p***o
发帖数: 714 | 1 【 以下文字转载自 Stockcafeteria 俱乐部 】
发信人: jhsph07 (银杏), 信区: Stockcafeteria
标 题: Re: ZT: EXEL
发信站: BBS 未名空间站 (Mon Jul 6 11:51:53 2009, 美东)
基本的意思是说， EXEL是做KI的， KI的成功率大概是４０％左右， EXEL的pipeline
上面大概有11个KI， 如果按统计规律， 应该有5个最后会被FDA
批准。
等果实最终成熟大概还需要两年的时间。
Exelixis proves skeptics wrong
Dec 19, 2008
Another company that gives its shareholders reasons to smile is Exelixis, following the mammoth deal with BMS. Exelixis licensed its most advanced compound, XL184, and its early stage RAF inhibitor, XL281 in a deal that includes an upfront cash payment of $195 million as well as an additional licensing payment of $45 million to be paid in 2009.
In an article from October, I estimated that XL184 and XL281, which had been developed under the GSK collaboration, would eventually be licensed, but I must admit that the timing and size of the deal caught me by surprise. This deal is obviously another validation of Exelixis’ technology and pipeline quality, but more than anything it is a monumental achievement for the company’s management who managed to land one of the most lucrative biotech deals in history during such a challenging period.
During the company’s third quarter conference call, when asked whether there was a change in interest from potential partners, Exelixis’ CEO, George Scangos, stunned listeners by saying that he sees an increase rather than a decrease in interest. The market and some of the analysts reacted with skepticism, suggesting that now that small biotech companies are cut off from the equity market, they would be forced to sign less attractive deals. Deals such as the Exelixis deal and the one signed by Arqule (ARQL) and Daiichi-Sankyo prove that the not only is the price of promising compounds going down, the trend is in the opposite direction. At the RBC Healthcare conference earlier this month, Genentech’s vice president of business development, Joseph McCracken, addressed this discrepancy. According to McCracken, who oversees collaborations with both Immunogen and Exelixis, the price of partnership deals has not gone down primarily because the demand from the big pharmaceuticals that must fill their pipelines has increased. This statement should reassure investors of companies like Exelixis that there is still a good market for quality compounds, recession or no recession.
With $260 million secured from BMS over the past three weeks, and the anticipated offload of costs related to the development of XL184 and XL281, Exelixis is now a much safer stock, and to some extent, today, after climbing 100% in less than a month, Exelixis looks cheaper than ever. Investors should expect additional licensing deals already in the first half of 2009, especially for XL765 and XL147, which target one of the most frequently dysregulated pathways in cancer. These compounds have potential utility in combination with many regimens for countless indications, so they require a broad and expensive clinical program that must be led by a large partner. The licensing of these compounds could add over a $100 million in upfront payments to Exelixis in the coming months and further offload its development costs.
The interest in kinase inhibitors for cancer is very high and pharma companies like BMS are very aggressive in expanding their oncology pipelines with almost a hundred kinase inhibitors in the clinic. Based on a recent review published in Nature Reviews Drug Discovery, they are doing that for a very good reason.
The authors, Ian Walker and Herbie Newell evaluated success rates of almost a thousand anti-cancer agents that entered clinical trials between January 1995 and September 2007. One of the most interesting outcomes of the analysis is that 47% of kinase inhibitors which entered phase I made it to the finish line vs. only 18% for all the oncology drugs. The authors suggest that this difference is a result of the targeted nature of kinase inhibitors and the use of biomarkers for identifying the right patients who are more likely to derive benefit from these agents.
Although the analysis refers only to historical data and there is no assurance that these statistics can be maintained going forward, it certainly implies that kinase inhibitors as a group can be considered as a relatively safe bet. Applying these ratios to a company like Exelixis puts things in a very interesting perspective. In 2009, Exelixis will be involved in at least 11 clinical programs of kinase inhibitors for cancer, so based on historic success rates, 5 of these compounds are expected to hit the market.
Obviously, these statistics may not be replicated and even if they do, there is no way of predicting the commercial success of an approved drug. In fact, the field of kinase inhibitors is so crowded that there will surely be some competition between drugs that hit the same target or approved for the same indication, which is why companies like Exelixis must find ways to differentiate their products. Some of the ways to differentiate a compound include having the first compound in the market for a specific target (first in class), proving superiority over competing drugs (best in class) and developing drugs with a unique spectrum of activity. Exelixis has been doing a great job in creating an impressive pipeline of kinase inhibitors, including several highly differentiated compounds. With the financial issue finally resolved, the market can focus again on the company’s broad pipeline as it generates material clinical data throughout 2009. |
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