The annual meeting of the American Society of Hematology (ASH) was concluded last week and provided investors a peek into the future of blood cancer treatment. Below are 5 companies that presented promising data that could change the therapeutic landscape in the coming years. (more…)
Developing oncology drugs is getting harder and harder. The rising regulatory hurdles, the constant flow of new agents and competition for trial participants all make getting a drug to market a formidable challenge. This is particularly true in drugs for blood cancers, a field that saw tremendous progress in the past decade and is becoming very crowded. As a result, even highly effective drugs require long and expensive studies with active regimens in the control arm and survival as an endpoint. (more…)
Immunogen becomes a $1B company
Immunogen (IMGN) concluded the week with a market cap of ~$1B, up 200% in less than a year. This valuation is quite unusual for a company that ascribes the vast majority of its value from a 3-5% royalty stake in a single drug - Roche’s T-DM1. T-DM1, which utilizes Immunogen’s antibody-drug conjugate (ADC) technology, comprises of Herceptin conjugated to a drug payload. It is in two phase III trials and multiple phase II studies in breast cancer. If proven effective, many believe T-DM1 will eventually replace Herceptin, at least in certain treatment lines.
More melanoma breakthroughs
This year’s meeting will probably be remembered as a historical event with regards to melanoma. Last year, it was a phase III trial for BMS’ (BMY) Yervoy (ipilimumab), which was the first in history to show a survival benefit in advanced melanoma patients (discussed in my ASCO 2010 write up). This trial led to Yervoy’s historical approval 3 months ago.
This year, investigators will present studies evaluating Yervoy as well as Plexxikon/Roche’s vemurafenib in pretreated melanoma patients. Yervoy was evaluated in combination with chemotherapy while vemurafenib was compared with chemotherapy. According to BMS’ and Roche’s press releases, both studies were successful and each drug led to a survival benefit. The extent of this benefit is still unknown and will be revealed only at the conference. (more…)
In its earnings release last week, Seattle Genetics (SGEN) did not surprise anyone with the financial guidance and expected timelines for approval of its lead agent, SGN-35. However, on the business development front, the release did include an intriguing announcement that did not receive the attention it deserved. The company announced that Genentech recently advanced 3 new antibody drug conjugates (ADC) based on Seattle Genetics’ technology to phase I, this is in addition to the CD22 ADC already in clinical testing.
The announcement has several important implications for Seattle Genetics. First, the number of clinical programs in its partnered pipeline instantly jumped 50% from 6 to 9. By definition, this provides Seattle Genetics with more shots on goal and increases chances of substantial milestones and royalties down the road. More importantly, it establishes Seattle Genetics’ technology as Genentech’s preferred ADC platform, an attractive position given Genentech’s dominance in oncology and ADCs in particular. (more…)
Last week, Sanofi-Aventis (SNY) announced disappointing results from a phase III trial evaluating iniparib in breast cancer. The drug failed to improve survival and progression-free survival (PFS) in breast cancer patients and although actual data were not published, approval is unlikely even for a subset of patients. Failed phase III trials are quite common in oncology, a field with one of the highest attrition rates in the pharmaceutical industry. Nevertheless, iniparib’s failure is particularly disturbing, as the phase III was supported by compelling results from a randomized controlled phase II trial as well as strong scientific rationale. Importantly, this trial could have broader implications as it raises questions regarding the role of randomized phase II trials as a go/no go decision point for pivotal trials.
As expected, earlier this month at the annual American Society of Hematology (ASH) meeting, Seattle Genetics (SGEN) reported positive results that will likely lead to the company’s first ever regulatory approval for Brentuximab vedotin (SGN-35). The data will transform Seattle Genetics into a commercial stage company, with an initial market opportunity of ~$250M in the US alone. In addition, the results further validate the company’s ADC (antibody drug conjugate) technology, which has broad utility and huge commercial potential. In particular, Seattle Genetics could become a market leader in hematology by next year’s meeting, with results for two additional ADCs.
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.
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.
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…)
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