While injury lawsuits over the diabetic medication Invokana (canagliflozin) continue to pile up against Johnson & Johnson subsidiary Janssen Pharmaceuticals, the manufacturer has entered into a distribution agreement with U.K.-based Mundipharma, giving the British company exclusive rights to sell Invokana and Vokanamet (known as Invokamet in the U.S.) in the European Union and Switzerland.
Like Johnson & Johnson, Mundipharma is a megalithic pharmaceutical giant, with numerous subsidiaries and divisions operating in over 120 countries around the world. Janssen will continue to produce the medication and will assist in dealing with some of the regulatory matters, but Mundipharma will have all rights pertaining to marketing, distribution and sales in 14 out of 17 European countries where reimbursements have been secured.
According to Mundipharma executive Chris Surridge, the agreement is about strengthening partnerships and preparing the primary care staff “as quickly as possible in order to get these medicines to patients that need them.” Cyril Titeux, vice-president of EMEA Stretegy at Janssen’s Paris headquarters, adds, “We at Janssen are committed to providing the best possible outcomes for people with type 2 diabetes and to ensuring Invokana and Vokanamet get to the people who may benefit from it the most.” He expressed his belief that the new partnership was the best way to achieve this stated goal.
However, there is some speculation that Janssen is concerned about their ability to grow Invokana sales in Europe, where – unlike the U.S. – there are strict pricing controls and greater competition. Industry observers note that sales of Invokana and Invokamet were down by 23% during the second quarter of 2017 compared to the year before.
This fall in revenue may very well be attributable to the growing litigation over Invokana, which has been linked to numerous injuries, including kidney failure, osteoporosis, diabetic ketoacidosis, heart attacks and lower limb amputations.
Allegedly, research and development staff as well as executives at Janssen and Johnson & Johnson were aware of these risks even before they submitted an application for approval. In 2009, just prior to Invokana’s approval, two prominent physicians expressed serious concerns to the FDA over the potential risks, as well as doubts about the clinical study. Despite these fears, approval for the drug was granted on the condition that Janssen would continue to conduct post-marketing studies. The rationale was that the risks of side effects were outweighed by the potential benefits.
Despite this, the European Medicines Agency began requiring a package label warning this year advising patients of the amputation risk. In the U.S., the FDA has not gone that far, but has issued an “advisory” to physicians about results of a recent clinical trial in which an association between Invokana and lower limb amputations was noted. Since then, that link has been confirmed. Some doctors in the U.S. are no longer prescribing Invokana. It has even been dropped from some insurance plans.
It is not certain what Janssen hopes to accomplish in its new partnership with Mundipharma, but chances are that they are going to attempt to milk every dollar or euro from Invokana before it is either taken off the market or dies a natural death because of a lack of sales.