Hold on here!!!! clips from the official PR's (still possible INSM had an omission in theirs re. severe)....they are identical except for the 1 bit about orphan status - it says Tercica has orphan for 'severe' primary IGFD, while INSM has orphan for primary IGFD. I think there has been serious confusion about this issue and based on the numbers at the bottom, I'd sure like to know what numbers really should be used for each instance. I find it interesting that severe primary IGF-1 is apparently the same thing as Primary IGFD (it's put in brackets), yet it seems that from the bottom paragraph, there are different markets for severe primary IGFD (whats that? Severe severe primary IGF-1?!!), and then primary IGFD.
Only 12000 US/europe have severe primary IGFD, while 60000 have primary IGFD (severe primary IGF-1). Ok, still with me? Well, the news releases state Tercica has orphan for ONLY severe primary IGFD - which should be the 12000 market, while INSM's news release clearly state orphan status for primary IGFD (not severe)......doesn't that say Tercica gets their 12000, yet we get the much bigger market of 60000?????
I read the official FDA letter, and it doesn't make the specification on its orphan status for Iplex (just says orphan per uses outlined above). But if you read the 3 paragraphs below, it definitely implies Tercica has the smaller of the 2 markets! Agree, disagree??? That means Tercica's target market is the $240million number, yet Iplex target market is $1.2 billion. Keep in mind I am not in this field, I am just straight translating from below on an issue which has definitely been a mystery for many people (market size).
I could be a total space cadet on this, but carefully breaking down below totally implies what I have stated!
Tercica, Inc. (Nasdaq: TRCA) announced today that the U.S. Food and Drug Administration (FDA) has approved Increlex(TM) (mecasermin [rDNA origin] injection) for the long-term treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to growth hormone. The FDA also designated Increlex as an orphan drug for severe Primary IGFD.
Insmed Incorporated (NASDAQ: INSM - News) announced today the United States Food and Drug Administration (FDA) approved IPLEX(TM) (mecasermin rinfabate (rDNA origin) injection) for the treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. As an orphan drug, IPLEX is entitled to seven years of marketing exclusivity for the treatment of Primary IGFD.
Tercica estimates that approximately 6,000 children in the U.S., and approximately the same number in the EU, are affected by severe Primary IGFD. The company plans to broaden the indicated use for Increlex in the U.S. and the EU with supplemental applications, pending positive results of ongoing clinical trials evaluating Increlex in children with Primary IGFD. Primary IGFD is characterized by height and IGF-1 levels that are two standard deviations below the mean, in spite of normal or elevated growth hormone levels. Tercica estimates that approximately 30,000 children in the U.S. are affected by Primary IGFD, which is also similar to the estimated EU market size.
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