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Good buying Opp today while the new drug is being settled. 151.00. Won't see this price for long. imo
AMGN has it's target price up to $8. something and concidered a strong buy...as for kids and grand kids...for me this is a hobby to make fast money! ASAP!
This is why you buy Nviv read and learn ,This is a post from a doctor, buy and hold for your kids or grandkids don,t worry this poster says it all here it is:I recently found this forum and wanted to share my opinion on where things stand today. I've held NVIV for the past 2 months pre-split. I happen to be a physician who sees patients with various types of nerve injury. I don't have any inside knowledge or contacts and everything I express here is my opinion based on what is public. I also write with the intent to respect the persons who have enrolled in the study.
NVIV offers the best hope for SCI patients today. Treatment has consisted of 1) Decompression 2) Steroids 3) Rehab 4) Prayers. The neuroscaffold (NS) has excellent basic science evidence and a good rational for why it works. At 90 days, patient #1 progressed from AIS-A to AIS-C. Less certain is Patient #2's status.
Patient #2 apparently had injury at the T5 level. Since then, she has shown ~2/5 hip flexion (L1-L2) and ~2/5 knee extension (L3). Note that her knee extension is likely improved compared to what is documented in Jordan's 90 day exam. Most spine patients do not improve more than 2-3 spine segments below the level of injury. She has thus far shown a 10 level improvement.
Now, there have been many questions about B&B, sometimes to the extent of disrespecting the privacy of the patients. Return of B&B is VERY important for the patients, but not as important to investors. Here's why:
Pathophysiology of spinal cord injury. Recovery after immediate and delayed decompression.
(JBJS Scientific Journal)
Patient #2 had a 2 day delay in decompression. We know from animal studies that 24H delay reduces B&B return by 70%. In clinical practice, our target is MRI in 1-2 hours and decompression within 6 hours. Hence, it is rather remarkable that she has had a 10 level improvement after such delay. Return of B&B would be ~16 levels from T5 (maybe less due to autonomic innervation).
Why I invest in NVIV: I see SCI patients regularly and I would love to see this technology benefit my patients .
sy2246 Less
AMGN mentioned late in the article:
Robots Go Viral with DNA
Micro-bots dissolve tumors, fight viruses
http://www.eetimes.com/document.asp?doc_id=1326106&_mc=NL_EET_EDT_EET_daily_20150325&cid=NL_EET_EDT_EET_daily_20150325&elq=c29e2ca27d234ccfab494d0bb89ceccc&elqCampaignId=22231&elqaid=24974&elqat=1&elqTrackId=3602b320f2ee4f8ebdc85a32a17f723a
Yeah---- literally as of now some $50.00 more per share... :)...
I don't know, maybe it's only me.. If so then Yippee!!!
Will I continue to post on here about my big figure gains,,, I highly doubt it...
Anyway back to my hideout with the children at the super sub 000000 boards....
Those that were with me,, consider yourself------- you know what.....
enjoy....
Anyone see AMGN partnering with EPGL for some of their BioMEMS tech? I see some folks on these boards are thinking AMGN fits the mold for EPGLs next big announcement next week.
$AMGN William Blair Reaffirms Market Perform On Amgen Following Positive Phase III ASPIRE Results http://www.smarteranalyst.com/2014/08/05/william-blair-reaffirms-market-perform-on-amgen-following-positive-phase-iii-aspire-results/
Evolocumab is not exactly under the radar, although I do get a sense that investors take its success for granted.
Just a lil alert,, Before I begin to write let me just say this--
I myself over the years of trading NEVER post upon any of my blue chip positions. The postings that I engage in here on IHUB has always been geared towards the many OTC/BB's symbols for which I dibby & dabble with. I have chosen to put this mini post alert here for reasons that are extremely important and directly pertain to my personal as well my professional life.. I am writing to my surprise as well I am writing to all others invested in or associated with Amgen. My interest is more geared towards the medical aspect of statins in regards to human mortality. For over 20 some odd years now we as medical practitioners are pinned to the wall with regard to conventional medicine. That being said, Ms. Jennifer Robinson and her team at the univ of Iowa are as well pinned to the wall by the forces that are! And might I add the forces that have always been AND ALWAYS WILL BE.! Not at liberality to speak upon the name of that governing entity. To sum up. The main reason upon my post here is to alert all investors with positions here @ Amgen that the company shall see tremendous gains in AMGEN'S PPS thanks to Dr. Harper's presentation..! As an investor myself I shall prosper as well as all others here. On the other hand as a practitioner I am as usual completely astonished once again. For my astonishment and disappointment is directly related to the WHO and the sheer neglect in the area of truth and transparency regarding well over 50 years of research. The research pertaining to what dyslipidemia as well, hyperlipemia and the cardiovascular risk factors pertaining to cholesterol and human mortality ..! What we have here is a Statin money machine. I'm talking revenues in the hundreds of billions of dollars. For this is an statin driven industry that is undoubtably one of the biggest pharmacuta money makers of all times.! Sadly the price and money to be made as always out weighs the human COST. Investors get ready for Evolocumab-- patients get ready for another blast to your liver. To be exact leaving aside all the medical hepatology jargon, we have in store for us now yet another massive wave of hepatotoxic events on it's way to us. As if we don't have enough already... As for Evolocumab is concerned it will be a hit.. $$$ as well a perfect storm hit to the liver via pcsk9...
