrences significantly.
OncoStem has developed a unique panel of ‘prognostic and predictive’ proteomic markers that is indicative of the aggressiveness of the cancer and hence enables prediction of the risk of recurrence within the first five years of initial diagnosis. These markers are now being validated using retrospective tumor samples diagnosed with Stage 1, 2 or 3A breast cancer. OncoStem is collaborating with Sapien to validate this test using such annotated tumor samples with associated treatment and outcomes. Once the test is validated, OncoStem and Sapien will pilot and commercialize this test across the Apollo network.
Other recurrence prediction tests such as Oncotype DX (Genomic Health Inc.) and Mammaprint (Agendia Inc.) have been launched globally and have had significant impact in the industry even though these tests only apply to Stage 1 patients who are lymph node negative, hormone receptor positive. OncoStem’s test is a significant innovation in that it can predict recurrences in both lymph node and hormone receptors negative or positive patients and is applicable across all stages of cancer.
Announcing this partnership Dr. Jugnu Jain, CSO- Sapien Biosciences said: “Sapien Biosciences was set-up as a bio-repository that will enable the development of cutting-edge diagnostics & therapeutics. The samples and associated medical data that are being systematically collated & ethically banked at Sapien are a very rich resource for the development of such novel diagnostic tests. Recurrence diagnostics in cancer is particularly dependent on the availability of reliable retrospective information which is acutely lacking in India. I am glad that Sapien is filling this huge gap and we are excited to be part of this collaboration with OncoStem to develop such a test that will represent a paradigm shift in breast cancer treatment."
To highlight the importance of the diagnostic test that OncoStem is developing Dr. Manjiri Bakre, CEO, OncoStem Diagnostics said: “OncoStem was founded with the vision of developing novel diagnostic tests to predict cancer recurrence, an area of huge unmet medical need. This breast cancer recurrence diagnostic is the first of many such tests in development across several cancer types and is designed to predict the patients' risk of cancer recurrence within the first five years of their initial diagnosis, based on the characteristics of their tumor sample. This will in-turn allow optimal & personalized treatment planning for each patient so that risk of such recurrence is minimized. We are excited to be collaborating with Sapien to validate our test using such a valuable resource of samples & associated data which is otherwise extremely difficult to obtain. This partnership will help us realize the potential of our novel diagnostic test and impact millions of breast cancer patients worldwide.”
Commenting on the partnership, Ms. Sangita Reddy, Joint Managing Director, Apollo Hospitalssays, “Apollo has been at the forefront of recognizing personalized medicine as the future of healthcare delivery and has been adopting cutting edge diagnostic tests to deliver better patient care & improve outcomes. Sapien was set-up with the vision of enabling such personalized medicine approaches and we are very excited to see this crystallize through partnerships such as this one with OncoStem. Cancer recurrence space is largely unexplored especially in India and needs immediate attention. I look forward to Apollo & Sapien pioneering the introduction & adoption of this important innovation from OncoStem across our network for the benefit of our patients.”
The OncoStem breast cancer recurrence diagnostic test is planned to be launched first within the Apollo network in India, followed by a worldwide launch in a phased manner starting late 2015-early 2016 and is steadily expected to garner market share in the highly lucrative breast cancer recurrence diagnostic space which is currently valued at $ 3 B globally and is expected to grow at 18% CAGR. Sapien's agreement with OncoStem includes a preferential launch of the OncoStem test across the Apollo Hospitals network through Sapien. Beside breast cancer, the Sapien-OncoStem collaboration also anticipates development of several such cutting-edge recurrence diagnostic tests across other cancer types.
About Apollo Hospitals Enterprise Ltd. (AHEL)
It was in 1983, that Dr. Prathap Reddy made a pioneering endeavor by launching India’s first corporate hospital - Apollo Hospital in Chennai. Now, as Asia largest and most trusted healthcare group, its presence includes over 8,600 beds across 50 Hospitals, 1,632 Pharmacies, 92 Primary Care and Diagnostic Clinics, 100 Telemedicine units across 10 countries. Health Insurance services, Global Projects Consultancy, 15 colleges of Nursing and Hospital Management, a Research Foundation with a focus on global Clinical Trials, epidemiological studies, genetic research and the upcoming first Proton Therapy Center across Asia, Africa and Australia.
In a rare honor, the Government of India issued a commemorative stamp in recognition of Apollo's contribution, the first for a healthcare organization. Apollo Hospitals Chairman, Dr. Prathap C Reddy, was conferred with the prestigious Padma Vibhushan in 2010. For more than 30 years, the Apollo Hospitals Group has continuously excelled and maintained leadership in medical innovation, world-class clinical services and cutting-edge technology. Our hospitals are consistently ranked amongst the best hospitals globally for advanced medical services and research.
About Sapien Biosciences Pvt. Ltd.
