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The Editorial                                                 Contents
Hippocrates himself would, today, be surprised at the
astonishing speed with which Medicine has
                                                              • Cover Story                      2
revolutionized itself. Gone are the days when diseases        -- Cancer Drugs Available...
were generalized and treatments meted out were not
specific. We have entered an era where technology has                   But Unavailable...
the power to pinpoint the cause of diseases at the
genetic level and then can proceed to recommend               • Article                          4
therapies that would specifically repair these aberrations.
The Human Genome Project has unraveled the                    -- “Onco”ntrol
mysterious ways in which the genes function and made
way for extensive research related to it.
Cancer is no longer considered a disease linked only to
                                                              • ‘Innov’Era                        5
environmental factors. Scientists have discovered that        -- ‘Can’cer Treatment: A Reality!!!
some forms of the disease like Breast cancer & Ovarian
cancer can occur due to genetic factors as well. Due to
this interdependence, Scientists are looking at therapies
                                                              • The Industry Buzz              6
that will work at the genetic level like                      -- NoMoreSulide
Pharmacogenomics, Gene Therapy, Stem Cell Therapy,
Antisense Therapy, etc. With this emerging new arena in       -- Biocon Suffers a Setback as Oral
sight we have thus dedicated this issue of The PUMBA
Gazette to Oncology and its prospective treatments.
                                                                 Insulin Trials Fail
To broaden our horizons on this topic we personally
interviewed Oncologists in Pune and got their perspective     • Candid Talk                 7
on the reasons of unavailability of Cancer drugs and what
the pharmaceutical companies are doing to remedy this         -- An Interview with Mr. Manish
issue.                                                          Pungaliya
Taking the theme further we interviewed Mr. Manish
Pungaliya, Director Ayugen Biosciences in order to
understand the scope of Pharmacogenomics in Cancer            • PUMBA News                       8
Treatment.
Also included is an article on the current Cancer
                                                              -- Dhruv ‘11
treatments that are available to patients.                    -- Nostalgia 2011
The periodical for this edition elaborates on the host of
alternative cancer therapies that are replacing the           -- National Seminar 2011
conventional treatments that were once thought as
irreplaceable.
                                                              -- Yukti
The BT news section focuses on the ban on Nimesulide
and phenylpropylamine drugs in India and on the huge
setback to the eagerly awaited oral insulin by Biocon.
We wind up the edition with PUMBA News bringing you
all the happenings that have taken place here in PUMBA.

“Reading maketh a full man; conference a ready
man; and writing an exact man.” - Francis Bacon

Sincerely Yours,
Editor-in-Chief:
Chime Y. Mishra (MBA Biotechnology - SEM IV)
The PUMBA Gazette Team
(The detailed project report shall be provided on enquiry.
Kindly send in your enquiries at
thepumbagazette@gmail.com)


                                                                                                      1
Cover Story
CANCER DRUGS AVAILABLE…                                        kinds of drugs yet or if they are being developed the long
                                                               duration between the approvals and the commercial
            BUT UNAVAILABLE…                                   availability is the negating factor as many lives are lost
 The Oncology market has grown at more than double             due to lack of treatment in this duration. Some also find
the rate of global pharmaceuticals, with a CAGR of 8.39%       one of the reasons to be the withdrawal of the drugs
during 2004–’08. But does the ultimate cause of any drug
development actually being achieved? Even with this
increase in the available drugs as well as reported cases,
are these drugs reaching the final consumer i.e., the
Patient? It is a rarely asked question but an important
one in analyzing the role of pharma companies in
contributing to the oncology treatments. It was the main
objective of this month’s survey by the PUMBA Gazette
team i.e., to assess the availability of cancer drugs to
patients in all terms: drug development, market capture,
cost factor, lack of quick approvals and withdrawals.
The oncologists in the Pune region were interviewed to
gather the information on the availability of drugs, the
reason for this non availability and chiefly the role
pharma companies are playing in making these drugs             which were found effective for disease curing owing to
available to patients.                                         the potential side-effects. E.g. Mylotarg of Wyeth which
                                                               was approved under the accelerated approval program of
AVAILABILITY OF DRUGS                                          FDA used for the treatment of relapsed acute myeloid
The most incident cancers in Pune were found to be             leukaemia (AML). It has been withdrawn owing to lack of
breast, cervical, oral and lung cancers with the most          any additional clinical benefit and increased toxicity when
recovered one to be breast cancer due to ample drugs           administered with chemotherapy. Another of the main
                                                               reasons was also found to be that a few drugs have not
                                                               yet been approved in India depriving Indian patients of
                                                               the benefits.

                                                               COST FACTOR
                                                               According to the survey of the PUMBA Gazette team, in
                                                               Pune region, almost 70% of the oncologists think that the
                                                               drug price being high affects the percentage of patients
                                                               recovering from cancer (recovery percentage). The
                                                               oncologists have almost 80 % of the patients visiting
                                                               them for treatment from lower and middle economic
                                                               strata (35% Low, 45% Middle). With this high share of
                                                               economically not well-to-do patients with not much of
                                                               income to spend in the costly cancer treatment, many
                                                               patients die untreated or have to withdraw in the middle,
                                                               i.e., less recovery percentage.
                                                                A study proves that the newly developed drugs are
available on the basis of an analysis on the availability of   costing even higher than the already available drugs.
drugs for certain types of cancer. Drugs are ample for         Some of the newly-approved brands cost USD 150-500K
Lymphoma too. However, the drugs are found to be just          per life year gained.
enough for the treatment of lung cancer, prostate cancer,            “...the addition of ixabepilone to capecitabine
ovarian cancer, colorectal cancer and leukaemia.                  (Xeloda) adds about $31,000 to the overall medical
According to oncologists the drugs are scarcely available          costs of metastatic breast cancer while providing
for treatment of pancreatic cancer.                               about 1 more month of ‘quality-adjusted’ survival”.
                                                                       Journal of Clinical Oncology, May 1, 2009.
REASONS FOR NONAVAILABILITY
Most of the doctors think high drug costs to be the chief      This and many more studies suggest that the drugs’ reach
reason for unavailability of the drugs followed by non         to the economically backwards is reducing. Ironically,
development and lack of approvals and trials duration.         with the development of newer drugs this class of society
There are many indications for which we don’t have any

