In the pharmaceutical industry, it is very common to see multiple drugs in development that go after the same target. Usually, there is a direct correlation between the recognition a target has and the number of competing agents. This is the case with “hot targets” such as PI3K,RAF and mTOR, which are pursued by many pharma and biotech companies.
In most cases (especially with targeted therapies), the different compounds are being developed in parallel, and there is no way of identifying a clear winner. This can persist even after approval. For instance, both BMS Pfizer and Novartis (NVS) have an mTOR inhibitor on the market for the treatment of renal cancer. It is clear both drugs are active but each compound was approved based on a different trial in a different patient population, so neither can claim superiority.
After a challenging year, Exelixis (EXEL) is finishing 2010 on a positive note, with the help of promising data for its lead agent, XL184. Last week at the EORTC conference, the company published data from a large phase II study in multiple cancer types. The results came at a crucial time for Exelixis, as many were questioning the value of XL184 following BMS’ (BMY) decision to opt-out of its development. As discussed in a previous post, when a partner like BMS dumps a late stage clinical asset after a licensing payment of over $150M, the alarm bells start ringing.
XL184 inhibits several targets, primarily VEGFR2 and Met. As a multi-targeted kinase inhibitor, the drug has some overlap with other drugs, primarily VEGFR inhibitors. There are two drugs that inhibit VEGFR (in addition to other targets) currently in the market as well as a long list of VEGFR inhibitors in late stage clinical testing from GSK (GSK), AstraZeneca (AZN), BMS and Aveo (AVEO). The main question regarding XL184 is whether the drug has a differentiated clinical profile in comparison to other VEGFR inhibitors. Based on recent data presented at EORTC the answer is a resounding “YES”. Read the rest of this entry »
The ESMO meeting is the most important oncology conference in Europe. This year in particular, it included very interesting data that affected the sentiment towards many biotech companies. Here, I intend to focus on what I view as three clear winners from the conference: Seattle Genetics (SGEN), Arqule (ARQL) and Dendreon (DNDN).
Seattle Genetics
Seattle Genetics is about to conclude the best year in its history, since it was incorporated 13 years ago. The company’s lead agent, SGN-35 (aka Brentuximab Vedotin), generated astonishing results in two types of blood cancers earlier this year. Based on the results in Hodkin’s Lymphoma, SGN-35’s approval seems inevitable, even though results are not from large randomized studies. Unlike T-DM1’s case, Seattle Genetics negotiated a special protocol assessment (SPA) with the FDA, implying that the trial design and endpoints are acceptable by the FDA.
Earlier today, both Immunogen (IMGN) and Exelixis (EXEL) announced two important partnership deals. As with any deal, both companies enjoy an injection of non-dilutive funds as well as a vote of confidence for the companies’ technologies. This time, however, it seems the deals, which could not have come in a better time, represent much more than that. Read the rest of this entry »
Array’s (ARRY) shares keep on fluctuating in the $2.5-$3.5 range, relatively unchanged from the beginning of 2010. It seems that the market is having trouble assessing the real value of the company and its pipeline, which includes 13 (!) drugs in clinical trials. With a market cap of ~$170M, the market puts an average price tag of $13M per asset, a ridiculously low valuation (assuming no value is assigned to the company’s discovery platform). The company’s long term debt (due in 2014) could be partially blamed for this anomaly, but the problem seems to be more related to the company’s business model. The good news is that during the next year the company is looking at multiple events that might change the way Wall Street views Array. Read the rest of this entry »
Immunogen (IMGN) is still trying to recuperate from the controversial rejection of T-DM1’s accelerated approval filing. The message Immunogen was trying to convey is that nothing has changed in terms of T-DM1’s long term potential. According to the company, the FDA’s problem was not with the drug’s stellar activity but the patient population enrolled on the trial. In just over a week from now, it could have the data to prove it.
The FDA’s decision to reject Roche’s filing for accelerated approval of T-DM1’s had quite an impact on Immunogen’s (IMGN) stock. There is no doubt that T-DM1 represents the company’s most valuable, even if it is in the form of a mid single digit royalty rate, due to its blockbuster potential and impressive clinical activity. This justifies to some extent last week’s market reaction, as the next potential approval for T-DM1 will is anticipated in mid 2012. Nevertheless, T-DM1 is facing multiple potential value creation events in the coming year, including an important data set for T-DM1 next month. In addition, the company is involved in 6 clinical stage programs (#7 is expected to enter the clinic this month), some of which are expected to generate data in the coming months. Although none of these programs are nearly as exciting as T-DM1, some of them could become more attractive with time.
Last week, Roche announced that the FDA was unwilling to accept T-DM1’s accelerated approval filing for breast cancer, sending Immunogen’s (IMGN) shares tumbling almost 40%. The filing was based on impressive results from a single arm phase II trial in 3rd line HER2 breast cancer. Typically, gaining regulatory approval requires a large, randomized phase III study but in cases of highly unmet need where patients are bereft of effective treatment options, the FDA may consider approval in a limited patient population.
Yesterday Pfizer (PFE) announced that Sutent failed to prolong survival of lung cancer patients when given in combination with Tarceva. The drug led to an increase in progression free survival (PFS), which was the secondary endpoint of the study. The results are not published and there are several open questions such as the extent of PFS improvement, benefit across different subtypes and use of Sutent in patients from the placebo cohort after progressing on Tarceva. Nevertheless, chances to see Sutent+Tarceva as a standard of care for 2nd/3rd line NSCLC are slim.
Pfizer’s failure provided some clarity for Arqule (ARQL) and its partner Daiichi Sankyo, who plan to initiate a phase III study for ARQ-197 in combination with Tarceva. The indication Arqule is pursuing is very similar to that pursued by Pfizer, so had the Sutent trial been successful, it would have adversely affect ARQ-197’s prospects in general and potentially the required clinical route.Read the rest of this entry »
Synta (SNTA) is recuperating nicely from last year’s meltdown following the failure of its melanoma drug, elesclomol. The company is gaining momentum thanks to its early stage Hsp90 (heat shock protein 90) inhibitor, STA-9090. STA-9090 seems to garner a lot of attention in the medical community following the presentation of encouraging phase I data at ASCO last June. Based on the preliminary results, STA-9090 could be what the industry has been waiting for: A broad and potent Hsp90 with an acceptable safety profile.
