Pediapharm Inc. Acquires Naproxen Suspension from Hoffmann-La Roche Limited
This acquisition of the Canadian regulatory dossier and product rights for the only approved naproxen suspension in Canada affirms Pediapharm’s commitment to rapidly expand its portfolio of pediatric specialty products.
TORONTO, ONTARIO and MONTREAL, QUEBEC–(Marketwired – July 2, 2014) - NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES
Pediapharm Inc. (“Pediapharm”) (TSX VENTURE:PDP) and Hoffmann-La Roche Limited (“Roche”) announced today they have entered into an asset purchase agreement regarding the Canadian rights to Roche’s naproxen suspension. Roche will retain the Naprosyn™ trademark and retains all product rights to the other oral dosage forms under this brand.
This product in its suspension form is only available under prescription (Rx) and is indicated for the treatment of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and juvenile rheumatoid arthritis. Due to the significant unmet medical need, it will be reintroduced to the market as Pediapharm naproxen suspension.
It is also indicated for the relief of minor aches and pains in muscles, bones and joints, mild to moderate pain accompanied by inflammation in musculoskeletal injuries (sprains and strains) and primary dysmenorrhea.
The product is primarily used for juvenile rheumatoid arthritis (JRA) in children 2 years or older due to its more flexible dose titration based on the child’s weight. It is the only available liquid form of naproxen on the Canadian market. It is estimated that there are over 6,000 children presently living with arthritis in Canada.
“Roche is pleased to be working with Pediapharm to ensure this important medication will remain available in Canada for the treatment of conditions like juvenile rheumatoid arthritis,” said Richard Wright, Vice President Sales and Marketing Specialty Care, Roche Canada. “Roche has a long history in developing treatments for rheumatoid arthritis and other auto-immune diseases, and this collaboration builds on our commitment to meet the needs of patients.”
At the same time, Roche and Pediapharm are working to establish a temporary special access to a similar liquid product. The companies will inform the medical community about this possibility in the near future.
“Naproxen helps treat the pain of juvenile arthritis; however, children can have difficulty swallowing pills, and liquid naproxen provides another way to administer this treatment to them,” said Dr. Rosie Scuccimarri, representative of the pediatric committee of the Canadian Rheumatology Association (CRA). “The CRA is pleased that Roche Canada and Pediapharm have collaborated to ensure that this important treatment will continue to be available to patients who require a liquid form of naproxen,” said past president Dr.Carter Thorne.
“Given the importance of providing formulations adapted for pediatric dosing, both companies have been seeking a short-term solution to reintroduce the product on the market. We are confident that in the interim, we will be able to work with the regulatory authorities to provide a short-term treatment option to patients that absolutely require a liquid formulation”, said Benoît Hébert, Pediapharm’s Vice President of Business Development and Licensing. “The speed at which this project has materialized into a beneficial transaction for both parties is yet another example of the expertise within Pediapharm.
“This transaction is Pediapharm’s first product acquisition and we feel there is significant growth potential for this product in the oral liquid NSAID market estimated to exceed 8M$, considering that the total Canadian prescription NSAID market is valued at more than 76 M$. I am very proud of this achievement as it highlights Pediapharm’s determination to support the pediatric community and finding solutions to their unmet medical needs. It further demonstrates our deal-making ability. We believe it paves the way for more product acquisitions in the near future,” said Sylvain Chrétien, President and Chief Executive Officer of Pediapharm Inc. “We expect this transaction to rapidly impact favorably our revenues as we re-launch the product.”
Pediapharm intends to make the naproxen suspension available again within the next 8 months.
About Hoffmann-La Roche Limited
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, infectious diseases, inflammation, metabolism and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2012 Roche had over 82,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 45.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
Naprosyn™ is a trademark of Hoffmann-La Roche Limited.
About the Canadian Rheumatology Association
The Canadian Rheumatology Association (CRA) is the national professional association for Canadian rheumatologists.
The mission of the CRA is to represent Canadian Rheumatologists and promote the pursuit of excellence in Arthritis Care, Education and Research. The CRA, re-established in 1993, in its current iteration, has organizational roots reaching back to the Canadian Rheumatic Disease Association (1936) and Canadian Rheumatism Association (1946). The goals of the association include advancing professional camaraderie, research and training to improve the health of Canadians with rheumatic diseases. Today, the CRA comprises over 500 members throughout all 10 provinces and territories.
Since its inception, the CRA has promoted and advanced the field of rheumatology by organizing networking, training and education opportunities for clinicians, students, allied health professionals and researchers. More recently the CRA has become involved in the promotion and coordination of funding for important rheumatology research (CIORA).
The CRA’s vision is to improve the care and quality of life of patients suffering from rheumatic conditions. According to a Health Canada study, an estimated 1 in 6 Canadians has some type of arthritis; two thirds of affected Canadians are under the age of 65 years. Arthritis and rheumatic diseases not only have a profound effect on patient quality of life, but also accounts for an estimated $33 billion burden on Canadians.
About Pediapharm Inc.
Pediapharm is the only Canadian specialty pharmaceutical company dedicated to serving the needs of the pediatric community. Its mission is to bring to the Canadian market the latest innovative pediatric products with the objective to improve the health and the well-being of children in Canada. Since its debut in 2008, Pediapharm has entered into numerous commercial agreements with partners from Canada and other countries around the world.
FORWARD LOOKING STATEMENTS FOR PEDIAPHARM
This news release contains forward-looking statements and other statements that are not historical. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions that could cause actual results to vary materially from target results and the results or events predicted in these forward-looking statements. As a result, investors are cautioned not to place undue reliance on these forward-looking statements.
The forward-looking statements contained in this news release are made as of the date of this release. Except as required by applicable law, the Corporation disclaims any intention and assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Forward-looking information reflects the current expectations or belief of the Corporation based on information currently available and such information is subject to a number of assumptions, risks and uncertainties described in details at pp. 35 to 41 of the Management Information Circular of Chelsea Acquisition Corporation dated November 12, 2013 available on SEDAR at www.sedar.com and other risks associated with being a specialty pharmaceutical company.
For more information about Pediapharm or its products, please visit www.pedia-pharm.com.
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Hoffmann-La Roche Limited
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Canadian Rheumatology Association
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