Key Developments: Alnylam Pharmaceuticals Inc (ALNY.O)
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17 Jun 2013
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Latest Key Developments (Source: Significant Developments)
Alnylam Pharmaceuticals Inc Initiates Phase I Clinical Study For ALN-TTRsc; Enters Into Exclusive Alliance With Sanofi 's Genzyme
Alnylam Pharmaceuticals Inc announced that it has initiated dosing in its Phase I clinical trial with ALN-TTRsc, an RNAi therapeutic targeting transthyretin (TTR) for the treatment of TTR-mediated amyloidosis (ATTR). The Phase I trial of ALN-TTRsc is being conducted in the U.K. as a randomized, double-blind, placebo-controlled, single- and multi-dose, dose-escalation study, enrolling up to 40 healthy volunteer subjects. The primary objective of the study is to evaluate the safety and tolerability of single and multiple doses of subcutaneously administered ALN-TTRsc. Secondary objectives include assessment of clinical activity of the drug as measured by serum TTR levels. Alnylam expects to present data from this trial in mid-2013. Upon completion of the Phase I trial, the company plans to start a Phase II clinical study of ALN-TTRsc in FAC patients by the end of 2013 and, assuming positive results, expects to start a pivotal trial for ALN-TTRsc in FAC patients in 2014. ATTR is an autosomal dominant inherited disease caused by mutations in the TTR gene, which is expressed predominantly in the liver. Alnylam entered into an exclusive alliance with Genzyme, a Sanofi company, to develop and commercialize RNAi therapeutics, including ALN-TTR02 and ALN-TTRsc, for the treatment of ATTR in Japan and the broader Asian-Pacific region. Alnylam plans to develop and commercialize the ALN-TTR program in North and South America, Europe, and rest of the world. Full Article
Medicines Co and Alnylam Pharmaceuticals Inc Form Strategic Alliance To Develop and Commercialize RNAi Therapeutics Targeting PCSK9 For Treatment Of Hypercholesterolemia
Medicines Co and Alnylam Pharmaceuticals Inc announced that they have formed an exclusive global alliance for the development and commercialization of Alnylam's ALN-PCS RNAi therapeutic program for the treatment of hypercholesterolemia. Under this alliance, Medicines Co and Alnylam intend to collaborate on the advancement of the ALN-PCS program. Alnylam's ALN-PCS program includes ALN-PCS02, an intravenously administered RNAi therapeutic which has completed a Phase I trial, and ALN-PCSsc, a subcutaneously administered RNAi therapeutic currently in pre-clinical development. Alnylam will continue the program for an estimated one to two years to complete certain pre-clinical and Phase I clinical studies. Medicines Co is responsible for leading and funding development from Phase II forward and commercializing the ALN-PCS program. Under the terms of the agreement, Medicines Co will make an upfront cash payment of $25 million to Alnylam. Alnylam may also receive potential development and commercial milestone payments of up to $180 million. Alnylam will be eligible to receive scaled double-digit royalties on global products sales of ALN-PCS products. Alnylam has completed a Phase I trial of ALN-PCS02 in healthy volunteer subjects with elevated baseline LDL-C. Full Article
Alnylam Pharmaceuticals Inc Announces Exercise Of Over-Allotment Option In Public Offering of Common Stock
Alnylam Pharmaceuticals Inc announced that the underwriters of its previously announced public offering of common stock have exercised their option to purchase an additional 1,200,000 shares at the public offering price of $20.13 per share. As a result, the Company will issue a total of 9,200,000 shares in the offering and will receive aggregate net proceeds, after underwriting discounts and commissions and other estimated offering expenses, of approximately $173.8 million. The offering is expected to close on or about January 22, 2013, subject to the satisfaction of customary closing conditions. J.P. Morgan Securities LLC and Morgan Stanley & Co. LLC are acting as joint book-running managers and representatives of the underwriters for the offering. Deutsche Bank Securities Inc., Piper Jaffray & Co., Leerink Swann LLC, Needham & Company, LLC and JMP Securities LLC are acting as co-managers for the offering. Full Article
Alnylam Pharmaceuticals Inc Prices Public Offering of Common Stock
