'We have enhanced patient access to insulin across India'

According to the Indian Heart Association, India is the diabetes capital of the world with a projected 109 million individuals with diabetes by 2035.

The disease currently affects more than 62 million Indians, which is more than 7.1% of India’s adult population. The high incidence is attributed to a combination of genetic susceptibility plus adoption of a high-calorie, low-activity lifestyle by India’s growing middle class. Additionally, a study by the American Diabetes Association reports that India will see the greatest increase in people diagnosed with diabetes by 2030.

With the increase in the incidence of diabetes in the country, DH’s Narayan Kulkarni spoke to Kiran Mazumdar-Shaw, Chairperson and Managing Director, Biocon, the first company worldwide to develop human insulin on a Pichia expression system to share Biocon’s programmes to reach the needy and its market share in the country. Excerpts from the interview:

According to a latest WHO report, the number of diabetes deaths in India is about 220,000. What kind of programmes are in place to reach the needy in the country?

Biocon entered the diabetes space over a decade ago when the disease was assuming epidemic proportions in India but treatment was, by and large, inaccessible to most due to the high cost of treatment. We, therefore, focussed on developing an affordable form of insulin in India using an innovative home-grown technology. In 2004, we successfully introduced our recombinant human insulin Insugen at less than half the prevailing prices, compelling MNC brands to drop prices, which hugely benefited diabetes patients. We launched Basalog, a long-lasting basal Insulin Glargine for type 1 and type 2 diabetes, at an affordable price point in 2009. Since then, we have been addressing the large need for affordable insulin therapy in India through our generic rh-insulin, analogs and easy to use devices. We have enhanced patient access to insulin across India through affordable therapy, resulting in improved diabetes management.

Our CSR arm, Biocon Foundation, has been working tirelessly at increasing diabetes awareness among marginalised communities through diabetes camps. Last fiscal, the footfalls at these camps crossed the 6,000-mark. Nearly 6,000 more benefited from the home visits that we conducted under this programme.

Our efforts are aimed at raising awareness about managing diabetes through a holistic disease management and lifestyle modification programme. Our endeavour is to empower ‘people with diabetes’ with the ability to ‘win with diabetes’ through treatment compliance, lifestyle modification, nutrition management and regular exercise.

Our patient-support programme, Winning With Diabetes, focuses on creating awareness on diabetes management and leading a healthy life through lifestyle modifications. Cumulatively, almost 3.50 lakh patients have been benefited by our diabetes care helpline. Similarly, nearly three lakh patients have received support through the Insulin Therapy Assistance Programme initiative aimed at better patient compliance to insulin therapy.

Over and above these programmes, we collaborate with the medical community for diabetes detection camps, patient education programmes and walkathons nationwide. Last fiscal year, over two lakh individuals were screened and nearly 25,000 participated in a comprehensive six-month diabetes education programme delivered by trained educators. We also collaborated for a new first-of-its-kind initiative that targeted the general public, The Diabetic Food Trail. Diabetes-friendly healthy food menu options were offered at over 120 restaurants across Mumbai, Delhi, Chennai and Bengaluru.

What are the updates relating to oral insulin (Insulin Tregopil) programme and when will it be launched?

Insulin Tregopil, a high potential oral insulin analog for type 1 and type 2 diabetes patients, is one of our key novel molecule programmes. We had declared positive results from the Phase I studies earlier this year in January. At this stage, we plan to take the asset into the next phase of clinical trials.

The next phase of development will look to validate the key findings from the Phase I studies in a larger patient population set. We are being advised by key opinion leaders and experts in the field of diabetes and endocrinology, and this, we believe is going to position us in a very attractive way for this asset. We will evaluate partnering or licensing the molecule for late stage development and commercialisation at a later date.

As a prandial insulin, Tregopil can prove to be a powerful weapon in the battle against diabetes, especially considering that the number of patients globally is expected to increase from almost 387 million in 2013 to 592 million by 2035.

In India, there are over 15 players in generic insulin with over 100 brands. What is the market share you have in this competitive market after launching India’s first human insulin in 2004?

Biocon has a 10% share in the Indian insulin market. Insugen is the biggest Indian brand of insulin. Basalog is the leading brand of Glargine. The launch of Basalog One, a ready-to-use disposable device in FY16, has strengthened our existing Basalog portfolio of vials, refills, and reusable devices. Basalog reported over 30% growth in the first quarter of FY17, which is significantly ahead of the market.

Our key diabetes therapies and our complementary portfolio of affordable treatment options for associated cardiovascular diseases have enabled us to create a holistic treatment portfolio for co-morbid diabetes, hypertension, and dyslipidemia.
(For full interview, visit www.deccanherald.com)

Globally the human insulin market is growing at a CAGR of 8.1%. What about the growth rate of Biocon in this space?

Globally, we are among the top three biosimilars players in rh-insulin and Insulin Glargine in terms of market share. Today, we enjoy market approvals in over 60 countries for rh-Insulin and over 20 countries for Insulin Glargine.

To target the opportunity for rh-insulin in the US market, we have entered into a co-development agreement with our long-standing Mexican partner, LaboratoriosPiSA.  Through this collaboration, we will introduce rh-Insulin under the Biocon brand to address the $1.5 billion-market opportunity in the US.

We crossed a significant milestone in Malaysia in Q1FY17 with Biocon’s rh-Insulin becoming the first product manufactured in Malaysia to be approved for commercialisation by the Ministry of Health (MoH), Malaysia. Biocon’s Insulin Glargine was also approved by the MoH, Malaysia. These approvals will open up commercialisation opportunities for the company and will enable us to address the needs of nearly 3.3 million diabetes patients in Malaysia. Regulatory filings for several other emerging markets are underway to enable commercial sales from the Malaysian facility.

We recently launched Insulin Glargine in Japan through our partner FUJIFILM Pharma. The Japanese launch for Glargine is likely to open some markets for us that rely on a developed country approval and provides confidence in terms of approvals in other developed markets. We are also developing Insulin Glargine for the developed markets outside of Japan in collaboration with Mylan. We are on track for filing Insulin Glargine in the EU and the US in FY17.

Biocon’s pipeline of generic human insulin and insulin analogs under development represent a global market opportunity of $18 billion as measured by innovator sales in calendar 2015.