DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
.....FOR BLOG HOME CLICK HEREFlag and hits
ORGANIC SPECTROSCOPY
SUBSCRIBE
Subscribe in a reader
Enter your email address:
Delivered by FeedBurner
Subscribe to New Drug Approvals by Email
Recent Comments
 | shivkr2 on SPSR Excellence Award 2025 – S… |
 | Bonkasaurus on Infigratinib phosphate |
 | PALOVAROTENE | ORGAN… on Palovarotene |
| Pfizer just purchase… on Temanogrel | |
| Pfizer To Cash In On… on Temanogrel |
Catalyst’s Firdapse Gets FDA ‘Breakthrough’ Designation
amifampridine
used as phosphate salt
Catalyst Pharmaceutical Partners Receives Breakthrough Therapy Designation From FDA for Firdapse(TM) for the Treatment of LEMS
CORAL GABLES, Fla., Aug. 27, 2013 (GLOBE NEWSWIRE) — Catalyst Pharmaceutical Partners, Inc. (Nasdaq:CPRX), a specialty pharmaceutical company focused on the development and commercialization of novel prescription drugs targeting rare (orphan) neuromuscular and neurological diseases, today announced that its investigational product
Firdapse(TM) (amifampridine phosphate) has received “Breakthrough Therapy Designation” by the U.S. Food and Drug Administration (FDA) for the symptomatic treatment of patients with Lambert-Eaton Myasthenic Syndrome (LEMS). Firdapse(TM) is Catalyst’s investigational therapy that is being evaluated for the treatment of the debilitating symptoms associated with LEMS, including muscle weakness.
read all ar
http://www.pharmalive.com/catalysts-firdapse-gets-fda-breakthrough-designation
3,4-Diaminopyridine (or 3,4-DAP) is an organic compound with the formula C5H3N(NH2)2. It is formally derived from pyridine by substitution of the 3 and 4 positions with an amino group.
With the International Nonproprietary Name amifampridine, it is used as a drug, predominantly in the treatment of a number of rare muscle diseases. In Europe, the phosphate salt of amifampridine has been licenced as Firdapse (BioMarin Pharmaceutical) in 2010 as an orphan drug
‘Better detection’ for Alzheimer’s and cancers
http://phys.org/news/2013-08-alzheimer-cancers.html
A new chemical discovery will lead to better monitoring and treatment for cancers and degenerative diseases, according to latest research by scientists.
In a paper published today in ChemComm an international team of researchers from the Universities of Birmingham, Bath and the East China University of Science and Technology in Shanghai outline a new approach to detecting ‘reactive oxygen’ using fluorescence.
Reactive oxygen, which includes peroxides or oxygen ions, causes cell damage and degeneration in the body and its presence in high doses can be a sign of diseases such as Alzheimer’s or cancers. The importance of reactive oxygen has led researchers to find new approaches for its quick and simple detection.
This latest research paves the way for new systems to detect changes in reactive oxygen levels which could help target interventions. Mapped using fluorescent imaging, the concentration of reactive oxygen in cells and tissue would…
View original post 129 more words
Amgen buys Onyx for for $10.4 billion, acquires the drug Krypolis
August 26, 2013 | By Márcio Barra
Amgen has announced today that it has agreed to buy Onyx Pharmaceuticals for $10.4 billion, giving Amgen, the largest biotechnology company by sales, access to a new blood cancer drug, Onyx’s Kyprolis. In an all-cash takeover, Amgen is to pay $125 a share for Onyx’s outstanding stock, with the acquisition expected to close at the beginning of the fourth quarter.
Krypolis (Carfilzomib), from Kypolis is an injectable tetrapeptide epoxyketone and a selective proteasome inhibitor, approved by the FDA on 20 July 2012 to treat patients with multiple myeloma, the second most commonly diagnosed blood cancer, who have received at least two prior therapies, including Velcade (bortezomib) and an immunomodulatory therapy.
View original post 277 more words
Patent Searching in India| Patent Searcher in India | India Patent – Patent Guide for Inventors
Medical Devices: Technology, Emerging Sectors, Patent Trends and Roadblocks
Bio Corp Legal denotes premium service offerings offered by Tech Corp Legal LLP, an international law firm in India focusing on technology laws and business intelligence services.
