ACER (MKap $29 M) 2x Phase 3 Assets +Covid 19 Daten im Q4 (Seite 23)

[Nivagl]

Antwort auf Beitrag Nr.: 71.516.327 von Ineos am 07.05.22 11:02:07

Hallo Ineos, schön endlich eine Antwort zu erhalten, es wurde langsam einsam hier😂.

Denke auch dass der Mai viel positives für uns bereithält!

[Ineos]

Antwort auf Beitrag Nr.: 71.516.792 von Ineos am 07.05.22 12:54:02

Zitat von Ineos: Profit Split between RLFTF and ACER on ACER-001 drug
Count Down till June 5, 2022 PDUFA date !!

RELIEF AND ACER THERAPEUTICS SIGN COLLABORATION AND LICENSE AGREEMENT FOR WORLDWIDE DEVELOPMENT AND COMMERCIALIZATION OF ACER-001 FOR THE TREATMENT OF UREA CYCLE DISORDERS AND MAPLE SYRUP URINE DISEASE
22 March 2021
Relief to potentially pay Acer up to $36 million and royalties in exchange for net profit share and territory rights

ACER-001 pre-NDA meeting with U.S. FDA scheduled in Q2 2021

Geneva, Switzerland, and Newton, MA, USA, March 22, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF,OTCQB: RLFTF)(“Relief”), a biopharmaceutical company with its lead compound RLF-100TM (aviptadil) in advanced clinical development to treat severe COVID-19 patients, and Acer Therapeutics Inc. (Nasdaq: ACER)(“Acer”), a pharmaceutical company focused on the acquisition, development, and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, today announced that the companies entered into a Collaboration and License Agreement (“CLA”) for worldwide development and commercialization of ACER-001. ACER-001 is a proprietary powder formulation of sodium phenylbutyrate (NaPB) designed to be both taste-masked and immediate release.

Under the terms of the CLA, Acer will receive an approximately $10 million cash payment within 15 business days of CLA execution (originally $14 million, to be offset by repayment of the $4.0 million outstanding balance of the prior loan, plus interest, from Relief to Acer). Relief will also pay Acer up to $20 million in U.S. development and commercial launch costs for the UCDs and MSUD indications. Acer will retain development and commercialization rights in the U.S., Canada, Brazil, Turkey and Japan. The companies will split net profits from Acer’s territories 60%:40% in favor of Relief. In addition, Relief has licensed the rights for the rest of the world, where Acer will receive from Relief a 15% royalty on all revenues received in Relief’s territories. Acer may also receive a total of $6 million in development milestone payments following the first European (EU) marketing approvals for UCDs and MSUD.

Gewinnaufteilung zwischen RLFTF und ACER bei ACER-001 Medikament
Count Down bis zum PDUFA-Termin am 5. Juni 2022!

RELIEF UND ACER THERAPEUTICS UNTERZEICHNEN KOLLABORATIONS- UND LIZENZVERTRAG FÜR DIE WELTWEITE ENTWICKLUNG UND VERMARKTUNG VON ACER-001 ZUR BEHANDLUNG VON HARNSTOFFZYKLUSSTÖRUNGEN UND AHORNSIRUP-HARN-KRANKHEIT
22. März 2021
Relief zahlt Acer potenziell bis zu 36 Millionen US-Dollar und Lizenzgebühren im Austausch für Nettogewinnbeteiligung und Gebietsrechte

ACER-001 Pre-NDA-Meeting mit der US-FDA für das 2. Quartal 2021 geplant

Genf, Schweiz, und Newton, MA, USA, 22. März 2021 - RELIEF THERAPEUTICS Holding AG (SIX: RLF,OTCQB: RLFTF) ("Relief"), ein biopharmazeutisches Unternehmen mit seinem Leitwirkstoff RLF-100TM (Aviptadil) in fortgeschrittener klinischer Entwicklung zur Behandlung schwerer COVID-19-Patienten, und Acer Therapeutics Inc. (Nasdaq: ACER) ("Acer"), ein pharmazeutisches Unternehmen, das sich auf den Erwerb, die Entwicklung und die Vermarktung von Therapien für schwere seltene und lebensbedrohliche Krankheiten mit erheblichem ungedecktem medizinischem Bedarf konzentriert, gaben heute bekannt, dass die Unternehmen eine Kooperations- und Lizenzvereinbarung ("CLA") für die weltweite Entwicklung und Vermarktung von ACER-001 abgeschlossen haben. ACER-001 ist eine patentrechtlich geschützte Pulverformulierung von Natriumphenylbutyrat (NaPB), die sowohl geschmacksmaskiert ist als auch sofort freigesetzt wird.

