Insmed (INSM) vs. Tercica (TRCA)
i own INSM and think it's less risky right now than TRCA
market cap of INSM (minus cash): $58 million
market cap of TRCA (" "): $143 million
also, this seems to be an important competitive advantage:INSM secured manufacturing capability from Baxter in April:
biz.yahoo.com
and, from p.19 of TRCA's 10-Q filed 5/13/04 (mentions INSM as competition):
"If another party obtains orphan drug and pediatric exclusivity for rhIGF-1 for children with IGFD, we may be precluded from commercializing rhIGF-1 in that indication.
...
Although we intend to file for orphan drug designation and obtain pediatric exclusivity where appropriate, we have not yet sought pediatric exclusivity for any indication. If a competitor obtains approval of the same drug for the same indication or disease before us, we would be blocked from obtaining approval for our product for seven years, or seven and one-half years if pediatric exclusivity applies, unless our product can be shown to be clinically superior. In addition, more than one product may be approved by the FDA for the same orphan indication or disease as long as the products are different drugs. As a result, if our product is approved and receives orphan drug status, the FDA can still approve other drugs for use in treating the same indication or disease covered by our product, which could create a more competitive market for us.
Our original plan was to obtain rhIGF-1 orphan drug designation for the treatment of growth hormone insensitivity syndrome, or GHIS. The Phase III clinical trial results we obtained from Genentech were for GHIS. Everywhere in this document where we discuss existing Phase III clinical trial results such results were from patients identified at the time as having GHIS. Since we now believe that Severe Pediatric IGFD, which is we believe substantially equivalent to GHIS, more accurately describes the patient population which we intend to treat with rhIGF-1, we plan to amend our current designation, but may as a result of comments from the FDA reconsider the GHIS designation, which may be a smaller patient population. We are aware of one other drug being developed by Insmed Incorporated, which we believe is a combination product containing rhIGF-1, that is in development for treatment of GHIS. This product has received an orphan drug designation from the FDA for the treatment of GHIS. The FDA could determine that this other product is the same drug as our product and is used for the same indication. If the FDA makes this determination and the other product is approved first, the approval of our rhIGF-1 for either Severe Pediatric IGFD or Pediatric IGFD could be blocked for up to seven and one-half years, which could force us to curtail or cease our operations. Even if our product is approved first, we may not be able to benefit from the orphan drug marketing exclusivity because products that are clinically superior may be approved for marketing by the FDA notwithstanding our initial approval and our initial orphan drug marketing exclusivity. "
Tom |