After reading the above-- many would ask--- why would you post the above? As well many would ask why would I be invested in Amgen to begin with.. My answers to the questions are wide and varied --- I shall add, I myself am heavily invested in the following areas. My intentions of investment in regards to the following are extremely profitable in both the human cause as well the finical gain that comes along with the following... Not going to put out so called symbol tips here, just a few words-- for one with even a slight medical background can gather his or hers own DD on the following.... We have here a Statin side effect combatted combination from AMGN...---- one would greatly Benefit from investing in { Homocysteine - Fibrinogen - C-reactive protein.. Just to name a few.. By the way those 3 alone are by Far much more of a risk factor for all cardiovascular related events compared to lipid levels. As matter of FACT they are 10 fold over increased
Risk factors compared to elevated cholesterol / Triglycerides alike. Those whom wish I continue upon this posting matter feel free.
Good luck Guy's
I guarantee Amgen is headed to the sky......
Not as high as the others. Most are well aware of what's next to sky rocket....
Heavy post--- for it's a heavy subject matter...
Be well all...
Amgen Announces Positive Top-Line Results From Phase 3 MENDEL-2 Trial Of Evolocumab (AMG 145) In Patients With High Cholesterol
Conf call transcript - updates
http://www.earningsimpact.com/Transcript/84606/AMGN/Amgen-Inc----Business-Update-Call
NEW YORK — Biotech drugmaker Amgen will buy cancer drug maker Onyx Pharmaceuticals for about $10.4 billion in cash in a deal that will add several cancer drugs to Amgen's stable and add to its pipeline of new drugs.
Amgen Inc. said Sunday it will acquire Onyx for $125 per share, and it expects to complete the deal at the beginning of the fourth quarter. The companies value the deal at $9.7 billion excluding Onyx's cash, and Amgen said it will use $8.1 billion in committed bank loans to finance the deal.
http://www.idahostatesman.com/2013/08/25/2725110/amgen-may-buy-cancer-drug-maker.html#storylink=cpy
Overall adjusted earnings per share increased 3% to $1.89
http://www.earningsimpact.com/Transcript/82349/AMGN/Q2-2013-Earnings-Call
USFDA expands the approved use of Xgeva(denosumab) to treat adults and some adolescents with giant cell tumor of the bone (GCTB) a rare and usually non-cancerous tumor.
11:01 AM.........6/13/2013....info released at 1:18 PM today.
Adva-27a is a GEM-difluourinated C-glycoside derivative of Podophyllotoxin that Sunshine is developing for various forms of drug-resistance cancers, most impressively topoisomerase 2-positive breast cancer patients. Competition in the oncology community is a short list, primarily etoposide, which is also a derivative of Podophyllotoxin. However, etoposide is ineffective against multi-drug resistant cancer lines, giving Adva-27a, as a completely new chemical entity, a distinct advantage and substantial area for market penetration. As such, it also likely makes it very attractive for partnering or acquisition opportunities to big pharma should clinical trials support the laboratory research.
Breast Cancer As First Targeted Indication. Roche dominates the breast cancer industry with its Herceptin and related products targeting HER-2 positive patients. Roche products only are designed for 20 percent of the breast cancer population, yet generate about $6 billion in sales annually. Sunshine Biopharma’s Adva-27a target a larger population.
Sunshine Biopharma is committed to developing novel therapies for the treatment of various forms of aggressive cancer types. The Company's initial drug candidate, Adva-27a, is a small molecule that has proven effective against different types of multidrug resistant cancer cell lines including breast cancer (MCF-7/MDR), small-cell lung cancer (H69AR), uterine carcinoma (MES-SA/Dx5) and pancreatic cancer (Panc-1).
According to the American Cancer Society approximately 1.5 million new cases of cancer are diagnosed each year in the U.S. Today, there are over 11 million Americans living with cancer. Virtually all cancers are either aggressive at the onset or become aggressive over time.
