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Last $119.53 USD
Change Today +0.83 / 0.70%
Volume 574.5K
As of 4:30 PM 07/7/15 All times are local (Market data is delayed by at least 15 minutes).

alnylam pharmaceuticals inc (ALNY) Snapshot

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alnylam pharmaceuticals inc (ALNY) Details

Alnylam Pharmaceuticals, Inc., a biopharmaceutical company, discovers, develops, and commercializes novel therapeutics based on RNA interference. The company’s clinical development programs include Patisiran and Revusiran, which are in Phase III clinical trials for the treatment of transthyretin-mediated amyloidosis; ALN-AT3 that is in Phase I clinical trial for hemophilia and rare bleeding disorders; ALN-CC5, which is in Phase I/II clinical trial for the treatment of complement-mediated diseases; and ALN-PCSsc that is in Phase I clinical trial for hypercholesterolemia. Its product development programs also include ALN-AS1 for the treatment of hepatic porphyrias; ALN-AAT for the treatment of alpha-1 antitrypsin deficiency liver disease; ALN-GO1 for the treatment of primary hyperoxaluria type 1; ALN-TMP for the treatment of beta-thalassemia and iron-overload disorders; ALN-AC3 for the treatment of hypertriglyceridemia; ANGPTL3 for the treatment of hypertriglyceridemia and mixed hyperlipidemia; ALN-AGT for the treatment of hypertensive disorders of pregnancy, including preeclampsia; ALN-HBV for the treatment of Hepatitis B Virus; ALN-HDV for the treatment of HDV infection; and ALN-PDL for the treatment of chronic liver infections. The company has strategic alliances and collaboration agreements with Genzyme Corporation; The Medicines Company; Monsanto Company; F. Hoffmann-La Roche Ltd; Isis Pharmaceuticals, Inc.; Novartis Pharma AG; Tekmira Pharmaceuticals Corporation; The University of British Columbia; Acuitas Therapeutics Inc.; Takeda Pharmaceutical Company Limited; Protiva Biotherapeutics, Inc.; Biogen Idec Inc.; Medtronic, Inc.; Kyowa Hakko Kirin Co., Ltd.; Cubist Pharmaceuticals, Inc.; and Ascletis BioScience Co., Ltd. Alnylam Pharmaceuticals, Inc. was founded in 2002 and is headquartered in Cambridge, Massachusetts.

256 Employees
Last Reported Date: 02/13/15
Founded in 2002

alnylam pharmaceuticals inc (ALNY) Top Compensated Officers

Chief Executive Officer and Executive Directo...
Total Annual Compensation: $689.6K
President and Chief Operating Officer
Total Annual Compensation: $515.0K
Vice President of Finance and Treasurer
Total Annual Compensation: $257.2K
Chief Medical Officer and Executive Vice Pres...
Total Annual Compensation: $463.5K
Senior Vice President, General Counsel and Se...
Total Annual Compensation: $210.8K
Compensation as of Fiscal Year 2014.

alnylam pharmaceuticals inc (ALNY) Key Developments

Alnylam Pharmaceuticals, Inc. - Special Call

To discuss on new interim Phase 1 results with ALN-AT3i

Alnylam Reports New Positive Clinical Data for ALN-AT3, a Subcutaneously Administered, Investigational RNAi Therapeutic Targeting Antithrombin (AT) for the Treatment of Hemophilia and Rare Bleeding Disorders

