Intellipharmaceutics Signs an Exclusive License and Commercial Supply Agreement with Mallinckrodt

TORONTO, Oct. 11, 2016  -- Intellipharmaceutics International Inc. (IPCI) (TSX:I) ("Intellipharmaceutics" or the "Company"), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that it has entered into a license and commercial supply agreement with Mallinckrodt LLC ("Mallinckrodt"), by which the Company has granted Mallinckrodt an exclusive license to market, sell and distribute in the United States the following extended release drug product candidates (the "licensed products") for which Intellipharmaceutics has abbreviated new drug applications ("ANDAs") filed with the U.S. Food and Drug Administration ("FDA"):

Quetiapine fumarate extended-release tablets (generic Seroquel XR®) – ANDA Tentatively Approved by FDA

Desvenlafaxine extended-release tablets (generic Pristiq®) – ANDA Under FDA Review

Lamotrigine extended-release tablets (generic Lamictal® XR™) – ANDA Under FDA Review

Collectively, the present annualized sales by third parties for the currently marketed versions of these products in the United States are approximately U.S. $2.5 billion.1

 

Under the terms of the 10-year agreement, Intellipharmaceutics will receive a non-refundable upfront payment of US$3 million in October 2016.  In addition, the agreement also provides for the Company to have a long-term profit sharing arrangement with respect to the licensed products. Intellipharmaceutics has agreed to manufacture and supply the licensed products exclusively for Mallinckrodt, and Mallinckrodt has agreed that Intellipharmaceutics will be its sole supplier of the licensed products marketed in the U.S. 

 

The agreement contains customary terms and conditions for an agreement of this kind, and is subject to early termination in the event the Company does not obtain FDA approvals of the licensed products by specified dates, or pursuant to any one of several termination rights of each party.

 

1 Represents sales for all strengths for the 12 months ended August 2016 in the U.S., including sales of generics in TRx MBS Dollars, which represents the projected new and refilled prescriptions representing a standardized dollar metric based on manufacturer’s published catalog or list prices to wholesalers, and does not represent actual transaction prices and does not include prompt pay or other discounts, rebates or reductions in price. Source: Symphony Health Solutions.

 

There can be no assurance as to when or if any of the licensed products will receive final FDA approval or that, if so approved, the licensed products will be successfully commercialized and produce significant revenues for the Company.

 

The CEO of Intellipharmaceutics, Dr. Isa Odidi, said, “We are very pleased to establish this long-term commercial partnership with Mallinckrodt, which follows last week’s tentative approval for our generic Seroquel XR®. Mallinckrodt is a respected pharmaceutical company with significant market presence in the U.S.  This partnership provides further recognition of Intellipharmaceutics' technology platform and pipeline.  We look forward to the commercialization of generic Seroquel XR® with Mallinckrodt following final approval.”

 

“This agreement aligns well with our strategy of strengthening our Specialty Generics business and expanding our pipeline. If approved, these drugs will provide patients with alternative treatment options for central nervous system disorders,” said Dr. Frank Scholz, Executive Vice President, Global Operations and President, Specialty Generics, Mallinckrodt Pharmaceuticals. “We look forward to working with Intellipharmaceutics to bring these products to market.”

 

About Intellipharmaceutics

 

Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Company's patented Hypermatrix™ technology is a multidimensional controlled-release drug delivery platform that can be applied to the efficient development of a wide range of existing and new pharmaceuticals. Based on this technology platform, Intellipharmaceutics has developed several drug delivery systems and a pipeline of products (which have received final FDA approval) and product candidates in various stages of development, including ANDAs filed with the FDA (and one Abbreviated New Drug Submission filed with Health Canada) in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes and pain.

 

Intellipharmaceutics also has New Drug Application (“NDA”) 505(b)(2) specialty drug product candidates in its development pipeline. These include Rexista® XR, an abuse deterrent oxycodone based on its proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System and PODRAS™ Paradoxical OverDose Resistance Activating System, and Regabatin™ XR (pregabalin extended-release capsules). Our current development effort is increasingly directed towards improved difficult-to-develop controlled-release drugs which follow an NDA 505(b)(2) regulatory pathway. The Company has increased its research and development emphasis towards new product development, facilitated by the 505(b)(2) regulatory pathway, by advancing the product development program for both Rexista® and Regabatin™. The 505(b)(2) pathway (which relies in part upon the approving agency's findings for a previously approved drug) both accelerates development timelines and reduces costs in comparison to NDAs for new chemical entities. An advantage of our strategy for development of NDA 505(b)(2) drugs is that our product candidates can, if approved for sale by the FDA, potentially enjoy an exclusivity period which may provide for greater commercial opportunity relative to the generic ANDA route.

 

About Mallinckrodt

 

Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical and biopharmaceutical products and therapies, as well as nuclear imaging products. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and hemostasis products; and central nervous system drugs. Mallinckrodt’s core strengths include the acquisition and management of highly regulated raw materials and specialized chemistry, formulation and manufacturing capabilities. Mallinckrodt’s Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing; and the Nuclear Imaging segment includes nuclear imaging agents. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

 

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Additional risks and uncertainties relating to the Company and our business can be found in the “Risk Factors” section of our latest annual information form, our latest Form 20-F, and our latest Form F-3 (including any documents forming a part thereof or incorporated by reference therein), as well as in our reports, public disclosure documents and other filings with the securities commissions and other regulatory bodies in Canada and the U.S., which are available on www.sedar.com and www.sec.gov. The forward-looking statements reflect our current views with respect to future events and are based on what we believe are reasonable assumptions as of the date of this document, and we disclaim any intention and have no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

 

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