Repligen Reports Phase 2b Results for RG2417 for Bipolar Depression
WALTHAM, Mass.--(BUSINESS WIRE)--Mar 7, 2011 - Repligen Corporation (NASDAQ: RGEN) announced today results of a Phase 2b clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar depression. The study did not demonstrate a statistically significant improvement in the symptoms of depression in all patients receiving RG2417 when compared to placebo over the eight-week treatment period. RG2417 was well tolerated and there were no serious adverse events related to drug treatment. A preliminary analysis indicates that the subset of patients (n=50) enrolled through academic medical centers showed a clinically meaningful improvement on the Montgomery-Asberg Depression Rating Scale (MADRS) score from weeks 2 through 8 when compared to placebo. No difference was observed between RG2417 and placebo for patients (n=125) enrolled at the commercial clinical trial sites. A similar pattern of response was observed with several of the secondary endpoints.
“While we are disappointed with the top-line results of the study, we plan to conduct further evaluation of the data including the observation of differences between the patients treated in academic and commercial sites to determine if there is a path forward with RG2417,” stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. “In the short term, our efforts remain focused on completing the Phase 3 trial for RG1068, our pancreatic imaging agent, for which we expect to announce results later this month, as well as advancing our lead compounds for Friedreich's ataxia and for spinal muscular atrophy into the clinic while maintaining a low cash burn and a strong balance sheet. For FY2011, ending March 31, 2011, we anticipate $27-$28M in revenues, and $60M in cash and investments and no debt.”
This was a double-blind, placebo-controlled trial in which 175 patients were enrolled at 12 academic and 17 commercial study sites, and randomized on a 1:1 basis to receive either RG2417 or a placebo twice a day for eight weeks. Patients in the RG2417 and placebo groups were clinically and statistically well matched in their symptoms at baseline. Evaluations for symptoms of depression were conducted at baseline and then weekly using the MADRS, a standardized, rater-administered scale, which has been used for numerous drug trials in bipolar disorder. In addition, patients conducted a weekly self-assessment of their symptoms, referred to as a patient-based MADRS. Additional secondary objectives included the Clinical Global Impression scale, subset analysis of patients based on prior episodes of depression, responder rates and remission rates.
About Repligen Corporation
Repligen Corporation is a biopharmaceutical company focused on building an integrated company by developing and marketing innovative drugs that deliver the benefits of protein therapies in the fields of neurology and gastroenterology. We have a core competency in the development and manufacturing of biologics products, which is the basis for our bioprocessing business and we have out-licensed certain biologics intellectual property, which provide ongoing sources of revenue. Repligen's corporate headquarters are located at 41 Seyon Street, Building #1, Suite 100, Waltham, MA 02453. Additional information may be requested at www.repligen.com.
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Investors are cautioned that statements herein which are not strictly historical statements, including, without limitation, expressed or implied statements regarding the clinical development plans for RG2417, future further evaluation of the data from the Phase 2b clinical trial of RG2417, the funding of the development and commercialization of RG2417, the commercial potential of RG2417, if approved as a therapy for patients with bipolar disorder, our future financial performance and position, management's strategy, plans and objectives for future operations, and other statements identified by words like “believe,” “expect,” “may,” “will,” “should,” “seek,” or “could” and similar expressions, constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with: the ˜top line” and or “preliminary” nature of the reported results of the Phase 2b clinical trial of RG2417; the success of our future clinical trials; our ability to obtain required regulatory approvals; the success of current and future collaborative relationships; our ability to raise additional capital to continue our drug development programs; our ability to obtain, maintain and protect intellectual property rights for our products and product candidates; our ability to successfully develop and commercialize products; and other risks detailed in Repligen's annual report on Form 10-K on file with the Securities and Exchange Commission and the other reports that Repligen periodically files with the Securities and Exchange Commission. Actual results may differ materially from those contemplated by these forward-looking statements. Repligen does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the publication of this press release, except as required by law.
Contact: Repligen Corporation
Walter C. Herlihy, 781-419-1900
President and Chief Executive Officer
Laura L. Whitehouse, 781-419-1812
Vice President, Market Development
Posted: March 2011