AXSM
Axsome Therapeutics, INC
NASDAQ
8-K: Axsome Therapeutics Settles Sunosi Patent Litigation with Unichem, Generic Entry Delayed Until 2042
Sentiment:
Settlement Announcement
5 June 2024 7:38 AM
Axsome Therapeutics has reached a settlement with Unichem Laboratories, delaying the launch of a generic version of Sunosi until at least June 30, 2042.
Delay expected
The settlement delays the entry of a generic version of Sunosi until at least June 30, 2042.
Summary
- Axsome Therapeutics has settled a patent litigation case with Unichem Laboratories regarding its product Sunosi.
- The settlement allows Unichem to launch a generic version of Sunosi no earlier than June 30, 2042.
- This date could be extended further due to potential pediatric exclusivity.
- The settlement agreement is subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice.
- Axsome has similar patent litigation pending against other parties.
Sentiment
Score: 7
Explanation: The settlement is a positive development for Axsome as it delays generic competition for Sunosi, but the long-term impact is uncertain and the company still faces other risks.
Positives
- The settlement delays the entry of a generic version of Sunosi until at least June 30, 2042, providing Axsome with continued market exclusivity for a significant period.
- The potential for pediatric exclusivity could further extend the exclusivity period for Sunosi.
Negatives
- The settlement acknowledges that a generic version of Sunosi will eventually enter the market, albeit not until 2042.
- Axsome still faces ongoing patent litigation with other parties regarding Sunosi.
Risks
- The settlement is subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice, which could potentially impact the agreement.
- Ongoing patent litigation with other parties could lead to further challenges to Sunosi's market exclusivity.
- The company's future success depends on the continued commercial success of Sunosi and Auvelity, as well as the success of its clinical trials and regulatory approvals for other product candidates.
Future Outlook
The company's future success depends on the continued commercial success of Sunosi and Auvelity, as well as the success of its clinical trials and regulatory approvals for other product candidates. The company also faces risks related to ongoing patent litigation and regulatory reviews.
Management Comments
- Axsome is committed to developing products that meaningfully improve the lives of patients and provide new therapeutic options for physicians.
Industry Context
This settlement is a common occurrence in the pharmaceutical industry, where companies seek to protect their intellectual property through patent litigation. The settlement delays generic entry, which is a key factor in maintaining revenue streams for branded drugs.
Comparison to Industry Standards
- Patent settlements in the pharmaceutical industry often involve delayed generic entry, with the brand-name company seeking to maximize its market exclusivity period.
- The 2042 date is a relatively long delay, which is beneficial for Axsome compared to some settlements that allow generic entry much sooner.
- Other pharmaceutical companies such as Teva, Mylan, and Viatris have also engaged in similar patent litigation and settlements to protect their branded products.
Stakeholder Impact
- Shareholders will likely view the settlement positively due to the extended market exclusivity for Sunosi.
- Patients may have to wait longer for a lower-cost generic version of Sunosi.
- Competitors may be impacted by the delayed entry of a generic version of Sunosi.
Next Steps
- Axsome and Unichem will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
- Axsome will continue to pursue patent litigation against other parties.
Legal Proceedings
- Axsome has settled patent litigation with Unichem Laboratories regarding Sunosi.
- Axsome has similar patent litigation pending against other parties in the U.S. District Court for the District of New Jersey.
Key Dates
- June 5, 2024: Date of the press release and 8-K filing announcing the settlement agreement.
- June 30, 2042: Earliest date Unichem is permitted to launch a generic version of Sunosi, subject to potential extension for pediatric exclusivity.
Keywords
Axsome Therapeutics, Sunosi, solriamfetol, patent litigation, Unichem Laboratories, generic, settlement, exclusivity, FDA, FTC, Department of Justice
AXSM
Axsome Therapeutics, INC
NASDAQ
Sector: TBD
Filings with Classifications
Delay expected
9 June 2025 7:05 AM
Regulatory Update
- The Refusal to File (RTF) letter from the FDA necessitates an additional controlled trial for AXS-14.
- This new trial is anticipated to be initiated in the fourth quarter of 2025, indicating a delay in the regulatory pathway and potential market entry for AXS-14.
