Wilder,
IMO, there is no way that you can administrate (surgery) antitrombotic agent without incidence of the bleeding in small percentage (2-5%) of the pts. What you need is quick acting antidote, which can prevent this to be very serious event and to be manageable. Penta does not have antidote, as far as I know.
This was from penta PIII (2.5 mg/kg dose) trial:
<<Bleeding rates within the two groups were also similar for the most clinically relevant bleeding criteria: fatal bleeding; bleeding in critical organs; and bleeding leading to intervention. Patients requiring a transfusion of more than or equal to 2 units and/or with a decrease of hemoglobin greater than or equal to 2g/dl, represented 2.3% of patients in the Org31540/SR90107A group and 1.4% of patients in the comparator group. Total incidence of other bleedings (minor) was similar in the two groups. >>
And from rNAP (3 mcg/kg dose group, every second day):
<<The incidence of major bleeding following rNAPc2 prophylaxis in this patient cohort was 2.3% versus an historical control value of 3% for LMWH.>>
To successfully compete in this market new drug has to be comparable or better in efficacy than LMWH with easy manageable side effects. I do not know is rNAP that drug. Drug has interesting mechanism of action and makes sense to me. However, currently I put small value on this program, protecting downside and living room for upside, if realized. Also, serine protease programs and cash are leverage, which can provide additional value in future.
Today from Aventis report:
<< Lovenox® (enoxaparin sodium), for the prevention and treatment of thrombosis as well as the treatment of unstable angina pectoris and myocardial infarction, posted a 33.3% rise in sales to 1.042 billion euros. Annual sales in the U.S. rose 36.2% to 647 million euros (+18.0% excluding currency effects). In November, the FDA approved Lovenox® as a new indication for the prevention of life-threatening blood clots in medical patients with severely restricted mobility during acute illness. >>
As I said early, rNIF will (or may) be main driver in next two-three years. I wish that PFE is more open, but this may indicate (in optimistic view) that they want to surprise market one day. IF drug is (current PIIb trial) as safe as CVAS reported early (no restriction in stroke origin and single dose, multiple hrs window, combination and synergistic activity with current anti-trombotic,… ), IF end-point(s) and trial size are within pivotal normative, IF drug do show definitive clinical benefit, …well.. than PFE may ask FDA for fast track and submit NDA by early `02. Those are all *IF* (to many one may say), but my bets are that they are for real.
Bottom line, you have $+250 MM capitalization company, which tomorrow may growth to $+2.5 BB.
Additional note, to dear friend, M. Lampert, at BVF: “ Sell quickly rest CVAS shares of yours, if you didn’t done already”. Why hesitate now?
Miljenko |
