StayBred™
Product Overview
StayBred™, a complementary technology to the SurBred™ test; is a novel single-chain LH analog for cows. This new hormone analog is believed to induce ovulation and produce a phenomenon that has been shown to reduce the rate of pregnancy loss in cows. Currently, 70% of dairy cows fail to conceive or maintain a viable pregnancy resulting in significant financial and production losses to the dairy StayBred™ LH (luteinizing hormone) analog for cows utilizes our patented "single chain gonadotropin" technology which we believe will offer cost and performance advantages (when manufacturing volumes are achieved) over conventional bovine hormone products available in the worldwide market.
We are on track to complete the initial proof of concept for StayBred™ using a recombinant form of LH during 2006. We also plan to file with the FDA an INADA and begin the registration process as soon as practical after successful large-scale clinical trials are completed using recombinant single chain bovine LH analog. Once the final formulation has been successfully tested and a mass production process has been decided upon, management may begin to market and test the product in the field on a limited basis via veterinary prescription.
We believe this drug may create a totally new pregnancy maintenance market for artificially inseminated dairy cows. It is estimated that there are over 20 million artificial insemination attempts in dairy cows in the United States alone. StayBred™ would be an applicable and beneficial product administered to dairy cows after each artificial insemination as a therapeutic treatment to maintain pregnancy. Based upon an assumed average selling price in the range of $10 to $11 per dose, we believe the total potential US market for StayBred™ could be approximately $200 million. With a modest 20 percent market penetration estimate, this product could generate approximately $40 million in gross revenue annually in the US market alone. We believe there are similar or greater potential markets outside the US. Actual market penetration forecasts would depend on a potential marketing partner's ability (who would share in the revenues) to penetrate the total market. We plan to enter into discussions and negotiations with major pharmaceutical companies who would have an ability to maximize the market for this product. We expect to conduct expanded clinical trials in the near future. As a recombinant hormone drug, this product will be prescribed and marketed by licensed veterinarians; the ultimate customers will be clients operating commercial dairy herds using timed (synchronized) breeding programs.
We anticipate the benefits and value of the StayBred™ product, if able to be successfully launched into the dairy industry are summarized as follows:
- Percentage of cows maintaining pregnancy may significantly increase by approximately 10 -50%.
- Saves the additional cost and manipulation to the animal of repeated reproduction treatments.
- Reduces average days a cow is "open" (un-bred), thereby improving overall milk production, and milk quality and calf production.
- Anticipated cost per application is easily cost justified to the dairy.
- The product is easy to administer.
- Technology is patented.
We believe that over time this product can potentially become our largest selling drug (once FDA approved) with a substantial worldwide market potential provided we are able to produce the product in large quantities at an attractive cost.
