HACKENSACK, N.J.--(BUSINESS WIRE)--ADMA Biologics, Inc. (ADMA), a late-stage biotechnology company focused on developing specialty immune globulin therapeutics and the commercialization of human plasma, today announced that it has entered into a long-term manufacturing, supply and license agreement with Biotest Pharmaceuticals Corporation (BPC) and a license agreement with Biotest AG, BPC’s parent company.
The long-term manufacturing, supply and license agreement with BPC, which operates a US Food and Drug Administration (FDA) approved manufacturing facility, requires ADMA to purchase exclusively from BPC its worldwide product supply for RI-002, its lead product candidate. RI-002 is a specialty immune globulin for primary immune deficiency patients, which is derived from human plasma containing high levels of Respiratory Syncytial Virus (RSV) antibodies. The ten-year agreement began on January 1, 2013 and is renewable for two additional five year periods, upon the mutual consent of ADMA and BPC.
Also in connection with the manufacturing, supply and license agreement, ADMA has out-licensed RI-002 to Biotest AG, to market and sell in Europe and selected countries in North Africa and the Middle East. In return for this license, Biotest AG will provide ADMA with certain services at no charge and will also compensate ADMA with cash upon the completion of certain milestones as well as pay a royalty based on a percentage of sales of RSV immune globulin in the territory. Additionally, Biotest AG has granted ADMA an exclusive license for marketing and sales of Biotest AG’s Varicella Zoster Immune Globulin (VZIG) in the United States and Canada, for which terms will be finalized in the next sixty days.
“The execution of these agreements with our partner, Biotest AG and BPC, solidifies the manufacturing and long-term supply for our lead product candidate as we initiate our Phase III clinical trial. Additionally, we are pleased to have Biotest AG as our partner to expand the market potential for our lead product candidate. Biotest has a successful track record of developing and commercializing novel plasma derived therapeutics in international markets,” stated Adam Grossman, President and Chief Executive Officer of ADMA. “We are very pleased to have also enhanced our product candidate pipeline through the in-licensing of VZIG for the United States and Canada.”
Further information with respect to these agreements may be obtained from a Current Report on Form 8-K which has been filed with the Securities and Exchange Commission and can also be viewed on the company’s website at: www.admabio.com.
About ADMA’s lead product candidate
ADMA’s lead product candidate, RI-002 is a specialty plasma-derived, polyclonal, Intravenous Immune Globulin, or IGIV, prepared with high levels of antibodies against respiratory syncytial virus, or RSV. ADMA is pursuing an indication for the use of this specialty IGIV product for treatment of patients diagnosed with primary immunodeficiency disease, or PIDD. Polyclonal antibodies are the primary component of IGIV products. PIDD is a disorder that causes a person’s immune system to not function properly. PIDD is caused by hereditary or genetic defects and can affect anyone regardless of age or gender.
About ADMA Biologics, Inc.
ADMA is a late-stage biotechnology company focused on developing specialty immune globulin therapeutics and commercialization of human plasma. ADMA’s mission is to develop and commercialize plasma-derived, human immune globulins targeted at niche patient populations some with unmet medical needs. In addition, ADMA operates ADMA Bio Centers, a wholly-owned subsidiary which is an FDA-licensed source plasma collection facility located in Norcross, Georgia.
Cautionary Statement Regarding Forward-Looking Information
This press release contains “forward looking statements.” Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain the words “estimate,” “project,” “intend,” “forecast,” “anticipate,” “plan,” “planning,” “expect,” “believe,” “will,” “will likely,” “should,” “could,” “would,” “may” or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements include, but are not limited to, statements concerning the timing, progress and results of the clinical development, regulatory processes, potential clinical trial initiations, potential investigational new product applications, biologics license applications, and commercialization efforts of the Company's product candidate(s). Forward-looking statements are subject to many risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements, including, but not limited to, the risks listed under the heading “Risk Factors” in Amendment No. 3 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on June 22, 2012 and Amendment No. 4 to our Registration Statement on Form S-1 filed with the Securities and Exchange Commission on August 10, 2012. Therefore, current and prospective security holders are cautioned that there also can be no assurance that the forward-looking statements included in this press release will prove to be accurate. In light of the significant uncertainties inherent to the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation or warranty by ADMA or any other person that the objectives and plans of ADMA will be achieved in any specified time frame, if at all. Except to the extent required by applicable laws or rules, ADMA does not undertake any obligation to update any forward looking statements or to announce revisions to any of the forward-looking statements.