Several intrinsic benefits which the market either ignores or has already built into the share price.
1) $5 million milestone payment from J & J
2) EU patent life extension for use in AML, but not for composition of matter
3) Extension of patient registry in AML for possible new rolling submission to FDA for U.S. approval in AML indication
4) Possible off-label use in U.S. without clearcut insurance reimbursement for AML indication (based on approval in a major regulated jurisdiction). Note: oncologists are known for off label use more than any other medical specialty and protocols often incorporate experimental cocktails
5) AML patients with financial resources will have access to non-reimbursed Rx wither in the U.S. or in Europe. Note: Dacogen is already approved in the U.S. for MDS (myelodysplatic syndrome) which frequently preceeds AML, providing a grey area for prescriptions and possibly, reimbursement as well. The big partners know how to work the system.
1) Orphan Drug status means similar drugs cannot be approved for up to 10 years.
2) Since Dacogen was previously approved for MDS with same J&J partner, Jannsen, the additional sales should be added to the Astex/Jannsen sales contract which should kick in the turbo royalty multiplier from 20-30%.. Also, this approval will not be starting from scratch. In fact, one might say they have a huge head start since they already have a tier 1 partner in place with established channel of distribution, current product sales to many of the same docs. One could easily argue that there could be little or no ramp up time and a very rapid market penetration scale.
Only one negative, merlo and batty might become even more depressed to observe Astex and Dr. M grow wealthier than they are today.. Let's hope they have a powerful antidepressant in the pipeline. GLTA!
Believe that Celgene is working on AML solution also. What happens because of the Orphan drug status that you talk about above with the Celgene drug? Enclosed Celgene Q2 CC transcript related to this topic:
"We continually work to optimize and leverage our global MDS franchise. Our Phase III registration study for VIDAZA in acute myeloid leukemia is advancing and should serve to expand its approved indication to include all categories of patients with AML. Investigator interest to conduct research with CC-486, or oral azacitidine, is very high with 2 specific strategies under active consideration. The first seeks to develop CC-486 for a subset of low-risk MDS, and the other will test CC-486 as maintenance therapy following transplantation or other induction therapy for AML."
Hey too too,
You must have a crystal ball. Man uso just received 50,000 shares at zero cost for his insight and hard work. Don't worry, he has 950,000 more shares to grant himself. See greystone comments.