Gemäß den Bedingungen des CLA erhält Acer innerhalb von 15 Werktagen nach Abschluss des CLA eine Barzahlung in Höhe von etwa 10 Mio. USD (ursprünglich 14 Mio. USD, die durch die Rückzahlung des ausstehenden Saldos des früheren Darlehens in Höhe von 4,0 Mio. USD zuzüglich Zinsen von Relief an Acer ausgeglichen wird). Relief wird Acer außerdem bis zu 20 Millionen US-Dollar an Entwicklungs- und Markteinführungskosten für die Indikationen UCDs und MSUD zahlen. Acer wird die Entwicklungs- und Vermarktungsrechte in den USA, Kanada, Brasilien, der Türkei und Japan behalten. Die Unternehmen werden die Nettogewinne aus den Gebieten von Acer im Verhältnis 60:40 zugunsten von Relief aufteilen. Darüber hinaus hat Relief die Rechte für den Rest der Welt lizenziert, wo Acer von Relief eine 15-prozentige Lizenzgebühr auf alle in den Gebieten von Relief erzielten Einnahmen erhalten wird. Acer kann außerdem nach den ersten europäischen (EU) Marktzulassungen für UCDs und MSUD insgesamt 6 Millionen Dollar an Entwicklungsmeilensteinzahlungen erhalten.

[Ineos]

Profit Split between RLFTF and ACER on ACER-001 drug :-)

Profit Split between RLFTF and ACER on ACER-001 drug
Count Down till June 5, 2022 PDUFA date !!

RELIEF AND ACER THERAPEUTICS SIGN COLLABORATION AND LICENSE AGREEMENT FOR WORLDWIDE DEVELOPMENT AND COMMERCIALIZATION OF ACER-001 FOR THE TREATMENT OF UREA CYCLE DISORDERS AND MAPLE SYRUP URINE DISEASE
22 March 2021
Relief to potentially pay Acer up to $36 million and royalties in exchange for net profit share and territory rights

ACER-001 pre-NDA meeting with U.S. FDA scheduled in Q2 2021

Geneva, Switzerland, and Newton, MA, USA, March 22, 2021 – RELIEF THERAPEUTICS Holding AG (SIX: RLF,OTCQB: RLFTF)(“Relief”), a biopharmaceutical company with its lead compound RLF-100TM (aviptadil) in advanced clinical development to treat severe COVID-19 patients, and Acer Therapeutics Inc. (Nasdaq: ACER)(“Acer”), a pharmaceutical company focused on the acquisition, development, and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, today announced that the companies entered into a Collaboration and License Agreement (“CLA”) for worldwide development and commercialization of ACER-001. ACER-001 is a proprietary powder formulation of sodium phenylbutyrate (NaPB) designed to be both taste-masked and immediate release.

Under the terms of the CLA, Acer will receive an approximately $10 million cash payment within 15 business days of CLA execution (originally $14 million, to be offset by repayment of the $4.0 million outstanding balance of the prior loan, plus interest, from Relief to Acer). Relief will also pay Acer up to $20 million in U.S. development and commercial launch costs for the UCDs and MSUD indications. Acer will retain development and commercialization rights in the U.S., Canada, Brazil, Turkey and Japan. The companies will split net profits from Acer’s territories 60%:40% in favor of Relief. In addition, Relief has licensed the rights for the rest of the world, where Acer will receive from Relief a 15% royalty on all revenues received in Relief’s territories. Acer may also receive a total of $6 million in development milestone payments following the first European (EU) marketing approvals for UCDs and MSUD.

