Catalyst Pharmaceuticals Completes the Acquisition of U.S. Rights to FYCOMPA® (Perampanel) CIII
Catalyst Pharmaceuticals (Nasdaq: CPRX) has announced the acquisition of U.S. rights to FYCOMPA® (perampanel) from Eisai Co., Ltd for $160 million. This acquisition enhances Catalyst's commercial portfolio and strengthens its presence in the neurology market, particularly in the treatment of epilepsy. The addition of FYCOMPA, projected to generate approximately $136 million in net revenues for the fiscal year ending March 31, 2023, is expected to be accretive to EBITDA and EPS in 2023. The company anticipates leveraging synergies with its existing product, FIRDAPSE®, to drive organic growth.
- Acquisition of FYCOMPA enhances Catalyst's product portfolio in neuroscience.
- Projected net revenues for FYCOMPA expected to be around $136 million for 2023 fiscal year.
- Expected to be accretive to EBITDA and EPS in 2023.
- Strong overlap of physician call points with FIRDAPSE supports marketing efficiency.
- Total cash purchase payment of $160 million may strain financial resources if revenues do not meet expectations.
Strengthens its Commercial Portfolio with the First and Only AMPA Receptor Antagonist Marketed Product for Epilepsy
Bolsters Presence in Neuroscience
Expected to be Accretive in 2023
CORAL GABLES, Fla., Jan. 25, 2023 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare diseases, today announced that it has successfully completed the acquisition of the U.S. rights for FYCOMPA® (perampanel) CIII, from Eisai Co., Ltd, ("Eisai"). The closing of the acquisition provides Catalyst with an increased U.S. commercial presence in neurology and an expanded product portfolio with an established, first-in-class, commercial stage epilepsy asset.
"The completion of the acquisition of U.S. rights to FYCOMPA marks an important step in the expansion and diversification of our portfolio of marketed products, adds a second complementary commercial product that will further strengthen Catalyst's financial position through increased revenue scale, and is expected to be accretive to EBITDA and EPS in 2023," said Patrick J. McEnany, Chairman and CEO of Catalyst. "Coupled with the continued growth of FIRDAPSE®, our flagship product, we look forward to leveraging our proven capabilities and expanded U.S. presence in neuroscience to drive organic growth for both FYCOMPA and FIRDAPSE. While we are focused on a seamless transition of FYCOMPA, we will also continue to execute our growth strategy into other rare neurological and epileptic diseases. We remain committed to enhancing our portfolio with innovative medicines that address critical unmet medical needs for patients with a continued disciplined approach to our capital allocation."
Strategic Rationale
- The addition of FYCOMPA serves as a complementary growth driver and a strategic market adjacency within neuroscience that establishes a potential gateway for Catalyst to expand into rare epileptic diseases.
- Strengthens and diversifies revenues and cash flow generation with the addition of a successfully U.S. marketed asset, by building upon the company's organic revenue growth of FIRDAPSE.
- The acquisition of FYCOMPA is expected to be accretive to EBITDA and EPS in 2023 and provides synergies to build on the company's proven operational and commercial execution in neurology.
- Strategically aligns with Catalyst's growth plans to optimize the FIRDAPSE franchise and invest in portfolio expansion opportunities.
- Physician call point for FYCOMPA overlaps about
45% with FIRDAPSE call points. - Net FYCOMPA revenues for the 2022 fiscal year ending March 31, 2023, are expected to be approximately
$136 million . FYCOMPA has gross profit margins similar to FIRDAPSE.
Additional Transaction Details
As previously disclosed, Catalyst made a total all-cash purchase payment of
About Catalyst Pharmaceuticals
With exceptional patient focus, Catalyst is committed to developing and commercializing innovative first-in-class medicines that address rare neurological and epileptic diseases. Catalyst's U.S. commercial product portfolio consists of FIRDAPSE® (amifampridine) Tablets 10 mg, approved for the treatment of Lambert-Eaton myasthenic syndrome ("LEMS") for adults and children ages six to seventeen. In January 2023, Catalyst acquired the U.S. commercial rights of FYCOMPA® (perampanel) CIII, a prescription medicine approved in people with epilepsy aged four and older alone or with other medicines to treat partial-onset seizures with or without secondarily generalized seizures, and with other medicines to treat primary generalized tonic-clonic seizures for people with epilepsy aged 12 and older. Further, Canada's national healthcare regulatory agency, Health Canada, has approved the use of FIRDAPSE for the treatment of adult patients in Canada with LEMS.
For more information, visit the Company's website at www.catalystpharma.com.
About FYCOMPA
FYCOMPA is a prescription medicine used in people with epilepsy aged 4 and older alone or with other medicines to treat partial-onset seizures with or without secondarily generalized seizures, and with other medicines to treat primary generalized tonic-clonic seizures for people with epilepsy aged 12 and older.
