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News Breaks
January 13, 2014
05:21 EDTALNY, SNYAlnylam, Genzyme form transformational alliance for RNAi therapeutics
Alnylam Pharmaceuticals (ALNY) and Genzyme, a Sanofi company (SNY), announced that they have formed a transformational alliance for the development and commercialization of RNAi therapeutics as genetic medicines. Alnylam will retain product rights in North America and Western Europe, while Genzyme will obtain the right to access Alnylam’s current “5x15”1 and future genetic medicines pipeline in the rest of the world, or ROW, including global product rights for certain programs. In addition, Genzyme becomes a major Alnylam shareholder through an upfront purchase of $700M of newly issued stock at approximately $80/share, representing an approximately 12% ownership position. This alliance significantly bolsters Alnylam’s balance sheet to over $1B in cash, enabling an increased investment in the company’s RNAi therapeutics pipeline and is expected to secure Alnylam’s financial independence through to multiple product launches. Upon the closing of the transaction, Genzyme will opt-in to patisiran, or ALN-TTR02, – an RNAi therapeutic currently in a Phase 3 trial for the treatment of transthyretin, or TTR-mediated amyloidosis, or ATTR patients with Familial Amyloidotic Polyneuropathy – for its ROW territories, while Alnylam retains full product rights in North America and Western Europe. Alnylam and Genzyme have also agreed to expand their current collaboration on ALN-TTRsc – an RNAi therapeutic currently in a Phase 2 trial for the treatment of ATTR patients with TTR amyloid cardiomyopathy – where the parties will co-develop and co-promote ALN-TTRsc in North America and Western Europe; Alnylam will maintain development and commercialization control with ALN-TTRsc and Genzyme will develop and commercialize the product in its ROW territories. The companies believe that this broadened collaboration on ALN-TTRsc will increase the product’s overall value, as significant market development and commercial operational scale is warranted to maximize the opportunity for both familial cardiac amyloidosis senile systemic amyloidosis manifestations of TTR cardiac amyloidosis.
News For ALNY;SNY From The Last 14 Days
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November 25, 2014
10:00 EDTSNYOn The Fly: Analyst Initiation Summary
Today's noteworthy initiations include: 3M Company (MMM) initiated with an Underperform at RBC Capital... Ametek (AME) initiated with an Outperform at RBC Capital... AstraZeneca (AZN) initiated with an Outperform at Exane BNP Paribas... Bayer (BAYRY) initiated with a Neutral at Exane BNP Paribas... Carlisle (CSL) initiated with a Sector Perform at RBC Capital... Colfax (CFX) initiated with a Sector Perform at RBC Capital... Dover (DOV) initiated with a Sector Perform at RBC Capital... Eaton (ETN) initiated with a Sector Perform at RBC Capital... Emerson (EMR) initiated with a Sector Perform at RBC Capital... Evercore Partners (EVR) initiated with an Outperform at Macquarie... Fifth Street Asset (FSAM) initiated with a Buy at MLV & Co.... Flowserve (FLS) initiated with an Underperform at RBC Capital... General Electric (GE) initiated with an Outperform at RBC Capital... GlaxoSmithKline (GSK) initiated with an Underperform at Exane BNP Paribas... Grainger (GWW) initiated with a Sector Perform at RBC Capital... Hanesbrands (HBI) initiated with a Buy at UBS... Hercules Technology (HTGC) initiated with a Neutral at Macquarie... HomeStreet (HMST) initiated with a Neutral at Macquarie... Honeywell (HON) initiated with an Outperform at RBC Capital... IDEX Corp. (IEX) initiated with an Outperform at RBC Capital... Illinois Tool Works (ITW) initiated with a Sector Perform at RBC Capital... Ingersoll-Rand (IR) initiated with a Sector Perform at RBC Capital... ManTech (MANT) initiated with a Buy at Maxim... Novartis (NVS) initiated with an Outperform at Exane BNP Paribas... Nu Skin (NUS) initiated with a Neutral at Citigroup... Oppenheimer Holdings (OPY) initiated with a Neutral at Macquarie... Pentair (PNR) initiated with an Outperform at RBC Capital... Raymond James (RJF) initiated with a Neutral at Macquarie... Roche (RHHBY) initiated with an Outperform at Exane BNP Paribas... Roper Industries (ROP) initiated with an Outperform at RBC Capital... SPX Corp. (SPW) initiated with a Sector Perform at RBC Capital... Sanofi (SNY) initiated with an Outperform at Exane BNP Paribas... Tyco (TYC) initiated with an Outperform at RBC Capital... United Technologies (UTX) initiated with an Outperform at RBC Capital... WESCO (WCC) initiated with an Outperform at RBC Capital... Xylem (XYL) initiated with a Sector Perform at RBC Capital.
05:25 EDTSNYSanofi initiated with an Outperform at Exane BNP Paribas
November 21, 2014
07:16 EDTSNYGenzyme says EU's CHMP adopts positive opinion for Cerdelga capsules
Genzyme, a Sanofi company, announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of Cerdelga capsules, an oral treatment for certain adults living with Gaucher disease type 1. The European Commission is expected to make a final decision on granting marketing authorization for Cerdelga in the EU in the coming months. Cerdelga was approved by the U.S. Food and Drug Administration in August, and is under review by other regulatory authorities around the world. The CHMP opinion was based on data from the Cerdelga clinical development program, which is the largest ever conducted in Gaucher disease, with approximately 400 patients treated in 29 countries. Genzyme has been researching an oral therapy for Gaucher disease for fifteen years.
