From TRCA's 10K page 44:
"If we lose our licenses from Genentech or Ipsen, we may be unable to continue our business.*
We have licensed intellectual property rights and technology from Genentech and from Ipsen. Under our license and collaboration agreements with Genentech and Ipsen, each of Genentech and Ipsen have the right to terminate our licenses if we are in material breach of our obligations under our agreements with them and fail to cure that breach.
Under the terms of the agreements, we are obligated, among other things, to use reasonable business efforts to meet specified milestones, including in the Genentech agreements, filing for regulatory approval in the United States for either a diabetes indication or a substitute indication by December 31, 2008.
If any of these agreements are terminated, then we would lose our rights to utilize the technology and intellectual property covered by that agreement to develop, manufacture, market and sell Increlex ™ for any indication and/or to develop, market and sell Somatuline ® Autogel ® . This may prevent us from continuing our business.
We are subject to Genentech’s option rights with respect to the commercialization of Increlex ™ for all diabetes and non-orphan indications in the United States. We are also subject to Ipsen’s right of first negotiation to develop and commercialize other products subsequently acquired or owned by us.*
Under our U.S. license and collaboration agreement with Genentech, Genentech has the option to elect to jointly commercialize rhIGF-1 for all diabetes and non-orphan indications in the United States. Orphan indications are designated by the FDA under the Orphan Drug Act, and are generally rare diseases or conditions that affect fewer than 200,000 individuals in the United States. With respect to those non-orphan and diabetes indications in the United States, once Genentech has exercised its option to jointly develop and commercialize, Genentech has the final decision on disputes relating to development and commercialization of such indications. Our ability to sublicense the development and commercialization of such products requires the consent of Genentech. In addition, under our license and collaboration agreement with Ipsen with respect to Increlex ™ , Ipsen has a right of first negotiation to develop and commercialize, in Ipsen’s territory, other products subsequently acquired or owned by us in the field of endocrinology. Accordingly, we may not receive a reasonable return on our investment if we develop new endocrinology products."
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"IMO TRCA does not have enough time to get any other approval for Increlex and it has too many side effects to be effective for diabetes. Throw in the batch failures and they will not be able to make it work.
So... NO new indications, NO license with DNA and of course the loss of Ispen as well, so what is the future for TRCA once the EMEA aproves Iplex ???
The insititutions have been dumping ever since the 10K and the CC call ...regrading batch failures where released."
by countingchange
Als je dit zo leest dan bestaat er de kans dat de deal met IPSEN en DNA op losse schroeven staat als TRCA geen goedkeuring krijgt in europa en INSM geen injunction krijgt.
Je kunt haast wel stellen dat TRCA gewoon kapot gaat als ze geen goedkeuring krijgen in europa.