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Turn of The Decade: Novel Glp-1’s To Emerge as the New Leader in Diabetes Class

  • ID: 1877972
  • Report
  • August 2011
  • MP Advisors
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FEATURED COMPANIES

  • Alkermes
  • AstraZeneca
  • Eli-Lilly
  • Hanmi Pharmaceuticals
  • Novo Nordisk
  • PharmaIn
  • MORE
Bydureon – A near term growth driver of the class

Novel delivery platforms and fixed dose combination of GLP-1’s + Insulin will drive growth in longer term

This decade of the diabetes therapy class will be marked by the domination of (Glucagon-like Peptide-1) GLP-1 agonist as we expect this class to grow faster than any other class of drugs in the diabetes space. The best in class clinical attributes of GLP-1’s (robust HbA1C reduction, reduced hypoglycemia, and significant weight loss) supported by compliance benefit positions it better than its competitor’s to make the most of the growth opportunity available in the diabetes market. Due to compliance issues and long term safety concerns, currently the use of GLP-1 is limited prior to insulin and after oral treatment options are exhausted.

The current prescribing pattern in the US and EU is reflective of the same. Non-Compliance which affects about 30% of the type 2 diabetes patients is a major issue and has a bearing on the diabetes treatment and its potential benefit. Innovation efforts are ongoing to enable convenient delivery of GLP-1’s. Longer acting versions, Transdermal, oral, nasal, and implants which can deliver once daily or up to once yearly dosing benefit are being explored. These new delivery platforms and formulation techniques in this class will significantly help compliance and will also bring further improvement in the current clinical profile.

There is a need for new treatment options in diabetes as diabetic patients remain largely uncontrolled and existing treatment options are losing out on safety issues. Reported mean HbA1c in major markets of world remain above the local targets. This reflects need of a treatment options which can offer robust efficacy and compliance; GLP-1’s best fit the bill. Thiazolidinedione (TZD) and sulfonylureas do offer solid efficacy benefits, but they are also associated with safety concerns and physicians are looking for alternatives. SGLT2 could have been a potential replacement for TZD’s/sulfonylurea, but they are not as efficacious and have also shown association with cancer (bladder and breast) in clinical trials, which raises a red flag on their approvable probability.

With every passing year, the evidence base on the long term safety of GLP-1’s is growing and this together with data from ongoing studies (LEADER and EXSCEL) exploring long term safety of GLP-1’s, the GLP-1’s should climb up in the diabetes treatment algorithm. Once the once weekly versions (Bydureon (EU approved), Syncria, Liraglutide once weekly depot version/semaglutide) are introduced in the market, GLP-1 penetration will increase in early stages, especially in obese patients which comprise 60% of the diabetics. GLP-1’s will initially replace sulfonylureas and TZD’s, which together comprise 37% of the market.

Fixed dose combinations of Insulin and GLP-1 under development will boost the usage of GLP-1 in combination with insulin, and should emerge as gold standard for the insulin dependent diabetes patients. The combination will help take care of weight gain, better glucose control and hypoglycemia – which are three major issues faced by insulin dependent patients.

There are about 34 GLP-1 pipeline candidates that are being designed for significant enhancement over current marketed GLP-1’s. The most advanced pipeline candidates have reported a solid proof of concept data, and promise mega blockbuster potential. A host of companies are working on novel delivery platforms and longer acting versions of existing compounds to override the compliance related issues associated with the current marketed GLP-1’s. Besides Lilly, Amylin and Novo Nordisk, Hanmi Pharmaceuticals, Intarcia therapeutics, Zealand Pharma, Transtech pharma, Ascendis Pharma are other companies, which have significant stakes in the GLP-1 class.

In the diabetes space, the emerging market especially represents a major opportunity. The growth in emerging markets is driven by growing diagnosis, insurance penetration improving affordability, improving patent situation and most important of all, the strong marketing efforts of the global pharmaceutical companies.

