SCRIPINTELLIGENCE.COM | ABOUT | SUBSCRIBE | CONTACT US

SPONSORS
NDA

R&D

Research for a lifetime of health


Pharmaceutical R&D is at a turning point. It always is, of course, but this time it's for real.
Obamacare in the US and the immediacy of the impacts of austerity measures in Europe have made it obvious to all but the most blinkered that the era of untrammelled expansion of healthcare costs, and drug costs in particular is over.


Innovation is still required through research and development; or rather, not innovation but amelioration, since it is no longer sufficient just to be new. The new R&D imperative now must be on expanding the dimensions of the improvement.

Much of current R&D in the pharmaceutical and biotechnology industries still aims at providing solutions to disease through the aegis of chemical or biological intervention. The unmet-ness of any medical need is both clearest and most poignant when the disease in question is in full rage, usually when a patient is close to death or suffering a substantial impact on their quality of life. The simplistic way in which pharmaceutical projects are often defined starts with the input of specialist physicians, those who would be at the cutting edge if they were surgeons, those who experience the guilt and impotence of being unable to help patients as they slide away from life and health.

Full Article

HCV 2012 - combining therapies, companies and assets


One year ago, the talk in hepatitis C circles was all of telaprevir and boceprevir, the protease inhibitors then still in registration developed respectively by Vertex/Johnson & Johnson and Merck. Both drugs had clearly shown a clinically significant impact in sustainably reducing the viral load in hepatitis C infected people, including those whose disease had relapsed or not responded to the standard of care treatment, a mixture of pegylated-interferon alfa and the antiviral ribonuclotide prodrug, ribavirin.


The questions at that time were all about which protease inhibitor would be approved first (boceprevir breasted the tape in both Europe and the US but only by a matter of days) and the relative market share be given their performance in clinical trials.

A year on and it is clear that both drugs are going to be billion dollar blockbusters. Seamus Wilkinson-Levine, an analyst with market data company Decision Resources says that Vertex’ Incivek/Incivo (telaprevir) is set to be the "fastest blockbuster in history, possibly in six months at the outside". A global launch in the summer led to a first quarter revenues for Incivek of $420 million, dwarfing the $31 million booked by Merck for Victrelis (boceprevir). It is broadly expected that Victrelis will catch up as Merck's lower pricing gains its drug traction in the less generous markets outside the USA.

Full Article



Last of the big spenders


Spare a thought for the chaps (and it usually is men – the management boards of pharmaceutical companies tend to be male-dominated) that run our big pharma companies. So many balls to keep in the air at any one time, so many people they have to keep sweet.


Arguably, nowhere is this truer than in the case of R&D. Sanofi’s CEO Chris Viehbacher hit the nail on the head recently when he said that if your R&D is found wanting (and that can probably be said of a lot of companies these days), you’re the bad guy. But if you succeed, it barely deserves a second thought.

We are constantly being told that pharmaceutical R&D is in a parlous state. A report produced by professional services firm KPMG earlier this year pointed out that the number of applications for "new medical entities" filed with the US FDA over the past decade has remained fairly constant at around 30 a year (although it fell to just 23 in 2010). But at the same time, the amount spent by pharma companies on R&D has been rising, at around 10% per annum (admittedly, it has slowed somewhat in the past two or three years). The obvious conclusion is that pharmaceutical R&D is becoming less efficient.

