For få minutter siden tikkede der er meget ineresant nyhed ind. Arena Pharmaceuticals har nemlig lige efter flere års søgen fundet en partner til deres anti fedme stof Lorcaserin. Det er Eisai der har lavet en aftale med dem for det amerikanske marked
Eisai betaler $50 mio opfront
$90 mio ved godkendelse
$1,16 mia i en one off betaliong som jeg på stående fod ikke lige kan gennemskue.(se mere længere nede)
En royalties der starter med 31,5% og vil stige til 36,5% for det salg der ligger ud over $750 mio
Lorcaserin står lige foran eksamens tid. Der er Advisory Committee meeting den 16 sep. Altså det møde hvor et uafhængigt ekspert panel skal komme med en anbefaling til FDA.
FDA skal selv komme med ders beslutning om godkendelse eller ej den 22 okt.
Dagens aftale er den første late stage aftale der nogensinde er lavet indenfor anti fedme området. Så det kunne da være nice om det her an få lirket boksen op. De andre big pharma selskaber holder får helt sikkert en aha oplevelse af det her.
Hvis vi ser på selve aftale så illustrere den meget godt at Eisai er en del i tvivl om det relle potentiale. For de betaler altså kun $50 mio upfront selvom Arena har brugt $200+ mio på at få stoffet hertil. Arena har da også tidligere offentligt sagt de ville have $100+ mio upfront.
Modsat så kan Arena få op til 36,5% i royalties hvilket er super højt. Den høje sats bliver dog hjulpet på vej af det faktum de selv har en fabrik der skal producere pillerne. Men det er stadig en flot sats. Og det viser meget godt den strategivej jeg også mener Neurosearch bør tage. Nemlig at nedjustere forventningerne til upfront betaliong markant for i stedet at gå efter høje royalties.
Lorcaserin er nok et af de mest sikre stoffer jeg nogensinde har set. Det er ren placebo bivirknings profil. Desværre for Arena så er vægttabet også yderst beskeden idet patienterne kun taber sig knap 3,5kg. Altså markant under de 8-10kg patienterne taber sig ved Qnexa fra Vivus, Contrave fra Orexigen og Tesofensine fra Neurosearch.
Men godt gået af Arena. Nu bliver det som agt spændende at se om det her er begivenheden der igangsætter flere ataler på nogle af de 3 andre nævnte stoffer. Mit udgangspunk e dog stadig der ikke kommer en aftale på Tesofensine. Så sker et er det ren upside. Om alle omstændigheder skal Neurosearch først have e ny snak med FDA om designet af fase 3 programmet. Så indtil det er på plads så sker er i hvert fald intet.
Hvisder er nogen der ønsker at tage et stort play så ka man forøvrigt købe Vivus her inden den 15 juli. For den dag er der Advisory Committee meeting om Qnexa. Hvis de anbefaer en godkendelse så vil jeg gætte på kursen stiger mindst 50%. Men formentligt også 100+% Og af de 3 stoffer der står lgie foran eksamen er det det jeg tror mest på
Companies Sign Marketing and Supply Agreement; Arena Eligible to Receive Over 30% of Eisai's Net Sales and $1.37 Billion in Other Payments -
SAN DIEGO, July 1, 2010 /PRNewswire via COMTEX News Network/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that Eisai Inc. will market lorcaserin for obesity and weight management in the United States following U.S. Food and Drug Administration (FDA) approval under the terms of a marketing and supply agreement between Arena Pharmaceuticals GmbH, a wholly owned subsidiary of Arena Pharmaceuticals, Inc., and Eisai. Lorcaserin, which Arena discovered and has developed for weight management, is intended for obese patients as well as overweight patients who have at least one weight-related co-morbid condition.
As part of the marketing and supply agreement, Arena has granted Eisai exclusive U.S. rights to commercialize lorcaserin. Arena will manufacture lorcaserin at its facility in Switzerland and sell finished product to Eisai for marketing and distribution in the United States.
