Explore Pharma February Issue - 2020

47 February 2020

ARTICLE

48 February 2020

49 February 2020

50 February 2020

NEWS

1. Trelegy Ellipta filing “accelerate” lifesaving cancer research. unveiled plans to collaborate on a
accepted by EMA for asthma In collaboration with its European new global licensing agreement to
develop and commercialise ST-501
By Anna Smith partners, Fondazione AIRC and for tauopathies including Alzheimer’s
Asociación Española Contra el Cáncer disease, and other neurological
The European Medicines Agency (AECC), the charity will choose diseases.
(EMA) has accepted GlaxoSmithKline’s successful teams from its CRUK The companies have detailed plans
regulatory submission seeking an Accelerator Awards programme to to leverage Sangamo’s proprietary
additional indication for Trelegy Ellipta develop new research tools, resources zinc finger protein (ZFP) technology
(fluticasone furoate/umeclidinium/ and infrastructure to improve delivered via adeno-associated virus
vilanterol) for the treatment of asthma. scientists’ understanding of cancer. (AAV) to modulate the expression of
key genes involved in neurological
The application for the joint GSK The project will also look at diseases.
and Innoviva drug, a once-daily, single- rare and hard-to-treat cancers, In addition to Alzheimer’s, the
inhaler triple therapy, is supported by helping to find better ways to treat partnership will focus on developing
the pivotal Phase III clinical CAPTAIN them, and investigate how to best and commercialising ST-502 for
study. The companies confirmed combine radiotherapy with the synucleinopathies including
that in the study the therapy met its latest immunotherapies, specifically Parkinson’s disease, a third undisclosed
primary endpoint, demonstrating a refocussing research efforts on neuromuscular disease target, and
statistically significant improvement in mesothelioma, an asbestos related up to nine additional undisclosed
lung function compared with the ICS/ cancer, cases of which continue to rise neurological disease targets.
LABA, Relvar/Breo Ellipta. globally. The organisations will collaborate
on a “new gene regulation therapy
As it stands there is no single Dr Iain Foulkes, executive director approach, working at the DNA level,
inhaled triple therapy available for the of research and innovation at CRUK, with the potential to treat challenging
treatment of asthma in Europe, and at said: “If current trends continue, the neurological diseases of global
least 30% of asthma patients continue world will see a 60% increase in cancer significance. We aim to develop and
to experience symptoms even when cases over the next two decades. advance these programs forward to
adherent to ICS/LABA treatment. Cancer is a global problem and no one investigational new drug applications,”
country can tackle it alone. said Alfred Sandrock Jr, executive vice
In October last year GSK also president, research and development
filed for a supplemental New Drug “Now the UK has left the European at Biogen.
Application (sNDA) to the US Food and Union, the need to retain collaborative As it stands, there are no disease
Drug Administration (FDA), seeking cancer research between the EU modifying treatments for patients
the same indication extension. and the UK has never been greater. with diseases such as Alzheimer’s
This partnership will also strengthen and Parkinson’s, mining there is
The drug is already approved in UK cancer research by the sharing an “urgency for the development
the European Union since November of expertise, new technologies and of medicines that will not just
2017 for the treatment of patients research talent.” address symptoms like the current
with Chronic Obstructive Pulmonary standards of care, but slow or stop
Disease (COPD), who are not Earlier this month Immatics the progression of disease,” reminded
adequately treated by an ICS/LABA Biotechnologies announced a Sandy Macrae, chief executive officer
combination, or a combination of new strategic collaboration with of Sangamo.
LABA and long-acting muscarinic GlaxoSmithKline (GSK), in order to He continued, “We believe that
antagonist (LAMA). develop novel adoptive cell therapies the promise of genomic medicine in
targeting multiple cancer indications. neuroscience is to provide a one-time
Recently, Novartis abandoned its treatment for patients to alter their
asthma therapy - fevipiprant - after The news also comes as scientists disease natural history by addressing
“disappointing” results in a late-stage have created one of the most the underlying cause at the genomic
trial, which showed the treatment “detailed” maps of breast cancer ever level.”
did not meet its clinically relevant achieved, showing how the complex Ultimately, Sangamo will receive
threshold for reduction in rate of cancer landscape - made up of cancer $350 million comprised of $125
moderate-to-severe exacerbation cells, immune cells and connective million in a license fee payment and
compared to placebo. tissue - varies between and within $225 million from the sale of new
tumours, depending on their genetic Sangamo stock upon the closing of the
2. European partnerships to makeup. transaction
‘accelerate’ cancer research
3. Biogen, Sangamo team up
By Anna Smith on neurological disease

Cancer Research UK (CRUK) is By Anna Smith
set to invest £27.4 million into seven
new international projects, hoping to Biogen and Sangamo have

