|3 Biotechs on our ASCO 2011 watchlist|
|By Patrick Crutcher|
|Friday, 25 March 2011 10:48|
Below is the first part in our coverage of companies we are following going into ASCO 2011. For those who don't know or realize, the American Society of Clinical Oncology(ASCO) Annual Meeting is one of the largest cancer oriented medical conferences in the country.Typically, many biotech companies announce some of their leading clinical data here and historically stocks have had huge runs into this conference; it’s important to be aware of those who will be attracting some attention. Below are 3 companies that we will be watching as ASCO 2011 approaches. We kept our focus on companies that are giving updates on pipeline candidates that are in Phase 2 or beyond, with some exceptions. Abstracts will be released on ASCO.org on May 18th at 6:00 PM EDT and the 2011 Annual Meeting takes place from June 3-7, 2011 in Chicago, Illinois.
First, ARIAD Pharmaceuticals(NASDAQ: ARIA) will likely have updates on their 2 key assets: ponatinib in chronic myeloid leukemia(Phase 2) and ridaforolimus in soft-tissue sarcoma(Phase 3). Back in mid-January, Ariad announced that the SUCCEED Phase 3 trial mets it’s primary endpoint with a 21% improvement in progression-free survival (3.1 weeks; p-value= 0.0001) and hazard ratio (HR=0.72; 28% reduction in risks) on full analysis; safety data was also consistent with previous results. There might be a silver lining in that the investigators saw a 31% reduction by ridaforolimus in the risk of progression compared to placebo (hazard ratio=0.69; p<0.0001) and a 52% improvement in median PFS (ridaforolimus, 22.4 weeks vs. placebo, 14.7 weeks). PFS is a difficult surrogate endpoint to measure, hence the difference we see between the investigators analysis and the independent review. ARIA anticipates presenting detailed data from the SUCCEED study of ridaforolimus in sarcoma in a “presentation at an upcoming medical meeting this year.” In all likelihood, this means ASCO and complete data should include the secondary endpoint of overall survival data. The hope is that the separation in hazard ratios should translate into a larger increase in overall survival; positive trends in overall survival would certainly benefit the potential approval of ridaforolimus. Ariad’s ridaforolimus program is currently partnered with Merck; Merck intends on submitting an NDA for soft tissue sarcoma later in 2011.
Apaziquone is a synthetic bio-reductive prodrug which is being investigated for the treatment of non-invasive bladder cancer. Apaziquone top-line results aren’t expected until 2012, but we could see an interim update or at ASCO 2011 in June. Apaziquone is currently partnered with Allergan(NYSE: AGN) in the US, EU and Canada. This study also has an SPA with the FDA and Fast Track designation; it’s composed of 2 separate trials of more than 1600 patients with a primary endpoint of 2 year tumor recurrence rate.
We also anticipate that they will have several presentations reiterating the long-term survival data in support of Zevalin for Non-Hodgkin’s Lymphoma. In December 2010, they had several very convincing presentations about long-term survival at ASH 2010. Zevalin sales have been slowly increasing over the past few years, but there is still a lot of market to capture. It’s now a matter of convincing doctors to use it and getting rid of the bioscan requirement which will likely come in November of this year.
Last, we want to revisit Array BioPharma(NASDAQ: ARRY). We think that 2011 should have read outs from their two MEK inhibitors, selumetinib and MEK-162. Phase 2 melanoma and non-small cell lung cancer(NSCLC) data on selumetinib will be reported by AstraZeneca(NYSE: AZN) later this year. AZN has 40 on-going or completed Phase 1 or 2 clinical trials with selumetinib. Selumetinib(aka AZD6244) is a 1st generation MEK inhibitor partnered with AZN; it’s the most advanced MEK inhibitor in the clinic. ARRY is potentially due double-digit royalties depending on sales levels. There are two ongoing Phase 2 trials in particular that will report data in 2011, one testing selumetinib plus DTIC vs. DTIC alone in 1st line melanoma patients with BRAF mutation and another testing selumetinib + Taxotere vs. Taxotere alone in 2nd line NSCLC patients with KRAS mutation. The melanoma trial completed enrollment of 91 patients in March 2010 with the primary end-point of overall survival. In 2nd line NSCLC patients with KRAS-mutation, trial completed enrollment of about 80 patients in July 2010 with the primary end-point of overall survival.
This data should bring more attention to their story and might shine more light on ARRY-162, the 2nd generation MEK inhibitor that was recently partnered with NVS. They should have some interim updates in regards to their Phase 1 trials using ARRY-162; Novartis has said they will be using it in several combinations with their PI3K inhibitor program soon. With a marketcap of about $170 million, they seem undervalued just based on the fact that they have nearly $98 million in cash and multiple partnerships(Amgen, Celgene). They also have several other wholly owned pipeline candidates(-380,-520) that add value.
Array BioPharma Reports Financial Results for the Second Quarter of Fiscal 2011 - http://bit.ly/hC4Eba