About AspenBio Pharma
Overview
AspenBio Pharma, Inc. (the “Company” or “AspenBio” also “we”, “us” or “our”) is an emerging bio-pharmaceutical company dedicated to the discovery; development, manufacture, and marketing of novel proprietary products that have large worldwide market potential. We were originally formed in August 2000, as a Colorado corporation to produce purified proteins for diagnostic applications and have successfully leveraged our foundational science and technology expertise to develop a pipeline of new products. Today, the Company is primarily focused on advancing towards commercialization, our recently patented blood-based human diagnostic test, AppyScore™ to aid in the diagnosis of human appendicitis and several novel reproduction drugs for use in high value animals.
Human Diagnostics
AppyScore is the only known blood-based test to the aid in diagnosis of appendicitis. The test is designed to provide a timely, quantitative, and objective assessment for appendicitis which we believe will significantly aid Emergency Department (“ED”) physicians in triaging patients complaining of abdominal pain. AppyScore measures the abundance of MRP 8/14, an inflammation biomarker which we have identified to be elevated in acute appendicitis and demonstrates a strong correlation to the severity of the disease. We believe the AppyScore product has the potential to enhance the accuracy and speed of diagnosis and improve the standard of care for acute appendicitis.
Appendicitis Overview and Market
Appendicitis is a rapidly progressing condition which typically occurs over a period of 24 to 36 hours from start to perforation. Failure to accurately diagnose and treat appendicitis before perforation can lead to serious complications and, in some cases, death. The current diagnostic and treatment paradigm for appendicitis includes review of the patient’s clinical presentation, health history, blood chemistry, and white blood count. Based on these indicators, patients that are considered to be at risk for appendicitis in the US are then typically sent for Computed Tomography (“CT”) imaging (or in some cases ultrasound) for further diagnosis and then surgery. Unfortunately, imaging-based methods are subject to interpretation and can lead to inaccurate or inconclusive diagnosis. One medical report (Graff et al., 2000 Acad Emerg Med Vol 7 n 11 pp 1244-55) which analyzed approximately 1,026 appendicitis patients from 12 hospitals found that an average of 18.6% of patients (ranging from 10.6% to 27.8% per hospital) were incorrectly diagnosed as not having appendicitis and were sent home, only to return to the emergency room with more advanced or perforated (burst) appendicitis. In addition, despite the extensive use of use of CT to help diagnose the condition, approximately 15% of appendectomies remove a normal appendix resulting in unnecessary surgery for the patient and unnecessary cost to the healthcare system. We believe that AppyScore represents a powerful new tool that will help surgeons minimize the negative appendectomy rate without increasing the incidence of perforation among patients with suspected appendicitis.
It is estimated that approximately 5-7% of the world’s population will get appendicitis in their lifetime. In the U.S. alone, we estimate that there are approximately 6,000,000 patients that enter emergency departments annually complaining of abdominal pain resulting in approximately 320,000 cases of appendicitis. To date there appears to be no individual sign, symptom, test, or procedure capable of providing an objective and reliable diagnosis of appendicitis. Although the use of a CT appears to be the most widely used diagnostic tool, its results are subject to interpretation and can be inconclusive. Misdiagnosis of appendicitis can lead not only to unnecessary surgery but also to delay of proper therapy for the actual underlying condition. In addition, approximately 58,000 patients annually suffer a perforated appendix because they are not diagnosed correctly and / or in time. A dilemma for surgeons is minimizing the negative appendectomy surgery rate without increasing the incidence of a life threatening perforation among patients referred for suspected appendicitis. We expect AppyScore will provide the only objective and quantitative approach to assist physicians in their diagnostic algorithm and rapidly provide important new information as doctors form their initial clinical impression in patients with acute right lower quadrant abdominal pain.
Clinical and Product Development
In December 2008 we completed an 800 patient pivotal clinical trial for AppyScore for use as an aid in the diagnosis of appendicitis. Based on these results, we plan to file a 510(k) with the United States Food and Drug Administration (“FDA”) to seek clearance of the AppyScore ELISA platform used in the pivotal trial. It is expected that the product’s intended use will be to aid in the diagnosis of appendicitis, when AppyScore is used in conjunction with other clinical findings and laboratory tests.
