Previously, Dr. Denner served as a senior managing director at Icahn Capital, a portfolio manager at Viking Global Investors, and a portfolio manager at Morgan Stanley Investment Management. Dr. Denner serves as a director of Biogen Idec Inc. and VIVUS, Inc., both biopharmaceutical companies.
He did that to help certain individual during active trading hrs, The fact is TOTALLY OPPOSITE.
Gleevec, developed by Novartis and approved in 2001, inhibits the action of that errant protein. It turned chronic myeloid leukemia from a death sentence into a chronic disease for many patients and is still considered the paragon of molecularly targeted drugs. Global sales were $4.7 billion in 2011.
But about 20 to 30 percent of patients have cancers that do not respond to Gleevec or that develop resistance to it.
So companies developed other drugs — Tasigna from Novartis and Sprycel from Bristol-Myers Squibb — that also inhibit the aberrant protein but work in many of the cases that are resistant to Gleevec. But some cases do not respond to those drugs, either.
Iclusig was designed by chemists and computers at Ariad to work against cancer cells with a mutation — known as T315I — that makes them resistant to Gleevec, Tasigna and Sprycel.
However, Iclusig was approved not only for patients with that mutation but for any patient who has tried one of the other three drugs without success
Mediterr J Hematol Infect Dis. 2014; 6(1): e2014003.
Published online 2014 January 2. doi: 10.4084/MJHID.2014.003
Nilotinib and dasatinib tested as a second line after imatinib failure and/or intolerance have been proven to be effective and safe drugs, with the possibility of rescuing about 50% of patients with different forms of resistance. Bosutinib was proven effective not only in the second line, but also in patients resistant to previous therapy with imatinib and nilotinib and/or dasatinib. All these drugs are less or completely ineffective in patients carrying the T315I mutation. In this latter subset a third-generation inhibitor, ponatinib, was tested with brilliant results, and recently approved for patients with resistance to previous TKIs lines. This agent allowed the rescue of the majority of patients with T315I mutation with most of responses being maintained. In the last edition of 2013 ELN recommendations, allogeneic bone marrow transplant should be considered at the time of starting second line after failure of any type of TKIs, whereas it is recommended for patients after failure of two previous TKIs.
ICLUSIG having potentials for $Billions per year for US and rest of the world. ICLUSIG can become front line treatment when physicians knows the inhibitors such as imatinib, dasatinib and nilotinib are effective drugs but are resistant to some BCR-ABL mutations. The pan-BCR-ABL kinase inhibitor ponatinib exhibits potent activity against native, T315I, and all other clinically relevant mutants, and showed better inhibition than the previously known inhibitors
We are almost doubling our 2014 and 2015 total revenue estimates for Ariad (ticker: ARIA) to $72.5 million and $159.5 million, respectively. We expect Iclusig peak global sales to be $450 million-$500 million with similar peak penetration in the U.S. and Europe--about 10% of the total chronic myeloid leukemia (CML) market or about 60% of the newly defined eligible market.
Legendary corporate raider Carl Icahn recently announced that he will be returning $1.76 Billion back to his investors. He will continue investing his own money. He is an excellent insider to imitate because his moves are usually bigger than an average hedge fund's and he has to report them more promptly on 13D forms because he usually takes act he began acquiring controlling positions in companies like TWA, Phillips Petroleum, RJR Nabisco, Texaco, Gulf & Western, Viacom, Motorola, Herbalife, Western Union, Dan River, Uniroyal, Fairmont Hotels, Marshall Field’s, American Can, Revlon, Kerr-McGee, Marvel Comics, USX, E-II (Culligan and Samsonite), Federal-Mogul, Blockbuster, Imclone, and Time Warner. He has also purchased stocks in Mylan Laboratories and King Pharmaceuticals. Later on, he sold KT&G (Korea Tobacco & Ginseng) for a huge amount of profit, Amylin Pharmaceuticals LLC acquired by Bristol Myers.
Join together to file a complaint against him to FED.
This early access approval goes substantially beyond the scope of the ongoing phase 3 trial which is studying DCVax-L only in newly diagnosed glioblastoma multiforme (grade IV glioma) patients. The exemption allows DCVax-L to be provided not only for this indication, but also for lower grade (less malignant) gliomas. It also extends beyond newly diagnosed gliomas (actually glioblastoma multiform) that are the focus of the phase 3 to include recurrent gliomas. The early access to DCVax allows patients to receive DCVax-L for all cases of glioma. This is stunning.
