2020 Disease Analysis on Type 1 Diabetes - Licensing and Asset Acquisition Deals

News provided by

Mar 09, 2020, 14:15 ET

DUBLIN, March 9, 2020 /PRNewswire/ -- The "Disease Analysis: Type 1 Diabetes" report has been added to ResearchAndMarkets.com's offering.

The research estimates that in 2018, there were approximately 46.6 million prevalent cases of type 1 diabetes in adults aged 20 years and over worldwide, and forecasts that number to increase to 51.8 million prevalent cases by 2027.

In children and adolescents aged below 20 years, there were approximately 1.08 million prevalent cases of type 1 diabetes worldwide in 2018, which are expected to increase to 1.12 million prevalent cases by 2027.

The overall likelihood of approval of a Phase I type 1 diabetes asset is 16.3%, and the average probability a drug advances from Phase III is 73.9%. Type 1 diabetes drugs, on average, take 8.5 years from Phase I to approval, which is the same as the average duration to approval in the overall endocrine space.

Despite the presence of multiple well-established products, the type 1 diabetes market is expected to see limited growth over the next decade. Future growth opportunities in the type 1 diabetes market are expected to be limited by its saturation with multiple maturing insulins, pricing pressures following the launches of biosimilars, and the expected failure of sodium-glucose cotransporter-2 (SGLT-2) inhibitors to gain approval in the lucrative US market.

It is expected that patients will continue to switch from Novo Nordisk's Levemir to its successor product Tresiba due to the company's promotion of Tresiba's longer duration of blood sugar control compared to Levemir.

Likewise, Sanofi is pursuing a comparable commercial strategy to Novo Nordisk by promoting its next-generation insulin glargine product Toujeo over Lantus, as Lantus continues to lose patient share to the more affordable biosimilar Basaglar. However, key opinion leaders interviewed by the research analysts suggest that physicians are unconvinced that Toujeo possesses tangible benefits over biosimilar insulin glargine to justify its higher price.

Payers are severely restricting the use of specific insulin brands in the US. As the list price of insulins continues to increase, cost is becoming a strong determining factor for the choice of insulin treatment. Interviewed endocrinologists emphasized the impact of pricing on prescribing trends, as price fluctuations in the US lead to regular switching among patients.

Tresiba is forecasted to see the greatest uptake of all the long-acting insulin therapies in type 1 diabetes. Its long-acting duration of 42+ hours and its flexible dosing window (it can be administered at different times each day) offer improved convenience for patients, along with strong glycated hemoglobin (HbA1c) reductions. In addition, favorable pricing compared to Lantus and Toujeo within the US market is expected to drive growth of Novo Nordisk's market share.

The maturation of multiple short-acting insulin products has resulted in companies promoting switching to successor products with extended patent protection to maintain their diabetes revenues. Novo Nordisk's NovoLog will be facing biosimilar competition from Sanofi's SAR341402, therefore Novo Nordisk is actively encouraging patients to switch to NovoLog's successor ultra-rapid product Fiasp, which is positioned as having a faster onset of activity than NovoLog. Similarly, Eli Lilly has developed a faster-acting version of Humalog, ultra-rapid lispro, which is currently in preregistration in the US.

Increasing out-of-pocket costs for patients and competition from Sanofi's Admelog (a biosimilar of Humalog) have resulted in developers of branded products launching authorized generics in order to increase competitiveness in US government-insured patients, who must make co-payments based on a percentage of a drug's list price. In May 2019, Eli Lilly launched an authorized generic of Humalog at 50% of the list price of branded Humalog in hopes of maintaining government-insured patient share. This was followed in January 2020 by Novo Nordisk's launch of an authorized generic version of NovoLog, also at a 50% discount to the branded product.

Pipeline product teplizumab has shown promising potential to prevent or delay the onset of type 1 diabetes, as Phase II data have demonstrated that a single course of the drug significantly delayed disease onset in at-risk patients by a median of two years. The data will support a planned rolling Biologics License Application (BLA) submission for the prevention or delay of type 1 diabetes in H1 2020, and the review process will be fast tracked due to breakthrough therapy designation granted by the US Food and Drug Administration (FDA). However, if approved, teplizumab is likely to face two challenges when attempting to enter the market, the first of which is appropriately pricing the product to reflect the market value of delaying or preventing diabetes while ensuring that a high upfront cost does not prevent reimbursement. Indeed, achieving widespread reimbursement will be particularly challenging given the lack of a currently approved comparator and the fact that the mean duration of any delay in the onset of diabetes may not be known at the time of approval. The second challenge is the lack of existing screening programs to detect patients that are at risk for type 1 diabetes, which could severely limit the drug's target population (at least initially). Teplizumab's commercial success will therefore require healthcare services, physicians, and industry to collaborate on creating and integrating accessible screening programs into different health services globally.

