medicines company (MDCO) Key Developments
The Medicines Company Names Dr. Fred Eshelman as Non-Executive Chairman of the Board of Directors
Aug 31 15
The Medicines Company announced that its Board of Directors has named Dr. Fred Eshelman, founder of Eshelman Ventures LLC, as non-executive Chairman of the company's Board of Directors, effective immediately. Dr. Clive Meanwell will remain the company's Chief Executive Officer and a member of the Board of Directors. Dr. Eshelman has more than 35 years of strategic development, executive, operational and financial leadership experience in the pharmaceutical and healthcare industries. He is the founder and former Chief Executive Officer and Executive Chairman of Pharmaceutical Product Development Inc. (PPD). Dr. Eshelman will serve as a Class II director with a term expiring at the 2017 Annual Meeting of Shareholders.
Alnylam Pharmaceuticals, Inc. and The Medicines Company Announces Positive Initial Results
Aug 30 15
Alnylam Pharmaceuticals, Inc. and The Medicines Company announced positive initial results from their ongoing Phase 1 clinical trial with ALN-PCSsc at ESC Congress 2015 held August 29, 2015 to September 2, 2015, in London. ALN-PCSsc is an investigational 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 (MAbs) that bind to PCSK9 in blood, ALN-PCSsc is a first in class investigational medicine that acts by turning off PCSK9 synthesis in the liver. In the Phase 1 study, subcutaneous administration of ALN-PCSsc resulted in an up to 83% lowering of LDL-C, with an up to 64 ± 5% mean maximum reduction, comparable to published results for anti-PCSK9 MAbs. Similar reductions in LDL-C were seen in patients on and off concomitant statin therapy. The effects of ALN-PCSsc were highly durable, with clinically significant and clamped reductions in LDL-C maintained for over 140 days, supportive of a once-quarterly and possibly bi-annual subcutaneous dose regimen. Maximal lowering effects on LDL-C were consistently achieved at a dose of 300 mg associated with a low injection volume of 1.5 mL; this dose was significantly below the 800 mg top dose studied per the Phase 1 protocol. Importantly, ALN-PCSsc was generally well tolerated with no clinically significant drug-related adverse events. The development leadership of ALN-PCSsc now transitions from Alnylam to The Medicines Company, who together announce initiation of the ORION development program, with an initial Phase 2 study planned to begin by end-2015 and a Phase 3 study expected to begin by end-2017. ORION is also expected to include a comparative study of ALN-PCSsc with anti-PCSK9 MAbs. The Phase 1 trial of ALN-PCSsc is being conducted in the U.K. as a randomized, single-blind, placebo-controlled, single ascending- and multi-dose, subcutaneous dose-escalation study. Enrollment in the study has been completed, but the study is ongoing with continued data collection and subject follow up. The study was designed to enroll up to 76 volunteer subjects with elevated baseline LDL-C (= 100 mg/dL), with subjects randomized 3:1, drug: placebo. The study was performed in two phases: a single ascending dose (SAD) phase and a multiple dose (MD) phase. The MD phase also includes subjects both on and off statin co-medication. The primary objective of the Phase 1 study is to evaluate the safety and tolerability of ALN-PCSsc. Secondary objectives include assessment of clinical activity as determined by knockdown of plasma PCSK9 levels and lowering of serum LDL-C levels, as well as pharmacokinetics of ALN-PCSsc. All results are based on data in the database as of August 4, 2015. A total of 69 subjects were enrolled in the study, with a mean baseline LDL-C of 146 mg/dL. A total of 24 subjects were enrolled in five SAD cohorts and received placebo (N=6) or study drug at fixed doses from 25 mg to 800 mg (N=3, per group; N=6 for the 800 mg cohort). A total of 45 subjects were enrolled in six MD cohorts, with subjects receiving: placebo (N=12); four doses of 125 mg once weekly (N=6); two doses of 250 mg