Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 48

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 48
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 priority review voucher, that application must be reviewed by FDA no later than 6 months after receipt.40 This guarantees
a much more rapid review by FDA compared to the standard review time.

Tropical disease PRVs were created under the
FDAAA to encourage pharmaceutical companies to develop treatments for specific neglected tropical diseases. As defined by the statute,
tropical diseases refer to certain “infectious disease[s] for which there is no significant market in developed nations and that
disproportionately affects poor and marginalized populations.”41 Because tropical diseases occur rarely in the United
States, obtaining approval from the FDA for treating these diseases would normally be unprofitable for pharmaceutical companies due to
the limited domestic market and the scope and significant financial costs of the post-marketing requirements imposed by FDA. Congress
intended to incentivize companies to turn their attentions to tropical diseases by providing a PRV to those companies that obtained approval
from FDA for a tropical disease drug product, and the granted PRV could then be sold to another company for money.

A PRV is an extremely valuable property interest.
For example, Rhythm Pharmaceutical, Inc. announced in 2021 that it had sold a PRV for $100,000,000.42

Accelerated Approval Pathway 

The FDA may grant accelerated approval to a drug
for a serious or life-threatening condition that provides meaningful therapeutic advantage to patients over existing treatments based
upon a determination that the drug has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit. The FDA
may also grant accelerated approval for such a condition when the product has an effect on an intermediate clinical endpoint that can
be measured earlier than an effect on irreversible morbidity or mortality (“IMM”), and that is reasonably likely to predict
an effect on IMM or other clinical benefit, taking into account the severity, rarity or prevalence of the condition and the availability
or lack of alternative treatments. Drugs granted accelerated approval must meet the same statutory standards for safety and effectiveness
as those granted traditional approval.

    40
    21 U.S.C. § 360n(a)(1).

    41
    21 U.S.C. § 360n(a)(3).

    42
    Ben Adams, Newly acquired Alexion pays $100M for Rhythm’s
    speedy review voucher, Fierce Biotech (Jan 6, 2021, 10:23 AM), available at https://www.fiercebiotech.com/biotech/newly-acquired-