AspenBio Pharma Advances BoviPure FSH Reproduction Drug

BoviPure FSH

AspenBio Pharma has received its INADA file number for BoviPure FSH (bovine follicle stimulating hormone) to officially start the FDA approval process.

In order to facilitate the product advancement, AspenBio has also executed a contract with AppTec Laboratory Services, Inc. ("AppTec") for the required GMP manufacturing and validation of this product.

Richard Donnelly, CEO of AspenBio Pharma, commented, "Advancing this drug into the FDA approval process and executing a manufacturing agreement with a well-respected cGMP partner is a major milestone for AspenBio and a key step towards the market introduction of one of our single-chain recombinant products."

"AppTec is excited about the opportunity to work with such a dynamic company as AspenBio in a critical aspect of their development program for bFSH," said Bonita L. Baskin, PhD, CEO of AppTec. "We look forward to working closely with AspenBio to meet and even exceed their development and manufacturing timelines."

Mr. Donnelly added, "These positive advances in the single-chain animal products are very exciting. The company also remains focused on continued advancement of the previously announced blood-based appendicitis tests, AppyScreen and AppyScore. Collection of samples under the 400-patient appendicitis trial continues to advance and we expect to announce this trial's updated and final results later in the third quarter."

BoviPure FSH is a novel single-chain recombinant FSH analog for cows. It is designed to aid in super-ovulation for embryo transfer in dairy and beef cows throughout the world. This niche market is comprised of a "small easy to reach" group of approximately 300 to 400 centers in the world that act as super-ovulation and embryo transfer (ET) locations. The current bovine FSH market is estimated to be between $15M and $20M worldwide, AspenBio believes this drug will garner a dominant market share position due the added labor savings, simplicity and convenience benefits of its one-dose BoviPure FSH drug.

Aspen also believes the product's many benefits will help grow the market substantially and also allow for premium pricing over the current $80 (US) average total drug cost for the current eight-dose treatment given every 12 hours for 4 days, using conventional animal derived FSH drugs. Research studies completed to date consistently demonstrate that new BoviPure FSH is effective using a single dose. Super-ovulation and embryo transfer is a growing world-wide business as advanced countries attempt to improve their breeding programs and developing countries are rapidly working to improve their herd stock for milk and meat production. If successfully approved by FDA, this product will be the only FSH product in the US animal market with an FDA approval.