Alnylam Pharmaceuticals Inc announced the pricing of an underwritten registered public offering of 8,000,000 shares of its common stock at a public offering price of $20.13 per share. All of the shares in the offering are to be sold by Alnylam. The offering is expected to close on or about January 22, 2013. J.P. Morgan Securities LLC and Morgan Stanley & Co. LLC are acting as joint book-running managers and representatives of the underwriters for the offering. Deutsche Bank Securities Inc., Piper Jaffray & Co., Leerink Swann LLC, Needham & Company, LLC and JMP Securities LLC are acting as co-managers for the offering. Alnylam has granted the underwriters a 30-day option to purchase up to 1,200,000 shares to cover overallotments, if any. Full Article
Alnylam Pharmaceuticals Inc Announces Proposed Public Offering Of $125 Million Of Common Stock
Alnylam Pharmaceuticals Inc announced that it has commenced an underwritten public offering of shares of its common stock to raise aggregate proceeds of approximately $125 million. All of the shares in the offering are to be sold by Alnylam. J.P. Morgan Securities LLC and Morgan Stanley & Co. LLC are acting as joint book-running managers and representatives of the underwriters for the offering. Alnylam intends to grant the underwriters a 30-day option to purchase up to an additional 15 % of the number of shares sold to cover over-allotments, if any. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Full Article
Alnylam Pharmaceuticals Inc Announces New Pre-clinical Data on RNAi Therapeutics for Treatment of Hemoglobinopathies
Alnylam Pharmaceuticals Inc announced that it has presented new pre-clinical data from its RNAi therapeutic program for the treatment of hemoglobinopathies at the 54th American Society of Hematology Annual Meeting being held December 8-11, 2012 in Atlanta. Alnylam scientists presented data showing that ALN-TMP, an RNAi therapeutic targeting Tmprss6, leads to disease modifying effects, including a correction in globin gene expression, in a model of β-thalassemia. These studies were conducted in collaboration with Boston Children’s Hospital. Alnylam’s program in hemoglobinopathies comprises part of its ‘Alnylam 5x15’ product strategy, by which the Company aims to advance five programs in clinical development, including programs in advanced stages, by the end of 2015. Alnylam scientists presented data showing that systemic administration of ALN-TMP, an RNAi therapeutic targeting Tmprss6, resulted in disease modifying effects in a model of β-thalassemia. In addition, ALN-TMP demonstrated pre-clinical efficacy in a model of hereditary hemochromatosis. In the pre-clinical studies, ALN-TMP administration resulted in a greater than 80% silencing of Tmprss6 mRNA levels and a greater than two-fold elevation of Hamp1, the gene that encodes for hepcidin, a liver hormone that negatively regulates iron transport and absorption. ALN-TMP administration resulted in an approximately 30% decrease in serum iron and non-heme liver iron, as well as a similar reduction in transferrin saturation. Full Article
Alnylam Pharmaceuticals Inc Presents New Pre-Clinical Data On RNAi Therapeutics For Treatment Of Alpha-1 Antitrypsin (AAT) Deficiency
Alnylam Pharmaceuticals Inc announced that it has presented new pre-clinical data with an RNAi therapeutic targeting alpha-1 antitrypsin (AAT) for the treatment of liver disease associated with AAT deficiency. These data were presented at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD, "The Liver Meeting") held November 9-13, 2012 in Boston. AAT deficiency is a rare genetic disease that can result in severe lung and liver pathology; approximately 10,000 patients are diagnosed worldwide. The new RNAi therapeutic program, ALN-AAT, represents a novel approach for the treatment of liver disease associated with AAT deficiency. ALN-AAT is a new RNAi therapeutic program for the treatment of liver disease associated with AAT deficiency. New data presented at the Liver Meeting are based on an AAT-targeting siRNA formulated in a lipid nanoparticle (LNP). The AAT siRNA was administered at doses ranging from 0.03 to 1.0 mg/kg in mice overexpressing a human Z-AAT transgene, resulting in robust, dose-dependent silencing of the target mRNA and protein. Specifically, a single intravenous dose of the drug resulted in 90% knockdown of liver mRNA and a greater than 80% decrease in serum AAT at 48 hours post-dose. These new data show that siRNA formulated in LNPs result in effective silencing of the HSC-specific gene target, collagen 1a1 (col1a1). Full Article
