Business Corner

Fulcrum Regulatory Services opens office in Vancouver

Paladin enters into South African market

Biovail Corporation subsidiary, Biovail Laboratories International SRL (BLS), has acquired certain AMPAKINE® compounds, including associated intellectual property, from Cortex Pharmaceuticals, Inc. for use in the field of respiratory depression, a brain-mediated breathing disorder.

The acquired compounds include the Phase 2 compound CX717, the preclinical compounds CX1763 and CX1942, and the injectable dosage form of CX1739.

As part of the acquisition transaction, BLS has also entered into a field limited license agreement with The Regents of the University of California.

Under the terms of the asset purchase agreement, BLS has paid an upfront fee of $9 million, expects to pay an additional $1 million upon the completion of a transition period, and could pay up to $15 million in potential milestones contingent on the successful demonstration of the utility of an intravenous formulation of CX717 in treating respiratory depression, the successful completion of a Phase 3 clinical program using an AMPAKINE® compound and approval from the U.S. Food and Drug Administration (FDA). BLS may also owe certain development milestones and/or low single-digit royalties on net sales to third parties.

Paladin Labs Inc. has completed an investment in South Africa’s Pharmaplan Ltd. The deal marks Paladin’s most significant corporate development initiative to date.

Pharmaplan is an independent South African specialty pharmaceutical company dedicated to the execution of a searchacquire-commercialize business model in the sub-Saharan African region. Under the terms of the agreement, Paladin acquires an initial 34.99 per cent ownership interest and has committed to increase its ownership position over time.

Dr. Gert Hoogland, founder and CEO of Pharmaplan, has committed to continue to lead, control and manage the Pharma-

BERESKIN & PARR_Biotechnology Focus_May2010.qxd plan business as CEO without any foreseen changes in his experienced management team.

According to IMS Health, the value of the South African pharmaceutical market is estimated to be $3 billion which represents a 13.6 per cent increase over the prior year as measured in local currency.

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Therapure Biopharma Inc. signs fill/finish contract with Kane Biotech Inc.

Bioscience industry applauds Ontario government for investment in research and innovation

Therapure Biopharma Inc. has reached a fill/finish agreementt with Kane Biotech Inc.), a Canadian biotechnology company based in Winnipeg, MB. Under the terms of the agreement, Therapure will provide custom fill/finish services for a key development-stage product for Kane Biotech. Financial terms were not disclosed.

Kane Biotech is a biotechnology company engaged in the development of products to prevent and disperse biofilms. Biofilms are a major cause of a number of serious medical problems including chronic infections and medical device related infections. Biofilms develop on surfaces such as catheters, prosthetic implants, teeth, lungs and the urogenital tract. They are pervasive, costly to deal with and approximately 80 per cent of all human bacterial infections involve biofilms. The healing of chronic wounds alone costs the US health care system $20 billion per year.

According to the Ontario Bioscience Industry Organization (OBIO), urgently needed capital should become more accessible to Ontario’s bioscience companies and help create jobs in the biotechnology sector, thanks to Ontario’s 2010 budget.

The announced increase in the budget of the Ministry of Research and Innovation coupled with anticipated adjustments to existing funding programs designed to encourage research and innovation were also applauded.

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In 2009, chief executive officers of Ontario-based bioscience companies identified the industry’s most pressing challenges and presented their recommendations for promoting growth in the sector to the Ontario Government. These recommendations of OBIO sought modifications to make existing funding programs more accessible and to accelerate commercialization, but did not ask for new money.

Dr. David Young, chair of the board of directors of OBIO, and managing partner, Actium Equity Partners, said: “The Ontario Government is listening to our industry and recognizing the economic potential of a vibrant and growing bioscience industry that can produce many of the medical therapies and technologies we now import and can create jobs. We encourage the Ontario Government in its commitment to innovation and the life-science sector by addressing the critical issue of access to capital.”

Program modifications sought by OBIO included adjustments to the Biopharmaceutical Innovation Program (BIP), owing to difficulties for Ontario life-science companies in accessing funds. The province has since announced the winding down of BIP as a prelude to adjustments in other programs that will reflect industry input.

OBIO also has struck expert committees to work with industry CEOs on finding new ways to leverage global risk capital into Ontario and on developing a strategy to maximize the scientific and economic potential of biotechnology.

Launched by chief executive officers of Ontario-based bioscience companies, OBIO provides executive-level input into provincial policies and economic strategy in order to advance the life-science sector. It is supported by members and sponsors, among whom are Amgen Canada, AstraZeneca Canada, Dalton Pharma Services, Dalton Medicinal Chemistry, The Equicom Group, Gowlings, HealthComm, Merck Frosst, Pfizer Canada, PricewaterhouseCoopers, Purdue Pharma Canada, RBC Royal Bank, Rx & D and VWR.