Mr
B N Manohar,
CEO, Stempeutics
Stempeutics, a stem cell
company
developing stem cell-based medicinal products, with facilities in
Bangalore, Manipal and Kuala Lumpur, is in the process of bringing the
first stem cell therapy product to the Indian, European and North
American markets
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Bangalore-based Stempeutics Research, a group company of Manipal
Education and Medical Group, opened the first-of-its-kind stem cell
research facility in Malaysia, citing the ease in getting early
approvals. Since its inception in 2008, Stempeutics has been working
together with the leading medical institutions in Malaysia, to drive
long-term research activities to further strengthen its leadership
position in the area of stem cell research.
Malaysian Presence
As a result of collaborative efforts, Stempeutics Research announced in
May 2010, that it has received clearance from Medical Research and
Ethics Committee, Ministry of Health, Malaysia, for conducting human
clinical trials in patients with ischemic cerebral stroke (CS), using
investigational new drug (IND)-based on mesenchymal stem cells, derived
from donated bone marrow.
Stempeutics became the first international company in Malaysia to get
the bionexus status from BiotechCorp. Also it has received National
Pharmaceutical Control Bureau (NPCB) certification for its
manufacturing facility for conforming to the requirement of current
good manufacturing practices (cGMP), in accordance with the
Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP guidelines
and its relevant annexes for isolation, processing and storage of
mesenchymal stem cells. Stempeutics is the first stem cell company in
Malaysia to have obtained this conformance certification. Stempeutics
has spent nearly
30 crore to set up a facility at Malaysia, with a
strength of 20 members. “We are planning to invest another
20 crore in
Malaysia to develop our first product from there. The phase II clinical
trials for our product ‘Stempeucel’ have been successful. We aim to
complete the phase III trial by 2013 and launch the product in the
market by 2014,” says Mr B N Manohar, CEO, Stempeutics.
“We have a very favorable environment in Malaysia where we get tax
benefits up to 10 years from the date we start making profit. Along
with that we have other customs duty incentives. With NPCB approval, we
can go to nearly 20 other countries which come under the Organization
of Islamic Conference (OIC), without any further clinical trials,” adds
Mr B N Manohar while commenting on the presence in Malaysia.
Global Challenges
On the challenges while entering the global market, Mr Manohar says,
“In the case of other countries, the main challenge is the regulatory
procedures. Especially, since we are focusing on the stem cell market
with no specific verified guidelines, we need to ensure that it is
universally acceptable. With the source being of Indian origin, its
acceptability abroad again poses as a challenge for us while we plan to
venture abroad. The regulatory guidelines in clinical trials has to be
followed. Money too plays a major factor when you plan to enter
the global market.”