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July 29, 2014
Bioniche Announces Submission of Orphan Drug Designation Application for MCNA in the United States

July 18, 2014
Bioniche Announces Intention to File for Marketing Approval of MCNA in the United States

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Corporate Development & Partnering

Our Vision & Strategy

  • We will focus our efforts on becoming a leading human therapeutics company, with a strong culture of innovation, outreach and collaborations in order to bring transformational products to patients in therapeutic areas of unmet need;
  • We will capitalize on our lead bladder cancer product, MCNA, by establishing a clear regulatory path for its approval in select jurisdictions, particularly the U.S. and Canada, and we will expand our network of development and commercialization partners to generate further revenues;
  • We will strategically evaluate opportunities to expand MCNA uses, such as, combinations of MCNA with approved targeted drugs or emerging immunotherapies as well as the potential use of MCNA as a cancer vaccine adjuvant;
  • We will aggressively build a leading human therapeutics pipeline through development-stage product licensing/acquisitions and will strategically evaluate company acquisitions that meet a stringent set of criteria.

MCNA Partnering

Current MCNA Partnerships
Bioniche has granted Paladin Labs (now part of Endo International plc) an exclusive license to market and distribute MCNA for bladder cancer in Canada, South Africa and Mexico. The companies have agreed to a net revenue sharing arrangement. Bioniche will be responsible for all product development and manufacturing costs and Paladin will be responsible for all sales and marketing costs in the said territories. Further, the agreement provides that Paladin will pay a series of potential sales performance milestones that can total up to $16 million during the term of the agreement.

New MCNA Partnership Opportunities
Bioniche is seeking additional partners to help support the development, regulatory approval and commercialization of MCNA outside of Canada, South Africa and Mexico. Ideal partners will have the financial bandwidth as well as the regulatory and commercial infrastructures and expertise necessary for the successful approval, commercialization and reimbursement of MCNA in the licensed territories.

Bioniche will consider a global partnership outside the territories licensed to Paladin and will also consider regional partnerships.

Building a Successful Pipeline

As part of its new corporate strategy, Bioniche will seek to build upon its lead MCNA product and aggressively build a leading human therapeutics pipeline through development-stage product licensing/acquisitions, and will strategically evaluate company acquisitions that meet a stringent set of criteria. We will initially focus our efforts primarily on identifying oncology products, however, we will remain opportunistic and strategically consider product opportunities in indications beyond oncology that demonstrate a clear path to proof of relevance in humans.

Capitalizing on new management team members’ expertise and successful track record in identifying, licensing/acquiring, and developing a wide range of therapeutics that make a meaningful difference in the lives of patients, Bioniche’s Corporate Development & Licensing team will be scouting for product opportunities worldwide. Through this outreach initiative, the team is seeking to build strategic relationships through a culture of transparency and innovation, and a strong desire to rapidly and efficiently bring transformational products to patients while ensuring that our interests are aligned with those of our shareholders, our partners and their respective shareholders and other key stakeholders.

We will employ a stringent screening process using clear scientific, medical and economic metrics to evaluate opportunities according to the following criteria. Bioniche will, nonetheless, be opportunistic when presented with opportunities failing to strictly meet all of these defined criteria.

  • Any therapeutic that demonstrates strong potential and addresses unmet medical needs (primarily oncology) including small molecules (including complex natural products), biologics (mAbs, mAb derivatives, ADCs, proteins, etc.), peptides, peptidomimetics, nucleic acids, gene therapy, cell therapy and more.
  • Therapeutics with direct activity on a known and biologically validated target or mechanism, as demonstrated by pharmacodynamic markers/biomarkers;
  • Therapeutics with a primary indication that will allow a meaningful clinical readout in a Phase II study; we will opportunistically and strategically consider opportunities beyond oncology that demonstrate a clear path to proof of relevance in human.
  • Therapeutics that are at advanced lead/pre-clinical development candidate stage through early Phase II with defined patient populations and best-in-class/first-in-class potential. Later stage opportunities will be considered on a case-by-case basis;
  • North American rights are required; worldwide rights are preferred;
  • Patent protection (composition of matter and uses);
  • Competitive advantage(s) that provide a sustainable edge over existing and potential competitors and alternative treatments.

For any inquiries, or if you wish to present a product or business opportunity, please contact:
Mathieu Boudreau, Ph.D., Senior Director, Corporate Development and Licensing

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