Daratumumab vs. Cafilzomib:
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Hvis vi ser på Carfilzomib i forhold til Daratumumab i kombination med Revlimid:
(Husk at Amgen købte ONXX for 10,4 mia. $ primært pga. Carfilzomib - se det i forhold til genmabs pt. 2 mia. $ market cap).
Carfilzomib og revlimid kombinationen gav følgende:
CR: 1,9%
VGPR: 36,5 %
PR: 34,6 %
ORR = 73 %
Daratumumab med Revlimid gav:
CR: 50 %
VGPR: 33 %
PR: 17%
ORR = 100%
(jeg har kun taget de første 6 patienter i darastudiet der har nået at blive behandlet længe nok endda med lav dosis)
(for de der ikke er inde i stoffet er CR det bedste respons, herefter VGPR og så PR og ORR er overall respons dvs. de andre 3 lagt sammen - herudover er der også mulighed for at patienterne kan opnå stabil desease SD).
Man skal passe på med at sammenligne æbler og pærer, men syntes det giver et ret godt billede af hvor stærke Daratumumab dataene er i forhold til et stof som Carfilzomib som der har været meget hype omkring.
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Jeg var selv aktionær i ONXX før de blev opkøbt af Amgen. De har en meget spændende teknologi og pipeline. Alligevel er det værd at bemærke at Amgen direkte nævner Carfilzomib i MM som en af hovedårsagerne til at de brugte over 10 mia. $ på ONXX. Sæt dette i relief til at de Dara data vi lige har set ser stærkere ud end Carfilzomib i kombination med Revlimid samt at Genmabs markedsværdi kun er 2 mia. $:
Amgen To Acquire Onyx Pharmaceuticals For $125 Per Share In Cash
Attractive Addition to Amgen's Leading Oncology portfolio and Pipeline
Kyprolis
(carfilzomib) for Injection is at Early Stages of Launch in Multiple Myeloma; Showing Strong Physician SupportAcquisition Expected to Contribute to Growth and Value for Amgen Shareholders
Amgen to Host Analyst/Investor Call Monday at 8:30 a.m. EDT (5:30 a.m. PDT)
THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., Aug. 25, 2013 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Onyx Pharmaceuticals, Inc. (NASDAQNXX) today announced that their Boards of Directors have unanimously approved a transaction under which Amgen will acquire all of the outstanding shares of Onyx for $125 per share in cash. The purchase price is $10.4 billion, or $9.7 billion net of estimated Onyx cash.
Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. Onyx has an important and growing multiple myeloma franchise, with Kyprolis
(carfilzomib) for Injection already approved in the United States (U.S.). In addition, Onyx has three partnered oncology assets: Nexavar (sorafenib) tablets (an Onyx and Bayer HealthCare Pharmaceuticals, Inc. compound), Stivarga (regorafenib) tablets (a Bayer compound), and palbociclib (a Pfizer, Inc. compound). Onyx also has multiple oncology compounds in various stages of clinical development.Amgen intends to effect the transaction through a tender offer and expects to close at the beginning of the fourth quarter, subject to the satisfaction of customary closing conditions, including the receipt of regulatory clearance.
"We believe that Amgen is ideally suited to realize the full potential of Onyx's portfolio and pipeline for the benefit of physicians and patients," said Robert A. Bradway, chairman and chief executive officer at Amgen. "Our acquisition of Onyx follows a thorough due diligence process and is fully consistent with our strategy of advancing innovative medicines that address serious unmet medical needs. We expect this acquisition will accelerate growth and enhance Value for Amgen shareholders.
"Amgen has a unique opportunity to add Value to Kyprolis, a product which is at an early and promising stage of its launch," Bradway continued.
Onyx holds global rights to Kyprolis, excluding Japan. Kyprolis has an orphan drug designation in the U.S. with exclusivity until July 2019, and patents in the U.S. which extend until at least 2025.
Amgen will benefit from the global rights to Onyx's innovative oncology portfolio and pipeline. Amgen intends to leverage its oncology capabilities and experience to support Onyx's clinical development programs and maximize Kyprolis' potential in the U.S. and the rest of the world.
