SYROS PHARMACEUTICALS, INC. Item 8.01 Other Events.
We face certain risks related to the development, marketing and commercialization of SY-2101, which could result in substantial harm to our business.
In
If we are to receive FDA approval for SY-2101 prior to
We are developing SY-2101 as an alternative to Trisenox®, an intravenously
administered arsenic trioxide product. The
In assessing whether a sponsor has demonstrated that its candidate product provides a "major contribution to patient care" when compared to the drug product with orphan drug exclusivity, the FDA will evaluate the question on a case by case basis and may in appropriate circumstances consider such factors as convenience of treatment location, duration of treatment, patient comfort, reduced treatment burden, advances in ease and comfort of drug administration, longer periods between doses, and the potential for self-administration of the product. Such demonstration to the satisfaction of the FDA is difficult to establish with limited precedents.
SY-2101 was granted an orphan drug designation by the FDA for the treatment of
APL in
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the burden on the healthcare system in delivery of life-saving medicines to patients in need. We intend to seek to demonstrate to the FDA that SY-2101 is "clinically superior" to Trisenox constituting a "major contribution to patient care" within the meaning of the FDA regulations and guidance. However, there can be no assurance that we will be successful in these efforts and, if we are not, the FDA will not approve SY-2101 until orphan drug exclusivity expires for Trisenox. Any failure to demonstrate "clinical superiority" for SY-2101 could prevent or delay FDA approval or cause SY-2101 to fail to receive or maintain orphan drug exclusivity status, which could have a material adverse effect on our business, prospects, financial condition and results of operations.
We do not have composition of matter patent protection with respect to the active pharmaceutical ingredient of SY-2101.
We do not have composition of matter patent protection for arsenic trioxide, the active pharmaceutical ingredient of SY-2101. Our competitors may be able to offer and sell products so long as these competitors do not infringe any other patents that we hold, including patents with claims directed to the formulation of SY-2101 drug product and/or methods of manufacture of SY-2101. In general, method patents are more difficult to enforce than composition of matter patents because, for example, of the risks that the FDA may approve an oral formulation of arsenic trioxide that is not covered by our formulation or manufacturing method patents. FDA approval of an oral formulation of arsenic trioxide that is not covered by our patents would limit our ability to generate revenue from the sale of SY-2101, if approved for commercial sale.
We, or any future collaborators, may not be able to obtain orphan drug designation or orphan drug exclusivity for our product candidates and, even if we do, that exclusivity may not prevent the FDA or the EMA from approving competing products.
Regulatory authorities in some jurisdictions, including
Even if we, or any future collaborators, obtain orphan drug designation for a
product candidate, we, or they, may not be able to obtain orphan drug
exclusivity for that product candidate. Generally, a product with orphan drug
designation only becomes entitled to orphan drug exclusivity if it receives the
first marketing approval for the indication for which it has such designation,
in which case the FDA or the
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Even if we, or any future collaborators, obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different drugs can be approved for the same condition and the same drug can be approved for different conditions. Even after an orphan drug is approved, the FDA can subsequently approve the same drug for the same condition if the FDA concludes that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care.
For example, even if SY-2101 were to be approved and receive orphan drug
exclusivity, that would not preclude a competitor from asserting a separate
"major contribution to patient care" argument based on a showing of clinical
superiority to SY-2101 due to, for example, a change in an inactive ingredient
that results in a more favorable profile or a statistically significant
improvement in an important safety parameter. In addition, since healthcare
providers can prescribe approved drug products for uses outside of their
approved labeling, it is possible that another drug product could be approved
for a different indication, such as relapsed/refractory APL, and be used "off
label" in the up-front setting. On
Our internal computer systems, or those of any collaborators or contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product development programs.
Despite the implementation of security measures and certain data recovery measures, our internal computer systems and those of our current and any future collaborators and other contractors or consultants are vulnerable to damage from cyber-attacks, computer viruses, unauthorized access, sabotage, natural disasters, terrorism, war and telecommunication and electrical failures. We have experienced, and may experience in the future, security breaches of our information technology systems. Any system failure, accident or security breach that causes interruptions in our operations, for us or those third parties with which we contract, could result in a material disruption of our product development programs and our business operations, whether due to a loss of our trade secrets or other proprietary information or other similar disruptions, in addition to possibly requiring substantial expenditures of resources to remedy. For example, the loss of clinical trial data from an ongoing, completed or future clinical trial could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach results in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we may incur liabilities, our competitive position could be harmed and the further development and commercialization of our product candidates may be delayed. In addition, we may not have adequate insurance coverage to provide compensation for any losses associated with such events.
We could be subject to risks caused by misappropriation, misuse, leakage, falsification or intentional or accidental release or loss of information maintained in the information systems and networks of our company, including personal information of our employees. In addition, outside parties have attempted, and may in the future attempt, to penetrate our systems or those of our vendors or fraudulently induce our employees or employees of our vendors to disclose sensitive information to gain access to our data. Like other companies, we may experience threats to our data and systems, including malicious codes and viruses, and other cyber-attacks. The number and complexity of these threats
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continue to increase over time. If a material breach of our security or that of our vendors occurs, the market perception of the effectiveness of our security measures could be harmed, we could lose business and our reputation and credibility could be damaged. We could be required to expend significant amounts of money and other resources to repair or replace information systems or networks. Although we develop and maintain systems and controls designed to prevent these events from occurring, and we have a process to identify and mitigate threats, the development and maintenance of these systems, controls and processes is costly and requires ongoing monitoring and updating as technologies change and efforts to overcome security measures become more sophisticated. Moreover, despite our efforts, the possibility of these events occurring cannot be eliminated entirely.
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