Moberg Pharma reports topline data in the North American phase 3 study and will regain rights to MOB-015 in EU
Moberg Pharma announces that MOB-015 (topical terbinafine) did not meet the primary endpoint in its North American phase 3 study using 8 weeks of daily dosing followed by weekly maintenance dosing. The study, conducted at 33 centers in the US and Canada with 384 patients, showed that the shorter treatment regimen was insufficient compared to the daily dosing throughout treatment period approved in 13 EU countries.
Following these results and strategic considerations, Bayer Consumer Health has decided to stop the upcoming launch of MOB-015, leading to a mutual termination of the license agreement. Moberg Pharma will regain full rights for MOB-015 in EU while retaining previously paid milestone revenues. The company will shift focus to the European market, where MOB-015 (branded as Terclara®) is already successful in Sweden, growing the market by 44% and achieving 76% mycological cure with daily dosing.
Moberg Pharma annuncia che MOB-015 (terbinafina topica) non ha raggiunto l'obiettivo primario nel suo studio di fase 3 in Nord America, che prevedeva 8 settimane di dosaggio giornaliero seguite da un dosaggio di mantenimento settimanale. Lo studio, condotto in 33 centri negli Stati Uniti e in Canada con 384 pazienti, ha rivelato che il regime di trattamento più breve non era sufficiente rispetto al dosaggio giornaliero durante l'intero periodo di trattamento approvato in 13 paesi dell'UE.
In seguito a questi risultati e considerazioni strategiche, Bayer Consumer Health ha deciso di fermare il lancio imminente di MOB-015, portando a una risoluzione reciproca dell'accordo di licenza. Moberg Pharma riporterà i diritti completi per MOB-015 nell'UE, mantenendo i ricavi per traguardi già pagati. L'azienda si concentrerà sul mercato europeo, dove MOB-015 (commercializzato come Terclara®) ha già avuto successo in Svezia, aumentando il mercato del 44% e raggiungendo una cura micologica del 76% con dosaggio giornaliero.
Moberg Pharma anuncia que MOB-015 (terbinafina tópica) no alcanzó el objetivo principal en su estudio de fase 3 en América del Norte, el cual consistió en 8 semanas de dosis diarias seguidas de una dosis de mantenimiento semanal. El estudio, realizado en 33 centros en EE. UU. y Canadá con 384 pacientes, mostró que el régimen de tratamiento más corto fue insuficiente en comparación con la dosificación diaria durante todo el período de tratamiento aprobada en 13 países de la UE.
Tras estos resultados y consideraciones estratégicas, Bayer Consumer Health ha decidido detener el próximo lanzamiento de MOB-015, llevando a una terminación mutua del acuerdo de licencia. Moberg Pharma recuperará los derechos completos sobre MOB-015 en la UE, manteniendo los ingresos de hitos previamente pagados. La empresa centrará su atención en el mercado europeo, donde MOB-015 (conocido como Terclara®) ya tiene éxito en Suecia, aumentando el mercado en un 44% y logrando un 76% de curación micológica con dosis diarias.
모버그 제약(Moberg Pharma)는 MOB-015(국소 테르비나핀)가 하루 8주 복용 후 주간 유지 용량을 사용하는 북미 3상 연구에서 주요 목표를 달성하지 못했다고 발표했습니다. 미국과 캐나다의 33개 센터에서 384명의 환자를 대상으로 실시된 이 연구는 짧은 치료 요법이 13개 EU 국가에서 승인된 치료 기간 동안 매일 투여되는 용량에 비해 불충분하다는 것을 보여주었습니다.
이러한 결과와 전략적 고려에 따라 바이엘 소비자 건강(Bayer Consumer Health)은 MOB-015의 예정된 출시를 중단하기로 결정했으며, 이는 라이센스 계약의 상호 종료로 이어집니다. 모버그 제약은 EU에서 MOB-015의 완전한 권리를 회복하고 이전에 지불된 이정표 수익을 유지하게 됩니다. 이 회사는 스웨덴에서 이미 성공적으로 판매되는 MOB-015(상표명: Terclara®)가 44%의 시장 성장과 76%의 진균 치료율을 달성한 유럽 시장에 집중할 것입니다.
Moberg Pharma annonce que MOB-015 (terbinafine topique) n'a pas atteint l'objectif principal de son étude de phase 3 en Amérique du Nord avec 8 semaines de dosage quotidien suivi d'un dosage de maintien hebdomadaire. L'étude, réalisée dans 33 centres aux États-Unis et au Canada avec 384 patients, a montré que le régime de traitement plus court était insuffisant par rapport au dosage quotidien pendant la période de traitement approuvé dans 13 pays de l'UE.
Suite à ces résultats et à des considérations stratégiques, Bayer Consumer Health a décidé d'arrêter le lancement imminent de MOB-015, ce qui entraîne une résiliation mutuelle de l'accord de licence. Moberg Pharma va retrouver les droits complets sur MOB-015 dans l'UE tout en conservant les revenus de jalons déjà payés. L'entreprise se concentrera sur le marché européen, où MOB-015 (commercialisé sous le nom de Terclara®) est déjà un succès en Suède, augmentant le marché de 44% et atteignant un taux de guérison mycologique de 76% avec une posologie quotidienne.
Moberg Pharma gibt bekannt, dass MOB-015 (topisches Terbinafin) das primäre Ziel in seiner nordamerikanischen Phase-3-Studie, die 8 Wochen tägliche Dosierung gefolgt von wöchentlicher Erhaltungsdosis umfasste, nicht erreicht hat. Die Studie, die an 33 Zentren in den USA und Kanada mit 384 Patienten durchgeführt wurde, zeigte, dass das kürzere Behandlungsregime im Vergleich zur täglichen Dosierung während des genehmigten Behandlungszeitraums in 13 EU-Ländern unzureichend war.