The acquisition of Onyx also adds to Amgen's robust late-stage pipeline. This pipeline includes nine innovative products for which registration-enabling data are anticipated by 2016. Four of these are innovative, first-in class oncology products. Onyx's pipeline complements Amgen's growing oncology portfolio.
In addition to accelerating Amgen's revenue growth, the acquisition of Onyx is expected to be accretive to Amgen's adjusted net income in 2015.
"After a careful and thorough evaluation process, our Board of Directors has determined that the all-cash transaction with Amgen maximizes Value for our stockholders and expands the potential of our commercial medicines and clinical pipeline to reach more patients globally," said Dr. Tony Coles, chairman and chief executive officer of Onyx.
Coles continued, "We are pleased to have reached this agreement with Amgen, a company that shares Onyx's vision for innovation on behalf of patients. This transaction is an important affirmation of the meaningful Value our employees have created, and we look forward to rewarding our stockholders with an immediate and attractive premium."
Bradway concluded, "Our two companies share a strong culture of innovation and a focus on patient needs. I look forward to bringing the talented people of Onyx and Amgen together as we continue to fulfill our commitment to unlocking the potential of biology for patients suffering from serious illnesses."
Benefits of the Transaction
Excellent Strategic Fit: Amgen's strategy is to advance innovative medicines that address serious unmet medical needs.
◦Amgen is a global leader in oncology. As a focused oncology company, Onyx's products and pipeline strengthen Amgen's leading position in this field.
◦Onyx's oncology pipeline adds to Amgen's existing pipeline that addresses areas of serious unmet medical need. Amgen's current pipeline includes nine products for which registration-enabling data are anticipated by 2016.
◦The acquisition of Onyx enables Amgen to continue building its position in international markets, capitalizing on its worldwide commercial, development and manufacturing capabilities. Onyx has global rights to Kyprolis (excluding Japan) and has clinical trials underway supporting an expected European Union (EU) filing in 2014.
◦Amgen's track record in quality and reliability of supply and efficiency in manufacturing will bring an added source of Value to the Onyx portfolio.
◦The transaction is expected to deliver meaningful revenue growth and return on capital and to be accretive to adjusted net income in 2015. This will support Amgen's commitment to continue to meaningfully increase its dividend over time.Positions Amgen to Address Growing Patient Needs in Multiple Myeloma
◦Kyprolis is at an early stage of its launch, with global rights, excluding Japan, held by Onyx. It has an orphan drug designation in the U.S. with exclusivity until July 2019, and patents in the U.S. which extend until at least 2025. Amgen believes there is a significant opportunity to grow Kyprolis, including potential expansion into earlier lines of multiple myeloma treatment and into international markets.Ongoing studies to support and extend Kyprolis' position in multiple myeloma include:
◦The ASPIRE trial, which is investigating the addition of Kyprolis to Revlimid (lenalidomide)1 and dexamethasone in patients with relapsed multiple myeloma who have received one to three prior therapies. An interim analysis is expected to read out in 2014. ASPIRE is the confirmatory trial for full U.S. approval as well as a registration-enabling study for relapsed multiple myeloma in the U.S. and EU.
◦The FOCUS trial, which could support the EU filing for the indication of relapsed/refractory multiple myeloma, is also expected to read out in 2014.
◦The ENDEAVOR trial, underway to compare Kyprolis to Velcade (bortezomib)2 in patients with relapsed multiple myeloma who have received one to three prior therapies.
◦The CLARION trial, underway to compare Kyprolis to Velcade in patients with newly diagnosed multiple myeloma.
◦Oprozomib, an investigational oral proteasome inhibitor, is in Phase 1b/2 trials and has the potential to play an important future role in the management of multiple myeloma.
◦Across the multiple myeloma platform, Amgen's experience in oncology can help guide Onyx's pipeline to successful approval and reimbursement.Provides Additional Sources of Revenue Growth and Profitability
◦Nexavar(sorafenib) tablets is Onyx and Bayer's oral kinase inhibitor, currently approved in the U.S. for unresectable hepatocellular carcinoma (HCC) and advanced renal cell carcinoma (RCC). It is being studied in locally advanced or metastatic HER2 negative breast cancer. Nexavar has also been submitted for U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval for the treatment of radioactive iodine-refractory differentiated thyroid cancer. Nexavar is co-developed by Onyx and Bayer except in Japan where Bayer manages all development. The companies co-promote Nexavar in the U.S. Outside of the U.S., Bayer has exclusive marketing rights, and Bayer and Onyx share profits globally, excluding Japan.
