Series-2, 2019

Kaleidoscope Working for a Better Tomorrow

From the

Hello &Welcome once again!

Greetings from Naprod Life Sciences!!

I am sure you enjoyed reading our maiden issue of “Kaleidoscope”. We

were overwhelmed with the kind of response that we received from you
which were truly encouraging.

I want to begin this issue with very happy news. Yes!! The long and
anxiously awaited EU GMP certification for our manufacturing facility
arrived eventually in the last week January 2019. Our entire team which
put in their heart and soul towards this project is overjoyed and rightfully
so. My heartiest congratulations to the entire Naprod team who slogged
it out to get this done. Needless to say, a plethora of business

opportunities will present themselves and we will be glad to offer our quality products and services to a wider
geography. Our challenge will be to consistently living upto your high expectations and our hard-earned
reputation.

This issue of Kaleidoscope has some interesting information on “Cancer Screening”; some news about a new
class of drugs that is revolutionizing the cancer treatment called CDK (4&6) inhibitors; an alarming news
about the rise of obesity related cancers in young adults in the USA; an interesting news item about the
unlikely connection between iridium of extraterrestrial origin and cancer care.

I sincerely hope you enjoy reading this issue of “Kaleidoscope”.

Best wishes!!

Mohan B. Jain
Managing Director
Naprod Life Sciences.
Kaleidoscope
Working for a Better Tomorrow

Section 1: NLS Bulletin

enquiries from across the world for business

opportunities in their respective
countries/regions.
d. These enquiries vary from site transfer projects,
market access permission requests and also
from Markets that implement referential pricing
policies.
e. Our internal teams are busy with market
potential survey, streamlining documentations
and doing production planning to meet the
incremental demand. More information on this
in subsequent issues…!

Other Developments:
a. 2019-20 is a year of new product development
for Naprod group of companies. This year we
· EU GMP accreditation induced will be commercializing new products from
excitement: different segments like anti-neoplastics,
a. Global Oncology plus supportive care market anesthetics, contrast media, parenteral nutrition
size is 133 Bn USD in 2017 up from 96 Bn USD in and immunosuppresants.
2013. b. 25 product will be cleared in 2019-20 which
b. Excluding Biologicals and Products which are include Lapatinib, Sorafenib, Bendamustine
protected under patent, nearly 30 % (40Bn USD) RTU*, Docetaxel RTU*,Topotecan, Polymyxin B,
of this market is open for countries that accept Colistimethate, Tacrolimus, Iohexol etc.
EU GMP.
c. All our new products will be available along with
c. As expected, with Naprod successfully CTD dossier.
complying with EU GMP audit, Naprod's
international business team is flooded with d. Naprod plant PPB, Kenya Audit completed.

Section 2: News from around the world of Medicine

high-risk HPV (hrHPV) testing alone every five
years, or hrHPV testing in combination with
cytology (co-testing) every five years.
The task force also recommended against
screening women younger than 21, women
older than 65 who previously have been
adequately screened, and women who've had a
hysterectomy with removal of the cervix and
w h o h a v e n o h i s t o r y o f a h i g h - g ra d e
precancerous lesion or cervical cancer.
Screening for cervical cancer saves lives and
a) USPSTF Updates Cer vical Cancer
identifies the condition early, when it is
Screening Regimen treatable. There are several effective screening
The U.S. Preventive Services Task Force strategies available, so women should talk to
(USPSTF) recommended primary care their doctor about which one is right for them.”
physicians screen women ages 21-29
USPSTF Updates Prostate Cancer Screening
every three years with cervical cytology.
Recommendations
For women ages 30-65, the task force
Men aged 55 to 69 years should decide whether
recommended screening with either to undergo periodic PSA screening after a
cervical cytology alone every three years,
Kaleidoscope
Working for a Better Tomorrow