"Through this agreement, we believe Eisai has an opportunity to bring a new option to market to address the significant and growing need for obesity treatments," said Lonnel Coats, President and Chief Executive Officer of Eisai Inc. "Additionally, by building on our expertise and success in the primary care and specialty areas, with strong synergy in our gastrointestinal franchise, this arrangement for the marketing of lorcaserin will enable Eisai to establish a strong presence in the United States for the medical management of obesity."
Under the terms of the agreement, Arena will receive an upfront payment of $50 million from Eisai and, upon regulatory approval and the delivery of product supply for launch, up to an additional $90 million in milestone payments. Arena will sell lorcaserin to Eisai for a purchase price starting at 31.5% of Eisai's annual net product sales, and the purchase price will increase on a tiered basis to as high as 36.5% on the portion of annual net product sales exceeding $750 million. Arena is also eligible to receive $1.16 billion in one-time purchase price adjustment payments based on annual sales levels of lorcaserin and up to an additional $70 million in regulatory and development milestone payments.
"Execution of this commercial agreement is a major milestone in our plans for lorcaserin," said Jack Lief, Arena's President and Chief Executive Officer. "We believe in Eisai's human health care mission to satisfy unmet medical needs and increase benefits to patients and their families. With Eisai, we have the right company to market lorcaserin in the United States, the right type of agreement to optimize lorcaserin's medical and commercial potential and the shared recognition that it is the right time to enter into this agreement to prepare for launch following FDA approval."
Conference Call & Webcast Scheduled for July 1, 2010, at 8:30 a.m. Eastern Time
Arena will host a conference call and webcast to discuss the agreement on Thursday, July 1, 2010, at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time). Jack Lief, Dominic P. Behan, Ph.D., Arena's Senior Vice President and Chief Scientific Officer, and William R. Shanahan, M.D., Arena's Senior Vice President and Chief Medical Officer, will host the conference call and webcast.
The conference call may be accessed by dialing 877.303.6132 for domestic callers and 678.809.1062 for international callers. Please specify to the operator that you would like to join the Arena Pharmaceuticals' conference call. The conference call will be webcast live under the investor relations section of Arena's website at www.arenapharm.com, and will be archived there for 30 days following the call. Please connect to Arena's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.
About Lorcaserin
Lorcaserin is a novel single agent that represents the first in a new class of selective serotonin 2C receptor agonists. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area involved in the control of appetite and metabolism. Stimulation of this receptor is strongly associated with feeding behavior and satiety. Arena has patents that cover lorcaserin in the United States and other jurisdictions, which in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.
Phase 3 Program Overview
The pivotal Phase 3 clinical trial program, BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) and BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management), evaluated nearly 7,200 patients treated for up to two years. In both trials, lorcaserin was well tolerated and produced statistically significant weight loss. These double-blind, randomized, placebo-controlled trials evaluated obese patients, BMI 30 to 45, with or without co-morbid conditions and overweight patients, BMI 27 to 29.9, with at least one co-morbid condition, such as hypertension, cardiovascular diseases or glucose intolerance.
In addition to the pivotal program, Arena is evaluating lorcaserin for weight management in obese and overweight patients with type 2 diabetes in its BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) trial. Results of BLOOM-DM are expected late this year, and Arena plans to file the results as a supplement to the New Drug Application (NDA).
About Eisai Inc.
Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business with fiscal year 2009 (year ended March 31, 2010) sales of approximately $3.9 billion. Eisai's areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd.
Eisai has a global product creation organization that includes U.S.-based R&D facilities in Maryland, Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com.
About Eisai Co., Ltd.
Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai employs approximately 11,000 employees worldwide.
About Arena Pharmaceuticals
Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena's most advanced drug candidate, lorcaserin, is intended for weight management and has completed a pivotal Phase 3 clinical trial program. Arena has filed an NDA for lorcaserin with the FDA, and the FDA has assigned a PDUFA date of October 22, 2010, for the review of the application. Arena Pharmaceuticals GmbH, a wholly owned subsidiary of Arena Pharmaceuticals, Inc., has granted Eisai Inc. exclusive rights to market and distribute lorcaserin in the United States.
