Synta is heating up

Sunday, August 8th, 2010


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: An broad and potent Hsp90 with an acceptable safety profile.

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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…)

The winner of ASCO 2010 - BMS

Thursday, July 1st, 2010

The hottest theme at this year’s 2010 ASCO (American Society of Clinical Oncology) annual meeting was without a doubt cancer immunotherapy, an old paradigm that deals with redirecting the patient’s immune system against tumors. After decades of failures, this concept is finally proving itself useful. There are basically two approaches:  1) cancer vaccines that aim at eliciting an immune response against specific targets on cancer cells and 2) immunomodulatory drugs that aim at stimulating the immune system in a more general manner (not target specific). The undisputed leader in cancer vaccines is Dendreon (DNDN), which currently has the only FDA approved cancer vaccine. Following ASCO, it looks like the leader in immunomodulation drugs is BMS (BMY).

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Biotech Portfolio Updates - Rigel Is Still On Track, Pfizer May Have Found Its Next Blockbuster

Wednesday, January 7th, 2009

 

In the pharmaceutical industry, 2008 will probably be marked by the big pharmas’ insatiable appetite for new drugs. Threatened by fierce generic competition, the pharmaceutical giants were not only eager to pay generous acquisition premiums for marketed products, but were also willing to pay a lot of money for investigational drugs with an early proof of concept in the clinic. Two recent examples for this trend are Arqule (ARQL) and Exelixis (EXEL), which recently signed two lucrative deals with Daiichi-Sankyo and Bristol-Myers Squibb (BMY), respectively.

 

Assuming this trend continues in 2009, it is crucial to identify small and medium companies with candidates whose activity has already been proven in clinical trials. One of the most interesting companies that fall into this category is Rigel Pharmaceutical (RIGL). The company is currently developing a validated drug with blockbuster potential, and is expected to announce a major collaboration deal during the first quarter.

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When There Is Blood In The Streets - Buy Biotech

Friday, October 10th, 2008

History has shown again and again that times like these represent a huge long term buying opportunity. This may be particularly true for the biotech segment that, despite weathering the storm better than other segments, has had its share of price declines. During the past several weeks, great biotech stocks, from small early stage companies to fully commercialized companies have been thrown out of portfolios like bad auction rate securities, but the truth is that the value proposition of most of these biotechs did not change at all, and is not likely to change as a result of market conditions. This is why current prices create the best opportunity to get into the biotech segment since 2002.

In the past, the pharmaceutical segment served as a safe haven at times like these, based on the notion that drug sales, especially those for the treatment of serious illnesses, remain unaffected by recession. Unfortunately, most pharmaceutical companies are in the midst of an innovation crisis, where their traditional blockbusters are gradually being cannibalized by generic competition, so the next couple of years will be very challenging for them, recession or no recession. Consequently, investors may want to look for growth in the relatively new entrants to the field – biotech companies. 

 

Biotech companies can be divided into two groups, each has its own merits and pitfalls.

The first group includes fully commercialized companies with a healthy balance sheet and cash generating products. These include all the big biotech companies such as Genentech (DNA), Amgen (AMGN) and Gilead (GILD). Because these companies can be found in every typical portfolio, they all got hit pretty badly from the recent sell-off due to indiscriminate panic selling. Nevertheless, the impact of an anticipated recession will have on these companies, who are selling drugs that address diseases such as cancer and AIDS, will be marginal.

 

The second group consists of smaller, development stage companies, with no commercially available drugs and several cash consuming development programs. The good news is that fundamentally, these companies have nothing to do with the global economy because they are not selling anything. The bad news is that they have to constantly find resources to finance the costly development of their drug candidates. Thus, the most important implication a market crisis has on this kind of companies is that it makes cash-raising almost impossible.

This is why investors should invest only in development-stage biotechs which have found a way around this problem. Some companies can generate cash from licensing their technology or intellectual property, some, like Array (ARRY) and Poniard (PARD) arranged a line of credit, some, like Seattle Genetics (SGEN), were smart enough to do a secondary offering under good market conditions, some, like Exelixis (EXEL) and Immunogen (IMGN), licensed some of their products and have someone else paying for the development. 

Bearing in mind that in the foreseeable future, licensing of technology and products will be the preferred way of getting cash, it would particularly be wise to pay attention to companies with unpartnered assets that are generating robust data in clinical trials as well as to platform companies that can license their technology on a non-exclusive basis. Evidently, when small companies have one way of raising cash blocked, it might reduce their leverage position in the alternative route of partnering. However, thanks to the pressure traditional pharmaceutical companies are currently under, they are starved for new promising candidates, which means that a good drug candidate still has tremendous value in the eyes of big pharmas. A good example for such a promising candidate is Rigel (RIGL) Pharmaceutical’s R788 that showed impressive results in treating rheumatoid arthritis, a disease with a market size exceeding $ 10 billion. Another good example for that may be Arqule’s (ARQL) ARQ-197, which already demonstrated its potential in a wide array of cancers and has a blockbuster potential.      

 

In order to put this approach to the test, I asked Pontifax’s Ran Nussbaum his help in building a virtual portfolio of promising biotech stocks. This portfolio is not intended for short term trading, but for long term investment of at least several years. Although we do not expect active trading in this portfolio, from time to time there may be changes as additional stocks will be added and existing holdings may be sold. Any future changes can be made only when markets are closed. On a more cautionary note, regardless of the attractiveness of all of these companies, all the inherent risks associated with biotech remain, including long time to market and statistically low success rates.

 

                                        Biotech Portfolio as of October 9th 2008

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Will Synta Break A 30 Year Old Record? (Part II)

Sunday, April 27th, 2008

 For the first part of this article click here. 

Synta launched a phase I trial in 2004 for the evaluation of elesclomol in combination with paclitaxel in advanced solid tumors. The trial enrolled 35 highly-pretreated patients, who received paclitaxel in combination with escalating doses of elesclomol. There were two partial responses (5.7%), one patient with kaposi’s sarcoma and another patient with ovarian cancer in addition to 15 patients who achieved stable disease. Because this was a combination trial, there was no way of knowing whether elesclomol had a synergistic effect with paclitaxel. Nevertheless, there was evidence that elesclomol can sensitize tumors to chemotherapy, as some of the patients who responded to the treatment had previously progressed during treatment with paclitaxel alone. Another important observation was that elesclomol and paclitaxel can be safely co-administered. Elesclomol then entered three phase II trials in melanoma, non-small-cell lung cancer (NSCLC) and soft tissue sarcoma. Both the NSCLC and the sarcoma trials failed to show a benefit from adding elesclomol to paclitaxel. The melanoma trial, on the other hand, produced a very impressive set of data.

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Will Synta Break A 30 Year Old Record? (Part I)

Sunday, April 13th, 2008

Synta Pharmaceuticals (SNTA) may look like the typical American biotech company: A promising phase III compound, which is, of course, partnered with a pharma giant, two agents in early clinical stages, a list of failed trials, and an alarming cash burn rate. Nonetheless, the story behind the company’s lead product, elesclomol, is shaping up as one of the most interesting events in oncology in recent years. Elesclomol is currently in a registrational phase III trial for metastatic melanoma, a major achievement by itself, however, if successful, this trial will mark two events on a historical scale.

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