Ariad and Exelixis look to shine at ASCO 2011 Print E-mail
By Patrick Crutcher   
Sunday, 08 May 2011 21:45

icon_stockbuzz With ASCO 2011 around the corner, we wanted to overview two oncology companies that the market will be watching closely: Exelixis Inc.(NASDAQ: EXEL) and Ariad Pharmaceuticals (NASDAQ: ARIA)

Both of these stocks have had significant appreciation over the past 6 months because of clinical data relating to their lead compounds: Ariad's ridaforolimus and Exelixis' cabozantinib(XL184). At ASCO 2011, both companies will be making significant presentations regarding both drugs that have material impacts on their valuation. We've learned that presentations on Ridaforolimus and Cabozantinib from both companies will be featured in the "Best of ASCO 2011" program.

Exelixis will be making 3 presentations on cabozantinib (XL184) covering castration-resistant prostate cancer(CRPC), ovarian cancer, and one covering the entire randomized discontinuation trial covering 9 distinct tumor types. Much of the excitement came out of results in November 2010(1/2) and February of this year, which showed that cabozantinib reduces or stabilizes metastatic bone lesions, tumor regression, bone pain and narcotic use, and improvements in hemoglobin for patients with anemia. The significant effect on bone metastases has creates a potential large market opportunity because of the lack of effective treatments and high rate of occurence of metastatic bone lesions in a number of cancers. The dual mechanism of action of cabozantinib, an inhibitor of MET and VEGFR2 kinases, appears very promising thus far and a more mature dataset at ASCO will help to further understand its potential. They are currently designing several Phase 3 trials to further evaluate cabozantinib in metastatic castration-resistant prostate cancer (mCRPC) and its ability to help prevent the formation of bone metastases and extend overall survival in patients with metastatic bone lesions.

In addition to these presentations, investors are still awaiting results from the Phase 3 trial(EXAM) in medullary thyroid cancer(MTC). During the recent conference call, they noted that the trial was fully enrolled in the first quarter and hoped to report top line results from the EXAM trial along the middle of this year. Assuming a positive outcome, they are planning to file an NDA for MTC by the end of 2011. Funny thing about cabozantinib is that the Bristol-Meyers Squibb(NYSE: BMY) dropped their partnership for the drug last year. Recently, rumors surfaced that Exelixis is in fact working with Goldman Sachs to find a buyer of the company. Exelixis currently has roughly $391 million in cash and cash equivalents. It will be interesting to see how their story develops over the next year.

ARIAD Pharmaceuticals has been riding a wave of good clinical data on their lead compounds, Ridaforolimus and Ponatinib. Ridaforolimus will be taking center stage at ASCO 2011, where they will be presenting full Phase 3 data from their SUCCEED study. They plan on presenting this data on Monday, June 6, 2011, at 4:30PM CDT. The presentation will include the primary and secondary endpoints along with data from predefined patient sub-analyses in the trial. As we know, ARIADannounced in January that the SUCCEED trial met the primary endpoint, showing an improvement progression-free survival over placebo, in patients with metastatic soft-tissue and bone sarcomas. The full data will be an important indicator of the approvability and future marketability of ridaforolimus. We also are expecting an update on two Phase trials in endometrial cancer, breast cancer, and ovarian cancer. Ridaforolimus is being co-developed under a partnership with Merck (NYSE: MRK), who recently stated their plans to file an NDA for the drug this year.

There is also some additional excitement on their early-stage drug, ponatinib, which showed promising Phase 1 data at the American Society of Hematology(ASH) meeting in December 2010. Ponatinib is currently enrolling a pivotal Phase 2 trial(PACE) for resistant and refractory patients with chronic myeloid leukemia (CML) and Philadelphia-positive acute lymphoblastic leukemia (Ph+ ALL). Ariad now anticipates completing enrollment in the PACE study by the 3rd quarter this year and is aiming for the presenting comprehensive interim data at ASH 2011. The trial currently has 52 study locations worldwide.

Ariad anticipates filing for marketing approval of ponatinib in the middle of next year, setting up the possibility for approval by the end of 2012. Ariad views this as a potential big market opportunity, since there are very few effective treatments in the 2nd/3rd line setting. It's also in an early Phase 1 study for acute myeloid leukemia(AML); they will be presenting some preliminary data from trial at ASCO on Friday, June 3rd. This program is currently unpartnered, although they have discussed out-licensing it out in Asia.

Disclosure: Long EXEL, no position currently in ARIA

Exelixis Announces First Quarter 2011 Financial Results -http://bit.ly/kshhpf

Exelixis' CEO end of 1st Quarter note "Finished a Successful First Quarter, Ramping Up for an Action-Packed Second Quarter"

ARIAD Announces Oral Ridaforolimus Achieved Primary Endpoint of Improved Progression-Free Survival in Patients with Metastatic Soft-Tissue or Bone Sarcomas in the Phase 3 SUCCEED Trial -http://bit.ly/fkZsvD

Previous ARIA coverage on December 1st -http://biomedreports.com/2010120160753/options-interest-on-2011-phase-3-data-catalyst.html

ARIAD Reports First Quarter 2011 Financial Results and Development Progress  - http://bit.ly/muRET1

Ponatinib effective in heavily pretreated CML patients with T3151 mutation - http://bit.ly/mjQjhw

ASH 2010: Ponatinib Inhibits Mutations That Block Treatment Paths for CML, ALL, and AML - http://bit.ly/jIdNtJ




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