roglitazar), India’s first NCE. Zydus
developed a 4 mg once-a-day pill that
can simultaneously control cholesterol
and glucose levels – a first of its kind
drug for Hypertriglycerdemia (elevated
triglyceride levels) and Diabetic Dys-
lipidemia (high cholesterol in diabetic
patients not controlled by statin drugs).
Now sold only in India, Lipaglyn is al-
ready a `50 crore drug.Hard Push
Though named in the ‘glitazar’ class of
drugs, which had safety issues, Lipa-
glyn’s molecular structure is different
from the glitazar family of drugs, says
Sharvil Patel. Zydus plans to take the
drug global. It is undergoing second
phase clinical trials in the US for treat-
ment of severe Hypertriglyceridemia
and Non-Alcoholic SteatoHepatitis (a
disease in which fat accumulates in the
liver). For treating fatty liver, according
to Sharvil Patel, there is no single-dose
pill available in the market and so he
feels their drug’s global potential is about
$25 billion (about `1,72,569 crore). Clin-
ical trials are on in India and the US for
additional indications like diabetes.
Zydus has already spent many hun-
dreds of crores to develop Saroglitazar
and is keeping fingers crossed for posi-
tive Phase II outcome by year-end. “We
have encouraging results so far, and if
everything goes well, it may take two-
three years for commercialisation in the
US. On a conservative basis, Saroglitazar
can become a $4-5 billion drug,” he says.
Another NCE under development is
Desidustat, an oral pill in the final phase
of clinical trials in India for treating anaemia in pa-
tients with chronic kidney disease (CKD). Currently
available agents for the treatment are injectable drugs
and intravenous iron supplements. The estimated
global market for treatment for anaemia related to
CKD is $10 billion, but it is too early to factor it rev-
enue plans, says Sharvil Patel.
Zydus is also developing NCEs in pain management
and cancer, but those are still to reach the clinical stage.
In the case of new biotech drugs called NBEs, Zydus has
already successfully developed an injection for rabies,
in collaboration with the WHO. Rabimab, a cocktail of
two monoclonal antibodies, is a first-in-class and has to
be injected at the site of the wound. This may be worth
hundreds of millions of dollars globally and Zydus plans
to take the injection to the US as well, besides getting
pre-approvals from the WHO.oping vaccines for diseases such as chikungunya, HPV
and hepatitis. Apart from the governments and WHO-
related vaccine business, Zydus also has a 100 crore private vaccine business. “Many of our vaccines, like for Varicella (chicken pox), do not have many competitors and I expect this business to grow to $200-250 million (1,381-1,726 crore) by 2023/24,” says Sharvil Patel.
He expects to earn about $500 million (3,452 crore) a year in the next four to five years from the sale of vaccines and biologics alone in India and emerging markets. The present size is much smaller: only about 300 crore.
But the biggest bet for Pankaj and Sharvil Patel is
the NCE segment, which the father heads. The Zydus
Research Centre in Ahmedabad is a 475,000-square
feet facility that employs over 400 scientists. In 2013,
the company announced the launch of Lipaglyn (Sa-
64 I BUSINESS TODAY I August 11 I 2019TOUGH
BUSINESS
NEW DRUG research takes 10-15
years and millions of dollars.
Shareholders are reluctant to
invest for that long, and finding
alternative funding sources
for such a long period, with
no returns, is difficult. Add to
that the fact that eight of 10
promising molecules that reach
clinical trial stage fail. Many
Indian companies have tried
and failed in this pursuit.
In 1997, scientists at Dr
Reddy’s Laboratories in
Hyderabad discovered a
molecule to treat Type-2
diabetes, Balaglitazone (named
after Tirupati deity Balaji). A
drug research company was
formed with funding from ICICI
Venture and a couple of PEs.
Two diabetes molecules under
development were licensed for
clinical trials. A few years later,
some lab rats died and trials in
the third and final phase were
discontinued. Within a few
years, the company stopped its
new drug research in the US,
and subsequently put new drug
discovery on a backburner.
Ranbaxy pursued a unique
malaria drug called Arterolane
till the last stage of trials. But
its sponsor, Medicines for
Malaria Venture (MMV), a WHO
body, backed out in 2007. In
2010, Ranbaxy's new owner,Daiichi Sankyo, merged its
new drug research with the
parent R&D department. Since
then there has been no news
of discoveries. Eventually,
Ranbaxy was sold to Sun
Pharma, which focussed more
on new platform technologies
for specialty generics than new
drug research.
The Piramals formed a new
drug discovery company in
2007, Piramal Life Sciences. In
2011, it was merged with Piramal
Enterprises, after the sale of
its formulation division. At one
point, the company had over
400 scientists and succeeded in
developing a biological drug for
cancer, which failed in 2012 in
the second phase of trials. Two
years later, Piramal exited drug
discovery.
Glenmark succeeded in
out-licensing seven molecules
to MNCs. But it could not take
any of these to global markets.