Last week’s approval of Alnylam’s (ALNY) Onpattro, the first FDA-approved siRNA drug, serves as a reminder for the bumpy road new technologies go through on their way to the market. From an investor perspective, siRNA has gone in and out of fashion over the years with dramatic shifts in market sentiment. It started with unrealistically high expectations, deteriorated to deep pessimism due to clinical setbacks, followed by gradual sentiment improvement in recent years (with some hiccups along the way). Continue reading
It is hard to overestimate the impact of the Novartis (NVS) /Avexis (AVXS) deal. So far, big biopharmas have had limited exposure to gene therapy and those that did get into the field focused on early-stage collaborations: Pfizer/Bamboo, Biogen/AGTC, Roche/ 4DMT, Abbvie/Voyager etc. This is understandable given the unique product profile gene therapies represent: One time irreversible treatment, lack of long term follow up and creative reimbursement models.
The $8.7B acquisition of Avexis, just three months after the deal with Spark (ONCE), makes Novartis the first pharma to embrace gene therapy as a commercial opportunity. The deals also make Novartis the undisputed gene therapy leader with (hopefully) two products on the market next year. Continue reading
The ECC/ESMO meeting, the European equivalent of ASCO, will take place next weekend. Historically, this event has received limited investor attention (since most of the important late stage stuff is reserved for ASCO) but in recent years its importance is growing as more practice-changing data are presented. As a proof of this trend, this year’s meeting will include the two most important breakthroughs in renal cancer in almost a decade. Continue reading
In a field characterized by binary “make or break” events, Avalanche Biotechnologies (AAVL) is a poster child. The company derives the majority of its valuation ($819M) from AVA-101, a gene therapy treatment for wet AMD (age-related macular degeneration) currently in phase 2. Top line results are expected within 1-2 months and should have a dramatic impact on the stock as well as the entire ophthalmology industry. Continue reading
ArQule (ARQL) has doubled in less than two months, following two years of weakness. While tivantinib’s phase III liver cancer is the company’s most visible asset, investors are starting to notice ArQule’s early stage pipeline and its potential to generate meaningful data in the coming year. Both ARQ 092 (Akt inhibitor) and ARQ 087 (FGFR inhibitor) are being tested in biomarker-enriched trials with the potential to have clear efficacy signals during 2015. Continue reading
Back in 2010, ADCs were the hottest theme in oncology with the potential to revolutionize cancer treatment. The excitement was based on promising results for Adcetris (Seattle Genetics [SGEN]) and Kadcyla (Immunogen [IMGN]), both of which utilized new and improved ADC technologies. Adcteris and Kadcyla were perceived as the ultimate cancer drugs: They had strong single agent activity and provided meaningful benefit to patients with limited toxicity. All that was left to do was replicating their success with additional antibodies to cover every tumor type. Continue reading
Last night, Roche and Foundation Medicine (FMI) announced a strategic collaboration under which Roche will become the majority owner in Foundation Medicine. Roche will become Foundation’s marketing partner and intends to use the company’s tests for its drug development projects.
Roche is paying $1.03B for 56.3% of the company, representing a price per share of $50 (109% premium over Friday’s close). For investors, the deal validates the bull thesis for Foundation (which I discussed here) as the undisputed leader of NGS-based tumor profiling. Turns out that being first matters also in the diagnostics business! Continue reading
Below is my traditional end of the year summary and a recap of catalysts for 2015. As always, I did my best to cover the most important events, let me know if I missed anything… I would like to use this opportunity and wish the readers of this blog a happy and prosperous new year.
Ohad Continue reading
After months of uncertainty regarding the fate of binimetinib, Array (ARRY) announced it regained full rights for the drug from Novartis (NVS). Binimetinib (MEK162) was originally partnered with Novartis in 2010 (discussed here) and has been aggressively pursued since. Novartis had to return binimetinib back following the acquisition of GSK’s (GSK) oncology portfolio which included Mekinist, a MEK inhibitor approved for melanoma. Although binimetnib has a high likelihood of returning to Array, the decision is still subject to final approvals for the GSK-Novartis deal. Continue reading
Clovis (CLVS) was one of ASCO’s clear losers following safety issues for its lead program, CO-1686. Despite demonstrating robust efficacy in T790M+ lung cancer, hyperglycemia associated with the drug raised concerns about its ultimate market positioning vs. its close competitor, AstraZeneca’s (AZN) AZD9291. Continue reading