Substitute skin for burn victims granted orphan drug and biologic status by FDA

A tissue replacement therapy creating a substitute skin to treat catastrophic burn victims using the […]

A tissue replacement therapy creating a substitute skin to treat catastrophic burn victims using the patients’ own skin cells has been granted a combined orphan drug and biologic product status by the U.S. Food and Drug Administration.

The “PermaDerm” technology is a substitute skin using epidermal and dermal components, according to Regenicin (OTCBB:RGIN.OB). Although it owns the commercialization rights for the artificial skin treatment, Swiss biopharmaceutical company Lonza retains exclusive manufacturing rights. It was originally developed by Shriners Hospital for Children in Ohio and University of Cincinnati.

The announcement about its treatment’s orphan status today sent the company’s share price skyrocketing by 75 percent from $0.13 a share to $0.27. Having orphan status gives the company up to seven years of market exclusivity and grants it some tax relief and exemptions from certain fees because the treatment is aimed at a relatively small patient population. The company received a combined orphan drug/biologic status for the therapy after having in contrast to its previous classification as a medical device.

PermaDerm has been in the development phase for several years due to its controversial history, mapped out in a timeline by self-described investigative reporter Sandy Vine, including a suspension of a study at the Shriners Hospital over alleged violations of clinical trial protocol. The next step for the company is to work with the FDA to determine what data can be used from the product’s development and what cannot, a spokesman for the company said. Once that process is concluded, it will it be able to disclose a new roadmap for the development of the skin substitute, a spokesman for Regenicin said in a phone interview.

The New Jersey-based company claims that in addition to helping to save lives, the therapy will also cut healthcare costs by reducing the need for additional surgeries, lessening the risk of infection and reducing the amount of time patients need to spend in the critical care unit. PermaDerm has been clinically tested in more than 150 pediatric and adult catastrophic burn patients, according to the company.

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