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FDA approves QALSODY™ (tofersen) as the first treatment targeting a genetic
cause of ALS

[423]Ionis logo with tagline (PRNewsfoto/Ionis Pharmaceuticals, Inc.)
__________________________________________________________________

News provided by
[424]Ionis Pharmaceuticals, Inc.

Apr 25, 2023, 19:10 ET

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* Accelerated approval marks a scientific advancement in treatment of
superoxide dismutase 1 (SOD1)-amyotrophic lateral sclerosis (ALS)
* Approval based on reduction of neurofilament, a biomarker
associated with neuronal damage in ALS
* QALSODY joins SPINRAZA^® as Ionis-discovered medicine approved for
treatment of a rare and fatal neurodegenerative disease

CARLSBAD, Calif., April 25, 2023 /PRNewswire/ -- [425]Ionis
Pharmaceuticals, Inc. (Nasdaq: [426]IONS) today announced that its
partner Biogen has received U.S. Food and Drug Administration (FDA)
approval of QALSODY™ (tofersen) 100 mg/15mL injection for the treatment
of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in
the superoxide dismutase 1 (SOD1) gene. This indication is approved
under accelerated approval based on a reduction in plasma neurofilament
light chain (NfL) observed in patients treated with QALSODY. Continued
approval for this indication may be contingent upon verification of
clinical benefit from ongoing trial(s). The ongoing Phase 3 ATLAS study
of tofersen in people with presymptomatic SOD1-ALS will serve as the
confirmatory study. QALSODY is the first and only approved treatment to
target a genetic cause of ALS and the latest Ionis-discovered medicine
to gain market approval.

Neurofilaments are proteins that are released from neurons when they
are damaged, making them a marker of neurodegeneration.

"Today's approval of QALSODY represents a scientific advancement for
the ALS community. We thank the people with SOD1-ALS whose
participation in the clinical studies made this day possible. We are
proud of the Ionis scientists whose dedication made the discovery of
this medicine possible, and we are appreciative of our partners at
Biogen for their ongoing commitment to ALS," said Brett P. Monia,
Ph.D., chief executive officer of Ionis. "The QALSODY approval
highlights our significant progress advancing RNA-based treatments
targeting severe neurological diseases."

Warnings and precautions associated with QALSODY were serious
neurologic events, including myelitis and or radiculitis; papilledema
and elevated intracranial pressure; and aseptic meningitis. If symptoms
consistent with myelitis, radiculitis papilledema, elevated
intracranial, or aseptic meningitis develop, diagnostic workup and
treatment should be initiated according to the standard of care.
Management may require interruption or discontinuation of QALSODY. The
most common adverse reactions that occurred in ≥10% of QALSODY treated
participants and more than the placebo arm were pain, fatigue,
arthralgia, CSF white blood cell increased, and myalgia.

The efficacy of QALSODY was assessed in a 28-week randomized,
double-blind, placebo-controlled clinical study in patients 23 to 78
years of age with weakness attributable to ALS and a SOD1 mutation
confirmed by a central laboratory. One hundred eight (108) patients
were randomized 2:1 to receive treatment with either QALSODY 100 mg
(n=72) or placebo (n=36) for 24 weeks (3 loading doses followed by 5
maintenance doses). Concomitant riluzole and/or edaravone use was
permitted for patients and at baseline 62% of patients were taking
riluzone, and 8% of patients were taking edaravone.

Over 28 weeks in VALOR, participants in the primary analysis population
(n=60) treated with QALSODY experienced less decline from baseline as
measured by the Revised Amyotrophic Lateral Sclerosis Functional Rating
Scale (ALSFRS-R) compared to placebo, though the results were not
statistically significant (QALSODY-placebo adjusted mean difference
[95% CI]: 1.2 [-3.2, 5.5]). In the overall intent-to-treat population
(n=108), QALSODY-treated participants experienced a 55% reduction in
plasma NfL compared to a 12% increase in placebo-treated participants
(difference in geometric mean ratios for QALSODY to placebo: 60%;
nominal p<0.0001). Additionally, levels of CSF SOD1 protein, an
indirect measure of target engagement, were reduced by 35% in the
QALSODY-treated group compared to 2% in the corresponding placebo group
(difference in geometric mean ratios for QALSODY to placebo: 34%;
nominal p<0.0001).

