Zynerba Pharmaceuticals Raises $13 Million to Develop First and Only Transdermal Cannabinoid Therapies

RADNOR, PA – (PR Newswire – October 15, 2014) Zynerba Pharmaceuticals, Inc., a specialty pharmaceutical company dedicated to the development of innovative transdermal cannabinoid treatments, today announced the successful closing of $13 million in funding. New investors in Zynerba include one of the top-seven life sciences public investors, Perceptive Advisors LLC. Proceeds of the fundraising will be used for development efforts for the first and only transdermal cannabinoid therapies as Zynerba prepares to initiate Phase 1 clinical studies in 2015 on ZYN001, a proprietary prodrug of THC transdermal patch, and on ZYN002, a proprietary cannabidiol (CBD) transdermal gel.

“We thank our new investors for their confidence in Zynerba as the first and only transdermal cannabinoid company,” said Armando Anido, chairman and CEO of Zynerba Pharmaceuticals. “This funding allows us to advance our two highly innovative and proprietary cannabinoid therapeutic development assets for large unmet patient populations. We believe these novel, synthetically produced candidates may offer unique advantages by delivering drug through the skin and into the bloodstream, presenting significant promise to patients.”

About Zynerba Pharmaceuticals
Zynerba Pharmaceuticals is dedicated to the development of innovative transdermal cannabinoid treatments for patients with high unmet medical needs using modern drug delivery technology and appropriate regulatory pathways. Zynerba is developing two therapeutic candidates based on proprietary transdermal technologies that, if successfully developed, may allow sustained, consistent and controlled delivery of therapeutic levels of cannabinoids. Transdermal delivery reduces adverse effects associated with oral dosing. ZYN001 will be studied in fibromyalgia, neuropathic pain and chronic cancer pain utilizing a synthetically manufactured prodrug of THC in a transdermal patch to deliver THC through the skin and into the bloodstream. Zynerba expects to initiate ZYN001 Phase 1 clinical studies in 2Q 2015. ZYN002 will be studied in epilepsy and rheumatoid arthritis, utilizing a proprietary gel to deliver synthetically manufactured cannabidiol (CBD), a non-psychotropic cannabinoid, through the skin and into the bloodstream. Zynerba expects to initiate ZYN002 Phase 1 clinical studies in 3Q 2015. Learn more at www.zynerba.com and follow the company on Twitter at @ZynerbaPharma.

Investor Contact
Armando Anido
Chairman and CEO
Zynerba Pharmaceuticals
610.263.0163

Media Contact
Jennifer Guinan
Sage Strategic Marketing
610.410.8111
Jennifer@sagestrat.com

 

Zynerba Pharmaceuticals Builds Management Team

Medical, Development and Legal Leadership Named

RADNOR, PA – (PR Newswire – October 1, 2014) Zynerba Pharmaceuticals, Inc., a specialty pharmaceutical company dedicated to the development of innovative transdermal cannabinoid treatments, today named three seasoned pharmaceutical executives to its management team. Donna Gutterman, PharmD, is a consultant who will serve in the role of vice president, medical affairs; Carol O’Neill will serve as vice president, development; and Suzanne Hanlon will serve as general counsel and vice president, human resources. Dr. Gutterman, Ms. O’Neill and Ms. Hanlon will lead the medical, development and legal effort for Zynerba, the first and only transdermal cannabinoid therapeutic company, as it prepares to initiate Phase 1 clinical studies in 2015 on ZYN001, a proprietary prodrug of THC transdermal patch, and ZYN002, a proprietary cannabidiol (CBD) transdermal gel.

Dr. Gutterman is a senior pharmaceutical executive with more than 30 years of experience in clinical development, medical affairs and commercialization in CNS therapy areas. During her career, she has led numerous successful clinical development programs, regulatory approvals and product launches. Prior to joining Zynerba, she served as head of medical affairs for NuPathe through approval and pre-launch of its lead product, Zecuity®, the first transdermal patch for migraine, prior to the company being acquired by Teva Pharmaceuticals in 2014. Previously, Dr. Gutterman served in a variety of executive roles at GlaxoSmithKline. There she was instrumental in the clinical development of Imitrex® and led the medical affairs teams in neurology and psychiatry. Additionally, she led several successful commercial product launches. She earned her Doctor of Pharmacy degree at the University of Kentucky College of Pharmacy and her MBA at the University of North Carolina (UNC) Kenan-Flagler Business School. Dr. Gutterman also serves on the visiting board at UNC Eshelman School of Pharmacy, is an instructor at NC State University and serves as a board member of several nonprofit organizations.

