Replies to post #90666 on Biotech Values

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ALS - IPLEX Deal pending ? Opinions please

- Deal with organisation like PCUT ?
- Deal with Merck?
- Deal with Roche?
- Sale of the company to merck, roche and ipsen ?

The recent observations by the USA patients on Iplex are in line with the italian data reported in 2009.
Monday febr 15th those results were published in pdf on Alsworldwide, an ALS patient advocacy group.
They were removed within 24 hrs of investors asking Insmed PR firm about it.

Now states:


" NEWSFLASH
INTERIM REPORT OF IPLEX FOR ALS

The Interim Report of the Investigational New Drug trial on the use of Iplex (mecasermin rinfabate) by middle-to-late stage Amyotrophic Lateral Sclerosis patients has been filed with the FDA, Insmed and Alpha Institutional Review Board. This report will be reprinted on this website once the requisite minimum thirty day waiting period is completed. Thank you for your patience."



Insmed has an optin agreement for iplex in amongst others MMD, Retinopathy with a royalty structure with Roche and Ipsen.

ALS for iND use can be provided by Insmed royalty free worldwide due to an agreement betweent Roche (former genentech) and themselves after USA PALS patients organised a march to washington to demand acces to iplex. After that the FDA limited the iND use to a dozen patients under the terms that their progress was structurally monitored.

Since that time all the USA PALS have been very very quiet despite earlier uproar.

Insmed too has been very quiet, last CC on nov 6th 2009. No PR since, not even one on granting of patent for purification of igf1 and igf1bp3 using ANY pharmaceutical salt. Effectively locking the IP for insmed for a long time, no way around them for both iplex and bp3.


MERCK ?

Merck bought the biogenerics facility of Insmed (their research lab used to develop iplex and turned to biogenerics plant) in february 2009 for 130 million dollar including the staff.Thus they should have a very keen eye on IPLEX potential.

Merck recently bought Avecia biologics production facility in the United Kingdom, the only plant that had produced iplex in the past. Could be coincidence.

Recent MERCK ceo comments that they are working with Insmed, might just be an oversight and intended to say they worked with the assets they bought of Insmed.
http://shearlingsplowed.blogspot.com/2010/01/seeking-alpha-points-to-ceo-clarks.html


PCUT ?

PCUT potential: PCUT earlier also stated a statement that they demanded IND access for USA pals when the italian data was released early 2009.
http://www.pcut.org/




Insmed sold on march 12-15th 2010 ?


Flatout sale of the company?

Currently only 17 staff , no CEO and chairman of the board running the company (melvin sharoky)
Cash at hand 124 million (.93 dollar per share)
No debt and current neutral cash flow.

10mln italian revenue for expanded acces program in ALS, but stockpile limited to 2yrs and no new production plant designated. Old plant sold in biogenerics deal to Merck.

Strong IP on iplex and bp3 binding protein.


Optin agreement with Roche and Ipsen after legal settlement.Ipsen focus on IGF1 treatments as well, iplex superior and recently additional strong patents on production/purification.
BP3 binding protein quite well described in pubmed etc to have good apoptotic properties, especially in combination therapy. Positive with herceptine combination etc mentioned.

Merck contender due to earlier deal.
Roche potentially due to ALS/bp3.
Ipsen for iplex in growth/healing.


The merck FOB deal prohibits Insmed to be sold prior to march 12th:

Section 1.9 titled
OBLIGATIONS OF SELLER (INSMED) DURING POST CLOSING
PERIOD - "Seller shall not liquidate or enter into
any other proceedings related to liquidation or
dissolution until the expiration of twelve months
period following the second closing."

Second closing was march 12th



Any other people willing to wager an opion?