At an interim analysis at 52 weeks of participants who had completed
VALOR and enrolled in an open-label extension (OLE) study, reductions
in NfL were seen in participants previously receiving placebo and who
initiated QALSODY in the OLE, similar to the reductions seen in
participants treated with QALSODY in VALOR. Earlier initiation of
QALSODY compared to placebo/delayed-start of QALSODY was associated
with trends for reduction in decline on measures of clinical function
(ALSFRS-R), respiratory strength (slow vital capacity
percent-predicted), and muscle strength (hand-held dynamometry
megascore), though they were not statistically significant. QALSODY was
also associated with a non-statistically significant trend towards
reduction of the risk of death or permanent ventilation. These
exploratory analyses should be interpreted with caution given the
limitations of data collected outside of controlled study, which may be
subject to confounding.

The approval of QALSODY was supported by 12-month integrated results
from VALOR and its OLE comparing earlier initiation of tofersen (at the
start of VALOR) to delayed initiation of tofersen (six months later, in
the OLE), that were published in The New England Journal of Medicine.

What is QALSODY?

QALSODY™ (tofersen) is a prescription medicine used to treat adults
with amyotrophic lateral sclerosis (ALS) associated with a mutation in
the superoxide dismutase 1 (SOD1) gene. This indication is approved
under accelerated approval based on reduction in plasma neurofilament
light chain (NfL) observed in patients treated with QALSODY. Continued
approval for this indication may be contingent upon verification of
clinical benefit in confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

What is the most important information that I should know about
QALSODY?

QALSODY can cause serious side effects, including:

Inflammation of the spinal cord (myelitis) and/ or irritation of the
nerve roots (radiculitis), including serious cases, have been reported
in patients treated with QALSODY. Contact your healthcare provider to
learn more about symptoms associated with myelitis or radiculitis, and/
or if you believe you are experiencing either of these
conditions. QALSODY may need to be interrupted or discontinued.

Swelling of the optic nerve (papilledema) and increased pressure inside
the skull (elevated intracranial pressure), including serious cases,
have been reported in patients treated with QALSODY. Contact your
healthcare provider to learn more about symptoms associated with
papilledema or elevated intracranial pressure, and/ or if you believe
you are experiencing either of these conditions.

Inflammation of the brain linings (aseptic meningitis), including
serious cases, have been reported in patients treated with QALSODY.
Contact your healthcare provider to learn more about symptoms
associated with aseptic meningitis, and/ or if you believe you are
experiencing this condition.

What should I tell my HCP before I start using QALSODY?

Before taking QALSODY, tell your healthcare provider if you are
pregnant, plan to become pregnant, or are breastfeeding or plan to
breastfeed.

What are the possible side effects of QALSODY?

The most common adverse reactions reported in patients treated with
QALSODY were pain (back pain, pain in arms or legs), feeling tired,
muscle and joint pain and increased white blood cell count in the
cerebrospinal fluid (CSF).

This information is not intended to replace discussions with your
healthcare provider.

These are not all the possible side effects of QALSODY. Please talk to
your healthcare provider if you experience any of these symptoms, or
other new symptoms that concern you.

Call your doctor for medical advice about side effects. You may report
side effects to FDA at 1-800-FDA-1088.

Please see full [427]Prescribing Information.

For more details on QALSODY, visit [428]www.QALSODY.com.

About QALSODY™ (tofersen)

QALSODY is an antisense oligonucleotide (ASO) designed to bind to SOD1
mRNA to reduce SOD1 protein production. QALSODY is indicated for the
treatment of ALS in adults who have a mutation in the SOD1 gene in the
U.S. This indication is approved under accelerated approval based on
reduction in plasma NfL observed in patients treated with QALSODY.
Continued approval for this indication may be contingent upon
verification of clinical benefit in confirmatory trial(s). QALSODY is
administered intrathecally as three loading doses administered at
14-day intervals followed by maintenance doses administered once every
28 days thereafter. In people with SOD1-ALS, mutations in their SOD1
gene cause their bodies to create a toxic misfolded form of SOD1
protein. This toxic protein causes motor neurons to degenerate,
resulting in progressive muscle weakness, loss of function, and
eventually, death.

Biogen licensed tofersen from Ionis under a collaborative development
and license agreement.