Ms. O’Neill has more than 18 years of development and operational experience in the biopharmaceutical industry. She has completed regulatory submissions and achieved approvals of new pharmaceutical products including a transdermal patch and a transdermal gel. Prior to joining Zynerba, she served as vice president, development operations of NuPathe where she successfully managed the development aspects of the clinical and nonclinical programs of the company’s lead product, Zecuity. Previously, she was senior director clinical operations at Auxilium Pharmaceuticals and senior director of operations analysis at Omnicare Clinical Research.

Ms. Hanlon is an accomplished attorney with 32 years of legal experience, particularly in public life sciences companies. She offers expertise in contracts, licensing, compliance, clinical trials, regulatory, litigation, intellectual property and employment law. Prior to joining Zynerba, she served as vice president, associate general counsel of NuPathe where she successfully led the intellectual property strategy and the contracts effort in addition to managing the human resources function and she partnered with senior management to complete a successful IPO. Previously, she was chief development counsel at Auxilium Pharmaceuticals and vice president of global contracts at Omnicare Clinical Research. Ms. Hanlon received her JD degree from Villanova University School of Law and is a member of the Pennsylvania Bar Association, the American Bar Association and the American Corporate Counsel Association.

“As we initiate an aggressive pre-clinical program for our two innovative transdermal cannabinoid treatments in development, we have succeeded in building a first-rate executive team with these vital executive positions,” said Armando Anido, chairman and CEO of Zynerba Pharmaceuticals. “Dr. Gutterman, Ms. O’Neil and Ms. Hanlon offer experience in transdermal development, regulatory approval and launch preparation, allowing Zynerba to capitalize on their knowledge and expertise as we work to advance our pipeline for the millions of patients who suffer from chronic and debilitating diseases such as fibromyalgia, neuropathic pain, chronic cancer pain, epilepsy and rheumatoid arthritis.”

About Zynerba Pharmaceuticals
Zynerba Pharmaceuticals is dedicated to the development of innovative transdermal cannabinoid treatments for patients with high unmet medical needs using modern drug delivery technology and appropriate regulatory pathways. Zynerba is developing two therapeutic candidates based on proprietary transdermal technologies that, if successfully developed, may allow sustained, consistent and controlled delivery of therapeutic levels of cannabinoids. Transdermal delivery reduces adverse effects associated with oral dosing. ZYN001 will be studied in fibromyalgia, neuropathic pain and chronic cancer pain utilizing a synthetically manufactured prodrug of THC in a transdermal patch to deliver THC through the skin and into the bloodstream. Zynerba expects to initiate ZYN001 Phase 1 clinical studies in 2Q 2015. ZYN002 will be studied in epilepsy and rheumatoid arthritis, utilizing a proprietary gel to deliver synthetically manufactured cannabidiol (CBD), a non-psychotropic cannabinoid, through the skin and into the bloodstream. Zynerba expects to initiate ZYN002 Phase 1 clinical studies in 3Q 2015. Learn more at www.zynerba.com and follow the company on Twitter at @ZynerbaPharma.

Investor Contact
Armando Anido
Chairman and CEO
Zynerba Pharmaceuticals
610.263.0163

Media Contact
Jennifer Guinan
Sage Strategic Marketing
610.410.8111
Jennifer at sagestrat dot com

Zynerba Pharmaceuticals Appoints New Leadership Team: Armando Anido Named Chairman and CEO, Terri Sebree Named President

First and Only Transdermal Cannabinoid Therapeutic Company Developing Two Pre-Clinical Assets

RADNOR, PA – (PR Newswire – October 1, 2014) Zynerba Pharmaceuticals, Inc., a specialty pharmaceutical company dedicated to the development of innovative transdermal cannabinoid treatments, today named two leading industry veterans with track records of success in patch and gel transdermal delivery to lead the company. Armando Anido will serve as chairman of the board and chief executive officer, and Terri Sebree will serve as president. Mr. Anido and Ms. Sebree will lead the first and only transdermal cannabinoid therapeutic company as it prepares to initiate Phase 1 clinical studies in 2015 on ZYN001, a proprietary prodrug of THC transdermal patch, and ZYN002, a proprietary cannabidiol (CBD) transdermal gel.