                                                                                                                             2
is getting even more deprived of treatment due to high       less than $75000/year before its withdrawal. Amgen has
costs.                                                       a price cap on Vectibix™ in USA since 2006 at $4000/
                                                             dose, approximately 20% less than the other antibody on
WHY THE COSTS ARE HIGH?                                      the market (BMS’s Erbitux®) for metastatic colorectal
Almost 50% of doctors directly blame the high costs of       cancer. Another of these initiatives are the Pay-for-
drugs on the pharma companies saying that the motive         Performance programs, e.g., in Britain, Johnson &
behind such high prices is just high profit as they are      Johnson offered a money-back guarantee if Velcade
ultimately doing a business and they are in business to      failed to reduce tumours by at least 25%. However,
add to their bottom line inconsiderate to the fact that      Indians are still waiting for any such price cap initiatives.
these drugs are necessities which need to reach more         . The accelerated drugs approvals have been beneficial
and more people. They also think that the unavailability     but a few people debate that whether accelerated
of any alternative also adds as an advantage to the          approvals are improved access to therapeutic
companies’ high profit motive until any competition          breakthroughs or early release of unsafe and ineffective
comes up. An equal number of respondents do not blame        drugs? This question is going to remain as we have
it on the companies directly but the need to recover the     examples on both the facets. Mylotarg was approved in
huge costs companies have put into the research and          2000 came out to be ineffective and withdrawn in June
development of these drugs as a reason behind the high       2010 and Cetuximab was approved under accelerated
prices.                                                      approval program in March 2004 for the treatment of
                                                             patients with metastatic colorectal cancer had till yet
ARE COMPANIES DOING ANYTHING?                                been proved good with a few non fatal side effects only.
A 29% of the oncologists’ perception is that the pharma      There are several Patient advocacy groups also who assist
companies are just profit oriented and are not playing       people in accessing the drugs through expanded access
any role in the drug reach increase. But a good 71% think    programs and compassionate use programs which allow
that even being profit oriented some initiatives are being   patients to receive investigational drugs earlier than
taken by the companies so as to make the drugs reach         phase III of the clinical trial process i.e., earlier than the
more and more patients. They have rated Pfizer, BMS,         FDA approval. When patient advocacy groups learned
Roche, Cipla and Novartis to be a few companies active in    that Herceptin was showing promise in clinical trials, they
doing so along with Intas Pharmaceuticals, EliLilly, Dr.     pressured the manufacturer, Genentech, to provide the
Reddy’s Laboratories and Innova Healthcare. Thirty           drug early to certain patients.
percent of oncologists say that the companies are giving
free samples to the patients so as to make it reach the      WHAT SHOULD COMPANIES DO?
poor. E.g., Novartis’ Gleevec®/Glivec® have been             Many doctors suggest that the companies should focus
provided free to the needy patients in India through the     more on research and development and the
                                                             multinationals should have their research centres in India
                                                             as the cost of drug development is found to be lesser in
                                                             India. The trials should be on larger scale involving more
                                                             and more people. The costing should be caps based done
                                                             on the basis of class and economic conditions of patients
                                                             being served. The rural market should be targeted as a
                                                             majority of population stays there and the facilities
                                                             should be provided to them not only getting the
                                                             companies reach more and more patients but also a
                                                             good-will creation in a larger mass. Many people lack
                                                             awareness so awareness programs could be a major
                                                             benefit to both the sides. Another way to reduce costs is
                                                             through licensing and supply deals across countries and
                                                             such collaborations which will finally reduce the costs
                                                             pressure on the patients. The parallel drug applications
                                                             i.e., a single drug to be applicable to other indications
Glivec International Patient Assistance Program (GIPAP).     could also be a good way to increase availability, so
Patient friendly company policies, reduced costs and         research should be directed in these directions as well.
accelerated approvals are few other initiatives by the
companies. Generics are a very good advantage for the        Compiled By:
patients as they are the cheaper substitutes to their        Richa Vijayvargiya, Shomali Naranje (MBA-BT SEM IV)
branded counterparts with the similar affectivity. A few     Apoorva Joshi, Ektaa Sharma, Neha Shedge, Gurudeep S.
                                                             Dodmani, Vinay Pantulwar (MBA-BT SEM II)
companies are also involved in inducing voluntary price
caps on their drugs like Genentech had a price cap on
Avastin at $55000/ year for households having income

                                                                                                                              3
Article
“ONCO”NTROL                                                  Cancer vaccines represent an emerging type of biological
  Cancer vaccines are medicines that belong to a class of    therapy that is still mostly experimental. Many clinical
substances known as biological response modifiers.           trials are underway to test vaccines as potential
Biological response modifiers work by stimulating or         treatments for a wide variety of cancer types.
restoring the immune system’s ability to fight infections
and diseases. There are two broad types of cancer
vaccines:
  * Preventive (or prophylactic) vaccines, which are
intended to prevent cancer from developing in healthy
people.
 * Treatment (or therapeutic) vaccines, which are
intended to treat an existing cancer by strengthening the
body’s natural defenses against the cancer.

Active Clinical Trials of Cancer Treatment Vaccines by
                                                             In one early-stage study, 18 of 20 patients who were
Type of Cancer:
                                                             vaccinated against non-Hodgkin's lymphoma stayed in
    Bladder Cancer
                                                             remission for an average of four year. The vaccine used in
    Brain Tumors
                                                             this study contained a protein specific to each patient’s
    Breast Cancer
                                                             tumor cells (that is, each patient was given an autologous
    Cervical Cancer
                                                             vaccine) as well as two other substances to help boost
    Hodgkin Lymphoma
                                                             the immune response. A large, randomized, phase III trial
    Kidney Cancer
                                                             of this vaccine is now under way.
    Melanoma
    Multiple Myeloma
                                                             From the market perspective, there are going to be
    Leukemia
                                                             multiple launches of vaccines between 2010 and 2013-
    Lung Cancer
                                                             14, which would substantially increase the market size
    Non-Hodgkin Lymphoma
                                                             and growth. The cost of three complete dose courses of
    Pancreatic Cancer
                                                             the vaccines ranges approximately from $380 to $400.
    Prostate Cancer
                                                             The cancer vaccines developmental pipeline is strong
    Solid Tumors
                                                             with about 239 products in various phases of clinical
                                                             development including 21 molecules in Phase III. The
Active Clinical Trials of Cancer Preventive Vaccines by
                                                             Phase III pipeline activity is strong. It mainly consists of
Type of Cancer:
                                                             clinical studies involving antigen/adjuvant vaccines
    Cervical Cancer
                                                             regimen. The Phase III pipeline also contains some novel
    Solid Tumors
                                                             therapeutic vaccines. These options are also present in
Worldwide, there is the potential to prevent 1.8 million
                                                             the Phase II stage pipeline. With all these factors, it is
cases of cancer (18%) each year by fighting infections.
                                                             likely that the options in the pipeline will cause a
The proportion is even larger in the third world, where an
                                                             dramatic change in the market in the near future and the
estimated one in four cancers is linked to infection.
                                                             market activity will primarily be dominated by the
The U.S. Food and Drug Administration (FDA) has
                                                             molecules in the Phase II and Phase I pipeline.
approved two vaccines, Gardasil® and Cervarix®, that
                                                             The questions that need to be answered via research:
protect against infection by the two types of Human
Papilloma Virus—types 16 and 18—that cause                         Whether vaccines will be more effective when
approximately 70 percent of all cases of cervical cancer              given in combination with other forms of cancer
worldwide. At least 17 other types of HPV are responsible             therapy
for the remaining 30 percent of cervical cancer cases.             Whether the vaccine should be administered
HPV types 16 and/or 18 also cause some vaginal, vulvar,               before chemotherapy, during chemotherapy or
anal, penile, and oro-pharyngeal cancers. Therefore,                  after the course is completed.
researchers must develop new vaccines that are able to             For therapeutic vaccines, the question is at which
prevent infections by all HPV types that can cause this               stage should the vaccination be given?
disease.                                                           Whether vaccines can be used in case of cancers
                                                                      in multiple tissues?
In April 2010, the FDA approved the first cancer
treatment vaccine. This vaccine, sipuleucel-T (Provenge®,    Compiled by:
manufactured by Dendreon), is approved for use in some       Shalet M. Koshy (MBA Biotechnology SEM IV)
men with metastatic prostate cancer.                         Anjali Joshi (MBA Biotechnology SEM II)