We provide IP business services in the following domains:
- Pharma
- Biotech
- Medical Diagnostics
- Cell Based Research
- Cell & Gene Therapy
- Food Tech
- Peptides
- Biological Manufacturing Chemical based technologies
- Healthcare
- Drug Approval
- Life Sciences & related industries.
Online Patent Searching Tools
View original post 517 more words
Bupropion review
Bupropion
Bupropion (/bjuːˈproʊpi.ɒn/ bew-proh-pee-on;[2] ) is a drug that is primarily used as an atypical antidepressant and smoking cessation aid. Marketed as Wellbutrin, Budeprion, Prexaton, Elontril, Aplenzin, or other trade names, it is one of the most frequently prescribed antidepressants in the United States. Marketed in lower-dose formulations as Zyban, Voxra, or other names, it is also widely used to reduce nicotine cravings by people who are trying to quit smoking. It is taken in the form of pills, and in the United States is available only by prescription.
Bupropion lowers seizure threshold, and its potential to cause seizures has been widely publicized. Bupropion is an effective antidepressant on its own, but it is also popular as an add-on medication in cases of incomplete response to first-line SSRI antidepressants. In contrast to many other antidepressants, bupropion does not cause weight gain or sexual dysfunction.
Bupropion was patented in 1969 by Burroughs Wellcome, which later became part of what is now GlaxoSmithKline. It was originally called amfebutamone, before being renamed in 2000.[3] Its chemical name is 3-chloro–N–tert-butyl-β-ketoamphetamine. It is asubstituted cathinone (β-ketoamphetamine), as well as a substituted amphetamine.
The drug is a mild psychostimulant. Its primary pharmacological action is as a dopamine reuptake inhibitor, and also to a lesser extent a norepinephrine reuptake inhibitor. Bupropion affects a number of neurotransmitter systems, and its mechanisms of action are only partly understood. It binds selectively to the dopamine transporter and makes dopamine reuptake inhibition twice as potent as norepinephrine reuptake inhibition.[4]
It also acts as a nicotinic acetylcholine receptor antagonist. Bupropion belongs to the chemical class of aminoketones and is similar in structure to stimulants such as cathinone and amfepramone, and to phenethylamines in general. Medically, bupropion serves as a non-tricyclic antidepressant fundamentally different from most commonly prescribed antidepressants such asselective serotonin reuptake inhibitors (SSRIs).
Medical uses
Depression
The most common use for bupropion is in the treatment of depression, where it is marketed by GlaxoSmithKline under the trade name Wellbutrin, or as a generic version under a variety of other names.
Bupropion is one of the most widely prescribed antidepressants, and the available evidence indicates that it is effective in clinical depression[5] — as effective as several other widely prescribed drugs, including sertraline (Zoloft), fluoxetine (Prozac), paroxetine(Paxil)[6] and escitalopram (Lexapro).[7] It has several features that distinguish it from other antidepressants. Unlike the majority of antidepressants, bupropion does not usually cause sexual dysfunction.[8] Bupropion treatment also is not associated with the somnolence or weight gain that may be produced by other antidepressants.[9]
The majority of depressed people suffer from insomnia, but there are some who instead experience constant sleepiness and fatigue. In this subgroup, bupropion has been found to be more effective than selective serotonin reuptake inhibitors (SSRIs) at alleviating the symptoms.[10] There appears to be a modest advantage for the SSRIs compared to bupropion in the treatment of anxious depression.[11]
According to surveys, the augmentation of a prescribed SSRI with bupropion is a common strategy among clinicians when the patient does not respond to the SSRI, even though this is not an officially approved indication for prescription.[12] The addition of bupropion to an SSRI (most commonly fluoxetine or sertraline) results in a significant improvement in the majority of patients who have an incomplete response to the first-line antidepressant.[12]
Smoking cessation
The next most common use is as an aid for smoking cessation, where it is marketed by GlaxoSmithKline under the trade name Zyban, or by other makers as a generic equivalent.
