Can Invokana Do A Januvia In India?

Invokana has all the attributes to be a winner, to go by comments from Janssen India, but achieving success for the new diabetes brand will hinge on pricing, deft marketing and wide acceptance from medical practitioners. Ace marketing executive and chief of the subsidiary’s pharma business, Sanjiv Navangul, apparently also plans to deepen access to the drug in India through other new approaches.

MUMBAI – A sharply increasing diabetic population, a distinctly differentiated mechanism of action, good safety profile and flexibility in treating patients across the spectrum – these factors and more are what Janssen Inc.’s India executives hope will work favorably for their newly launched, first-in-class sodium glucose co-transporter-2 (SGLT-2) inhibitor Invokana (canagliflozin).

As for pricing, which is an oft-debated point for patented products in India, compared to MSD’s Januvia (sitagliptin) - seen by medical specialists as its nearest rival - Invokana will be available at INR51 ($0.82) per tablet or about INR8 costlier, but still significantly lower than the price charged for Invokana in the U.S.

Raring To Go

The overall effort for Invokana in India is being led by Sanjiv Navangul, Managing Director, Janssen India, known for his extensive work in propagating a unique disease management approach for Januvia in his previous stint at MSD India, and taking it to record sales within a few years.

Launched in the U.S. back in 2013, Invokana sailed through Indian regulatory review procedures earlier this year, and at least two more approvals are expected to follow suit in the same class for rivals AstraZeneca PLC and Boehringer Ingelheim GMBH (Also see "Green Light For Janssen’s Canagliflozin In India" - Scrip, 4 Jan, 2015.) and (Also see "AZ’s Dapagliflozin Closes On Canagliflozin With India’s SEC Nod" - Scrip, 2 Oct, 2014.).

Navangul indicated a limited first mover advantage in India in explaining the differentiated approach of Invokana, but given the sheer size of the local market he noted that advantage may fade as new drugs are introduced.

Janssen already markets its glucometers in India and may leverage its existing connections with diabetes specialists to market Invokana through a newly set up dedicated marketing team. But AstraZeneca and Boehringer also both have their respective inroads through existing DPP-4 inhibitors, namely Trajenta (linagliptin) and Onglyza (saxagliptin) (Also see "India Case Study: Novartis’ Galvus Inches Closer To Merck’s Januvia As Battle For Brand Supremacy Rages On" - Scrip, 30 Nov, 2011.).

Also, Janssen did not rule out partnerships with local generic players and said “those options are always on the table,” noting that the real point to examine is the value that such partnerships can bring to doctors and patients.

Briefing media, Vikram Singh, head of medical affairs and pharmacovigilance, Janssen India, highlighted Invokana’s mechanism of action as different from the existing therapies. Citing global guidelines shared by the American Diabetes Association, Singh said the drug has been recommended for use second after metformin, mostly crediting the “outstanding clinical development of the drug, a good portion of which was done in India.

“The kidney plays an important role in the metabolism of glucose and the pathogenesis of diabetes but till now the kidney has not been explored as a route to effectively manage diabetes, and SGLT-2 inhibitors actually act through kidneys and prevent kidneys from reabsorbing the glucose and hence allowing it to filter out through urine,” he said.

Safety, Efficacy Data Robust

The product had been assessed for efficacy and safety in over 11,000 patients at the time of filings with the U.S. FDA, including a thousand patients from India, who were tested from early stage patients on monotherapies and also in combination with sulfonylureas, gliptins and as an add-on to insulins. Singh noted that the longer duration of Invokana is a feature that scores over conventional sulfonylureas and gliptins, which were seen to wane faster compared to Invokana in clinical studies.

“For the 300mg dose [of Invokana], actually the efficacy was significantly better than the other drugs. Apart from that the safety profile was found to be very good and produced benefits like significant weight loss and better control of blood pressure,” he said.

Interestingly, Invokana is undergoing a long-term cardiovascular outcome and safety analysis study termed CANVAS and company officials said they expect the results to be disclosed by 2017.

Asked if the side-effects seen in other SGLT-2 drugs in Japan may pose a challenge in India, Navangul said Invokana data had been similar to that seen in clinical trials and expressed confidence that the drug will show a good profile in the ongoing studies.

Addressing Access Issues?

Sales of Invokana in the U.S. are starting to pick up lately and in the first quarter of the year jumped nearly three-fold to $278 million. Stressing that the drug may see a quick pick up in India, Navangul asserted that the acceptance of Invokana was also fast in the U.S. as compared to other therapies when new prescription generation was assessed.

“Every medical community is waiting for an option for a product that has a good safety and efficacy profile,” he said. But he cautiously added that it was important to see where the medical community positions Invokana in their course of treatment, and that this will give a better indication after three to six months of the confidence level.

Navangul said the likelihood of Invokana becoming a hit in India can be gauged from the high patient numbers, pegged at over 60 million at present, in addition to the fact that no diabetes treatment has a high market share, as only 40% of patients may be getting treatment (Also see "India Faces Diabetes "Tsunami," Conference Told" - Scrip, 1 Dec, 2008.).

“I think the ability to create more access for our drug is more relevant at this stage to understand revenue projections in India,” he remarked, hinting that with the success of the DPP-4 market in India, certain expectations and benchmarks can be built for future sales from new products.

Questioned if the company will look at new access strategies, Navangul said the internet had equalized a lot of knowledge and that there is no longer a knowledge divide. “We need to concentrate on the issue of how we help doctors to manage the patients well and how we can partner with the medical community to see better outcomes.

“It is not important to see how many patients we treat at a time as much as looking at better compliance and better outcomes for the patient because that is where the economic burden is important to start thinking about,” he said.

Clearly, the company also plans to work on additional strategies for penetrating the drug deeper in India, as Navangul added: “Watch this space for how we think we can lead in the industry on trying to understand what works better in this area,” underplaying pricing as a key access barrier to patients. But no further details were revealed for the time being.