Current Scenario

Despite the high prevalence of obesity, treatment rates with antiobesity drugs remain low. DRG’s epidemiological findings reveal that in the G7 countries (United States, France, Germany, Spain, United Kingdom, and Japan), only 3% of the total prevalent cases of obesity and overweight received antiobesity medications in 2016. These low treatment rates are a result of poor reimbursement, safety concerns secondary to major drug withdrawals, and low awareness of antiobesity drugs among physicians and patients. Until 2012, Roche’s Xenical (orlistat) and generic phentermine were the only available drugs for weight loss in the United States. The period from 2012 to 2016 saw a significant number of FDA and EMA approvals of antiobesity drugs. Eisai’s Belviq, Vivus’s Qsymia, Orexigen’s Contrave, and Novo Nordisk’s Saxenda were launched in the United States during 2012-2016. In Europe, Saxenda and Mysimba (Contrave) successfully reached the market. However, the available drugs elicit modest weight-loss and are associated with safety issues. Worse still, the late-stage pipeline for obesity remains sparse, with only one drug in Phase III, Johnson & Johnson’s combination of canagliflozin and phentermine.

Novo Nordisk - the “trailblazer” in obesity

Despite high unmet need and huge patient number to be treated, most of the major pharmaceutical companies refrained from investing in R&D for antiobesity drugs. However, Novo Nordisk followed a different path and launched Saxenda in all the major markets (U.S. launch in 2015, European launch in 2016) except France and Japan. Saxenda is the higher dose of glucagon-like peptide-1 (GLP-1) receptor agonist, liraglutide, which was first launched for type 2 diabetes as Victoza. The company in its 2016 annual report stated that Saxenda has captured 35% of the value market share in the United States. The company plans to establish its leadership in obesity and is making significant investment in R&D for antiobesity drugs. The company has a strong presence in the early-stage pipeline for obesity, with seven novel compounds, all with different mechanisms of actions (Refer to the table below for the list of Novo Nordisk’s early-stage molecules for obesity).

“Dual game” of obesity and type 2 diabetes

Owing to a negative reputation created by high profile withdrawals of centrally acting drugs, big pharmaceutical companies have considered the development of antiobesity drugs as prohibitively risky.  With the development of peripherally acting molecules from the antidiabetic drug classes, pharmaceutical companies aim to specifically avoid the CNS effects that led to the withdrawals of antiobesity drugs. Further, Saxenda’s launch motivated Big Pharmas including Johnson & Johnson, AstraZeneca, Novartis, and Sanofi to adopt Novo Nordisk’s low-risk strategy of diversifying the diabetes portfolio to obesity. Interestingly, all of these major pharmaceutical companies have an established portfolio in type 2 diabetes. These companies are aiming to capitalize on the strong association between type 2 diabetes and obesity. Moreover, these companies already have a large sales force targeted toward endocrinologists for selling antidiabetic drugs. Therefore, if successful, these companies do not need to make extra investments to sell their potential antiobesity drugs.

 

Johnson & Johnson’s “low-risk” path

Johnson & Johnson is following a low-risk pathway to enter the market for prescription antiobesity drugs, without making any investment in the development of a novel molecule. The company’s prudent move of development of canagliflozin and phentermine combination is a blend of Novo Nordisk’s and Vivus’s strategies for Saxenda and Qsymia, respectively. The company followed Novo Nordisk’s approach of indication expansion of its antidiabetic drug, and Vivus’s tactic of combining the most used generic antiobesity drug, phentermine, with another marketed drug.

Future perspective

The years before 2012 witnessed a dry period for the approvals of antiobesity drugs, with the FDA pushing back several potential antiobesity drugs. However, post-2012, the FDA became more receptive to antiobesity drug approvals. These FDA approvals may be giving pharmaceutical companies positive signals to venture into the antiobesity drugs market. With the increasing investments by large pharmaceutical companies in obesity, it is increasingly likely that the unmet need for an antiobesity drug that elicits sustained weight loss, and is safe and well-tolerated will be fulfilled. We anticipate that there is a strong likelihood that Johnson & Johnson’s combination of canagliflozin and phentermine, and Novo Nordisk’s semaglutide will launch before 2025. These expected launches have the potential to expand the market for prescription antiobesity drugs.

Major Pharmaceutical Companies with their Early Phase Molecules for Obesity

Major pharmaceutical Company Molecule in pipeline Phase of development Mechanism of action Is the molecule currently under development for type 2 diabetes?
Novo Nordisk Semaglutide Phase II Glucagon-like peptide 1 (GLP-1) receptor agonist Yes
Tri-agonist 1706/NN9423 Phase I Triple agonist of GLP-1, gastric inhibitory peptide (GIP) and glucagon (GCG) receptors No
AM833/NN9838 Phase I Amylin analogue No
G530S/NN9030 Phase I Glucagon analogue No
FGF21 Obesity/NN9499 Phase I Fibroblast growth factor 21 analogue No
GG-co-agonist 1177/NN9277 Phase I Dual agonist of GLP-1 and GCG receptors No
PYY 1562/NN9747 Phase I Peptide YY hormone analogue Yes
Johnson & Johnson HM12525A/

JNJ-64565111

Phase I Dual agonist of GLP-1 and GCG receptors Yes
Novartis LIK066 Phase II Sodium glucose transport 1 and 2 inhibitor (SGLT-1/2 inhibitor) Yes
AstraZeneca MEDI0382 Phase II Dual agonist of GLP-1 and GCG receptors Yes
Sanofi Efpeglenatide/

HM-11260C

Phase II GLP-1 receptor agonist Yes
Source: Company reports, websites, press releases

 


 

 

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