3SOF

on fire !!

anybody invested?

Ive got 4k shares I've held for awhile Laonda.  I hope TRCA, DNA, and INSM can come to some agreement as the Doctor expressed in the NYT article.  I really don't know what to believe as far as the lawsuit.  I've read a lot about it, but opinions obviously vary.  All I know is that I have 3 children, and if I had a chance to give my child 1 shot a day instead of 2, there is no way I would opt for 2, so IPLEX IMHO is going to get a lion share of the patients choosing between Increlex and Iplex, the 2 approved drugs, but the lawsuit just hangs ove the head of the stock like a disease.

I'm still holding...with a 40% loss 

So go INSM go

Amarens

There's a gap and a pseudo gap to be filed....

I'm still in also. I have a habit(bad?) of buying on the way down if i believe in the stock. Sitting on a 14% loss,which may turn into a gain in the very near future. Patience is indeed a virtue. GLTA! soxguy

insm up 20% after hours. Watch it tommorow. soxguy

insm up in premarket. No news,just speculation.

nice INSM chart on no news

fyi:
latest analyst report:
Insmed "buy"

Monday, February 19, 2007 4:07:30 AM ET
Lazard Capital Markets

NEW YORK, February 19 (newratings.com) - Analysts at Lazard Capital maintain their "buy" rating on Insmed Inc (ticker: INSM). The target price is set to $3.

In a research note published on February 16, the analysts mention that as a result of stipulation submitted to the court by Insmed and Tercica, the preliminary injunction hearing has been delayed. The reasons for the delay in the hearing and when it would be scheduled appear uncertain, the analysts say.

I'm sure this is the take of a bagholder, but this is a buy at .89  If it dips below, I will do the unthinkable and average down and then hold.

Short stature was not what was going to make IPLEX huge in the first place, and now the lawsuit is put to bed, and DNA is motivated to help in the future.  The 7.5 million judgement goes away, and the path is cleared for the big money to be made down the line free the lawsuit cloud.  I had hoped for a buyout settlement, but dems da breaks.

The problem is that they now have no drug on the market - i.e. no revenues (I know, revs from IPLEX to date were pretty paltry), are cutting their workforce substantially, have very litle cash, so we can expect further dilution in the coming months, have to split revenues from IPLEX with TRCA/DNA for further indications... the list goes on and on.  People are shouting that they will make $300M a year from IPLEX in Italy, but this is totally unrealistic.  I really think INSM is in deep trouble now, and I would wait for the dust to settle before buyin any more.  It could easily go down to .50 before basing.  We have all seen what happens to Biotechs when bad news hits them, especially when they have little or no revenues.  They get creamed.... and then they get creamed some more.  Just look at BBC (Bodisen Biotech).  The only thing htat absolutely shocked me yesterday, was that I realised I could short INSM!!!  Wish I had known that earlier!!

What I think is so strange is that INSM was one of the only stocks to be rallying last week when everything else was getting killed.  This kind of contrarian movement is difficult for me to understand, with the news we now know has come out.  Perhaps funds that were "in the know" were pumping INSM up, knowing it is the kind of company that has a strong enough following among traders who will dive in based upon price movement alone, only to take them to the cleaners?

Technically, there should be support at .85, and .90 is a key level as well, but I really think it may be a long time before we see INSM trading above 1.20 again.

Just my thoughts (and I have put my money in INSM many times, and mostly lost my shirt on this one, if I do say so myself)

This one moving in the pre-market.......
+21.57%.......Volume @ 474,500






Press Release Source: Insmed Inc.


Insmed Releases Positive Results from IPLEX Phase II HIV-Associated Adipose Redistribution Syndrome Clinical Study
Monday April 30, 9:00 am ET


RICHMOND, Va.--(BUSINESS WIRE)--Insmed Inc., (Nasdaq:INSM - News) today announced positive results from a Phase II investigator-sponsored clinical study of the company's drug IPLEX(TM) in HIV-infected patients affected with HIV-associated Adipose Redistribution Syndrome (HARS).


Preliminary results from the study, being conducted at the University of California, San Francisco, showed that three months of 0.5 mg/kg/day IPLEX treatment in seven patients increased IGF-I levels 3-fold and was associated with significant improvements in fasting glucose levels, the amount of insulin secreted during an oral glucose tolerance test, and overall insulin sensitivity. Moreover, there was a significant reduction in trunk fat and a positive downward trend in waist circumference when compared to baseline. Lipid profiles also tended to improve.

