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Alexza gets EU thumbs-up for Adasuve, Loxapine

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File:Loxapine.svg

LOXAPINE

2-Chloro-11-(4-methylpiperazin-1-yl)dibenzo[b,f][1,4]oxazepine

FEBRUARY 22, 2013

Alexza Pharmaceuticals of the USA and partnerFerrer are celebrating after getting the green light for their inhaled antipsychotic Adasuve.

The European Commission has granted marketing authorisation to Adasuve (loxapine) for the rapid control of mild-to-moderate agitation in adults with schizophrenia or bipolar disorder. The approval is based on two Phase III studies involving over 650 patients which showed that the drug demonstrated statistically significant reductions in agitation from baseline compared to placebo.

The approval requires that patients receive regular treatment immediately after control of acute agitation symptoms, and that Adasuve is administered only in a hospital setting. Also, short-acting beta-agonist bronchodilator treatment should be available for treatment of possible severe respiratory side-effects.

Alexza chief executive Thomas King noted that Adasuve is the first authorised non-injectable therapy for these indications, noting that it will be launched on both sides of the Atlantic in the third quarter – US approval was granted in December.

Spain’s Ferrer has Adasuve rights in Europe, Latin America, Russia and the Commonwealth of Independent States countries. Chief executive Jordi Ramental said the focus for the initial EU launch will be Germany and Austria in 2013, adding that “at the same time, we are compiling the registration dossiers for the non-EU countries in our licensed territory”.


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DR ANTHONY CRASTO

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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