Even if Seelos' product candidates receive regulatory approval in the U.S., it may never receive approval or commercialize Seelos' products outside of the
In order to market any products outside of the U.S., Seelos must establish and comply with numerous and varying regulatory requirements of other countries
regarding safety and efficacy. Approval procedures vary among countries and can involve additional product testing and additional administrative review periods. The time required to obtain
approval in other countries might differ from that required to obtain FDA approval. The regulatory approval process in other countries may include all of the risks detailed above regarding FDA
approval in the U.S. as well as other risks. Regulatory approval in one country does not ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one
country may have a negative effect on the regulatory process in others. Failure to obtain regulatory approval in other countries or any delay seeking or obtaining such approval would impair
Seelos' ability to develop foreign markets for its product candidates.
Even if any of Seelos' product candidates receive regulatory approval, its product candidates may still face future development and regulatory
If any of Seelos' product candidates receive regulatory approval, the FDA, the EMA or comparable foreign authorities may still impose significant restrictions on
the indicated uses or marketing of the product candidates or impose ongoing requirements for potentially costly post-approval studies and trials. In addition, regulatory agencies subject a
product, its manufacturer and the manufacturer's facilities to continual review and periodic inspections. If a regulatory agency discovers previously unknown problems with a product, including
adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory agency may impose restrictions on that product, Seelos'
collaborators or Seelos, including requiring withdrawal of the product from the market. Seelos' product candidates will also be subject to ongoing FDA, the EMA or comparable foreign
authorities' requirements for the labeling, packaging, storage, advertising, promotion, record-keeping and submission of safety and other post-market information on the drug. If Seelos' product
candidates fail to comply with applicable regulatory requirements, a regulatory agency may:
- issue warning letters or other notices of possible violations;
- impose civil or criminal penalties or fines or seek disgorgement of revenue or profits;
- suspend any ongoing clinical trials;
- refuse to approve pending applications or supplements to approved applications filed by Seelos or Seelos' collaborators;
- withdraw any regulatory approvals;
- impose restrictions on operations, including costly new manufacturing requirements, or shut down Seelos' manufacturing operations; or
- seize or detain products or require a product recall.
The FDA, the EMA and comparable foreign authorities actively enforce the laws and regulations prohibiting the promotion of off-label uses.
The FDA, the EMA and comparable foreign authorities strictly regulate the promotional claims that may be made about prescription products, such as Seelos'
product candidates, if approved. In particular, a product may not be promoted for uses that are not approved by the FDA, the EMA or comparable foreign authorities as reflected in the product's
approved labeling. If Seelos receive marketing approval for its product candidates for Seelos' proposed indications, physicians may nevertheless use Seelos' products for their patients in a
manner that is inconsistent with the approved label, if the physicians personally believe in their professional medical judgment that Seelos' products could be used in such manner. However, if
Seelos is found to have promoted its products for any off-label uses, the federal government could levy civil, criminal or administrative penalties, and seek fines against Seelos. Such
enforcement has become more common in the industry. The FDA, the EMA or comparable foreign authorities could also request that Seelos enter into a consent decree or a corporate integrity
agreement, or seek a permanent injunction against Seelos under which specified promotional conduct is monitored, changed or curtailed. If Seelos cannot successfully manage the promotion
of its product candidates, if approved, Seelos could become subject to significant liability, which would materially adversely affect Seelos' business, financial condition and results of
If Seelos' competitors have product candidates that are approved faster, marketed more effectively, are better tolerated, have a more favorable safety
profile or are demonstrated to be more effective than Seelos', Seelos' commercial opportunity may be reduced or eliminated.
The biopharmaceutical industry is characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products. While
Seelos believes that its technology, knowledge, experience and scientific resources provide it with competitive advantages, Seelos faces potential competition from many different sources,
including commercial biopharmaceutical enterprises, academic institutions, government agencies and private and public research institutions. Any product candidates that Seelos successfully
develops and commercializes will compete with existing therapies and new therapies that may become available in the future.