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dew
thanks for the above post,
i know you have probaby stated this already but i cant find it. how does vrtx news affect boceprevir now, the thing that sticks out to me is the "rash" and boceprevir seems to have less side effects.
care to comment
thanks
dough
dew
how big of market do you for see for both these drugs 2-3 billion seems doable. especially with mrk sales force.
thanks
dough
Merck has a very strong record of research and development, Anderson said, and Schering-Plough acquisition shores up the company's pipeline over the next few years.
"From 2010-2015, Merck/Schering-Plough offers the highest growth of the 10 names we cover in the U.S. and Europe," he said.
Anderson deemed the thrombin receptor antagonist the most important drug in the Schering-Plough pipeline.
http://www.schering-plough.com/binaries/Products-in-Development.pdf
looks like mrk got good one here
Merck continues to rally on Schering drug data
Friday March 13, 3:20 pm ET
Merck jumps after Schering-Plough posts anti-clotting drug news; analyst lifts stock to 'Buy'
NEW YORK (AP) -- Shares of Merck and Co. surged Friday after Schering-Plough Corp., which it plans to acquire, reported positive trial results for an anti-clotting drug.
Before the start of trading, Schering-Plough said its drug candidate SCH 530348 met its chief goal in a mid stage clinical trial. The drug is intended to reduce clots during surgery without causing increased bleeding, and is part of the pipeline of heart drugs that led Merck to agree to buy Schering-Plough for $41.1 billion on March 9.
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Merck shares advanced $3.32, or 13.8 percent, to $27.36 in afternoon trading, continuing a three-day rally which has seen its stock climb 14.5 percent. The shares dropped to a 13-year low of $20.05 following the Schering-Plough buyout announcement.
In a client note, Bernstein Research analyst Tim Anderson said SCH 530348, also called a thrombin receptor antagonist, could eventually grow to several billion dollars a year. He upgraded Merck shares to "Outperform" from "Market Perform," and said the Schering-Plough buyout strengthens Merck's position in the coming years.
Merck has a very strong record of research and development, Anderson said, and Schering-Plough acquisition shores up the company's pipeline over the next few years.
"From 2010-2015, Merck/Schering-Plough offers the highest growth of the 10 names we cover in the U.S. and Europe," he said.
Anderson deemed the thrombin receptor antagonist the most important drug in the Schering-Plough pipeline.
dew
is this good thing or bad thing in your opinion
thanks
dough
ARIA continues to be strong going thru its 200 day moving avg
anyone else hearing anything here
http://stockcharts.com/h-sc/ui?s=aria
Barclay's report on Ariad 18-Jan-09 12:48 am This was from Barclay, formerly Lehman Bros.
January 15, 2009
ARIAD Pharmaceuticals (ARIA - US$ 1.19) 1-Overweight
Company Update
ARIA Management Update
Investment Conclusion
We are maintaining our 1-Overweight rating on
shares of ARIA following a meeting with
management yesterday in SF. Overall programs
remain on track with broadening development of
deferolimus beyond sarcoma to
HRPC/NSCLC/mBC and endometrial CA,
sufficient balance sheet to see programs to fruition
with partner Merck and option value to favorable
resolution of NFkB litigation with LLY.
Overview
ARIA management met yesterday with the BCS biotech team to provide an update on key programs and corporate initiatives. With primary
focus on balance sheet risk ARIA highlighted expected early 1Q09 cash balance of $51M with expected cash burn of $24M. Additional
options for financing include partnering of earlier assets, potential reallocation of spending in the Merck agreement, and access to a $200M
R&D advances beginning by YE10.