Worse than expected
9 June 2025 7:05 AM
Regulatory Update
- The FDA issued a Refusal to File (RTF) letter for the AXS-14 NDA, indicating the application was not sufficiently complete for substantive review.
- This requires Axsome to conduct an additional controlled trial, delaying the potential approval and commercialization of AXS-14.
Capital raise
13 May 2025 7:06 AM
8-K Filing
- Axsome conducted a private placement of 140,000 shares of common stock to Blackstone at a price of $107.14 per share.
- The gross proceeds from the private placement were approximately $15 million.
- Purchasers agreed to a lock-up period of 120 days from the closing date, restricting the sale or transfer of the securities.
Capital raise
5 May 2025 4:47 PM
Quarterly Report
- The Company may use a combination of public and private equity offerings, debt financings, other third-party funding, strategic alliances, licensing arrangements or marketing and distribution arrangements if market conditions are favorable or as a result of other strategic considerations to finance its future cash needs.
Delay expected
5 May 2025 4:47 PM
Quarterly Report
- If Subtenant is delayed in completing the New Premises Subtenant Work and vacate the Original Premises within four (4) months of the New Premises Commencement Date, subject to Force Majeure, then, notwithstanding anything to the contrary contained herein, Subtenant shall not be required to pay holdover rent as set forth in Section 3 above for the amount of time that Prime Landlords actions delayed Subtenant in completing the New Premises Subtenant Work (such amount of time, the Prime Landlord Delay) and the Original Premises Termination Date shall be extended by such period of Prime Landlord Delay; provided however that maximum amount of time for the delay in Subtenant paying holdover rent pursuant to Section 3 hereof shall be an additional thirty (30) days so that if Subtenant has not vacated the Original Premises and delivered possession of the Original Premises to Sublandlord due to Prime Landlord Delay within five (5) months of the New Premises Commencement Date, for whatever reason whatsoever, Subtenant shall pay such holdover rent pursuant to Section 3 hereof.
Better than expected
5 May 2025 4:47 PM
Quarterly Report
- Revenue increased significantly year over year.
- Net loss decreased year over year.
Better than expected
5 May 2025 7:33 AM
Quarterly Report
- The company's revenue growth exceeded expectations, driven by strong sales of AUVELITY and SUNOSI.
- The approval of SYMBRAVO and positive clinical trial results for solriamfetol in ADHD and SYMBRAVO in migraine patients were better than expected.
Worse than expected
1 April 2025 7:06 AM
Press Release
- The PARADIGM Phase 3 trial did not meet its primary endpoint in the overall patient population, indicating worse than expected results.
Better than expected
25 March 2025 7:06 AM
Clinical Trial Results
- The FOCUS Phase 3 trial achieved both its primary and key secondary endpoints, demonstrating statistically significant improvements in ADHD symptoms and disease severity compared to placebo.
Capital raise
18 February 2025 5:10 PM
Annual Results
- The company may need to raise additional financing to support its continuing operations.
- The company may seek to fund its operations through public or private equity, debt financings, or other sources.
Worse than expected
18 February 2025 5:10 PM
Annual Results
- The company's net loss increased from 2023 to 2024.
- Research and development expenses increased from 2023 to 2024.
- Selling, general, and administrative expenses increased from 2023 to 2024.
Better than expected
18 February 2025 7:06 AM
Annual Results
- The company's revenue growth exceeded expectations, driven by strong sales of Auvelity and Sunosi.
- The FDA approval of Symbravo was a positive development, expanding the company's commercial portfolio.
- The successful completion of Phase 3 trials for AXS-05 and AXS-12 positions the company for potential NDA submissions and future product launches.
Delay expected
18 February 2025 7:06 AM
Annual Results
- Topline results from the ENGAGE Phase 3 trial of solriamfetol in BED are now anticipated in 2026.
Better than expected
30 January 2025 5:55 PM
Press Release
- SYMBRAVO demonstrated statistically significant superiority compared to rizatriptan on sustained pain freedom from 2 to 24 hours.
