Somerset, NJ & Tokyo, Japan – January 19, 2015 — Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, and Mitsubishi Gas Chemical Company, Inc. (MGC), today jointly announced that they have entered into a partnership agreement to co-promote Catalent’s proprietary GPEx® technology in the Asian market. MGC is a major chemical engineering company, and recently established a subsidiary, MGC Pharma Co., Ltd., to provide contract development, and clinical and commercial manufacturing of biologics in Asia. Through the collaboration, MGC Pharma’s customers will benefit from GPEx technology’s production of stable and high yielding cell lines, while bringing their development programs to market faster.
Under the agreement, Catalent will engineer the cell lines and carry out development, and MGC Pharma will provide Phase III and commercial manufacturing. Additionally, MGC and MGC Pharma will be able to offer biosimilar cell lines produced using GPEx technology to pharmaceutical partners for further product development and commercialization.
“There are great synergies between MGC Pharma and Catalent in terms of technologies and business structure,” commented Masami Orisaku, President of MGC Pharma. “MGC and Catalent will complement each other in the growth of our biologics businesses and in supporting our customers’ requirements in the Asian market.”
Mike Jenkins, Vice President of Business Development, Catalent Biologics, Asia Pacific, added, “This agreement will allow Catalent to continue to grow its biologics development and manufacturing interests of multiple NBEs and biosimilars, particularly in the Asia Pacific market. The collaboration with MGC Pharma fits Catalent’s strategy for growth in what we consider to be a promising region.”
Tadahiro Matsumura, President of Catalent Japan commented: “We are very excited to offer not only reliable softgel business solutions but also superior biologics solutions to our customers in Asia. This collaboration reinforces our position as a leading supplier of advanced drug delivery technologies and development solutions.”
MGC Pharma was launched in April 2014 in response to emerging social needs for medical proteins obtained solely from mammalian cell cultures. MGC Pharma currently has analytical facilities in Niigata, Japan, and is establishing larger scale cGMP manufacturing sites utilizing GPEx mammalian cell lines and single-use bioreactor (SUB) technologies.
Catalent Biologics has expressed over 460 cell lines for clients using the GPEx technology, with dozens of on-going clinical trials throughout the world and five products currently on the market. The company’s state-of-the-art facility in Madison, WI employs single-use technologies to offer flexible, cGMP production from 10 L to 1,000 L scale, and non-GMP production up to 250 L scale. Manufacturing is supported by integrated analytical, formulation development and viral clearance capabilities, small-scale and large-scale process development laboratories, and separate microbiology and Quality Control functions.
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About MGC Pharma, Inc.
MGC Pharma can apply various techniques like cell culture, purification, scale-up and QC which MGC, a parent company of MGC Pharma, has developed up until today to mammalian cell culture. Moreover, we can contribute to technological development for high quality and safety treatment while providing contract development and production service for biopharmaceutical production including antibody medicine. For more information, visit http://www.mgc-pharma.com
About Mitsubishi Gas Chemical Company, Inc.
Since its inception in 1918, MGC has consistently worked toward the creation of new technologies and values. From basic chemicals to functional materials and health care, we have provided uniquely innovative products in a wide range of fields. In 2000 we introduced an in-house company system, creating the current MGC Group as a conglomeration of over 120 companies in Japan and overseas, built upon 4 core companies. With the establishment of the new company, MGC will develop relevant operation quicker than before and strengthen its competitiveness in the field which will allow MGC to win contracts manufacturing of substances used for antibody drugs. MGC is headquartered in Tokyo, Japan. For more information, visit http://www.mgc.co.jp
Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 8,000 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents, and in fiscal 2014 generated more than $1.8 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com
Forward Looking Statements
This release contains both historical and forward-looking statements. All statements other than statements of historical fact are, or may be deemed to be, forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally can be identified by the use of statements that include phrases such as “believe,” “expect,” “anticipate,” “intend,” “estimate,” “plan,” “project,” “foresee,” “likely,” “may,” “will,” “would” or other words or phrases with similar meanings. Similarly, statements that describe our objectives, plans or goals are, or may be, forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Catalent, Inc.’s expectations and projections. Some of the factors that could cause actual results to differ include, but are not limited to, the following: participation in a highly competitive market and increased competition may adversely affect the business of the Company; demand for the Company’s offerings which depends in part on the Company’s customers’ research and development and the clinical and market success of their products; product and other liability risks that could adversely affect the Company’s results of operations, financial condition, liquidity and cash flows; failure to comply with existing and future regulatory requirements; failure to provide quality offerings to customers could have an adverse effect on our business and subject the Company to regulatory actions and costly litigation; problems providing the highly exacting and complex services or support required; global economic, political and regulatory risks to the operations of the Company; inability to enhance existing or introduce new technology or service offerings in a timely manner; inadequate patents, copyrights, trademarks and other forms of intellectual property protections; fluctuations in the costs, availability, and suitability of the components of the products the Company manufactures, including active pharmaceutical ingredients, excipients, purchased components and raw materials; changes in market access or healthcare reimbursement in the United States or internationally; fluctuations in the exchange rate of the U.S. dollar and other foreign currencies; adverse tax legislation initiatives or challenges to the Company’s tax positions; loss of key personnel; risks generally associated with information systems; inability to complete any future acquisitions and other transactions that may complement or expand the business of the Company or divest of non-strategic businesses or assets and the Company’s ability to successfully integrate acquired business and realize anticipated benefits of such acquisitions; offerings and customers’ products that may infringe on the intellectual property rights of third parties; environmental, health and safety laws and regulations, which could increase costs and restrict operations; labor and employment laws and regulations; additional cash contributions required to fund the Company’s existing pension plans; substantial leverage resulting in the limited ability of the Company to raise additional capital to fund operations and react to changes in the economy or in the industry, exposure to interest rate risk to the extent of the Company’s variable rate debt and preventing the Company from meeting our obligations under our indebtedness. For a more detailed discussion of these and other factors, see the information under the caption “Risk Factors” in our 10-K for the fiscal year ended June 30, 2014, filed with the Securities and Exchange Commission. All forward-looking statements speak only as of the date of this release or as of the date they are made, and Catalent, Inc. does not undertake to update any forward-looking statement as a result of new information or future events or developments except to the extent required by law.