Prometic Provides Business Update and Reports Financial Results for the Period Ended September 30, 2007
Market Wire, November, 2007
ProMetic Life Sciences Inc. (TSX: PLI) ("ProMetic") today provided an update on PBI-1402 and on protein technologies business activities, 2008 financial guidance, near term milestones, and reported financial results for the three and nine months ended September 30, 2007.
"The company has made significant progress throughout 2007 with impressive clinical results with PBI-1402 and revenue growth in our protein technologies division. We are poised for even greater achievements in the months and year to come," said Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic.
A web cast to discuss ProMetic's highlights and upcoming milestones, including data presented at the upcoming 49th Annual Meeting of the American Society of Hematology ("ASH"),is being scheduled for the week of December 10th, following our presentation at ASH.
MILESTONES - OUTLOOK
PBI -1402
Following the selection of ProMetic's abstract on the PBI-1402 Phase II clinical trial in chemotherapy-induced anemia ("CIA") patients for presentation during the 49th Annual Meeting of ASH in December, ProMetic's abstract is now available on the ASH web site at http://www.hematology.org/meetings/2007/index.cfm . More substantive information will be reported in conjunction with a poster to be presented at ASH's annual meeting on December 9, 2007.
- ProMetic announced the expansion of the original Phase II clinical trial in CIA patients to enroll more patients at the lowest dose showing efficacy. Results from the expanded trial are expected in the second quarter of 2008;
- The Company has additionally initiated a clinical trial in patients that develop anemia related to their cancer ("Cancer Related Anemia" or "CRA"). Today, a very small number of CRA patients are treated with recombinant erythropoietin (rhEPO). New FDA guidelines are likely to lead to a further reduction of the use of rhEPO in CIA or CRA patients. CIA and CRA indications represent a significant opportunity for ProMetic because the orally active PBI-1402 is a first in class drug candidate to treat anemia via a different mechanism of action than rhEPO. Results from the CRA trail are also expected in 2008;
- The Company has also released information confirming the ability of PBI-1402 to boost red blood cells and hemoglobin level in a pre-clinical model that simulates the most severe case of chronic kidney disease ("CKD") requiring renal dialysis in humans. This is a breakthrough discovery in that PBI-1402, given orally, was shown to correct anemia even when there was very little or no EPO present in the body. This new data is instrumental in the design of the PBI-1402 clinical trial targeting anemia in CKD patients where their anemia, unlike that of CIA or CRA patients, is caused by a reduced production of EPO from their compromised kidneys;
- Partnering discussions have been accelerated with the positive Phase II clinical data in CIA patients and additional data now available. The novel mechanism of action of PBI-1402 is opening up a new field for the treatment of anemia which further enhances the potential value of PBI-1402.
Protein Technologies
In 2008 we anticipate that our Protein Technologies business to generate revenue exceeding $30 million. An estimated $8 million - $10 million revenue will come from the Bioseparation business, revenue from Tecpar will range from $5 million to $7 million, the plasma derived therapeutics revenue will range from $8 million to- $10 million and PRDT will contribute revenues of between $7 million to $10 million.
- Further expansion of our relationship with Kedrion for additional and valuable therapeutics is expected in the fourth quarter. We also anticipate the adoption of ProMetic's technology by a large and established plasma fractionator in Asia the fourth quarter. This is following on the agreement that has been entered into by Kedrion in which ProMetic's proprietary plasma process has been adopted by Kedrion for the manufacturing of hyperimmunes. This agreement contributes short term cash to ProMetic as well as royalties on Kedrion's sales. In addition, ProMetic retains the rights to the finished hyperimmune products for the North American market.
- In the forthcoming months, ProMetic's prion reduction affinity resin will be used by multiple European plasma fractionators. In addition to Kedrion, who has confirmed the use of the prion reduction resin for its future hyperimmune products, we anticipate another fractionator to integrate ProMetic's prion reduction technology for one of its plasma-derived products;
- All studies on the P-Capt® prion filter, requested by the National Blood Services of the U.K. and Ireland, in addition to those required for regulatory approval, have been completed. A pre-adoption clinical evaluation of the P-Capt® filters in patients is underway in Ireland and in the U.K. These studies are undertaken by the National Blood Services as standard procedures prior to concluding any long-term procurement agreement, such as would be the case with MacoPharma;
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