Between Endo's agreement with BDSI versus Endo's agreement with BNC... as far as I can tell, Endo is not paying for the development expenses of PhIII clinical trials for Bema Bup*. In contrast, as we all know, Endo is paying all expenses for BNC/Urocidin's PhIIIb clinical trials. See summary of agreements at bottom of page.
The cost of PhIIIb clinical trials, now ongoing for Urocidin, is estimated at between $60+ million and $90 million depending on source quoted (i.e., Dr. Morales comment or Aussie source).
I think everyone would agree that not one penny of the above $60+ to $90 million commitment from Endo (just for development expenses) has been recognized by the market and factored into BNC's current price.
Given that we are just days away from the one-year anniversary of the first patient being recruited into PhIIIb trials and Urocidin's PhIIIa trial results were solid+++ and, BNC (and Endo) continues to keep this one of "Canada's best kept secrets"...maybe BNC should have requested this $ amount be received in quarterly milestone payments as the trial progressed (i.e., added these $s to revenue and then expensed it covering actual trial expenses). No change in net profit for BNC, BUT revenue line (and expense line) are bumped dramatically. Markets seem to take note of jumps in higher revenue and, explaining the reason for the higher expense is another excuse to tell about Urocidin's PhIIIb progress that Endo is fully funding.
Regarding the annual $ figure...picking a near-mid point of $80 million for Endo's commitment and dividing by 4? years = $20 million added to BNC's revenue and then expenses each year.
A little bit more "sizzle"...I think. Particularly in light of our current situation, "Canada's Best Kept Secret". Have a good week-end! rg
*Note: "BEMA Bup, as its known for short, failed to meet the primary endpoint of a Phase III trial completed earlier this year.
RALEIGH, N.C. , Jan. 6, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI - News) today announced the signing of a worldwide license and development agreement with Endo Pharmaceuticals (Nasdaq: ENDP - News) for the exclusive rights to develop and commercialize BEMA Buprenorphine for the treatment of chronic pain.
Financial terms of the agreement include:
- $30 million upfront payment to BDSI upon execution of the definitive agreement;
- $95 million in potential milestone payments based on achievement of pre-defined intellectual property, clinical development and regulatory events;
- $55 million in potential sales milestones upon achievement of designated sales levels; and
- Tiered, mid to upper teen royalty on U.S. net sales
Under terms of the agreement, Endo will be responsible for the manufacturing, distribution, marketing and sales of BEMA Buprenorphine on a worldwide basis. Endo will commercialize BEMA Buprenorphine outside the U.S. through its own efforts or through regional partnerships. Both companies will collaborate on the planning and finalization of the Phase 3 clinical development program and regulatory strategy for BEMA Buprenorphine for chronic pain. BDSI will maintain responsibility for the conduct of planned clinical studies leading up to the submission of the New Drug Application (NDA). Endo will have the responsibility of submitting the NDA and managing the interactions with FDA.
BELLEVILLE, Ontario, February 12, 2010 – Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology driven Canadian biopharmaceutical company, today announced that it has met the obligations associated with two milestones under its licensing agreement with Endo Pharmaceuticals (Nasdaq: ENDP) for exclusive rights to develop and market Bioniche’s proprietary product for non-muscle-invasive bladder cancerin North America. The achievement of these milestones triggers a total payment of US$8 million to Bioniche from Endo.
Endo Pharmaceuticals has also elected to exercise its option for exclusive rights to develop and market the product globally. As a result of the decision, Endo will all assume all external development expenses for the product.
“We are pleased with this decision by Endo,” stated Graeme McRae, Chairman, President and CEO of Bioniche Life Sciences Inc. “We look forward to ongoing collaboration in addressing the global market opportunity for our bladder cancer product, as well as effectively completing the clinical development program and achieving product registrations in global jurisdictions.”
Under the licensing agreement, Bioniche has the potential to receive a total of US$110 million in payments associated with the achievement of certain clinical, regulatory and commercial milestones. The achievement of the first milestone of US$6 million was announced by the Company in November 2009. Future milestones will be announced as they are achieved and, with its exclusive manufacturing supply contract, Bioniche will also receive a net-sales-based revenue stream upon product approval.
Bioniche’s patented intravesical formulation of Mycobacterial Cell Wall-DNA Complex (MCC) developed for the treatment of non-muscle-invasive bladder cancer (UrocidinTM) is undergoing a U.S. Food and Drug Administration (FDA) fast tracked Phase III registration study of the product for the treatment-refractory indication. Future plans to further develop UrocidinTM are being defined and will be disclosed by Endo.