Sapien Biosciences is a joint venture between Apollo Hospitals & Saarum Innovations to create a world-class bio-bank and personalized medicine company that leverages Apollo’s leadership position in healthcare and Saarum’s cutting-edge life sciences research expertise for novel clinical and R&D applications. Sapien’s primary objective is to build a high-quality bio-repository that integrates ethically consented human samples with associated medical, pathological & treatment data and leverage this resource to develop & deliver high-end diagnostic applications. Further Sapien has entered into an alliance with Apollo Hospitals that allows Sapien to front-end Apollo’s personalized medicine initiatives. This allows Sapien to bring novel cutting-edge diagnostics to Apollo, either on its own or in collaboration with best-of-breed global institutions world-wide thereby enabling world-class healthcare to improve patient outcomes. Sapien has fully functional labs located within the Apollo Health City Campus in Hyderabad. For more information about Sapien Biosciences, visit www.sapienbio.com.
About OncoStem Diagnostics Pvt. Ltd.
OncoStem is a start-up diagnostic oncology company. It is founded by a Cell Biology veteran with significant experience in US, Singapore and India in cancer biology and cancer drug discovery. It is funded by Artiman, an early-stage Silicon Valley-based venture fund that INVESTS
in white space companies that create or disrupt multi-billion dollar markets. OncoStem is primarily focused on developing novel diagnostic tests which will predict ‘risk of disease recurrence’ and thus enable physicians to prescribe targeted drugs to prevent cancer recurrence. OncoStem’s initial focus is breast cancer as it is the most common cancer in women across the globe but it also plans to develop similar tests for other cancers such as oral, glioma, lung and colon.Source: http://www.moneylife.in/business-wire-news/sapien-biosciences-partners-with-oncostem-diagnostics-to-develop-breast-cancer-recurrence-diagnostic-test/42686.html
Apollo to set up standalone oncology units
s part of its focus on specialty care, Apollo Hospitals is coming up with standalone oncology centres. Apollo is looking at having standalone centres in tier I cities, while in tier II they will part of the hospitals.
After launching sugar clinics, dental, dialysis and knee clinics, now Apollo will be focusing on oncology. “Oncology accounts for 12 per cent of the in-patient revenues of the group. The incidence of cancer is also growing at 14 per cent in India. In revenue terms Apollo is the largest in oncology care and we are looking at standalone centres for comprehensive treatment,” said Krishnan Akhileswaran, group CFO, Apollo Hospitals.
Apollo has eight oncology centres that offer surgical, medical and radiological treatment for cancer. But most of them are part of multi-specialty centres. The new centres would be 70-80 bed facilities.
Source: http://www.mydigitalfc.com/news/apollo-set-standalone-oncology-units-694
After launching sugar clinics, dental, dialysis and knee clinics, now Apollo will be focusing on oncology. “Oncology accounts for 12 per cent of the in-patient revenues of the group. The incidence of cancer is also growing at 14 per cent in India. In revenue terms Apollo is the largest in oncology care and we are looking at standalone centres for comprehensive treatment,” said Krishnan Akhileswaran, group CFO, Apollo Hospitals.
Apollo has eight oncology centres that offer surgical, medical and radiological treatment for cancer. But most of them are part of multi-specialty centres. The new centres would be 70-80 bed facilities.
Source: http://www.mydigitalfc.com/news/apollo-set-standalone-oncology-units-694
Saturday, 14 February 2015
FDA approves Lenvima for a type of thyroid cancer
The U.S. Food and Drug Administration today granted approval to Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease).
The most common type of thyroid cancer, DTC is a cancerous growth of the thyroid gland which is located in the neck and helps regulate the body’s metabolism. The National Cancer Institute estimates that 62,980 Americans were diagnosed with thyroid cancer and 1,890 died from the disease in 2014. Lenvima is a kinase inhibitor, which works by blocking certain proteins from helping cancer cells grow and divide.
“The development of new therapies to assist patients with refractory disease is of high importance to the FDA,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval gives patients and healthcare professionals a new therapy to help slow the progression of DTC.”
Lenvima was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that, if approved, would provide significant improvement in safety or effectiveness in the treatment of a serious condition. The drug also received orphan product designation because it is intended to treat a rare disease. Lenvima is being approved approximately two months ahead of the prescription drug user fee goal date of April 14, 2015, the date when the agency was scheduled to complete its review of the application.
Lenvima’s efficacy was demonstrated in 392 participants with progressive, radioactive iodine-refractory DTC who were randomly assigned to receive either Lenvima or a placebo. Study results showed Lenvima-treated participants lived a median of 18.3 months without their disease progressing (progression-free survival), compared to a median of 3.6 months for participants who received a placebo. Additionally, 65 percent of participants treated with Lenvima saw a reduction in tumor size, compared to the two percent of participants who received a placebo. A majority of participants randomly assigned to receive the placebo were treated with Lenvima upon disease progression.
The most common side effects of Lenvima were high blood pressure (hypertension), fatigue, diarrhea, joint and muscle pain (arthralgia/myalgia), decreased appetite, decreased weight, nausea, inflammation of the lining of the mouth (stomatitis), headache, vomiting, excess protein in the urine (proteinuria), swelling and pain in the palms, hands and/or the soles of the feet (palmar-plantar erythrodysesthesia syndrome), abdominal pain and changes in voice volume or quality (dysphonia).
