Although diabetes has been high on the radar screen of healthcare providers and public health administrators for years, the number of patients (mostly Type 2, or adult-onset) continues to rise—and at a pace that is accelerating. The Centers for Disease Control and Prevention counted 18.8 million diagnosed cases in 2010, and 7.0 million undiagnosed—25.8 billion total, or 8.3% of the US population. Worldwide, the World Health Organisation (Geneva) estimates that 346 million people have diabetes.
Today, many are eagerly awaiting the FDA approval of the several new medications in the latest class of antidiabetic therapies — the SGLT-2 class (SGLT stands for sodium glucose transport inhibitors). Lasky notes that “the SGLT-2 class of diabetes therapies is truly innovative, as these medications will be the first of their kind whose MOA is to remove excess glucose — the offending item — from the body, by increasing the amount of glucose eliminated by the kidneys.” Investigational data show that this can lower blood glucose levels and help to reduce body weight.
Today, dapagliflozin from AstraZeneca/Bristol-Myers Squibb is expected to be the first to launch (as it has been filed with FDA); however, an FDA Advisory panel recently voted against approval of dapaglifozin due to possible cancer risks. Johnson & Johnson’s canagliflozin and Boehringer Ingelheim’s empagliflozin are in Phase III, and several other companies have SGLT-2 compounds in Phase II development.
The race for the top of India's fast growing anti-diabetes drugs market is heating up, with the Indian arm of German pharmaceutical drug firm Boehringer Igelheim (BI) accelerating its plans to launch Jardiance, its latest bet in a new class of anti-diabetes drugs named SGLT-2 inhibitors (sodium glucose cotransporter 2).
Global firms such as Janssen Pharmaceuticals and AstraZeneca are ahead with their local launches in the same drug segment, but BI expects an edge with Jardiance in the backdrop of its recently disclosed clinical trial data that demonstrated a clutch of benefits in addition to offering better glucose control against existing compounds.
Also, as a class, SGLT-2 compounds have shown significant weight reduction when pitted against older drugs that have often led to weight gain or have remained weight neutral. The long term clinical trial for empagliflozin — known as EMPA REG — was conducted on 7,000 patients, of which a large pool of patients were from India, top company executives told ET.
BI, which has a relatively new presence in India, has seen a strong acceptance for its existing offerings such as Trajenta and Trajenta Duo, two patented drugs that compete against similar brands from Novartis, Merck and AstraZeneca.
Sharad Tyagi, MD, Boehringer Ingelheim, said the larger aim is to lead the segment and the benefits of Jardiance should see it emerge as a much stronger product in the market.
Tyagi said BI is "looking at seriously evaluating local partnering opportunities closely", but added the thought is more about building the value of the molecule and brand and how the science is presented. BI, for itself, has more than doubled its specialised field force for its anti-diabetes drugs from 160 around two years ago to 400. AstraZeneca's competing brand Forxiga is available in India for 43 a tablet while Janssen's Invokana is marketed at 51 per tablet. The Indian market for anti-diabetes products is primarily formed by hundreds of branded generic drugs.
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