InterMune and the Ten-Bagger Quest: Idiopathic Pulmonary Fibrosis (ITMN)

December 17, 2010 · Filed Under fda, Lung · Comment 

InterMune Inc. (NASDAQ: ITMN) was already known by many investors and was already a very volatile issue.  With shares having nearly doubled on key drug news, InterMune is back on the map.  You can almost hear the call for a ten-bagger alert from the year’s lows.

The stock is soaring on news out of Europe that the EMA adopted a positive opinion that actually recommends granting marketing approval for its Esbriet (pirfenidone) in adults.  The indication is for treating mild to moderate idiopathic pulmonary fibrosis, a fatal lung disease.  The FDA in the United States rejected the drug despite a positive indication in a panel review.

The benefits are a reduction in the rate of deterioration of lung function that is measured by a lower decline of what is called the “percent-predicted forced vital capacity.”  Also shown was a benefit in the six-minute walking test.

Pulmonary fibrosis causes progressive scarring of lung tissue.  As far as overall pulmonary fibrosis without getting into the various stages of the disease, the National Heart Lung and Blood Institute said that there is no cure and that many still live 3 years to 5 years after being diagnosed.

We wanted to know how many people have IPF… The Pulmonary Fibrosis Foundation notes, “There is a lack of newly published data to demonstrate an accurate estimate for the incidence of idiopathic pulmonary fibrosis in the United States. The most recent estimates indicate that approximately 128,000 Americans have IPF, although there are published estimates that suggest the number may be as high as 200,000. Varying terminology and lack of standard diagnostic criteria have complicated the accrual of accurate data.”  That is a U.S. figure, and we have been looking for data on the E.U. and rest of world figures (to be updated soon).

A ten-bagger implies a rise of tenfold… 1,000%.  It is rare to see such moves, but investors need to consider where InterMune has been. The 52-week trading range is $8.34 – 49.46 and yesterday’s close was $14.27.  InterMune shares went from $15 to almost $50 from March to May of this year, but by June shares were sucking wind and were under $10.00.

InterMune came public in 2000 and shares hit above $50.00 and $55,00 in late-2000 and went above $50 again in late-2001 and early-2002.  This might not quite fit the profile for a ten-bagger, but it all depends on how well the company can do ahead in its trials and bringing product to the market.

At 10:00 AM EST we have shares up 105% at $29.24 and we have already seen 8.3 million shares traded against an average daily volume of 940,000 shares.  Even after the pop today, InterMune is still a small cap to mid-cap stock with a $1.64 billion market cap.

JON C. OGG

Ikaria: BioHealth IPO with Profits and Revenues

May 13, 2010 · Filed Under Cardiac, Financial, Heart, Lung · 1 Comment 

The newest initial public offering in the realm of biotech and biohealth has just been filed by a company called Ikaria Inc.  While terms were not disclosed, it plans to sell up to $200 million in common stock per the SEC filing.

The New Jersey-based biotherapeutics company plans to take the ticker “IKAR” on NASDAQ.  The underwriting group is rather large: Goldman Sachs, Morgan Stanley, Credit Suisse, Lazard Capital Markets, Cowen & Co., and Wedbush PacGrow Life Sciences.

Unlike many BioHealth pre-public companies which file to come public, Ikaria has revenues.  2009 sales were $274 million.  The company also had had net income of $13 million and EBITDA of $109 million in 2009.

Ikaria is focused on developing and commercializing new therapeutics and interventions designed to meet the significant unmet medical needs of critically ill patients.

Its net sales are generated from INOtherapy, most of which come from the medical gas called Inomax used to treat a certain type of respiratory failure and is approved for hypoxic respiratory failure in term-infants and in premature infants.  INOtherapy is sold in the United States, Puerto Rico, Canada, Australia, Mexico and Japan.  Inomax is also in clinical trials for other indications.

Other focal areas are Hepatorenal Syndrome, where kidneys start to fail, as well as treating post heart attack patients.

OTHER PROPOSED TREATMENTS:

  • LUCASSIN, a Terlipressin/vasopressin receptor agonist, is for Hepatorenal Syndrome Type 1 with a pivotal phase III expected to start in 2010;
  • IK-5001, a sodium alginate and calcium gluconate/mechanical support of infarcted heart muscle, targeted for cardiac remodeling and subsequent congestive heart failure following a heart attack with an expected Pivotal phase II/III expected to commence in 2011.
  • IK-1001, a sodium sulfide to treat conditions characterized by tissue ischemia is in the clinical program in planning stage.
  • IK-6001, is a Fibrinogen Bb15-42/anti-inflammatory indicated for conditions characterized by vascular leakage and is in pre-clinical stages.

FULL SEC FILING

JON C. OGG

FDA Dishes The Unexpected to InterMune (ITMN)

May 4, 2010 · Filed Under fda, Financial, Lung · Comment 

InterMune Inc. (NASDAQ: ITMN) is going to put the hurt on the biotech sector this week.  Shares closed down 5.4% at $45.44 on fairly active trading.  But then came a trading halt a few minutes before the market close for “NEWS PENDING.” The FDA just squashed it….

The FDA issued a complete response letter for its New Drug Application for Esbriet for the treatment of patients with idiopathic pulmonary fibrosis to reduce decline in lung function.  A complete response letter by the FDA means a review is completed, but when there are one or more than one reasons precluding an approval:

  • The FDA has requested an additional clinical trial to support the efficacy of Esbriet in IPF patients. InterMune intends to meet with the FDA as soon as possible to explore the best ways to address the points raised by the Agency and to discuss pathways to approval.

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