Numerous studies have provided evidence that bupropion substantially reduces the severity of nicotine cravings and withdrawal symptoms.[13] For example, in one large-scale study, after a seven-week treatment, 27% of subjects who received bupropion reported that an urge to smoke was a problem, versus 56% of those who received placebo. In the same study, 21% of the bupropion group reported mood swings, versus 32% of the placebo group.[14] A typical bupropion treatment course lasts for seven to twelve weeks, with the patient halting the use of tobacco about ten days into the course. Bupropion approximately doubles the chance of quitting smoking successfully after three months. One year after treatment, the odds of sustaining smoking cessation are still 1.5 times higher in the bupropion group than in the placebo group.[13]
The evidence is clear that bupropion is effective at reducing nicotine cravings. Whether it is more effective than other treatments is not as clear, due to a limited number of studies. The evidence that is available suggests that bupropion is comparable to nicotine replacement therapy, but somewhat less effective than varenicline (Chantix).[13]
Seasonal Affective Disorder
Bupropion was approved by the U.S. Food and Drug Administration (FDA), in 2006, for the prevention of seasonal affective disorder.[15]It was the first drug approved specifically for this condition.
Attention deficit hyperactivity disorder
There have been numerous reports of positive results for bupropion as a treatment for attention deficit hyperactivity disorder (ADHD), both in minors and adults.[16] However, in the largest to date double-blind study of children, which was conducted by GlaxoSmithKline, the results were inconclusive. Aggression and hyperactivity as rated by the children’s teachers were significantly improved in comparison to placebo; in contrast, parents and clinicians could not distinguish between the effects of bupropion and placebo.[16] The 2007 guideline on the ADHD treatment from American Academy of Child and Adolescent Psychiatry notes that the evidence for bupropion is “far weaker” than for the FDA-approved treatments. Its effect may also be “considerably less than of the approved agents… Thus it may be prudent for the clinician to recommend a trial of behavior therapy at this point, before moving to these second-line agents.”[17] Similarly, the Texas Department of State Health Services guideline recommends considering bupropion or a tricyclic antidepressant as a fourth-line treatment after trying two different stimulants and atomoxetine.[18]
Sexual dysfunction
Bupropion is one of few antidepressants that do not cause sexual dysfunction.[19] A range of studies demonstrate that bupropion not only produces fewer sexual side effects than other antidepressants, but can actually help to alleviate sexual dysfunction.[20] According to a survey of psychiatrists, it is the drug of choice for the treatment of SSRI-induced sexual dysfunction, although this is not an indication approved by the U.S. Food and Drug Administration. 36% of psychiatrists preferred switching patients with SSRI-induced sexual dysfunction to bupropion, and 43% favored the augmentation of the current medication with bupropion.[21] There have also been a few studies suggesting that bupropion can improve sexual function in women who are not depressed, if they have hypoactive sexual desire disorder.[22]
Obesity
A recent meta-analysis of anti-obesity medications pooled the results of three double-blind, placebo-controlled trials of bupropion. It confirmed the efficacy of bupropion given at 400 mg per day for treating obesity. Over a period of 6 to 12 months, weight loss in the bupropion group (4.4 kg) was significantly greater than in the placebo group (1.7 kg). It was not, however, significantly different from the weight loss produced by several other established medications, such as sibutramine, orlistat and amfepramone.[23]
Other uses
There has been controversy about whether it is useful to add an antidepressant such as bupropion to a mood stabilizer in patients with bipolar depression, but recent reviews have concluded that bupropion in this situation does no significant harm and may sometimes give significant benefit.[24][25]
Bupropion has shown no effectiveness in the treatment of cocaine dependence, but there is weak evidence that it may be useful in treating methamphetamine dependence.[26]
Based on studies indicating that bupropion lowers the level of the inflammatory mediator TNF-alpha, there have been suggestions that it might be useful in treatinginflammatory bowel disease or other autoimmune conditions, but very little clinical evidence is available.[27]
Bupropion—like other antidepressants, with the exception of duloxetine (Cymbalta)[28]—is not effective in treating chronic low back pain.[29] It does, however, show some promise in the treatment of neuropathic pain.[30]
Bupropion is a substituted cathinone. It is synthesized in two chemical steps starting from 3′-chloro-propiophenone. The alpha position adjacent to the ketone is firstbrominated followed by nucleophilic displacement of the resulting alpha-bromoketone with t-butylamine and treated with hydrochloric acid to give bupropion as the hydrochloride salt in 75–85% overall yield.a, b a Mehta NB (June 25, 1974). “United States Patent 3,819,706: Meta-chloro substituted α-butylamino-propiophenones”. USPTO. Retrieved June 2, 2008. b, ^ Perrine DM, Ross JT, Nervi SJ, Zimmerman RH (2000). “A Short, One-Pot Synthesis of Bupropion (Zyban, Wellbutrin)”. Journal of Chemical Education 77 (11): 1479.Bibcode:2000JChEd..77.1479P. doi:10.1021/ed077p1479.