51 February 2020

4. Subcutaneous Remsima people with RA from the intravenous they receive their treatment.
launched in UK (IV) formulation to the SC formulation “We anticipate that more
of CT-P13 treatment at Week 30 was
By Anna Smith comparable to maintaining CT-P13 SC personalised and tailored treatments
up to Week 54 will enter the market in 2020.
Celltrion has announced the Competition will be strong in certain
launch of its subcutaneous Remsima Celltrion has also submitted a disease areas and, as a result, we expect
(infliximab) formulation, offering a new further variation to the marketing to see significant reductions in market
treatment option for UK physicians authorisation of the subcutaneous share for the reference products.”
and their patients. drug to include the inflammatory
bowel disease indication, with a In the UK, more than 400,000
The new option is the first and decision expected in mid-2020. people have RA. It typically affects
only subcutaneous formulation of the more women than men and the most
Remicade biosimilar, and is indicated A spokesperson for the company common age for people to develop RA
for the treatment of patients with told PharmaTimes: “The drug offers is between 40 and 60 years old.
rheumatoid arthritis (RA). patients with RA an alternative option
to IV administration through self-
The South Korean company injection at home in less than two
confirmed that the approvals - both minutes, reducing hospital attendance
European and UK - was based on and providing patients in the UK with
clinical evidence including results more flexibility and control over how
from a study that showed switching

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52 February 2020

MANAGEMENT | INTERVIEW

CRITICAL FLUID TRANSFER & SEALING
SOLUTION FOR PHARMA, BIOTECH,
INJECTABLE & F&B PROCESSING INDUSTRY

Please brief us about company’s AND SURGICAL APPLICATIONS. presence in Bangladesh, Germany, Iran,
global reach ? Our head office is in Mira Road, off Switzerland, Dubai, Slovenia, and Spain.
Mumbai; and our manufacturing site Currently, our employee strength is
Alpesh Gandhi: IWe are the is at Silvassa, Gujarat. We have branch more than 275.
leading manufacturer of MEDICAL/ offices in Mumbai, Goa, Indore, Roorkee, Which are your focus areas?
PHARMA/FOOD GRADE PLATINUM Baddi, Sikkim, Baroda, Ahmedabad,
CURED SILICONE TUBINGS, BRAIDED Hyderabad, Vishakhapatnam, Alpesh Gandhi: Our products are
HOSES, INFLATABLE SEALS & SILICONE Bengaluru and Chennai. We also have speciallymadetosuitthepharmaceutical,
RUBBER COMPONENTS FOR MEDICAL, an office in New York, USA; and a direct biotech, food processing, plastics, and
BIOLOGICAL, PHARMA, FOOD PROCESS

Mr. Alpesh Gandhi, Managing Director, Ami Polymer Pvt Ltd February 2020
53

MANAGEMENT | INTERVIEW

medical industries, though we also cater and develop applications after and assure Quick Development, Fastest
to a number of other sectors, such as understanding customer requirements Delivery, Ultimate Quality and also very
steel, engineering, aerospace, textile, and demands perfectly, before Competitive Rates.
solar and steel. developing the product. The R&D
team has also been instrumental in Could you brief us on Indian & Global
Brief us in details about sealing in developing a number of import perspective of your industry?
silicon which you are offering? substitutes. This way, we save on
import duties; are able to do Alpesh Gandhi: Founded in 1996,
Alpesh Gandhi: We offer wide customization faster, and remain cost- Ami Polymer Pvt. Ltd. is a leading
range of silicone rubber products for the competitive. Our emphasis on R&D manufacturer of biopharmaceuticals
most precious and intricate applications also ensures that we don’t have to grade elastomer tubings, reinforced
for the food, pharma, medical and keep inventories for long, and our hoses, gaskets as well as extrude,
heavy engineering sectors in India and products are always of international moulded components – supplying
worldwide. standards. to industries as varied as
pharmaceutical, biotech, food
What is the role of R&D activity in Brief us what are your quality policy processing, plastics, and medical
your company? for your business?

Alpesh Gandhi: We have a Alpesh Gandhi: The Company
full-fledged R&D team that indulge believes in “Be in business with ethics”
in a lot of reverse engineering

54 February 2020

industries, among others. In an interview separately for different regions. It’s a Please send us the product photographs
with Explore pharma, Alpesh Gandhi, boon for those doing legitimate business, or illustration which will go with the
Managing Director, Ami Polymer, throws as transactions have become easier. interview which will be beneficiary for
light on a wide range of matters that GST has not only emboldened those our readers
have defined the company’s growth who are doing legitimate business, but
including its emphasis on obtaining the has also helped increase their number,
best of global quality certifications, and because only those coming under the
the impact of the government policies. GST bracket, are entitled to get credit
The interview extracts. for business transactions. Manipulations
have come down drastically.
What is impact of GST and Budget on
your company? What is your vision for your
company?
Alpesh Gandhi: It’s a great relief for
those having pan-India operations to Alpesh Gandhi: To be global Leader
treat all regions across India as a single in Inflatable Seals, Pharma Tubings and
market, and not having to pay taxes Silicone Rubber Implants.

55 February 2020

56 February 2020

EXPLORE PHARMA 57 JULY 2019

EXPLORE PHARMA 57 JULY 2019
57 February 2020

58 February 2020

59 February 2020

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