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2014 was a
year of unprecedented financial activity for the biotech industry. Nearly 80
biotech IPOs were completed in the U.S. alone, raising a staggering $6 billion.
Globally, over 125 life sciences companies completed IPOs raising over $10
billion. That makes 2014 one of the best years for biotech IPOs in over a
decade and points to how investors are betting on the breakthrough potential of
biotherapeutics.
The good
year was topped off by the spectacular success of Juno Therapeutics Inc.'s IPO
that generated $264 million, making it the largest U.S. biotech offering in the
last 15 years.
Juno is
developing cellular immunotherapies for the treatment of leukemia and lymphoma.
These cellular immunotherapies use human T-cells as therapeutics to recognize
and kill cancer cells. Today, the area of T-cell immunotherapy is a hotbed of
clinical research activity worldwide – applications range from cancers like
melanoma to autoimmune diseases such as psoriasis, multiple sclerosis and rheumatoid
arthritis.
In fact,
Biocon is probably the first company in the world to have successfully launched
a novel Anti CD-6 targeting monoclonal antibody, Itolizumab, which leverages
this breakthrough innovation to treat psoriasis.
Increasing
Acceptance of Biosimilars
The
runaway success of Juno's IPO validates the increasing acceptance of biologics
therapy in modern medicine. The use of biologics – the kind of products that
Juno and Biocon are developing – is fast gaining traction around the globe because
they can address medical needs that conventional therapeutics cannot, including
many cancers, immunological and genetic diseases.
Over the
foreseeable future, more than 60% of new drugs will be biologics. This shift
will be catalysed by a growing preference for these therapies as well as their
progressive genericization as the first set of biologics lose their patents.
The U.S.,
the biggest pharma market in the world, moved closer to articulating a clear
approval pathway for biosimilars in 2014 after the Food & Drug
Administration (FDA) accepted the biosimilar applications of Sandoz, Celltrion
and Apotex. Sandoz filed a biosimilar (351(k)) application with the FDA for a
biosimilar of Amgen’s Neupogen (Filgrastim). Celltrion followed with an application
for its biosimilar of Janssen’s Remicade (Infliximab) and Apotex with its
follow-on version of Amgen's Neulasta (Pegfilgrastim).
China
issued draft guidelines on biosimilars this year, thus becoming the 21st
country to shape a distinct biosimilars regulatory pathway.
The
European Medicines Agency’s approval to Eli Lilly/Boehringer Ingelheim's
insulin glargine product Abasria, a biosimilar of Sanofi’s blockbuster Lantus,
was another significant milestone in 2014.
India also
experienced a build-up of momentum on the biosimilars front with several new
launches in 2014.
Biocon
launched the world’s most affordable Biosimilar Trastuzumab, CANMAb™, for
treating HER2-positive metastatic breast cancer earlier this year. A large
number of patients have already benefited from CANMAb™. Zydus Cadila followed
up with the launch of biosimilar Adalimumab for treating rheumatoid arthritis
and other autoimmune disorders. Ranbaxy too launched biosimilar Infliximab for
treating rheumatoid arthritis in India through a licensing deal with Epirus
Biopharmaceuticals, a US and Swiss-based biopharmaceutical company.
Emerging
Trends-2015
Given the
significant developments in the field of pharma\biotech in Indian and overseas,
here are my predictions for 2015.
>
Increased Traction in Biosimilars
Pressure
on healthcare budgets is leading governments the world over to articulate
regulatory guidelines for expediting the approval of affordably priced
biosimilars for use by the public. As global consensus builds around regulatory
guidelines and the biotech industry approaches its own patent cliff,
biosimilars will begin to gain traction globally in 2015.
As the
number of biosimilars grows and confidence in their safety and efficacy leads
to broad acceptance, I believe we will see a convergence in the interpretation
and implementation of biosimilar guidelines in developed and emerging markets.
>
Surge in Immuno-bio therapeutics
Cancer
immunotherapies, gene therapy and regenerative medicines that can stimulate the
body’s own immune mechanism to fight disease, repair itself and in some cases
provide cures will increasingly score over therapies that simply treat symptoms
of disease.
The use of
immune modulation to augment the body’s normal immune machinery and boost its
ability to fight chronic diseases is currently seeing frenetic clinical
activity. Unlike therapies that treat disease symptoms, these immunotherapy
drugs tackle the problem at its root and thus have excellent safety and
efficacy profile, longer remission periods and low infection rates.
>
Spotlight on Orphan Drugs
Orphan
drugs are going to see heightened R&D activity and regulatory approvals in
2015. Despite the many difficulties of developing new drugs for rare diseases,
Big Data analytics now allow speedy and efficient gathering, integration and
analysis of multiple, large datasets on small patient pools. A record 260
orphan drug designations were granted in the US for 2013, according to
EvaluatePharma's Orphan Drug Report.
Of the 35
new molecular entities approved by the US FDA in 2014, 15 were orphan drug
designations. This makes 2014 the year when the most orphan drug approvals were
given by the FDA since the Orphan Drug Act was implemented in 1983.
Rare-disease
treatments could account for $176 billion in sales by 2020, or 19% of all
prescription drug sales, according to projections by EvaluatePharma.
>
New Pricing Models
Innovator companies are relooking at
their business models and exploring partnering options with existing
Indian pharmaceutical companies to address the affordability and accessibility
issues surrounding their products. After criticism from politicians, activists
and insurers over the $1,000-a-day Hepatitis C drug Sovaldi, U.S. drugmaker
Gilead Sciences has entered into licensing agreements with seven India-based
drugmakers that will sell far cheaper versions of the drug in 91 developing
nations. Gilead has said it would Sovaldi available in Indian at a price of
$300 per bottle, or around $900 for a 12-week course, which is about 1% of the
US price.
Given that
the cost of many new drugs is unsustainable for even the wealthiest countries
in the world, I foresee a growing number of collaborative efforts aimed at
driving down prices and making products affordable to larger patient
populations.
>
New Models of Healthcare Delivery
New
technology will lead to rapid changes in healthcare delivery, especially in
emerging markets.
Already,
new digital technologies are leading to the emergence of decentralized models
of healthcare delivery that capitalize on mobile and point-of-care diagnostics.
Biocon’s CSR wing is involved in a public-private-partnership (PPP) project
that involves the setting up of electronic diagnostic facilities and e-health
centers at primary health centers in rural areas. This model allows the capture
of patients’ vital statistics like blood pressure, pulse, haemoglobin and blood
sugar. These patient records, which are available on an electronic system,
provides easy access for treating doctors both at the primary health centers
and at tertiary hospitals. These online patient records allow telemedicine
consultation for patients who require specialist advice and provide doctors
with the relevant information needed for accurate diagnosis and medicine
prescription.
This
patient data can also be made available to the government to study disease
patterns and to create a database, which will help implement evidence-based
health care interventions.
Conclusion
Overall,
2015 promises to be an exciting year for the pharma\biotech industry as new technology and globalization creates a world that is a
boundary less bazar of equitable opportunities interconnected and supported on
a shared platform of knowledge. I truly believe that knowledge- sharing will
lead to the development of research-driven cutting-edge therapies that can
address the relatively unmet needs of patients through differentiated products
in challenging therapeutic spaces and thereby address the global right to
healthcare.
Kiran Mazumdar Shaw, CMD, Biocon Ltd
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