Full Article

2011 new product approvals


US NBE/NCE Approvals - Nov 2010 - Oct 2011
Brand name
Generic name Marketing Authorisation
Holder		 Indication Date NCE/NBE
Egrifta tesamorelin Theratechnologies lipodystrophy in HIV patients 10/11/2010 NBE
Halaven eribulin mesylate Eisai advanced breast cancer 15/11/2010 NCE
Viibryd vilazodone Trovis Pharma depression 21/01/2011 NCE
Corifact Factor XIII concentrate CSL Behring (CSL) Factor XIII deficiency 17/02/2011 NBE
Edarbi azilsartan Takeda hypertension 25/02/2011 NCE
Daliresp roflumilast Forest Labs chronic obstructive airways
disease		 28/02/2011 NCE
Benlysta belimumab Human Genome Sciences systemic lupus erythematosus
09/03/2011		 NBE
Yervoy ipilimumab Bristol Myers Squibb melanoma 25/03/2011 NBE
Horizant ER gabapentin enacarbil GlaxoSmithKline restless legs syndrome 06/04/2011 NCE
Zictifa vandetanib AstraZeneca thyroid cancer 06/04/2011 NCE
Zytiga abiraterone Centocor Ortho Biotech (Johnson &
Johnson)		 prostate cancer 28/04/2011 NCE
Tradjenta linagliptin Boehringer Ingelheim / Lilly type 2 diabetes 02/05/2011 NCE
Victrelis boceprevir Merck & Co hepatitis C 13/05/2011 NCE
Edurant rilpivirine Tibotec (Johnson & Johnson) HIV/AIDS 20/05/2011 NCE
Incivek telaprevir Vertex Pharmaceuticals hepatitis C 23/05/2011 NCE
Dificid fidaxomicin Optimer Pharmaceuticals Clostridium difficile infection 27/05/2011 NCE
Potiga ezogabine Valeant Pharmaceuticals epilepsy 10/06/2011 NCE
Nulojix belatacept Bristol-Myers Squibb transplant rejection
15/06/2011		 NBE
Arcapta Neohaler indacaterol maleate Novartis chronic obstructive pulmonary
disease		 01/07/2011 NCE
Xarelto rivaroxaban Ortho-McNeil (Johnson & Johnson) venous thrombosis 01/07/2011 NCE
Brilinta ticagrelor AstraZeneca acute coronary syndromes 20/07/2011 NCE
Zelboraf vemurafenib Roche (licensed from Plexxikon
(Daiichi Sankyo))		 melanoma 17/08/2011 NCE
Adcetris brentuximab vedotin Seattle Genetics
Hodgkin's		 lymphoma and
systemic anaplastic large cell
lymphoma
 19/08/2011 NBE
Firazyr
icatibant acetate Shire (licensed from Sanofi) hereditary angioedema 25/08/2011 NBE
Xalkori crizotinib Pfizer non-small cell lung cancer 26/08/2011 NCE

 

EU NBE/NCE Approvals - Nov 2010 to Oct 2011
Brand name
Generic name Marketing Authorisation
Holder		 Indication Date NCE/NBE
Aflunov prepandemic influenza
vaccine (H5N1)		 Novartis H5N1 subtype of Influenza A 29/11/2010 NBE
Brilique/Possia ticagrelor AstraZeneca acute coronary syndromes 03/12/2010 NCE
Fluenz influenza vaccine, live
attenuated		 MedImmune (AstraZeneca) influenza prophylaxis 27/01/2011 NBE
Esbriet pirfenidone InterMune Europe (InterMune) idiopathic pulmonary fibrosis 28/02/2011 NCE
Pumarix inactivated split
influenza virus,
containing H5N1
antigen
Glaxo SmithKline Biologicals
(Glaxo SmithKline)		 influenza prophylaxis 04/03/2011 NBE
Jevtana cabazitaxel Sanofi-Aventis prostate cancer 17/03/2011 NCE
Gilenya fingolimod Novartis multiple sclerosis 17/03/2011 NCE
Halaven eribulin Eisai breast cancer 17/03/2011 NCE
Trobalt retigabine GlaxoSmithKline epilepsy 28/03/2011 NCE
Eliquis apixaban Bristol-Myers Squibb prevention of venous
thromboembolic events		 18/05/2011 NCE
Cinryze C1-esterase inhibitor ViroPharma hereditary angioedema 15/06/2011 NBE
Nulojix belatacept Bristol-Myers Squibb transplant rejection 17/06/2011 NBE
Benlysta belimumab GlaxoSmithKline / Human Genome
Sciences		 systemic lupus erythematosus 13/07/2011 NBE
Yervoy ipilimumab Bristol-Myers Squibb melanoma 13/07/2011 NBE
Victrelis boceprevir Merck Sharp & Dohme (Merck &
Co)		 hepatitis C 18/07/2011 NCE
Fampyra fampridine Biogen Idec multiple sclerosis 20/07/2011 NCE
Trajenta linagliptin Boehringer Ingelheim type 2 diabetes 24/08/2011 NCE
Vibativ telavancin Astellas nosocomial lung infections,
including MRSA		 02/09/2011 NCE
Zytiga abiraterone Janssen-Cilag (Johnson & Johnson) prostate cancer 05/09/2011 NCE
Dexdor dexmed etomidine Orion Corporation sedation 16/09/2011 NCE
Incivo telaprevir Janssen-Cilag (Johnson & Johnson) hepatitis C 19/09/2011 NCE

