SOURCE: The Medicines Company

The Medicines Company

November 29, 2010 12:20 ET

The Medicines Company Reaches Agreement With FDA on Special Protocol Assessment for Oritavancin Phase 3 Trials

Enrollment Planned to Begin Before Year-End 2010

PARSIPPANY, NJ--(Marketwire - November 29, 2010) - The Medicines Company (NASDAQ: MDCO) today announced that it has received notification from the United States Food and Drug Administration (FDA), under the Special Protocol Assessment (SPA) process, that the design and planned analysis of Phase 3 clinical trials for oritavancin in patients with acute bacterial skin and skin structure infection (ABSSSI) adequately address the objectives necessary to support a regulatory submission.

With the SPA agreement in place, the Company plans to start the identical "SOLO-1" and "SOLO-2" clinical trials to evaluate the efficacy and safety of single-dose oritavancin as compared to multiple doses of vancomycin for the treatment of patients with ABSSSI.

Stephan Billstein MD, The Medicines Company's Vice President of Infectious Disease Medicine, said, "We are grateful for the FDA working through the design of the SOLO trials. The design strictly adheres to recently published guidance from the FDA, and also reflects important input from regulators in the European Medicines Agency (EMA) and from infectious disease leaders. We believe the protocol represents the best of contemporary research standards for non-inferiority studies of antibiotics in the treatment of ABSSSI."

Dimitrios Goundis, PhD, The Medicines Company's Head of Research and Development, added, "In collaboration with a range of experts including regulators, Dr. Billstein's team has come up with a strong protocol design that meets the highest global standards of development methodology, and tests the hypothesis that a single 1,200 mg intravenous dose of oritavancin is non-inferior to 7-10 days of intravenous vancomycin treatment. If the trials meet their objectives, the data will be used to support worldwide regulatory submissions."

The SOLO-1 and SOLO-2 trials are identical multicenter, double-blind, randomized clinical studies. Reflecting recent FDA guidance documents, the primary efficacy endpoint is a composite of resolution of fever and cessation of spread of visible infection without the use of rescue antibiotics at 48 to 72 hours following initiation of treatment. Secondary endpoints include "Clinical Cure" -- an endpoint which represents a clinical investigator's assessment of the patient's response to therapy for the signs and symptoms of the ABSSSI infection. 

The trials are statistically powered to evaluate non-inferiority of oritavancin versus vancomycin. Approximately 1,000 patients will be enrolled in each of the two trials which will be conducted in parallel at different study sites. The protocols and statistical plans stipulate that if the non-inferiority primary endpoints of both trials are met, an assessment of superiority of oritavancin to vancomycin with respect to the primary efficacy endpoint will also be undertaken.

Special Protocol Assessment
As described by the FDA, the SPA is an evaluation by FDA of clinical protocols and other protocols to assess whether they are adequate to meet scientific and regulatory requirements. Special Protocol Assessments provide valuable information for sponsors, significantly reducing regulatory uncertainty and business risks in drug development.

European Evaluation
The Medicines Company has also met with the European Medicines Agency (EMA), and has received agreement on major components of the Phase 3 clinical development program.

About The Medicines Company
The Medicines Company (NASDAQ: MDCO) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well being of critically ill patients. The Medicines Company's website is www.themedicinescompany.com.

Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates" and "expects" and similar expressions, including the Company's preliminary revenue results, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include the Company's ability to develop its global operations and penetrate foreign markets, whether the Company's products will advance in the clinical trials process on a timely basis or at all, whether the Company will make regulatory submissions for product candidates on a timely basis, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, risks associated with the establishment of international operations, whether the Company is able to obtain or maintain patent protection for the intellectual property relating to the Company's products; and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed on November 9, 2010, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.

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