-
- Brunton L, Chabner B, Knollman B. Goodman and Gilman’s The Pharmacological Basis of Therapeutics, Twelfth Edition. McGraw Hill Professional; 2010.
- ^ entry “Bupropion (By mouth)” at “PubMed Health” (from the US government agency NIH, National Institutes of Health, retrieved March 31, 2013.
- ^ The INN originally assigned in 1974 by the World Health Organization was “amfebutamone”. In 2000, the INN was reassigned as bupropion. See World Health Organization (2000). “International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 83” (PDF). WHO Drug Information 14 (2). Archived from the original on May 31, 2011. Retrieved June 22, 2009.
- ^ Arias HR, Santamaría A, Ali SF (2009). “Pharmacological and neurotoxicological actions mediated by bupropion and diethylpropion”. Int. Rev. Neurobiol. International Review of Neurobiology 88: 223–55. doi:10.1016/S0074-7742(09)88009-4. ISBN 978-0-12-374504-0. PMID 19897080.
- ^ Moreira R (October 2011). “The efficacy and tolerability of bupropion in the treatment of major depressive disorder”. Clin Drug Investig. 31 Suppl 1: 5–17.doi:10.2165/1159616-S0-000000000-00000. PMID 22015858.
- ^ Thase ME, Haight BR, Richard N, Rockett CB, Mitton M, Modell JG, VanMeter S, Harriett AE, Wang Y (August 2005). “Remission rates following antidepressant therapy with bupropion or selective serotonin reuptake inhibitors: a meta-analysis of original data from 7 randomized controlled trials”. J Clin Psychiatry 66 (8): 974–81.doi:10.4088/JCP.v66n0803. PMID 16086611.
- ^ Clayton AH, Croft HA, Horrigan JP, Wightman DS, Krishen A, Richard NE, Modell JG (May 2006). “Bupropion extended release compared with escitalopram: effects on sexual functioning and antidepressant efficacy in 2 randomized, double-blind, placebo-controlled studies”. J Clin Psychiatry 67 (5): 736–46. doi:10.4088/JCP.v67n0507.PMID 16841623.
- ^ Clayton AH (2003). “Antidepressant-Associated Sexual Dysfunction: A Potentially Avoidable Therapeutic Challenge”. Primary Psychiatry 10 (1): 55–61.
- ^ Dhillon S, Yang LP, Curran MP (2008). “Bupropion: a review of its use in the management of major depressive disorder”. Drugs 68 (5): 653–89.doi:10.2165/00003495-200868050-00011. PMID 18370448.
- ^ Baldwin DS, Papakostas GI (2006). “Symptoms of fatigue and sleepiness in major depressive disorder”. J Clin Psychiatry. 67 Suppl 6 (Suppl 6): 9–15. PMID 16848671.
- ^ Papakostas GI, Stahl SM, Krishen A, Seifert CA, Tucker VL, Goodale EP, Fava M (August 2008). “Efficacy of bupropion and the selective serotonin reuptake inhibitors in the treatment of major depressive disorder with high levels of anxiety (anxious depression): a pooled analysis of 10 studies”. J Clin Psychiatry 69 (8): 1287–92.doi:10.4088/JCP.v69n0812. PMID 18605812.
- ^ a b Zisook S, Rush AJ, Haight BR, Clines DC, Rockett CB (February 2006). “Use of bupropion in combination with serotonin reuptake inhibitors”. Biol. Psychiatry 59 (3): 203–10. doi:10.1016/j.biopsych.2005.06.027. PMID 16165100.
- ^ a b c Wu P, Wilson K, Dimoulas P, Mills EJ (2006). “Effectiveness of smoking cessation therapies: a systematic review and meta-analysis”. BMC Public Health 6: 300. doi:10.1186/1471-2458-6-300. PMC 1764891. PMID 17156479.
- ^ Tønnesen P, Tonstad S, Hjalmarson A, Lebargy F, Van Spiegel PI, Hider A, Sweet R, Townsend J (August 2003). “A multicentre, randomized, double-blind, placebo-controlled, 1-year study of bupropion SR for smoking cessation”. J. Intern. Med. 254(2): 184–92. doi:10.1046/j.1365-2796.2003.01185.x. PMID 12859700.
