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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?


To: NeuroInvestment who wrote (7579)12/20/2002 10:04:06 PM
From: Miljenko Zuanic  Read Replies (1) | Respond to of 52153
 
Harry,

NBIX polymorph patent deal with process chemistry for preparation and conversion between two crystalline forms, one melts at 173-179 C and other (desired) at 193-197 C. This 20 degree difference in melting range effect physical property of each form.

From patent:
<< As the higher melting point polymorph, Form I has significant advantages over the polymorphic mixture of Compound 1 prepared according to known techniques. Specifically, Form I exhibits superior physical stability, thus allowing processing and manufacture of solid dosage forms without conversion to a different polymorphic form. This, in turn, enhances the milling and compaction properties of the drug substance.

In addition, the lower melting point polymorph, Form II, also has significant advantages over the polymorphic mixture of Compound 1 as prepared according to known techniques. Specifically, Form II exhibits superior water solubility over Form I and generally greater solubility in a range of organic solvents as compared to Form I (See Table 13). Form II is generally more soluble in polar and protic solvents than is Form I. Enhanced solubility of a compound will generally increase the bioavailability of that compound. When absorption of a drug is dissolution rate limited, use of the more soluble and faster dissolving form improves the rate and extent of bioavailability. >>

I do not know Indoplon chemistry and what form they are using in IR/MR. Also, it is hard to see here great difference to warrant essential needs for pure form in solid formulation/processing. So, when I first time read this patent (from EU) I did thought that it does give some protection from generic. But, at the some time they have pending composition patent and I was relieved.

Message 17463647
Message 17468833

NBIX and DOVP were very, VERY LUCKY, that Indoplan is not directly mentioned and claimed in Cyanamid patents, like Sonata is. Today they will not have composite patent protection until 2020.

While we are discussing NBIX, may I ask about CRFr program? Where do you see current clinical candidate and what to expect with follow-up?

Best,

Miljenko