                                                                                                                            4
‘Innov’Era
‘CAN’CER TREATMENT: A REALITY!!!                              and the general population. This presents a sizeable
                                                              market opportunity. Research is being conducted in both
In India, cancer is a silent crisis. It goes largely
                                                              ovarian cancer and prostate cancer, which could have
unreported, and elicits little of the attention it deserves
                                                              wide-market implications. Specifically, companies are
from health authorities preoccupied with other pressing
                                                              looking to validate new biomarkers in order to create
health problems. Efforts at prevention and early
                                                              more accurate tests.
detection are extremely limited, as are diagnostic and
treatment services. Cancer survival rates in India are
                                                              Apart from commonly used chemotherapy, hormonal
exceptionally poor. Lack of awareness, stigma, and
                                                              therapy and radiotherapy, few therapies like stem cell
reliance on traditional healers mean most people do not
                                                              transplantation, electromagnetic radiation therapy,
seek medical help in time. Also, there is a common
                                                              dendritic cell (antigen presenting cells) based vaccines,
perception that cancer is transmissible, which leads to
                                                              antisense therapy etc. have emerged as novel ways to
patients being shunned by family and friends and inhibits
                                                              treat cancer. As the name suggests, stem cell
people from accessing screening or acknowledging early
                                                              transplantation is transplantation of multipotent
symptoms. More than two third of cancer patients are
                                                              hematopoietic stem cells or blood, often derived from
first seen with late stage disease, which has a poor
                                                              bone marrow, umbilical cord blood or hemopoietic stem
prognosis and is long, difficult and costly to treat.
                                                              cells derived from a placenta into the patient as part of
                                                              the therapy.
Despite public policy measures to prevent cancer, such as
tobacco control and vaccination against HPV (Human
                                                              In electromagnetic radiotherapy, low power, non-
Papilloma Virus), cancer is sure to remain a significant
                                                              ionizing, non thermal, radio or sub-radio frequency
public health problem throughout the 21st century. The
                                                              electromagnetic waves are produced which are helpful in
demographic shift towards an ageing population and the
                                                              treating the cancer.
usage of high–tech modern medicine throughout the
emerging economies of Asia and Africa will lead to the
                                                              A dendritic cell based cancer vaccine induces strong
expansion of the market for cancer diagnostics globally.
                                                              anticancer immunity by its potent immune-inducing
                                                              abilities. It is a new paradigm in cancer treatment which
Early diagnosis of cancer is essential to determine the
                                                              induces not only strong anti-tumour immunity but also
treatment regime. Computerized tomography, positron
                                                              immune memory to prevent tumour recurrence or
emission tomography, magnetic resonance imaging and
                                                              metastasis. In this vaccine a live attenuated virus is used
ultrasound imaging are some of the techniques used for
                                                              which infects both healthy cells and tumour cells but it
cancer detection. However these techniques are
                                                              selectively replicates in tumour cells resulting in killing
expensive, require lab facilities and highly trained
                                                              tumour cells and leaving healthy cells unaffected. It also
technicians, they are time consuming and cannot be
                                                              results in production of antigens which induces tumour
taken into the field. Nanotechnology is one of the recent
                                                              specific immune response, resulting in identifying and
technologies used for cancer diagnosis. Nanotechnology
                                                              destroying tumour cells systematically.
is in a unique position to produce a new generation of
early cancer detection techniques with higher sensitivity
                                                              Antisense therapy has emerged as an exciting and
and delivery of the drug to the target site.
                                                              promising strategy for cancer therapy which works at the
                                                              genetic level to prevent mutated or overactive genes by
The latest Technologies in Oncology Diagnostics range
                                                              directing the synthesis of proteins that are causing
from body imaging and cytology to molecular diagnostics
                                                                                              cancer. They are different
and pharmacogenomics. The imaging techniques involve
                                                                                              from conventional drugs
Magnetic Resonance Imaging (MRI), X-ray, Computed
                                                                                              as these are designed to
Tomography (CT), Ultrasound, Positron Emission
                                                                                              interact with protein
Tomography (PET), Single Photon Emission Computed
                                                                                              molecules after they are
Tomography (SPECT) and Flow Cytometry. Similarly, the
                                                                                              produced.        Antisense
molecular diagnostics include Fluorescence In-Situ
                                                                                              drugs have a more
Hybridization (FISH), Polymerase Chain Reaction (PCR),
                                                              selective action, and they have the potential to be more
HPV testing, Immunoassays & Biomarkers, Microarrays
                                                              effective and less toxic than conventional drugs.
and Comparative Genomic Hybridization (CGH).
Molecular diagnostics and biomarkers are the key drivers
                                                              Compiled by:
of the oncology diagnostics market. Virtual colonoscopy,
                                                              Hitesh Patil (MBA-BT SEM IV)
using CT scans to build a picture of the colon, is becoming
                                                              Neha Shedge & Seema Pawar (MBA-BT SEM II)
an increasingly accepted alternative to invasive
colonoscopy for colorectal screening in high risk groups


                                                                                                                            5
The Industry Buzz
NOMORESULIDE…                                                 Paracetamol and Ibuprofen were trying to get the drug
                                                              banned because of the higher revenues it generated and
It seems that the Drug Technical Advisory Board of India      it had nothing to do with the adverse effects it caused.
has pulled its socks and rolled its sleeves once again. It    However the test results as well as the reports from the
has finally decided to impose ban on the                      market always pointed that the problems posed are
commercialization two very controversial drugs being          serious and need attention.
sold in Indian market namely NIMESULIDE and PHENYL
PROPYLAMINE (widely known as PPA). The move comes             BIOCON SUFFERS A SETBACK AS ORAL
after the debate that has lasted for a decade. The debate
was whether to ban Nimesulide in India or not.                INSULIN TRIALS FAIL...
The Nimesulide drug has already been banned in the            Biocon suffered a serious setback this month when the
developed countries like Britain, Canada, Sweden,             results of the clinical trials on the much awaited oral
Denmark, New Zealand, Japan and many more. In USA             insulin drug failed. The clinical trials on the drug failed to
the drug was not even filed for marketing. The main           meet the primary goals.
reason behind the ban imposed on the drug is the severe
liver damage it causes. It was marketed in India despite of   The drug is named as IN-105 by the company and had
being banned in the developed countries.                      cleared the Phase II of the clinical trials. The drug in
                                                              clinical trials has to prove the efficacy test to reach the
                                                              very important phase III. In the human clinical trials of IN-
                                                              105, it was supposed to lower the level of glycated
                                                              haemoglobin by 0.7% however it failed to lower the
                                                              levels as compared to placebo.

                                                              In this case the effects on placebo were higher than
                                                              expected by the researchers. The company said that they
                                                              had not considered certain facts about the placebo and
                                                              the assumptions proved to be wrong. However the
                                                              company claims to have collected enough data to show
                                                              that the results are positive and the research is on right
                                                              track.

