Guest Post by Craig Dunbar, VP, Product Development, Blend Therapeutics
Big-pharma has long realized the unique value of inhaled therapies to treat chronic diseases by local delivery to the lungs. GlaxoSmithKline’s Advair™ Diskus is in a category on its own in the pharmaceutical industry, having lost US patent protection four years ago while increasing worldwide sales to over $8 billion in 2013. Teva and Sandoz have both admitted defeat in bringing a generic Advair™ on to the US market due to technical complexity and insurmountable regulatory barriers.
2006, the same year that Advair™ was approved, saw the first approval of a pulmonary insulin product, Exubera™, developed by Nektar and Pfizer. This marked a pinnacle of a decade long pursuit of new pulmonary drug development technologies to enable systemic delivery of proteins, with Pfizer having invested $2.8 billion in Exubera™, and competitors Lilly/Alkermes and NovoNordisk/Aradigm following suite with alternative technologies. However, Exubera was dogged by safety concerns, FDA recommending regular lung exams, a 6 month launch delay due to manufacturing difficulties, and poor acceptance by patients, physicians and payers. Just one year after launch the product was pulled from the market, marking the collapse of the pulmonary insulin market.
So where does this leave pulmonary drug delivery today? Mannkind recently (Apr 2, 2014) received an approval recommendation by FDAs advisory committee for Afrezza®, a pulmonary insulin product that improves glycemic control in type 1 and 2 diabetics, opening the way to approval in July of 2014. The boom and bust of the 90s decanted the more robust pulmonary technologies based on particle engineering and simple delivery devices, with Civitas continuing to develop Alkermes’ large porous particle technology for the treatment of Parkinson’s disease, and Pulmatrix developing novel particle engineering technologies for asthma. Further, new drugs, technologies, and clinical development strategies continue to emerge from both big pharma and small biotechs, recognizing the unique opportunities, and challenges, associated with inhaled therapeutics.
On April 29th, from 8-10am, MassBio is hosting a Forum on this important topic entitled Innovation & New Opportunities in Pulmonary Drug Delivery for Local & Systemic Treatment of Chronic Diseases.