ADVA-27A " BREAKTHROUGH IN THE CLINIC" Imagine getting on board this heavyweight champion at its startup stage
Spread the love carebear
SUNSHINE BIOPHARMA DECLARES AN INTERNATIONAL BREAKTHROUGH ADVA-27A NOVEL ANTI-CANCER COMPOUND
ADVA-27A INTERNATIONAL BREAKTHROUGH ANTI CANCER DRUG
Is amgn going to by out AMBS rumers, any ifo please pass on thanks
How high will she go?
Is this all do to the good news on skin cancer? Or is there some other good news I have overlooked?
Is this due to shorty being squeezed?
Can u email me this link please
Charles.r.frost@gmail.com
Great Story on EmergingGrowth.com...
The pharmaceutical sector is a very lucrative and competitive industry. And for emerging growth companies, it is difficult to make a meaningful impact in this cutthroat industry.
Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, Vosaroxin, to improve the lives of people with cancer.
Sunesis Pharmaceuticals’ work translates to a rosy top line as demonstrated by the $25 million it earned from a previously announced royalty purchase agreement with Royalty Pharma. It took possession of $15 million from the second tranche of a 2011 venture loan facility. It raised $17.3 million from the sale of 3.6 million shares of common stock and $1.4 million from the gross exercise of 0.6 million warrants to purchase common stock. This not only shows that Sunesis is able to raise capital for research purposes, but it also represents the company’s keen interest in creating shareholder value.
The company is in the follow-up stage of trials of Vosaroxin, having completed a Phase 2 trial in ovarian cancer patients in 2010. However, broader market tailwinds will propel the company through the next decade. Vosaroxin is a first-in-class anticancer quinolone derivative, a class of compounds that has not been used previously for the treatment of cancer. As of now, notable breakthroughs are being made with the drug, particularly as complete remissions have been observed in patients treated with Vosaroxin in combination with Cytarabine.
Just like its bigger competitors, Amgen Inc. (NASDAQ: AMGN) and Gilead Sciences Inc. (NASDAQ: GILD), Sunesis also wants to make a big impact. To ensure this, it has entered into a collaboration agreement with Millennium Pharmaceuticals for the development of Sunesis’ inhibitor. It also announced the license of the company’s LFA-1 inhibitor program to SARcode Corporation, a privately held bio-pharmaceutical company. In addition, it has announced a collaboration agreement with Biogen Idec Inc. (NASDAQ: BIIB) to discover, develop, and commercialize inhibitors of Raf kinase and up to five additional oncology kinase targets.
All these developments will signal the market’s gravitation toward Sunesis products. Considering that ovarian cancer is the eighth most common cancer among women, it would be accurate to say that vosaroxin will be relevant in the market. In addition, the future promise of FDA approval brightens the long-term picture and promises longevity. With a market capitalization of $226 million and a 52-week range $1.29 – $6.85 (the stock is currently trading close to its high at around $4), it would be accurate to say that Sunesis Pharmaceuticals will gain tremendous value in the next few years.
See the full story here... http://emerginggrowth.com/emerging_growth_stock_picks/emerging-growth-pharmaceutical-company-sunesis-pharm-nasdaq-snss-creates-gravitational-pull-towards-their-products/01/29/2013
In what way are the results weak? Here is AMGN’s PR:
http://finance.yahoo.com/news/amgen-announces-results-phase-3-150000162.html
weak results for phase III. I'll sell my shares right here. Monday should be red. sell-off is coming.
Why is your "Senior Scientist" Feng He on MCET's papers/posters? I would think Amgen has a no compete clause unless they have a joint venture agreement. Any clues or info on any joint venture or buyout of MCET? MCET is cheap right now and if Amgen buys out or has a joint venture with them that could be a good short term investment.
PRA Announces Strategic Relationship with Amgen
Biosimilar Development Program
RALEIGH, N.C., April 26, 2012 /PRNewswire via COMTEX/ -- PRA, a leading Clinical
Research Organization, announces a new agreement with Amgen for a series of Phase
III studies to develop several biosimilar drugs on a worldwide basis. It is
intended that PRA will serve as the sole provider of CRO services for these
studies. A global leader in the biotechnology space, Amgen conducted a thorough
search process to identify a CRO for Amgen's biosimilar development program and
selected PRA. Amgen and PRA signed the agreement in April 2012.
Under the new agreement, Amgen and PRA will work together to execute Phase III
studies related to Amgen's current biosimilar portfolio. The agreement is
intended to govern the entire anticipated scope of Amgen's global biosimilar
portfolio.
"This agreement reflects and confirms PRA's commitment to providing full service
support to our clients' development pipelines," said Kent Thoelke, PRA's
Executive Vice President of Scientific and Medical Affairs. "Our mission is to
assist our clients across all phases of biotech drug development by combining
therapeutic and operational expertise with local knowledge to help them meet
their development goals. As such, this relationship represents a key milestone in
PRA's commitment to supporting our clients' biosimilar development programs.
