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re: Feuerstein
Quote from the article: "Feuerstein added that the company might be a takeover candidate at some point, just not by the above companies, especially since it has a small market cap at its current valuation."
Call buyers have been active in Ariad Pharmaceuticals, Inc.'s (NASDAQ:ARIA) options pits in recent months, per data from the International Securities Exchange (ISE), Chicago Board Options Exchange (CBOE), and NASDAQ OMX PHLX (PHLX). Specifically, ARIA's 50-day call/put volume ratio of 14.51 across these exchanges ranks in the 86th annual percentile.
Echoing this call-skewed bias is ARIA's Schaeffer's put/call open interest ratio (SOIR) of 0.31, which rests lower than 61% of all comparable readings taken in the past year. In other words, short-term speculators are slightly more call-heavy than usual toward the security.
In the front-month series -- which expires at tonight's close -- peak call open interest is found at the April 9 strike, where 4,310 contracts are housed. Looking out to the May-dated series, call players have shown a preference for the 10 strike, where 16,190 contracts currently reside. According to the ISE, CBOE, and PHLX, the majority of the positions at both strikes have been bought to open in recent months. Of note, a move north of $10 would mark the equity's highest perch since October 2013.
Technically speaking, ARIA has been a standout, boasting a year-to-date lead of 31%. In fact, the shares hit an annual high of $9.23 earlier, after the firm unveiled updated clinical data on its alk+ non-small cell lung cancer treatment, brigatinib. However, the security has not been able to avoid broad-market headwinds, and was last seen off 1.1% at $9.
source: http://www.schaeffersresearch.com/commentary/content/blogs/ariad+pharmaceuticals+inc+aria+option+bulls+cheer+new+highs/trading_floor_blog.aspx?blogid=125216
Here is the Form 483 (dated Oct 16 2014).
Thanx to prosper_control!
re: Tim Clackson
Timothy P Clackson, President of ARIAD Pharmaceuticals, recently cashed-in 49,035 options. The options were exercised at prices ranging between $2.62 and $4.49, while the disposals took place at $8.00 per share, on February 20, 2015. Clackson continues to hold 428,232 shares of the company.
[...]
This sale was effected pursuant to a rule 10b5-1 trading plan adopted by the reporting person in June 2014.
source: http://www.conferencecalltranscripts.org/4/summary/?id=1483621
and http://www.sec.gov/Archives/edgar/data/884731/000112760215007937/xslF345X03/form4.xml
FMI: Foundation Medicine to Be Added to NASDAQ Biotechnology Index
Foundation Medicine, Inc. (FMI) today announced that the Company will be added to the NASDAQ Biotechnology Index (NASDAQ:NBI), effective prior to the market open on Monday, December 22, 2014.
source: http://finance.yahoo.com/news/foundation-medicine-added-nasdaq-biotechnology-113000777.html
FMI: Google to offer Foundation Medicine's cancer tests as latest health benefit
By Christina Farr
SAN FRANCISCO, Nov 5 (Reuters) - Google will soon start covering the cost of Foundation Medicine's DNA tests for employees and their family-members suffering from cancer, as part of its health benefits portfolio.
Foundation Medicine's chief executive Michael Pellini gave a nod to the deal with Google during a corporate earnings call on Wednesday, according to a person who listened in. Pellini said Google employees were made aware of this new benefit last week.
Google declined to comment.
Foundation Medicine helps steer oncologists to a drug treatment based on the patient's genetic profile. Its two commercially available tests range from $5,800 to $7,200.
Google will start covering these tests in January, 2015.
[...]
Google's investment arm Google Ventures has previously invested in Foundation Medicine. Google Ventures' partner Krishna Yeshwant sits on Foundation Medicine's board.
source: http://finance.yahoo.com/news/google-offer-foundation-medicines-cancer-223350254.html
no, it is not a rumor (look at new timetable):
http://www.ema.europa.eu/ema/index.jsp?curl=search.jsp&&q=iclusig&sort=date%3AD%3AS%3Ad1
ARIAD downgraded to Sell from Neutral at Citigroup
Citigroup downgraded ARIAD to Sell citing a limited U.S. market opportunity for Iclusig and potential downside from future updates.
Citi raised its price target for shares to $5.50 from $2.50.
source: theflyonthewall.com
CHMP meeting highlights:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/12/news_detail_001992.jsp&mid=WC0b01ac058004d5c1
In ARIADs case, no news is good news, I guess.