 

Japanese NCE/NBE Approvals - Nov 2010 to Oct 2011
Brand name
Generic name Marketing Authorisation
Holder		 Indication Date NCE/ NBE
Edirol eldecalcitol Chugai (Roche); co-marketed by Taisho osteoporosis Nov-10 NCE
Stelara
ustekinumab Janssen Pharma (Johnson & Johnson) psoriasis Nov-10 NBE
Feburic
febuxostat Teijin hyperuricaemia Jan-11 NCE
Memary
memantine Daiichi Sankyo Alzheimer’s disease Jan-11 NCE
Prazaxa


dabigatran Boehringer Ingelheim stroke prevention in atrial
fibrillation		 Jan-11 NCE
Reminyl


galantamine Janssen (Johnson & Johnson);
co-marketed by Takeda		 Alzheimer’s disease Jan-11 NCE
Romiplate
romiplostim Kyowa Hakko Kirin thrombo-cytopenic purpura Jan-11 NBE
Sonias
pioglitazone + glimepiride Takeda type 2 diabetes Jan-11 NCE
Surepost
repaglinide Dainippon Sumitomo type 2 diabetes Jan-11 NCE
Vidaza
azacitidine Nippon Shinyaku myelodysplastic syndrome Jan-11 NCE
Exelon/Rivastach


rivastigmine Novartis (co-marketed with Ono
Pharmaceutical)		 Alzheimer’s disease Apr-11 NCE
Halaven
 eribulin Eisai breast cancer Apr-11 NBE
Lexapro
escitalopram Mochida (co-marketed with Mitsubishi
Tanabe Pharma)		 depression Apr-11 NCE
Lipacreon pancrelipase Abbott (to be marketed by Eisai) pancreatic dysfunction Apr-11 NBE
Lixiana edoxaban Daiichi Sankyo venous thromboembolism Apr-11 NCE
Mircera

 methoxy polyethylene glycolepoetin
beta		 Chugai (Roche) renal anaemia Apr-11 NBE
Betanis mirabegron Astellas overactive bladder Jul-11 NCE
Cubicin

daptomycin Banyu (Merck & Co)
 methicillin-resistant Staphylococcus aureus (MRSA)
infection		 Jul-11 NCE
Gardasil

 human papillomavirus
quadrivalent vaccine		 Merck & Co human papillomavirus infection Jul-11 NBE
Nexium

esomeprazole AstraZeneca (co-promoted by Daiichi
Sankyo)		 acid-related conditions Jul-11 NCE
Onbrez

indacaterol maleate Novartis chronic obstructive pulmonary
disease		 Jul-11 NCE
Rotarix attenuated rotavirus vaccine GlaxoSmithKline rotavirus infection Jul-11 NBE
Simponi

golimumab Janssen (Johnson & Johnson); to be
marketed by Mitsubishi Tanabe Pharma		 rheumatoid arthritis Jul-11 NBE
Tradjenta

linagliptin Boehringer Ingelheim / Lilly
(co-promoted by Daiichi Sankyo)		 type 2 diabetes Jul-11 NCE
Zolinza
vorinostat Merck & Co (to be marketed by Taiho
(Otsuka))
 T-cell lymphoma Jul-11 NCE
Faslodex fulvestrant AstraZeneca breast cancer Sep-11 NCE
Ilaris

canakinumab Novartis cryopyrin-associated periodic
syndrome		 Sep-11 NBE
Imusera

fingolimod

 Novartis / Mitsubishi Tanabe multiple sclerosis Sep-11 NCE
Telavic telaprevir Mitsubishi Tanabe (licensed from Vertex) hepatitis C Sep-11 NCE