Amgen is a blue chip company and a world leader with a global reputation for
excellence in bringing biologic therapies to patients with grievous illnesses.
PRA has a strong track record in executing our clients' global registration
trials and helping to bring new drugs to market. We are delighted to announce
this strategic relationship with Amgen."
About PRA PRA is transforming clinical trials through our people, innovation and
transparency. PRA provides personalized service customized to the unique
requirements of each study. We support our global reach and innovative approach
through flexible and reliable service, delivered by skilled employees dedicated
to ensuring that sponsors achieve their long-term goals.
We serve our clients across all phases of pharmaceutical and biotech drug
development by combining therapeutic and operational expertise with local
knowledge. Offering services in 80+ countries and serving sponsors for 30+ years,
we have amassed a level of expertise that has enabled us to work on a variety of
compounds, ranging from niche treatments and therapies to blockbuster drugs. But
at PRA, we are looking to the future, not the past. Our increasingly
forward-thinking approach to transforming the clinical trial landscape will
continue to make a difference to healthcare patients around the world.
To learn more about PRA, please visit praintl.com, email endpoints@praintl.com or
call our Global Headquarters.
SOURCE PRA
Copyright (C) 2012 PR Newswire. All rights reserved
Musings on the Turkish acquisition: #msg-74827710.
AMGN - Amgen Goes to Turkey, Loses Biotech Cred
http://www.thestreet.com/story/11508115/1/amgen-goes-to-turkey-loses-biotech-cred.html?CM_VEN=AD|TWR|JC
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YCharts Dashboard ~ http://ycharts.com/companies/AMGN/dashboard
InsideStocks Opinion ~ http://www.insidestocks.com/texpert.asp?sym=AMGN&code=XDAILY
InsideStocks Profile ~ http://www.insidestocks.com/profile.asp?sym=AMGN&code=XDAILY
InsideStocks Quote ~ http://www.insidestocks.com/quote.asp?sym=AMGN&code=XDAILY
InsideStocks Projection ~ http://charts3.barchart.com/procal.asp?sym=AMGN
Zacks Quote ~ http://www.zacks.com/stock/quote/AMGN
Zacks Estimates ~ http://www.zacks.com/research/report.php?type=estimates&t=AMGN
Zacks Company Reports ~ http://www.zacks.com/research/report.php?type=report&t=AMGN
Knobias ~ http://knobias.10kwizard.com/files.php?sym=AMGN
StockScores ~ http://www.stockscores.com/quickreport.asp?ticker=AMGN
Trade-Ideas ~ http://www.trade-ideas.com/StockInfo/AMGN/HOT_TOPIC.html
Morningstar ~ http://performance.morningstar.com/stock/performance-return.action?region=USA&t=AMGN&culture=en-US
Morningstar Shareholders ~ http://investors.morningstar.com/ownership/shareholders-overview.html?t=AMGN®ion=USA&culture=en-us
Morningstar Transcripts~ http://www.morningstar.com/earnings/NoTranscript.aspx?t=AMGN®ion=USA
Morningstar Key Ratios ~ http://financials.morningstar.com/ratios/r.html?t=AMGN®ion=USA&culture=en-US
Morningstar Executive Compensation ~ http://insiders.morningstar.com/trading/executive-compensation.action?t=AMGN®ion=USA&culture=en-us
Morningstar Valuation ~ http://financials.morningstar.com/valuation/price-ratio.html?t=AMGN®ion=USA&culture=en-us
CCBN (Thompson Reuters) ~ http://ccbn.aol.com/company.asp?client=aol&ticker=AMGN
TradingMarkets ~ http://pr.tradingmarkets.com/?lid=leftPRbox&sym=AMGN
OTCBB ~ http://www.otcbb.com/asp/SiteSearch.asp?Criteria=AMGN&searcharea=e&image1.x=0&image1.y=0
Insidercow ~ http://www.insidercow.com/history/company.jsp?company=AMGN&B1=Search%21
Forbes News ~ http://search.forbes.com/search/find?tab=searchtabgeneraldark&MT=AMGN
Forbes Press Releases ~ http://search.forbes.com/search/find?&start=1&tab=searchtabgeneraldark&MT=AMGN&pub=businesswire,prnewswire&searchResults=pressRelease&tag=pr&premium=on
Forbes Web ~ http://search.forbes.com/search/web?MT=UNGS&start=1&max=10&searchResults=web&tag=web&sort=null
YouTube Symbol Search ~ http://www.youtube.com/results?search_query=AMGN
Buy-Ins ~ http://www.buyins.net/tools/symbol_stats.php?sym=AMGN
Quotemedia ~ http://www.quotemedia.com/results.php?qm_page=47556&qm_symbol=AMGN
Earnings Whispers ~ http://www.earningswhispers.com/stocks.asp?symbol=AMGN
Bloomberg Snapshot ~ http://investing.businessweek.com/research/stocks/snapshot/snapshot.asp?ticker=AMGN
Bloomberg People ~ http://investing.businessweek.com/research/stocks/people/people.asp?ticker=AMGN
Financial Times ~ http://markets.ft.com/Research/Markets/Tearsheets/Summary?s=AMGN
Investorpoint ~ http://www.investorpoint.com/ enter "AMGN" and click search.