Better than expected
30 December 2024 7:56 AM
Clinical Trial Results
- The ACCORD-2 trial met its primary endpoint with a statistically significant result, demonstrating a 3.6-fold lower risk of relapse compared to placebo, which is better than expected.
- The ACCORD-2 trial also met its key secondary endpoint, showing statistically significant prevention of relapse of agitation, which is better than expected.
- AXS-05 reduced the worsening of overall Alzheimer's disease severity compared to placebo in the ACCORD-2 trial, which is better than expected.
Better than expected
26 November 2024 7:05 AM
Clinical Trial Results
- The trial met its primary endpoint with statistically significant results, showing a reduction in cataplexy attacks compared to placebo.
- The drug also demonstrated statistically significant improvements in cognition and overall narcolepsy symptoms, exceeding expectations.
Worse than expected
12 November 2024 9:43 AM
Quarterly Report
- The company's net loss increased compared to the same period last year, indicating worse than expected results.
Capital raise
12 November 2024 9:43 AM
Quarterly Report
- The company may use a combination of public and private equity offerings, debt financings, other third-party funding, strategic alliances, licensing arrangements or marketing and distribution arrangements if market conditions are favorable or as a result of other strategic considerations to finance its future cash needs.
Better than expected
12 November 2024 7:07 AM
Quarterly Report
- The company's revenue growth significantly exceeded expectations, with Auvelity sales growing by 113% year-over-year.
- The company is progressing its pipeline faster than expected with multiple topline results expected in the near term.
- The company has sufficient cash to fund operations into cash flow positivity, which is better than expected.
Better than expected
1 October 2024 5:24 PM
Loan Agreement Amendment
- The loan amendment provides better terms for Axsome, including an increased tranche commitment, extended availability periods, and more flexible performance covenants.
Worse than expected
5 August 2024 4:30 PM
Quarterly Report
- The company reported a net loss of $79.3 million for the quarter, which is worse than the net loss of $67.2 million reported for the same period in the previous year.
Capital raise
5 August 2024 4:30 PM
Quarterly Report
- The company may use a combination of public and private equity offerings, debt financings, other third-party funding, strategic alliances, licensing arrangements or marketing and distribution arrangements if market conditions are favorable or as a result of other strategic considerations to finance its future cash needs.
Better than expected
5 August 2024 7:05 AM
Quarterly Report
- The company's revenue growth of 87% year-over-year and Auvelity sales growth of 135% year-over-year significantly exceeded expectations.
Delay expected
5 June 2024 7:38 AM
Settlement Announcement
- The settlement delays the entry of a generic version of Sunosi until at least June 30, 2042.
Capital raise
6 May 2024 5:20 PM
Quarterly Report
- The company may use a combination of public and private equity offerings, debt financings, other third-party funding, strategic alliances, licensing arrangements or marketing and distribution arrangements if market conditions are favorable or as a result of other strategic considerations to finance its future cash needs.
Worse than expected
6 May 2024 5:20 PM
Quarterly Report
- The company's net loss increased significantly compared to the same period last year, indicating worse than expected financial performance.
Worse than expected
6 May 2024 7:05 AM
Quarterly Report
- The company's net loss of $68.4 million for the quarter was significantly worse than the $11.2 million loss in the same period of 2023.
Worse than expected
25 March 2024 9:06 AM
Patient Survey Results Announcement
- The survey results show that a high percentage of patients continue to experience symptoms despite being on treatment, indicating that current treatments are not as effective as expected.
Better than expected
25 March 2024 9:02 AM
Clinical Trial Results
- The results of the SYMPHONY trial were better than expected, as AXS-12 demonstrated statistically significant improvements across multiple endpoints compared to placebo.
Delay expected
20 February 2024 7:05 AM
Annual Results
- The completion of the ADVANCE-2 trial for Alzheimer's disease agitation is now anticipated in the second half of 2024, due to enrollment trends and market dynamics, which is a delay from previous expectations.
Better than expected
20 February 2024 7:05 AM
Annual Results
- The company's revenue growth of 309% year-over-year significantly exceeded expectations.
- Auvelity's sales of $130.1 million in its first full year of launch surpassed initial projections.
- Sunosi's 67% year-over-year revenue growth was also better than anticipated.
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