Aug. 6, 2014, 5:35 PM
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Jul. 22, 2014, 8:43 AM
- The USPTO issues a notice of allowance to Alnylam's (NASDAQ:ALNY) patent application 13/693,478. The allowed patent broadly covers single- or double-stranded chemically modified RNA therapeutics conjugated with an N-acetylgalactosamine (GalNAc) ligand independent of length, sequence or disease target.
- GalNAc-siRNA conjugates enable durable silencing of liver-expressed disease genes with subcutaneous does administration and a wide therapeutic index. The delivery approach is part of the company's 5x15 genetic medicine strategy.
Jun. 19, 2014, 11:43 AM
- Alpha-1 Foundation philanthropy subsidiary The Alpha-1 Project (TAP) enters into a collaboration agreement with Alnylam Pharmaceuticals (ALNY -0.5%) for the continued advancement of RNAi therapeutic ALN-AAT for the treatment of alpha-1 antitrypsin (AAT) deficiency-associated liver disease.
- TAP's mission is to work with patients, academia, public health organizations and the private sector in the pursuit of cures and therapies for chronic obstructive pulmonary disease (COPD) and liver disease caused by AAT deficiency.
- Financial terms of the agreement are not disclosed.
- Related ticker: (ARWR -1.6%)
Jun. 13, 2014, 9:22 PM
- Arrowhead Research (ARWR -9.7%) says it is unencumbered in its efforts to develop its HBV drug candidate ARC-520. It has broad access to the IP necessary to develop the product and has no restrictions on its freedom to operate. The company signed a license agreement with Alnylam (ALNY) in January 2012 for HBV-related IP plus it owns other patents related to the drug's technology. It believes that ARC-520 does not infringe on any patents in Alnylam's McSwiggen patent estate.
- ARWR shares took it on the chin today due to the market's perception that ALNY's HBV patents may be a issue for ARWR.
Jun. 13, 2014, 11:41 AM
- Shares of Arrowhead Research (ARWR -16.1%) are down on heavy volume in response to the patent award to Alnylam Pharmaceuticals (ALNY -0.2%) expanding its McSwiggen patent estate for RNAi therapeutics. The just-awarded patent (no. 8,618,277) covers the development of RNAi therapeutics for HBV. One of Arrowhead's lead product candidates is ARC-520, an RNAi-based therapeutic for the treatment of chronic HBV infection.
Jun. 12, 2014, 10:13 AM
- The USPTO issues patent no. 8,618,277 to Alnylam (ALNY +1.3%) in its McSwiggen patent estate, which broadly describes chemical modifications of RNAi therapeutics needed to achieve drug-like properties in siRNA. The 277 patent includes important claims related to the development of RNAi therapeutics for the treatment of hepatitis B infection. It is exclusive to the company.
- The McSwiggen patent estate includes 23 granted patents around the world and is a core component of Alnylam's IP portfolio for the advancement of RNAi therapeutics. It obtained the estate via its acquisition of Sirna Therapeutics from Merck (MRK -1%).
May 12, 2014, 9:26 AM
- Certain traders are apparently swinging from trees this morning as they pop shares of Alnylam (ALNY) 8% on modest volume in premarket action in response to its announcement of a significant reduction in HBV surface antigen in preclinical testing on four monkeys with its RNAi therapeutic ALN-HBV product candidate. The product reduced HBsAg as much as 2.3 log10 compared to 0.5 log10 which is the generally accepted minimum reduction indicating immunologic cure. While encouraging, a colossal amount of work and time remains before any such product will reach the market.
- Alnylam purchased the assets from Merck (MRK) in January for $175M ($25M cash + stock). Merck acquired the assets via its acquisition of Sirna Therapeutics in 2006 for $1.1B. Merck's exit at a significant loss is a clear signal that the road to commercialization will be long and arduous.
- Alnylam hopes to file an IND by the end of 2015.
May 12, 2014, 9:12 AM
May 8, 2014, 4:14 PM| Comment!
May 7, 2014, 5:35 PM
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Apr. 15, 2014, 12:06 PM
- Shares of RNA interference firm Tekmira Pharmaceuticals (TKMR -14.5%) continue their slide in early trading. Prices have cratered 60% since the 6x run-up peaked at $31.48 on March 13.
- Although Big Pharma has lost much of its enthusiasm for RNA interference, some analysts remain bullish. RBC Capital has a $30 PT on the stock and Maxim Group has $31. Stifel Nicolaus is a bit more modest with $19.
- Most of the firm's 2013 revenue of $15.5M came from its contract with the DOD for the development of an Ebola treatment ($9.8M) and a milestone payment from Alnylam (ALNY -4.5%) ($5M) that was triggered by the start of the Phase 3 clinical trial for ALN-TTR02 (patisiran).
Apr. 2, 2014, 8:30 AM
- The European Medicines Agency has recommended that Alnylam's (ALNY) ALN-TTRsc be designated as an orphan medicinal product for the treatment of transthyretin (TTR)-mediated amyloidosis (ATTR).
- ATTR is part of a group of conditions called Amyloidosis in which proteins that are usually soluble become insoluble and start to build up in various organs or tissues, such as the peripheral nerves and heart. ATTR is often fatal.
- ALN-TTRsc is in a pilot Phase 2 trial of 15 patients.
Mar. 6, 2014, 9:22 AM
- Alnylam Pharamaceuticals (ALNY) finalizes its buy of Merck's (MRK) Sirna Therapeutics that was previously disclosed on January 12.
- The total purchase price is $175M ($25M cash and $150M in ALNY common stock).
- The transaction represents a significant haircut for Merck considering the $1.1B cash price it paid for Sirna in 2006.
Feb. 24, 2014, 12:04 PM
- "When we first launched coverage of Tekmira (TKMR +8.9%) on June 18, 2013 at $4.80 we modeled our expectations with a high degree of conservatism using a 30% risk rate across the complete model," says analyst Jason Kolbert. "We are now lowering that discount rate from 30% to 15%."
- The new price target of $31 is up from $17 previously.
- The lower discount rate is thanks to progress of Tekmira partners Alnylam (ALNY -1.1%), Marqibo, and Monsanto, and the ever-rising evidence of the viability of SiRNA and the platform required to deliver it. He notes the gains in Isis Pharma last week amid preliminary test data, and the continued rise in Alnylam since Sanofi agreed to pay $700M for access to rare-disease treatments, and took a 12% stake in the company.
Feb. 14, 2014, 8:18 AM
- Analyst Alan Carr reiterates his Buy rating and boosts the price target to $94 from $65 following last night's Q4 results.
- "Management reiterated plans to bring at least 6-7 candidates into clinical development by YE15, including two into Phase 3 by YE14," he notes. "Key milestones this year include data from the ALN-TTRsc Phase 2, ALN-AT3 Phase 1, and ALN-TTR02 Phase 2 OLE trials, all in 4Q14."
- "The Jan 2014 Sanofi collaboration provides a large cash infusion, allowing a much larger R&D effort that may accelerate time to commercialization of multiple programs across multiple territories."
- The $94 price target is based on 25x 2020 EPS estimates, discounted by 25% annually.
- ALNY unchanged premarket
Feb. 13, 2014, 4:01 PM| Comment!
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