Lenvima may cause serious side effects, including cardiac failure, blood clot formation (arterial thromboembolic events), liver damage (hepatotoxicity), kidney damage (renal failure and impairment), an opening in the wall of the stomach or intestines (gastrointestinal perforation) or an abnormal connection between two parts of the stomach or intestines (fistula formation), changes in the heart’s electrical activity (QT Interval Prolongation), low levels of calcium in the blood (hypocalcemia), the simultaneous occurrence of headache, confusion, seizures and visual changes (Reversible Posterior Leukoencephalopathy Syndrome), serious bleeding (hemorrhage), risks to an unborn child if a patient becomes pregnant during treatment, and impairing suppression of the production of thyroid-stimulating hormone.
Lenvima is marketed by Woodcliff Lake, New Jersey-based Eisai Inc.
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Source: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm434288.htm
Pfizer wins early FDA approval for a potential cancer blockbuster
Pfizer ($PFE) picked up a speedy FDA nod for palbociclib, a breast cancer treatment with blockbuster potential, barreling toward the market as it works to carve out a bigger share of the oncology space.
The drug, which works by inhibiting the enzymes CDK4 and CDK6, is now cleared for use in postmenopausal women with metastatic breast cancer. The approval is based on Phase II data and comes more than two months ahead of the agency's decision deadline, completing what has been a charmed trip through the regulatory process for Pfizer. The oral treatment, which will sell as Ibrance, is expected to bring in sales between $3 billion and $5 billion a year at its peak, according to Leerink analyst Seamus Fernandez.
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| FDA oncology chief Dr. Richard Pazdur |
The approval puts Pfizer ahead of a coming crowd of CDK inhibitors, including promising contenders from Eli Lilly ($LLY) and Novartis ($NVS), and gives the company a first major success as it begins a new era in cancer treatments. Palbociclib's lightning-fast approval also affirms FDA oncology chief Dr. Richard Pazdur's willingness to hurry along so-called breakthrough treatments that could change the standard of care, a cause for optimism among developers of similar drugs.
Pfizer's drug is specifically indicated for women whose cancers respond to estrogen receptor but don't express human epidermal growth factor receptor 2 (HER2), and it's to be used in combination with the oncology drug Femara (letrozole), the FDA said.
Pfizer's drug is specifically indicated for women whose cancers respond to estrogen receptor but don't express human epidermal growth factor receptor 2 (HER2), and it's to be used in combination with the oncology drug Femara (letrozole), the FDA said.
"The addition of palbociclib to letrozole provides a novel treatment option to women diagnosed with metastatic breast cancer," Pazdur said in a statement. "The FDA is committed to expediting marketing approval of cancer drugs through our accelerated approval regulations."
Pfizer is moving on from last year's pursuit of AstraZeneca ($AZN), a $118 billion gambit driven largely by the allure of that company's immuno-oncology pipeline. In the ensuing months, Pfizer struck a slew of deals to cobble together some promising new assets that could help it catch up with the titans of the field, payingMerck KGaA $850 million up front for the PD-L1 inhibitor MSB0010718C and promising as much as $2 billion more to collaborate on up to 20 new cancer immunotherapies.
The deal took the pressure the pressure off of Pfizer and its business development squad in the aftermath of the AstraZeneca debacle, CEO Ian Read said last month, adding that "our research pipeline, middle stage to late stage, is strong, and I would rather take our capital right now and direct it to opportunities to accelerate EPS growth."
And palbociclib's success is an affirmation of Pfizer's ability to compete with the leaders in oncology, Read said in a statement Tuesday.
"I am proud of the clinical program for Ibrance, which was discovered in Pfizer laboratories, and the innovation we are able to bring forward to the breast cancer community today," Read said. "... Today's FDA approval of Ibrance marks a pivotal milestone that demonstrates the strength of our science, provides an important medicine to patients in need and underscores the contributions our company can make to society."
Pfizer's late-stage pipeline includes bococizumab, a member of a newfangled class of cardio therapies with blockbuster expectations, and ertugliflozin, a Merck ($MRK)-partnered DIABETES TREATMENT
Source: http://www.fiercebiotech.com/story/pfizer-wins-early-fda-approval-potential-cancer-blockbuster/2015-02-03
Friday, 13 February 2015
Enhancing oncology treatment through PPP
PPPs can be instrumental in improving quality of diagnostic and treatment services to cancer patients, opines Dr Ashok Mehta, Medical Director, Brahma Kumaris’ Global Hospital & Research
Cancer is an important public health problem due to a sharp rise in the incidence of cancer in India. At any point of time, there are nearly 25 lakh patients in the country, with over 10 lakh new cases every year being added. Six lakhs die each year due to cancer. It is projected that 16 lakh new patients of cancer will be seen in 2020. Currently, there are only a limited number of formal screening programmes and regular examinations to identify individuals with the disease before visible symptoms. Early diagnosis is also hindered by lack of local specialised education of medical personnel and by the non availability of state-of-art medical equipment. 80-90 per cent of lung and prostate cancer and more than half of breast cancer patients report to the hospitals in advanced stage1. Treatment of advanced cancer results in poor cure rates and tremendous suffering to the patient and the family, besides financial calamity.
Dr Ashok Mehta
The sharp rise in the incidence of cancer can be attributed to urbanisation, industrialisation, changes in life style, population growth and an increased longevity. Due to the increasing volumes of cancer patients the number of deaths attributed to this disease will grow exponentially over the next decade.
