Kalytera Licenses Transdermal Drug Delivery Technology from Delivra Corp.

Delivra has entered into a technology licensing agreement with Kalytera Therapeutics.

Based in California, Kalytera is a pharmaceutical company developing a portfolio of non-psychoactive cannabinoid and endocannabinoid-like medicines that it believes will address large unmet market needs.

Kalytera seeks to commercialize its proprietary synthetic cannabinoid therapies across a range of disease states, with an initial focus on bone health.

“Synthetic and natural cannabinoid therapies are an expanding field of medicine with significant potential. This agreement provides an opportunity for Delivra to pair our leading transdermal technologies with Kalytera and its partners, who have a proven track record in pioneering synthetic cannabinoid compounds to address a range of pervasive conditions,” said Chris Schnarr, President of Delivra.

“We believe our delivery platform provides a strong value proposition both for existing and new active pharmaceutical ingredients and anticipate that this transaction will be one in a series of deals that showcase the breadth and value of the Delivra technology.”

Under the terms of the License, Delivra will license its proprietary transdermal delivery technology to Kalytera for its exclusive use with two synthetic cannabinoid compounds which Kalytera has under license (KAL436/439 and KAL671) and only for use with respect to specific indications which include bone healing, osteogenesis imperfecta, and osteoporosis. The licensed territory is worldwide, but excludes Canada.

During the term of the license, Kalytera is required to make various milestone payments to Delivra through a combination of cash and Kalytera stock, immediately and then as and when it progresses through the US FDA drug approval process over the next several years, followed by a royalty to Delivra on resulting product sales once an approved drug is on the market.

In addition, Kalytera may also take up a non-exclusive license for the use of Delivra technology for transdermal delivery of cannabis plant extracts or isolated active ingredients from the cannabis plant, for the specific indications noted above, in non-FDA regulated markets. This license is non-exclusive worldwide, and excludes Canada.

This license would include an immediate cash payment upon exercise as well as a further milestone payment on the first commercial sale of a resulting product, followed by a royalty to Delivra on resulting product sales once an approved drug is on the market.

“Many oral medications degrade during passage through the gastrointestinal tract,” said Dr. Stuart Silverman, M.D., FACP, FACR, Co-Chair of Kalytera’s Scientific Advisory Board . “This may effect efficacy or it may cause other unwanted side effects. We were attracted to Delivra’s technologies which have demonstrated the ability to reliably deliver molecules through the skin, with desirable pharmacokinetics.”

“In concert with the research now underway at Hebrew University and Tel Aviv University, securing a delivery platform and partner is an important step in advancing Kalytera’s drug candidates towards the clinic,” said Dr. Raphael Mechoulam, Ph.D., Co-Chair of Kalytera’s Scientific Advisory Board.

If all milestones are met, the total cash and stock payments would be approximately USD $1.4 million. The royalty percentage is not being disclosed, for commercial and competitive reasons. Unless terminated earlier, the License has a term of ten (10) years and is subject to optional additional two (2) year renewal terms. There can be no guarantees that the milestones in the License will be met or that any milestone payments or royalty payments will be made.