Scilex Holding Announces Issuance of Halal Certification for its ZTlido® product by Circle H International, Inc.
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Insights
The receipt of Halal Certification for Scilex's ZTlido product represents a strategic move to penetrate markets with significant Muslim populations. The certification, which ensures that products comply with Islamic law, is particularly relevant for health care companies looking to expand in the Middle East and North Africa (MENA) region. This is an area where consumers place a high value on Halal compliance and it can be a differentiator in market acceptance.
The certification can potentially lead to increased market share and revenue for Scilex, as it opens up access to countries like the UAE and Saudi Arabia, which are known for their stringent regulatory environments. The emphasis on non-opioid, non-addictive pain management solutions aligns with global trends towards safer pain management therapies and could resonate well in these new markets. The Halal certification may also serve as a mark of quality and ethical production, which can enhance brand reputation and customer trust.
However, the actual impact on the company's financial performance will depend on the execution of market entry strategies, local partnerships and the ability to navigate complex regulatory landscapes. It is also essential to consider the competitive environment in these regions and whether there are existing players with established Halal-certified products.
Obtaining Halal Certification is a significant regulatory milestone for Scilex, as it indicates compliance with a set of standards that are critical for entering Islamic markets. The certification process often involves rigorous assessment of the production process, ingredients and supply chain to ensure they meet Islamic dietary laws. This can sometimes require changes to manufacturing processes or sourcing, which can have cost implications for the company.
For Scilex, the certification by Circle H International, a body recognized by prominent Islamic institutions, could facilitate smoother entry into MENA markets by potentially easing the regulatory approval process. It is indicative of the company's commitment to meeting diverse cultural and religious needs, which can be an advantage when dealing with health authorities in these regions.
From a regulatory perspective, the certification could also preempt certain barriers to market entry and may reduce the time to market for Scilex's products. However, the company must remain vigilant about maintaining the certification standards, as any deviation could lead to revocation of the certification and damage to the company's reputation.
The strategic focus on the UAE and Saudi Arabia as initial targets for Scilex's expansion is informed by the size and potential of these markets. Both countries have been investing heavily in healthcare infrastructure and are increasingly open to innovative medical solutions. The Halal Certification aligns with the cultural and religious practices in these regions and is likely a calculated move to appeal to local demographics.
Business development efforts will need to be culturally sensitive and tailored to the unique business environments of these countries. Partnerships with local entities could be key in navigating the business landscape and Scilex will need to assess whether its current business model is adaptable to the local context. For example, considerations around pricing, distribution channels and marketing strategies will be essential to capture the full potential of these markets.
It is worth noting that while the certification opens doors, sustained success will require ongoing engagement with local stakeholders, continuous market research and possibly even product adaptation to meet local preferences and regulatory requirements.
- The certification has the potential to open access to Islamic markets globally, expanding potential markets for Scilex’s innovative FDA approved non-opioid therapies and pipeline candidate products.
- The certification is an important prerequisite for health care and covers health and wellness as well as non-addictive pain management products.
- Announcement advances the global expansion strategy for Scilex with plans for growing its presence in the Middle East and North Africa region with an initial focus on the UAE and Saudi Arabia.
PALO ALTO, Calif., March 15, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced that it received Halal Certification of its commercial product ZTlido, indicating that ZTlido has undergone rigorous assessment to determine that it is permissible or acceptable in accordance with Islamic standards. The Halal certification was issued under the authority of Circle H International, Inc. (“Circle H”) and offers the Company the opportunity to provide ZTlido to Islamic markets globally. This announcement supports the global expansion strategy for Scilex, which Scilex anticipates will include a presence in the Middle East and North Africa (MENA) region with an initial priority focus on the UAE and Saudi Arabia.
“Obtaining the broadly inclusive Halal Certification is a critical and important milestone in Scilex’s plan to expand to potential Islamic markets for our innovative non-opioid non-addictive pain management therapeutic pipeline candidates and FDA approved products. With the global Muslim population representing over
Circle H issued the Halal Certification based on the global standards promulgated by its esteemed Circle H Sharia Advisory Council (the “Council”). Circle H and the Council are recognized and supported by prominent governmental and non-governmental organizations and Islamic universities. Religious leaders drawn from these prominent institutions sit on or advise Circle H and the Council, for the development and support of its Halal standards.
For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com.
For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com.
For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com.
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About Scilex Holding Company
Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and are dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system)
In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA™” or “SP-102”), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica for which Scilex has completed a Phase 3 study and has granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system)
Scilex Holding Company is headquartered in Palo Alto, California.
Forward-Looking Statements
This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the potential for the Halal Certification to expand access to Islamic markets globally and the impact it has on Scilex’s global expansion strategy, Scilex’s plans to focus on expanding in the UAE and Saudi Arabia, Scilex’s expectation to launch Gloperba® in the first half of 2024 and plans to initiate a Phase 2 clinical trial in 2024 for SP-104.
Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks associated with the unpredictability of trading markets and whether a market will be established for Scilex’s common stock; general economic, political and business conditions; risks related to COVID-19 (and other similar disruptions); the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks described in Scilex’s most recent periodic reports filed with the Securities and Exchange Commission, including Scilex’s Annual Report on Form 10-K for the year ended December 31, 2023, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law.
Contacts:
Investors and Media
Scilex Holding Company
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Palo Alto, CA 94303
Office: (650) 516-4310
Email: investorrelations@scilexholding.com
Website: www.scilexholding.com
SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned.
ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company.
Gloperba® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company.
ELYXYB® is a registered trademark owned by Scilex Holding Company.
All other trademarks are the property of their respective owners.
© 2024 Scilex Holding Company All Rights Reserved.
FAQ
What certification did Scilex Holding Company receive for its product ZTlido?
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