The supply of cancer diagnostic and treatment facilities has not been able to keep pace with the demand largely on account of high initial INVESTMENTrequired; low paying power of the general population, shortage of cancer specialists and skilled manpower, and limited awareness.
required; low paying power of the general population, shortage of cancer specialists and skilled manpower, and limited awareness.
It is estimated that currently there are about 25 regional cancer centres, 210 radiation therapy installations, 160 government hospitals and 350 private hospitals providing specialised oncology treatment in our country. Major cancer centres, mainly located in metro cities, are overcrowded and have long waiting lists. Only a very small percentage amongst the other hospitals provide comprehensive cancer treatment using a combination of surgical, medical and radiation oncology facilities under one roof.
Despite some laudable accomplishments in the health sector, the picture is generally bleak in oncology though India has some state-of-the-art, globally comparable tertiary care facilities. Economic Survey (2013) reported that India spends around 4.1 per cent of GDP (government spends one per cent approximately) on health making India the worst performer among the Brazil, Russia, India, China, South Africa (BRICS) group.
The problem of cancer treatment gets compounded with rising costs, uneven quality, increasing demand, etc. This calls for an urgent re-thinking on the part of the Government and private healthcare providers if they want to seriously address the impending calamity that would occur in the absence of some concerted, meaningful and effective measures.
Public Private Partnership (PPP) initiatives in healthcare is the much talked about `mantra’ since over a decade. Unable to meet the growing demands for healthcare, the Government is actively looking at the PPP model, due to public sector insufficiencies to provide efficient, effective good healthcare for cancer, compounded by lack of resources and management issues.
PPPs can serve as an instrument to improve quality of diagnostic and treatment services to cancer patients and enhance public benefits in the form of an increase in capacity.
Improved access to diagnostics and radiation therapy capabilities are needed. We have less than 0.08 PET-CT per million population. 620 more linear accelerators (Linac) are needed by 2020 to reach the global average of 5.4 Linacs/mn population. Limited facilities of radiation therapy machines coupled with limited availability of specialists is restricting access to cancer care for majority of the patients.
Government of Bihar through Bihar Medical Services & Infrastructure Corporation Ltd (BMSICL) has one of the largest plans for providing cancer diagnostic and treatment services with private participation and has taken initiative to set up a ‘cancer cluster’ in Bihar. Cancer treatment centres is being planned through the ‘build and operate’ concept. The model envisages government involvement in providing space, building and other infrastructural facilities whereas the private partner would be responsible for providing equipment and manpower as well as running and maintaining the facilities. Supervision and monitoring would be done by government through authority/ agency/ committee.
Cancer needs to be diagnosed and treated across all strata of society and both in the rural as well as urban settings. The model could assume a ‘hub-and-spoke’ format. Cancer-screening centres could be set up at strategic locations. Patients requiring advanced diagnostics and treatment could be directed to the hub which would be a tertiary care comprehensive cancer centre. The hub would offer all forms of cancer care, surgery, radiation therapy, chemotherapy, rehabilitation, etc.
Expansion of oncology care in Maharashtra is being planned as PPP projects at various community health centres (CHCs) and district hospitals. The comprehensive cancer centres could be established in major cities of the state again as PPP projects. This entire programme could be unfolded in a phased manner. This would ensure testing the model in phase one and replicating it in subsequent, yet rapid phases.
The PPP model of healthcare delivery needs to be fundamentally designed in such a way that the functions are carried out by professionally managed, proficient organisations.
The challenge is to convince and partner with non-public sector (NGOs, trusts, private providers) to develop cancer care facilities through innovative public-private partnerships that adopt equitable, quality service delivery, ethical practice and community partnership.
Private partners can assist in realising the government’s development goals and in devising comprehensive cancer care projects. They can also help in identifying and garnering appropriate and sufficient INVESTMENTS.
.
Healthcare delivery being a state matter, the government needs to create a conducive PPP environment for attracting private participation by way of initiatives such as support in infrastructure set up like land acquisition or providing space, offer inability gap funding, budgetary provisions for capital and operating expenses of PPP formulate specific guidelines and capacity building within government for managing PPP projects, etc.
There would be a certain component of indigent (free) and subsidised patient care that the government would refer to these hospitals through a ‘gate-keeper mechanism’. Such a method would help filter out the truly needy and economically challenged patients that could get free/ subsidised treatments. Government formulated health insurance schemes for this category of patients would further help in allowing the needy patients affordable care as well as cover some of their treatment costs.
At the national level, in 2009, the Health Minister’s Cancer Patient Fund (HMCPF) was created within the Rashtriya Arogya Nidhi scheme (RAN). It established a revolving fund in the regional cancer centres (RCC) to speed up financial assistance as treatment subsidies for poor patients. A sum of up to Rs one lakh was proposed as assistance to cancer patients in the BPL category.
