Micell Technologies Announces Development and Distribution Agreement to Bring MiStent SES to China
— Hefei Life Science will fund and manage clinical development and distribution —
DURHAM, N.C., October 1, 2013 — Micell Technologies, Inc. has entered into an agreement with Hefei Life Science Technology Park Investment and Development Co., Ltd. (Hefei Life Science), for the clinical development, marketing and distribution of the MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES®) in the People’s Republic of China (“PRC”), including Hong Kong and Macau. Hefei Life Science, based in Anhui Province in Eastern China, will fund and manage clinical development programs necessary to obtain regulatory approval for MiStent SES in the Chinese markets.
Under the agreement, Micell will manufacture and supply MiStent SES for clinical and commercial use. Sinopharm, based in Shanghai and the first Chinese pharmaceutical company included in the Fortune Global 500 list, will provide distribution and logistical support while SinoMedCare, of Shanghai, will contribute marketing and sales support. The agreement includes annual purchase commitments commencing upon regulatory approval of MiStent SES for commercial sale in China.
“This agreement creates a strong opportunity for MiStent SES to enter the Chinese market and build upon our recent CE Mark approval in Europe,” commented Arthur J. Benvenuto, Micell’s Chairman and Chief Executive Officer. “Sinopharm and SinoMedCare bring strengths to this partnership with Hefei Life Science that we expect will make this important medical innovation in the coronary stent market readily accessible to patients in Greater China.”
About the MiStent SES
The MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES®) is designed to optimize healing in patients with coronary artery disease. MiStent’s rapidly absorbable coating is intended to precisely and consistently control drug elution and limit polymer exposure duration to reduce the safety risks associated with current commercially available drug-eluting stent technologies.
The innovative MiStent SES system includes a proprietary stent coating that contains crystalline drug (sirolimus) and an absorbable polymer. The coating provides controlled and sustained release of therapeutic levels of drug as the polymer softens and disperses from the stent into the adjacent tissue. These properties are intended to enhance safety as compared to conventional permanent polymer DES.
Using an approved drug (sirolimus) and polymer (PLGA), Micell’s patented supercritical fluid technology allows a rigorously controlled drug/polymer coating to be applied to a bare-metal stent. The MiStent SES leverages the benefits of Eurocor’s (CE Marked) Genius® MAGIC Cobalt Chromium Coronary Stent System, a state-of-the-art bare-metal stent, which has demonstrated excellent deliverability, conformability and flexibility.
Results of animal studies have determined that the coating is cleared from the stent in 45 to 60 days leaving a bare metal stent and the polymer is completely absorbed into the surrounding tissue within 90 days to promote long-term patency and compatibility with the artery.
Micell was granted CE (Conformité Européenne) Mark approval for MiStent SES for the European Economic Union in June 2013, but is not approved in the United States or any other countries. A two year follow-up of DESSOLVE I and II clinical studies subjects was completed in 2013, and they currently are undergoing long-term follow-up.
About Micell Technologies Inc.
Micell Technologies is a biomedical company that is enhancing the performance of medical devices with innovative drug-delivery systems. Its unique surface and polymer modification technologies enable Micell to precisely and consistently control drug elution and polymer exposure duration, creating the potential for a therapeutic solution to coronary artery disease without the long-term safety concerns of currently available drug-eluting stents. Micell is also developing a drug-coated balloon for vascular interventions. Visit us at www.www.micell.com. Cooley LLP represented Micell in the transaction.
About Hefei Life Science
Hefei Life Science was established in Hefei Economic and Technological Development Area, Anhui P.R. China in December 2005. The main objective of the company is to bring high-tech bio-pharmaceutical projects with internationally advanced level and good market prospects to Hefei Life Science Park.
Hefei Life Science is engaged in the development and production of biological products, and distribution of pharmaceutical products and medical devices. The Company’s mission is to provide our patients with pharmaceutical products and medical devices with high quality, high efficacy, and safety profile for the benefit of patients.
Hefei Tianmai Biotechnology Development Co.Ltd. (“HTBT”), a subsidiary of Hefei Life Science, has established an advanced manufacturing plant in accordance with European standards and has successfully developed recombinant human insulin. HTBT is in the process of developing insulin analogues and plans to sell the products around the world.
Sinopharm Group Co., Ltd and its subsidiaries (“Sinopharm Group”) have integrated operations in the following business segments, namely pharmaceutical distribution segment, retail pharmacy segment and other business segment.
The Sinopharm Group is the industry leader in the distribution of pharmaceutical and healthcare products in China both in terms of its market share and the geographical coverage of its distribution network. As a leading pharmaceutical distributor in China, the Sinopharm Group will benefit from the rapid growth, consolidation, and structural reform in the pharmaceutical and healthcare industry in the PRC.
The Sinopharm Group has rapidly increased its market share and profits in a highly fragmented industry by taking advantage of its economies of scale and nationwide distribution network, through which the Sinopharm Group offers a wide range of value- added supply chain services for its customers and suppliers.
SinoMedCare is a leading, innovation-driven pharmaceutical marketing platform in the PRC. SinoMedCare grasps the development directions of the China pharma industry, and provides solutions to the challenges faced by foreign manufacturers in market access and market penetration.
SinoMedCare is the first marketing platform in the pharma industry in China which focuses on supporting multinationals penetrating the broader market, upgrading and modernizing distribution channel in tier 3 cities, and providing a complete package of value-added services. SinoMedCare has invested heavily in building up the first refined operations service platform in the industry based on cloud technology, and elevated marketing services in the large market to a new level.
The investors of SinoMedCare include professional venture capital firm VIVO.
Caution Regarding Forward-Looking Statements
This press release contains forward-looking statements that can be identified by the fact that they do not relate strictly to historical or current facts. Forward looking statements include words such as “anticipates,” “estimates,” “expects,” “projects,” “intends,” “plans,” “believes” and words and terms of similar substance in connection with the results of a post-marketing clinical program and the commercialization and sale of the MiStent SES® in Europe and other markets. We caution readers that the forward looking statements contained in this press release are predictions based on our current analysis of and expectations about future events and speak only as of the date of this press release. These forward looking statements are not guarantees of future performance and are subject to risks and uncertainties, including, but not limited to the following: the results of any further clinical trials and studies; our ability to obtain regulatory approval of the MiStent SES in other jurisdictions; the successful development and commercialization of the MiStent SES in Europe and other markets; the ability of the MiStent SES to effectively and successfully compete with current commercially available drug-eluting stent technologies in Europe and other markets; and our ability to maintain and protect our proprietary stent coating technology. Actual results, performance or achievements could differ materially and adversely from those expressed or implied by any forward looking statement contained in this press release.
Micell, Micell Technologies, the Micell Logo, MiStent and MiStent SES are among the trademarks of Micell Technologies, Inc.
Contact: Micell Technologies
Arthur J. Benvenuto, Chairman & CEO