Hotstocked ~ http://www.hotstocked.com/ enter "AMGN" and click search.
Raging Bull ~ http://ragingbull.quote.com/mboard/boards.cgi?board=AMGN
Hoovers ~ http://www.hoovers.com/search/company-search-results/100003765-1.html?type=company&term=AMGN
DD Machine ~ http://www.ddmachine.com/default.asp?m=stocktool_frame.asp?symbol=AMGN
SEC Form 4 ~ http://www.secform4.com/insider/showhistory.php?cik=AMGN
OTCBB Pulse ~ http://www.otcbbpulse.com/cgi-bin/pulsequote.cgi?symbol=AMGN
Failures To Deliver ~ http://failurestodeliver.com/default2.aspx enter "AMGN" and click search.
http://www.coordinatedlegal.com/SecretaryOfState.html
http://regsho.finra.org/regsho-Index.html
http://www.shortsqueeze.com/?symbol=AMGN&submit=Short+Quote%99
DTCC (PENSON/TDA) Check - (otc and pinks) - Note ~ I did not check for this chart blast. However, I try and help you to do so with the following links.
IHUB DTCC BOARD SEARCH #1 http://investorshub.advfn.com/boards/msgsearchbyboard.aspx?boardID=18682&srchyr=2011&SearchStr=AMGN
IHUB DTCC BOARD SEARCH #2: http://investorshub.advfn.com/boards/msgsearchbyboard.aspx?boardID=14482&srchyr=2011&SearchStr=AMGN
Check those searches for recent AMGN mentions. If AMGN is showing up on older posts and not on new posts found in link below, The DTCC issues may have been addressed and fixed. Always call the broker if your security turns up on any DTCC/PENSON list.
http://investorshub.advfn.com/boards/msgsearchbyboard.aspx?boardID=18682&srchyr=2011&SearchStr=Complete+list
For a complete list see the pinned threads at the top here ---> http://tinyurl.com/TWO-OLD-FARTS
MACDlinks
Amgen Inc. First Quarter Earnings Sneak Peek http://wll.st/JjaYFz
AMGN PRESS RELEASE: Amgen and AstraZeneca Announce Collaboration to
Jointly Develop and Commercialize Clinical-Stage Inflammation Portfolio
Collaboration Comprises Five Monoclonal Antibodies
Brodalumab (AMG 827) Phase 3 Trial Planned in 2012
THOUSAND OAKS, Calif. and LONDON, April 2, 2012 /PRNewswire/ -- Amgen
(NASDAQ:AMGN) and AstraZeneca Plc, today announced an agreement to jointly
develop and commercialize five monoclonal antibodies from Amgen's clinical
inflammation portfolio (AMG 139, AMG 157, AMG 181, AMG 557 and brodalumab (AMG
827)).
The companies believe all the molecules have novel profiles and offer the
potential to deliver important treatments across multiple indications in
inflammatory diseases. The collaboration will provide Amgen with additional
resources to optimally progress its portfolio, and Amgen will benefit from the
strong respiratory, inflammation and asthma development expertise of MedImmune,
AstraZeneca's biologics arm. The collaboration will also capitalize on
AstraZeneca's global commercial reach in respiratory and gastrointestinal
diseases. The agreement does not include certain territories previously
partnered by Amgen for brodalumab with Kyowa Hakko Kirin and AMG 557 with
Takeda.
Under the terms of the agreement, AstraZeneca will make a one-time $50
million upfront payment and the companies will share both costs and profits.
Based on current plans, approximately 65 percent of costs for the 2012-2014
period will be funded by AstraZeneca. Thereafter, the companies will split
costs equally. Amgen will book sales globally and will retain a low
single-digit royalty for brodalumab and a mid single-digit royalty for the rest
of the portfolio, after which the companies will share profits equally.
AstraZeneca will lead the development and commercial strategy of AMG 139, AMG
157 and AMG 181, while Amgen will lead the development and commercial strategy
of brodalumab and AMG 557. Each development and commercialization lead will be
under the oversight of joint governing bodies. For brodalumab, commercial
promotion will be split. Amgen will promote in dermatology indications in the
United States (U.S.) and Canada, and in rheumatology indications in the U.S.,
Canada and Europe. AstraZeneca will promote in respiratory and, initially, in
dermatology indications of brodalumab across all territories outside the U.S.,
Canada and those markets where Amgen has existing partnerships. Allocation of
promotional rights for other territories, indications and molecules will be
agreed later between the companies.