Key catalysts remain on track with SUCCEED phase III data expected by YE09, proof-of-concept data for -534 by ASH and NfKB appellate
court decision within a few months of arguments on February 6th. We have previously estimated incremental value of NfKB jury verdict at
$2.50/share ($65M + 2.3% royalty on Evista/Xigris) with incremental value to elimination of capital market risk.
lot of talk about this lly court date, anyone following this
thanks
dough
ARIAD Announces 2009 Key Corporate Objectives
Clinical Data on Deforolimus and AP24534 Anticipated in Second Half of Year
Tuesday January 13, 2009, 7:30 am EST
Yahoo! Buzz Print Related:Ariad Pharmaceuticals Inc.
CAMBRIDGE, Mass.--(BUSINESS WIRE)--ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA - News) today announced 2009 key corporate objectives and financial guidance, details of which will be presented at the 27th Annual JPMorgan Healthcare Conference on January 15, 2009 in San Francisco, California.
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Symbol Price Change
ARIA 1.20 0.00
{"s" : "aria","k" : "c10,l10,p20,t10","o" : "","j" : ""} “The past year was the most productive in ARIAD’s history. We achieved the corporate objectives established at the beginning of 2008 and set the stage for the future growth of the Company,” said Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “With our continuing focus and momentum, we expect to generate important data from our clinical trials of deforolimus and AP24534, advance our next internally discovered drug candidate into development and prepare to commercialize our potential oncology products.”
Dr. Berger will outline a series of key corporate goals for ARIAD in 2009 that will move the Company closer to realizing its vision of transforming the lives of cancer patients with breakthrough medicines. These corporate goals include:
Continue to maximize the deforolimus opportunity through execution of the global development plan in collaboration with Merck & Co., Inc.,
Advance ARIAD’s innovative oncology pipeline, including AP24534 and its latest novel oncology product candidate,
Further establish its manufacturing, operations and commercial infrastructure to prepare its product candidates for market, and
Strengthen its balance sheet to maintain a solid financial position.
“Our partnership with Merck is strong and vibrant, and the deforolimus development program, including the SUCCEED trial, is moving ahead on plan and on budget,” he added. “We expect to complete enrollment in the SUCCEED trial before the end of the year, leading to the second interim efficacy analysis. Additionally, we continue to see the potential commercial opportunity for deforolimus expanding as we explore the clinical utility of deforolimus in many different types of cancers. At the same time, our AP24534 development program in hematological malignancies is proceeding as planned, and we expect our investigators to present the first clinical data on this product candidate later in the year.”
Maximize and Execute on the Deforolimus Opportunity
The two primary drivers of the deforolimus opportunity are completion of the SUCCEED Phase 3 trial of oral deforolimus in patients with metastatic sarcomas and completion of the Phase 2 trials of deforolimus in patients with other types of solid tumors. The SUCCEED trial is enrolling patients around the world and is currently on track for full patient accrual in fourth quarter 2009, as initially projected when the trial was started in late 2007. Additionally, the first and second interim efficacy analyses of the trial are expected to take place this year, with their exact timing based on the occurrence of a pre-specified number of clinical events. The Company expects to begin filing the initial portions of the new drug application (NDA) for oral deforolimus by next year.
Phase 2 clinical studies evaluating deforolimus in patients with breast, endometrial and prostate cancer are enrolling, and a fourth Phase 2 clinical trial of deforolimus in patients with non-small cell lung cancer is expected to begin in 2009. Initial Phase 2 clinical data are also anticipated this year. Deforolimus is being studied both as a single agent and in combination with various targeted agents, including bevacizumab (Avastin®) and trastuzumab (Herceptin®), driven by their mechanisms of action and biology. Deforolimus is also being studied in combination with Merck’s IGF-1R inhibitor in patients with solid tumors, in a pediatric population of patients with solid tumors, and in Japanese cancer patients to potentially provide access to the Japanese market.