                                                              The Biotech giant now has extended its arms to the
                                                              global partnerships for the further research on the
Along with Nimesulide, Phenyl Propylamine, Cisapride
                                                              molecule. The company plans to enter into global
are the other two drugs which DTAB has banned in India.
                                                              partnerships and thus conduct more research and more
PPA is the drug used in popular brands like D’cold, Vicks
                                                              clinical trials. The company is highly optimistic about the
Action 500 often prescribed for cold and cough remedies.
                                                              output of the research studies and the clinical trial
PPA was reported to be the reason of stroke in many
                                                              report.
young women. Whereas Cisapride prescribed to increase
the gastric motility in the upper GIT was reported to
                                                              This drug and molecule being one of the most promising
cause serious heart related problem such as disturbed
                                                              and the emerging market has given a lot of hopes to the
rhythms of heart beats.
                                                              company as well as the Indian Biotechnology. It will be
                                                              interesting to see how the molecule, on which Biocon has
The Nimesulide tablet holds the market of Rs. 2710
                                                              been researching since around 2001, fares in coming
Crores in Rs. 50000 Indian Pharma Market. According to
                                                              days.
the Drug Controller the drug should have been banned in
India before 10 years ago but were not banned.
                                                              Compiled by:
                                                              Sumantsinh Girase (MBA Biotechnology SEM IV)
Previously, two more drugs were banned in India. Those
were Rosiglitazone which is an anti diabetes drug and the
other one is Sibutramine. These were banned in India in
the month of November.

In the defence, the manufacturers and the marketers of
Nimesulide argued that the manufacturers of

                                                                                                                               6
Candid Talk
AN INTERVIEW WITH MR. MANISH                                  up with government organizations that can help bring
                                                              these tests to the common man at subsidized rates.
PUNGALIYA
                                                              Q.4. What is the current share of pharmacogenomics in
                              Pharmacogenomics can            the Indian diagnostic industry? And what is your
                              be described as the study       forecast for the next 5 years for this industry?
                              of the effects of genetic       The current share of pharmacogenomics in the
                              variation on the efficacy       diagnostics industry is somewhere around 5-6 %.
                              and toxicity of a particular    However, this scenario will definitely change in the future
drug. Today oncology and pharmacogenomics is a hot            as the growth potential is tremendous and the Indian
topic in the current diagnostics market. In order to          molecular diagnostics market is expected to cross US$ 3
understand this association, the interview team spoke         billion by 2015. In keeping with the proportion of the
with Mr. Manish Pungaliya, Director, Ayugen                   pharmacagenomics market share, there will be an
Biosciences. Ayugen is one of the few companies               exceptional growth in this sector too.
currently working in the field of pharmacogenomics
testing.                                                      Q.5. What are the current as well as the untapped
                                                              opportunities in cancer pharmacogenomics?
Q.1. “Pharmacogenomics, a powerful tool to enhance            There is a host of other tests that are available that can
cancer treatment”. What are your views on this                be developed to check the side effects and efficacy of a
statement?                                                    drug in a patient’s body based on drug metabolism and
Pharmcogenomics is drawing attention towards itself in        site of action. Also there are other genomics tests which
oncology because most of the new drugs to treat it are        try and understand the gene and protein expression in
based on targeted therapies i.e. they target a particular     the patient’s body once the drug has been administered.
pathway or a gene in a pathway or a protein. Therefore,
most of these drugs will only work based on a particular      Q.6. What factors should a new entrant take into
genetic profile of the tumour. Pharmacogenomics can           account before stepping into this field?
guide practitioners through its genetic profiling tests as    A new entrant must keep in mind that they should be
well as about which medication will work in a patient and     ready with a full fledged marketing plan and a proper
which won’t work.                                             implementation plan to create awareness among the
                                                              practitioners. Another factor for consideration is to try
Q.2. Even though pharmacogenomics plays a vital role in       and bring the cost down from the current levels. The
cancer treatment, do you think it is being utilised           major aspect to be worked upon is the awareness levels
efficiently in India as compared to western countries? If     in the market since it’s a new field in India. Initially the
not so, what do you think are the probable reasons for        investment would be high but the returns on investment
its underutilisation?                                         will certainly follow. Therefore any new entrant must
Pharmacogenomics is not being utilized to its full            have enough patience to fuel this industry.
potential in our country because most of the doctors
don’t know about the tests and their usage. They are not      Compiled by: The PUMBA Gazette Interview Team
aware about the benefits and the power of these tests
and even if the doctors are aware of the test they don’t
know how to apply them. But the bright side is that more
and more pharmaceutical companies are pushing the use
of these tests with their drugs, thus the awareness and
usage will increase rapidly in the future. There is also a
cost factor involved in the successful application of this
technique and currently it’s a barrier to the acceptance of
this form of therapy.

Q.3. What steps can be taken to get Pharmacogenomics
Diagnostics for cancer treatment within the reach of the
common man?
In the future the cost of the test will automatically come
down as the volume of patients increase, which is bound
to happen, considering the utility of these tests. Apart
from this best way to get the costs down would be to tie



                                                                                                                             7
The PUMBA News
DHRUV ‘11                                                   were adjudged as the best artists through a poll
                                                            conducted during the event. Thus, another event was
DHRUV ’11, one of the most awaited cultural events was
                                                            successfully organized by Alumni cell, the heart of
held from 17th -19thJan 2011. This year the theme for
                                                            PUMBA.
DHRUV was “AQUATICA.” This event gives the students,
from leading B-Schools, an opportunity to present their
managerial, cultural & sports skills to come out and        NATIONAL SEMINAR 2011
perform in front of all & compete with others. More than    National seminar 2011, a National level seminar, was
5000 participants registered their names for various        held on 29th January, 2011 at Le Meridian, Pune. This
events. The Grand Finale was held on 19th Jan 2011 at       year, the topic of discussion was ‘India on the horizon –
‘Alpabachat Bhavan’ which comprised of the finals for       The dawn of a global era’. Dr. Santosh Bhave, Vice
‘dance competition’ and ‘fashion show’. The chief guest     President - HR, Bharat Forge Ltd. graced the event as the
for the Grand Finale was Mr. Nandkishor Kapote, the         Chief guest and Dr. R.K. Shevgaonkar, Hon. Vice
renowed Kathak dancer and disciple of Pandit Birju          Chancellor, UoP, as the Guest of Honour along with Dr.
Maharaj. The judges for the evening were Abhilasha          (Capt.) C.M. Chitale, the Head of Department of
Mahant Choudhary, Director ‘Nach India’ and Vikram ,        Management Sciences (PUMBA). The curtain raiser
Choreographer from Jhalak Dikhla Ja.’ The event             movie, based on the theme, was an apt introduction of
concluded with overall prize distribution and tallying of   the current Indian scenario. There were three panel
points won in various competitions. The General             discussions in the seminar with the topics being India’s
Championship rolling Trophy is given on the basis of        Global Footprint - How far have we reached?,
collective ranking in each individual event of DHRUV. For   Infrastructure Jeopardized- Why can’t we walk the talk?
the third consecutive year the trophy for DHRUV’11 was      and Globalization and National Commitment-Can they
won by Indira Institute Of Management, Pune.                go hand in hand?. The panelists included Mr. Rajesh
                                                            Ghonasgi, CFO, Persistent Systems Ltd., Mr. Diniar
NOSTALGIA 2011                                              Patel, Editor-Supplement,      Times     Of     India, Mr.
                                                            Unnikrishnan Menon, AGM - Exports, IPCA Labs, Dr. P C
Nostalgia`11, An Odyssey to Remember is an annual
                                                            Nambiar, Director - EXIM, Serum Institute of India, Mr. P
Alumni meet & was held on 22nd January, 2011 at the
                                                            Srinivasan, Global Business Head, Chemical Division,
PUMBA campus. This event is a casual gathering of
                                                            Thermax Ltd., and members of Faculty of PUMBA. The
alumni & is meant for recapturing the past memories of
                                                            seminar was concluded with a valedictory speech by Dr.
PUMBA. It’s an attempt to strengthen the relation
                                                            Ashok Joshi, Dean, Faculty of Management, University of
between PUMBA and its alumni. This year the event
                                                            Pune. With this seminar, the Seminar cell has indeed
revolved around the theme of ‘Journey’. Deviating from
                                                            added another feather in its cap!
the usual on-stage program, the PUMBA campus was
converted into a fete with various games organized by
the students. These were enjoyed by the alumni and the      YUKTI
fun atmosphere pepped up the interactions.                   “Yukti” a business plan competition was organized by the
                                                            ED Cell at PUMBA campus on 25th January, 2011. The
                                                            event consisted of two segments. In the first segment,
                                                            “BIZZolution”, candidates were given 100 seconds to
                                                            present their business ideas. The second segment,
                                                            “BIZZplanmania”, only shortlisted candidates presented
                                                            their complete business plan. Students from leading B –
                                                            Schools like JBIMS, N.L. Dalmia, K.J. Somaiya, MIT,
                                                            Sinhgad Institute participated in these events. Reputed
                                                            Industrial personalities were invited to judge the business
                                                            plan competition. Vishwas Kale (Vijayesh Industries) and
                                                            K.J. Bhumkar (Ex-CMD, Bank of Maharashtra) were the
                                                            esteemed judges.
The Event was inaugurated by Dr. Capt. C.M. Chitale,
Professor and Head of Department, PUMBA. The alumni,        Compiled by: Nazaneen Saify (MBA BT Sem IV)
who have helped PUMBA in the past year, were                Mehraj Deshmukh and Nikhil Bhalerao (MBA BT Sem II)
honoured as Star Alumni. Also, PUMBA Art Exhibition,
wherein the paintings, sketches and photographs by the
students were displayed, was appreciated. Prof.
Aniruddha Joshi along with Abhimanyu Tadwalkar of
MBA BT 2nd year & Bhushan Astulkar MBA- BT 1st year,