"We are delighted to join forces with Amgen in developing and commercializing
these novel clinical-stage assets that add value to our pipeline and build on
our expertise in biologics. This creative collaboration will make the most of
both companies' respective capabilities, including AstraZeneca's extensive
global reach, to help bring these potentially innovative treatment options for
a variety of respiratory and inflammatory diseases to patients around the
world," said David Brennan, Chief Executive Officer, AstraZeneca.
"We are very excited at the prospect of collaborating with a well-respected
organization like AstraZeneca to advance our inflammation pipeline," said Kevin
Sharer, Chairman and CEO at Amgen. "We believe this collaboration has the
potential to bring more therapies to patients sooner, across more geographic
areas. We are impressed with AstraZeneca's extensive experience in developing
and launching products in the respiratory and gastroenterology areas, and
believe this collaboration is an opportunity to work with a partner that has
leading regulatory and commercial expertise in inflammation indications."
NOTES TO EDITORS
About the inflammation portfolio included in the agreement
Under the agreement, the companies will jointly develop and commercialize the
following five assets from Amgen's clinical-stage portfolio:
-- Brodalumab (AMG 827) is a human monoclonal antibody that binds to and
blocks signaling via the IL-17 receptor. Brodalumab is being investigated
for psoriasis (completed Phase 2 and planned Phase 3), psoriatic
arthritis (Phase 2) and asthma (Phase 2).
-- AMG 139 is a human monoclonal antibody. AMG 139 is being investigated in
Phase 1b for Crohn's disease.
-- AMG 181 is a human monoclonal antibody. AMG 181 is being investigated in
Phase 1a and Phase 1b for ulcerative colitis and Crohn's disease.
-- AMG 557 is a human monoclonal antibody that binds to B7-related protein 1
(B7RP-1). AMG 557 is being investigated in Phase 1b for autoimmune
diseases such as systemic lupus erythematosus.
-- AMG 157 is a human monoclonal antibody that blocks interaction of thymic
stromal lymphopoietin (TSLP) with the TSLP receptor. AMG 157 is being
investigated in Phase 1b for asthma.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative human
therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first
companies to realize the new science's promise by bringing safe and effective
medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have
changed the practice of medicine, helping millions of people around the world
in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease
and other serious illnesses. With a deep and broad pipeline of potential new
medicines, Amgen remains committed to advancing science to dramatically improve
people's lives. To learn more about our pioneering science and our vital
medicines, visit www.amgen.com. Follow us on www.twitter.com/amgen.
About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a
primary focus on the discovery, development and commercialization of
prescription medicines for gastrointestinal, cardiovascular, neuroscience,
respiratory and inflammation, oncology and infectious disease. AstraZeneca
operates in over 100 countries and its innovative medicines are used by
millions of patients worldwide. For more information please visit:
www.astrazeneca.com.
Amgen Forward Looking Statements
This news release contains forward-looking statements that are based on
Amgen's current expectations and beliefs and are subject to a number of risks,
uncertainties and assumptions that could cause actual results to differ
materially from those described. All statements, other than statements of
historical fact, are statements that could be deemed forward-looking
statements, including estimates of revenues, operating margins, capital
expenditures, cash, other financial metrics, expected legal, arbitration,
political, regulatory or clinical results or practices, customer and prescriber
patterns or practices, reimbursement activities and outcomes and other such
estimates and results. Forward-looking statements involve significant risks and
uncertainties, including those discussed below and more fully described in the
Securities and Exchange Commission (SEC) reports filed by Amgen, including
Amgen's most recent annual report on Form 10-K and most recent periodic reports
on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q
and 8-K for additional information on the uncertainties and risk factors
related to Amgen's business. Unless otherwise noted, Amgen is providing this
information as of April 2, 2012 and expressly disclaims any duty to update
information contained in this news release.
No forward-looking statement can be guaranteed and actual results may differ
materially from those Amgen projects. Discovery or identification of new
product candidates or development of new indications for existing products
cannot be guaranteed and movement from concept to product is uncertain;
consequently, there can be no guarantee that any particular product candidate
or development of a new indication for an existing product will be successful
and become a commercial product. Further, preclinical results do not guarantee
safe and effective performance of product candidates in humans. The complexity
of the human body cannot be perfectly, or sometimes, even adequately modeled by
computer or cell culture systems or animal models. The length of time that it
takes for Amgen to complete clinical trials and obtain regulatory approval for
product marketing has in the past varied and Amgen expects similar variability
in the future. Amgen develops product candidates internally and through
licensing collaborations, partnerships and joint ventures. Product candidates
that are derived from relationships may be subject to disputes between the
parties or may prove to be not as effective or as safe as Amgen may have
believed at the time of entering into such relationship. Also, Amgen or others
could identify safety, side effects or manufacturing problems with Amgen's
products after they are on the market. Amgen's business may be impacted by
government investigations, litigation and products liability claims. Amgen
depends on third parties for a significant portion of its manufacturing
capacity for the supply of certain of its current and future products and
limits on supply may constrain sales of certain of its current products and
product candidate development.
