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First DPP-4 Inhibitor for Type 2 Diabetes in NZ

28 February 2008


World’s First Approved DPP-4 Inhibitor for Type 2 Diabetes Now Available In New Zealand


New Zealanders with Type 2 diabetes now have access to a new medicine which is significantly less likely to cause weight gain or dangerously low blood sugar; thanks to Merck Sharp & Dohme New Zealand's (MSDNZ) once-daily tablet, JANUVIA® (sitagliptin, MSD), which was approved for use in New Zealand today.

Whilst there have been no new oral medications for New Zealanders with Type 2 diabetes since 2002, an injectable incretin mimetic was registered in 2007. JANUVIA is expected to be available to purchase on prescription from March.

JANUVIA is the first in a new class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors which enhance the body’s own ability to lower blood sugar (glucose) when it is elevated. This unique way of working is different from any other Type 2 diabetes treatments available in New Zealand.

Professor Russell Scott, Christchurch School of Medicine and Health Sciences, says, “DPP-4 inhibitors are an important breakthrough. Approximately two out of three adults being treated for diabetes are not achieving target blood sugar levels, suggesting that current therapies have significant limitations.

"JANUVIA is an exciting new medicine that effectively lowers blood sugar levels with fewer of the unwanted side effects often associated with existing therapies, such as weight gain and abnormally low blood sugar. This lack of side effects and the fact it only needs to be taken once daily, means people are more likely to stay on their medication and keep within their target blood sugar range."

Managing Director of MSDNZ, Alister Brown, says "JANUVIA is an important new advance in diabetes therapy and as a company we are committed to developing world class products that will support the work already underway in New Zealand, and around the world, to help prevent and manage this serious epidemic. There are approximately 214,000 New Zealanders currently affected by Type 2 diabetes and this is likely to grow to over 385,000 in the next 15 years.

"People with diabetes can develop heart disease, kidney disease, blindness and arterial problems resulting in limb amputation, and increase mortality. This costs the New Zealand health system upwards of $540 million every year and this figure continues to increase."

President of Diabetes New Zealand, Mike Smith, says "While the Government has made diabetes a health priority, there have been no new medications or technologies for improving diabetes control for a long time, which is frustrating for the many thousands of New Zealanders who are not able to achieve their glucose targets.

"An increased investment by the Government early in the diabetes treatment process has the potential to significantly reduce the long term costs of diabetes, while also improving the health and wellbeing of New Zealanders. If left unchecked the cost of Type 2 diabetes is projected to triple by 2021 to more than $1.78 billion – a figure equivalent to 15 percent of New Zealand's healthcare spending."

JANUVIA is now available in 60 countries and is comparable in cost to other modern, once daily diabetes medicines which are currently funded in New Zealand. MSDNZ is entering into negotiations with PHARMAC about funding JANUVIA for patients who could most benefit.

New Zealand contributed to the global clinical trials for JANUVIA which were undertaken in Europe, Asia Pacific and the Americas. The trials were conducted over the past five years with 146 New Zealand patients from five regions taking part.

ENDS

About JANUVIA
JANUVIA is Merck Sharp & Dohme’s oral, once-daily dipeptidyl peptidase-4 (DPP-4) inhibitor for the treatment of type 2 diabetes. In controlled clinical development studies JANUVIA was not associated with weight gain from baseline, and the incidence of hypoglycaemia (when blood sugar becomes too low) was similar to placebo.

JANUVIA is a potent and highly selective DPP-4 inhibitor. DPP-4 inhibitors work by enhancing a natural body process that lowers blood sugar, the incretin system. When blood sugar is elevated, incretins work in two ways to help the body regulate high blood sugar levels: they trigger the pancreas to increase the release of insulin and signal the liver to stop producing glucose. DPP-4 inhibitors enhance the body’s own ability to control blood sugar levels by increasing the active levels of these incretin hormones in the body, helping to decrease blood sugar levels in patients with type 2 diabetes.

About Type 2 Diabetes
Type 2 diabetes is a condition in which the body has elevated blood sugar or glucose. With Type 2 diabetes, the body may not make enough insulin (which helps the body use glucose), and the insulin that the body produces may not work as well as it should.

Patients with diabetes can develop heart disease, kidney disease, blindness, vascular or neurological problems that can lead to amputation, and they can suffer increased mortality.

Diabetes is one of the most significant diseases affecting the modern age. Diabetes is the fifth leading cause of death globally. Currently, more than 194 million people worldwide have diabetes. If nothing is done to slow the epidemic, the number will exceed 333 million by 2025.

About Merck
Merck & Co., Inc., which operates in many countries as Merck Sharp & Dohme (MSD), is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines in more than 20 therapeutic categories. The company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.

Recognising the toll that the diabetes epidemic is taking globally, Merck & Co., Inc has committed its research efforts toward diabetes as one of the nine major therapeutic areas of focus to help bring hope to patients and stop this growing pandemic.

Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2005, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.

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