AVEO’s (AVEO) controversial drug, tivozanib, will face an FDA’s advisory committee (Oncologic Drugs Advisory Committee or ODAC) on May 2nd. Despite the negative sentiment around AVEO, I still view tivozanib as an approvable drug with a compelling risk/benefit profile and expect an overwhelmingly positive ODAC recommendation. The FDA does not always follow the ODAC’s recommendations, but in tivozanib’s case it should be regarded as an important risk mitigation event. Continue reading
Following the failure of ArQule’s (ARQL) tivantinib in lung cancer, market attention shifted to the ongoing phase III in liver cancer. With a $173 market cap and $130M in cash, the market ascribes little value to tivantinib. In addition, the market completely ignores 2 additional clinical programs (both in phase I): ARQ092 is an Akt inhibitor that was developed with Daiichi Sankyo (Daiichi recently returned rights to ArQule) and ARQ087 is an FGFR inhibitor. Continue reading
Predicting future sales for a given drug is always challenging, let alone in a case like Incyte’s (INCY) Jakafi (Marketed in Europe under the name Jakavi by Novartis), which is the first drug in history to receive approval for myelofibrosis (MF). With no precedents to serve as a benchmark, it is still unclear how big Jakafi can be. However, based on Incyte’s recent 2013 guidance and remarks from the head of Novartis’ (NVS) oncology business unit, it has a high likelihood to reach $1B already in 2016.
After a great 2012, Onyx (ONXX) is well positioned as one of the few remaining commercial stage biotech companies with a diverse oncology pipeline. The company has 4 assets: Nexavar (co marketing agreement with Bayer), Kyprolis (wholly owned in US +EU), Stivarga (20% royalties from Bayer), PD-0332991 (~7.5% royalties from Pfizer).
In the last post of the year, I will try to provide a status update as well as key 2013 milestones for the stocks in our portfolio. I would like to use this opportunity to wish everybody happy holidays and a happy New Year.
Seattle Genetics’ (SGEN) main task is expanding Adcetris’ use outside of approved niche indications (Hodgkin’s Lymphoma and ALCL). As an anti-CD30 antibody-drug conjugate (ADC), Adcetris has potential utility wherever CD30 is expressed by tumors. Continue reading
The American Society of Hematology’s (ASH) annual meeting is the most important event in the field of hematology. Although blood cancers represent the minority of cancer cases, the field is garnering a lot of attention thanks to great advancements over the past decade which translated to huge commercial success stories. This year’s meeting, scheduled for next month, will include important data for the following companies.
AVEO (AVEO) is down 45% in less than 3 months due to uncertainties around its lead program, tivozanib. Tivozanib was recently submitted for FDA approval in renal cancer based on positive phase III data showing superiority over the approved drug, Nexavar. Although tivozanib led to superior progression-free survival (PFS) and was substantially safer than Nexavar, investors are concerned about Regulatory and market positioning risks. Continue reading
Synta (SNTA) reported updated results for its Hsp90 inhibitor, ganetespib, in non-small cell lung cancer (NSCLC). Synta is evaluating ganetespib in a randomized phase II trial (the GALAXY trial) where ganetespib is given in combination with standard chemotherapy. This update comes 3 months after the previous read-out, which I discussed here.
Roche recently disclosed a decision to start phase III with GDC-0973 (formerly XL518), a MEK inhibitor licensed from Exelixis (EXEL) to Genentech 6 years ago. The trial is expected to start next month and will evaluate GDC-0973 in combination with Roche’s Zelboraf in patients with BRAF-mutated melanoma. This is an extremely positive catalyst for Exelixis, who now has a second drug in pivotal studies with a high likelihood of success and a substantial market opportunity. Continue reading
BMS’ PD-1 antibody – As good as it gets
The biggest news at this year’s ASCO came from BMS’ (BMY) PD-1 antibody, BMS-936558. This antibody belongs to a new class of antibodies that stimulate patients’ immune system to attack cancer. This approach has been recently validated with another BMS antibody, Yervoy, which was approved last year for melanoma.
Based on results presented at the meeting, BMS-936558 is superior to Yervoy by any measure. In fact, it is probably one of the most promising oncology drugs ever to be tested in humans. It induces tumor shrinkage in a substantial portion of patients, creates an immune response that keeps the disease under control for long periods and it does so with limited side effects. To make things even better, there might be a way to pre-select patients who are more likely to respond to this agent. Continue reading