Aprecia is the first and only company offering the proprietary ZipDose® product platform that leverages three-dimensional printing (3DP) to create fast-melt pharmaceuticals
inVentiv Health, the industry’s only full commercialization outsourcing organization, provides Aprecia the expertise and resources to launch its company and initial pharmaceutical products
BURLINGTON, MA and LANGHORNE, PA – June 4, 2014 – inVentiv Health (“inVentiv”), a life science knowledge and services company, and Aprecia Pharmaceuticals (“Aprecia”), a specialty pharmaceutical company, announced today an exclusive sales and marketing alliance.
This partnership will launch the Aprecia brand, as well as provide comprehensive commercialization of Aprecia’s pioneering technology platform and initial pharmaceutical products.
Aprecia is the first and only pharmaceutical company offering the proprietary ZipDose® product platform using three-dimensional printing (3DP) technology to create fast-melt products. These products promise to change how patients experience taking their medicine by making drugs easier to administer and swallow. Aprecia has completed clinical work and expects to file its first New Drug Application with the Food and Drug Administration (FDA) in the second half of 2014.
inVentiv Health has directly supported the development and/or commercialization of 60 percent of all drugs approved by the FDA in the last 5 years. By partnering with inVentiv, Aprecia gains access to the industry’s only full commercialization outsourcing organization.
Under the terms of the agreement, inVentiv will partner with Aprecia as its exclusive provider of comprehensive commercialization services and will share in the success of the commercialization efforts. inVentiv will invest time and materials to launch Aprecia and to commercialize its products in exchange for a negotiated royalty from future sales. inVentiv’s services include: sales teams and sales training, strategic and tactical market access services, non-personal promotion, advertising, public relations, adherence services, and full management of the commercialization teams.
“Getting medicine into the human body reliably and accurately is both a challenge and an enormous opportunity,” said Don Wetherhold, Chief Executive Officer of Aprecia. “To realize the potential of our technology and move quickly into market, we sought a partner that could execute every phase and function in commercialization -- and inVentiv was the obvious choice.”
Wetherhold added that with access to inVentiv’s vast commercial services, “Aprecia anticipates achieving rapid market penetration while retaining control of our proprietary products.”
Michael Griffith, Executive Vice President of inVentiv Health, said,“inVentiv Health offers innovative companies a unique outsourcing model for comprehensive commercialization.”
“We are pleased to have entered into this agreement with Aprecia and are looking forward to introducing their innovative technology platform and their much-needed products. Because of our unmatched expertise of pharmaceutical launches, clients know they can count on inVentiv Health to transform their assets into commercial success,” Griffith said.
About Aprecia Aprecia is a unique specialty pharmaceutical company built upon an innovative and proprietary three dimensional printing (3DP) technology platform. The company has an exclusive worldwide license for 3DP originally developed at Massachusetts Institute of Technology for use in pharmaceutical applications. Aprecia’s 3DP platform can give rise to multiple product enhancing dosage forms to be used in a variety of therapeutic categories. The company expects that its initial products will be based on its proprietary, orally-dispersing ZipDose® technology. Aprecia’s ZipDose® products will focus on opportunities where there is an unmet need for medicines that are easier to take — children, elderly, and special patient groups. Aprecia expects to file its first New Drug Application with the FDA the 2nd half of 2014. The company is privately owned, with Prasco Laboratories, and the E. Thomas Arington Family holding controlling interest. For more information visit http://www.aprecia.com.
About inVentiv Health inVentiv Health, Inc. is a life science knowledge and services company purpose-built for the new healthcare marketplace. inVentiv has created a new model by converging a vast range of essential services to fully align with our client's development and commercialization goals. With more than 12,000 employees supporting clients in 70 countries, our global scale and broad expertise make us an attractive strategic partner for companies seeking to get medicines to patients in a complex operating, regulatory and reimbursement environment. inVentiv Health's clients include more than 550 life sciences companies, including all 20 of the largest biopharmaceutical companies in the world. inVentiv Health, Inc. is privately owned by inVentiv Group Holdings, Inc., an organization sponsored by affiliates of Thomas H. Lee Partners, L.P., Liberty Lane Partners and members of the inVentiv management team. inVentiv Health transforms promising ideas into commercial reality for the financial success of our clients and the delivery of better treatments to patients worldwide. For more information, visit http://www.inVentivHealth.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks that may cause our performance to differ materially. These forward-looking statements reflect our current views about future events and are subject to risks, uncertainties and assumptions. We wish to caution readers that certain important factors may have affected and could in the future affect our actual results and could cause actual results to differ significantly from those expressed in any forward-looking statement. Such factors include, without limitation: the impact of our substantial level of indebtedness on our ability to generate sufficient cash to fulfill our obligations under our existing debt instruments or our ability to incur additional indebtedness; the impact of customer project delays and cancellations and our ability to sufficiently increase our revenues and manage expenses and capital expenditures to permit us to fund our operations; the impact of the consummation of our acquisition of Catalina Health Resource, LLC and any future acquisitions; the impact of any change in our current credit ratings and the ratings of our debt securities on our relationships with customers, vendors and other third parties; the impact of any additional leverage we may incur on our ratings and the ratings of our debt securities; our ability to continue to comply with the covenants and terms of our senior secured credit facilities and to access sufficient capital under our credit agreement or from other sources of debt or equity financing to fund our operations; the impact of any default by any of our credit providers; our ability to accurately forecast costs to be incurred in providing services under fixed price contracts; our ability to accurately forecast insurance claims within our self- insured programs; the potential impact on pharmaceutical manufacturers, including pricing pressures, from healthcare reform initiatives or from changes in the reimbursement policies of third-party payers; our ability to grow our existing client relationships, obtain new clients and cross-sell our services; the potential impact of financial, economic, political and other risks, including interest rate and exchange rate risks, related to conducting business internationally; our ability to successfully operate new lines of business; our ability to manage our infrastructure and resources to support our growth, including through outsourced service providers; our ability to successfully identify new businesses to acquire, conclude acquisition negotiations and integrate the acquired businesses into our operation, and achieve the resulting synergies; any disruptions, impairments, or malfunctions affecting software as well as excessive costs or delays that may adversely impact our continued investment in and development of software; the potential impact of government regulation on us and on our client base, including the impact of the final HIPAA Privacy Rule on the willingness of pharmaceutical manufacturers to sponsor patient adherence programs; our ability to comply with all applicable laws as well as our ability to successfully adapt to any changes in applicable laws on a timely and cost effective basis; our ability to recruit, motivate and retain qualified personnel; any potential impairment of goodwill or intangible assets; consolidation in the pharmaceutical industry; changes in trends in the healthcare and pharmaceutical industries or in pharmaceutical outsourcing, including initiatives by our clients to perform services we offer internally; our ability to convert backlog into revenue; the potential liability associated with injury to clinical trial participants; the actual impact of the adoption of certain accounting standards; and our ability to maintain technological advantages in a variety of functional areas, including sales force automation, electronic claims surveillance and patient compliance. Holders of our debt instruments are referred to reports provided to investors from time to time and the offering memoranda provided in connection with the issuance of our notes for further discussion of these risks and other factors.