Lexicon continues to pursue first-to-market status for Zynquista for type 1 diabetes in the US, and launched an appeal against the FDA's initial complete response letter (CRL), but this was unsuccessful. Thus, the company has now appealed to the Center for Drug Evaluation and Research, and is expecting a final judgment to be made in February 2020, but we expect this will also fail given that no new trial data have been added to the NDA to allay safety concerns and Lexicon has stated it does not wish to initiate further studies. An FDA decision on Jardiance's supplementary New Drug Application (sNDA) is expected in late Q1/early Q2, but a rejection is widely expected given the Endocrinologic and Metabolic Drugs Advisory Committee panel voted 14-2 against approval in November 2019. While SGLT-2 inhibitors may offer benefits to type 1 diabetes patients beyond improved glycemic control (namely blood pressure reduction and weight loss), our base case is that the class will not gain FDA approval for type 1 diabetes without additional studies to further investigate the risk of diabetic ketoacidosis (DKA) and the effectiveness of proposed risk-management strategies, and thus far none of the companies have publicly announced any intention to conduct such studies.

Key Topics Covered:

1. OVERVIEW

Latest key takeaways

2. DISEASE BACKGROUND

Disease definition
Patient segmentation
Disease diagnosis

3. TREATMENT

Daily insulin replacement therapy is required to prevent hyperglycemia

4. EPIDEMIOLOGY

Prevalence in adults (20-85+ years)
Prevalence in children and adolescents (0-19 years)

5. MARKETED DRUGS

6. PIPELINE DRUGS

7. KEY REGULATORY EVENTS

Empagliflozin Likely Needs Another Trial After Rebuke By US FDA Panel
EMA Accepts First Diabetes Drug Onto PRIME
AstraZeneca's Farxiga Fails To Get FDA OK As Insulin Supplement In Type 1 Diabetes
Sanofi Files First Biosimilar Insulin Aspart In Challenge To NovoRapid
AZ's Forxiga Gets Type 1 Diabetes EU Okay As Sanofi Suffers US Setback

8. PROBABILITY OF SUCCESS

9. LICENSING AND ASSET ACQUISITION DEALS

With $260m Settlement From Sanofi, Lexicon Looks For New Zynquista Partner

10. CLINICAL TRIAL LANDSCAPE

Sponsors by status
Sponsors by phase
Recent events

11. DRUG ASSESSMENT MODEL

Long-acting insulins
Rapid-acting insulins
Non-insulin treatments

12. MARKET DYNAMICS

Current dynamics
Market opportunity
Threat of substitution
Payer pressure / buyer power

13. FUTURE TRENDS

Questionable clinical benefit and pricing pressure from biosimilars will slow uptake of next-generation products
Pricing pressure in the US diabetes market will shift prescribing trends towards affordable insulins
Teplizumab uptake will be dependent on overcoming pricing and reimbursement issues, along with the introduction of screening programs to identify at-risk patients
SGLT-2 inhibitors are expected to have slow uptake in the EU and Japan due to narrow target populations, DKA risk, and minor glycemic benefits

14. CONSENSUS FORECASTS

15. RECENT EVENTS AND ANALYST OPINION

Zynquista for Type 1 Diabetes (December 02, 2019)
Jardiance for Type 1 Diabetes (November 13, 2019)
Jardiance for Type 1 Diabetes (November 11, 2019)
Toujeo for Type 1 Diabetes (October 31, 2019)
Farxiga for Type 1 Diabetes (July 15, 2019)
SAR341402 for Type 1 Diabetes (June 9, 2019)
LY900014 for Type 1 Diabetes (June 9, 2019)
Teplizumab for Type 1 Diabetes (June 9, 2019)
Multiple Drugs for Type 1 Diabetes (June 8, 2019)
HDV-L for Type 1 Diabetes (June 8, 2019)
TTP399 for Type 1 Diabetes (June 6, 2019)
NN9828 for Type 1 Diabetes (May 31, 2019)
Zynquista for Type 1 Diabetes (March 22, 2019)
CLBS03 for Type 1 Diabetes (February 13, 2019)

16. KEY UPCOMING EVENTS

17. KEY OPINION LEADER INSIGHTS

18. UNMET NEEDS

Better options for glucose administration
Innovative therapies with new mechanisms of action
Prevention of type 1 diabetes
Faster-acting short-acting analogs

19. BIBLIOGRAPHY

Prescription Information

20. APPENDIX

For more information about this report visit https://www.researchandmarkets.com/r/b9zitm

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Media Contact:

Research and Markets
Laura Wood, Senior Manager
[email protected]

For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

SOURCE Research and Markets