By: Patrick Crutcher

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 hope to comment on at a later time. Admittedly, the data for Onyx would seem to suggest their ODAC on June 20th might go better than expected. One of the most impressive datasets came out of Array Biopharma (NASDAQ:ARRY). First, data from their partnered drug with Astra-Zeneca, Selumetinib, did not disappoint[link]. Although OS was not statistically significant, it was very encouraging to see almost a double(9.4 mo vs 5.2 mo).(Remember, AZN changed primary endpoints during the...

By: Jason Chew

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. Although all suffer losses, according to a study by Bernstein Research, the outlook for Big Pharma companies vary drastically. Two charts are presented below; one shows the relative amount of pharmaceutical revenue that is expected to be lost between 2010 and 2020. The second adjusts this by adding in non-pharmaceutical revenue and potential pipeline contributions. The graphs look a bit different, with the latter showing growth for a few companies, but the general ordering of each...

By: Jason Chew

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) (Baseline — Day 56) ≥ 5 percentage points ≥ 10 percentage points VX-809 alone (200mg, 400mg or 600mg) for 28 days followed by KALYDECO (250mg, q12h) + VX-809 (200mg, 400mg, 600mg dose groups combined) for 28 days             46% (17/37)           30% (11/37) Placebo           0 (0/11)           0 (0/11)   There was a second endpoint of reduction of sweat chloride. This endpoint was not met at the interim analysis. Even so, Vertex shares have since soared 73% from $37.41 to $64.70 on the strong lung function data. Analysts noted reduction...

By: Tro Kalayjian

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 to approve the product, given the mediocre efficacy profile. This result was sooner than expected. Our put ratio spread, will expire without any gains and likewise without any losses. Our Previous Coverage: VVUS - Initial Report – 12/16/11 VVUS – Quick Update – 01/09/12 VVUS – Understanding the AdComm – 02/20/12 VVUS - Vivus PDUFA Trading Strategy - 03/15/12 VVUS, OREX, ARNA - EMOC Understanding the EMDAC - 03/27/12 ARNA: AdCom Trade Strategy - 05/07/12 ARNA – Quick take on FDA...

By: Tro Kalayjian

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 share, will help move Depomed towards profitability. Furthermore, we are very pleased with the Gralise launch. We note that price increases for Gralise and the change of focus to primary care will bolster the bottom line. Of particular note, over 30% of Gralise scripts are from off-label use, which we think will be the biggest driver for total sales. The pipeline is also progressing, enrolling is underway for their phase II Parkinson's candidate, furthermore the company...

By: Jason Chew

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 2015 to 2016 timeframe with an all-oral combination. This was duly noted by both the company and analysts. Idenix appears quite optimistic and seems to believe only Gilead is ahead of them in this race, and not by much. The company has big plans for IDX184 (big plans I say). As mentioned previously, Idenix seeks to test their lead nucleotide with at least two protease inhibitors. There are multiple reasons for this. For one, Idenix does not...

By: Tony Pelz

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By: Tro Kalayjian

Our coverage of the anti-obesity sector continues. Yesterday, the FDA released the briefing documents regarding Arena's application for Lorcaserin. Lorcaserin, or Lorqess, is a novel therapeutic candidate for treatment of obesity. Brief History: In 2010, Arena submitted the NDA for Lorcaserin, a subsequent AdCom voted against the application, five on the roster voted for the application and nine voted against. In early 2012, Arena resubmitted the application to the FDA, with some new clinical and non-clinical data. The FDA accepted the application and set a PDUFA date for June 27th, 2012, with an intermediate Advisory Committee on May 10th, 2012 Key Dates: 09/27/10 - Adcom #1 (5 for, 9 against) 10/23/10 - CRL Issued 01/04/12 - NDA Resubmitted 05/10/12 - Adcom #2 06/27/12 - PDUFA #2 Briefing Documents: FDA Briefing Information Appendix to the FDA Briefing Information Arena Briefing Information Draft Questions Committee Roster Our...

By: Andrew Goodwin

The Needham Healthcare conference was held April 3-4, 2012, and as usual, find my notes below. The webcasts can be accessed at this link with the username "needham" and password "healthcare." Remember that you can always search with a ticker symbol or keyword in the upper right corner of the Chimera site to bring up all articles and updates related to that stock. Additional slides, figures, links, and details for many companies is also available over at the BiotechDueDiligence site and blog.   Alnylam (NASDAQ: ALNY) - presenter was President/COO General corporate commentary Now have treated >500 patients with RNAi, including ~100 with systemic delivery. 5x15 strategy: goal is 5 products in development through 2015, alone or with partners (this bar has been significantly lower from the initial claim of 5 in late-stage trials by 2015 when...

By: Tony Pelz