Advance AP24534 and Innovative Oncology Pipeline
ARIAD expects to report clinical proof-of-concept data in 2009 for its second oncology product candidate, AP24534, currently being evaluated in a multi-center Phase 1 trial of patients with drug-resistant and refractory hematological malignancies, including chronic myeloid leukemia (CML) and acute myeloid leukemia (AML). AP24534 is an oral, multi-targeted kinase inhibitor that is designed for use in a variety of cancer types. Preclinical data of AP24534 reported last year show that this product candidate potently inhibits the kinase targets associated with drug-resistant CML, including all known mutant variants of the target protein, Bcr-Abl, as well as targets associated with AML. The potential of AP24534 in specific solid tumors will also be explored through additional clinical studies.
ARIAD plans to advance its third oncology product candidate into preclinical development this year in anticipation of filing an investigational new drug application (IND). ARIAD scientists have discovered targeted kinase inhibitors that potently inhibit the emerging and promising cancer target, anaplastic lymphoma kinase (ALK). This target has been implicated in specific forms of non-small cell lung cancer, lymphomas and neuroblastoma, among others, and regulates multiple pathways important for cancer pathogenesis. ARIAD’s research on ALK inhibition builds on the Company’s long-standing success in applying its expertise in cell signaling, cancer biology and computational drug-discovery to the design and characterization of small-molecule drugs. The Company expects to present initial scientific data on this new product candidate at a major oncology meeting this year.
Strengthen Balance Sheet and Maintain Solid Financial Position
The Company expects to end fiscal year 2008 with approximately $39 million in cash and marketable securities, or approximately $51 million when including a $12.5 million milestone payment to be received from Merck related to the Phase 2 clinical trial in patients with advanced prostate cancer that began in the fourth quarter of 2008. The Company expects to report cash used in operations in 2008 of approximately $51 million, or approximately $38.5 million when including the prostate cancer trial milestone. These adjusted amounts are consistent with the most recent guidance provided by ARIAD. The Company also expects to report a net loss for 2008 of approximately $74 million, also in line with its most recent financial guidance.
For fiscal year 2009, the Company estimates cash used in operations of $24 million to $28 million, a decrease of approximately $23 million to $27 million from 2008, reflecting an expected increase in milestone payments from Merck of approximately $37 million based on the expected initiation of certain Phase 2 and Phase 3 clinical trials of deforolimus. In addition, the Company estimates a net loss of approximately $78 million to $82 million, an increase of approximately $4 million to $8 million from 2008, reflecting primarily the costs of the on-going development of deforolimus in conjunction with Merck. The financial projections for 2009 exclude additional potential partnering revenues beyond the Merck oncology collaboration.
“We are demonstrating strong financial discipline in managing the Company and are assessing several sources of incremental funding for our programs. We expect to bring one or more of these initiatives to fruition early this year,” said Edward M. Fitzgerald, senior vice president and chief financial officer. “We are committed to strengthening our balance sheet and ensuring that we are well positioned financially to support our key business objectives for 2009. Importantly, our collaboration with Merck is intended to make the development of deforolimus essentially cost-neutral to ARIAD based on the projected flow of milestone payments from Merck and Merck’s funding of its share of development costs.”
Presentation Reminder
As previously announced, Dr. Berger will provide an overview of the Company at the 27th Annual JPMorgan Healthcare Conference on January 15, 2009 in San Francisco, California, at 10:30 a.m. PT (1:30 p.m. ET), highlighting the plans for the Company’s oncology product candidates, its drug-discovery programs and financial guidance for fiscal year 2009.
The ARIAD presentation will be webcast live and can be accessed by visiting the investor relations section of the Company's website at http://www.ariad.com/investor. A replay will be available on the ARIAD website approximately twenty-four hours after the presentation and will be archived for four weeks.
About ARIAD
masterlongevity
thanks for the post, just curious why imgn has not seem to react more to what seems very good news. besides it being early, it does appear to be the next blockbuster in treatment of breast ca.
dough
ARIA adds some very impressive board members today, looks to be gearing for the NDA.
Press Release Source: ARIAD Pharmaceuticals, Inc.