Notably, normal glucose tolerance was restored in half of the six patients diagnosed with impaired glucose tolerance (IGT) at the start of the study. These IGT patients also experienced a significant decrease in visceral adipose tissue (VAT). Impaired glucose tolerance is characterized by blood glucose between 140 and 200 mg/dl at the 120-minute measurement of an oral glucose tolerance test. The next phase of the study is underway to explore an IPLEX dose of 1.0 mg/kg/day given for six months.

"Our study has demonstrated that a low dose of IPLEX increased IGF-I levels 3-fold and positively impacted abnormal glucose metabolism, dyslipdemia and abnormal fat distribution, which are present in a significant number of HIV patients treated with highly active antiretroviral therapy (HAART)," said Morris Schambelan, M.D., the study's principal investigator and professor of medicine and director of the General Clinical Research Centers at University of California, San Francisco, and chief of endocrinology at San Francisco General Hospital.

"We are very encouraged by these preliminary results with low-dose IPLEX. We believe a product that improves fat distribution while also improving insulin sensitivity would be a valuable therapy for this patient population, and the positive effects on insulin sensitivity observed in this study are consistent with what we observed in our previous studies with IPLEX in patients with diabetes. These results support the most important differentiating property of our product in this patient population, which is IPLEX's ability to improve glucose homeostasis. Competitor products such as TH9507 and growth hormone reportedly either do not alter glucose homeostasis or exacerbate it, respectively. When considering that up to 40% of this population has impaired glucose homeostasis, then this property of IPLEX becomes even more valuable," said Dr. Geoffrey Allan, president and Chief Executive Officer of Insmed.

Study Description

The ongoing, open-label, investigator-sponsored Phase II clinical study is designed to evaluate the safety and efficacy of IPLEX in two cohorts of subjects, the first of which received a 0.5 mg/kg/day dose and the second of which will receive 1.0 mg/kg/day dose. The primary endpoints of the study are to determine the safety and tolerability of IPLEX and its effects on visceral fat and insulin sensitivity.

About HARS

An estimated 80,000 HIV patients in the U.S. have HARS, according to published reports. This disorder is marked by abnormal metabolism, including central fat accumulation (visceral adiposity and buffalo hump) with or without fat loss in the limbs. These features have increased markedly with the advent of highly active antiretroviral therapy (HAART) for HIV. Recent studies performed in subjects on HAART suggest nearly 40% of individuals develop the morphologic features characteristic of this syndrome.

About IPLEX

IPLEX was approved in the United States in December 2005 for the treatment of children with growth failure due to severe primary IGF-I deficiency (Primary IGFD). IPLEX (rhIGF-I/rhIGFBP-3) is a complex of recombinant human insulin-like growth factor-I (rhIGF-I) and its predominant binding protein IGFBP-3 (rhIGFBP-3). The drug is also being investigated for various other indications with unmet medical needs, including myotonic muscular dystrophy, retinopathy of prematurity and amyotrophic lateral sclerosis (also known as ALS or Lou Gehrig's disease).

About the University of California, San Francisco

The University of California, San Francisco (UCSF), is a leading university that consistently defines health care worldwide by conducting advanced biomedical research and providing leading life science education and complex patient care. For more information, please visit www.ucsf.com.

About Insmed

Insmed is a biopharmaceutical company focused on the development and commercialization of drugs for the treatment of metabolic diseases and endocrine disorders with unmet medical needs. For more information, please visit www.insmed.com.

Forward-Looking Statements

Statements included within this press release, which are not historical in nature, may constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements regarding planned clinical study design, our regulatory and business strategies, plans and objectives of management and growth opportunities for existing or proposed products. Such forward-looking statements are subject to numerous risks and uncertainties, including risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, the company may lack financial resources to complete development of product candidates, the FDA may interpret the results of our studies differently than we have, competing products may be more successful, demand for new pharmaceutical products may decrease, the biopharmaceutical industry may experience negative market trends and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. As a result of these and other risks and uncertainties, actual results may differ materially from those described in this press release. For further information with respect to factors that could cause actual results to differ from expectations, reference is made to reports filed by the Company with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. The forward-looking statements made in this release are made only as of the date hereof and Insmed disclaims any intention or responsibility for updating predictions or financial guidance contained in this release.

Contact:
Investor Relations International
Haris Tajyar, 818-382-9702
[email protected]

--------------------------------------------------------------------------------
Source: Insmed Inc.

This Analysis was requested sometime ago in the «Analysis on Demand» thread, which is available only for 3SOF Premium Members (14-Day Free Trial available).


