BUSINESS CORNER Rx&D member companies invested $1.1 billion in research and development (R&D) in Canada last year despite an economic recession, a global industry restructuring and patient access gaps for new medicines and vaccines according to a PMPRB report. “The commitment of our member companies to do research and development for the benefit of Canadians remains strong,” said Russell Williams, president of Canada’s Research-Based Pharmaceutical Companies (Rx&D). “Since 1993, Rx&D member companies’ total investment in R&D in Canada has averaged over 10 per cent of sales. The commitment made in 1987 was based on a favourable environment of access and reimbursement. That environment has significantly deteriorated and the commitment may no longer be sustainable unless Canada becomes more internationally competitive.” Mr. Williams noted that Canada is losing its competitive edge in attracting clinical trials as indicated in the Sciences and Technology Innovation Council Report on clinical research commissioned by the federal government. In fact, due to deficiencies in the research infrastructure, it is estimated that almost 20 per cent of the committed investments from industry are not used and thus not reported by PMPRB. “Governments, research institutions and industry need to work cooperatively to reduce duplication and coordinate efforts to make our country a global destination for
clinical trials research. Clinical trials account for more than 75 per cent of applied research investments in Canada,” added Mr. Williams. In addition, Rx&D calls for improvements to intellectual property protection. “We need a comprehensive approach where innovators can rely on an improved and more stable data protection regime. Our IP protections should be consistent with or better than those of our major trading partners. For example, Canada does not have an effective right of appeal for innovators in patent invalidity proceedings, but does offer an appeal for generics in the same proceedings, creating a one-sided and inequitable system,” indicated Mr. Williams. Reducing the access gap to provide Canadians in all provinces more timely access to new treatments should also be a priority to all governments. A recent Rx&D international study found that Canada ranked 20th out of 25 countries in providing access to new medicines under public drug plans. “We have the talented people to make Canada a research and innovation powerhouse,” Mr. Williams added. “We need a strategy to compete globally competition and capture a greater share of investment. The time to do it is now.” The PMPRB Report also shows Canadian patients also receive excellent value for their brand name prescription medicine. Price increases were within the rate of inflation which was 0.3 per cent in 2009. Over
Russell Williams
New report confirms $1 billion plus invested in 2010 by Canada’s Pharmaceutical Sector
the past decade, prices for innovative medicines were below the international median. In contrast, several studies have shown that Canadian generic drug prices are among the highest in the world. For example, the federal Competition Bureau found that Canadians and our health care system could save up to $800 million a year “if generic drugs were sold in a more competitive market.” Concerned with high generic drug prices in Canada, the Health Council of Canada released last week a discussion paper to highlight “the complex reasons as to why generic drug prices are so high and the longstanding lack of transparency about how prices are set.” “Working collaboratively, we can develop policies that will create more jobs and investment in the knowledge economy while giving patients choice and improved access to the new medicines and vaccines that improve and save lives,” concluded Mr. Williams.
Dealmakers n Canadian pharmaceutical services company Dalton Pharma Services (Toronto, ON) has entered into a manufacturing services agreement with Cambridge, MA specialty pharma company Zafgen Inc. Dalton Pharma Services will provide aseptic fill/finish services and analytical support under cGMP for Zafgen’s lead obesity treatment. “Dalton’s expert capabilities in the sterile manufacture of API’s and analysis combined with its strength in aseptic filling solidified the manufacturing agreement,” said James Vath, head of Drug Discovery and Development for Zafgen. “Adding Zafgen to our growing list of strategic relationships with innovative pharmaceutical clients is an important milestone for Dalton”, said Peter Pekos, president and CEO.
Medicure Inc. (Winnipeg, MN) announces its subsidiary, Medicure International, Inc. (Barbados) and Iroko Cardio, LLC (Philadelphia, PA) have entered into an agreement to advance
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AGGRASTAT® (tirofiban HCl) in each of their respective territories. Under the terms of the agreement, Medicure International will transfer to Iroko Cardio tirofiban drug substance and the rights to purchase additional quantities from a third party, and Iroko Cardio will make available to Medicure International certain analytical methods for testing tirofiban and, if requested by Medicure International, certain data related to high dose bolus use of AGGRASTAT®. As consideration for the agreement, Iroko Cardio will make payment to Medicure International of US$1.91 million within six months from the date of the agreement. If Medicure International uses the Iroko Cardio data to obtain approval in the U.S. for high dose bolus use of AGGRASTAT®, Iroko Cardio may earn royalties of up to US$3.5 million on future U.S. sales of AGGRASTAT®. Advitech Inc. (Quebec, QC) and Natunola Health Biosciences Inc. (Winchester, ON) have entered into a merger agreement to com-
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bine the business of both companies with the intent of creating a leading company in personal care and health food ingredients. Pursuant to the merger, Advitech will acquire all of the issued and outstanding shares of Natunola by way of an amalgamation between Natunola and 7894716 Canada Inc., a wholly-owned subsidiary of Advitech. The Natunola shareholders will receive common shares of Advitech based on a ratio of 4.75 common shares of Advitech (or 1.1875 common shares following a proposed 4 to 1 consolidation of Advitech shares for each common share of Natunola. All outstanding options to acquire Natunola common shares which are not exercised prior to the closing of the transaction will, subject to TSX Venture Exchange policies, be exchanged for Advitech options on the same terms. Following the Amalgamation, the Natunola shares will be delisted from the TSX-V and Natunola will continue its activities as a wholly-owned subsidiary of Advitech.