◦Stivarga (regorafenib) tablets is Bayer's oral multiple kinase inhibitor, currently approved in the U.S. for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy. It is also indicated for the treatment of patients with locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate. Stivarga is a Bayer compound developed by Bayer and jointly promoted by Bayer and Onyx in the U.S. In 2011, Bayer entered into an agreement with Onyx, under which Onyx receives a 20 percent royalty on all global net sales of Stivarga in oncology.
◦Palbociclib is Pfizer's investigational oral, small molecule cyclin-dependent kinase 4/6 inhibitor being developed by Pfizer in a Phase 3 trial for ER+, HER2-negative advanced breast cancer. Palbociclib has received Breakthrough Therapy designation by the U.S. FDA based on preliminary Phase 2 data showing improvement in median progression-free survival in combination therapy. Onyx will receive an 8 percent royalty on future worldwide sales of palbociclib. -
Tillader mig lige at udpensle begreberne yderligere (mest fordi jeg selv har været i tvivl om hvad de betød)
CR: Complete Response
VGPR: Very Good Partial Response
PR: Partial Response
MR: Minimal Response
SD: Stable Disease
PD: Progressive Disease
Og selv hvis man medregner de patienter der ikke er færdigbehandlede er dårligste resultat stable disease
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Michael Novod - Nordea (klippet fra Euroinvestor poster teddyb):
During the weekend we had the pleasure of meeting lead investigator Professor Torben Plesner as well as representatives from Genmab and Janssen at the Daratumumab+Lenalidomide+Dex poster at ASH in New Orleans. Looking at the preliminary data from the GEN503 trial with Daratumumab in combination with Lenalidomide and Dexamethasone in relapsed or refractory multiple myeloma patients, our conclusion is that the data looks truly impressive. It is early data and only based on 11 patients, but responses look extremely robust and the side-effect profile of Daratumumab seems very benign. We also note that the interest for this poster was huge, the data was very well received and with much enthusiasm and we believe that Janssen is satisfied with the Daratumumab results so far. We expect significant news flow on Daratumumab into 2014 and new combo trials are currently starting enrolment, which Janssen has also been advertising at ASH. We also expect the first larger phase III trials to be initiated during 2014. Looking at the safety profile in the GEN503 trials, we would not be surprised if Janssen opts for the 16 mg/kg dose. Overall, we believe the market underestimates the significant deal that Genmab has with Janssen and the potential for Daratumumab to become the "Rituximab" of the multiple myeloma space. We have a Strong Buy rating with a target price of DKK 300 per share (40% upside). We see Genmab as a very strong case for 2014 and it remains a conviction call for us.
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Der er andre der har lagt mærke til dara: @HelpWithMyeloma: #ASH13IMF New Therapies: Palumbo and Mikhael both think immunotherapies daratumumab and CD138 are winners! #ASH13 #Myeloma
sent from iPhone
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Kursmål: Prøver lige at samle lidt aktuelle kursmål omkring Genmab
Pr. dags dato:
Nordea 303
Danske 276 (her er jeg ikke sikker på om det er nyeste mål)
Jeffries 280
Jyske 210
Goldman sachs 175Disse 5 giver et gnsn kursmål på 249
Noter:
Goldman´s kursmål indebærer bl.a. at prissætningen af Arzerra nærmest sker ud fra en forventning om mindre end det faktiske salg.
Dertil skal siges at Nordea i sin analyse spekulerer i muligheden for et ændret scenarie, såfremt Daratumumab bliver en gamechanger indenfor MM. I så fald angiver de et kursmål omkring 400 som det rette. Indtil videre holder de fast i scenarie 1 og kursmål 303.
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Reuters har en udvidet dækning af analytikeranbefalinger:
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