As the private partner/ NGO would infuse substantial funds into the venture, it is but imperative that it be allowed to treat ‘full- fee paying patients’ thus cross-subsidising the weaker sections. Private partner would look for a reasonable return on its large INVESTMENTS for supporting the government in providing quality cancer care. There could be a well-defined profit-sharing arrangement between the government and the private player. The government could re-employ their share of the profit into similar hub-and-spoke models across the state.
for supporting the government in providing quality cancer care. There could be a well-defined profit-sharing arrangement between the government and the private player. The government could re-employ their share of the profit into similar hub-and-spoke models across the state.
PPPs will help increase the facilities for skilled human resources training of medical, para-medical and nursing staff to enhance good cancer care delivery standards. Community participation would instill a sense of social responsibility and empowerment for the members of the society who would act as informed and involved partners.
It is absolutely essential, nay mandatory that good and prompt healthcare reaches the common man in all spheres and geographies in India. It is obvious that resources are available but the will to spend it correctly and in a timely and honest manner is imperative. Time is apt to promote PPP for improving cancer care as the answer to get to the bottom of the problem and the pyramid. Yet this effort should be done with a great degree of honesty and conviction and a readiness to deliver to the masses what otherwise appears as only an unfulfilled agenda.
Cancer is the top priority area in view of increasing incidence and large number of patients who would need to be diagnosed early and treated properly to protect from extreme suffering and eventual painful death. New treatments being introduced in advanced countries are so expensive that they are beyond reach of an average citizen even in those countries. Expenditure on cancer is expected to grow by over 20 per cent over the decade. PPP should play a vital role to increase the facilities for cancer treatment manifolds and reduce the cost of treatment.
It is a challenge to increase access to quality cancer care. PPP appears to be a viable alternative. Working with NGOs having good track record will provide community participation.
References:
1. Tumours more than five cm in size or spread beyond the breast to other parts of the body
Source: http://www.financialexpress.com/article/healthcare/knowledge/enhancing-oncology-treatment-through-ppp/41203/
RTI International to Organize a Two Day Symposium on Cancer Prevention in India in New Delhi from 19th - 20th February, 2015
Did you know that according to 2012 statistics from the International Agency for Research on Cancer, approximately 13 percent of the global burden of cancers—about 1 million new cases and more than 700,000 deaths annually—occur in India alone!
Keeping in view the gravity of the disease, RTI International, one of the world’s leading independent, nonprofit research and development organizations dedicated to improving the human condition is hosting a two day ‘Symposium’ from 19th – 20th February, 2015 at MetropolitanHOTEL, New Delhi, on “Cancer Prevention in India” along with the American Cancer Society, Public Health Foundation of India (PHFI), Institute of Cytology and Preventive Oncology (ICPO), and Harvard Global Equity Initiative. This meeting brings together various bodies, both national and international, to collectively and collaboratively address and brainstorm various aspects of early detection and prevention of cancer in India.
, New Delhi, on “Cancer Prevention in India” along with the American Cancer Society, Public Health Foundation of India (PHFI), Institute of Cytology and Preventive Oncology (ICPO), and Harvard Global Equity Initiative. This meeting brings together various bodies, both national and international, to collectively and collaboratively address and brainstorm various aspects of early detection and prevention of cancer in India.
According to RTI’s India Country Director, Dr. Suneeta Krishnan, “India ranks very high on our list of priority countries because our research shows that existing tools for prevention can be more effectively used in India to bring down the high burden of illness. Therefore this is a clarion call for key stakeholders – government, health care providers, researchers, survivors, patient advocates, private sector, and foundations – to collaboratively address cancer prevention. The goal of our symposium is to facilitate knowledge exchange and dissemination on how to overcome barriers and implement, scale up and sustain prevention, including education, screening, early detection, and treatment linkages, in India. I am excited to see this symposium come to fruition, and am committed to advancing this agenda in India.”
Eminent personalities who are participating in the symposium are R Sankaranarayanan, World Health Organization, Ambassador Sally Cowal, American Cancer Society, C.K. Mishra, Government of India along with other dignitaries from India and abroad.
Source: http://indiaeducationdiary.in/Shownews.asp?newsid=33282
Sanofi to Shrink Cancer Operations, Narrow Focus of Genzyme R&D
Sanofi, France’s largest drugmaker,
plans to shrink its embattled cancer business and narrow the focus within
Genzyme’s research unit as part of a wider reorganization of research and
development.
About
100 jobs will be eliminated at the company in North America, Elias Zerhouni,
head of R&D at Paris-based Sanofi, said in a phone interview. Tal Zaks, who
has led the oncology unit since last year, will leave, people with knowledge of
the matter said. Zaks, 49, declined to comment on his plans.
Sanofi
is making the changes, an acknowledgment that the cancer business didn’t meet
expectations, with Chairman Serge Weinberg at the helm following the October
ouster of Chief Executive Officer Chris Viehbacher. The company is preparing to
introduce as many as six products this year.
The
changes are “adjustments according to the fortunes or misfortunes of particular
programs,” Zerhouni said. The new CEO will inherit a company that has, over the
past five years, done a “huge amount of restructuring, everywhere around the
world, including France.”
Shares
of Sanofi climbed 14 percent since Oct. 28, the day before the CEO’s ouster,
matching the advance in the Bloomberg Europe Pharmaceutical Index.
The
drugmaker will stop operating oncology as a separate division. It will move
cancer research into global R&D operations, a person with knowledge of the
matter said, asking not to be identified as the plans aren’t yet public.
