The Medicines Company Announces Results of Phase 1 Study for Novel Investigational Intravenous Anesthetic, ABP-700

01 Jun 2015

The Medicines Company (NASDAQ:MDCO) announced Phase 1 results for ABP-700, a novel, positive allosteric modulator of the GABAA receptor currently being developed for general anesthesia and procedural sedation. The results were presented at the 2015 Annual Dutch Society of Anesthesiology Conference in Maastricht, Netherlands.

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<p>
  The first-in-human, double-blind, placebo-controlled study in 60 
  subjects was designed to assess the safety, tolerability, 
  pharmacokinetics and pharmacodynamics of ABP-700 after single ascending 
  intravenous bolus doses. Study results showed linearly dose proportional 
  pharmacokinetics and pharmacodynamic effects which were rapidly 
  reversible, consistent with pre-clinical animal studies. Adverse events 
  were mild with the exception of one subject with moderate tachycardia. 
  No serious adverse events were reported.
</p>
<p>
  “We are very excited to study this new short-acting hypnotic-anesthetic 
  drug for both anesthesia and sedation purposes,” said Professor Michel 
  Struys, principal investigator for the trial and Professor and Chair, 
  Department of Anesthesiology, University Medical Center Groningen, 
  Netherlands. “This first-in-humans study gave us a first impression of 
  the rapid pharmacokinetic and dynamic characteristics of ABP-700. We 
  will use the data to further optimize the dosing scheme.”
</p>
<p>
  “Anesthetic agents are fraught with all sorts of serious problems, 
  including depressing breathing, lowering blood pressure, and even 
  suppressing adrenal gland function,” said Dr. Douglas E. Raines, MD, 
  Anesthesiologist and Professor of Anesthesia, Massachusetts General 
  Hospital and Harvard Medical School, and inventor of ABP-700. “After 
  spending two decades researching how these agents work, my colleagues 
  and I thought that we might be able to use what we had learned to design 
  agents aimed at addressing these problems.”
</p>
<p>
  In the US and EU, more than 60 million people undergo general 
  anesthesia, including treatment with intravenous anesthetics. More than 
  120 million people undergo procedural sedation, at least 25% of which 
  are administered with anesthesiologist supervision. Over the past 
  decade, the number of surgical procedures performed has steadily 
  increased and the proportion of those performed on an outpatient basis 
  now exceeds 70% in most parts of the United States. At the same time, 
  surgical care and procedural medicine have moved towards lighter 
  anesthesia, minimal and focused procedural sedation, and teams that 
  include many non-physician care providers. Throughout the world, there 
  is pressure to provide high quality surgical care services with shorter 
  stays to address the increasing costs and increasing demand for surgical 
  care. In light of these trends, new agents need to be developed that are 
  capable of producing highly specific depth of sedation or anesthesia, 
  yet also be rapidly reversible.
</p>
<p>
  “Although the development program for ABP-700 is early, we are excited 
  about these findings, which we feel support continued clinical 
  development of ABP-700 for both induction and/or maintenance of general 
  anesthesia and procedural sedation,” said Jason Campagna, MD, PhD, 
  Senior Vice President, Health Science, Surgery and Perioperative Care, 
  The Medicines Company.
</p>
<p>
  Full results of ANVN-01 as well as preliminary results of ANVN-02, the 
  ongoing Phase I infusion study, will be presented at an upcoming medical 
  conference. Two additional Phase I dose optimization studies are in 
  progress.
</p>
<p>
  <b>About ABP-700</b>
</p>
<p>
  ABP-700, an investigational product not approved for commercial use in 
  any market, is a novel, positive allosteric modulator of the GABA<sub>A </sub>receptor 
  currently being developed for general anesthesia and procedural 
  sedation. ABP-700 is from a family of compounds invented by Dr. Douglas 
  Raines at the Massachusetts General Hospital, all based on existing 
  anesthetics which are variants of etomidate.
</p>
<p>
  <b>About The Medicines Company</b>
</p>
<p>
  The&nbsp;Medicines Company's&nbsp;purpose is to save lives, alleviate suffering 
  and contribute to the economics of healthcare by focusing on 3000 
  leading acute/intensive care hospitals worldwide. Its vision is to be a 
  leading provider of solutions in three areas: serious infectious disease 
  care, acute cardiovascular care and surgery and perioperative care. The 
  company operates in the&nbsp;Americas,&nbsp;Europe&nbsp;and the&nbsp;Middle East, and&nbsp;Asia 
  Pacific regions with global centers today in&nbsp;Parsippany, NJ, USA 
  and&nbsp;Zurich,&nbsp;Switzerland.
</p>
<p>
  <b>Forward-Looking Statements</b>
</p>
<p>
  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," "expects," “hopes” and “potential” and 
  similar expressions, 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 whether ABP-700 will advance in the clinical trials 
  process on a timely basis or at all, whether physicians, patients and 
  other key decision makers will accept clinical trial results, whether 
  the Company will make regulatory submissions for ABP-700 on a timely 
  basis or at all, whether its regulatory submissions will receive 
  approvals from regulatory agencies on a timely basis or at all, the 
  Company’s ability to successfully compete with potential competitors 
  which may discover, develop or commercialize competing products more 
  successfully than we do, 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 with the 
  SEC on May 5, 2015, which are incorporated herein by reference. The 
  Company specifically disclaims any obligation to update these 
  forward-looking statements.
</p>
<p>
</p>


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or
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