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Biotech Stock Mailbag: 2013 Clinical Trials Calendar


BOSTON ( TheStreet) -- I'm just back from covering the American Society of Clinical Oncology (ASCO) annual meeting -- and still recovering -- so apologies in advance for a less-full Biotech Stock Mailbag this week.

Bruce L. writes:

Besides the FDA Drug Approval Calendar, it would be helpful to know when phase III results are going to be announced. I just stumbled upon Insmed (INSM), which will announce phase III results soon and the stock has run from $3 to $11 in a few months. The run-up is where you can make a lot of money without the risk of the FDA. Publishing a list of quarterly clinical trial results would be very helpful. Keep up the good work!"

Insmed's lead product is Arikace, an inhaled antibiotic engineered to deliver an already-approved antibiotic known as amikacin directly into the lungs of patients with rare lung infections. Arikace is being studied in a phase III clinical trial of cystic fibrosis patients, with results expected in the middle of the year. This study is intended for an approval filing in Europe and Canada.

The FDA imposed a clinical hold on a similar Arikace study in the U.S., which was later lifted, but Insmed's plans to develop the antibiotic here are still unclear, pending results from the European study. Insmed is also conducting a phase II study of Arikace in patients with non-tuberculous mycobateria (NTM) lung disease and a nine-month dog toxicity study.

Results from Insmed's NTM study are expected in the fourth quarter.

Bruce's overall point about the stock-moving power of clinical trial results is a good one. Take a look at what happened to Clovis on Monday if you're a doubter.

Here's a rundown of companies with significant clinical trial results expected this year:

MannKind (MNKD)
Afrezza, Type 1 and 2 diabetes
Top-line results from two phase III studies expected in August.
After two FDA rejections, MannKind is back seeking another shot at approval of its inhaled, fast-acting insulin. The data from these two phase III studies, if positive, will form the basis of the Afrezza resubmission.

Vical (VICL)
Allovectin for melanoma
Top-line results from a phase III study expected in the third quarter
The long-delayed Allovectin study is finally almost complete. I explained the bear thesis on Vical and Allovectin in a previous Mailbag.

Orexigen Therapeutics (OREX) and Takeda
Contrave, obesity
Interim analysis of the cardiovascular outcomes study could take in the second or third quarter.
Under an agreement with FDA, Orexigen and its partner Takeda will conduct an interim analysis of the Contrave study once 87 major adverse cardiovascular events have been recorded. If the interim analysis returns clean heart-safety data for Contrave, the obesity drug will be resubmitted to FDA for a second review.

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