FYCOMPA, an oral medication, is a selective non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) receptor antagonist. The precise mechanism by which FYCOMPA exerts its antiepileptic effects in humans is unknown.
FYCOMPA is supplied as 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg film-coated tablets, and as a 0.5 mg/mL oral suspension formulation. FYCOMPA has been designated by the U.S. Drug Enforcement Administration as a federally-controlled substance (CIII). To date, FYCOMPA has been prescribed to over 500,000 patients globally.
FYCOMPA is expected to have patent protection through at least May 23, 2025, with possible patent protection into June 2026.
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including (i) whether Catalyst's expectation that the acquisition transaction will prove to be accretive to EBITDA and EPS during 2023 will prove to be accurate, (ii) whether Catalyst can successfully integrate the FYCOMPA business into its business activities, and (iii) those factors described in Catalyst's Annual Report on Form 10-K for the 2021 fiscal year, Catalyst's Quarterly Report on Form 10-Q for the third quarter of 2022, and Catalyst's other filings with the SEC, could adversely affect Catalyst. Copies of Catalyst's filings with the SEC are available from the SEC, may be found on Catalyst's website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.
Important Safety Information: INDICATION FOR FYCOMPA
FYCOMPA® (perampanel) is indicated in patients with epilepsy aged 4 years and older for partial-onset seizures (POS) with or without secondarily generalized seizures and adjunctive therapy for patients aged 12 years and older for primary generalized tonic-clonic (PGTC) seizures.
IMPORTANT SAFETY INFORMATION FOR FYCOMPA
WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS
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SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS
In the partial-onset seizures clinical trials, hostility- and aggression-related adverse reactions occurred in
SUICIDAL BEHAVIOR AND IDEATION
Antiepileptic drugs (AEDs), including FYCOMPA, increase the risk of suicidal thoughts or behavior in patients. Anyone considering prescribing FYCOMPA or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Patients, their caregivers, and families should be informed of the risk and advised to monitor and immediately report the emergence or worsening of depression, suicidal thoughts or behavior, thoughts about self-harm and/or any unusual changes in mood or behavior. Should suicidal thoughts and behavior emerge during treatment, consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.
DIZZINESS AND GAIT DISTURBANCE
FYCOMPA caused dose-related increases in events related to dizziness and disturbance in gait or coordination. Dizziness and vertigo were reported in
SOMNOLENCE AND FATIGUE
FYCOMPA caused dose-dependent increases in somnolence and fatigue-related events. Somnolence was reported in
FALLS
Falls were reported in
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS)
DRESS, also known as multiorgan hypersensitivity, has been reported in patients taking AEDs, including FYCOMPA. DRESS may be fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling, in association with other organ system involvement. If signs or symptoms are present, immediately evaluate the patient and discontinue FYCOMPA if an alternative etiology for signs or symptoms cannot be established.
WITHDRAWAL OF AEDs
A gradual withdrawal is generally recommended with AEDs to minimize the potential of increased seizure frequency, but if withdrawal is a response to adverse events, prompt withdrawal can be considered.
MOST COMMON ADVERSE REACTIONS
The most common adverse reactions in patients aged 12 years and older receiving FYCOMPA (≥
DRUG INTERACTIONS
FYCOMPA may decrease the efficacy of contraceptives containing levonorgestrel. Plasma levels of perampanel were decreased when administered with known moderate and strong CYP3A4 inducers, including, carbamazepine, phenytoin, or oxcarbazepine. Multiple dosing of FYCOMPA 12 mg per day enhanced the effects of alcohol on vigilance and alertness, and increased levels of anger, confusion, and depression. These effects may also be seen when FYCOMPA is used in combination with other CNS depressants.
PREGNANCY AND LACTATION
Physicians are advised to recommend that pregnant patients taking FYCOMPA enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. Caution should be exercised when FYCOMPA is administered to pregnant or nursing women as there are no adequate data on the developmental risk associated with use in pregnant women, and no data on the presence of perampanel in human milk, the effects on the breastfed child, or the effects of the drug on milk production.
HEPATIC AND RENAL IMPAIRMENT
Use in patients with severe hepatic or severe renal impairment is not recommended. Dosage adjustments are recommended in patients with mild or moderate hepatic impairment. Use with caution in patients with moderate renal impairment.
DRUG ABUSE AND DEPENDENCE
FYCOMPA is a Schedule III controlled substance and has the potential to be abused and lead to drug dependence and withdrawal symptoms including anxiety, nervousness, irritability, fatigue, asthenia, mood swings, and insomnia.
Please see full Prescribing Information, including Boxed WARNING.
Source: Catalyst Pharmaceuticals, Inc.
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