RNAi specialist Alnylam Pharmaceuticals touted the potential of its long-term strategy on a call with investors to discuss its first quarter earnings Thursday afternoon while admitting that lack of product uptake and compliance due to COVID-19 played a role in the 6% decrease in reported revenues.
“The first RNAi therapeutic targeting a CNS disorder, ALN-APP, has entered Phase I, a very exciting milestone for our platform,” Alnylam CEO Yvonne Greenstreet told investors and media during the call. ALN-APP is being studied in patients with early-onset Alzheimer’s disease. Greenstreet added that initial data from this study are anticipated in late 2022.
Greenstreet went on to discuss what she said are the company’s three key growth drivers. The first, “is the potential near-term expansion of our ATTR (transthyretin-mediated (ATTR) amyloidosis) franchise, where we aim to become the global leader in delivering impactful, highly differentiated medicines for patients.”
Greenstreet noted the second key driver as the expansion from targeting only rare diseases with RNAi therapeutics to also targeting prevalent diseases. The third, she said, is "sustainable innovation" and the ability to find "new and validated targets" for pipeline expansion.
Alnylam presented positive 18-month data from the HELIOS-A Phase III study of Vutrisiran, a subcutaneously administered investigational RNAi therapeutic, in hereditary TTR (hATTR) amyloidosis with polyneuropathy. Earlier this month, Alnylam announced that the PDUFA date for vutrisiran in this indication had been extended by three months to July 14th in order to allow for pending inspection classification at a third-party secondary packaging and labeling facility. This, the company said, was to avoid the likelihood that the U.S. Food and Drug Administration would issue Alnylam a complete response letter.
On the call, Alnylam was quick to reiterate that the delay was not related to any questions of safety or efficacy with vutrisiran itself.
Alnylam announced another delay Thursday, that of the development of another asset, zilebesiran. The company attributed this delay to a much more sinister reason – the invasion of Ukraine, now heading into its third month and causing disruption on a multi-faceted and global scale.
Zilebesiran is being studied in the Phase II KARDIA-1 monotherapy study for the treatment of mild-to-moderate hypertension.
“We announced this morning that we are experiencing enrollment [delays] in part due to impacts of the situation in Ukraine as well as the ongoing pandemic. We're expanding the geographic footprint of the study, and are also streamlining certain aspects of the protocol to facilitate enrollment,” the company said during the call, adding that, as a result, Alnylam now expects enrollment in the study to be complete in early 2023 with topline results expected around the middle of next year.
Elsewhere in the pipeline, Alnylam announced the initiation of a Phase I study of ALN-XDH in patients with gout. As with the Phase I study of ALN-APP, results for this indication are also expected in late 2022.
As for the performance of AbbVie’s established products, Onpattro (patisiran) which treats polyneuropathy caused by hATTR, saw global net product revenues of $137 million in Q1, which represents a slight 1% decrease compared with the previous quarter. This made up a sizeable chunk of the company’s overall $187 million in Q1 revenue, with Givlaari (givosiran) bringing in $35 million (a decrease of 13% from Q4), and Oxlumo (lumasiran) adding another $15 million.
Alnylam also modified its 2022 net product revenue guidance from between $900 million and $1 billion to between $870 and $930 million.
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