[Ineos]

Acer und Relief :-)

https://newsfilter.io/a/2b6ffe91cdfb66e5c8914236da47869e

Moin Nivagl ! Es geht voran und wer weiß was uns noch im
Wonnemonat Mai im positiven Sinne erwartet ! :-)

[Nivagl]

Acer Therapeutics and Relief Therapeutics Announce Presentation of ACER-001 Data at the Genetic Metabolic Dieticians International Conference

NEWTON, MA and GENEVA, SWITZERLAND – May 6, 2022 – Acer Therapeutics Inc. (Nasdaq: ACER) (“Acer”) and its collaboration partner, Relief Therapeutics Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (“Relief”), today announced the presentation of data evaluating the bioavailability, bioequivalence and taste attributes of ACER-001 (sodium phenylbutyrate) compared to sodium phenylbutyrate (BUPHENYL®) powder during poster sessions at the recent Genetic Metabolic Dieticians International (GMDI) Conference on May 5, 2022, in Las Vegas, Nevada.

“We are pleased to present results from these two studies at another renowned genetic metabolic conference,” said Adrian Quartel, MD, CMO of Acer. “These data further support our belief that, if approved, ACER-001 could offer an alternative to current therapies that may lead to meaningful clinical outcomes in patients with Urea Cycle Disorders (UCDs).”

“Despite available treatments, there remains an unmet medical need for additional management options for the treatment of UCDs,” added Raghuram (Ram) Selvaraju, Chairman of Relief. “We look forward to the Prescription Drug User Fee Act (PDUFA) target action date on June 5, 2022 and potential approval by the U.S. Food and Drug Administration (FDA) of Acer’s new drug application for ACER-001 for the treatment of UCDs. Assuming a favorable decision from the FDA, we plan to submit a Marketing Authorization Application in the EU for the product during 2022.”

ACER-001 Data Presented at GMDI

A copy of each poster presentation from the 2022 GMDI Conference is available on Acer’s website at: https://www.acertx.com/publications-and-presentations/.

ACER-001: A Potential Alternative to Sodium and Glycerol Phenylbutyrate for Treatment of Urea Cycle Disorders1

This poster summarizes results from two Phase 1 bridging studies that evaluated the bioavailability and bioequivalence of ACER-001 (sodium phenylbutyrate) compared to sodium phenylbutyrate (BUPHENYL®) powder. The objectives of the two studies were to determine the bioequivalence of ACER-001 administered as a suspension relative to sodium phenylbutyrate (BUPHENYL®) powder administered as a solution in healthy adult volunteers after a single dose under fasting and fed conditions, and to assess the effect of a high-fat meal on the pharmacokinetics (PK) of ACER-001.

The data presented concluded that ACER-001 was bioequivalent to sodium phenylbutyrate (BUPHENYL®) powder under both fed and fasting conditions. Higher levels of phenylbutyrate (PBA) and phenylacetate (PAA), a conjugate base of phenylacetic acid, were observed when ACER-001 was administered under fasting versus fed conditions. A similar reduction in the PK of sodium phenylbutyrate (BUPHENYL®) powder under fed conditions was observed between the fasted and fed studies. Adverse events in these studies showed no major safety signals and were similar to sodium phenylbutyrate (BUPHENYL®). These studies suggest investigating administration of nitrogen scavengers under fasting conditions, which may ultimately provide lower dose options and increase dosing flexibility.

Taste-Masked Coating of Sodium Phenylbutyrate (ACER-001) Improves the Palatability of Sodium Phenylbutyrate for Treatment of Urea Cycle Disorders2

The second poster presented at GMDI details results from two Phase 1, open-label, repeated measures, taste assessment studies of polymer coated sodium phenylbutyrate (ACER-001) and sodium phenylbutyrate (BUPHENYL®) powder. The studies included healthy panelists who were required to complete a training program for a minimum of six months that educated panelists on the identification, description, and quantification of sensory attributes of products.

The objective of the two taste assessment studies was to identify and quantify the intensity of perceived flavor attributes of ACER-001 relative to sodium phenylbutyrate (BUPHENYL®) powder. Results from both studies concluded that ACER-001 was shown to have overall lower flavor intensity scores than sodium phenylbutyrate (BUPHENYL®) powder when administered within five minutes of preparation.

[Nivagl]

So, habe gerade meine, wahrscheinlich, letzte Position Acer gekauft. Von mir aus kann das Spiel beginnen!

[Nivagl]

Habe soeben meine erste Position Acer gekauft, bin sehr optimistisch hier!

