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 The Medicines Company MDCO and Alnylam Pharmaceuticals, Inc. 
 ALNY today announced that The Medicines Company has agreed with 
 the U.S. Food and Drug Administration (FDA) on plans for the Phase III 
 clinical program for inclisiran, which is designed to support the 
 submission of a New Drug Application (NDA). The Company has received 
 final, End-of-Phase II meeting minutes from the FDA.
 
 
 The Phase III program will comprise clinical trials in subjects with 
 atherosclerotic cardiovascular disease (ASCVD) and familial 
 hypercholesterolemia (FH), and will collectively enroll approximately 
 3,000 subjects randomized to treatment with inclisiran (1,500) or 
 placebo (1,500).
 
 
 The primary endpoint for all pivotal trials will be LDL-C change from 
 baseline.
 
 
 Subjects will be studied for 18 months. The dose of inclisiran will be 
 300 mg given subcutaneously on day-1, day-90 and then every six months 
 thereafter. Subjects will receive a total of four doses of inclisiran 
 during the 18-month study period.
 
 
 Although not part of the first NDA, The Medicines Company will also 
 perform a cardiovascular outcomes trial in approximately 14,000 subjects 
 with ASCVD and/or risk equivalents, such as diabetes, to determine the 
 effects of LDL-C lowering with inclisiran on cardiovascular outcomes. 
 The design of the outcomes trial has also been agreed with the FDA and 
 the primary efficacy endpoint of the trial will be a composite of 
 coronary heart disease death, non-fatal myocardial infarction and fatal 
 and non-fatal ischemic stroke. These endpoints have been demonstrated to 
 be modifiable in previous, similar outcomes trials. The duration of the 
 outcomes trial will be long enough to accumulate a sufficient number of 
 events to provide overwhelming statistical power to ascertain treatment 
 group differences and maximize the clinical effect size associated with 
 LDL-C lowering. Assuming success, results of the outcomes trial will be 
 submitted to the FDA as a supplemental NDA.
 
 
 "We are grateful to the FDA for its expertise, advice and support. 
 Cardiovascular disease is a serious threat to the health of Americans, 
 and it is clear that the FDA is committed to facilitating the 
 development and approval of effective and safe drugs to address this 
 important public health problem," said Clive Meanwell, M.D., Ph.D., 
 Chief Executive Officer of The Medicines Company. "Based on data from 
 our Phase II ORION-1 study and the previous Phase I study – both 
 published in The New England Journal of Medicine – we are 
 confident that inclisiran reduces LDL-C meaningfully. We have also been 
 highly encouraged by the safety data in these prior studies. 
 Furthermore, inclisiran's highly-differentiated dosing schedule has the 
 potential to transform the burden placed on millions of patients who so 
 badly need to lower LDL-C levels. We anticipate completing the LDL-C 
 lowering program quickly and expect to submit an NDA for ASCVD and FH at 
 or around the end of 2019. We believe our agreement with the FDA on the 
 Phase III clinical development program for inclisiran is highly 
 favorable and adds significantly to inclisiran's strategic value."
 
 
 Dr. Meanwell added, "Although not required for the NDA, we will also 
 perform an aggressive cardiovascular outcomes trial in high-risk 
 subjects with ASCVD and/or risk-equivalents, such as diabetes. We 
 believe that positive outcomes data, with primary outcome clinical 
 effects greater than those reported for anti-PCSK9 monoclonal 
 antibodies, will drive a high level of competitiveness in the worldwide 
 market – which we expect to become very large."
 
 
 "The Medicines Company's agreement with the FDA supports a clear path 
 forward for further inclisiran development and regulatory review. 
 Indeed, we're pleased with the excellent progress made by our colleagues 
 at The Medicines Company to advance this potential, innovative medicine 
 to patients in need, and we intend to fully support them in their 
 efforts," said John M. Maraganore, Ph.D., Chief Executive Officer of 
 Alnylam. "Moreover, we believe the planned development path for 
 inclisiran positions this promising potential medicine to contribute 
 meaningfully to our Alnylam 2020 goals."
 
 
 About Inclisiran
 
 
 Inclisiran (formerly known as PCSK9si and ALN-PCSsc) is an 
 investigational GalNAc-conjugated RNAi therapeutic targeting PCSK9 – a 
 genetically validated protein regulator of LDL receptor metabolism – 
 being developed for the treatment of hypercholesterolemia. In contrast 
 to anti-PCSK9 monoclonal antibodies that bind to PCSK9 in blood, 
 inclisiran is a first-in-class investigational medicine that acts by 
 turning off PCSK9 synthesis in the liver.
 
 
 The Medicines Company and Alnylam Pharmaceuticals, Inc. are 
 collaborating in the advancement of inclisiran pursuant to their 2013 
 agreement. Under the terms of the agreement, Alnylam completed certain 
 pre-clinical studies and the Phase I clinical study, with The Medicines 
 Company leading and funding the development of inclisiran from Phase II 
 forward, as well as potential commercialization.
 
 
 About The Medicines Company
 
 
 The Medicines Company is a biopharmaceutical company driven by an 
 overriding purpose – to save lives, alleviate suffering and contribute 
 to the economics of healthcare. The Company's mission is to create 
 transformational solutions to address the most pressing healthcare needs 
 facing patients, physicians and providers in three critical therapeutic 
 areas: serious infectious disease care, cardiovascular care and surgery 
 and perioperative care. The Company is headquartered in Parsippany, New 
 Jersey, with global innovation centers in California and Switzerland.
 