- ^ “First drug for seasonal depression”. FDA Consum 40 (5): 7. 2006.PMID 17328102.
- ^ a b Cantwell DP (1998). “ADHD through the life span: the role of bupropion in treatment”. J Clin Psychiatry. 59 Suppl 4: 92–4. PMID 9554326.
- ^ Pliszka S; AACAP Work Group on Quality Issues (July 2007). “Practice parameter for the assessment and treatment of children and adolescents with attention-deficit/hyperactivity disorder”. J Am Acad Child Adolesc Psychiatry 46 (7): 894–921.doi:10.1097/chi.0b013e318054e724. PMID 17581453.
- ^ Pliszka SR, Crismon ML, Hughes CW, Corners CK, Emslie GJ, Jensen PS, McCracken JT, Swanson JM, Lopez M (June 2006). “The Texas Children’s Medication Algorithm Project: revision of the algorithm for pharmacotherapy of attention-deficit/hyperactivity disorder”. J Am Acad Child Adolesc Psychiatry 45 (6): 642–57.doi:10.1097/01.chi.0000215326.51175.eb. PMID 16721314.
- ^ Serretti A, Chiesa A (June 2009). “Treatment-emergent sexual dysfunction related to antidepressants: a meta-analysis”. J Clin Psychopharmacol 29 (3): 259–66.doi:10.1097/JCP.0b013e3181a5233f. PMID 19440080.
- ^ Stahl SM, Pradko JF, Haight BR, Modell JG, Rockett CB, Learned-Coughlin S (2004). “A review of the neuropharmacology of bupropion, a dual norepinephrine and dopamine reuptake inhibitor”. Prim Care Companion J Clin Psychiatry 6 (4): 159–166. doi:10.4088/PCC.v06n0403. PMC 514842. PMID 15361919.
- ^ Dording CM, Mischoulon D, Petersen TJ, Kornbluh R, Gordon J, Nierenberg AA, Rosenbaum JE, Fava M (September 2002). “The pharmacologic management of SSRI-induced side effects: a survey of psychiatrists”. Ann Clin Psychiatry 14 (3): 143–7.doi:10.3109/10401230209147450. PMID 12585563.
- ^ a b Foley KF, DeSanty KP, Kast RE (September 2006). “Bupropion: pharmacology and therapeutic applications”. Expert Rev Neurother 6 (9): 1249–65.doi:10.1586/14737175.6.9.1249. PMID 17009913.
- ^ Li Z, Maglione M, Tu W, Mojica W, Arterburn D, Shugarman LR, Hilton L, Suttorp M, Solomon V, Shekelle PG, Morton SC (April 2005). “Meta-analysis: pharmacologic treatment of obesity”. Ann. Intern. Med. 142 (7): 532–46. doi:10.7326/0003-4819-142-7-200504050-00012. PMID 15809465.
- ^ Gijsman HJ, Geddes JR, Rendell JM, Nolen WA, Goodwin GM (September 2004). “Antidepressants for bipolar depression: a systematic review of randomized, controlled trials”. Am J Psychiatry 161 (9): 1537–47. doi:10.1176/appi.ajp.161.9.1537.PMID 15337640.
- ^ Yatham LN, Kennedy SH, O’Donovan C, Parikh SV, MacQueen G, McIntyre RS, Sharma V, Beaulieu S (December 2006). “Canadian Network for Mood and Anxiety Treatments (CANMAT) guidelines for the management of patients with bipolar disorder: update 2007”. Bipolar Disord 8 (6): 721–39. doi:10.1111/j.1399-5618.2006.00432.x.PMID 17156158.
- ^ Kampman KM (June 2008). “The search for medications to treat stimulant dependence”. Addict Sci Clin Pract 4 (2): 28–35. doi:10.1151/ascp084228.PMC 2797110. PMID 18497715.
- ^ Mikocka-Walus AA, Turnbull DA, Moulding NT, Wilson IG, Andrews JM, Holtmann GJ (2006). “Antidepressants and inflammatory bowel disease: a systematic review”.Clin Pract Epidemiol Ment Health 2: 24. doi:10.1186/1745-0179-2-24.PMC 1599716. PMID 16984660.