Auch heute wieder ein Zuzug bei Relief für die spätere Vermarktung von Acer-001.

https://www.relieftherapeutics.com/newsblog-detail/?newsID=2…

"Drew's addition to the company reflects our continued commitment to building out our U.S. commercial team in anticipation of the rollout of PKU GOLIKE(R), the flagship product line of our wholly owned subsidiary, APR Applied Pharma Research, SA (APR), and the upcoming June 5, 2022 Prescription Drug User Fee Act (PDUFA) date and potential launch of ACER-001 to treat Urea Cycle Disorders, in collaboration with Acer Therapeutics," stated Mr. Kim. "Drew's success in launching numerous products in the rare disease space, as well as her proven skills in digital technology and team building, gained from her tenures at Intercept Pharmaceuticals and Cubist Pharmaceuticals, make her a key member of the U.S. commercial team as we optimize our emerging rare disease pipeline."

[Nivagl]

ACER-001, a novel powder formulation of sodium phenylbutyrate (NaPB) designed to
be both taste-masked and immediate release (IR) is targeted for development and
commercialization in two rare diseases:

1) Urea Cycle Disorders (UCDs): (peak sales CHF 130+ mn – 505(b)(2) pathway): bioequivalence to Buphenyl obtained under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act; completing additional non-clinical work and 12-month long-term stability data; 5 June 2022 PDUFA date with first launches expected in 2022; potential 3 years Hatch-Waxman market exclusivity; taste-masked formulation US patent issued that protects the compound into 2036; potential to obtain Orphan Drug Designation in the EU providing 10 years market exclusivity; targeted to replace Horizon’s UCDs drugs Buphenyl and Ravicti and attract new and non-compliant sufferers of UCDs.

2) Maple Syrup Urine Disease (MSUD): (peak sales CHF 80+ mn – POC established): based on the encouraging POC results a phase IIb/III trial is planned for 2022; potential US launch in 2023 and EU launch in 2024; obtained Orphan Drug Designation in the US, which provides 7 years market exclusivity; there are currently no drugs approved to treat MSUD

ACER-001 in urea cycle disorders (UCDs) – rNPV of CHF 0.043/share

We forecast peak sales of ACER-001 in urea cycle disorders (UCDs) to amount to CHF 130+ mn. ACER-001, in-licensed from Acer Therapeutics, is a novel powder and immediate release (IR) formulation of sodium phenylbutyrate, is targeted to provide a compelling alternative to Horizon Therapeutics’ Buphenyl (glycerol phenylbutyrate) with a novel taste masking formulation that potentially can be taken without food at a competitive pricing. The FDA set a 5 June 2022 PDUFA data when it expects to conclude its review of ACER-001 in UCDs with a first launch in the US to occur in 2022. Relief is entitled to 60% of net profits in the Acer territories (US, Canada, Brazil, Turkey and Japan), while Acer will receive a 15% net royalty on ROW sales by Relief, next to regulatory milestones upon approval in the EU.
We calculate a rNPV of CHF 0.043 per share for ACER-001 in UCD assuming an 80% (Section 505(b)(2)) success rate.

ACER-001 in Maple Syrup Urine Disease (MSUD) – rNPV of CHF 0.015/share

We forecast peak sales of ACER-001 in Maple Syrup Urine Disease (MUSD) to amount to CHF 80+ mn. Based on encouraging POC trial results, Acer and Relief plan to start phase IIb/III development of ACER-001 in MSUD in 2022 with a potential launch in the US in 2023 and in the EU in 2024. We calculate a rNPV of CHF 0.015 per share for ACER-001 in MSUD assuming a 35% (POC) success rate and considering the regulatory milestones, profit split, and sales royalties according to the proposed global agreement with Acer.

vL Relief Therapeutics Valuation Report 21FEB22.pdf

[Nivagl]

Ich werde nächste Woche wohl bei Acer Therapeutics einsteigen.
Das scheint mir hier eine (relativ) sichere Wette für 50 - 100% Kursgewinn bis zum 5. Juni zu sein.
Ich bin bei Relief investiert und was ich bisher über das Acer Management gelesen habe, wie die mit Relief zusammenarbeiten stimmt mich positiv!
Sehr interessant ist auch, dass Relief vor kurzem einen "hochdekorierten" Salesman für die USA angeheuert hat. Die sind sich der Sache sicher und wollen Acer-001 professionell vermarkten!
Auch sehr spannend dass Acer im Nasdaq gehandelt wird, dort können Biotech Firmen bei positiven News ganz schön durchstarten.

[Niller84]

News!

https://relieftherapeutics.com/newsblog/acer-therapeutics-an…