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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.
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.
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