Alnylam Adds Office Space, Employees Ahead of Aug. 11 PDUFA Date for Patisiran

Alnylam John Maraganore

After a slight delay, things remain on schedule for Alnylam Pharmaceuticals’ new $200 million manufacturing facility. The company expects the site to open in late 2019, which could follow regulatory approval of patisiran, its RNAi treatment for Hereditary ATTR Amyloidosis.  

As the Cambridge, Mass.-based company remains upbeat about potential U.S. Food and Drug Administration approval of patisiran, the company has been rapidly expanding. In addition to the 200,000 square-foot manufacturing facility under construction, the company has acquired additional square footage around the Cambridge area. The Boston Business Journal reported this week that Alnylam has added additional office space in the crowded Kendall Square area of Cambridge, including a 72,000 square-foot space on Kendall Street and space on Main Street.

The additional areas will be necessary to provide space for the company’s rapidly expanding headcount. Alnylam has a goal of having approximately 1,500 employees by 2020. When Alnylam broke ground on its new manufacturing space two years ago, company officials told BioSpace that at least 150 people would be employed at that site.

Alnylam has been steadily growing. The Boston Business Journal noted that over the past few months Alnylam has reached about 800 employees, more than halfway to its 1,500 goal. About 50 of those employees were added over the past few months, the Journal said.

The addition of space and headcount will help Alnylam meet its goals of being able to field new RNAi treatments every year for the next four years. Company spokesperson Christine Lindenboom told the Journal that Alnylam has four other RNAi therapies already involved in or beginning to be involved in Phase III clinical trials. That’s if each trial goes well, that could set the stage for one new approved treatment each year, Lindenboom said.

The first one could be patisiran. The FDA could approve the RNA treatment in less than a week. The regulatory agency set a PDUFA date of Aug. 11. The FDA accepted the New Drug Application for patisiran in February, along with a priority review status, which would expedite a drug review. If approved, patisiran will be marketed as Onpattro. In July patisiran received positive support from Europe’s Committee for Medicinal Products for Human Use.

Following patisiran, Alnylam could be looking at potential approval of givosiran for the treatment of acute hepatic porphyrias next year and three potential therapies in 2020, lumasiran, fitusiran, and inclisiran, The Motley Fool reported Tuesday. An interim Phase III analysis of givosiran is anticipated in the early fall. The Fool noted that if data is positive, it could support a potential NDA next year.

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