PS: This site shows that iclusig is still approved. So no suspension.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002695/human_med_001656.jsp&mid=WC0b01ac058001d124
As far as I know, news from the meetings are usually released on fridays.
btw. here is the agenda of the EMA meeting (CHMP): http://www.ema.europa.eu/docs/en_GB/document_library/Agenda/2013/12/WC500158398.pdf
Iclusig is on page 18.
I guess, the outcome of the meeting was good.
Officially, we will hear more on friday.
This is old news! This paper was published Nov. 27th.
Imo, ARIA was up today because there is hope that there is no suspension!
“Many of the events with TKIs tend to happen at the beginning of the exposure, and new events later on are unlikely or at least the incidence decreases significantly,” Cortes said. “What we’re seeing with ponatinib is the cumulative incidence continues to grow. There’s no drop-off after the first few months of exposure when patients usually are at a decreased risk for other common, less serious adverse events.”
Yet the benefits seen with ponatinib warrant further investigation, Cortes said.
“Defining the population at greater risk for adverse events, and identifying an intervention that would eliminate or at least significantly mitigate these risks, are two areas that we need to work on to make this drug useable,” Cortes said.
http://www.healio.com/hematology-oncology/hematologic-malignancies/news/online/%7B2b1d6109-030d-42e5-b795-2e678358a6f5%7D/ponatinib-demonstrated-activity-in-patients-with-cml-phall
FYI: FDA Cancer Czar Floats Change to Drug Review Process
Each passing year, evidence grows that there is no single type of “breast cancer” or “lung cancer.” These broad categories simply refer to diverse tumors that just happen to originate in certain parts of the body. Scientists now know that what matters most in determining the behavior of a particular cancer (and its response to specific therapy) are the molecular pathways that drive malignant cell growth instead of where the tumor begins in the body. A tumor in the lung and a tumor in the breast, for example, may have more in common with one another (and be fueled by abnormalities in the same pathway) than two different breast cancer malignancies.
And yet, cancer drugs are still approved by the U.S. Food and Drug Administration on a disease-by-disease basis. So if researchers think that an individual drug for, say, chronic myeloid leukemia might work against a different kind of tumor because the two illnesses share similar biological underpinnings, they have to conduct a whole new clinical trial and go through the approval process all over again for the second condition.
That standard approach might be about to change. A new process, in which the FDA approves cancer drugs on the basis of which malfunctioning growth pathways they target rather than on what doctors call the resultant condition, has been quietly batted about on the sidelines of conferences or over drinks among oncologists for the past couple years. Although the FDA has not formally proposed any such change, the agency’s cancer czar, Richard Pazdur, floated the idea at a public conference on cancer care earlier this month in Washington, D.C., suggesting the idea may be gaining official traction.
If enacted, such a regulatory scheme could conceivably speed along clinical trials because it would allow investigators to draw from a large pool of people with diverse tumors that act along the same pathway instead of culling thousands of people with the same official cancer type. "Much still needs to be learned, but as we further understand cancers, it is possible we could see a shift from approving drugs based on disease type to the molecular pathways that drive them," says Stephanie Yao, an FDA spokesperson.
There is a catch: because each drug is a unique molecular entity, it has the potential to behave slightly differently in the body even if it targets the same pathway as another drug with a sterling record. Take ponatinib, a drug that targets the hallmark molecular abnormality in chronic myeloid leukemia (CML). Several other drugs that inhibit the same biological target had already been approved for frontline CML treatment. Promising early-stage trial results led to ponatinib’s application being fast-tracked, and it was approved in December 2012. Last month, however, less than a year after it received its clearance, the medication was taken off the market because the evidence revealed an uptick in life-threatening blood clots and cardiovascular issues. If ponatinib had been cleared under the proposed new scheme, however, several cancer doctors worry that the deleterious impacts may not have been picked up as quickly.
With a faster process a drug might get to market before as much safety data were collected. Once the FDA green-lights a drug and it is ushered into the hands (and IVs) of patients, there is no real incentive for a company to continue to collect information about side effects in any systematic way. When they learn about bad reactions to the drug they are legally required to report them, but they do not regularly survey patients as they do during the approval process. “There is no track record that this [new approach] would work,” says Hagop Kantarjian, the chair of the department of leukemia at the University of Texas M. D. Anderson Cancer Center. “It could be a way to clear drugs faster, but the better way to do that would be to reduce the hurdles to clear,” he says. Of course, because the proposal has not actually been put forward by FDA it is hard to tell exactly what the level of scrutiny would be for drugs that were cleared through such an avant-garde approach.