Arena Pharmaceuticals(R) and Arena(R) are registered service marks of the company.
Eisai betaler $50 mio opfront
$90 mio ved godkendelse
$1,16 mia i en one off betaliong som jeg på stående fod ikke lige kan gennemskue.(se mere længere nede)
En royalties der starter med 31,5% og vil stige til 36,5% for det salg der ligger ud over $750 mio
Lorcaserin står lige foran eksamens tid. Der er Advisory Committee meeting den 16 sep. Altså det møde hvor et uafhængigt ekspert panel skal komme med en anbefaling til FDA.
FDA skal selv komme med ders beslutning om godkendelse eller ej den 22 okt.
Dagens aftale er den første late stage aftale der nogensinde er lavet indenfor anti fedme området. Så det kunne da være nice om det her an få lirket boksen op. De andre big pharma selskaber holder får helt sikkert en aha oplevelse af det her.
Hvis vi ser på selve aftale så illustrere den meget godt at Eisai er en del i tvivl om det relle potentiale. For de betaler altså kun $50 mio upfront selvom Arena har brugt $200+ mio på at få stoffet hertil. Arena har da også tidligere offentligt sagt de ville have $100+ mio upfront.
Modsat så kan Arena få op til 36,5% i royalties hvilket er super højt. Den høje sats bliver dog hjulpet på vej af det faktum de selv har en fabrik der skal producere pillerne. Men det er stadig en flot sats. Og det viser meget godt den strategivej jeg også mener Neurosearch bør tage. Nemlig at nedjustere forventningerne til upfront betaliong markant for i stedet at gå efter høje royalties.
Lorcaserin er nok et af de mest sikre stoffer jeg nogensinde har set. Det er ren placebo bivirknings profil. Desværre for Arena så er vægttabet også yderst beskeden idet patienterne kun taber sig knap 3,5kg. Altså markant under de 8-10kg patienterne taber sig ved Qnexa fra Vivus, Contrave fra Orexigen og Tesofensine fra Neurosearch.
Men godt gået af Arena. Nu bliver det som agt spændende at se om det her er begivenheden der igangsætter flere ataler på nogle af de 3 andre nævnte stoffer. Mit udgangspunk e dog stadig der ikke kommer en aftale på Tesofensine. Så sker et er det ren upside. Om alle omstændigheder skal Neurosearch først have e ny snak med FDA om designet af fase 3 programmet. Så indtil det er på plads så sker er i hvert fald intet.
Hvisder er nogen der ønsker at tage et stort play så ka man forøvrigt købe Vivus her inden den 15 juli. For den dag er der Advisory Committee meeting om Qnexa. Hvis de anbefaer en godkendelse så vil jeg gætte på kursen stiger mindst 50%. Men formentligt også 100+% Og af de 3 stoffer der står lgie foran eksamen er det det jeg tror mest på
Companies Sign Marketing and Supply Agreement; Arena Eligible to Receive Over 30% of Eisai's Net Sales and $1.37 Billion in Other Payments -
SAN DIEGO, July 1, 2010 /PRNewswire via COMTEX News Network/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) today announced that Eisai Inc. will market lorcaserin for obesity and weight management in the United States following U.S. Food and Drug Administration (FDA) approval under the terms of a marketing and supply agreement between Arena Pharmaceuticals GmbH, a wholly owned subsidiary of Arena Pharmaceuticals, Inc., and Eisai. Lorcaserin, which Arena discovered and has developed for weight management, is intended for obese patients as well as overweight patients who have at least one weight-related co-morbid condition.
As part of the marketing and supply agreement, Arena has granted Eisai exclusive U.S. rights to commercialize lorcaserin. Arena will manufacture lorcaserin at its facility in Switzerland and sell finished product to Eisai for marketing and distribution in the United States.
"Through this agreement, we believe Eisai has an opportunity to bring a new option to market to address the significant and growing need for obesity treatments," said Lonnel Coats, President and Chief Executive Officer of Eisai Inc. "Additionally, by building on our expertise and success in the primary care and specialty areas, with strong synergy in our gastrointestinal franchise, this arrangement for the marketing of lorcaserin will enable Eisai to establish a strong presence in the United States for the medical management of obesity."
