THE PIPELINE REPORT 2016 (VI): Respiratory

Benralizumab Kyowa Hakko Kirin/AstraZeneca 


Indication: Asthma/COPD (Ph.III) 
What the clinical trials found: Patients taking benralizumab vs. placebo in a Phase IIb study saw a significant reduction in asthma exacerbation rate over a one-year period. The study met secondary endpoints with patients experiencing lung function and asthma control improvements as measured by the ACQ-6. Overall, frequencies of AEs were similar for benralizumab and placebo. Common cold and skin reactions at the injection site occurred more frequently with benralizumab than placebo. 
Credit Suisse Success Probability: 60%. Expected launch: 2017 (Source: Credit Suisse) 
Credit Suisse revenue forecast: $676 million in annual global sales by 2020 
What the analysts are saying: Benralizumab is part of a new era of treatments for severe asthma that will provide benefits we haven't had for uncontrolled patients. With few options other than medium- to high-dose inhaled corticosteroids and LABAs, patients suffer from both the emotional and physical burden of extended symptomatic states and multiple hospital visits due to exacerbations. Additional effective therapies are a high-level unmet need in this market. Primary concerns remain around potential safety concerns and identifying patients who will benefit from treatments. Still, most physicians see the clinical value these new entries offer and are optimistic about future patient outcomes. —Anita Agier, head of Disease Atlas, GfK Healthcare 

Revefenacin Theravance Biopharma/Mylan 

Indication: COPD (Ph.III) 
What the clinical trials found: Data from the Phase-IIb study showed a rapid onset of action, with a median time to achieve a clinically relevant improvement in lung function (at least 100mL increase in FEV1) of 30 minutes for doses of 88 mcg and above. TD-4208 (revefenacin) also reduced the need for short-acting inhaled rescue medication in a dose-dependent manner. The agent was generally well tolerated and had AE rates similar to placebo. Credit Suisse Success Probability: 50%. Expected launch: 2019 (Source: Credit Suisse) 
Credit Suisse revenue forecast: $225 million in annual global sales by 2020 
What the analysts are saying: Communicated as potentially a best-in-class drug and first nebulized LAMA, revefenacin may be desirable for some patient types or by preference. The delivery method is thought to achieve a faster and more effective relief of symptoms. The overall impact on the patient quality of life could be perceptively considerable. However, revefenacin will face the same obstacles as any asset entering into a highly competitive, dynamic and undifferentiated market: What real value will it offer compared to current therapies, and at what price? —Anita Agier, head of Disease Atlas, GfK Healthcare 

Selexipag Actelion 

Indication: PAH (Pre-reg.) 
What the clinical trials found: Trial results (Ph. III, GRIPHON) showed a 40% decrease in the risk of a morbidity or mortality event, compared with placebo (p < 0.0001), in patients with pulmonary artery hypertension (PAH). All patients had a significant increase of 12 meters in six-minute walk distance at week 26 (p = 0.0027), with an improvement of 34 meters in PAH-treatment naive patients (p = 0.0002). Overall tolerability of selexipag was consistent with prostacyclin therapies.  
Credit Suisse Success Probability: 85%. Expected launch: 2016 (Source: Credit Suisse) 
Credit Suisse revenue forecast: $982 million in annual global sales by 2020 What the analysts are saying: Selexipag is possibly the most promising new treatment for patients with PAH, a rare and debilitating condition. Its formulation, trial results and novel effects targeting the prostacyclin pathway provide optimism for physicians that patients will be treated more proactively, although the relative effects and long-term outcome benefits compared to current prostacyclin formulations remain a question. —Anita Agier, head of Disease Atlas, GfK Healthcare

Ver anterior: 
THE PIPELINE REPORT 2016 (V):Metabolic