- ^ “FDA clears Cymbalta to treat chronic musculoskeletal pain”. FDA Press Announcements. Food and Drug Administration. November 4, 2010. Retrieved August 19, 2013. “The U.S. Food and Drug Administration … approved Cymbalta (duloxetine hydrochloride) to treat chronic musculoskeletal pain, including discomfort from osteoarthritis and chronic lower back pain.”
- ^ Urquhart DM, Hoving JL, Assendelft WW, Roland M, van Tulder MW (2008). “Antidepressants for non-specific low back pain”. In Urquhart DM. Cochrane Database Syst Rev (1): CD001703. doi:10.1002/14651858.CD001703.pub3. PMID 18253994.
- ^ Shah TH, Moradimehr A (August 2010). “Bupropion for the treatment of neuropathic pain”. Am J Hosp Palliat Care 27 (5): 333–6. doi:10.1177/1049909110361229.PMID 20185402.
GLENMARK-A new way for a new world
http://www.glenmarkpharma.com/GLN_NWS/homepage.aspx?res=P_GLN
http://www.glenmark-generics.com/
| Type | Public |
|---|---|
| Traded as | BSE: 532296NSE: GLENMARK) |
| Industry | Pharmaceuticals, Drugs &Healthcare |
| Founded | 1977 |
| Founder(s) | Gracias Saldanha |
| Headquarters | Mumbai, Maharashtra[1], India |
| Key people | Glenn Saldanha, MD & CEO [2] |
| Products | Medicines and Vaccines |
| Revenue |  1031.10 crore(US$160 million) (2009–2010)[3] |
| Employees | 7,000 [4] |
| Subsidiaries | Glenmark Generics Ltd[5] |
| Website | www.glenmarkpharma.com |
Glenmark Pharmaceuticals is a pharmaceutical company headquartered in Mumbai, India. [6] It manufactures and markets generic formulation products and active pharmaceutical ingredients (API), both in the domestic and international markets. In the formulation business, its business spans segments such as Dermatology, Internal Medicine, Paediatrics, Gynaecology, ENT andDiabetes.
It has four manufacturing facilities for formulations and additional three facilities for APIs. These manufacturing facilities are located in the states of Maharashtra, Goa, Himachal Pradesh and Gujarat in India.
It operates in 95 countries through its subsidiaries, Glenmark Pharmaceuticals USA, Glenmark Pharmaceuticals UK. Glenmark Pharmaceuticals SA. [7]
HEAD OFFICE AT ANDHERI MUMBAI INDIA
- http://www.glenmarkpharma.com/UITemplate/HtmlContainer.aspx?res=P_GLN_CONTACT
- “If I were FM | Glenn Saldanha, managing director and CEO, Glenmark Pharmaceuticals – Economy and Politics”. livemint.com. 2009-07-01. Retrieved 2010-09-30.
- “BSE Plus”. Bseindia.com. Retrieved 2010-09-30.
- Glenmark Pharmaceuticals Ltd. (2529483): Stock Quote & Company Profile – BusinessWeek”. Investing.businessweek.com. Retrieved 2010-09-30.
- “Glenmark Pharmaceuticals | TopNews”. Topnews.in. Retrieved 2010-09-30.
- “about Glenmark Pharmaceuticals”. http://www.ibef.org. Retrieved 2010-09-30.
- “Glenmark Pharmaceuticals acquires Bouwer Bartlett, South Africa”. domain-b.com. 2005-12-26. Retrieved 2010-09-30.
WORLD-CLASS CAPABILITIEIS: Glenn Saldanha (left), Managing Director and CEO, along with Dr. Michael Buschle, President Biologics, Glenmark Pharmaceuticals at a press conference in Mumbai on Monday. Photo: Paul Noronha
RESEARCH CENTRE AT MAHAPE INDIA
Glenmark Pharma – The persevering innovator
Every Tuesday, unmindful of the gridlocked traffic, Glenn Saldanha, the 43-year-old Chairman of Glenmark Pharmaceuticals Ltd, or GPL, makes it a point to visit his research centre at Mahape in Navi Mumbai. It is the hub of Glenmark’s focus on creating new chemical entities, or NCEs, R&Dspeak for original drugs. Leading the innovation for Saldanha are his lab coat-clad scientists and researchers peering into the test tubes, burettes and pipettes at the Mahape facility.