 
 About Alnylam Pharmaceuticals
 
 
 Alnylam ALNY is leading the translation of RNA interference 
 (RNAi) into a whole new class of innovative medicines with the potential 
 to transform the lives of patients who have limited or inadequate 
 treatment options. Based on Nobel Prize-winning science, RNAi 
 therapeutics represent a powerful, clinically validated approach for the 
 treatment of a wide range of debilitating diseases. Founded in 2002, 
 Alnylam is delivering on a bold vision to turn scientific possibility 
 into reality, with a robust discovery platform and deep pipeline of 
 investigational medicines, including three product candidates that are 
 in late-stage development or will be in 2017. Looking forward, Alnylam 
 will continue to execute on its "Alnylam 2020" strategy of building a 
 multi-product, commercial-stage biopharmaceutical company with a 
 sustainable pipeline of RNAi-based medicines. For more information about 
 our people, science and pipeline, please visit <a xmlns="http://www.w3.org/1999/xhtml" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.alnylam.com&amp;esheet=51547585&amp;newsitemid=20170426005497&amp;lan=en-US&amp;anchor=www.alnylam.com&amp;index=1&amp;md5=6ba7deea518a2d6bf678404b3a515a2e" rel="nofollow" rel="nofollow">www.alnylam.com</a> 
 and engage with us on Twitter at @Alnylam.
 
 
 The Medicines Company Forward-Looking Statements
 
 
 Statements contained in this press release 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 
 &#34;believes,&#34; &#34;anticipates,&#34; &#34;expects,&#34; "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&#39;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 clinical trials for inclisiran will advance in the 
 clinical process on a timely basis, or at all, or succeed in achieving 
 their specified endpoints; whether physicians, patients and other key 
 decision makers will accept clinical trial results; whether the Company 
 will make regulatory submissions for inclisiran on a timely basis, or at 
 all; whether the Company's regulatory submissions will receive approvals 
 from regulatory agencies on a timely basis, or at all; and such other 
 factors as are set forth in the risk factors detailed from time to time 
 in the Company&#39;s periodic reports and registration statements filed with 
 the Securities and Exchange Commission, including, without limitation, 
 the risk factors detailed in the Company&#39;s Annual Report on Form 10-K 
 filed with the Securities and Exchange Commission on March 1, 2017, 
 which are incorporated herein by reference. The Company specifically 
 disclaims any obligation to update these forward-looking statements.
 
 
 Alnylam Forward-Looking Statements
 
 
 Various statements in this release concerning Alnylam&#39;s future 
 expectations, plans and prospects, including without limitation, 
 Alnylam&#39;s views with respect to the potential for RNAi therapeutics, 
 including inclisiran, its expectations regarding the timing of clinical 
 studies, its expectations regarding scientific and regulatory support 
 for inclisiran, its expectations regarding its STAr pipeline growth 
 strategy, and its "Alnylam 2020" guidance for the advancement and 
 commercialization of RNAi therapeutics, constitute forward-looking 
 statements for the purposes of the safe harbor provisions under The 
 Private Securities Litigation Reform Act of 1995. Actual results and 
 future plans may differ materially from those indicated by these 
 forward-looking statements as a result of various important risks, 
 uncertainties and other factors, including, without limitation, 
 Alnylam&#39;s ability to discover and develop novel drug candidates and 
 delivery approaches, successfully demonstrate the efficacy and safety of 
 its product candidates, the pre-clinical and clinical results for its 
 product candidates, which may not be replicated or continue to occur in 
 other subjects or in additional studies or otherwise support further 
 development of product candidates for a specified indication or at all, 
 actions or advice of regulatory agencies, which may affect the design, 
 initiation, timing, continuation and/or progress of clinical trials or 
 result in the need for additional pre-clinical and/or clinical testing, 
 delays, interruptions or failures in the manufacture and supply of our 
 product candidates, obtaining, maintaining and protecting intellectual 
 property, Alnylam&#39;s ability to enforce its intellectual property rights 
 against third parties and defend its patent portfolio against challenges 
 from third parties, obtaining and maintaining regulatory approval, 
 pricing and reimbursement for products, progress in establishing a 
 commercial and ex-United States infrastructure, competition from others 
 using technology similar to Alnylam&#39;s and others developing products for 
 similar uses, Alnylam&#39;s ability to manage its growth and operating 
 expenses, obtain additional funding to support its business activities, 
 and establish and maintain strategic business alliances and new business 
 initiatives, Alnylam&#39;s dependence on third parties for development, 
 manufacture and distribution of products, the outcome of litigation, the 
 risk of government investigations, and unexpected expenditures, as well 
 as those risks more fully discussed in the &#34;Risk Factors&#34; filed with 
 Alnylam&#39;s most recent Annual Report on Form 10-K filed with 
 the Securities and Exchange Commission (SEC) and in other filings that 
 Alnylam makes with the SEC. In addition, any forward-looking statements 
 represent Alnylam&#39;s views only as of today and should not be relied upon 
 as representing its views as of any subsequent date. Alnylam explicitly 
 disclaims any obligation, except to the extent required by law, to 
 update any forward-looking statements.
 
 
 The scientific information referenced in this news release relating to 
 inclisiran is preliminary and investigative. Inclisiran has not been 
 approved by the U.S. Food and Drug Administration, European Medicines 
 Agency, or any other regulatory authority and no conclusions can or 
 should be drawn regarding its safety or effectiveness.
 
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