Under the terms of the agreement, Arena will receive an upfront payment of $50 million from Eisai and, upon regulatory approval and the delivery of product supply for launch, up to an additional $90 million in milestone payments. Arena will sell lorcaserin to Eisai for a purchase price starting at 31.5% of Eisai's annual net product sales, and the purchase price will increase on a tiered basis to as high as 36.5% on the portion of annual net product sales exceeding $750 million. Arena is also eligible to receive $1.16 billion in one-time purchase price adjustment payments based on annual sales levels of lorcaserin and up to an additional $70 million in regulatory and development milestone payments.
"Execution of this commercial agreement is a major milestone in our plans for lorcaserin," said Jack Lief, Arena's President and Chief Executive Officer. "We believe in Eisai's human health care mission to satisfy unmet medical needs and increase benefits to patients and their families. With Eisai, we have the right company to market lorcaserin in the United States, the right type of agreement to optimize lorcaserin's medical and commercial potential and the shared recognition that it is the right time to enter into this agreement to prepare for launch following FDA approval."
Conference Call & Webcast Scheduled for July 1, 2010, at 8:30 a.m. Eastern Time
Arena will host a conference call and webcast to discuss the agreement on Thursday, July 1, 2010, at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time). Jack Lief, Dominic P. Behan, Ph.D., Arena's Senior Vice President and Chief Scientific Officer, and William R. Shanahan, M.D., Arena's Senior Vice President and Chief Medical Officer, will host the conference call and webcast.
The conference call may be accessed by dialing 877.303.6132 for domestic callers and 678.809.1062 for international callers. Please specify to the operator that you would like to join the Arena Pharmaceuticals' conference call. The conference call will be webcast live under the investor relations section of Arena's website at www.arenapharm.com, and will be archived there for 30 days following the call. Please connect to Arena's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.
About Lorcaserin
Lorcaserin is a novel single agent that represents the first in a new class of selective serotonin 2C receptor agonists. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area involved in the control of appetite and metabolism. Stimulation of this receptor is strongly associated with feeding behavior and satiety. Arena has patents that cover lorcaserin in the United States and other jurisdictions, which in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.
Phase 3 Program Overview
The pivotal Phase 3 clinical trial program, BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) and BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management), evaluated nearly 7,200 patients treated for up to two years. In both trials, lorcaserin was well tolerated and produced statistically significant weight loss. These double-blind, randomized, placebo-controlled trials evaluated obese patients, BMI 30 to 45, with or without co-morbid conditions and overweight patients, BMI 27 to 29.9, with at least one co-morbid condition, such as hypertension, cardiovascular diseases or glucose intolerance.
In addition to the pivotal program, Arena is evaluating lorcaserin for weight management in obese and overweight patients with type 2 diabetes in its BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) trial. Results of BLOOM-DM are expected late this year, and Arena plans to file the results as a supplement to the New Drug Application (NDA).
About Eisai Inc.
Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales). The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business with fiscal year 2009 (year ended March 31, 2010) sales of approximately $3.9 billion. Eisai's areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd.
Eisai has a global product creation organization that includes U.S.-based R&D facilities in Maryland, Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com.
About Eisai Co., Ltd.
Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care system. Eisai employs approximately 11,000 employees worldwide.
About Arena Pharmaceuticals
Arena is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases. Arena's most advanced drug candidate, lorcaserin, is intended for weight management and has completed a pivotal Phase 3 clinical trial program. Arena has filed an NDA for lorcaserin with the FDA, and the FDA has assigned a PDUFA date of October 22, 2010, for the review of the application. Arena Pharmaceuticals GmbH, a wholly owned subsidiary of Arena Pharmaceuticals, Inc., has granted Eisai Inc. exclusive rights to market and distribute lorcaserin in the United States.
Arena Pharmaceuticals(R) and Arena(R) are registered service marks of the company.