Genzyme will concentrate on rare diseases and neuro-immunology disorders, the person
said.
The
changes were to be presented today to employees.
The
drugmaker will eliminate some jobs while hiring in areas that are a priority,
Zerhouni said.
Cancer’s Weakness
The
cancer unit had been “the hope and aspiration of a renewal of the oncology
business line” when it was formed in 2009, Zerhouni said. “By 2015, our core
business has not increased. Why would you incur a huge infrastructure cost that
is inherent to a division with a business that is not strong enough to do
that?”
The
unit, based in Cambridge, Massachusetts, was created shortly after Viehbacher
took the helm. Sanofi purchased BiPar Sciences Inc. the same year, gaining
access to the experimental cancer treatment iniparib, which the former CEO
touted as important to Sanofi’s transformation. The drug failed a key trial in
2011. The introduction of Jevtana therapy in the U.S. in 2010 also
disappointed, two people said. Sanofi also lost patent protection for Taxotere
and Eloxatin.
In
oncology, the drugmaker will “step back a little bit, reinvest in R&D,
focus on things that are more promising, and just catch the next wave,”
Zerhouni said.
One
treatment with great potential is an anti-CD38 monoclonal antibody to treat
multiple myeloma that’s in mid-stage development, he said.
Oncology Acquisitions
Sanofi
will also consider acquisitions in oncology, looking well into the future,
Zerhouni said.
“There’s
nothing that’s off-limits,” he said. “I have a pretty comfortable position
because I have a pretty full late-stage portfolio all the way to 2017-2018.”
The
changes to the company, building upon alterations made by Viehbacher, have been
planned over almost nine months, Zerhouni said.
Sanofi
said in November that by 2020 it plans to introduce 18 new products that could
garner cumulative sales of 30 billion euros ($34 billion) over the first five
years. Total revenue was 33.8 billion euros last year.
The
100 jobs represent about 2 percent of Sanofi’s workforce in Massachusetts. The
drugmaker has a global total of more than 100,000 employees.
Cancer Research
Going
forward, Sanofi’s oncology research will be led by Vicky Richon, who will
report to Chief Scientific Officer Gary Nabel, one of the people said. Oncology
activities, including cancer research, will be based in Cambridge and Vitry,
near Paris.
Jevtana
and other cancer medicines will be folded into Sanofi’s global marketing
organization, led by Pascale Witz, two people said. Matthew Ros will lead the
oncology commercial operations, one of the people said.
Sanofi
purchased Genzyme Corp., the largest maker of treatments for rare genetic
diseases, in 2011. Last year, the French company accessed additional
experimental drugs for rare diseases by buying a stake in Alnylam
Pharmaceuticals Inc.
At
Genzyme, Sanofi plans to build on success with multiple sclerosis treatments
and “adjust resources so that we can do more of the rare-disease programs,”
Zerhouni said. “The Alnylam relationship is a good one and we have programs
that are entering stage three faster than I thought,” he said, referring to
late-stage drug trials.
R&D Hub
The
Sanofi-Genzyme R&D center, which was led by Richard Gregory until December,
is now overseen by Jim Burns, who is also head of Sanofi’s R&D hub in
Massachusetts, one person said.
The
drugmaker has had some high-profile departures since Viehbacher’s ouster,
including Andrew Plump, who was senior vice president for research and
translational medicine, and Paul Sekhri, who ran integrated care.
Still,
the company is retaining talent and attracting top researchers, Zerhouni said.
“People don’t leave an R&D organization when they see the portfolio that we
have,” he said.
GSK Pharma to transfer cancer drug portfolio to Novartis arm
GlaxoSmithKline Pharmaceuticals board today approved transfer of its cancer
drugs portfolio to an arm of Novartis in India in return for acquiring vaccines portfolio as part
of a global deal between the two-multinational pharma giants struck last year.
The company, which today reported a 61.24 per cent drop in its net profit at Rs 45.30 crore
for the October-December period, said its board approved the transactions on an asset sale basis with Novartis Healthcare Pvt Ltd.
"Pursuant to the global deal, the company will have its distribution rights terminated for the oncology portfolio in return for accessing the
distribution rights of the acquired vaccines portfolio," GlaxoSmithKline Pharmaceuticals Ltd said in a filing to the BSE.
The transaction would be profit neutral for the company, it added.
"The closing of the asset sales between the companies is subject to the receipt of all applicable legal and regulatory approvals, consent,
permissions and sanctions as may be necessary from concerned authorities, as well as the closing of the global transactions between
GSK and Novartis," the company said.
Last year, London-based GlaxoSmithKline Plc had entered into agreement with Basel-based Novartis AG to acquire the latter's vaccines
business and manufacturing capabilities and sell the rights of its oncology portfolio, related R&D activities and AKT inhibitors currently in
development to the Swiss firm.
In a separate filing, GlaxoSmithKline Pharmaceuticals said its board has decided to seek shareholder approval for appointment of seven
independent directors and re-appointment and appointment of its whole-time directors.
The company's net sales rose to Rs 646.15 crore during the October-December period as against Rs 630.63 crore during the same period
of the previous fiscal.
