Abbott and Surmodics have announced an agreement whereby Abbott will have exclusive worldwide commercialisation rights for Surmodics’ SurVeil drug-coated balloon (DCB) to treat the superficial femoral artery, which is currently being evaluated in a US pivotal clinical trial. Separately, Abbott also received options to negotiate agreements for Surmodics’ below-the-knee and arteriovenous (AV) fistula drug-coated balloon products, which are currently in pre-clinical development.
As part of the agreement, Surmodics, a leading provider of medical device and in vitro diagnostic technologies to the healthcare industry, will supply the SurVeil drug-coated balloon to Abbott. The two companies will collaborate on product development, clinical trials and regulatory activities to obtain marketing approval in the USA and Europe. The SurVeil drug-coated balloon will add to Abbott’s line of vascular devices for treating peripheral artery disease (PAD), including stents and vessel closure devices.
The drug-coated balloon includes a proprietary drug-excipient formulation for a durable balloon coating and is manufactured using an innovative process to improve coating uniformity. Pre-clinical data have shown a three- to five-times higher target tissue drug concentration, a more evenly distributed and durable drug effect, and lower incidence of downstream drug particles compared to the control drug-coated balloon.
“The SurVeil drug-coated balloon is the first device developed by Surmodics that combines our proprietary drug-delivery and surface technologies with our exceptional design, development and manufacturing capabilities,” said Gary Maharaj, Surmodics’ president and chief executive officer. “We are excited to enter this partnership with Abbott given its deep expertise in vascular care products and its worldwide strength in the market. We look forward to working together with Abbott to realise the full potential of our SurVeil drug-coated balloon to help people with peripheral artery disease.”
Surmodics’ SurVeil drug-coated balloon is currently being evaluated in the TRANSCEND pivotal clinical trial and is being compared with the current market-leading drug-coated balloon in treating PAD in the legs. The SurVeil drug-coated balloon is currently for investigational use only.
Pursuant to the terms of the agreement, Surmodics will receive a US$25 million upfront payment and may earn an additional US$67 million for various product development milestones. Upon the regulatory approval of the device, Surmodics will be responsible for the manufacture and supply of clinical and commercial quantities of the product and will realise revenue based on initial product sales to Abbott as well as a share of profits resulting from third-party sales.