1. Profile

Insmed Incorporated (INSM), a biopharmaceutical company, engages in the development and commercialization of drugs to treat metabolic diseases, endocrine disorders, and oncology. Its lead product candidate IPLEX, a recombinant protein product candidate, is in Phase II clinical trials for the treatment of myotonic muscular dystrophy, the common form of adult-onset muscular dystrophy. It is also conducting a Phase II clinical study for investigating IPLEX as a treatment for HIV associated adipose redistribution syndrome; a Phase I clinical study investigating IPLEX as a treatment for retinopathy of prematurity, a disease where the small blood vessels in the back of the eye and the retina grow abnormally; and an expanded access program in Italy to provide IPLEX to physicians for patients with amyotrophic lateral sclerosis, a neurodegenerative disease that affects nerve cells in the brain and the spinal cord. In addition, Insmed is developing INSM-18, a small molecule tyrosine kinase inhibitor that is under Phase I/II clinical trials for the treatment of breast, lung, pancreatic, and prostate tumors; and rhIGFBP-3, a Phase I clinical product candidate for the treatment of breast, prostate, liver, ovarian, and colon cancers. The company has license and collaborative agreements with Fujisawa Pharmaceutical Co., Ltd. to use IGF-I therapy for the treatment of extreme or severe insulin resistant diabetes; and a license to Pharmacia AB's portfolio of regulatory filings pertaining to rhIGF. Insmed was founded in 1999 and is headquartered in Richmond, Virginia.

2. Stock Price History



Before I begin let me start by saying that I dislike biotechnology stocks in general, and the reason for that is simple, I dislike them because most of them keep diluting shareholder's value. This happens because most biotechnolohy companies don't sell anything and have huge losses, so to survive they need a continuous flow of capital. They get this capital by issuing and selling new shares to investors. Every time a new share is printed existing shareholders see the value of their shares being diminished as they represent less of the company.

On this issue INSM looks like the champion of dilution, with the share count rising 122 fold since 1999. The company printed 21 million new shares just in the first half of 2007.

A second issue, as I look to INSM's profile, I see it has changed. When I first met this company and was still an ignorant on fundamental analysis (I guess that one year from now I'll consider I was an ignorant now), the company was developing IPLEX to cure children whom had a rare disease which made them abnormally small. I see IPLEX is being studied for other uses now.

I don't know enough to know the potential market for these other uses of the drug, or how long they are from being marketed. I just know that whatever rise the stock may have, it will be used to sell some more shares. This has been the history of this company and I don't see any change in the near or medium term future.

This isn't to say it is impossible for INSM to double or triple if there's some of those "bombastic" news releases which characterize biotech stocks. But will it be sustainable? I doubt it.

Anyway, I see sctrben made his analysis on the stock and likes it, so I just wish I'm wrong or incomplete, good luck

This Analysis was requested sometime ago in the «Analysis on Demand» thread, which is available only for 3SOF Premium Members (14-Day Free Trial available).

Somehow you forgot quite some items though.

INSM has an expanded acces program for ALS patients in italy.
Iplex used for ALS, reimbursement near 140.000 euros per patient.
Patient count earlier this summer 30. Few month legal hurdle for patients to get it reimbursed fully.

Also there are opt-in agreements with genentech and trca upon phase III enabling data.
Which means once phase IIb trials are complete they have 90 days to opt-in.
Agreement is 50% of all PAST and 50% of all future cost in return for sharing the profits.

Now iplex has cost quite a bit to  research, 50% of past cost would amount to quite a sum, even more so if you consider current cashburn of ~1,5million dollar per month  and that does not include increases in the ALS program.

They also have the capacity to produce up tp 3-4 biologics in their own fda approved itp facility where they produce the very complex igfbp3 compound as well.

Also recent investment report on INSM
http://www.xs4all.nl/~surg3on/INSM/Biotech.evaluation-Oct.07-INSM.NAS.pdf

If you would be so kind to comment there
Seeing curretn market cap this IS one of he gold nuggets out there with a 2-13 month timeframe for considerable gains. and a 1-4 year timeframe for full appreciation!

Investor presentation from July (with ceut) for rough overview as well

http://www.xs4all.nl/~surg3on/INSM/CEUT.presentation.july.12th.2007/

Update on ALS reimbursement

450 euros = Italian ALS reimbursement per patient per day :
thats 164.200 euros per year  equals to 234.000$ us dollars

http://www.sangiovannirotondonet.it/index.php?option=com_content&task=view&id=970&Itemid...