No. This is not retroactive. However'
Argatroban (Novastan)has already been granted priority review
(fast track status) by the FDA as the article below describes>.
Priority Review generally means that w/in 6 months the company will have an approvable letter, and then negotiations will begin to hammer out the package insert (product labelling) and initial marketing materials.
But the "urgency" of an unmet medical need is debatable. Consider this. The incidence of HIT (heparin induced thrombocytopenia)is rare, and it may be getting rarer. The use of standard unfractionated heparin is on the decline in the United States and worldwide. LMWH (low molecular weight heparin), and specifically Lovenox (enoxaparin) has been steadily replacing the use of heparin in high risk procedures of all kinds, venous and arterial.
LMWH has considerably less risk of causing HIT in patients, in the range of 1-2%. So, the HIT market is slowly diminishing. We can't forget Orgaran (danaparoid)is already on the market, which can be used as an alternative to heparin in patients with HIT right now.
The real market will hopefully develop in PTCA and elsewhere, but the FDA had some flexibility with determining how to handle their NDA.
In terms of other drugs, always remember. Many promising drugs fail in Phase III trials (look at Cephalon), and what you need to look at is the success of a drug through the process, not obscure future market potential for a drug that might break its leg out of the gate.
Once is Magic, twice is Science, thrice is Nice!
When will Novastan be launched? SKB will be launching the product with its own hospital sales force in the 2nd quarter or beyond of 98, no sooner. It is not feasible any earlier. As a stockholder, I am hoping for the best and expecting???
Best of Luck!
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Thursday September 4 8:32 AM EDT
Company Press Release
Source: Texas Biotechnology Corporation
Texas Biotechnology's NOVASTAN(R) NDA Granted Priority Review
Status by the FDA
HOUSTON, Sept. 4 /PRNewswire/ -- Texas Biotechnology Corporation (AMEX:TXB) announced today that the Company's
recently filed New Drug Application (NDA) for NOVASTAN(R) (argatroban) has been granted priority review status by the
U.S. Food and Drug Administration (FDA).
On August 6th, Texas Biotechnology and SmithKline Beecham announced an agreement to market and co-develop
NOVASTAN in the U.S. and Canada as anticoagulant therapy in patients with heparin-induced thrombocytopenia (HIT). In
addition to HIT, NOVASTAN is also being evaluated in other indications including use as an adjunct to thrombolytic agents in
acute myocardial infarction.
''We are pleased the FDA is considering our NOVASTAN NDA for priority review,'' said David B. McWilliams, President
and Chief Executive Officer of Texas Biotechnology. He added, ''we would anticipate receiving a response to our filing from
the FDA by the end of the second quarter 1998.''
HIT is an immune reaction to heparin, the most widely used injectable anticoagulant. The disease may lead to widespread
clotting which can result in significant morbidity and mortality. Currently, there is no alternative in the United States to heparin for
patients who develop HIT. It is estimated that approximately 275,000 patients are at risk for this adverse drug effect annually.
Texas Biotechnology Corporation is developing a new generation of therapeutics focused on preserving the functional integrity
of the vascular system. In addition to its NOVASTAN program, Texas Biotechnology is also conducting a Phase II study of its
lead endothelin-A receptor antagonist in congestive heart failure and intends to initiate Phase II testing of its novel selectin
antagonist for asthma in the third quarter of 1997. Texas Biotechnology Corporation expertise in computer-aided small
molecule drug design has generated important lead compounds for the inhibition of cell adhesion, endothelin, growth factors and
programmed cell death. For additional information, visit the Company's Internet web site at tbc.com .
This press release contains forward-looking information that is subject to certain risks, trends and uncertainties that could cause
actual results to differ materially from those projected. Among those risks, trends and uncertainties are attainment of research
and clinical goals of product candidates. In particular, careful consideration should be given to cautionary statements made in the
various reports Texas Biotechnology has filed with the Securities and Exchange Commission.
SOURCE: Texas Biotechnology Corporation
More news for referenced ticker symbols: TXB, and related industries: medical. |