discussion of the potential benefits and harms indication for abemaciclib within five months. In
with their clinician. According to USPSTF, there September 2017, abemaciclib became the first
is “moderate certainty” of a “small” benefit of and only cyclin-dependent kinase (CDK) 4 & 6
reducing death with screening of men in this age inhibitor approved in combination and as a
group. single agent in metastatic breast cancer.
In addition, the USPSTF newly recommends Specifically, abemaciclib was approved for use in
against PSA screening for men older than 70 combination with fulvestrant for the treatment
because the harms generally outweigh the of women with HR+, HER2- advanced or
benefits. m e t a s t a t i c b re a s t c a n c e r w i t h d i s e a s e
progression following endocrine therapy and as
ESMO 2018: Major trial shows targeted drug – monotherapy for the treatment of adult patients
palbociclib – extends breast cancer survival with HR+, HER2- advanced or metastatic breast
Women taking palbociclib together with cancer with disease progression following
hormone therapy lived seven months longer endocrine therapy and prior chemotherapy in
than those on hormone treatment alone – the metastatic setting.
adding to previous data showing the
combination could delay the disease's Ribociclib approved for Additional Indications
progression. The drug's benefit was stronger in in HR+/HER2- Advanced Breast Cancer
women who had previously responded to In July 2018, ribociclib (Kisqali) received
hormone therapy – who lived 10 months longer approval for additional indications from the US
w i t h t h e c o m b i n a t i o n t r e a t m e n t .T h e FDA for women with hormone-receptor
international PALOMA-3 clinical trial was led by positive, human epidermal growth factor
researchers at The Institute of Cancer Research, receptor-2 negative (HR+/HER2-) advanced or
London, and The Royal Marsden NHS metastatic breast cancer. Ribociclib is now the
Foundation Trust, and involved 144 research only CDK4/6 inhibitor indicated for use with an
centres in 17 countries. aromatase inhibitor for the treatment of pre-,
peri- or postmenopausal women in the US, and
Abemaciclib receives additional approval as also is indicated for use in combination with
initial treatment for advanced breast cancer fulvestrant as both first- or second-line therapy
Abemaciclib (Verzenio) in combination with an in postmenopausal women
aromatase inhibitor (AI) as initial endocrine-
based therapy for the treatment of Obesity-related cancers rising in young adults
postmenopausal women with hormone in the US
receptor-positive (HR+), human epidermal A new study finds rates are increasing for six of
growth factor receptor 2-negative (HER2-) 12 cancers related to obesity in younger adults in
advanced or metastatic breast cancer was the United States, with steeper increases in
approved by FDA in February 2018. This progressively younger ages and successively
additional FDA approval marks the third younger generations. Excess body weight is a
known carcinogen, associated with more than a
Kaleidoscope
Working for a Better Tomorrow

dozen cancers and suspected in several more. problems swallowing or earache is a greater
Exposures to carcinogens during early life may war ning sign of lar yngeal cancer than
have an even more important influence on hoarseness alone, new research concludes.
cancer risk by acting during crucial
developmental periods. New 3D imaging technique reveals how
pancreatic cancers start
Simply shining light on 'dinosaur metal' The pancreas is a crucial organ that sits behind
compound kills cancer cells our stomach and plays a key role in digestion. It
A new compound based on iridium, a rare metal relies on a network of ducts linking it to other
which landed in the Gulf of Mexico 66 million digestive organs, and the most common
years ago, hooked onto albumin, a protein in pancreatic cancers are found in the ducts.
blood, can attack the nucleus of cancerous cells However, until now it has only been possible to
when switched on by light, researchers have see 2D slices of these ductal cancers, which
found. The treatment of cancer using light, contained an unexplained variety of abnormal
called Photodynamic therapy, is based on shapes. By analysing developing cancers in 3D,
chemical compounds called photosensitizers, researchers defined two distinct types of cancer
which can be switched on by light to produce formation originating from ductal cells:
oxidising species, able to kill cancer cells. 'endophytic' tumours which grow into the ducts
Clinicians can activate these compounds and 'exophytic' tumours which grow outwards.
selectively where the tumour is (using optical The researchers also applied the technique to
fibres) thus killing cancer cells and leaving other organs, and found that cancers in the
healthy cells intact. airways of the lungs and ducts in the liver
behave in the same way. This shows that the
Engineering a cancer-fighting virus mechanism discovered is not specific to the
Hokkaido University, Japan researchers have pancreas and also applies to other cancers.
engineered a virus that selectively targets and Professor Andrew Biankin, Cancer Research UK's
kills cancer cells. The virus, called dl355, has an pancreatic cancer expert, says: “ This
even stronger anticancer effect than another technological breakthrough has the potential to
engineered virus currently used in clinical unlock many unanswered questions of great
practice. importance in how we understand and treat
pancreatic cancer. It's crucial we better grasp
Persistent sore throat could be larynx cancer how these cancers behave from the earliest
warning stages, to help develop treatments for a disease
Gps should consider larynx cancer when where survival rates have remained stubbornly
patients report a persistent sore throat, low.”
particularly when combined with other
seemingly low-level symptoms. A persistent
sore throat combined with shortness of breath,
Kaleidoscope
Working for a Better Tomorrow

Section 3: Humor is the best medicine!!

NAPROD LIFE SCIENCES PVT. LTD.

Corporate Office: 304, Town Centre-1, Andheri-Kurla Road,
Andheri (E), Mumbai - 400 059, Maharashtra, India.
Tel.: +91 2 4093 9000 Website : www.naprodgroup.com