                                                                                                                          8

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The PUMBA Gazette - january 2011

  • 1. 0
  • 2. The Editorial Contents Hippocrates himself would, today, be surprised at the astonishing speed with which Medicine has • Cover Story 2 revolutionized itself. Gone are the days when diseases -- Cancer Drugs Available... were generalized and treatments meted out were not specific. We have entered an era where technology has But Unavailable... the power to pinpoint the cause of diseases at the genetic level and then can proceed to recommend • Article 4 therapies that would specifically repair these aberrations. The Human Genome Project has unraveled the -- “Onco”ntrol mysterious ways in which the genes function and made way for extensive research related to it. Cancer is no longer considered a disease linked only to • ‘Innov’Era 5 environmental factors. Scientists have discovered that -- ‘Can’cer Treatment: A Reality!!! some forms of the disease like Breast cancer & Ovarian cancer can occur due to genetic factors as well. Due to this interdependence, Scientists are looking at therapies • The Industry Buzz 6 that will work at the genetic level like -- NoMoreSulide Pharmacogenomics, Gene Therapy, Stem Cell Therapy, Antisense Therapy, etc. With this emerging new arena in -- Biocon Suffers a Setback as Oral sight we have thus dedicated this issue of The PUMBA Gazette to Oncology and its prospective treatments. Insulin Trials Fail To broaden our horizons on this topic we personally interviewed Oncologists in Pune and got their perspective • Candid Talk 7 on the reasons of unavailability of Cancer drugs and what the pharmaceutical companies are doing to remedy this -- An Interview with Mr. Manish issue. Pungaliya Taking the theme further we interviewed Mr. Manish Pungaliya, Director Ayugen Biosciences in order to understand the scope of Pharmacogenomics in Cancer • PUMBA News 8 Treatment. Also included is an article on the current Cancer -- Dhruv ‘11 treatments that are available to patients. -- Nostalgia 2011 The periodical for this edition elaborates on the host of alternative cancer therapies that are replacing the -- National Seminar 2011 conventional treatments that were once thought as irreplaceable. -- Yukti The BT news section focuses on the ban on Nimesulide and phenylpropylamine drugs in India and on the huge setback to the eagerly awaited oral insulin by Biocon. We wind up the edition with PUMBA News bringing you all the happenings that have taken place here in PUMBA. “Reading maketh a full man; conference a ready man; and writing an exact man.” - Francis Bacon Sincerely Yours, Editor-in-Chief: Chime Y. Mishra (MBA Biotechnology - SEM IV) The PUMBA Gazette Team (The detailed project report shall be provided on enquiry. Kindly send in your enquiries at thepumbagazette@gmail.com) 1
  • 3. Cover Story CANCER DRUGS AVAILABLE… kinds of drugs yet or if they are being developed the long duration between the approvals and the commercial BUT UNAVAILABLE… availability is the negating factor as many lives are lost The Oncology market has grown at more than double due to lack of treatment in this duration. Some also find the rate of global pharmaceuticals, with a CAGR of 8.39% one of the reasons to be the withdrawal of the drugs during 2004–’08. But does the ultimate cause of any drug development actually being achieved? Even with this increase in the available drugs as well as reported cases, are these drugs reaching the final consumer i.e., the Patient? It is a rarely asked question but an important one in analyzing the role of pharma companies in contributing to the oncology treatments. It was the main objective of this month’s survey by the PUMBA Gazette team i.e., to assess the availability of cancer drugs to patients in all terms: drug development, market capture, cost factor, lack of quick approvals and withdrawals. The oncologists in the Pune region were interviewed to gather the information on the availability of drugs, the reason for this non availability and chiefly the role pharma companies are playing in making these drugs which were found effective for disease curing owing to available to patients. the potential side-effects. E.g. Mylotarg of Wyeth which was approved under the accelerated approval program of AVAILABILITY OF DRUGS FDA used for the treatment of relapsed acute myeloid The most incident cancers in Pune were found to be leukaemia (AML). It has been withdrawn owing to lack of breast, cervical, oral and lung cancers with the most any additional clinical benefit and increased toxicity when recovered one to be breast cancer due to ample drugs administered with chemotherapy. Another of the main reasons was also found to be that a few drugs have not yet been approved in India depriving Indian patients of the benefits. COST FACTOR According to the survey of the PUMBA Gazette team, in Pune region, almost 70% of the oncologists think that the drug price being high affects the percentage of patients recovering from cancer (recovery percentage). The oncologists have almost 80 % of the patients visiting them for treatment from lower and middle economic strata (35% Low, 45% Middle). With this high share of economically not well-to-do patients with not much of income to spend in the costly cancer treatment, many patients die untreated or have to withdraw in the middle, i.e., less recovery percentage. A study proves that the newly developed drugs are available on the basis of an analysis on the availability of costing even higher than the already available drugs. drugs for certain types of cancer. Drugs are ample for Some of the newly-approved brands cost USD 150-500K Lymphoma too. However, the drugs are found to be just per life year gained. enough for the treatment of lung cancer, prostate cancer, “...the addition of ixabepilone to capecitabine ovarian cancer, colorectal cancer and leukaemia. (Xeloda) adds about $31,000 to the overall medical According to oncologists the drugs are scarcely available costs of metastatic breast cancer while providing for treatment of pancreatic cancer. about 1 more month of ‘quality-adjusted’ survival”. Journal of Clinical Oncology, May 1, 2009. REASONS FOR NONAVAILABILITY Most of the doctors think high drug costs to be the chief This and many more studies suggest that the drugs’ reach reason for unavailability of the drugs followed by non to the economically backwards is reducing. Ironically, development and lack of approvals and trials duration. with the development of newer drugs this class of society There are many indications for which we don’t have any 2
  • 4. is getting even more deprived of treatment due to high less than $75000/year before its withdrawal. Amgen has costs. a price cap on Vectibix™ in USA since 2006 at $4000/ dose, approximately 20% less than the other antibody on WHY THE COSTS ARE HIGH? the market (BMS’s Erbitux®) for metastatic colorectal Almost 50% of doctors directly blame the high costs of cancer. Another of these initiatives are the Pay-for- drugs on the pharma companies saying that the motive Performance programs, e.g., in Britain, Johnson & behind such high prices is just high profit as they are Johnson offered a money-back guarantee if Velcade ultimately doing a business and they are in business to failed to reduce tumours by at least 25%. However, add to their bottom line inconsiderate to the fact that Indians are still waiting for any such price cap initiatives. these drugs are necessities which need to reach more . The accelerated drugs approvals have been beneficial and more people. They also think that the unavailability but a few people debate that whether accelerated of any alternative also adds as an advantage to the approvals are improved access to therapeutic companies’ high profit motive until any competition breakthroughs or early release of unsafe and ineffective comes up. An equal number of respondents do not blame drugs? This question is going to remain as we have it on the companies directly but the need to recover the examples on both the facets. Mylotarg was