Alnylam Pharmaceuticals Inc. ($ALNY) boosted its patent portfolio with new allowances from USPTO as the regulatory authority issued the notices with regard to patent application 15/483,354 and patent application, 14/943,612. The first patent was acquired by the company from Merck in 2014 and forms a part of the McSwiggen patent family and the second one is related to RNA agents of any length with at least one 2’-O alkyl modification and 4-20 phosphorothioate linkages conjugated to a GalNAc moiety of any valency. These new allowances will offer an additional layer of security to the company’s developmental efforts. The news came on the top of another news related to the company’s Givosiran, which received Breakthrough Therapy designation from the FDA for the prophylaxis of attacks in patients with acute hepatic porphyria. The designation is given to speed up the process of development and review of the drugs designed for treating serious ailments.
These positive news had positive impact on the company stock as its market price rose 31 percent in the past one month. The company stock is now almost 100 percent up on Year to Date basis while its 12 months gain stands at 18 percent. The stock is expected to keep up the momentum as the company also recently announced its new deal with the FDA in collaboration with The Medicines Company to address the issue of 18-month, pivotal phase 3 trial for Inclisiran. The company’s solid position was also highlighted by its quarterly earnings announcement which reported its quarterly at $19 million, up from $7.3 million it had reported for the corresponding quarter of the previous year, highlighting the company’s stronger liquidity position. The company also managed its R&D expenses better as the charge came down to $87 million. Down from $96.3 million it had spent a year back.
One of the biggest risk faced by the company is with regard to its operating results. For the first quarter, the company announced its quarterly GAAP loss at $107.3 million, or $1.25 per share on both a basic and diluted basis, up from a net loss of $103.0 million, or $1.21 per share on both a basic and diluted basis for the same period in the previous year.
Main upcoming catalyst is the announcement of top-line results from the APOLLO Phase 3 study of patisiran. The announcement is expected to be reported by September. The positive data is expected to provide boost to the company’s stock price.
John Maraganore, Ph.D.
Chief Executive Officer
Since 2002, John Maraganore has served as the CEO and a Director of Alnylam. Prior to Alnylam he served as an officer and a member of the management team for Millennium Pharmaceuticals, Inc. As Senior Vice President, Strategic Product Development for Millennium, he was responsible for the company’s product franchises in oncology, and cardiovascular, inﬂammatory, and metabolic diseases.
Chief Operating Officer
Yvonne brings 25 years of global experience in the pharmaceutical industry, where she has been in senior roles in research and development, strategy, and portfolio management.