ARIAD Expands Management Team with Executive Appointments in Regulatory Affairs, Manufacturing and Information Technology
Tuesday January 6, 2009, 7:30 am EST
Yahoo! Buzz Print CAMBRIDGE, Mass.--(BUSINESS WIRE)--ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA - News) today announced the appointment of three senior executives to ARIAD’s management team in newly created positions: Daniel M. Bollag, Ph.D. as senior vice president, regulatory affairs and quality, Andreas Woppmann, Ph.D. as vice president, manufacturing operations and Kelly M. Schmitz as vice president, information technology and operations.
“We are very pleased to welcome these talented professionals to our senior management team,” said Harvey J. Berger, M.D., chairman and chief executive officer. “Their broad industry expertise augments our current leadership team and demonstrates our commitment to building a fully integrated oncology business. We look forward to benefiting from their knowledge and experience as we advance our corporate goals for 2009 and beyond. With these key appointments, we have rounded out our senior management team as part of our enterprise transformation.”
Daniel M. Bollag, Ph.D.
Senior Vice President, Regulatory Affairs and Quality
Dr. Bollag will lead regulatory strategy and operations, including the anticipated filing of a new drug application for oral deforolimus in patients with metastatic sarcomas. He will also be responsible for directing the Company’s global quality systems. Dr. Bollag has approximately fifteen years experience in the pharmaceutical industry, of which the last six have been focused on regulatory affairs. Prior to joining ARIAD, he served as vice president, regulatory affairs for Genzyme Corporation, and associate vice president, global regulatory affairs at Sanofi-Aventis Pharmaceuticals, Inc. At Genzyme, he was the regulatory executive responsible for plerixafor (Mozobil™), a recently approved hematopoietic stem-cell mobilizing agent for use in certain types of cancer patients. Prior to that, Dr. Bollag conducted research elucidating the anti-tumor properties of epothilones at Merck & Co., Inc. and contributed to the development of ixabepilone (Ixempra™) as a program management executive at Bristol-Myers Squibb, Inc. Dr. Bollag received a Ph.D. degree in biochemistry from Cornell University and completed a postdoctoral research fellowship at Princeton University.
Andreas Woppmann, Ph.D.
Vice President, Manufacturing Operations
Dr. Woppmann will lead global manufacturing, supply chain, logistics and process development for pre-approval and commercial products, including ongoing preparation for potential launch of oral deforolimus. Dr. Woppmann brings extensive operational experience to ARIAD, gained over more than twenty years in the global biotechnology and pharmaceutical industry, including the successful development, licensure and commercialization of more than ten pharmaceutical products. Most recently, Dr. Woppmann was vice president, pharmaceutical development, operations and quality at Indevus Pharmaceuticals, Inc., where he led the transformation from development to the commercial stage. Previously, he held management positions at Biogen Idec, Inc., Transkaryotic Therapies, Inc. (Shire plc) and Antigenics, Inc. Dr. Woppmann received his doctorate from the Free University of Berlin for research conducted at the Max-Planck Institute for Molecular Genetics in Berlin, Germany.
Kelly M. Schmitz
Vice President, Information Technology and Operations
Mr. Schmitz will oversee ARIAD’s expanding information technology and operations infrastructure. Mr. Schmitz brings more than twenty years of experience in the field of information technology and is actively involved with several industry organizations. Prior to joining ARIAD, Mr. Schmitz served as vice president, solutions practice for Maxiom Consulting Group, and information technology director, business applications and production for Cubist Pharmaceuticals, Inc. He has a B.S. degree in Recombinant Gene Technology from the State University of New York.