We have received our Pre-IDE response from the FDA and are pursuing a 510(k) (Pre-Market Notification) regulatory clearance which we expect to file with the FDA in 2009. The basis of a 510(k) filing will be one of comparing the new diagnostic entity to an existing assay, or “predicate” that is substantially equivalent. Although we plan to file using a predicate, we expect that because AppyScore is the first test to aid in the diagnosis of appendicitis, we may not find a comparable test (predicate) which already has FDA clearance. However, if that happens we would then expect to be told by FDA that there is no acceptable substantially equivalent predicate and the application will be routed into the de novo process, a procedural method that places a new diagnostic test on the de novo path (meaning that this would be a new classification of device).
To date, around 50 products have successfully followed this path since this approach came into effect in 1997. If AppyScore follows the de novo process there are benefits, including once cleared it may allow greater flexibility to make product modifications and upgrades.
Our commercialization plan to maximize the value and effectiveness of the AppyScore product in the marketplace is to advance the FDA 510(k) clearance process on our ELISA test while simultaneously completing development and testing of our rapid assay cassette with reader instrument. This reader instrument is in advanced prototype development and has many features and benefits over the current ELISA test format. The benefits include rapid results in fifteen minutes versus forty five minutes for the ELISA, a fully integrated automated standalone assay system that significantly reduces operator dependence, reduces the potential for error and is designed to interface with the hospital’s LIMS system. It is expected that clinical trials of this rapid assay with reader will commence either in late 2009 or early 2010. Trials will be designed to support the 510(k) application for this platform, as well as enhance the clinical utility of AppyScore.
Animal Healthcare
Through our “single-chain gonadotropin” platform technology we licensed from Washington University in St. Louis and further developed by AspenBio, we are developing animal healthcare products focused on reproduction, initially in bovine, to be followed by other livestock species of economic importance. Our largest opportunity to date in this area is BoviPure LH™ – a recombinant hormone analog that induces ovulation and reduces the risk of pregnancy loss in dairy cows. We are also developing a novel breakthrough drug designed for super-ovulation of cows: BoviPure FSH™, a single-chain bovine FSH analog that works in a single dose versus conventional FSH drugs which require a total of 8 doses to be given every 12 hours for consecutive 4 days. Both of these drugs, BoviPure LH and BoviPure FSH were licensed in 2008 to Novartis Animal Health under a long-term world-wide development and marketing agreement and are currently advancing in the FDA approval process.
BoviPure LH
BoviPure LH is a novel single-chain LH analog for cows which is currently in the early stages of FDA approval. This new hormone analog is believed to induce ovulation and produce a phenomenon that has been shown to reduce the rate of pregnancy loss or embryonic loss in cows. Currently, 70% of dairy cows fail to conceive or maintain a viable pregnancy after artificial insemination (AI) resulting in significant financial and production losses to the dairy. BoviPure LH utilizes our exclusively licensed “single-chain gonadotropin” recombinant drug technology which we believe will offer cost and performance advantages over conventional bovine hormone products available in the worldwide market. We believe this drug may create a totally new pregnancy maintenance market to enhance dairy economics for artificially inseminated dairy cows.
It is estimated that there are between 16 and 20 million artificial insemination attempts annually in dairy cows in the United States alone. Recent research has indicated that BoviPure LH may provide additional economic benefits to expand the market potential for use with artificial insemination in dairy cows. We believe the US pregnancy maintenance annual market for BoviPure LH could exceed $200 million annually which would be marketed under the Novartis agreement. With a modest 20 percent market penetration estimate, this product could exceed $40 million in gross revenue annually in the U.S. market alone. We believe there are similar or greater potential markets outside the U.S.
Human Diagnostic Antigens
AspenBio is a supplier of purified proteins for diagnostic applications to large medical diagnostic companies and research institutions. We manufacture and market approximately 20-30 purified protein products primarily for use as controls by diagnostic test kit manufacturers and research facilities, to determine whether diagnostic test kits are functioning properly. In 2008, we had approximately $821,000 in revenue from these products.
