Biomarin(NASDAQ: BMRN) is a company that specializes in developing treatments for rare diseases. They currently have 4 approved drugs in Kuvan for PKU, Naglazyme for MPS VI Aldurazyme for MPS I, Firdapse(approved in the EU only) for LEMS. The majority of their current revenue comes from sales of Naglazyme with 2012 revenue guidance of $250 […]
ARQL – Post-ASCO take on Arqule
At ASCO 2012, Arqule (NASDAQ: ARQL) presented the full results from their randomized Phase 2 trial of Tivantinib in previously treated second-line treatment in hepatocellular carcinoma (HCC). In the ITT population, time-to-tumor progression was statistically significant with a hazard ratio [HR] = 0.64 (p-value = 0.04) with 6.9 weeks vs. 6.0 weeks. No real difference […]
Updates from the Jefferies Global Healthcare Conference
The 2012 Jefferies Global Healthcare Conference was held June 4-7, 2012. You can access the full schedule and webcasts here. I’ll provide brief updates on the presentations by several companies in this post. Keep your eye on the Chimera Proprietary Calendar for all upcoming investor meetings, with links to the webcasts and schedules. Note that […]
INCY- 12-week RA Results Follow-up
Incyte and partner Eli Lilly presented complete full 12-week results for its JAK inhibitor INCB28050 (LY300904), now known as baricitinib June 8 at EULAR as a late-breaker. A total of 301 subjects with inadequate response to methotrexate (MTX) were enrolled in Eastern Europe, India, Mexico, and the U.S. The trial was run by Lilly. This is a […]
ARRY – Post-ASCO take on Array Biopharma
Now that I have had some time to digest most of what I saw and heard at ASCO 2012, I wanted to share some of my thoughts on Array Biopharma (NASDAQ: ARRY). They had 2 key presentations: full data from their randomized Phase 2 of Selumetinib + Docetaxel(S+D) versus Docetaxel(D) in 2nd-line patients with KRAS […]
INCY – Outstanding 3-Month RA Data
Data from the 12-week portion of Incyte’s 24-week Phase IIb study in patients with moderate to severe RA were released in an abstract ahead of EULAR today. In this 301 patient trial, patients were randomized to placebo, 1mg, 2mg, 4mg, or 8mg INCB28050 (also known as LY3009104). All endpoints were met for the 4mg and […]
Some thoughts on data at ASCO 2012 (Days 1,2)
Medivation (NASDAQ:MDVN), Johnson & Johnson (NYSE: JNJ) and Dendreon (NASDAQ: DNDN) are woven in a closely watched battle in prostate cancer. JNJ’s AA-302 has been chopped up many ways and there are some weird things that come to mind. We don’t think the AA-302 was all that damaging to Dendreon’s Provenge, but the headline risk […]
EASL – A Look Back- Lessons Learned
There were some early winners and losers this year at EASL. Here we examine a few new interferon-free combination treatments, the most exciting development in HCV today; and look outward to determine how the future may shape up. The Good News: The star of the stage, once again, was GS-7977 (formerly PSI-7977). Gilead’s nucleotide polymerase […]
IDIX – The Patent Interference Case
In early March, Idenix announced the USPTO (US Patent and Trademark Office) had declared a patent interference between its U.S. Patent Application no. 12/131,868 and Pharmasset’s (now Gilead’s) U.S. Patent no. 7,429,572. Idenix, with the earlier filing date, has been designated the senior party in this dispute, where the principal issue is to determine priority […]
ASCO 2012 presentations on my schedule
With the 2012 Annual Meeting of the American Society of Clinical Oncology(ASCO 2012) set to kickoff on Friday, June 1st (thru the 5th), I thought I would share my list of must-see presentations(the bolded ones with links). Abstracts for all others can be found here[link]. There are so many presentations but so little time, it […]
Heat Shock Protein 90 (HSP90) inhibitors: Back in the spotlight – Part 1
Heat Shock Protein 90 (HSP90) was originally proposed as a cancer drug target in the 1990s, though no drug in this class have ever successfully completed a randomized clinical trial, let alone achieve regulatory approval. Despite repeated setbacks, HSP90 inhibitors are poised to find a significant niche in the evolving cancer treatment landscape. We will […]
EXEL – On Overall Survival And Bone Scans
Exelixis’ abstract of its final data from its pivotal Phase III study of cabozantinib in medullary thyroid (MTC) cancer was released on May 16th during the ASCO abstracts data dump. Investors already knew from top-line data released October 2011 that the drug was highly active and met the primary endpoint of progression free survival (PFS) […]
CLDX – Departing comments on Celldex
With Celldex Therapeutics (NASDAQ: CLDX) due to report results today at 4:30pm EST, we wanted to take a few moments to review a few additional points. For those unfamiliar with the Celldex story, see our recent article[link]. In my opinion, success in this and future trials depends on several variables: whether CDX-011 actually hits GPNMB […]
AMRN – Update on Amarin’s AMR101 as PDUFA date draws closer
Amarin Corp (NASDAQ: AMRN) released first quarter 2012 financial results and held a conference call on May 8, 2012. It is often hard to distinguish the signal from the noise when it comes to chatter about AMRN on Twitter and other venues, so we will try to objectively update where things stand as the July […]
Quick commentary on ASCO12 abstracts
Last night we had the release of the abstracts for the 2012 Annual Meeting of the American Society of Clinical Oncology(ASCO12 for short). It’s quite the data deluge. Below is some quick commentary on my read on abstracts related to several companies. Onyx(NASDAQ: ONXX) and Seattle Genetics (NASDAQ: SGEN) both had interesting datasets that we […]
INCY – An Acquisition Target?
Today, any biotech company with a promising product may be considered a potential acquisition target. Incyte Pharmaceuticals can certainly be considered one such candidate. It is well known that Big Pharma has been struggling with a lack of productivity, exacerbated by expiring patents on their biggest drugs. Some companies have managed this better than others. […]
VRTX – Vertex Sweat Chloride to FEV1 Correlation in Cystic Fibrosis
Vertex released interim data May 7th of an ongoing combination study of VX-809 and KALYDECO in Cystic Fibrosis patients with two copies of the F508del mutation. Results were very good- VX809 plus Kalydeco led to significant improvements in lung function (as measured by absolute change in percent predicted FEV1). Treatment Group Absolute Improvement from Baseline in Lung Function (FEV1) […]
ARNA, VVUS & OREX – Update after Lorcaserin AdCOM
Yesterday, the FDA Advisory Committee voted strongly in favor of approving Lorcaserin, for the treatment of obesity. Previously, our group felt that ARNA’s Lorcaserin along with OREX’s Contrave would eventually gain regulatory approval, but that there would be some delay. In the case of ARNA, we were impressed at how eager the Advisory Committee was […]
DEPO, SNTS, XNPT, PFE – Update on Q1 Earnings
DEPO – Reaffirming Buy Yesterday, Depomed reported better-than-expected earnings for the first quarter. Gralise revenue was $1.75 million, Glumetza revenue was $9.2 million, Janumet XR was $0.2 million. We are reaffirming our BUY recommendation for this company. We feel that increases in total sales for Glumetza, price increases, and an increase in the percentage revenue […]
IDIX – To Market By 2015?
Idenix presented at the 37th Deutsche Bank Annual Health Care Conference May 7th. Yeah, not the most exciting event, but still worth mentioning. CEO Ron Renault gave a run-down of the company’s highlights, mostly rehashed from previous presentations, but there were some interesting tidbits. It will be key to be on the market by the […]