Source: http://news.yahoo.com/fda-cancer-czar-floats-change-drug-review-process-120000099.html
FYI: Pfizer withdraws Bosulif in Germany
Published on Friday, November 15, 2013
Pfizer Inc. (NYSE:PFE) broke off pricing negotiations with Germany's Statutory Health Insurance Funds Association (GKV-Spitzenverband) for Bosulif bosutinib and said it will no longer market the Orphan cancer drug in Germany. Pfizer said there was "no prospect of reaching an agreement" on Bosulif's price after the first round of negotiations. Last month, Germany's Federal Joint Committee (G-BA) said Bosulif has an "unquantifiable" additional benefit for adults with chronic, accelerated or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) -- the indication for which the dual inhibitor of BCR-ABL and Src kinase has conditional approval in the EU (see BioCentury Extra, Oct. 17).
Pfizer said this is the first time an Orphan drug has been taken off the market in Germany because of drug pricing law AMNOG. In August, Pfizer and the country's Institute for Quality and Efficiency in Healthcare (IQWiG) estimated that Bosulif would cost the German statutory health insurance funds (GKV) up to EUR 34.4 million ($46 million) per year.
http://www.biocentury.com/dailynews/company/2013-11-15/pfizer-breaks-off-german-pricing-talks-withdraws-bosulif
This is old news... - the CHMP has not published its decision, yet.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2012/07/event_detail_000654.jsp&mid=WC0b01ac058004d5c3
Hopes and dreams... - Hans Loland shares his story in the AACR Cancer Progress Report 2013. He has been living with chronic myelogenous leukemia (CML) since 2008:
Re: EPIC trial (from the CC)
Ying Huang
Barclays Capital
Good morning, thanks for taking my questions as well the first one is based on the event rate you have seen from the EPIC trial. Can you elaborate what you have in terms of from both of events compared to what we saw from and then second question is given the new development what are you seeing about the SG&A and then particularly I guess the sales and marketing expenses. Thank you.
Corporate Participant
Again, I'll take the first question so, we have seen events in the Iclusig of the trial. I think it's somewhat doesn't really matter how many events that we'd seen I think the situation is now that we have a higher concern about those events you know Vascular events in particular now that we are in the new regulatory situations that we sit in. We have visibility on those events that has grown, the events and accumulate overtime. And I think in the context of that, that makes it a clear decision from the patients safety and also development point of view to terminate the trial.
It's really difficult to think about and obviously the pace try as much moment rial than the EPIC trial growth. Frank, do you would add anything?
Timothy P. Clackson, Ph.D.
President of Research and Development and Chief Scientific Officer
I don't think I would add much other than that we didn't cross any pre-defined threshold. The DMC did not stop the trial. It's really our evaluation of the data. In the context of what we have learned over the last week or so about regulatory acceptance of our data in the climate for potential registration.
source: http://www.earningsimpact.com/Transcript/84137/ARIA/Ariad-Pharmaceuticals,-Inc----Corporate-Conference-Call/Page/2#sthash.KwbrJhmD.dpbs
ARIA: The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC), at its 4-7 November meeting, reviewed new information on the cancer medicine Iclusig (ponatinib) that suggests that side effects such as vascular occlusive events (blood clots obstructing the arteries or veins) occur at a higher rate than initially observed at the time of granting the European Union (EU) marketing authorisation in July 2013.
Conditions related to thrombosis such as myocardial infarction (heart attack) are known side effects of Iclusig and the current EU product information mentions the risk of myocardial infarction, cerebral infarction (stroke) and related disorders.
The PRAC advice is that patients and healthcare professionals may continue to use this medicine with increased caution in its authorised use and should monitor carefully for evidence of thromboembolism (formation of blood clots in the veins and arteries) and vascular occlusion.
Iclusig is an anticancer medicine belonging to the class of tyrosine kinase inhibitors, used to treat patients with chronic myeloid leukaemia and Philadelphia-chromosome positive acute lymphoblastic leukaemia. In the EU, since the initial approval, the medicine’s use had been limited to patients who had no other available treatment options with medicines of this class, for example because they were intolerant to other medicines of this class or their disease was resistant to such treatment.
The PRAC has advised that the product information should be updated to include strengthened warnings on the cardiovascular risk and guidance on optimising the patient’s cardiovascular therapy before starting treatment. This advice will now be considered by the Agency’s Committee for Medicinal Products for Human Use (CHMP), in the context of an ongoing procedure started on 24 October 2013 to update the product information of this medicine. The CHMP is expected to issue an opinion during its next meeting, which will take place from 18 to 21 November.
