Product
Daliresp
Approval Date
March 1, 2011
Release Date
Third quarter 2011
Company
Forest Laboratories
Class
Selective phosphodiesterase-4 (PDE4) inhibitor
Indication
To reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations
Active Ingredient
Roflumilast
Agency Roster
Centron (professional)
Marketing Strategy/Execution
Forest is deploying primary care and specialty care sales forces, numbering about 1,200 reps total, to promote Daliresp. Detailing will begin in April followed by the full launch around August. Roflumilast’s distinguishing traits—it’s the first oral drug approved for COPD in a new class of medicines called PDE4 inhibitors—may show up in journal advertising by Forest, which typically spends heavily on the channel to reach docs. Safety issues (psychiatric side effects) and a label limiting use to patients with severe COPD may hamper uptake. Forest will price the med comparably to competitors Spiriva and Advair. Spiriva, which has annual sales of $2 billion, recently also received approval for treating COPD exacerbations. Credit Suisse analyst Catherine Arnold forecasts Daliresp sales of $55 million this fiscal year, peaking at $800 million in financial year 2020. Patents cover the drug until then.
Physician Outlook
The approval of Daliresp (roflumilast) introduces a new COPD treatment option specifically for patients with severe chronic bronchitis and a history of exacerbations. It is the first selective phosphodiesterase-4 (PDE-4) inhibitor, offering a new anti-inflammatory option that can be added to existing inhaled therapies such as long-acting beta agonists and antimuscarinics. Given the wide use of inhaled anti-inflammatory combination therapies such as Advair, it will be interesting to see how this drug is incorporated into treatment. However, for this challenging patient population, it is welcome addition to existing COPD therapies.
-Louise Gillis, associate vice president, research, Gfk HealthCare (March 2010)
Recent MM&M Coverage
Company news: Forest Labs
Also in the Pipeline (courtesy of Adis R&D Insight)
Drug: Eklira
Manufacturer:Forest Laboratories
Indication: Chronic obstructive pulmonary disease
Active ingredient: Aclidinium bromide
Phase: III
Drug: AD 237
Manufacturer:Novartis
Indication: Chronic obstructive pulmonary disease
Active ingredient: Glycopyrrolate inhalation
Phase: III
Drug: NVA237
Manufacturer:Novartis
Indication: Chronic obstructive pulmonary disease
Active ingredient: Glycopyrrolate/indacaterol
Phase: III
Drug: ‘719/VI
Manufacturer:GlaxoSmithKline
Indication: Chronic obstructive pulmonary disease
Active ingredient: LAMA + LABA
Phase: III
Drug: Onbrez Breezhaler
Manufacturer:Novartis
Indication: Chronic obstructive pulmonary disease
Active ingredient: Indacaterol
Phase: Preregistration
Drug: MFF258
Manufacturer:Schering-Plough
Indication: Chronic obstructive pulmonary disease
Active ingredient: Mometasone/formoterol
Phase: III
Drug: BI-1744
Manufacturer:Boehringer Ingelheim
Indication: Chronic obstructive pulmonary disease
Active ingredient: Olodaterol
Phase: III
Drug: FF/VI
Manufacturer:Theravance
Indication: Chronic obstructive pulmonary disease
Active ingredient: Vilanterol/fluticasone furoate
Phase: III
Source: Wolters Kluwer Pharma Solutions
Pharmacology
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Clinical Trials
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Adverse Reactions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Adults
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Children
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Precautions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Interactions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
