Mundipharma Announces Launch of INVOKANA® and VOKANAMET® in Norway for the Treatment of Type 2 Diabetes as Part of Exclusive Distribution Agreement with Janssen

CAMBRIDGE, England–(BUSINESS WIRE)–The Mundipharma network of independent associated companies is pleased
to launch the type-2 diabetes mellitus (T2DM) treatments Invokana^®
(canagliflozin) and Vokanamet^® (canagliflozin,
metformin) in Norway. In line with the partnership with Janssen
Pharmaceutica NV, Mundipharma now exclusively distributes and markets
these treatments across 18 countries in the European Economic Area (EEA)
and Switzerland. With the launch in Norway, Invokana and Vokanamet
are now available across the whole of Scandinavia, following
the launches in Sweden and Denmark.

Invokana, a once-daily oral tablet, is part of the sodium glucose
co-transporter 2 (SGLT2) inhibitor class and has been approved in the
European Union since 2013.² Vokanamet combines two
oral glucose-lowering medicinal products (canagliflozin and metformin)
with different and complementary mechanisms of action.

“We are delighted to extend our European footprint for Invokana
and Vokanamet to provide healthcare
professionals in Norway with two new treatment options to manage type 2
diabetes,” said Dr Vinicius Gomes de Lima, European Medical
Affairs Lead. “Type 2 diabetes is a growing epidemic in Europe and
effective treatments are needed to help reduce the burden of the disease
in patients. Invokana and Vokanamet
have shown improvement in glycaemic control and reduction of
cardiovascular morbidity and mortality as well as improvements in renal
outcomes which is of real importance in this disease.”

Approximately 58 million people in Europe currently live with T2DM,
which is set to rise to 67 million by 2045.  If left
untreated, patients are at greater risk of developing serious
complications, such as cardiovascular (CV) disease and kidney failure.

Last year, the European Medicines Agency (EMA) approved label updates
for Invokana and Vokanamet to include data on the
reduction in major adverse CV events in patients with T2DM who had
either a history of CV disease or at least two CV risk factors.
The label update was supported by the results from the CANVAS clinical
trial, the largest completed CV outcomes trial to date for an SGLT2
inhibitor.⁶ The American Diabetes Association (ADA) and
European Association for the Study of Diabetes (EASD) also issued a
Consensus Report in October 2018 which recommends SGLT2 inhibitors with
a proven CV benefit as the preferred oral treatment after metformin for
T2DM patients with chronic kidney disease (CKD) or clinical heart
failure and atherosclerotic CV disease.

New data for canagliflozin from the CREDENCE study will be presented at
the upcoming World Congress of Nephrology during the late-breaking
abstract session on Monday 15^th April. The study evaluated
the effect of canagliflozin on renal protection in patients with T2DM
and CKD.