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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 LIFE SCIENCES 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 PLUS year tenure till date June 2021, 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, 90 Lakh plus views on dozen plus blogs, 233 countries, 7 continents, 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 33 lakh plus views on New Drug Approvals Blog in 233 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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10 MAR 2013, MAA EU SUBMITTED, APPROVED US, CANADA, LURASIDONE, LATUDA, SCHIZOPRENIA, DAINIPPON SUMITOMO


LURASIDONE

(3aR,4S,7R,7aS)-2-[((1R,2R)-2-{[4-(1,2-benzisothiazol-3-yl)-piperazin-1-yl]methyl}cyclohexyl)methyl]hexahydro-1H-4,7-methanisoindol-1,3-dione

STATUS AS ON 10 MARCH 2012

Lurasidone (trade name Latuda) is an atypical antipsychotic developed by Dainippon Sumitomo Pharma.[1] It was approved by the U.S. Food and Drug Administration (FDA) for treatment of schizophrenia on October 28, 2010[2] after a review that found that two of the four Phase III clinical trials supported efficacy, while one showed only marginal efficacy and one was not interpretable because of high drop-out rates.[3] It is currently pending approval for the treatment of bipolar disorder in the United States.

Clinical effects

In clinical studies, lurasidone alleviates positive symptoms (e.g., hallucinations, delusions) without inducing extrapyramidal side effects except for akathisia,[4] despite its potent D2 antagonistic actions. Effectiveness against negative symptoms of schizophrenia has yet to be established.

Lurasidone may be useful for treating the cognitive and memory deficits seen in schizophrenia. In animal studies, it reversed dizocilpine-induced learning and memory impairment and was found to be superior in doing this to all of the other antipsychotics examined, including risperidone, olanzapine, quetiapine, clozapine, aripiprazole, and haloperidol.[5][6] Lurasidone has activity at several serotonin receptors that are involved in learning and memory, and unlike most other antipsychotics, lacks any anticholinergic effects (which are known to impair cognitive processes and memory).[5] These properties may underlie its improved effectiveness in treating these symptoms relative to older agents.[5]

References

  1. Meyer JM, Loebel AD, Schweizer E (September 2009). “Lurasidone: a new drug in development for schizophrenia”. Expert Opinion on Investigational Drugs 18 (11): 1715–26. doi:10.1517/13543780903286388. PMID 19780705.
  2.  “FDA approves Latuda to treat schizophrenia in adults” (Press release). USFDA. 2010-10-28. Retrieved October 29, 2010.
  3. FDA Clinical Review of lurasidone for the treatment of schizophrenia Nakamura M, Ogasa M, Guarino J, et al. (June 2009).
  4. “Lurasidone in the treatment of acute schizophrenia: a double-blind, placebo-controlled trial”. The Journal of Clinical Psychiatry 70 (6): 829–36. doi:10.4088/JCP.08m04905. PMID 19497249.
  5.  Ishiyama T, Tokuda K, Ishibashi T, Ito A, Toma S, Ohno Y (October 2007). “Lurasidone (SM-13496), a novel atypical antipsychotic drug, reverses MK-801-induced impairment of learning and memory in the rat passive-avoidance test”. European Journal of Pharmacology 572 (2-3): 160–70. doi:10.1016/j.ejphar.2007.06.058. PMID 17662268.
  6. Enomoto T, Ishibashi T, Tokuda K, Ishiyama T, Toma S, Ito A (January 2008). “Lurasidone reverses MK-801-induced impairment of learning and memory in the Morris water maze and radial-arm maze tests in rats”. Behavioural Brain Research 186 (2): 197–207. doi:10.1016/j.bbr.2007.08.012. PMID 17881065.
  7. Dainippon Sumitomo Pharma (August 26, 2009). “Lurasidone Demonstrated Efficacy in Treating Patients with Schizophrenia in Pivotal Phase III Study”.
  8.  “Latuda: Prescribing Information”. Psychotherapeutic Drugs. Retrieved 2010-12-17.
  9.  “Latuda”. Drugs.com. Retrieved 2010-12-17.
  10.  “Atypical antipsychotics and risk of cerebrovascular accidents”. Retrieved 28 July 2012.

LATUDA® (lurasidone hydrochloride) Schizophrenia,Bipolar disorder

  • Developed in-house
  • LATUDA® (lurasidone hydrochloride) is an atypical antipsychotic agent which is believed to have an affinity for dopamine D2, serotonin 5-HT2A and serotonin 5-HT7 receptors where it has antagonist effects. In addition, LATUDA is a partial agonist at the serotonin 5-HT1A receptor and has no appreciable affinity for histamine or muscarinic receptors. In the clinical trials supporting the U.S. FDA approval, the efficacy of LATUDA for the treatment of schizophrenia was established in four, short-term (6-week), placebo-controlled clinical studies in adult patients who met DSM-IV criteria for schizophrenia. In these studies, LATUDA demonstrated significantly greater improvement versus placebo on the primary efficacy measures [the Positive and Negative Syndrome Scale (PANSS) total score and the Brief Psychiatric Rating Scale-derived from PANSS (BPRSd)] at study endpoint. A total of five short-term placebo controlled clinical trials contributed to the understanding of the tolerability and safety profile of LATUDA. LATUDA was approved for the treatment of schizophrenia by the U.S. Food and Drug Administration (FDA) in October 2010, and launched by Sunovion in February 2011 in the U.S. Launched in Canada for the treatment of schizophrenia in September 2012.
  • Development stage:
    Schizophrenia: Submitted MAA (Europe: Co-development with Takeda Pharmaceutical)
    Phase III in Japan
    In addition, Phase III study is ongoing in the U.S., Europe, etc. to test the hypothesis that LATUDA is effective in the long term maintenance treatment of schizophrenia.
    Bipolar I Depression: Submitted in the U.S. and Canada.
    In addition, plans to submit an MAA in Europe through Co-development with Takeda Pharmaceutical. (Phase III in Europe).
    Bipolar Maintenance: Phase III in the U.S. and Europe, etc.
    MDD with mixed features: Phase III in the U.S

