And was first launched in Denmark in November 1996. Further launches have followed in Austria, Switzerland and Germany, with launches in France and the UK planned for 1997. Following on from Professor Chadwick's requirement for novel AED's to possess a novel mechanism of action, Neil Upton SmithKline Beecham, Harlow ; , described the discovery and pre-clinical pharmacology of SB-204269 trans- + ; 6-acetyl-4S- 4-fluorobenzoylamino ; -3, 4-dihydro-2, 2-dimethyl-2Hbenzo[b]pyran-3R-ol ; . SB-204269 was developed starting from the observation that K + conductances are intimately involved in the inhibition of neuronal excitability and cell firing. The group at SB therefore proposed that drugs which stimulate the opening of K + channels should diminish neuronal excitability. Experiments with the prototypical KATP channel opener, cromakalim, demonstrated that this compound could inhibit seizures in a variety of rodent models. A series of analogues of cromakalim was examined for anticonvulsant activity following p.o. administration in the mouse maximal electroshock seizure threshold MEST ; test and improved activity was observed when the pyrrolidinone ring at the 4-position in the cromakalim molecule was replaced with a 4-fluorobenzamide group. The team at SB then investigated the effect of changing the stereochemistry at the 3- and 4-positions on anticonvulsant and antihypertensive activity in this series of benzamides. It was shown that the anticonvulsant activity resided mainly in the 3R, 4S enantiomer, whereas the 3S, 4R enantiomer was responsible for the antihypertensive effect. Further investigation of the structure-activity relationships in the series led to the replacement of the 6-cyano group with a 6-acetyl group, resulting in SB-204269. The compound has been shown to be an orally-effective anticonvulsant agent, at doses 0.1-30 mg kg ; devoid of overt behavioural depressant properties, in rat models of both electrically and chemically evoked tonic extension seizures. SB204269 also selectively reduces focal electrographic seizure activity in an in vitro elevated K + rat hippocampal slice model at concentrations 0.1-10 M ; that have no effect on normal synaptic activity and neuronal excitability. SB-204269 was found to be inactive in a wide range of binding and functional assays, leading the team to conclude that they had a compound with a novel mechanism of action. Using 3H labelled SB-204269 they went on to demonstrate the presence of a stereoselective binding site in rat forebrain. The KD of SB-204269 50 nM ; for this binding site was shown to correspond to the effective brain concentration of the compound in the rat MEST test and for a range of analogues there was a positive correlation between affinity for the binding site and activity in the anticonvulsant test. The pharmacological specificity of the binding site was.
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Here and the products made from those ideas will flow out to capture the world. And our inventors will rightfully be compensated for their creations. There is no doubt that there is a high level of patent awareness in India - witness the recent furore over neem, turmeric and most recently the unfortunate Ramar Pillai episode. Our newspapers carried banner headlines that dealt with the patent issue - something that even caught the admiration of Westerners who did not see this level of awareness in their own countries. It is clear that the nation is ready to respect its innovators and give them the tools that are necessary to commercialize their inventions. I foresee that introduction of a strong patent regime will revitalize our creative energies and launch a surge of the innovatve spirit such as this nation has not experienced since independence. I would like to digress briefly at this point to say a few words about my experience in fostering innovation at Dr. Reddy's Research Foundation. When we had originally planned this investment in a pharmaceutical R & D facility there were no dearth of detractors - the comments ranging from - "it is too expensive" to "it is not possible to match the innovative skills of the MNC's". The decision to go ahead was made easier for us by the new economic environment and the signing of the GATT. If we wanted to become a significant player in the world we had to innovate products that the world would buy from us. In 1993 DRF became operational. To start with we had 60, 000 Sft of laboratory space and about 50 PhD's covering a range of disciplines in chemistry and biology. From the beginning we intended to create infrastructure of uncompromisingly high standards. This was coupled to a recruitment policy designed in such a way that scientists with complementary skills were brought together to form natural teams. We focussed on a few areas ensuring quality and not quantity. Today, only two and a half years later, we are starting to see the fruits of this investment. We have filed 10 patents for new chemical entities NCE's ; discovered by us in the USA and expect to be in clinical trials with our first compound late in 1997. This is a remarkable accomplishment given our relative inexperience in this endeavour. Our experience is encouraging and bodes well for the future. It.
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