Charlottesville, Virginia, September 10, 2015, and Osaka, Japan, September 11, 2015 – Gencia LLC and Takeda Pharmaceutical Company Limited announced today a partnership to develop a new class of small molecule drugs as potential treatments for hematological and inflammatory diseases. Called Mitochondrial Agonists of the Glucocorticoid Receptor (MAGR), such compounds may offer the therapeutic potential of conventional glucocorticoid drugs (steroids). However, MAGR are chemically distinct and may function differently than steroids.
The initial aim of the collaboration will be joint research and development leading to two preclinical drug candidates, one each in the areas of inflammation and oncology. Takeda will explore opportunities to conduct clinical trials for drug candidates identified by the partnership. Under the agreement, Gencia will receive upfront payments and preclinical milestones for the two compounds and aggregate clinical, commercialization and sales milestones with the potential for approximately $500 million in payments by Takeda. Gencia also will receive royalties on sales of any successfully commercialized products arising from the partnership. Further details of the agreement were not disclosed.
"This collaboration and license agreement with Takeda marks an important milestone in the growth and development of our company," said Allen Cunningham, President and Chief Executive Officer of Gencia. "Takeda's strength in drug discovery and development, and in particular their commitment to oncology and inflammation drug research, provides Gencia with the opportunity to advance our mitochondrial targeting platform and MAGR compounds into the clinic, and ultimately to patients in need of these therapies. We are very pleased to have Takeda as our partner in this endeavor."
Added Tetsuyuki Maruyama, Ph.D., General Manager, Head of Pharmaceutical Research Division at Takeda, "We are delighted to partner with Gencia to create new medicines designed to be chemically and functionally different from steroids, but that may still be effective in treating a broad spectrum of diseases for which chronic steroids are currently prescribed. We expect to change the paradigm for how patients are treated by potentially avoiding the issues that result from long-term steroid use."
Glucocorticoid drugs are used in front-line, combination, maintenance and relapse therapy in the treatment of many hematological and inflammatory diseases. However, side-effects, lack of response or induced resistance frequently limit glucocorticoid use. Gencia's MAGR agonists have shown activity in numerous steroid-sensitive and steroid-resistant pharmacology models. Gencia and Takeda will explore potential therapeutic uses of MAGRs and the possibilities for their safe and effective chronic use.
About Gencia Corp.
Gencia Corp. is a privately held company focused on the discovery and development of first-in-class therapeutics for important medical needs, based on proprietary mitochondrial targeting technology and novel insights into the role of mitochondria in human health, aging, and disease. For more information on the company, please visit our website at http://www.genciabiotech.com.
About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda (TSE: 4502) is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine.
Additional information about Takeda is available through its corporate website, http://www.takeda.com.
Takeda's Forward-Looking Statements
This press release contains "forward-looking statements." Forward-looking statements include all statements other than statements of historical fact, including plans, strategies and expectations for the future, statements regarding the expected timing of filings and approvals relating to the transaction, the expected timing of the completion of the transaction, the ability to complete the transaction or to satisfy the various closing conditions, future revenues and profitability from or growth or any assumptions underlying any of the foregoing. Statements made in the future tense, and words such as "anticipate," "expect," "project," "continue," "believe," "plan," "estimate," "pro forma," "intend," "potential," "target," "forecast," "guidance," "outlook," "seek," "assume," "will," "may," "should," and similar expressions are intended to qualify as forward-looking statements. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors and security holders are cautioned not to place undue reliance on these forward-looking statements.
Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to: required regulatory approvals for the transaction may not be obtained in a timely manner, if at all; the conditions to closing of the transaction may not be satisfied; competitive pressures and developments; applicable laws and regulations; the success or failure of product development programs; actions of regulatory authorities and the timing thereof; changes in exchange rates; and claims or concerns regarding the safety or efficacy of marketed products or product candidates in development.
The forward-looking statements contained in this press release speak only as of the date of this press release, and neither Gencia nor Takeda undertake any obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If one or more of these statements is updated or corrected, investors and others should not conclude that additional updates or corrections will be made.
Allen Cunningham, CEO
Joan Kureczka, Gencia Media Contact
For Takeda Pharmaceuticals Company Limited:
Ai Yoshikawa – Japan
Corporate Communications Dept.
Sandra MacTavish – USA