(MORE TO FOLLOW) Dow Jones Newswires
April 02, 2012 16:02 ET (20:02 GMT)
040212 20:02 -- GMT
AMGN news -- btw not released in US so far: Daiichi Sankyo Co : Daiichi Sankyo Files for Approval in Japan to Market AMG 162 (denosumab), a Treatment for Osteoporosis
http://www.4-traders.com/DAIICHI-SANKYO-CO-6498062/news/DAIICHI-SANKYO-CO-Daiichi-Sankyo-Files-for-Approval-in-Japan-to-Market-AMG-162-denosumab-a-Trea-14234504/
Background info on Xgeva sBLA: #msg-57938233, #msg-70374629.
17:33:31 AMGN - FDA to Review Potential New Use of XGEVA(R) (Denosumab) at Oncologic Drugs Advisory Committee Meeting
(Denosumab) at Oncologic Drugs Advisory Committee Meeting
PR Newswire
THOUSAND OAKS, Calif., Dec. 29, 2011
THOUSAND OAKS, Calif., Dec. 29, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN)
today announced the U.S. Food and Drug Administration (FDA) has invited the
Company to participate in a meeting of the Oncologic Drugs Advisory Committee
(ODAC) on Feb. 8, 2012 to discuss the supplemental Biologics License
Application (sBLA) for XGEVA(R) (denosumab) to treat men with
castration-resistant prostate cancer (CRPC) at high risk of developing bone
metastases.
The ODAC will review results from clinical studies in support of this new
indication, including the pivotal '147 trial, a randomized, placebo-controlled,
multi-center Phase 3 study that compared XGEVA to placebo in prolonging bone
metastasis-free survival in men with non-metastatic CRPC who were at high risk
for bone metastases based on prostate specific antigen criteria.
Amgen plans to discuss the proposed sBLA with ODAC, to support the use of
XGEVA in the treatment of men with non-metastatic CRPC; a patient population
for whom there are no approved treatments to delay or prevent the spread of
cancer to bone.
The sBLA was submitted on June 27, 2011, and a Prescription Drug User Fee Act
action date has been scheduled for April 26, 2012. If approved, this will be
the second indication for XGEVA in the United States (U.S.).
About XGEVA
XGEVA is the first and only RANK Ligand inhibitor approved by the FDA
indicated for the prevention of skeletal-related events (SREs) in patients with
bone metastases from solid tumors. XGEVA was initially approved following a six
month priority review by the FDA. XGEVA is not indicated for the prevention of
SREs in patients with multiple myeloma. XGEVA is the first novel bone
metastases treatment for advanced cancer patients in nearly a decade. Delivered
as an every four week 120 mg subcutaneous injection, XGEVA provides a unique
option for urologists and oncologists to prevent SREs in patients with bone
metastases from solid tumors.
XGEVA is a fully human monoclonal antibody that binds to RANK Ligand, a
protein essential for the formation, function and survival of osteoclasts (the
cells that break down bone). XGEVA prevents RANK Ligand from activating its
receptor, RANK, on the surface of osteoclasts, thereby decreasing bone
destruction.
XGEVA has been studied in over 7,000 patients with cancer. In clinical
trials, XGEVA demonstrated a clinically meaningful improvement compared to the
previous standard of care in preventing bone complications. XGEVA is also being
investigated for the potential use to delay the onset of bone metastasis in
adjuvant breast cancer.
XGEVA Important Safety Information
XGEVA can cause severe hypocalcemia. Correct pre-existing hypocalcemia prior
to XGEVA treatment. Monitor calcium levels and administer calcium, magnesium
and vitamin D as necessary. Advise patients to contact a healthcare
professional for symptoms of hypocalcemia.
Osteonecrosis of the jaw (ONJ) can occur in patients receiving XGEVA.
Patients who are suspected of having or who develop ONJ while on XGEVA should
receive care by a dentist or an oral surgeon. In these patients, extensive
dental surgery to treat ONJ may exacerbate the condition.
