YORKTONHEMOSOL (HML $15.20, TSE)
Recommendation: STRONG BUY
12 to 18-Month Target: $30.00
Biopure Completes Patient Enrollment in U.S. Phase III Hemopure® Trial
EVENT: Biopure (BPUR, NASDAQ), a leading competitor of Hemosol’s, announced that it has completed the enrollment of all
680 patients in its Phase III clinical trial to evaluate its oxygen therapeutic drug, Hemopure®, for use in orthopedic surgery. This
means that the Phase III treatments have been concluded and all of the patients will be observed during follow-up visits over the next
six weeks while quantifiable results are analyzed. To date, more than 1,300 patients have been enrolled in 22 completed or ongoing
clinical trials, including the pivotal Phase III trial. Hemopure® has been administered to more than 750 patients. The ongoing trials
include a Phase II trial being conducted at military hospitals in trauma and other surgery patients and a Phase I safety trial using the
product as an adjunct in patients receiving radiation therapy for brain tumours (countering radiation induced anemia). Biopure
expects to file for U.S. FDA approval by mid-2001 and plans to follow with applications in the European Union and Canada
COMMENT: Biopure extracts bovine (cow) hemoglobin while Hemosol treats and purifies hemoglobin derived from FDA-approved
human blood. Both processes claim to remove bacterial, viral, cellular and any other material that may be present in the
original donor blood. Both forms of hemoglobin are chemically cross-linked to increase the stability of the drug and both products
are claimed to deliver a more-than-adequate oxygen supply to human tissue.
Recently, Hemosol completed a Phase III clinical trial in Canada and the United Kingdom exploring the use of Hemolink during
coronary artery bypass graft (CABG) surgery. Involving 288 patients, that study determined that during CABG surgery the reliance
on human donor blood could be safely reduced by a statistically significant amount. A new drug submission (NDS) was filed with
Health Canada’s Therapeutic Products Division and Hemolink was granted Canadian priority review status (meaning that the
approval process is reduced from 12 to 6 months) on August 28, 2000. A U.S. Phase II study has been completed (60 patients) for
the same indication with the same results. The start of its 300 patient U.S. Phase III for CABG indications is imminent and
Hemosol is expected to file a U.S. NDA during the second half of 2001. Hemosol is also expected to begin Phase II studies in the
U.S. for other indications (such as anemia) before year-end 2000.
It is apparent that, at this time, Biopure and Hemosol are seeking different primary markets (orthopedic and CABG surgery,
respectively). However, it can be expected that shortly after a beachhead is secured, each will seek market expansion and in the end, the
two products will compete directly in the major surgery and anemia markets. In our projections, we have not assumed any superiority
for Hemolink over other products, except for projecting greater market share for Hemolink in CABG, as Hemosol will have more
clinical data for this indication. However, we consider Hemopure to be at a marketing disadvantage, particularly in Europe, as a result of
its bovine origin. This may be partially offset by Hemopure’s lower cost and broad availability of its raw material.
CONCLUSION: While it appears that Biopure is approximately six months ahead of Hemosol, we consider this difference
immaterial. We have a Strong Buy recommendation on Hemosol and a $30.00 target price.
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