approved in huge costs companies have put into the research and 2000 came out to be ineffective and withdrawn in June development of these drugs as a reason behind the high 2010 and Cetuximab was approved under accelerated prices. approval program in March 2004 for the treatment of patients with metastatic colorectal cancer had till yet ARE COMPANIES DOING ANYTHING? been proved good with a few non fatal side effects only. A 29% of the oncologists’ perception is that the pharma There are several Patient advocacy groups also who assist companies are just profit oriented and are not playing people in accessing the drugs through expanded access any role in the drug reach increase. But a good 71% think programs and compassionate use programs which allow that even being profit oriented some initiatives are being patients to receive investigational drugs earlier than taken by the companies so as to make the drugs reach phase III of the clinical trial process i.e., earlier than the more and more patients. They have rated Pfizer, BMS, FDA approval. When patient advocacy groups learned Roche, Cipla and Novartis to be a few companies active in that Herceptin was showing promise in clinical trials, they doing so along with Intas Pharmaceuticals, EliLilly, Dr. pressured the manufacturer, Genentech, to provide the Reddy’s Laboratories and Innova Healthcare. Thirty drug early to certain patients. percent of oncologists say that the companies are giving free samples to the patients so as to make it reach the WHAT SHOULD COMPANIES DO? poor. E.g., Novartis’ Gleevec®/Glivec® have been Many doctors suggest that the companies should focus provided free to the needy patients in India through the more on research and development and the multinationals should have their research centres in India as the cost of drug development is found to be lesser in India. The trials should be on larger scale involving more and more people. The costing should be caps based done on the basis of class and economic conditions of patients being served. The rural market should be targeted as a majority of population stays there and the facilities should be provided to them not only getting the companies reach more and more patients but also a good-will creation in a larger mass. Many people lack awareness so awareness programs could be a major benefit to both the sides. Another way to reduce costs is through licensing and supply deals across countries and such collaborations which will finally reduce the costs pressure on the patients. The parallel drug applications i.e., a single drug to be applicable to other indications Glivec International Patient Assistance Program (GIPAP). could also be a good way to increase availability, so Patient friendly company policies, reduced costs and research should be directed in these directions as well. accelerated approvals are few other initiatives by the companies. Generics are a very good advantage for the Compiled By: patients as they are the cheaper substitutes to their Richa Vijayvargiya, Shomali Naranje (MBA-BT SEM IV) branded counterparts with the similar affectivity. A few Apoorva Joshi, Ektaa Sharma, Neha Shedge, Gurudeep S. Dodmani, Vinay Pantulwar (MBA-BT SEM II) companies are also involved in inducing voluntary price caps on their drugs like Genentech had a price cap on Avastin at $55000/ year for households having income 3
  • 5. Article “ONCO”NTROL Cancer vaccines represent an emerging type of biological Cancer vaccines are medicines that belong to a class of therapy that is still mostly experimental. Many clinical substances known as biological response modifiers. trials are underway to test vaccines as potential Biological response modifiers work by stimulating or treatments for a wide variety of cancer types. restoring the immune system’s ability to fight infections and diseases. There are two broad types of cancer vaccines: * Preventive (or prophylactic) vaccines, which are intended to prevent cancer from developing in healthy people. * Treatment (or therapeutic) vaccines, which are intended to treat an existing cancer by strengthening the body’s natural defenses against the cancer. Active Clinical Trials of Cancer Treatment Vaccines by In one early-stage study, 18 of 20 patients who were Type of Cancer: vaccinated against non-Hodgkin's lymphoma stayed in  Bladder Cancer remission for an average of four year. The vaccine used in  Brain Tumors this study contained a protein specific to each patient’s  Breast Cancer tumor cells (that is, each patient was given an autologous  Cervical Cancer vaccine) as well as two other substances to help boost  Hodgkin Lymphoma the immune response. A large, randomized, phase III trial  Kidney Cancer of this vaccine is now under way.  Melanoma  Multiple Myeloma From the market perspective, there are going to be  Leukemia multiple launches of vaccines between 2010 and 2013-  Lung Cancer 14, which would substantially increase the market size  Non-Hodgkin Lymphoma and growth. The cost of three complete dose courses of  Pancreatic Cancer the vaccines ranges approximately from $380 to $400.  Prostate Cancer The cancer vaccines developmental pipeline is strong  Solid Tumors with about 239 products in various phases of clinical development including 21 molecules in Phase III. The Active Clinical Trials of Cancer Preventive Vaccines by Phase III pipeline activity is strong. It mainly consists of Type of Cancer: clinical studies involving antigen/adjuvant vaccines  Cervical Cancer regimen. The Phase III pipeline also contains some novel  Solid Tumors therapeutic vaccines. These options are also present in Worldwide, there is the potential to prevent 1.8 million the Phase II stage pipeline. With all these factors, it is cases of cancer (18%) each year by fighting infections. likely that the options in the pipeline will cause a The proportion is even larger in the third world, where an dramatic change in the market in the near future and the estimated one in four cancers is linked to infection. market activity will primarily be dominated by the The U.S. Food and Drug Administration (FDA) has molecules in the Phase II and Phase I pipeline. approved two vaccines, Gardasil® and Cervarix®, that The questions that need to be answered via research: protect against infection by the two types of Human Papilloma Virus—types 16 and 18—that cause  Whether vaccines will be more effective when approximately 70 percent of all cases of cervical cancer given in combination with other forms of cancer worldwide. At least 17 other types of HPV are responsible therapy for the remaining 30 percent of cervical cancer cases.  Whether the vaccine should be administered HPV types 16 and/or 18 also cause some vaginal, vulvar, before chemotherapy, during chemotherapy or anal, penile, and oro-pharyngeal cancers. Therefore, after the course is completed. researchers must develop new vaccines that are able to  For therapeutic vaccines, the question is at which prevent infections by all HPV types that can cause this stage should the vaccination be given? disease.  Whether vaccines can be used in case of cancers in multiple tissues? In April 2010, the FDA approved the first cancer treatment vaccine. This vaccine, sipuleucel-T (Provenge®, Compiled by: manufactured by Dendreon), is approved for use in some Shalet M. Koshy (MBA Biotechnology SEM IV) men with metastatic prostate cancer. Anjali Joshi (MBA Biotechnology SEM II) 4