The most common adverse reactions in patients receiving XGEVA were
fatigue/asthenia, hypophosphatemia and nausea. The most common serious adverse
reaction in patients receiving XGEVA was dyspnea. The most common adverse
reactions resulting in discontinuation of XGEVA were osteonecrosis and
hypocalcemia. Please visit www.amgen.com or www.xgeva.com for full U.S.
prescribing information.
XGEVA Regulatory Status
XGEVA has been approved in the U.S., Canada, the European Union (EU),
Switzerland, Australia and Russia for the prevention of SREs in patients with
bone metastases from solid tumors. XGEVA is not approved to prevent SREs in
patients with multiple myeloma.
Amgen has also submitted marketing applications for XGEVA in Mexico, South
Africa, Gulf Cooperation Council countries, Morocco, and Egypt. In Japan, Amgen
is working with its licensing partner, Daiichi Sankyo Company, Limited and a
marketing application was submitted. In addition, Amgen and GlaxoSmithKline
(GSK) have a collaboration agreement for the commercialization of XGEVA in a
number of countries where Amgen does not currently have a commercial presence.
In these countries, marketing applications are filed by GSK.
Bone Metastases and SREs: Prevalence and Impact
Bone metastases occur in more than 1.5 million patients with cancer worldwide
and are most commonly associated with cancers of the prostate, lung, and
breast, with incidence rates as high as 90 percent of patients with metastatic
disease. [ii] [iii] [iv]
Approximately 50-70 percent of cancer patients with bone metastases will
experience debilitating SREs.[v] [vi] [vii] Events considered to be SREs
include fractures, spinal cord compression, and severe bone pain that may
require surgery or radiation. [viii] Such events can profoundly disrupt a
patient's life and can cause disability and pain. [ix] [x] [xi]
Denosumab and Amgen's Research in Bone Biology
The denosumab development program demonstrates Amgen's commitment to
researching and delivering pioneering medicines to patients with unmet medical
needs. Amgen is studying denosumab in numerous tumor types across the spectrum
of cancer-related bone diseases. Over 11,000 patients have been enrolled in the
denosumab oncology clinical trials. In addition to the prevention of SREs,
XGEVA is also being evaluated for its potential to delay bone metastases in
adjuvant breast cancer.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative human
therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first
companies to realize the new science's promise by bringing safe and effective
medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have
changed the practice of medicine, helping millions of people around the world
in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease
and other serious illnesses. With a deep and broad pipeline of potential new
medicines, Amgen remains committed to advancing science to dramatically improve
people's lives. To learn more about our pioneering science and our vital
medicines, visit www.amgen.com. Follow us on www.twitter.com/amgen.
Forward Looking Statements
This news release contains forward-looking statements that are based on
management's current expectations and beliefs and are subject to a number of
risks, uncertainties and assumptions that could cause actual results to differ
materially from those described. All statements, other than statements of
historical fact, are statements that could be deemed forward-looking
statements, including estimates of revenues, operating margins, capital
expenditures, cash, other financial metrics, expected legal, arbitration,
political, regulatory or clinical results or practices, customer and prescriber
patterns or practices, reimbursement activities and outcomes and other such
estimates and results. Forward-looking statements involve significant risks and
uncertainties, including those discussed below and more fully described in the
Securities and Exchange Commission (SEC) reports filed by Amgen, including
Amgen's most recent annual report on Form 10-K and most recent periodic reports
on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q
and 8-K for additional information on the uncertainties and risk factors
related to our business. Unless otherwise noted, Amgen is providing this
information as of Dec. 29, 2011 and expressly disclaims any duty to update
information contained in this news release.
No forward-looking statement can be guaranteed and actual results may differ
materially from those we project. Discovery or identification of new product
candidates or development of new indications for existing products cannot be
guaranteed and movement from concept to product is uncertain; consequently,
there can be no guarantee that any particular product candidate or development
of a new indication for an existing product will be successful and become a
commercial product. Further, preclinical results do not guarantee safe and
effective performance of product candidates in humans. The complexity of the
human body cannot be perfectly, or sometimes, even adequately modeled by
computer or cell culture systems or animal models. The length of time that it
takes for us to complete clinical trials and obtain regulatory approval for
product marketing has in the past varied and we expect similar variability in
the future. We develop product candidates internally and through licensing
collaborations, partnerships and joint ventures. Product candidates that are
derived from relationships may be subject to disputes between the parties or
may prove to be not as effective or as safe as we may have believed at the time
of entering into such relationship. Also, we or others could identify safety,
side effects or manufacturing problems with our products after they are on the
market. Our business may be impacted by government investigations, litigation
and products liability claims. We depend on third parties for a significant
portion of our manufacturing capacity for the supply of certain of our current
and future products and limits on supply may constrain sales of certain of our
current products and product candidate development.
(MORE TO FOLLOW) Dow Jones Newswires
12-29-11 1733ET
17:33 122911
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