Nach diesen Ergebnissen und strategischen Überlegungen hat Bayer Consumer Health beschlossen, den bevorstehenden Launch von MOB-015 zu stoppen, was zu einer gegenseitigen Beendigung des Lizenzvertrags führt. Moberg Pharma wird die vollen Rechte an MOB-015 in der EU zurückgewinnen und gleichzeitig bereits gezahlte Meilenstein-Einnahmen beibehalten. Das Unternehmen wird sich auf den europäischen Markt konzentrieren, wo MOB-015 (unter dem Markennamen Terclara®) bereits in Schweden erfolgreich ist, den Markt um 44% erweitert und bei täglicher Dosierung eine mykologische Heilungsrate von 76% erreicht.
- Successful market performance in Sweden with 44% market growth
- 76% mycological cure rate achieved with daily dosing regimen
- Company retains previously received milestone payments from Bayer
- Regaining full rights to MOB-015 in EU market
- Failed to meet primary endpoint in North American Phase 3 study
- Bayer cancels planned MOB-015 launch
- Only 1.5% of patients achieved complete cure vs 0% for vehicle
- Need to reassess US market strategy
- Loss of strategic partnership with Bayer
In line with previous communication on September 13th 2024, the results now confirm that the primary endpoint was not met. The North American Phase 3 study was conducted at 33 study centers in the US and
The expectation on the North American study was to strengthen the product claims further. With a positive outcome, it would have been a competitive advantage to only need weekly treatments after the initial phase. The study results establish the fact that daily treatment for only 8 weeks is insufficient and that a longer daily treatment regimen, as approved in EU, is required for topical treatment of onychomycosis.
Bayer Consumer Health has conducted an extensive review on its pipeline and decided to stop the upcoming launch of MOB-015 due to strategic reasons and the topline data received. Therefore, Bayer and Moberg Pharma has expressed a mutual intent to terminate the license agreement whereby Moberg Pharma regains the full rights for MOB-015 in EU and retains milestone revenues already paid by Bayer.
We remain confident of the competitive profile of MOB-015, as seen in the recent successful launch in
Our intended strategy has been to combine direct sales in the
"While the topline results of the North American study creates new conditions, the data reinforce the superior efficacy of daily dosing, which is already approved and thriving in the Swedish market. We now have the opportunity to establish a stronger presence in EU and capturing a larger part of the value chain for this great product", says Anna Ljung, CEO of Moberg Pharma AB.
The primary endpoint, the proportion of patients achieving complete cure of their target toenail at 52 weeks, was achieved in 1.5 percent of the patients for MOB-015 and in none of the patients receiving vehicle (p=ns). Complete cure is a composite endpoint that requires both a completely clear nail and mycological cure. Mycological cure, defined as both negative KOH and negative dermatophyte culture, was achieved in 25.0 percent of the patients on active treatment (p=0.030). Treatment success (mycological cure and almost or completely clear great toenail) assessed by the investigator was achieved in 11.2 percent of the patients in active treatment (p=0.003).
MOB-015 was generally well tolerated. No safety issues were identified in the trial and no serious adverse events related to MOB-015 were reported.
On December 11th, 2024, at 12:00 pm CEST, Moberg Pharma's CEO Anna Ljung, CMO Anders Bröijersén, and CSO Amir Tavakkol will answer questions during a telephone conference. The Q&A session will be held in English.
To participate in the conference, please dial in on one of the numbers below before the conference starts:
SE: +46 8 10 884 80 16. Access Code: 972764
US: +1 855 979 6654. Access Code: 972764
For additional information, please contact:
Anna Ljung, CEO, telephone: +46 70 766 60 30, e-mail: anna.ljung@mobergpharma.se
Anders Bröijersén, Chief Medical Officer, telephone: + 46 76 001 15 76, e- mail: anders.broijersen@mobergpharma.se
Amir Tavakkol, Chief Scientific Officer, telephone: +1 973 307 4856, e- mail: amir.tavakkol@mobergpharma.se
About this information
This information is information that Moberg Pharma AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication at 8.30 pm CEST on December 10th, 2024, through the contact persons above.
About MOB-015 and Onychomycosis
Approximately
About Moberg Pharma, www.mobergpharma.com
Moberg Pharma AB (publ) is a Swedish pharmaceutical company focused on commercializing proprietary innovations based on drug delivery of proven compounds. The company's drug MOB-015 is a novel topical treatment for onychomycosis (nail fungus) with market approval in 13 EU countries. MOB-015 is sold in
[1] Source: IQVIA MIDAS, Pharmacy Sell-Out data, April-September 2024
This information was brought to you by Cision http://news.cision.com
The following files are available for download:
Moberg Pharma reports topline data in the North American phase 3 study and will regain rights to MOB-015 in EU |
View original content:https://www.prnewswire.com/news-releases/moberg-pharma-reports-topline-data-in-the-north-american-phase-3-study-and-will-regain-rights-to-mob-015-in-eu-302328104.html
SOURCE Moberg Pharma
FAQ
What were the results of MOB-015's North American Phase 3 trial?
Why did Bayer terminate the MOB-015 license agreement?
How is MOB-015 performing in the Swedish market?
What is Moberg Pharma's (MBGRF) new strategy following the Phase 3 results?