About ARIAD
aria i know most dont like the ceo of this company but come on .72 cents for a company with a very good product in phase 3 parterned with mrk. i am buying alot down here. anyone else???
dew you wrote " One of the few areas Peter Kim declined to discuss on the webcast was MRK’s program in AD. Why? I would hazard a guess that MRK does not want to tip off WYE, ELN, and LLY about what it knows."
i could not agree with you more. very odd they did not talk at all, and if you look at there slides, they are very active in this area.
thanks agian for your input
dough
dew
thanks for the update on mrk, i do appreciate your response.
i am currently invested in mrk, and looking to add alot more over the next few months. i feel mrk longterm, combined with its pipeline seems like very good buy here.
i am really am excited about there chf drug, and the staph vaccine looks to be huge.
anyway enough babbling, good day and thanks
dough
thanks for replying
Dew when you get time could you comment on post 69811 and 69813
i own both itmn and vrtx. but mrk look like it has a serious threat here. imho
thanks
dough
more on mrk MK-7009
E. Lawitz and colleagues presented results from a study of the safety, tolerability, and antiviral activity of Merck's NS3/4A protease inhibitor MK-7009. The agent previously demonstrated potent activity in HCV replicon systems and infected chimpanzees.
In the present study, 33 treatment-naive and treatment-experienced chronic hepatitis C patients (85% men) with HCV genotype 1 (73% 1a) and high baseline viral load were randomly assigned to receive placebo or MK-7009 monotherapy at doses of 125 mg once-daily (qd), 600 mg qd, 25 mg twice-daily (bid), 75 mg bid, 250 mg bid, or 500 mg bid for 8 days. They were then followed for 14 days after the last dose.
After 8 days of therapy, the maximum observed decrease in HCV RNA was about 4 log10 IU/mL, and 70% overall achieved more than a 3 log10 decrease in HCV RNA at least once. The most common AEs overall were diarrhea and nausea. No serious adverse events (AEs) were reported, no pattern of laboratory or ECG abnormalities was observed, and no participants discontinued the study due to clinical or laboratory AEs.
"MK-7009 has potent antiviral activity during 8 days of monotherapy in patients with chronic genotype 1 HCV infection," the investigators concluded. "In these patients, MK-7009 was generally well-tolerated with no serious AEs, discontinuations due to AEs or safety laboratory abnormalities. Further development of this HCV NS3/4A protease inhibitor, including studies in combination with other anti-HCV agents, is warranted."
In a related pharmacokinetics study of MK-7009 in healthy HCV negative volunteers, investigators likewise observed no serious AEs. Taking the drug with a high-fat meal did not have a meaningful effect on plasma levels. Accumulation occurred over the 14-day dosing period in all subjects, and the apparent terminal half-life was about 4.5 hours regardless of dose, which suggests the feasibility of twice-daily dosing.
Mrk mk-7009 Protease inhibitor summary its early but looks very good imho. well tolerated, and oral.
http://www.natap.org/2008/AASLD/AASLD_09.htm
dough
mrk for the first time releases its MK-7009
protease inhibitor
twice daily dosing, no side effects trying to post a link to the webcast but having trouble
dew what do you think
mrk new breast cancer drug hopefully this link will work
http://www.nytimes.com/2007/12/21/scienc...
http://www.nytimes.com/2007/12/21/science/21stem.html?_r=1&hp=&adxnnl=1&oref=slogin&adxnnlx=1198674268-UcpcaFrfjw9U0XRFYy0o6w
and the last 3 paragraphs of this article very interesting research
http://www.cancerpublications.com/newsletter/other/merck_slide/august_06/article3/article.html
curious what others think of this article in nytimes and possible outcomes for merck, looks to have great potential and possibly the best hope for breast cancer in longtime
http://www.nytimes.com/2007/12/21/scienc...
the more i research, the more i see how exciting this could be
http://www.cancer.gov/Templates/drugdict...
MK0752
A synthetic small molecule with potential antineoplastic activity. MK0752 inhibits the Notch signaling pathway, which may result in induction of growth arrest and apoptosis in tumor cells in which the Notch signaling pathway is overactivated. The Notch signaling pathway plays an important role in cell-fate determination, cell survival, and cell proliferation.