Archive for the ‘kinase inhibitors’ Category

Exelixis - Back on Track

Tuesday, November 23rd, 2010

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”. (more…)

Winners of ESMO 2010

Monday, October 25th, 2010

 

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.

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Immunogen and Exelixis – Right Deals At The Right Time

Monday, October 11th, 2010

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. (more…)

Array Biopharma– A Wall Street Anomaly

Sunday, October 3rd, 2010

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. (more…)

Pfizer’s failure provides clarity for Arqule

Tuesday, August 24th, 2010



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. (more…)

Exelixis – What’s Next?

Sunday, July 25th, 2010


Exelixis (EXEL) came under a lot of pressure recently and the stock is now trading near its 52 week low following two unrelated events that took place last month. In late June, the company announced the resignation of its CEO, George Scangos, who was appointed as Biogen Idec’s (BIIB) CEO. Earlier that month, the company announced BMS (BMY) decided to give back rights for Exelixis’ flagship product, XL184. Adding to the pressure are interesting but not stellar clinical results for some of the company’s compounds at ASCO and potentially an additional partnership termination. (more…)

How Array Got its Groove Back

Sunday, April 25th, 2010


Array’s (ARRY) recent licensing deal with Novartis (NVS) is another evidence of pharma’s appetite for new oncology compounds, especially for targeted agents. Facing a patent cliff and dwindling internal pipelines, pharmaceutical companies are willing to pay a generous price for promising early stage compounds.

This is why companies with broad platform technologies that can feed the industry with new compounds represent an attractive investment opportunity. These companies include (in alphabetical order)  Arqule (ARQL), Array, Exelixis (EXEL), Immunogen (IMGN), Micromet (MITI) and Seattle Genetics (SGEN). From that list, Array has been the worst performer in 2009 due to liquidity fears as well as lack of exciting clinical data for its proprietary compounds. The two recent deals with Amgen (AMGN) and Novartis helped Array strengthen its balance sheet, but more importantly, they prove that the company’s discovery and early stage development capabilities have been underestimated by the market. (more…)

Arqule Joins The Phase III Club

Sunday, April 11th, 2010

No matter how diversified or well managed a biotech company is, eventually there is no escape from binary events. These events usually come in the form of data readout from clinical trials that can make or break the stock. Two weeks ago, Arqule (ARQL) announced topline results from a much anticipated   phase II trial of its lead agent, ARQ 197, in lung cancer. The trial is evaluating ARQ 197 in combination with the approved drug, Tarceva, in patients with non-small cell lung cancer (NSCLC) who have been previously treated with chemotherapy. Although the data set is not a clear slam dunk, it generated an impressive efficacy signal that warrants advancing ARQ 197 into phase III. This, coupled with the progress the company has made on other fronts in the past year makes Arqule one of most attractive biotech stocks in the market.

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Incyte – Life After Debt (Part II)

Sunday, October 18th, 2009

For part I click here

 

On top its JAK programs, Incyte has been developing two additional programs it intends to out-license. The first program is INCB13739 for diabetes, which already reached clinical proof of concept and could be licensed imminently. The second program, INCB7839 for breast cancer, is less advanced but could become very interesting later this year depending on data from an ongoing trial.

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Incyte - Life After Debt (Part I)

Sunday, October 11th, 2009

Last week, Incyte (INCY) sold over $130M worth of stock and $400M worth of convertible debt in an effort to solve its balance sheet issues. Thanks to the stronger cash position, the company can finally be evaluated based on its promising pipeline rather than its capital structure. More importantly, it will be able to complete a series of business development deals and focus on becoming a commercial stage company.

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