“Almost 30 to 40 per cent of my time spent on business goes into issues relating to innovation,” he says. That includes thinking about research strategy, deciding on which chemical targets to focus on and which therapeutic segments to chase, and even hiring key R&D talent. Today, out of Glenmark’s 600-odd scientists, 400 are involved in NCE research.
The past 13 years have convinced the ardent admirer of Steve Jobs, the iconic former CEO of Apple, that the future lies in innovation. “If you look at how some of the largest corporations of the world were built, it is clear you need to have innovative products,” says Saldanha, a pharmacist by training, who voraciously reads scientific journals to stay updated on current scientific thought and trends. “Look at what Apple has created… that is the way to build a mega corporation, and that is the key reason why, despite our setbacks, we believe so heavily in innovation.”
Creating an NCE has been the Holy Grail for Indian pharma companies, including giants such as Dr Reddy’s Laboratories and Ranbaxy Laboratories (now owned by Daiichi Sankyo of Japan), but without any major success so far. These companies have reviewed their focus on NCE research and some branched into related activities like differentiated products. So has Glenmark, but it also soldiers on with drug discovery as its key focus area. With five molecules currently undergoing trials in various phases, the company now leads the charge of the Indian drug research industry.
Even one successful launch, say that of revamilast (for asthma and rheumatoid arthritis), which has potential peak sales of $2 billion worldwide, could change the fortunes of the company, though one can never be sure till it actually happens. Next year, Glenmark is likely to have half a dozen compounds in Phase II human trials. Saldanha hopes to hit the market with one or more of his drugs between 2015 and 2017. This potential upside is precisely why Glenmark is in this listing of Tomorrow’s Goliaths, and not any of the other bigger or faster-growing companies.
Undiminished zest
“Every year we expect two more molecules to get into clinical trials,” says Saldanha, his zest undiminished by past failures. “In 2008, in a span of one or two quarters, our entire pipeline pretty much got wiped out, but we never lost our commitment and passion.” At that time its most advanced molecule, oglemilast, used for treating patients with chronic obstructive pulmonary disease, had to be abandoned when its Phase IIb trials produced unsatisfactory results. It also had to suspend clinical development of GRC 6211, a compound for treating osteoarthritis pain, because of side effects.
Unlike other companies that reduced NCE development efforts when faced with similar situations, Glenmark persevered. “We never downsized our research team and did not cut back on budgets,” says Saldanha. “We did not even cut travel and our scientists continued to participate in major global conferences.” It is hardly surprising that his core R&D team has stayed put. Consider Neelima Joshi, 48, Senior Vice President and Head of NCE R&D, who was part of the dozen-odd people who set up the Mahape facility in 2000.
Even then, she says, Glenmark’s management was clearly focused on innovation and the move was in anticipation of the product patent regime that was to come in 2005. It was the impending change in India’s patent law that shaped the mind of the 29-year-old Saldanha in 1998, when he returned to India after working with Eli Lilly and PricewaterhouseCoopers to run his father Gracias Saldanha’s formulations business. After India became a signatory to General Agreement on Tariffs and Trade, it changed its patent law in 2005 from a process patent, which encouraged creation of copies of blockbuster original drugs with minor process changes, to a product patent, where the original drug’s patent itself is recognised in India, thereby prohibiting the creation of copies. This key change, and Saldanha’s passion for research, convinced him to steer Glenmark the NCE way.
However, not everyone agrees with Glenmark’s approach to NCE development, especially of giving away a promising molecule in the early stages to big multinational companies for further R&D. The argument: outlicensing a molecule at a later stage can give a company better valuations. The alternative is to do what Piramal Healthcare wants to – not outlicense. “We believe in taking the drug from the bench to market,” says Dr Swati A. Piramal, Vice Chairperson of Piramal Healthcare, which hopes to deploy the funds it got from sale of its formulations business to Abbott for its R&D efforts. “We are now at the end of the 10 years, having begun in 2002, and we hope between 2012 and 2015, we will hit the market with a new drug.”
While Piramal’s approach is a bench-to-market one, others such as Sun Pharma have developed a different model. Sun Pharma has created a separate research entity called Sun Pharma Advanced Research Centre, better known as SPARC, whose sustainability is built by making differentiated and innovative “generic-plus” products (in simple language, the risk is less, as the basic ingredient is known, but the company is developing a patented technology and a better-targeted product with intellectual property built in). What is more, the returns from this are to help fund the research programme.