"The quarterly performance was impacted by supply constraints," the company said.
GlaxoSmithKline Pharma shares ended at Rs 3,254 apiece on the BSE, down 0.36 per cent from their previous close.
drugs portfolio to an arm of Novartis in India in return for acquiring vaccines portfolio as part
of a global deal between the two-multinational pharma giants struck last year.
The company, which today reported a 61.24 per cent drop in its net profit at Rs 45.30 crore
for the October-December period, said its board approved the transactions on an asset sale basis with Novartis Healthcare Pvt Ltd.
"Pursuant to the global deal, the company will have its distribution rights terminated for the oncology portfolio in return for accessing the
distribution rights of the acquired vaccines portfolio," GlaxoSmithKline Pharmaceuticals Ltd said in a filing to the BSE.
The transaction would be profit neutral for the company, it added.
"The closing of the asset sales between the companies is subject to the receipt of all applicable legal and regulatory approvals, consent,
permissions and sanctions as may be necessary from concerned authorities, as well as the closing of the global transactions between
GSK and Novartis," the company said.
Last year, London-based GlaxoSmithKline Plc had entered into agreement with Basel-based Novartis AG to acquire the latter's vaccines
business and manufacturing capabilities and sell the rights of its oncology portfolio, related R&D activities and AKT inhibitors currently in
development to the Swiss firm.
In a separate filing, GlaxoSmithKline Pharmaceuticals said its board has decided to seek shareholder approval for appointment of seven
independent directors and re-appointment and appointment of its whole-time directors.
The company's net sales rose to Rs 646.15 crore during the October-December period as against Rs 630.63 crore during the same period
of the previous fiscal.
"The quarterly performance was impacted by supply constraints," the company said.
GlaxoSmithKline Pharma shares ended at Rs 3,254 apiece on the BSE, down 0.36 per cent from their previous close.
Source: http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/gsk-pharma-to-transfer-cancer-drug-portfolio-to-novartis-arm/articleshow/46218615.cms
Saturday, 7 February 2015
India’s Medanta to open hospital in Dubai
A 250-bed hospital is expected to open in Dubai Healthcare City (DHCC) in early 2017, to offer improved care for patients in need of specialist treatment.
Medanta Hospital will offer broad-ranging specialities, including cardiology, orthopaedics, neurology, oncology, and liver and renal transplants.
The development is being completed in tandem with DHCC and Indian health care provider Medanta. It will be Medanta’s first UAE hospital.
It is hoped the facility will capitalise on Dubai’s growing medical tourism industry and replicate the success of Medanta’s hospital at Gurgaon, near New Delhi. Between 2009 and March 2014, the hospital completed more than 150,000 procedures and surgeries. Up to 20,000 international in-patients have been treated since 2010.
Dr Raja Easa Al Gurg, vice-chairwoman at DHCC, said: “As Dubai steadily gains recognition for providing world class health care and establishing itself as a medical tourism hub, we have witnessed an increasing number of medical tourists year on year. Part of our strategy is the focus on high quality, specialised health care. The establishment of Medanta at DHCC is an indicator of the strength of strategic partnerships and channelling of efforts to meet the demand for specialised medical treatments in the emirate and beyond.”
Source: http://www.thenational.ae/uae/health/indias-medanta-to-open-hospital-in-dubai
FDA Approved Drugs for Oncology 2014
Akynzeo (netupitant and palonosetron); Helsinn; For the prevention of chemotherapy-induced nausea and vomiting, Approved October 2014
Beleodaq (belinostat); Spectrum Pharmaceuticals; For the treatment of relapsed or refractory peripheral T-cell lymphoma, Approved July 2014
Blincyto (blinatumomab); Amgen; For the treatment of Philadelphia chromosome-negative relapsed /refractory B cell precursor acute lymphoblastic leukemia, Approved December 2014
Cyramza (ramucirumab); Eli Lilly; For the treatment of gastric cancer, Approved April 2014
Imbruvica (ibrutinib); Pharmacyclics; For the treatment of chronic lymphocytic leukemia, Approved February 2014
Keytruda (pembrolizumab); Merck; For the treatment of unresectable or metastatic melanoma, Approved September 2014
Lynparza (olaparib); AstraZeneca; For the treatment of previously treated BRCA mutated advanced ovarian cancer, Approved December 2014
Opdivo (nivolumab); Bristol-Myers Squibb; For the treatment of unresectable or metastatic melanoma, Approved December 2014
Zydelig (idelalisib); Gilead; For the treatment of relapsed CLL, follicular B-cell NHL and small lymphocytic lymphoma, Approved July 2014
Zykadia (ceritinib); Novartis; For the treatment of ALK+ metastatic non-small cell lung cancer, Approved April 2014
Venus Remedies eyes collaborations to commercialise its oncology drugs pipeline
Venus Remedies is now scouting for suitable collaborations for co-development or technology commercialisation of its oncology research pipeline products including VRP007, a targeted therapy for cancer treatment.