  • 6. ‘Innov’Era ‘CAN’CER TREATMENT: A REALITY!!! and the general population. This presents a sizeable market opportunity. Research is being conducted in both In India, cancer is a silent crisis. It goes largely ovarian cancer and prostate cancer, which could have unreported, and elicits little of the attention it deserves wide-market implications. Specifically, companies are from health authorities preoccupied with other pressing looking to validate new biomarkers in order to create health problems. Efforts at prevention and early more accurate tests. detection are extremely limited, as are diagnostic and treatment services. Cancer survival rates in India are Apart from commonly used chemotherapy, hormonal exceptionally poor. Lack of awareness, stigma, and therapy and radiotherapy, few therapies like stem cell reliance on traditional healers mean most people do not transplantation, electromagnetic radiation therapy, seek medical help in time. Also, there is a common dendritic cell (antigen presenting cells) based vaccines, perception that cancer is transmissible, which leads to antisense therapy etc. have emerged as novel ways to patients being shunned by family and friends and inhibits treat cancer. As the name suggests, stem cell people from accessing screening or acknowledging early transplantation is transplantation of multipotent symptoms. More than two third of cancer patients are hematopoietic stem cells or blood, often derived from first seen with late stage disease, which has a poor bone marrow, umbilical cord blood or hemopoietic stem prognosis and is long, difficult and costly to treat. cells derived from a placenta into the patient as part of the therapy. Despite public policy measures to prevent cancer, such as tobacco control and vaccination against HPV (Human In electromagnetic radiotherapy, low power, non- Papilloma Virus), cancer is sure to remain a significant ionizing, non thermal, radio or sub-radio frequency public health problem throughout the 21st century. The electromagnetic waves are produced which are helpful in demographic shift towards an ageing population and the treating the cancer. usage of high–tech modern medicine throughout the emerging economies of Asia and Africa will lead to the A dendritic cell based cancer vaccine induces strong expansion of the market for cancer diagnostics globally. anticancer immunity by its potent immune-inducing abilities. It is a new paradigm in cancer treatment which Early diagnosis of cancer is essential to determine the induces not only strong anti-tumour immunity but also treatment regime. Computerized tomography, positron immune memory to prevent tumour recurrence or emission tomography, magnetic resonance imaging and metastasis. In this vaccine a live attenuated virus is used ultrasound imaging are some of the techniques used for which infects both healthy cells and tumour cells but it cancer detection. However these techniques are selectively replicates in tumour cells resulting in killing expensive, require lab facilities and highly trained tumour cells and leaving healthy cells unaffected. It also technicians, they are time consuming and cannot be results in production of antigens which induces tumour taken into the field. Nanotechnology is one of the recent specific immune response, resulting in identifying and technologies used for cancer diagnosis. Nanotechnology destroying tumour cells systematically. is in a unique position to produce a new generation of early cancer detection techniques with higher sensitivity Antisense therapy has emerged as an exciting and and delivery of the drug to the target site. promising strategy for cancer therapy which works at the genetic level to prevent mutated or overactive genes by The latest Technologies in Oncology Diagnostics range directing the synthesis of proteins that are causing from body imaging and cytology to molecular diagnostics cancer. They are different and pharmacogenomics. The imaging techniques involve from conventional drugs Magnetic Resonance Imaging (MRI), X-ray, Computed as these are designed to Tomography (CT), Ultrasound, Positron Emission interact with protein Tomography (PET), Single Photon Emission Computed molecules after they are Tomography (SPECT) and Flow Cytometry. Similarly, the produced. Antisense molecular diagnostics include Fluorescence In-Situ drugs have a more Hybridization (FISH), Polymerase Chain Reaction (PCR), selective action, and they have the potential to be more HPV testing, Immunoassays & Biomarkers, Microarrays effective and less toxic than conventional drugs. and Comparative Genomic Hybridization (CGH). Molecular diagnostics and biomarkers are the key drivers Compiled by: of the oncology diagnostics market. Virtual colonoscopy, Hitesh Patil (MBA-BT SEM IV) using CT scans to build a picture of the colon, is becoming Neha Shedge & Seema Pawar (MBA-BT SEM II) an increasingly accepted alternative to invasive colonoscopy for colorectal screening in high risk groups 5
  • 7. The Industry Buzz NOMORESULIDE… Paracetamol and Ibuprofen were trying to get the drug banned because of the higher revenues it generated and It seems that the Drug Technical Advisory Board of India it had nothing to do with the adverse effects it caused. has pulled its socks and rolled its sleeves once again. It However the test results as well as the reports from the has finally decided to impose ban on the market always pointed that the problems posed are commercialization two very controversial drugs being serious and need attention. sold in Indian market namely NIMESULIDE and PHENYL PROPYLAMINE (widely known as PPA). The move comes BIOCON SUFFERS A SETBACK AS ORAL after the debate that has lasted for a decade. The debate was whether to ban Nimesulide in India or not. INSULIN TRIALS FAIL... The Nimesulide drug has already been banned in the Biocon suffered a serious setback this month when the developed countries like Britain, Canada, Sweden, results of the clinical trials on the much awaited oral Denmark, New Zealand, Japan and many more. In USA insulin drug failed. The clinical trials on the drug failed to the drug was not even filed for marketing. The main meet the primary goals. reason behind the ban imposed on the drug is the severe liver damage it causes. It was marketed in India despite of The drug is named as IN-105 by the company and had being banned in the developed countries. cleared the Phase II of the clinical trials. The drug in clinical trials has to prove the efficacy test to reach the very important phase III. In the human clinical trials of IN- 105, it was supposed to lower the level of glycated haemoglobin by 0.7% however it failed to lower the levels as compared to placebo. In this case the effects on placebo were higher than expected by the researchers. The company said that they had not considered certain facts about the placebo and the assumptions proved to be wrong. However the company claims to have collected enough data to show that the results are positive and the research is on right track. The Biotech giant now has extended its arms to the global partnerships for the further research on the Along with Nimesulide, Phenyl Propylamine, Cisapride molecule. The company plans to enter into global are the other two drugs which DTAB has banned in India. partnerships and thus conduct more research and more PPA is the drug used in popular brands like D’cold, Vicks clinical trials. The company is highly optimistic about the Action 500 often prescribed for cold and cough remedies. output of the research studies and the clinical trial PPA was reported to be the reason of stroke in many report. young women. Whereas Cisapride prescribed to increase the gastric motility in the upper GIT was reported to This drug and molecule being one of the most promising cause serious heart related problem such as disturbed and the emerging market has given a lot of hopes to the rhythms of heart beats. company as well as the Indian Biotechnology. It will be interesting to see how the molecule, on which Biocon has The Nimesulide tablet holds the market of Rs. 2710 been researching since around 2001, fares in coming Crores in Rs. 50000 Indian Pharma Market. According to days. the Drug Controller the drug should have been banned in India before 10 years ago but were not banned. Compiled by: Sumantsinh Girase (MBA Biotechnology SEM IV) Previously, two more drugs were banned in India. Those were Rosiglitazone which is an anti diabetes drug and the other one is Sibutramine. These were banned in India in the month of November. In the defence, the manufacturers and the marketers of Nimesulide argued that the manufacturers of 6