In addition to the ongoing OLE of VALOR, QALSODY is being studied in
the Phase 3, randomized, placebo-controlled ATLAS study to evaluate
whether QALSODY can delay clinical onset when initiated in
presymptomatic individuals with a SOD1 genetic mutation and biomarker
evidence of disease activity (elevated plasma NfL). The primary
efficacy endpoint is the proportion of participants with emergence of
clinically manifest ALS. ATLAS is currently more than 50 percent
enrolled with clinical trial sites in 14 countries worldwide with an
estimated primary completion date in 2026. More details about ATLAS
(NCT04856982) can be found at [429]clinicaltrials.gov.

About Amyotrophic Lateral Sclerosis and SOD1-ALS

Amyotrophic lateral sclerosis (ALS) is a rare, progressive and fatal
neurodegenerative disease that results in the loss of motor neurons in
the brain and the spinal cord that are responsible for controlling
voluntary muscle movement. People with ALS experience muscle weakness
and atrophy, causing them to lose independence as they steadily lose
the ability to move, speak, eat, and eventually breathe. Average life
expectancy for people with ALS is three to five years from time of
symptom onset.

Multiple genes have been implicated in ALS. Genetic testing helps
determine if a person's ALS is associated with a genetic mutation, even
in individuals without a known family history of the disease.
Currently, there are no genetically targeted treatment options for ALS.
SOD1-ALS is diagnosed in approximately 2% of all ALS cases, impacting
about 330 people in the United States. While there are medications
approved for broad ALS, no available treatments target a genetic
mutation associated with ALS. Approximately 5-10% of people with ALS
are thought to have a genetic form of the disease; however, they may
not have a known family history of the disease.

About Ionis' Neurology Franchise

Ionis' neurology franchise addresses all major brain regions and
central nervous system cell types and currently has three Phase 3
studies ongoing with 12 therapies in clinical development, several of
which Ionis plans to commercialize directly. Ionis is discovering and
developing potential treatments for many neurological diseases for
which there are few or no disease modifying treatments, including
common diseases like Alzheimer's and Parkinson's as well as rare
diseases such as amyotrophic lateral sclerosis (ALS) and Alexander
disease. Ionis has discovered and developed three commercially
available neurological disease medicines, including the first approved
treatment for spinal muscular atrophy, a medicine to treat hereditary
transthyretin-mediated amyloid polyneuropathy (ATTRv-PN), and now
QALSOLDY for SOD1-ALS.

About Ionis Pharmaceuticals, Inc.

For more than 30 years, Ionis has been a leader in RNA-targeted
therapy, pioneering new markets and changing standards of care with its
novel antisense technology. Ionis currently has three marketed
medicines and a promising late-stage pipeline highlighted by
cardiovascular and neurological franchises. Our scientific innovation
began and continues with the knowledge that sick people depend on us,
which fuels our vision to become the leader in genetic medicine,
utilizing a multi-platform approach to discover, develop and deliver
life-transforming therapies.

To learn more about Ionis visit [430]www.ionispharma.com and follow us
on Twitter @ionispharma.

Ionis' Forward-looking Statement

This press release includes forward-looking statements regarding Ionis'
business and the therapeutic and commercial potential of QALSODY
(tofersen), Ionis' technologies and Ionis' other products in
development. Any statement describing Ionis' goals, expectations,
financial or other projections, intentions or beliefs is a
forward-looking statement and should be considered an at-risk
statement. Such statements are subject to certain risks and
uncertainties including those inherent in the process of discovering,
developing and commercializing medicines that are safe and effective
for use as human therapeutics, and in the endeavor of building a
business around such medicines. Ionis' forward-looking statements also
involve assumptions that, if they never materialize or prove correct,
could cause its results to differ materially from those expressed or
implied by such forward-looking statements. Although Ionis'
forward-looking statements reflect the good faith judgment of its
management, these statements are based only on facts and factors
currently known by Ionis. As a result, you are cautioned not to rely on
these forward-looking statements. These and other risks concerning
Ionis' programs are described in additional detail in Ionis' annual
report on Form 10-K for the year ended Dec. 31, 2022, which is on file
with the Securities and Exchange Commission. Copies of this and other
documents are available from the Company.

In this press release, unless the context requires otherwise, "Ionis,"
"Company," "we," "our" and "us" all refer to Ionis Pharmaceuticals and
its subsidiaries.

Ionis Pharmaceuticals^® is a registered trademark of Ionis
Pharmaceuticals.

SOURCE Ionis Pharmaceuticals, Inc.
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