05:39 EDTSNYMannKind, Sanofi on track to launch Afrezza in Q1, says Piper Jaffray
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November 20, 2014
06:09 EDTSNYSanofi says has potential to launch up to six new drugs in 2015
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05:22 EDTSNYRegeneron, Sanofi receive FDA Breakthrough Therapy designation in AD
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November 19, 2014
08:17 EDTSNYRegeneron, Sanofi report new data from six alirocumab trials
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07:52 EDTSNY, ALNYInforma Business Information to hold a conference
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07:11 EDTSNYSanofi drawing up list of CEO candidates to repalce Viehbacher, Reuters reports
Sanofi's (SNY) board is in the process of drawing up a short list of CEO candidates to replace Chris Viehbacher, sources tell Reuters. Jean-Rene Fourtou, a Sanofi director and the honorary chairman of media group Vivendi (VIVHY), has been selected to lead the appointments and governance committee that will select the next CEO. Smith & Nephew (SNN) CEO Olivier Bohuon, AstraZeneca (AZN) CEO Pascal Soriot and former Wyeth CEO Bernard Poussot have been rumored to be potential contenders for the CEO position. Reference Link
November 18, 2014
15:48 EDTSNYGenzyme, Isis present KYNAMRO data at AHA meeting
Genzyme, a Sanofi (SNY) company, and Isis Pharmaceuticals (ISIS) announced that new two-year data from a phase 3 long-term extension study of KYNAMRO injection was presented at a scientific session at the annual American Heart Association meeting. In the study, a retrospective analysis showed that patients treated with KYNAMRO for a mean of two years had a significant reduction in Major Adverse Cardiovascular Events compared to two years prior to therapy. The rate of MACE in patients treated with KYNAMRO for two years were adjudicated by an independent committee and compared to the rate of MACE in the same patients based on their medical history prior to treatment with KYNAMRO. In this analysis, MACE were identified in 62% of patients during two years prior to KYNAMRO treatment, and 9% of patients during a mean of 24.4 months after initiation of treatment with KYNAMRO.
12:16 EDTSNYSanofi to host seminar on New Medicines
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November 17, 2014
17:03 EDTALNYAlnylam presents new pre-clinical data on RNAi therapeutic programs
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07:16 EDTSNYMilken Institute--Faster Cures to hold a conference
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07:09 EDTALNYAmerican Heart Association to hold a conference
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November 16, 2014
14:44 EDTSNYRegulus, Sanofi present new data enhancing the preclinical profile of RG-012
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12:56 EDTSNYGenzyme’s Lemtrada approved by the FDA
Genzyme, a Sanofi company, announced that the U.S. Food and Drug Administration has approved Lemtrada, alemtuzumab, for the treatment of patients with relapsing forms of multiple sclerosis. Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS. “Today’s approval is the culmination of more than a decade of work by Genzyme to develop Lemtrada,” said Genzyme President and CEO, David Meeker. “Lemtrada demonstrated superior efficacy over Rebif on annualized relapse rates in the two studies which were the basis for approval. A comprehensive risk evaluation and mitigation strategy will be instituted in order to help detect and manage the serious risks identified with treatment.” The FDA approval of Lemtrada is based on two pivotal randomized Phase III open-label rater-blinded studies comparing treatment with Lemtrada to Rebif in patients with relapsing remitting MS who were either new to treatment or who had relapsed while on prior therapy . In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a. The clinical development program for Lemtrada involved nearly 1,500 patients with more than 6,400 patient-years of safety follow-up. “The unmet need in MS remains high,” said Edward Fox, M.D., Ph.D., Director of the Multiple Sclerosis Clinic of Central Texas. “It is a great day for people living with relapsing forms of MS in the United States, who will now have access to this new meaningful treatment”.
November 14, 2014
14:53 EDTSNYCVS Express Scripts implementing drug price controls, says Cleveland Research
Cleveland Research believes that CVS (CVS) and Express scripts are implementing rebates and price controls on drug. The firm expects the companies to increase their focus on controlling durg prices next year, and adds that they have already itnroduced prior authorization criteria for hepatitis drug. Publicly traded drug companies include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Makers of hepatits c drugs include AbbVie (ABBV) and Gilead (GILD),
06:31 EDTALNYAlnylam to host conference call
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06:04 EDTALNYAlnylam announces positive initial phase 2 data with Revusiran
Alnylam announced positive initial Phase 2 data with revusiran, an investigational RNAi therapeutic targeting transthyretin for the treatment of TTR cardiac amyloidosis. In the pilot Phase 2 study, revusiran was found to be generally well tolerated in TTR cardiac amyloidosis patients. Revusiran demonstrated clinical activity with an up to 98.2% knockdown of serum TTR – the disease causing protein. This included similar knockdown effects toward wild type and mutant TTR protein within V122I patients, who represent the most common genotype associated with inherited forms of TTR cardiac amyloidosis. In the five week course of treatment, there were no significant changes observed in a number of exploratory clinical measurements. Revusiran utilizes Alnylam’s proprietary GalNAc-conjugate delivery platform that enables subcutaneous delivery of RNAi therapeutics with a wide therapeutic index. The primary objective of the study was to evaluate the safety and tolerability of revusiran. The secondary objectives were to assess the clinical activity of revusiran toward serum levels of TTR and characterize the drug’s pharmacokinetic profile. In addition, a number of exploratory clinical measurements were performed at baseline and days 42 and 90 after start of dosing.

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