In addition to changes in the product information, the PRAC also highlighted the need to carry out an in-depth review of the medicine’s benefit-risk profile.
http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2013/11/WC500154025.pdf
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC), at its 4-7 November meeting, reviewed new information on the cancer medicine Iclusig (ponatinib) that suggests that side effects such as vascular occlusive events (blood clots obstructing the arteries or veins) occur at a higher rate than initially observed at the time of granting the European Union (EU) marketing authorisation in July 2013.
Conditions related to thrombosis such as myocardial infarction (heart attack) are known side effects of Iclusig and the current EU product information mentions the risk of myocardial infarction, cerebral infarction (stroke) and related disorders.
The PRAC advice is that patients and healthcare professionals may continue to use this medicine with increased caution in its authorised use and should monitor carefully for evidence of thromboembolism (formation of blood clots in the veins and arteries) and vascular occlusion.
Iclusig is an anticancer medicine belonging to the class of tyrosine kinase inhibitors, used to treat patients with chronic myeloid leukaemia and Philadelphia-chromosome positive acute lymphoblastic leukaemia. In the EU, since the initial approval, the medicine’s use had been limited to patients who had no other available treatment options with medicines of this class, for example because they were intolerant to other medicines of this class or their disease was resistant to such treatment.
The PRAC has advised that the product information should be updated to include strengthened warnings on the cardiovascular risk and guidance on optimising the patient’s cardiovascular therapy before starting treatment. This advice will now be considered by the Agency’s Committee for Medicinal Products for Human Use (CHMP), in the context of an ongoing procedure started on 24 October 2013 to update the product information of this medicine. The CHMP is expected to issue an opinion during its next meeting, which will take place from 18 to 21 November.
In addition to changes in the product information, the PRAC also highlighted the need to carry out an in-depth review of the medicine’s benefit-risk profile.
http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2013/11/WC500154025.pdf
Third quarter 2013 conference call changed to Tuesday, November 12, 2013.
http://investor.ariad.com/phoenix.zhtml?c=118422&p=irol-newsArticle&ID=1871115&highlight=
re: Alex Denner and ARIA
Yesterday on Twitter:
Adam Feuerstein ?@adamfeuerstein 28 Okt
Hey Alex Denner: You should get involved with $ARIA. Better use of your time than $VVUS and $ASTX. Change at $ARIA needed.
Hey Alex Denner: You should get involved with $ARIA. Better use of your time than $VVUS and $ASTX. Change at $ARIA needed.
— Adam Feuerstein ✡️ (@adamfeuerstein) October 28, 2013
The FDA has not made a decision on an ODAC meeting, yet, but the company said in their last CC that one is likely(!) in Q01/2013.
FYI: Pfizer (PFE) Offer Weighed By Ariad Pharmaceuticals (ARIA) BOD
Quote: "Sierra's leads now indicate that Pfizer (PFE) has it's merger and acquisition team on the ground in Massachusetts and have an offer in hand, Sierra's leads advise that the BOD of Ariad Pharmaceuticals is scheduled to vote behind closed doors on the offer prior to the conference call discussing 3rd quarter financials scheduled for November 6th, 2013. As a result of NDA's Sierra does not expect official word out until the deal is rejected or accepted, Sierra plans to raise the question at the upcoming conference call!"
http://sierraworldequityreview.blogspot.de/2013/10/the-2013-biotech-buyouts-continue-as.html
PS: I do not trust these guys from Sierra.
re: possible ODAC Panel to review Iclusig’s risk/benefit early next year
"faith is gone" - isn't that a clear sign for the anticyclical investor?!
;o)
Btw, I agree with everything she says about Ariads management. They have made lots of (strategical) mistakes since 2012. I hope this slap in their face will wake them up.
Bloomberg article about the cc: http://www.bloomberg.com/news/2013-10-18/ariad-stops-iclusig-study-because-of-blood-clot-safety-reports.html?cmpid=yhoo
Some quotes:
“It’s the end of Ariad as we know it,” Mike King, an analyst with JMP Securities, said in a telephone interview today. The risks will relegate Iclusig to “break glass in case of emergency” use only, said King, who predicted the company may fire workers and halt plans to expand its headquarters.