Mr. Anido has more than 30 years of executive, operational and commercial leadership experience in the biopharmaceutical industry. Prior to Zynerba, Mr. Anido served as chief executive officer of two publicly traded companies. Most recently, he was the chief executive officer of NuPathe, which was acquired by Teva Pharmaceuticals in February 2014. At NuPathe, he led the company through FDA approval of its lead product, Zecuity®, the first transdermal patch for migraine, to pre-launch before successfully selling the company to Teva. He also served as president and CEO of Auxilium Pharmaceuticals, where under his leadership, sales grew from $42 million in 2005 to more than $260 million in 2011, driven by the rapid growth of Testim® gel, and market capitalization increased from $200 million to more than $900 million.

Ms. Sebree offers more than 30 years of executive, development and operational experience in the biopharmaceutical industry, particularly in CNS product development including epilepsy, pain, depression and schizophrenia. She has completed more than 10 regulatory submissions and approvals of new pharmaceutical products, including transdermal patch and gel products. Prior to Zynerba, Ms. Sebree co-founded and served as President of NuPathe where she successfully led the effort to develop, achieve regulatory approval and complete manufacturing of the company’s lead product, Zecuity. Previously, Ms. Sebree served as senior vice president, development of Auxilium Pharmaceuticals where she led the Testim gel development and approval program.

“Armando and Terri both have demonstrated the ability to rapidly grow pharmaceutical companies and are uniquely experienced in leading the development, regulatory approval and commercialization of both patch and gel transdermal pharmaceuticals,” said Philip Wagenheim, former chairman and current board member of Zynerba. “We are confident that these high-caliber leaders will strategically guide the company as it enters clinical development of these novel transdermal candidates in the coming months.”

“As the first and only transdermal cannabinoid company, Zynerba is well positioned as it develops two highly innovative therapeutic treatments for the millions of patients who suffer from chronic and debilitating diseases such as fibromyalgia, neuropathic pain, chronic cancer pain, epilepsy and rheumatoid arthritis,” said Armando Anido, chairman and CEO of Zynerba Pharmaceuticals. “These novel synthetically produced candidates may offer unique advantages by delivering drug through the skin and into the bloodstream. Terri and I believe that these proprietary treatments, combined with a large population of underserved patients, offer significant promise, and we look forward to advancing our pipeline.”

About Zynerba Pharmaceuticals
Zynerba Pharmaceuticals is dedicated to the development of innovative transdermal cannabinoid treatments for patients with high unmet medical needs using modern drug delivery technology and appropriate regulatory pathways. Zynerba is developing two therapeutic candidates based on proprietary transdermal technologies that, if successfully developed, may allow sustained, consistent and controlled delivery of therapeutic levels of cannabinoids. Transdermal delivery reduces adverse effects associated with oral dosing. ZYN001 will be studied in fibromyalgia, neuropathic pain and chronic cancer pain utilizing a synthetically manufactured prodrug of THC in a transdermal patch to deliver THC through the skin and into the bloodstream. Zynerba expects to initiate ZYN001 Phase 1 clinical studies in 2Q 2015. ZYN002 will be studied in epilepsy and rheumatoid arthritis, utilizing a proprietary gel to deliver synthetically manufactured cannabidiol (CBD), a non-psychotropic cannabinoid, through the skin and into the bloodstream. Zynerba expects to initiate ZYN002 Phase 1 clinical studies in 3Q 2015. Learn more at www.zynerba.com and follow the company on Twitter at @ZynerbaPharma.

Investor Contact
Armando Anido
Chairman and CEO
Zynerba Pharmaceuticals
610.263.0163

Media Contact
Jennifer Guinan
Sage Strategic Marketing
610.410.8111
Jennifer at sagestrat dot com