FDA Calendar Updates 7/30/10

Jul 30th, 2010 by BioRunUp

EXAS - Clinical Trial Results for ColoRectal Cancer Screen 10/29/10

ALRT - FDA 510(k) Filing for Health-e-Connect (HeC) System — Health Care for Diabetes Patients.  ESTIMATED Date of 3/31/10

HOLX - FDA Advisory Panel for breast cancer screening / diagnosis on 9/24/10

AZN - FDA PDUFA for Brilinta 9/16/10

MKGAY - FDA Priority Review for Cladribine Tablets 12/8/10

Tags: ALRT, EXAS

Posted in FDA Calendar | No Comments »

ARNA – A “Poster Child” for Run-Ups

Jul 29th, 2010 by BioRunUp

We first discussed ARNA back on May 20th, back when ARNA was $2.90 a share. That is a far cry from today’s close of nearly $7 per share.  Take a look at the incredible chart for ARNA over the past few months.  Can ARNA maintain this momentum up to the FDA Panel on September 16th?  Can the 200% price increase hold?  Good questions, and only time will tell…

Chart

Tags: arna

Posted in Breakout, FDA Panel | 11 Comments »

AMRN- Clinical Trial with Upcoming Catalysts

Jul 29th, 2010 by BioRunUp

I respect Mike Havrilla as a person, pharmacist, and trader, so when I found out that he expressed much confidence in a clinical trial, I wanted to learn more.  I am passing this information on to my subscribers.

I currently have no position in AMRN, but I am looking to open one after the October Run-Ups.

For more information on the benefits of a premium membership to MikeHavRx.com, click here.

The following was written by Mike Havrilla:

Amarin Corp. (NASDAQ:AMRN) is developing AMR101 (Ethyl-EPA) as a prescription-grade omega-3 fatty acid that has been marketed in Japan for over 10 years as EPADEL by Mochida Pharma. Ethyl-EPA is differentiated from Glaxo’s (NYSE:GSK) $1 billion dollar product LOVAZA (omega-3-acid ethyl esters) in the following key areas:

  • no fishy smell / taste or GI side effects such as burping = better patient compliance since these are both taken every day
  • - lacks Ethyl-DHA omega-3 fatty acid component, which can raise bad cholesterol (LDL) levels
  • - potential to address a much larger patient population including those with triglyceride levels of 200-500 mg/dL vs. LOVAZA, which is indicated for patients with triglyceride levels greater than 500 mg/dL
Amarin is fully funded through a potential NDA filing with ongoing partnership discussions. My current estimate is for patient enrollment to conclude by late 2010 to early 2011 (ahead of the most recent company guidance) with results expected by mid-2011 under this scenario since both studies have 12-week treatment periods. It should also be noted that both studies are being conducted under Special Protocol Assessments (SPA) with the FDA without the need for Phase 2 studies, supported by over 10 years of use in Japan and previous studies conducted by Amarin for a variety of neurological conditions.
ANCHOR study: ClinicalTrials.gov ID NCT01047501 was last updated on 5/3/10 and is currently recruiting participants: “Evaluation of the Effect of Two Doses of AMR101 (Ethyl Icosapentate) on Fasting Serum Triglyceride Levels in Patients With Persistent High Triglyceride Levels (≥ 200 mg/dL and < 500 mg/dL) Despite Statin Therapy.”
MARINE study: ClinicalTrials.gov ID NCT01047683 was last updated on 6/9/10 and this study is no longer recruiting patients, which provides a strong hint that enrollment is likely to be completed soon and well ahead of the Company’s previous guidance. The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to placebo in lowering fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ 500 and ≤ 2000 mg/dL.
Looking at the financials, Amarin is fully funded through a potential NDA filing and ended 1Q10 with $44 million in cash and no debt with approximately 99 million shares of common stock outstanding. On a fully diluted basis, Amarin has about 148 million shares of common stock, which includes 7.8 million options outstanding with an average exercise price of $2.71 and 41.2 million warrants outstanding at an average exercise price of $1.75.
Amarin is currently the largest holding in my Ameritrade account because of the following factors:
  • an under the radar opportunity with little research analyst coverage and largely unknown by Wall Street
  • targeting an enormous market opportunity that encompasses cardiovascular disease and the evolving recognition of the need to treat triglycerides, which has the potential to become a multi-billion market opportunity similar in scope and size to statin drugs such as the world’s top selling drug Lipitor that is about to face generic competition
  • many potential big pharma suitors, including obvious names such as Glaxo given the potential threat to their billion dollar drug LOVAZA, which is currently the only FDA-approved prescription omega-3 fatty acid product and Pfizer (NYSE:PFE) which will soon face generic competition for Lipitor and may look for another potential blockbuster drug in the area of cardiovascular disease
  • potential for a milestone-based partnership ahead of the pivotal results since Ethyl-EPA represents a relatively low-risk of clinical development since it has been used for over a decade in Japan and represents a purified version of the major component in LOVAZA
  • potential for the Company to complete patient enrollment and report results from the pivotal studies ahead of current guidance (please note the timeline has already been shortened by one year from the Company’s original guidance of reporting Phase 3 results in 2012)

