Light-based acne treatment goes global via license/JV agreement

THE DAILY MEDICAL TECHNOLOGY NEWS SOURCE 

Light-based acne treatment goes global via  license/JV agreement

By Amanda Pedersen, Senior Staff Writer

MONDAY, JULY 21 , 2014

The dermatology market just got a little bit brighter. 

Klox Technologies (Laval, Quebec), a company developing a light-based technology for acne treatment and other dermatology indications, has gained global market access through a worldwide license and joint venture agreement with Leo Pharma (Ballerup, Denmark).

Leo Pharma will help Klox to further develop and commercialize its Biophotonic technology platform in dermatology, which includes a CE-marked treatment for moderate to severe acne. The worldwide agreement excludes Canada, where Klox already has a partner that launched the device a few months back. Leo Pharma has also agreed to make an equity investment in Klox. The deal paves the way for Leo Pharma’s first medical device therapy and first global market entry in acne.

The non-abrasive, non-thermal device comprises a multi- LED light used in conjunction with a photoactivable converter gel. It works by targeting the underlying problems that lead to acne vulgaris, as well as stimulating collagen synthesis and healing in traumatized skin, thereby promoting healing in the epidermis and deeper in the dermis, Klox said. Completed within a 15-minute treatment cycle including preparation, treatment requires twice-weekly application over six weeks. In clinical trials, the acne Biophotonic system demonstrated highly statistically significant improvements in moderate to severe acne sufferers, Lise Hébert, president/CEO of Klox, told Medical Device Daily.

 

The way it works is the converter gel is applied to the area being treated, which is then illuminated by the lamp. The interactions that take place aid in the creation of an environment favoring repair.

 

“Within the field of dermatology, acne was something that we felt was indeed an unmet need,” Hébert said. “Yes, there are many products on the market, mostly topical or antibiotics, but in the case of severe acne very, very little innovation was going on.”

Other companies in the space would repackage or reformulate existing products, but there was no treatment on the horizon that would really be a game changer, Hébert said.

 
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She noted that the company designed its European trial based on FDA parameters and guidance so that the data could one day be useful in the U.S. as well. The trial enrolled moderate and severe acne patients, mostly teens and young adults.

 

“The surprise that we got, that was not necessarily predicted, was that the lens not only addresses the acne but has a favorable impact on scarring,” Hébert said. The trial also examined the persistence of the efficacy over a six-month period, she said, and of the patients that have met that six-month follow up, “not a single one reverted to baseline.”

 

Hébert said the partnership with Leo further validates the technology and its applicability in multiple therapeutic areas. She said the two companies will develop and commercialize Biophotonic therapies in dermatology with the intent of bringing patients efficacious products with a good safety profile.

 

“This deal also represents the completion of a significant step in Klox’s strategic roadmap aimed at achieving sustainable, commercial profitability in the short to medium term,” Hébert said. She added that the agreement with Leo also helps Klox focus resources on developing the company’s wound care program, which Klox plans to commercialize as early as the first half of 2015 in Europe.

 

Leo Pharma will be responsible for clinical and commercial activities, including manufacturing. Also, Leo has agreed to provide financial support for Klox R&D in dermatology. The financial terms were not disclosed but the companies noted that it includes a “significant upfront, as well as double-digit, escalating, tiered royalty rate based on product sales.”

 

Klox wanted a strategic partner like Leo because the dermatology market is very large and already has several large, successful companies, so to compete in the space would require a large sales force and a lot of marketing dollars, she said.

“Today, there is a significant unmet need for alternative acne therapies. With this technology, Leo Pharma aims at soon offering a new treatment solution that is non-invasive and effective. We hope it will enable patients to integrate acne therapy into their everyday lives and successfully manage their condition,” said Gitte Aabo, president/CEO of Leo Pharma. “By partnering with innovative companies like Klox, Leo Pharma aims to push the boundaries of dermatology care and deliver more treatment solutions that make a real difference to the lives of people with skin diseases.”

Hébert told MDD that the company’s goal is to initiate a trial in the U.S. in the very near term and also to launch into commercial activities in Europe because the product is already approved there. Also, she said, the two companies will start working on the next product in Klox’s technology platform. The company also expects to get approval in Europe this summer for the next indication of the technology, which will be wound healing. //