Consistent with the trial protocol, CytRx used two approaches to evaluate the efficacy of aldoxorubicin compared to doxorubicin in patients with soft tissue sarcomas: assessment by the study investigators, as well as assessment by a blinded central laboratory review. In this study, both investigator assessment and central lab review showed an unambiguous 80-100% improvement in PFS among patients treated with aldoxorubicin. In an intent-to-treat analysis, the investigator-assessed median PFS was 8.4 months for aldoxorubicin patients versus 4.7 months for doxorubicin patients (p=0.0002), while the blinded central lab review indicated that median PFS for aldoxorubicin patients was 5.7 months versus 2.8 months for doxorubicin patients (p=0.018). Per investigators, 67.1% of aldoxorubicin patients had not progressed at 6 months, compared with 36.1% of doxorubicin-treated patients (p=0.005). By blinded central lab review, 46.8% of aldoxorubicin patients had not progressed at 6 months, compared with 23.7% of doxorubicin patients (p=0.038).
Jorge E. Cortes, MD
Published Online: Tuesday, February 5, 2013
Ponatinib works by blocking the function of BCR-ABL, the abnormal protein responsible for causing leukemia in certain cells. One important property that ponatinib possesses, according to Cortes, makes it difficult for tumors to develop resistant clones. There is currently an ongoing phase II study at MD Anderson Cancer Center evaluating ponatinib as initial therapy for patients with CML in the chronic phase. The primary objective of the study is to estimate the proportion of patients with previously-untreated chronic phase CML attaining complete cytogenetic response (CCyR) at six months of treatment with ponatinib. -
Be ready Proxy voting is done and 19th is cut off date.
Company Acquirer Deal Size Lead Products Stage at Acquisition
1. Cougar Biotechnology J&J $970M Zytiga: Hormone Independent Prostate Cancer Phase III Clinical Trials
2. Biovex Amgen $1B OncoVEX: Melanoma Head and Neck Cancer Phase II/III Clinical Trials
3. Micromet Amgen $1.16B Blinatumomab: Leukemia Lymphoma Solitomab: Advanced Solid Tumors Phase I & II Clinical Trials
4. Avila Therapeutics Celgene $925M AVL-292: B Cell Cancers Avilomics Phase I Clinical Trials
5. NWBO - Solid Intellectual Property Coverage:
DCVax Product and Platform
DCVax®-L for brain cancer:
§ orphan status granted in US (allows 7 years market exclusivity)
§ orphan status granted in EU (allows 10 years market exclusivity)
DCVax®-Prostate and DCVax®-Direct:
§ composition and methods coverage issued
Other platform coverage:
§ isolation, maturation and “education” of dendritic cells
§ TFF system -- automation of manufacturing
§ methods of delivery to patients
• Immune therapies for cancer: right time, right place.
• DCVax® platform technology. Multiple chances to win.
• 3 product lines: 2 products at Phase III stage, 1 product at Phase I/II
• 2 products applicable to all solid tumor cancers (cancers in any tissues)
• Phase III trial and manufacturing in both US & Europe
• Late stage: Phase III trial underway; top line results in 2014.
• News flow from multiple other programs while Phase III under way
• Positive clinical results to date: adding years, without toxicity
• Attractive product economics, due to cost effective batch mfg.
Iclusig commercially available to patients in the United States,” stated Marty J. Duvall, executive vice president and chief commercial officer for ARIAD. ”Iclusig is now in our distribution channel with Biologics, and our dedicated sales force will begin promoting Iclusig immediately. We are highly confident in our commercial launch of Iclusig and look forward to reporting on our progress on a quarterly basis.”
This is coming soon at Larkin presentation on 12th Feb 2014
If the interim results are good: pps will be above 10$
If the interim results are extremely good with the BLA status grant: pps will be above 20$
CYTR - going forward very strong as Doxorubicin not available and Aldo showing strong clinical outcome.
Sarissa Capital Management , an activist investment fund and run by Alex Denner, disclosed that they have increased their stake in the company. They now hold 12 million shares, which is 6.5% ownership as against their previous stake of 6.2%. Sarissa has assumed the position of second biggest stakeholder for Ariad and has been in talks with the company, demanding representation on its board. Apart from this, Denner has also reiterated the faith in Ariad’sIclusig,which, according to him has greater potential to benefit a broader range of the population. As of now, GlaxoSmithKline Plc, Eli Lilly & Co. and Shire Plc, are rumored to be eyeing acquisition of Ariad
-Both Johnson & Johnson Inc.’s -Janssen Pharmaceuticals unit and Enzon Pharmaceuticals Inc. - Enzon doxorubicin are struggling to get the supply. FDA gave fast track approval to Sun Pharma - India to meet the short supply. Aldoxorubicin is the first and only single agent to surpass doxorubicin as a first-line treatment for soft tissue sarcomas and study shows two reviews both showed an “unambiguous” improvement of 80% to 100% in patients using aldoxorubicin over doxorubicin. Based on present clinical findings and fewer phase-III results FDA might change the status for Aldodoxorubicin as Fast Track approval.
Eli Lilly & Co. (NYSE: LLY) was mentioned as one suitor, and its $59 billion market cap would make this more than doable. One report showed that Lilly would take a friendly approach, valuing the stock at more twice its current value.