Tribute Pharmaceuticals Canada Inc., a specialty pharmaceutical company with a primary focus on the acquisition, licensing, development and promotion of healthcare products in Canada and the U.S., is pleased to announce that its wholly owned subsidiary, Tribute Pharmaceuticals International Inc., a Barbados corporation, has acquired the U.S. rights to Fibricor® and its related authorized generic (the “Product”) from a wholly owned step-down subsidiary of Sun Pharmaceutical Industries Ltd. (“Sun Pharma”). Financial terms of the deal include the payment of US$10 million as follows: US$5 million on closing; US$2 million payable 6 months from closing; and, US$3 million payable 12 months from closing. Sales of the Product during the twelve month period ending April 30, 2015 were approximately US$4.7 million.
Fibricor® is indicated as adjunctive therapy to diet for treatment of severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL) and as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia.
Fibricor® is a unique and patent protected fenofibric acid formulation that competes in the approx. US$2.5 billion triglyceride lowering medication market. Fibricor® contains the lowest dose of fenofibric acid or fenofibrate available in the U.S., consisting of 105mg and 35mg tablet presentations. The Product is protected by four patents extending out to August 20, 2027.
Velocity Health Securities, Inc. acted as the exclusive financial advisor to Sun Pharma on this transaction.
In connection with the Fibricor® acquisition Tribute has entered into an employment agreement with William (Billy) Maichle to run Tribute’s newly created U.S. operations and serve as President of Tribute Pharmaceuticals US, Inc. (“Tribute U.S.”). Mr. Maichle has over 18 years of experience in the industry including responsibilities in the fibrate, cardiovascular and generic markets. In 2007, while the Chief Operating Officer at ProEthic Pharmaceuticals, Mr. Maichle licensed and launched Lipofen® (fenofibrate) in the U.S. market. In addition to being responsible for all drug development activities at ProEthic, Mr. Maichle provided oversight for all commercial operations including trade relations, managed markets, sales force and internal operations, as well as responsibility for the company’s generic subsidiary, Midlothian Laboratories. Under his direction, sales of Lipofen® consistently grew and ProEthic was acquired by Kowa Pharmaceuticals (Nagoya, Japan) largely due to the success with the Lipofen® launch. In 2009, Mr. Maichle was instrumental in negotiating a co-promotion deal for the cardiovascular brand Livalo® (pitavastatin) with Eli Lilly & Company, adding substantial resources to Livalo’s pending launch.
In 2010, Mr. Maichle became the Chief Operating Officer (later the Chief Executive Officer) at Nautilus Neurosciences, Inc., and launched Cambia® (which Mr. Maichle developed at ProEthic/Kowa) in May 2010 with a small specialty sales force. Cambia® continued strong growth and the company received two Paragraph IV patent challenges. Under Mr. Maichle’s direction, the company successfully litigated both challenges and ensured exclusivity for the foreseeable future. Cambia was sold to Depomed in December 2013 for US$50 million.
Following his departure from Nautilus, Mr. Maichle has operated a thriving, global consulting business, Kamryn Partners, with clients across North America, Latin America and Europe.
“We are very pleased with these events for a multitude of reasons,” stated Rob Harris, President and CEO of Tribute. “The Fibricor® acquisition marks Tribute’s commercial entrance into the U.S. market. Fibricor® provides Tribute with an approved, marketed product currently generating revenues and competing in a multi-billion dollar market, which we intend to use as a platform for building our U.S. commercial infrastructure. Most importantly, the acquisition of Fibricor® is immediately accretive.” Mr. Harris went on to say, “in connection with this acquisition, the Company is also announcing the hiring of Billy Maichle as the President of the newly created Tribute U.S. subsidiary. Billy has extensive experience in the U.S. specialty pharmaceutical market along with a vast knowledge of Cambia®, Tribute’s lead promoted product in Canada. We are thrilled to welcome him on board.”