AMRN Pipeline

Tags: AMRN, mikehavrx.com

Posted in Clinical Trial | 4 Comments »

EXAS Updates – Detection Technology Achieves 100% Sensitivity

Jul 28th, 2010 by BioRunUp

This post is to update you on some recent developments and research done on EXAS.  Clink on the title to read the article we published on Monday: “EXAS- Data Validation Study with a 10/29/10 Catalyst Date“.

Today, July 28th Exact Sciences reported their Q2 earnings.  Some of the highlights include:
Continue Reading »

Tags: EXAS

Posted in Clinical Trial | 3 Comments »

“Thank You!” from BioRunUp.com

Jul 27th, 2010 by BioRunUp

I would like to send out a little note thanking the subscribers and supporters of BioRunUp.com

Today, we reached a milestone- crossing the 1,000 subscriber mark.   We also have over 750 followers on Twitter.  We feel this is quite an accomplishment, as BioRunUp.com has only been on the web for 3 months, and the majority of this time we were in a tumultuous market. We are striving to make BioRunUp.com an environment where biotech traders can visit everyday for new and relevant content, helpful resources, and a productive sharing of information.

Over these months we have been proud to release the following:

Please attempt to make the best out of these resources as possible. Just as a reminder- to make sure you are getting the most out of the site, check out the “User Guide” as well as our “Research Tools (Links)”

Thank you for your support and, as always, if you have an idea on how to make BioRunUp.com better, send us an email at comments@biorunup.com

Now, lets continue playing the “Run-Up” and experiencing a successful 2010!

Posted in Off Topic | 10 Comments »

Want to Gamble? ISA.TO PDUFA Date is 8/3/10

Jul 27th, 2010 by BioRunUp

Remember Isotechnika?  ISA.TO (or IPHAF) is the company whose FDA Advisory Panel was cancelled with only a few days notice.  The explanation the company gave was vauge at best.  However, the company claims the Priority Review PDUFA date of 8/3/10 for Voclosporin is still valid, and they expect to hear from the FDA by that time.  That date is less than 1 week away, and although it is a VERY risky play, some may chose to jump in last minute for a possible run-up or even an unexpected approval.

Take a look at the chart for ISA.TO over the past few months:

Continue Reading »

Tags: iphaf, isa.to

Posted in FDA PDUFA | 6 Comments »

EXAS- Data Validation Study with a 10/29/10 Catalyst Date

Jul 26th, 2010 by BioRunUp

It is not often that I get excited about playing clinical trials.  Generally I feel that they are too risky, as the majority of the time there is not a set catalyst date to allow for a run-up.  What can happen with clinical trials and data validation studies are the results are announced unexpectedly.  You may go to bed with $5 shares and wake up with $1 shares. However, there is the rare occasion when we have the opportunity to play the run-up on a clinical trial. (Note: EXAS 2Q earnings are to be released 7/28)

EXAS (Exact Sciences) is one of these rare occasions, and the prospects are exciting.  Take a look:

Continue Reading »

Tags: EXAS

Posted in Clinical Trial | 11 Comments »

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