Alnylam Pharmaceuticals, Inc. announced that new positive data from its ongoing Phase 1 clinical trial with ALN-AT3 – an investigational RNAi therapeutic for the treatment of hemophilia and rare bleeding disorders (RBD) – were reported in an oral presentation at the International Society on Thrombosis and Haemostasis (ISTH) 2015 Congress being held June 20 – 25, 2015 in Toronto, Ontario, Canada. Additional study results from 12 hemophilia A and B subjects demonstrated that subcutaneous administration of ALN-AT3 achieved potent and dose-dependent knockdown of AT of up to 86%. AT knockdown was highly durable, with effects lasting over two months after the last dose, supporting further evaluation of a once-monthly subcutaneous dose regimen. In addition, AT knockdown was associated with statistically significant increases in thrombin generation with a mean increase of up to 350% and marked improvements in whole blood clotting; these results demonstrate a re-balancing of hemostasis in severe hemophilia subjects. In an exploratory post-hoc analysis, a reduced frequency of bleeding was observed at higher AT knockdown levels including a maximum bleed-free interval of 114 days. Importantly, ALN-AT3 was found to be generally well tolerated, including no clinically significant increases in D-dimer, a biomarker of pathologic clot formation. Based on these data, the company expects to accelerate the advancement of ALN-AT3 with pivotal studies planned to begin in mid-2016. The ongoing Phase 1 trial of ALN-AT3 is being conducted in Bulgaria, Russia, Switzerland, and the U.K. as a single- and multi-dose, dose-escalation study comprised of three parts. Part A – which is complete – was a randomized, single-blind, placebo-controlled, single-dose, dose-escalation study (n=4 per cohort; 3:1 randomization of ALN-AT3: placebo) in healthy volunteer subjects. This part of the study was completed after the first dose cohort received a single subcutaneous dose of ALN-AT3 at 30 micrograms per kilogram (mcg/kg). Part B of the study – which is now complete – was an open-label, multi-dose, dose-escalation study that enrolled 12 subjects with severe hemophilia A or B. Subjects in Part B received 3 weekly subcutaneous doses of ALN-AT3 at doses of 15, 45, or 75 mcg/kg with a volume per injection ranging from 0.2 to 0.7 mL. Part C of the study – which is ongoing – is an open-label, multi-dose, dose escalation study of up to 12 subjects with moderate or severe hemophilia A or B in which subjects are receiving 3 monthly subcutaneous doses of ALN-AT3. The initial dose cohort of Part C has received ALN-AT3 at a dose of 225 mcg/kg (volume less than 1mL), which is equivalent to the cumulative dose level from 3 weekly doses of 75 mcg/kg that was found to be generally well tolerated in Part B. The primary objective of Parts B and C of the study is to evaluate the safety and tolerability of multiple doses of subcutaneously administered ALN-AT3 in hemophilia subjects. Secondary objectives include assessment of clinical activity as determined by knockdown of circulating AT levels and increase in thrombin generation at pharmacologic doses of ALN-AT3. For subjects enrolled at select sites in the U.K. and Switzerland, the effects of ALN-AT3 are also being monitored by ROTEM® thromboelastometry, which measures clotting time and clot strength in whole blood following a physiologic coagulation stimulus. In addition, exploratory analyses of bleeding are being performed. In the U.K., enrollment has been aided by the Southern Academic Coagulation Consortium (SACC). New results were presented from 12 hemophilia subjects in Part B of the ongoing Phase 1 study in an oral presentation at ISTH and include all available data as of the data cut-off date of June 2, 2015. Subcutaneous doses of ALN-AT3 resulted in potent, dose-dependent and statistically significant knockdown of plasma AT of up to 86%. At the top dose of 75 mcg/kg (n=3), the mean maximum AT knockdown was 59 ± 7% (p less than 0.05), with nadir levels achieved between days 28 and 42. AT knockdown was found to be highly durable, with effects lasting over two months after the last dose. For example, at the 45 mcg/kg dose, mean AT knockdown was 36 ± 11% at day 70. AT knockdown with ALN-AT3 was associated with statistically significant increases in thrombin generation and improvements in whole blood clot formation, providing continued evidence for a re-balancing of hemostasis and potential correction of the hemophilia phenotype in severe hemophilia subjects. The association between levels of AT knockdown and thrombin generation was assessed in a post hoc exploratory analysis in which AT knockdown was categorized into tertiles. In the high tertile (greater than 66% AT knockdown), ALN-AT3 administration resulted in mean increases in thrombin generation of 350 ± 239% (p less than 0.05). In this same tertile, the observed level of thrombin generation (120 ± 81 nM peak thrombin) was comparable to levels observed in healthy volunteers (120 ± 33 nM peak thrombin) from Part A of the Phase 1 study, demonstrating an apparent normalization of thrombin generation. Thrombin generation is known to be a biomarker for bleeding frequency and severity in people with hemophilia (Dargaud, et al., Thromb Haemost; 93, 475-480 (2005)). Additional evaluation of the effects of ALN-AT3 employed the use of ROTEM® thromboelastometry in 3 severe hemophilia subjects in which ALN-AT3 administration resulted in statistically significant, AT knockdown-dependent improvements in whole blood clot formation, including a shortening of clot formation time (CFT). At day 35, the CFT for all 3 subjects was significantly shorter than on day 1, with an over three-fold shortening of CFT from 1,166 ± 614 sec to 323 ± 46 sec (p less than 0.05).

Alnylam Pharmaceuticals, Inc. - Special Call

To discuss new Phase 1/2 clinical results with ALN-CC5


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Price/Sales 159.0x
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