  • 8. Candid Talk AN INTERVIEW WITH MR. MANISH up with government organizations that can help bring these tests to the common man at subsidized rates. PUNGALIYA Q.4. What is the current share of pharmacogenomics in Pharmacogenomics can the Indian diagnostic industry? And what is your be described as the study forecast for the next 5 years for this industry? of the effects of genetic The current share of pharmacogenomics in the variation on the efficacy diagnostics industry is somewhere around 5-6 %. and toxicity of a particular However, this scenario will definitely change in the future drug. Today oncology and pharmacogenomics is a hot as the growth potential is tremendous and the Indian topic in the current diagnostics market. In order to molecular diagnostics market is expected to cross US$ 3 understand this association, the interview team spoke billion by 2015. In keeping with the proportion of the with Mr. Manish Pungaliya, Director, Ayugen pharmacagenomics market share, there will be an Biosciences. Ayugen is one of the few companies exceptional growth in this sector too. currently working in the field of pharmacogenomics testing. Q.5. What are the current as well as the untapped opportunities in cancer pharmacogenomics? Q.1. “Pharmacogenomics, a powerful tool to enhance There is a host of other tests that are available that can cancer treatment”. What are your views on this be developed to check the side effects and efficacy of a statement? drug in a patient’s body based on drug metabolism and Pharmcogenomics is drawing attention towards itself in site of action. Also there are other genomics tests which oncology because most of the new drugs to treat it are try and understand the gene and protein expression in based on targeted therapies i.e. they target a particular the patient’s body once the drug has been administered. pathway or a gene in a pathway or a protein. Therefore, most of these drugs will only work based on a particular Q.6. What factors should a new entrant take into genetic profile of the tumour. Pharmacogenomics can account before stepping into this field? guide practitioners through its genetic profiling tests as A new entrant must keep in mind that they should be well as about which medication will work in a patient and ready with a full fledged marketing plan and a proper which won’t work. implementation plan to create awareness among the practitioners. Another factor for consideration is to try Q.2. Even though pharmacogenomics plays a vital role in and bring the cost down from the current levels. The cancer treatment, do you think it is being utilised major aspect to be worked upon is the awareness levels efficiently in India as compared to western countries? If in the market since it’s a new field in India. Initially the not so, what do you think are the probable reasons for investment would be high but the returns on investment its underutilisation? will certainly follow. Therefore any new entrant must Pharmacogenomics is not being utilized to its full have enough patience to fuel this industry. potential in our country because most of the doctors don’t know about the tests and their usage. They are not Compiled by: The PUMBA Gazette Interview Team aware about the benefits and the power of these tests and even if the doctors are aware of the test they don’t know how to apply them. But the bright side is that more and more pharmaceutical companies are pushing the use of these tests with their drugs, thus the awareness and usage will increase rapidly in the future. There is also a cost factor involved in the successful application of this technique and currently it’s a barrier to the acceptance of this form of therapy. Q.3. What steps can be taken to get Pharmacogenomics Diagnostics for cancer treatment within the reach of the common man? In the future the cost of the test will automatically come down as the volume of patients increase, which is bound to happen, considering the utility of these tests. Apart from this best way to get the costs down would be to tie 7
  • 9. The PUMBA News DHRUV ‘11 were adjudged as the best artists through a poll conducted during the event. Thus, another event was DHRUV ’11, one of the most awaited cultural events was successfully organized by Alumni cell, the heart of held from 17th -19thJan 2011. This year the theme for PUMBA. DHRUV was “AQUATICA.” This event gives the students, from leading B-Schools, an opportunity to present their managerial, cultural & sports skills to come out and NATIONAL SEMINAR 2011 perform in front of all & compete with others. More than National seminar 2011, a National level seminar, was 5000 participants registered their names for various held on 29th January, 2011 at Le Meridian, Pune. This events. The Grand Finale was held on 19th Jan 2011 at year, the topic of discussion was ‘India on the horizon – ‘Alpabachat Bhavan’ which comprised of the finals for The dawn of a global era’. Dr. Santosh Bhave, Vice ‘dance competition’ and ‘fashion show’. The chief guest President - HR, Bharat Forge Ltd. graced the event as the for the Grand Finale was Mr. Nandkishor Kapote, the Chief guest and Dr. R.K. Shevgaonkar, Hon. Vice renowed Kathak dancer and disciple of Pandit Birju Chancellor, UoP, as the Guest of Honour along with Dr. Maharaj. The judges for the evening were Abhilasha (Capt.) C.M. Chitale, the Head of Department of Mahant Choudhary, Director ‘Nach India’ and Vikram , Management Sciences (PUMBA). The curtain raiser Choreographer from Jhalak Dikhla Ja.’ The event movie, based on the theme, was an apt introduction of concluded with overall prize distribution and tallying of the current Indian scenario. There were three panel points won in various competitions. The General discussions in the seminar with the topics being India’s Championship rolling Trophy is given on the basis of Global Footprint - How far have we reached?, collective ranking in each individual event of DHRUV. For Infrastructure Jeopardized- Why can’t we walk the talk? the third consecutive year the trophy for DHRUV’11 was and Globalization and National Commitment-Can they won by Indira Institute Of Management, Pune. go hand in hand?. The panelists included Mr. Rajesh Ghonasgi, CFO, Persistent Systems Ltd., Mr. Diniar NOSTALGIA 2011 Patel, Editor-Supplement, Times Of India, Mr. Unnikrishnan Menon, AGM - Exports, IPCA Labs, Dr. P C Nostalgia`11, An Odyssey to Remember is an annual Nambiar, Director - EXIM, Serum Institute of India, Mr. P Alumni meet & was held on 22nd January, 2011 at the Srinivasan, Global Business Head, Chemical Division, PUMBA campus. This event is a casual gathering of Thermax Ltd., and members of Faculty of PUMBA. The alumni & is meant for recapturing the past memories of seminar was concluded with a valedictory speech by Dr. PUMBA. It’s an attempt to strengthen the relation Ashok Joshi, Dean, Faculty of Management, University of between PUMBA and its alumni. This year the event Pune. With this seminar, the Seminar cell has indeed revolved around the theme of ‘Journey’. Deviating from added another feather in its cap! the usual on-stage program, the PUMBA campus was converted into a fete with various games organized by the students. These were enjoyed by the alumni and the YUKTI fun atmosphere pepped up the interactions. “Yukti” a business plan competition was organized by the ED Cell at PUMBA campus on 25th January, 2011. The event consisted of two segments. In the first segment, “BIZZolution”, candidates were given 100 seconds to present their business ideas. The second segment, “BIZZplanmania”, only shortlisted candidates presented their complete business plan. Students from leading B – Schools like JBIMS, N.L. Dalmia, K.J. Somaiya, MIT, Sinhgad Institute participated in these events. Reputed Industrial personalities were invited to judge the business plan competition. Vishwas Kale (Vijayesh Industries) and K.J. Bhumkar (Ex-CMD, Bank of Maharashtra) were the esteemed judges. The Event was inaugurated by Dr. Capt. C.M. Chitale, Professor and Head of Department, PUMBA. The alumni, Compiled by: Nazaneen Saify (MBA BT Sem IV) who have helped PUMBA in the past year, were Mehraj Deshmukh and Nikhil Bhalerao (MBA BT Sem II) honoured as Star Alumni. Also, PUMBA Art Exhibition, wherein the paintings, sketches and photographs by the students were displayed, was appreciated. Prof. Aniruddha Joshi along with Abhimanyu Tadwalkar of MBA BT 2nd year & Bhushan Astulkar MBA- BT 1st year, 8