Drug industry analysts say that Pfizer Inc.’s decision to abandon its inhaled insulin product Exubera will be a major blow to the ongoing portfolio restructuring exercise initiated in India by Pfizer Ltd.
Exubera was viewed as a significant brand to be added to the domestic portfolio for the Indian company, which is a 49% subsidiary of the US drug maker.
Pfizer India, after divesting the consumer health business following a global deal by the parent, has been in the process of restructuring its product portfolio by introducing at least five-six new products from the international pipeline to sustain the growth. Exubera was one among them for which the company had prepared a local market analysis.
In an earlier interview, Pfizer India managing director Kewal Handa had said the company had “applied for necessary clearances and that it was gearing up for the launch of Exubera here.”
On Monday, a Pfizer India spokesperson said: “The parent company has announced that it will be returning the worldwide rights for Exubera to Nektar, the company from which it licensed the inhaled insulin technology. This is a decision by Pfizer to stop marketing Exubera globally. We will not be launching the product in India or any other country where the product has not been launched as yet.”
“In India, a few patients have been prescribed Exubera by their treating physicians,” said the spokesperson. “Pfizer will support these patients for the next three months. In this period we will encourage their treating physicians to help them transition to other glucose-lowering therapies.”
Pfizer will take a charge of $2.8 billion for costs associated with Exubera, making it one of the most expensive failures in the history of the pharmaceutical industry. The abrupt discontinuation also calls into question whether inhaled insulin, once viewed as a potential multibillion-dollar market worldwide, will ever be able to compete with conventional injectable insulin as a treatment for diabetes.
A pharma analyst with Edelweiss Securities Pvt. Ltd said: “Though diabetes is not a large therapeutic segment for Pfizer at present, Exubera would have been an important product for the company in India to sustain growth in the wake of the divestment of its consumer health business, which was actually supporting its revenue flow to a great extent.”
Sujay Shetty, associate director (pharmaceutical and life sciences practice), PricewaterhouseCoopers India, said: “Since the country is one of the largest diabetes markets in the world at present, any new products for diabetes management would have been successful in India, provided the market positioning is worked out well, though it is difficult to make specific comments about Exubera impact on Pfizer at this point in time.”
“With the world’s largest population of diabetics, India was set to see the launch of a range of novel diabetes treatments from foreign drug makers such as Pfizer, Eli Lilly and Merck. The companies are variously pitching convenience, innovative delivery systems or a touch of the esoteric and Pfizer’s Exubera was important among these new launches,” said another leading analyst, who is not authorized to be quoted.
The Rs1,200 crore domestic diabetes treatment market is growing at 20-22% a year, with various forms of insulin accounting for the largest chunk, Rs310 crore. India has 32 million diabetics and the number is estimated to grow to 57.2 million by 2025.
Merck & Co.’s Januvia is a pill that needs to be taken only once a day. And Eli Lilly will soon launch Byetta, a product developed from the saliva of the gila monster, which helps in controlling diabetes and in weight loss.
(Alex Berenson of The New York Times contributed to this story.)