On the other hand, Hyderabadbased Dr Reddy’s, one of the pioneers of India’s drug discovery journey, has today rationalised its research programme. It had, in fact, tried out a unique model of creating the country’s first integrated drug development company, Perlecan Pharma, which had equity capital commitments from ICICI Venture and other investors. But it soon saw the outside investors exit and brought back Perlecan into the Dr Reddy’s fold after delays in progress of candidates were not acceptable to some partners who had wanted early monetisation.
Beyond NCEs
Dr Reddy’s has now widened its scope beyond NCEs to differentiated products and formulations where improvements are made on existing products that have limited competition in the market. Its only Phase III candidate, balaglitazone, a diabetes drug, has yet to deliver the goods; the asset class it belongs to, glitazone, has had to deal with an overhang of safety concerns, especially in cases where there is a prolonged use of the drug. Yet, Dr Reddy’s sees sense in Glenmark’s model. “It is a viable model and a right strategy for a small company as Indian companies do not have the capacity to take the drug on their own to the market,” says Satish Reddy, Chief Operating Officer and Managing Director of Dr Reddy’s. “They will need to depend on upfront and milestone payments, and royalties.”
Analysts are cautiously optimistic as Glenmark will have some six compounds in Phase II only next year. Plus the fact that Glenmark has still not hit the market with a new drug weighs it down. “It has had no material success so far; they may make it big but it is difficult to say right now,” says a Mumbai-based analyst.
On his part, Saldanha argues that he has already recovered his R&D investments. “Till date, we have spent about $120 million in innovation research; against that we have got around $200 million as upfront and milestone payments.”
Says Nomura Financial Advisory and Securities in a recent report: “Glenmark has generated outlicensing income every year from 2004/05 to 2011/12 – except 2008/09. Average licensing income has been Rs 1 billion over the eightyear period. With seven development assets in the pipeline, we believe Glenmark will be able to continue to book licensing income, although the quantum and timing cannot be predicted.”
With standalone revenues of Rs 1,154.63 crore and consolidated revenues of almost Rs 3,000 crore, Glenmark hopes to hit the $1-billion mark soon. And if one of the NCEs sails through, the impact on the topline will be significant – a huge distance travelled for a company that clocked less than Rs 100 crore in the late 1990s. Certainly, Saldanha’s long drives on the Mumbai roads to his R&D headquarters are proving worthwhile.
WATCH A VIDEO
…
WATCH A VIDEO
Fast moving snails spread deadly dog disease across UK
http://www.bbc.co.uk/news/science-environment-23798012
Despite their lethargic reputations, snails can travel at a relatively speedy one metre per hour, say researchers.
By attaching multicoloured LED lights, the scientists were able to track their movements over a 24-hour period.
The gastropods were fast enough to explore the length of an average UK garden in a single night.
But scientists are worried that the fast-moving snails are spreading a parasite that is deadly for dogs.
Over the past few years the wet summers enjoyed across the UK have proved the ideal breeding grounds for snails.
“They are not just lettuce munchers, they are carriers of parasites that can kill your dogs”
Dr Dave Hodgson University of Exeter
According to the Royal Horticultural Society, their numbers increased by 50% last year.
As well as being a pest for gardeners, snails can also spread a parasite called Angiostrongylus vasorum.
This lungworm is a particular threat to…
View original post 434 more words
Small molecule, API biz to be growth drivers for company: Kiran Mazumdar Shaw, Biocon
“We have focused on creating key growth drivers and have structured the company along those growth drivers,” says Kiran Mazumdar Shaw. (BCCL)…………. owner BIOCON
MY, DR AMC COMMENTS- BIOCON GREAT PERFORMANCE, U ARE EVERYWHERE
Kiran Mazumdar Shaw: We have focused on creating key growth drivers and have structured the company along those growth drivers. These growth drivers are beginning to deliver very strongly for us.
The first is our small molecule business vertical, which is about our historic statins and immunosuppressant’s API business. This particular vertical going forward is envisioned to go up the value chain along an ANDA path and we believe that will improve the quality of earnings in this particular vertical, which for a long time was under pressure because of commoditisation of statins.http://economictimes.indiatimes.com/opinion/interviews/small-molecule-api-biz-to-be-growth-drivers-for-company-kiran-mazumdar-shaw-biocon/articleshow/21975113.cms
New Drug Approvals 