once every two weeks (N=6); two doses of 300 mg once every four weeks (N=6); two doses of 300 mg once every four weeks with statin co-medication (N=4); two doses of 500 mg once every four weeks (N=6); and two doses of 500 mg once every four weeks with statin co-medication (N=5). In the SAD cohorts, ALN-PCSsc administration was associated with potent, dose-dependent, and highly durable knockdown of PCSK9 and lowering of LDL-C. An up to 86% maximal knockdown of PCSK9 relative to baseline was achieved, with an up to 82 ± 2% mean maximum PCSK9 knockdown (p<0.001, compared to placebo). Even in the lowest dose group of 25 mg, significant knockdown of PCSK9 was observed. Maximal effects toward PCSK9 were achieved at the 300 mg dose, with further dose escalation yielding minimal additive effects; the volume of drug at the 300 mg dose was 1.5 mL. Knockdown of PCSK9 was highly durable, with a 62 ± 5% mean effect (p<0.05, compared to baseline) in the 300 mg cohort maintained at 140 days after a single dose. In the SAD cohorts, an up to 78% maximal lowering of LDL-C was achieved, with an up to 58 ± 4% mean maximum LDL-C lowering (p<0.01, compared to placebo); absolute levels of LDL-C as low as 30 mg/dL were observed. As with PCSK9 knockdown, maximal, fully saturating effects on LDL-C lowering were achieved at the 300 mg dose. Reductions in LDL-C were highly durable, with a 44 ± 1% mean lowering (p<0.001, relative to baseline) in the 300 mg cohort maintained at 140 days after a single dose; data collection beyond 140 days is ongoing. The least squares mean (LSM) % reduction in LDL-C from baseline at 12 weeks – a measure used in studies of anti-PCSK9 MAbs – was 50.1% in the 300 mg cohort; this is comparable to the 50-60% range of values reported for MAbs, but was achieved after just a single dose. The durable effects of ALN-PCSsc support a once quarterly, and possibly bi-annual, low volume subcutaneous dose regimen for evaluation in further clinical studies.
Alnylam Pharmaceuticals, Inc., The Medicines Company - Special Call
Aug 24 15
To discuss initial ALN-PCSsc Phase 1 clinical results
The Medicines Company Reports Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended June 30, 2015
Jul 29 15
The Medicines Company reported unaudited consolidated earnings results for the second quarter and six months ended June 30, 2015. For the quarter, the company reported net revenue of $90,472,000 against $183,774,000 a year ago. Loss from operations was $78,994,000 against $31,886,000 a year ago. Loss before income taxes was $67,837,000 against $28,602,000 a year ago. Net loss was $46,539,000 against $5,174,000 a year ago. Net loss attributable to the company was $46,592,000 or $0.71 per share basic and diluted against $5,157,000 or $0.08 per share basic and diluted a year ago. Net loss attributable to company adjusted was $42,752,000 or $0.65 per share diluted against net income attributable to company adjusted of $20,587,000 or $0.31 per share diluted a year ago.
For the six months, the company reported net revenue of $216,988,000 against $361,009,000 a year ago. Loss from operations was $90,698,000 against $17,135,000 a year ago. Loss before income taxes was $57,054,000 against $11,512,000 a year ago. Net loss was $41,533,000 against $10,179,000 a year ago. Net loss attributable to the company was $41,558,000 or $0.63 per share basic and diluted against $10,153,000 or $0.16 per share basic and diluted a year ago. Net loss attributable to company adjusted was $37,076,000 or $0.57 per share diluted against net income attributable to company adjusted of $42,696,000 or $0.64 per share diluted a year ago.
The Medicines Company Announces Distribution Agreement with Sandoz in US
Jul 17 15
The Medicines Company has signed an agreement with Sandoz Inc. for the distribution of an authorized generic of its anticoagulant, ANGIOMAX, or bivalirudin, for injection, in the US. This agreement with Sandoz, itself a leader in the generics market, helps to ensure that bivalirudin remains a high quality product in this market.