AL Nylam PHARM

Artificial Learning

Nylam

2020

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Alnylam's Response to COVID-19

March 30, 2020

Alnylam Pharmaceuticals

Updated July 17, 2020

The COVID-19 pandemic is having a significant impact on people and communities all over the world and will continue to do so for an indefinite period. At Alnylam, we’re closely monitoring developments and guidance from governments and health authorities on a daily basis. We are making adjustments to our operations as needed to support the health and safety of our employees and partners around the globe while continuing to provide the best possible support for the patient communities, health care providers and caregivers we serve.

We are working on a potential new treatment option to combat SARS-CoV-2, the virus that causes the COVID-19 disease, with our partner Vir Biotechnology. Click here for more details.

Additionally, we have joined forces with 19 other leading life sciences companies to form the COVID R&D Alliance, which is committed to working together to identify and accelerate promising therapeutic candidates for COVID-19 and its related symptoms. 

Protecting Our Global Workforce

We understand that our >1,400 employees are our greatest asset and have taken several steps to protect them and their families. We have implemented a global work from home policy for all employees who are able to perform their duties remotely. We are working closely with local governments and health authorities to ensure that our employees who support critical business functions in our laboratories, drug manufacturing and other facilities are able to continue our efforts in bringing medicines to patients with serious conditions. We also have in place a comprehensive employee assistance program that is designed to support our employees' health and well-being during this time, and we're supporting employees with flexible solutions to assist them during school shutdowns.

Minimizing the Spread of COVID-19

In addition to our global work from home policy, we have taken a number of steps to do our part to help minimize the spread of COVID-19. In February, we implemented travel restrictions for all employees, which have been expanded to cover all non-essential travel. Internal meetings are now conducted using video conferencing technology. Additionally, our customer-facing employees in most markets have moved to virtual interactions with healthcare providers, administrators, patients, payers, regulators and other government employees.

Ensuring a Reliable Supply of our Medicines

Our supply chain operations continue to deliver for our commercial and investigational medicines. We are continually monitoring our drug manufacturing operations, supply chain and partner operations to understand and take steps to mitigate any potential impact of COVID-19 on our ability to deliver a reliable supply of both our commercially approved and investigational medicines. Currently we have sufficient inventory of drug and raw materials to meet our projected demand plus appropriate safety stock and don't at this time anticipate any significant impact from COVID-19 on the manufacture of our commercial products or product candidates in clinical studies. Ensuring the quality and safety of our medicines remains a top priority. 

Supporting our Clinical Trials

The potential impact of COVID-19 on clinical trials operations is a dynamic situation that we’re closely monitoring. We are proactively working with our clinical trials sites and CRO partners to enable studies to continue with as little interruption as possible. For questions regarding our clinical trials, in the US, please call 877.ALNYLAM (877.256.9526) and in the EU, please call +31 20 369 7861 or email us at clinicaltrials@alnylam.com.

Supporting Patients & HCPs

Our teams in countries around the world are doing all they can to help patients, families, caregivers, and healthcare providers who need support related to ONPATTRO or GIVLAARI in those countries where GIVLAARI is available commercially or through expanded/managed access. In the U.S., Alnylam Assist – our U.S. patient services program, is maintaining regular business hours and can be reached at alnylamassist.com or by calling 833.256.2748. Outside of the U.S., please email us at medinfo@alnylam.com or from within Europe, call +31 20 369 7861, from Canada, call 877.356.9526, from Japan, call 03-4520-8966 and from Brazil, call 0800-0474597.

Healthcare providers and patients who need assistance with Alnylam Act, our 3rd party genetic testing and counseling program available in the U.S., Canada and Brazil, can find more information here.

Supporting our Communities

We are committed to supporting the communities in which we live and work as they respond to the COVID-19 pandemic. Alnylam has made monetary donations to the Boston Resiliency Fund and the Life Sciences Cares COVID-19 Response Fund and is joining with other life sciences companies in making donations of personal protective equipment (PPE), disposable lab coats and certain lab supplies to Boston-area hospitals through MassBio’s Massachusetts Life Sciences Emergency Supply Hub effort and also through the efforts of the Biotechnology Innovation Organization (BIO). At the same time, we are working with our regional leads to determine how we can support regional and local efforts.

About our SARS-CoV-2 Collaboration with Vir Biotech

 

During a moment like this, it’s incumbent upon all of us in the global life sciences community to harness the full potential of our technologies, pipelines, people and products to assess how we can address public health needs. Based on our understanding of SARS-CoV-2, the features of Alnylam’s RNAi therapeutics technology, and our existing work in novel forms of drug delivery, we believe that RNAi therapeutics represent a promising approach for targeting coronaviruses, like SARS-CoV-2. – John Maraganore, CEO of Alnylam

On March 4, 2020, we announced with our partner Vir Biotechnology, Inc. an expansion of our existing collaboration in infectious diseases to include the development and commercialization of RNAi therapeutics targeting SARS-CoV-2, the virus that causes the disease COVID-19. Under the agreement, the companies are utilizing Alnylam’s recent advances in lung delivery of novel conjugates of siRNA – the molecules that mediate RNAi – together with Vir’s infectious disease expertise and established capabilities, to bring forward one or more siRNA development candidiates to treat SARS-CoV-2 and potentially other coronaviruses. The collaboration will focus on development of siRNAs that Alnylam recently identified that target highly conserved regions of the coronavirus RNA genome.

Early work by Alnylam scientists in January and February allowed us to design and synthesize over 350 siRNAs targeting all available SARS-CoV and SARS-CoV-2 genomes, which will be screened in in vitro potency assays. Potent siRNA lead candidates will be further evaluated by scientists at Vir for in vitro and in vivo anti-viral activity, leading to the selection of a development candidate (DC). Read more here.

On April 2, 2020, we announced a further expansion of our partnership with Vir to include up to three additional targets focused on host factors for SARS-CoV-2, including ACE2 and TMPRSS2, both of which are considered critical for viral entry, with the potential for an additional host target to emerge from Vir's functional genomics work. Read more here.

On May 4, 2020, we announced with Vir, the selection of a development candidate (DC) for ALN-COV (also referred to as VIR-2307), an investigational RNAi therapeutic targeting the SARS-CoV-2 genome. We plan to meet with the U.S. Food and Drug Administration (FDA) and other regulatory authorities soon to discuss a potential accelerated path for filing an Investigational New Drug (IND) or IND equivalent application at or around year-end 2020, less than a year since program initiation. We plan to advance ALN-COV/VIR-2703 as an inhalational formulation for the potential treatment and/or prevention of COVID-19. Read more here.

Business Outlook

We remain committed to continuing to operate our business to serve the needs of our patients and advance our mission to build a top-tier, independent biopharmaceutical company founded on RNAi. Given the fluidity of the COVID-19 pandemic however, we do not yet know the potential impact of COVID-19 on our business operations. We will continue to monitor the situation closely and work diligently with our partners and stakeholders to continue supporting patient access to our approved medicines, advancing our product candidates under regulatory review as well as our clinical studies to the extent safe to do so for patients, caregivers and HCPs, and ensuring the continuity of our manufacturing and supply chain. We plan to provide an update on our business and financial condition on our first quarter financial results conference call.

Media Inquiries

Please contact Christine Lindenboom, SVP Investor Relations and Corporate Communications at +1-617-682-4340

Safe Harbor

This business update includes forward-looking statements based on our current expectations and beliefs that are subject to risks and uncertainties. Our actual results may differ materially. Please consult the risk factors section of our SEC filings.http

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