Ariad will work in the next few weeks to put a new financial and operating plan in place, Chief Executive Officer Harvey Berger told analysts and investors on a conference call. It’s premature to discuss the potential for a partnership or sale of the company, he said in response to a question.
“We are working as a team on a substantially revised financial plan that will extend out our cash runway substantially beyond where we are today,” Berger said. “We’re taking a fresh look at every component of our budget, every near- and long-term expenditure,” he said, citing clinical trials, facilities and people.
Cory Kasimov, an analyst with JPMorgan Chase & Co. (JPM), downgraded his rating of Ariad stock today to “neutral.”
“After last week’s safety update/implosion, and now this, we can’t in good faith continue to tell people to buy this name,” Kasimov wrote in a research note. We “are stepping to the sidelines until we can get more clarity on the future of this drug.”
Iclusig price in Germany = 7350 EURO = US$ 9750
Quote:drugbase.de
Packungsgrößen (PZN) Preis (EURO)
60 St. (08807759) 7350,24
30 St. (08810299) 7350,24
RBC Capital today maintained an Outperform rating on ARIAD Pharmaceuticals (NASDAQ: ARIA) with a price target of $36.00. Analyst Michael Yee pointed out that April sales of Iclusig rose 58% month-over-month to $4.1 million. The note cites Wolters Kluwer data. Lee said growth was consistent with recent survey info that predicting sizable share gains in second-line CML. Iclusig appears to be on track for Q2 sales of $13-$14 million, he said.
source: http://www.streetinsider.com/Analyst+Comments/April+Data+on+ARIADs+%28ARIA%29+Iclusig+Supports+Bullish+Thesis+-+RBC/8362266.html
Edit:Now I see, that 2damoon1 has already posted the link to this story.
COST
•
AWP (January 2013):
Iclusig 45mg tablets (30): $11,496
Iclusig 45mg tablets (1): $383.20
Iclusig 15mg tablets (1): $191.60
source: http://www.rmhp.org/docs/provider/iclusig_%28ponatinib%29.pdf?sfvrsn=4
I think all the bad news is out (HB selling, lower script numbers, limited EU use) and longs are getting scared... - I think there are worse times to add to a long position, so I bought some more @18.44.
DVAX: Dynavax Receives FDA Complete Response Letter on HEPLISAV(TM) Biologic License Application
BERKELEY, CA--(Marketwire - Feb 25, 2013) - Dynavax Technologies Corporation ( NASDAQ : DVAX ) announced today that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA or Agency) regarding its Biologic License Application (BLA) for HEPLISAV, an investigational adult hepatitis B vaccine.
In the CRL, the FDA specified that the indication in adults 18-70 years of age cannot be approved without further evaluation of safety in this broad age group. The FDA also continues to express concern that novel adjuvants may cause rare autoimmune events. However, the Agency indicated its willingness to continue discussions regarding a more restricted use of HEPLISAV. Dynavax plans to discuss the CRL with the FDA to identify the most expeditious path to approval for HEPLISAV, particularly in adults who may receive the greatest benefit from HEPLISAV.
Furthermore, the FDA requested additional data from Dynavax's process validation program and clarifying information on the manufacturing controls and facilities related to the assurance of the quality of the commercial product. Dynavax believes it can provide the information but the exact timeframe for its response cannot be determined until it has met with the Agency.
Dynavax plans to meet with the FDA to discuss the steps necessary for potential approval of HEPLISAV and currently believes the meeting can take place within 6 weeks. Following its meeting with the FDA, Dynavax will provide updates as appropriate.
Dynavax's BLA was accepted for review by the FDA in June 2012. On November 15, 2012, the FDA's Vaccines and Related Biological Products Advisory Committee (Committee) voted 8 to 5 with 1 abstention that there was insufficient data to adequately support the safety of HEPLISAV, although the Committee voted 13 to 1 that HEPLISAV data adequately demonstrated immunogenicity.
Dynavax's Marketing Authorization Application continues to be under review in Europe.
Conference Call Today
Dynavax management will host a conference call today at 9:00 a.m. Eastern Time (6:00 a.m. Pacific Time) and individuals may participate in the conference call by dialing (866) 428-9517 (domestic) or (224) 357-2389 (international).
To access a live audio webcast of the conference call, please visit the Company's website at http://investors.dynavax.com/newsevents.cfm
A replay of the webcast will be available on the Dynavax website approximately two hours after the conference call concludes through March 8, 2013.
http://finance.yahoo.com/news/dynavax-receives-fda-complete-response-110000612.html