Dainippon Sumitomo receives approval for Surepost, Repaglinide in combination with biguanides and thiazolidenediones


Repaglinide is an antidiabetic drug in the class of medications known as meglitinides, and was invented in 1983. It is sold by Novo Nordisk under the name of Prandin in theU.S., GlucoNorm in Canada, Surepost in Japan,Repaglinide in Egypt by EIPICO, andNovoNorm elsewhere. In Japan it is produced by Dainippon Sumitomo Pharma.

Repaglinide lowers blood glucose by stimulating the release of insulin from the pancreas. It achieves this by closing ATP-dependent potassium channels in the membrane of the beta cells. This depolarizes the beta cells, opening the cells’ calcium channels, and the resulting calcium influx induces insulin secretion.

28 feb2013
Dainippon Sumitomo Pharma Co., Ltd. has received approval for “SUREPOST® tablet 0.25 mg” and “SUREPOST ®tablet 0.5 mg” (generic name: repaglinide), a rapid-acting insulinsecretagogue, for the additional indications of combination therapy with biguanides and combination therapy with thiazolidinediones in Japan as of February 28, 2012. SUREPOST is a rapid-acting insulin secretagogue that stimulates postprandial insulin secretion by acting on the sulfonylurea receptor in pancreatic beta cells, thereby ameliorating postprandial blood glucose and lowering HbA1c in type 2 diabetes patients.About Repaglinide
Repaglinide is approved and marketed in over 90 countries worldwide, under the brand name “Prandin ® ” in the United States and “NovoNorm ® ” in European countries. The drug generates about $500m in worldwide sales.
In Japan, DSP took over development of the drug from Novo Nord isk A/S and continued clinical studies, then in January 2011 received manufacturing and market ing approval for the drug under the brand name SUREPOST ® as monotherapy as well as in combination with alpha-glucosidase inhibitors. SUREPOST ®was launched by DSP in May 2011. In Phase 3 clinical studies in Japan invo lving patients with type 2 diabetes who showed insufficient glycemic control even with the administration of bi guanide (metformin) or thiazolidinedione (pioglitazone), both of the SUREPOST ®combination arms ameliorated postprandial blood glucose and showed a significant difference in the primary endpoint of lowering HbA1c levels compared to the placebo combination arm, demonstrating the safety and efficacy of the drug.

Precursor drugs to repaglinide were invented in late 1983 by scientists at Dr Karl Thomae GmbH, a German drug manufacturer located at Biberach an der Riß in southern Germany which was acquired by Boehringer Ingelheim in 1990. The drug that became repaglinide was later licensed by Boehringer to Novo Nordisk, which filed an Investigational New Drugapplication for the compound with the Food and Drug Administration (FDA) in April 1992. Novo Nordisk filed its New Drug Application (NDA) for Prandin in July 1997 and it was quickly approved, gaining FDA approval in December 1997. The drug was the first of the meglitinide class. It was branded Prandin because its quick onset and short duration of action concentrates its effect around meal time (the prandium was the Roman meal which is comparable to the modern lunch).

After several attempts to file for U.S. patent protection, a filing was made in March 1990 which eventually became U.S. Patents 5,216,167 (June 1993), 5,312,924 (May 1994) and 6,143,769 (November 2000). After filing its NDA for repaglinide in 1997, Novo Nordisk applied for patent extension under the Hatch-Waxman Act. This process, called patent term restoration, allows drug patents to be extended based on the time that a drug spent in clinical trials and in the approval process. Previously it had been decided by the U.S. Patent and Trademark Office that the expiration date of U.S. Patents 5,216,167 and 5,312,924 would be 5 September 2006. In February 2001 Prandin’s patent life was extended to 14 March 2009 in response to Novo Nordisk’s patent term restoration application, with U.S. Patent 5,216,167 having been reissued as RE37035.[1]

Prior to the end of repaglinide’s patent term, Novo Nordisk obtained a new patent, U.S. Patent 6,677,358 (January 2004), covering the combination therapy of repaglinide together with the generic anti-diabetic drug metformin. This new patent was due to expire June 2018. In January 2011, a federal court ruled Novo Nordisk’s new patent invalid on the grounds of obviousness, and unenforceable on the grounds of inequitable conduct on the part of Novo Nordisk’s patent attorneys.[2]

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