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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.
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April 24, 2014
09:47 EDTALNYAlnylam management to meet with Needham
Meeting to be held in Kansas City, MO on May 1 hosted by Needham.
April 23, 2014
06:54 EDTSNYCambridge Healthtech Institute to hold a conference
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06:54 EDTSNYGlobal Technology Community to hold a summit
7th Annual Diabetes Summit is being held in Cambridge, MA on April 23-25.
06:53 EDTSNYFood & Drug Law Institute to hold a conference
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06:16 EDTSNYPharmaceutical companies narrowing focus, WSJ reports
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April 21, 2014
11:33 EDTSNYAward of $16M to Sanofi, Abbott for damages upheld on appeal
The Court of Appeals for the Federal Circuit affirmed a lower court ruling that Glenmark Pharmaceuticals infringed a patent related to the antihypertension drug Tarka that is owned by or exclusively licensed to Sanofi (SNY), Abbott Labs (ABT), and their related companies. In the prior case, Glenmark admitted infringement and the jury awarded $15.2M in lost profits and about $800K in price erosion damages. The appeals court affirmed the district court's jurisdiction in the matter, as well as its judgment and related rulings. Reference Link
08:36 EDTSNYAastrom announces definitive agreement to acquire Sanofi's CTRM business
Aastrom Biosciences (ASTM) announced that it has entered into a definitive agreement to acquire Sanofi's (SNY) Cell Therapy and Regenerative Medicine, or CTRM, business for a purchase price of $6.5M, with $4M payable in cash at closing and $2.5M payable in the form of a promissory note. The acquisition is subject to customary closing conditions and is scheduled to close in approximately three weeks. Through the CTRM acquisition, Aastrom is acquiring global commercial rights to three marketed autologous cell therapy products. Aastrom will also acquire global manufacturing and production centers located in the United States and Denmark.
08:32 EDTSNYAastrom announces definitive agreement to acquire Sanofi's CTRM business
07:21 EDTSNYFDA Pediatric Advisory Committee to hold a meeting
The Committee discusses pediatric-focused safety reviews including MDT's Activa Dystonia Therapy, (BAX's Advate and Tisseel, NVS' Famvir, Tibotec's (JNJ subsidiary) Intelence, UCB Pharma's Keppra, MRK's Maxalt, BAYRY's Natazia, Digestive Care's Pertzye, JNJ's Prezista, BMY's Reyataz, SNY's Sklice, PFE's Torisel, Aptalis' Ultresa, and GILD's Viread in a meeting being held in Bethesda, Maryland on April 21 at 8 am. Webcast Link
April 16, 2014
13:51 EDTALNYAlnylam COO critical of big pharma, FierceDrugDelivery reports
After Novartis (NVS) decided to end its RNAi research, Alnylam COO Barry Greene told FierceDrugDelivery that big pharma has "never been able to innovate." Greene attributes the recent sell-off in Alnylam shares to "generally bearish sentiment on Wall Street regarding biotech stocks in particular." Reference Link
09:15 EDTSNYImpax launches generic Renvela for kidney disease licensed from Sanofi
Impax Laboratories (IPXL) is commencing shipment of authorized generic Renvela 800 mg tablets, through Global Pharmaceuticals, Impax's generics division. Renvela is indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. Under the terms of a settlement agreement, Sanofi (SNY) company Genzyme agreed to grant Impax a license to sell an allotment of a specified number of bottles of an authorized generic version of Renvela tablets commencing on April 16. Impax continues to pursue approval of its pending Abbreviated New Drug Application for generic Renvela with the FDA.
April 15, 2014
07:35 EDTALNYAlnylam outlook not affected by Novartis decision, says JMP Securities
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06:32 EDTSNYPatients paying much more for specialty drugs, NY Times says
The amount that patients with certain diseases must pay for specialty drugs has increased significantly, a research firm reported, according to The New York Times. Meanwhile, consumers' use of health care increased in 2013 for the firm time in three years, the newspaper quoted the firm, the IMS Institute for Healthcare Informatics, as saying. Publicly traded drug makers 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). Publicly traded health insurers include AMERIGROUP (AGP), Aetna (AET), Centene (CNC), Cigna (CI), Health Net (HNT), Healthspring (HS), Humana (HUM), Molina Healthcare (MOH), UnitedHealth (UNH), WellCare (WCG) and WellPoint (WLP).Reference Link
April 14, 2014
14:42 EDTALNYAlnylam slips after Novartis reportedly cuts back RNAi development
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April 11, 2014
07:06 EDTSNYVIVUS announces avanafil clinical data presentation
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