We forecast $10b in cumulative peak sales for this class of drugs by the turn of this decade as we see innovation efforts around this class will result in improved compliance, convenient delivery and improved safety profile which should drive GLP-1’s evolution to a front line treatment option.
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FEATURED COMPANIES

  • Alkermes
  • AstraZeneca
  • Eli-Lilly
  • Hanmi Pharmaceuticals
  • Novo Nordisk
  • PharmaIn
  • MORE
1. Post DPP-IV, GLP-1 analogue to become the next growth driver for type 2 diabetes market
- GLP-1 analogues to become multibillion market in Type 2 diabetes space
- GLP-1 class – Growth Drivers
- Key Opinion Leaders Insights (Endocrinologist)
- Clinical data comparison between different class of antidiabetics
- Growing Evidence on Long term safety should allow GLP-1 uptake to accelerate
- Currently available therapy and Current treatment algorithm by Joint ADA and EASD and NICE guidelines
- Analysis of early stage and preclinical GLP-1 analogues under development
- Emerging late stage newer mechanism to treat type 2 diabetes vis-à-vis GLP-1 class

2. Pipeline GLP-1 candidates are targeted to overcome the key hurdles limiting the uptake of approved GLP-1’s
- Clinical profile of pipeline compounds in the GLP-1
- How do the newer pipeline candidates address the limitations of current GLP-1’s?
- Beyond compliance-pipeline longer acting versions also bring a better clinical profile

3. Key Catalysts that will gradually transform the treatment paradigm in diabetes space
- Estimated launch milestones of pipeline GLP-1 agonists

4. Our view on the late stage GLP-1 analogues
- Clinical data comparison of late stage GLP-1 analogues
- Bydureon will lead the growth of the GLP-1 class in near to mid term
- DURATION 6 Results–Bydureon once weekly advantage outweighs moderate efficacy difference against Victoza
- Efficacy difference is inconsistent: Victoza and Byetta against Lantus
- Duration-6 head to head comparison bydureon vs. Victoza
- Clinical profile of Bydureon studies (DURATION Programe)- Albiglutide
- Lixisenatide
- Dulaglutide
- Semaglutide / once weekly Liraglutide Depot
- Fixed dose combination of GLP-1 analogue + Insulin
- Lixinetide and basal Insulin
- Victoza and Insulin Degludec

5. Market Size Forecast of GLP-1 analogues
- GLP-1 analogues current market size – to 2020
- GLP-1 current market share in comparison to other therapy class
- GLP-1 market growth against total prescription and diabetes care (past, current and future)
- Current share of Victoza in overall GLP-1 market
- GLP-1 analogues are expected to take market share from which antidiabetic class
- Market share forecast of each GLP-1 analogue pipeline candidate

6. Early stage Pipeline of GLP-1 analogues and upcoming rising star from the space
- Novel Exenatide formulation
- Clinical profile for Exenatide once monthly (PhII)
- Preclinical and PhI data and advantages of HM11260C (PhI)
- Benefits of XTEN Technology in VRS-859 (Versatis)
- Review on Oral GLP-1 analogue
- NN9924-GIPET Technology
- ZTGK1
- ORMD 0901
- PhI/Preclinical GLP-1 analogue
- Insulin + GLP-1 analogue combination

7. Comprehensive Review on Novel Delivery Technology on pipeline GLP-1 agonists
- Implants
- ITCA 650 – DUROS Technology for 3 m , 6 m and 12 m delivery
- Mechanism of delivery of drug
- Efficacy and safety data
- Hydrogel Technology
- ACP-03 – Transcon Linker and Hydrogel Technology
- Inhalation Powder
- Advantages of MKC 253
- Transdermal patch
- VioDor – RF-Microchannel technology
- Our view on the different formulations of pipeline GLP-1 analogues

8. Geographywise difference in prescribing habits of existing GLP-1’s
- US vs. EU- Probable reason for difference in prescribing habits
- Label difference of the approved GLP-1’s
- Percentage share of prescription by PCP and Endocrinologist for GLP-1 agonist
- Antidiabetics Prescription pattern in major EU countries
- Mean HbA1c in Type 2 diabetes in various countries
- Geographywise difference in Type 2 diabetic patient’s profile
- Current market share difference of each antidiabetics

9. Future of GLP-1 analogues as antiobese drugs
- Obesity trends and diabetes prevalence in the US
- Relationship between Diabetes and Obesity
- Overweight and obesity prevalence in selected countries
- Liraglutide is ahead in the race
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- Eli-Lilly
- Novo Nordisk
- Sanofi
- GlaxoSmithKline
- Pfizer
- AstraZeneca
- Boehringer Ingelheim
- Amylin
- Alkermes
- Human Genome Science
- Zealand Pharma
- Intarcia
- Hanmi Pharmaceuticals
- Prolor Biotech
- Ascendis Pharma
- PharmaIn
- Versartis
- CellMed AG
- Oramed
- Emisphere technologies
- Zydus Cadila
- TransTech Pharma
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