Tercica Inc. (TRCA)

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TRCA main platform was free igf1 and optin rights for iplex (igf1 ifgbp3 compound)

No, a lot more to the INSM/TRCA story. Feel free to comment if anything unclear

Insm lost a production patent case against trca/dna (with trca being the licensee from dna) on the a part of the production process of IGF1.
(no such patent in europe due to retractment on prior art btw)

Jury found in trca/dna's favour.
Result was not a verdict though, but a settlement.

insm was allowed to continue expanded acces program in italy where iplex is used in ALS patients. Patients use court orders to get mandatory reimbursement from italian ministry of health. Reimbursement 140.000 euros per patient per year.
Latest update in march were 90 expanded access ALS patients , up from 30 in sept '07.
There is no fixed denial or approval for futher ALS development. Cephalon holds patent right of use for igf1 in ALS, but the eap has the full cooperation of cephalon.

INSM was forced to withdraw iplex from the short stature market for which it is approved and not sell it for that indicatin in the US.

INSM was allowed to pursue MMD, ROP, HARS as specifically permitted indications for the igf1-igfbp3 compound.
(which can be given in up to four time higher dosage than free igf1, not to mention anti carcigenic properties of bp3 compound on its own)

The catch is that trca has a first optin right on orphan indications and genentech on non orphan indications for the specifically allowed indications.

Deal of the optin: Upon IIb data trca and/or genentech has the right to optin within 90 days. Optin consists of reimbursement of 50% of all past cost and 50% of all future cost in return for 50% of the profit, where insm remains in control of production/pricing.
If no optin is used than insm only has to pay a 4% royalty.

results for MMD expected early 2009.

So the iplex program is still very much alive.

Since iplex is a complex biologic as well and insm owns its own (now fda approved) production facility, in 2007 they started increasing their focus on biognerics.

They have been granted and started a phase I study for ins-19 (neupogen generic) several weeks ago in europe.
They intend to use that data in any US phase III trial that the company expects will be included in US biogeneric legislation.

The company is looking for a biogenric partner since they cannot finance phase III biogeneric trials on their own, nor dot hey have the marketing clout to push it on the market.
They need one prior to end of Q3 as well due to cash restraints. (might be longer if ALS patient count keeps rising)


IPlex (igf1-igfbp3) indications:

Myotonic muscular dystrophy still very much on the table, 2mln grant for phase IIb and a very enthusiastic dr moxley who tried free igf1 in the 90s but abandoned it due to dosage restraints.

ROP (Retinopathy of prematurity)=further out, being researched externally, no big funds from insm

HARS (hiv lipodystrophy)= on backburner atm to conserve cash

NDGA,( cancer drug ): other insm compound has been started in a phase II trial payed and done by UCSF (university of san francisco) in prostate cancer indication.

BP3 binding protein itself has anti carcigenic properties of its own and has proven to increase efficacy in herceptin amonst others.
Do not see insm pursuign that one on their own on the short term due to trial sizes and cash burn.
More likely to see a partner for that part.

Their short term focus besides iplex is very much biognerics though which they have proven to be very skilled in producing.
Trca has/had alot of trouble just getting free igf1 produced by contract production.
Insm does its own production with no batch failures.

INMS general DD
http://investorshub.advfn.com/boards/board.aspx?board_id=1433

recent phase II prostate cancer trial run by UCSF
http://www.clinicaltrials.gov/ct2/show/NCT00678015?term=ndga&rank=1

Biogenerics Overview
http://www.xs4all.nl/~surg3on/INSM/20080429-Insmed_CBI_Conference.pdf