Tekmira Pharmaceuticals Corp and Alnylam Pharmaceuticals, Inc. Restructure Relationship and Settle All Litigation
Tekmira Pharmaceuticals Corp announced that it has entered into a settlement agreement with Alnylam Pharmaceuticals, Inc. that resolves all litigation between the companies, and has signed a new licensing agreement that restructures the relationship and provides clarity on all intellectual property and licensing issues between the companies. As a result of the restructuring and new agreements, Tekmira will receive $65 million within 10 days and is eligible to receive $10 million in near-term milestone payments expected to be received in 2013. As part of this settlement and restructuring, all previous agreements between the companies are terminated and a new license agreement has been established that provides clear terms outlining Tekmira's LNP intellectual property. Under the terms of the new license agreement: Alnylam will transfer all agreed-upon patents and patent applications related to LNP technology for the systemic delivery of RNAi therapeutic products, including the MC3 lipid family, to Tekmira, who will own and control prosecution of this intellectual property portfolio. Tekmira is the only company able to sublicense LNP intellectual property in future platform-type relationships; Tekmira will receive a total of $65 million in cash payments within 10 days. This includes $30 million associated with the termination of the manufacturing agreement and $35 million associated with the termination of the previous license agreements. Full Article
Alnylam Pharmaceuticals Inc Wins Patent Infringement Case Against Tekmira Pharmaceuticals Corp
Alnylam Pharmaceuticals Inc announced that the U.S. District Court of the District of Massachusetts has ruled in favor of Alnylam and has denied Tekmira Pharmaceuticals Corporation’s motion to dismiss certain claims and motion to disqualify Alnylam’s counsel in an infringement suit filed in January 2012. The infringement suit against Tekmira is based upon Alnylam’s allegations that Tekmira has improperly provided lipid nanoparticle (LNP)-formulated small interfering RNA (siRNA) molecules to pharmaceutical collaborators. As announced, the Court has ruled that Alnylam has standing in suing Tekmira for infringement of several patents that Tekmira has exclusively licensed to Alnylam. In addition, Alnylam announced that it has expanded the infringement action with a suit in Canada. Alnylam alleges Tekmira is infringing this patent in its collaboration activities and in its own research and development efforts. Full Article
Alnylam Pharmaceuticals Inc Complete Results From Phase IIb Trial With Aln-RSV01, An Inhaled Rnai Therapeutic For Treatment Of Respiratory Syncytial Virus (RSV) Infection
Alnylam Pharmaceuticals Inc announced complete results from its Phase IIb trial with ALN-RSV01 for the treatment of respiratory syncytial virus (RSV) infection in lung transplant patients. The data were presented at the European Respiratory Society’s (ERS) Annual Congress held in Vienna, September 1-5, 2012. As reported previously, the study narrowly missed the primary endpoint of reduced day 180 BOS in an intent-to-treat (ITTc) analysis of confirmed RSV infected patients, but achieved statistically significant reductions in prospectively defined analyses of ITTc patients with their last observation carried forward (LOCF), and of ITTc patients treated per protocol (PP). At the ERS meeting, new results were presented on secondary endpoints and certain post-hoc analyses that support the efficacy of ALN-RSV01 in this setting. Further, and as reported earlier, ALN-RSV01 was found to be generally safe and well tolerated in the study. Alnylam plans to discuss these complete results with U.S. and European regulatory authorities, and communicate future development plans for ALN-RSV01 at year’s end. New study findings presented at the ERS meeting included results from key secondary endpoints and certain post-hoc analyses of data. As it pertains to key secondary endpoints, ALN-RSV01 treatment resulted in a statistically significant reduction in day 90 BOS as compared with placebo as measured in the ITTc population (p=0.044) with an overall effect size of 52%. Full Article
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