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Published on 12/03/08 at 07:52pm

Type 2 diabetes driving epidemic

Type 2 diabetes poses one of the greatest public health threats of the 21st century. As well as increasing the potential patient population, type 2 diabetes has also raised the profile of the disease. However, a new Datamonitor report estimates that while 55 million people are affected by type 2 diabetes, only 50% of patients are diagnosed, and only 80% of those actually receive treatment.

The majority of the western world is in the grips of a diabetes epidemic - driven by type 2 diabetes - that goes hand in hand with the escalating incidence of obesity. However, alarmingly, in some working class and poor communities, the disease is so prevalent that its victims almost take it as a matter of course.

Diabetes is one of the principal causes of blindness, kidney disease, heart attacks and strokes, as well as non-traumatic amputations. The diabetes epidemic has unfolded in conjunction with the ageing global population and rapid cultural changes such as increasing urbanization, dietary changes and decreased physical activity. Datamonitor found that diagnosis rates for type 2 diabetes across the seven major markets ranged from 58% in Germany to a worryingly low 37% in France.

Type 2 diabetes is harder to detect because patients may remain asymptomatic for a long time. As a result, type 2 diabetes is usually only diagnosed as part of a routine check-up, or diagnostic tests initiated as a result of a different condition.

The WHO predicts that developing countries will bear the brunt of this epidemic in the 21st century, with approximately 80% of all new cases of diabetes expected to appear in developing countries. The prevalence of diabetes in these countries is anticipated to reach 330 million by 2025, representing 76% of the total number of people with diabetes worldwide.

The American Diabetes Association predicts that the cost of diabetes will exceed $192 billion in the US in 2020, and the direct cost of diabetes care alone is currently estimated to be $100 billion. Needless to say, there is vast market potential for drugs that can reduce this cost burden.

Diabetes remains one area of the cardiovascular franchise where there is opportunity for growth. Although there are a number of well-established classes of anti-diabetic medications, there is a residual unmet need for an effective, safe drug therapy with the ability to halt or reverse disease progression. It is predicted that by 2016 a large proportion of the top 10 cardiovascular brands will be diabetes therapies.

Particular interest has been shown in the novel classes of incretin mimetics - GLP-1 agonists and DPP-4 inhibitors - that have shown some potential to improve time to secondary failure through pancreatic B-cell salvage; drugs like Merck's Januvia and Amylin/Lilly's Byetta are likely to be adopted by international guidelines and recommended treatment algorithms in the near future.

However, novel compounds are to come under ever-careful scrutiny in terms of long-term safety data. The thiazolidinedione's (TZDs) recently found themselves in the spotlight when GlaxoSmithKline's Avandia's safety was brought into question by Dr Steve Nissen's meta-analysis that associated it with increased risk of ischemic events. This means that physicians and the FDA may require new drugs to stand the test of time before they recommend or initiate them at first- or second-line therapy.

The only non-pharmacological treatment available for type 2 diabetes is dietary advice and the initiation of exercise/weight loss regimes. If aggressive lifestyle modifications are implemented early enough, they can be enough to prevent disease progression, and even reverse the disease. However, as with most diseases, prevention is better than cure. Governments now realize the scale of the obesity problem and recognize the need to take action to combat this super-size scenario.

Related research:

Stakeholder Insight: Type 2 Diabetes " TARGET="_blank">The Diabetes Market Outlook to 2011 " TARGET="_blank"> GlaxoSmithKline plc: PharmaVitae Profile

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7TM and Dr Reddy's join hands in drug discovery

7TM Pharma and Dr Reddy's Laboratories have entered into drug discovery collaboration on selected drug targets in the area of metabolic disorders.

Under the terms of the agreement, 7TM Pharma and Dr Reddy's will collaborate to identify clinical candidates for pre-selected targets. Both the parties will jointly develop these candidates from the preclinical stage up to Phase IIa (proof-of-concept). On successful completion of a Phase IIa study, the companies may either license-out the candidate for further development and commercialization to a larger pharmaceutical company or continue the further co-development and commercialization jointly.

Mette Kirstine Agger, CEO of 7TM Pharma, said: "It is exciting to be working with Dr Reddy's, as they have developed strong R&D capabilities and combining this with 7TMs expertise in the GPCR area and SD3 (7TM's technology platform) we are looking forward to a fruitful collaboration."

AlphaMed announces breakthrough in development of recombinant protein

AlphaMed Pharmaceuticals has successfully expressed a humanized version of the therapeutic protein alpha 1-antitrypsin or AAT.

AlphaMed scientists expressed their recombinant AAT utilizing the company's proprietary production system in yeast. The yeast has been genetically altered to produce a molecule virtually identical to that which is manufactured by the human body.

AlphaMed is currently seeking developmental partners to continue its research for both topical and injectible or inhalable AAT therapies. The company has successfully completed its second round of financing and has initiated a third round to complete Phase I clinical trials and initiate Phase II clinical trials.

Genta and Daiichi sign licensing agreement for oncology product

Genta has entered into an exclusive worldwide licensing agreement with Daiichi Sankyo Company, for the development and commercialization of an oncology product, tesetaxel.

Under terms of the agreement, Daiichi Sankyo will receive upfront payments, payments pursuant to the achievement of certain milestones, and royalties on product sales.

Raymond Warrell, Jr., chairman and CEO of Genta, said: "During our extended analysis of this compound, FDA provided clear and specific guidance regarding the tasks that would be required to lift the clinical hold. We believe these tasks are straightforward and we look forward to resuming key clinical trials."

Neuro-Hitech signs agreement with Numoda to review Alzheimer's study

Neuro-Hitech has entered into an agreement with Numoda, pursuant to which Numoda will review the results of the company's recently completed Phase II clinical trial of Huperzine A in mild to moderate Alzheimer's disease patients.

After completing its review and delivering a report of its findings to Neuro-Hitech, Numoda will also assist the company in interpreting and presenting the results to potential licensing partners, purchasers or acquisition or merger candidates.

Gary Shearman, CEO of Neuro-Hitech, said: "Based upon a detailed review of Phase II results of Huperzine A, we feel confident that there is substantial support within the results that Huperzine A can become a safe and effective treatment for Alzheimer's disease. We continue to plan for future clinical trials and develop our regulatory approval and commercial strategy."

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