Senior Vice President of Commercialization & Strategy
Vice President of Medical Affairs
Senior Director of Supply Chain Operations
RAMSEY, N.J., July 6, 2015 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company that develops, manufactures and intends to commercialize specialty plasma-based biologics for the primary immunodeficiency (PI) population and the treatment and prevention of certain infectious diseases, announced recent multiple senior appointments to the Company's commercial team as part of ADMA's ongoing commercialization activities, in preparation for its planned Biologics License Application (BLA) filing with the U.S. Food and Drug Administration (FDA) for RI-002.
"We are very pleased to announce the recent appointments of Mr. James Hauert, Dr. Doris Connell, Pharm.D. and Ms. Theresa Gwaltney," noted Adam Grossman, President and CEO of ADMA. "As we continue to execute on our 2015 objectives, the addition of these key team members will each individually add valuable commercial expertise as we position ADMA for the commercialization of our lead product candidate, RI-002."
James Hauert, has been appointed Senior Vice President, Commercialization & Strategy. Mr. Hauert is responsible for building a commercialization infrastructure to ensure market utilization and adoption of ADMA's product candidates, as well as revenue generation and growth for the overall organization. Mr. Hauert has over 25 years of U.S. and global marketing and sales experience, including a previous role with Baxter Healthcare Corporation, where he served as Vice President Marketing & Strategy, North America, BioScience Division. Mr. Hauert has led numerous product launches, developing core messaging for branding campaigns and in revitalizing products throughout the life cycle. Mr. Hauert obtained his Masters of Business Administration from the Lake Forest Graduate School of Management, and a Bachelor of Science in Accountancy from DePaul University.
Doris Connell, Pharm.D. has been appointed Vice President, Medical Affairs. Dr. Connell is responsible for developing the company's medical information, medical education scientific plan and strategy with senior management in efforts to support the company's product candidates. Dr. Connell is also responsible for developing, organizing, staffing and training the Medical Science Liaison (MSL) and Medical Information teams. Dr. Connell brings over 20 years of medical affairs experience in a variety of therapeutic indications. Most recently, Dr. Connell served as the Therapeutic Area Director at GlaxoSmithKline where she managed MSL Directors and teams across several therapy areas and led commercialization and launch efforts. Prior to GlaxoSmithKline, Dr. Connell was with Human Genome Sciences as a Director, Medical Science Liaisons (Immunology) responsible for supporting new product launch and leading the national MSL team. Prior to Human Genome Sciences, Dr. Connell was with Daiichi Sankyo as a Regional Director, Field Medical Affairs where she managed MSLs through product launches, supported marketing initiatives and lead MSL payer and market access initiatives. Dr. Connell obtained her Bachelor of Arts, Biology at the University of Maryland and Doctor of Pharmacy at the University of Maryland School Of Pharmacy. Dr. Connell is a licensed pharmacist.
Theresa Gwaltney has been appointed Senior Director, Supply Chain Operations. Ms. Gwaltney is responsible to ensure the company is able to manufacture, process, package, fill and distribute ADMA's investigational, clinical and commercial drug products, specifically RI-002. Ms. Gwaltney will work with the senior management team and ADMA's contract vendors to coordinate the logistical supply chain for RI-002. Ms. Gwaltney brings over 25 years of management experience in materials management operations, contract manufacturing, purchasing, inventory control, warehousing and distribution, along with oversight of all logistic operations and material and supplier management. Most recently, Ms. Gwaltney served as the Director, Supply Chain Operations at Shire, (previously ViroPharma Biologics and Lev Pharma). Prior to Lev Pharma, Ms. Gwaltney was Quality Team Leader at Eli Lily, and Associate Director, Materials Management at MedImmune. Ms. Gwaltney received her Bachelor of Science of Electrical Engineering from Purdue University.
About ADMA Biologics, Inc. ADMA is a late-stage biopharmaceutical company that develops, manufactures and intends to market specialty plasma-based biologics for the treatment and prevention of PI and certain infectious diseases. ADMA's mission is to develop and commercialize plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases. The target patient populations include immune-compromised individuals who suffer from an underlying immune deficiency disease or who may be immune-compromised for medical reasons. ADMA's lead product candidate, RI-002 has completed its Phase III clinical trial and has met the primary endpoint. For more information, please visit the company's website at www.admabiologics.com.
About ADMA's lead product candidate RI-002: ADMA's lead product candidate, RI-002, is a specialty plasma-derived, polyclonal, Intravenous Immune Globulin (IGIV) derived from human plasma containing naturally occurring polyclonal antibodies (e.g., Streptococcus pneumoniae, H. influenza type B, Cytomegalovirus (CMV), measles, tetanus, etc.) as well as standardized, high levels of antibodies to respiratory syncytial virus (RSV). ADMA is pursuing an indication for the use of this specialty intravenous immune globulin (IGIV) product candidate for treatment of patients diagnosed with primary immune deficiency disease (PIDD). Polyclonal antibodies are the primary active component of IGIV products. Polyclonal antibodies are proteins that are used by the body's immune system to neutralize microbes, such as bacteria and viruses. Data review indicates that the polyclonal antibodies that are present in RI-002 support the ability of this product to prevent infections in immune-compromised patients. ADMA's analysis demonstrated that the Phase III trial has met the primary endpoint with no serious bacterial infections (SBI) reported. These results more than meet the requirement specified by the FDA guidance of ≤ 1 SBI per patient-year.
This press release contains "forward-looking statements" pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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," "target," "anticipate," "plan," "planning," "expect," "believe," "will," "will likely," "is 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 interpretations of final data, possible characteristics of RI-002, acceptability of RI-002 for any purpose by physicians patients or payers, timing and ability of a filing with the FDA of a BLA, likelihood and timing of FDA action with respect to any further filings by the Company, results of the clinical development, continuing demonstrations of safety, comparability of results of RI-002 to other comparably run IVIG trials, improvements in clinical outcomes, market data and incidence of infection, regulatory processes, potential clinical trial initiations, potential investigational new product applications, biologics license applications, expansion plans, the achievement of clinical and regulatory milestones, commercialization efforts of the Company's product candidate(s) and trends relating to demand for source plasma. Forward-looking statements are subject to many risks and uncertainties that could cause our actual results and the timing of certain events to differ materially from any future results expressed or implied by the forward-looking statements, including, but not limited to, risks as to whether final and secondary data will be accepted as encouraging, positive or will otherwise lead to an effective or approved product, whether we will be able to demonstrate efficacy or gain necessary approvals to market and commercialize any product, whether the FDA will accept our data, permit us to submit a BLA, grant a license, or approve RI-002 for marketing, whether we will meet any of our clinical or regulatory milestones, whether we will develop any new products or expand existing ones, whether we will receive FDA approval of our new facility, whether there may be changes in regional and worldwide supply and demand for source plasma, whether we will be able to attract sufficient donors and operate our new facility effectively or profitably, whether we can sell our plasma in the marketplace at prices that will lead to adequate amounts of revenue, whether we will be able to sustain the listing of our common stock on the NASDAQ Capital Market, whether we will meet any timing targets expressed by the Company, and other risks and uncertainties described in our filings with the U.S. Securities and Exchange Commission, including our most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto. 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.
CONTACT: Brian Lenz Vice President and Chief Financial Officer 201-478-5552 www.admabiologics.com
Released July 6, 2015