Its research arm is now working to come up with revolutionary drugs to reduce side-effects. These include Taxedol which is a ready-to-use single vial injectable, VRP1620, a cancer detection therapy and VRP007 . All these drugs are in different stages of development but under patent protection. “We are hopeful of introducing this product in the domestic market by the last quarter of this year,” Dr Manu Chaudhary, joint managing director, Venus Remedies and director, research, Venus Medicine Research Centre told Pharmabiz in an email.
In order to ensure accuracy in research, Venus embarked on collaborations with well known India and international pharma majors during its submissions of common technical dossier (CTD) for regulated markets. With University of Illinois, Chicago, it teamed up for cancer detection. It is also looking to increase the ambit of the alliance for CTD development of technologies going off-patented in regulated markets. Now we are open to suitable collaborations for co-development or technology commercialisation of our R&D pipeline products, such as the VRP007 therapy, said Dr Chaudhary.
The company already has an adequate oncology drug portfolio covering Docetaxel, Paclitaxel, Gemcitabine, Oxaliplatin, Bortezomib and Pemetrexed. It is conducting phase III clinical trials for VRP1620, a new chemical entity (NCE), which is based on selective tumour targeting. VRP1620 specifically increases tumour blood flow. It will take three-five years for VRP007 to come to the market. It will help in alleviating cancer through specific and selective targeting.
These novel drugs are known for targeted delivery. It would reduce side-effects which is one of the main causes of cancer-associated mortality, she added.
India is expected to report 7 lakh fatal cases from cancer by 2015. In such a scenario, oncology drugs have become more crucial than ever before. The escalating prevalence of cancers of all kinds and the ever rising unmet needs in the field of cancer treatment creates a great opportunity for pharma companies. However, inadequate funds for research and lack of help from the government are the major reasons why India lags behind others when it comes to research on innovative drugs, she said.
Indian oncology drug market is dominated by global majors which offer sophisticated diagnostic techniques, advanced technologies and easy-to-use and affordable therapies. Over 1 million cancer cases are diagnosed annually in India, and this number may reach 5 million over the next decade. However, there is always a ray of hope with the development of indigenous technologies, which will be available at a lower cost with better patient compliances.
There are only a handful of Indian pharma companies focusing on oncology. Lack of government support and encouragement for R&D , coupled with time-consuming regulatory framework, insufficient patent protection and delayed regulatory approvals, are the key challenges. Thus, when it comes to prescriptions by oncologists, a majority global companies’ drugs are prescribed. However, the trend can be reversed if the government provides support to Indian companies conducting R&D in the field of oncology, said Dr Chaudhary.
Source: http://www.pharmabiz.com/NewsDetails.aspx?aid=86599&sid=1
Its research arm is now working to come up with revolutionary drugs to reduce side-effects. These include Taxedol which is a ready-to-use single vial injectable, VRP1620, a cancer detection therapy and VRP007 . All these drugs are in different stages of development but under patent protection. “We are hopeful of introducing this product in the domestic market by the last quarter of this year,” Dr Manu Chaudhary, joint managing director, Venus Remedies and director, research, Venus Medicine Research Centre told Pharmabiz in an email.
In order to ensure accuracy in research, Venus embarked on collaborations with well known India and international pharma majors during its submissions of common technical dossier (CTD) for regulated markets. With University of Illinois, Chicago, it teamed up for cancer detection. It is also looking to increase the ambit of the alliance for CTD development of technologies going off-patented in regulated markets. Now we are open to suitable collaborations for co-development or technology commercialisation of our R&D pipeline products, such as the VRP007 therapy, said Dr Chaudhary.
The company already has an adequate oncology drug portfolio covering Docetaxel, Paclitaxel, Gemcitabine, Oxaliplatin, Bortezomib and Pemetrexed. It is conducting phase III clinical trials for VRP1620, a new chemical entity (NCE), which is based on selective tumour targeting. VRP1620 specifically increases tumour blood flow. It will take three-five years for VRP007 to come to the market. It will help in alleviating cancer through specific and selective targeting.
These novel drugs are known for targeted delivery. It would reduce side-effects which is one of the main causes of cancer-associated mortality, she added.
India is expected to report 7 lakh fatal cases from cancer by 2015. In such a scenario, oncology drugs have become more crucial than ever before. The escalating prevalence of cancers of all kinds and the ever rising unmet needs in the field of cancer treatment creates a great opportunity for pharma companies. However, inadequate funds for research and lack of help from the government are the major reasons why India lags behind others when it comes to research on innovative drugs, she said.
Indian oncology drug market is dominated by global majors which offer sophisticated diagnostic techniques, advanced technologies and easy-to-use and affordable therapies. Over 1 million cancer cases are diagnosed annually in India, and this number may reach 5 million over the next decade. However, there is always a ray of hope with the development of indigenous technologies, which will be available at a lower cost with better patient compliances.
There are only a handful of Indian pharma companies focusing on oncology. Lack of government support and encouragement for R&D , coupled with time-consuming regulatory framework, insufficient patent protection and delayed regulatory approvals, are the key challenges. Thus, when it comes to prescriptions by oncologists, a majority global companies’ drugs are prescribed. However, the trend can be reversed if the government provides support to Indian companies conducting R&D in the field of oncology, said Dr Chaudhary.
Source: http://www.pharmabiz.com/NewsDetails.aspx?aid=86599&sid=1
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