Jeg fatter ikke hvis det er sandt, for vi har intet hørt fra Genmab eller GSK. Selve strategien om at køre på emerging markets er der ikke noget nyt, men at man vil prøve arzerra her allerede kan altså betyde 1 af 2 ting.
1. Rituxian har intet salg i indien
2. Arzerra er super stærk....
Hvis Arzerra begynder at køre på 3 kontinenter kan det altså godt blive rigtigt stort.
P.T. Jyothi Datta
Mumbai, Feb. 15
Multinational drug-maker GlaxoSmithKline Pharmaceuticals Ltd is set to increase its field-force, and introduce several products including patent-protected ones, over the next 12-18 months.
Having added about 200 people to its field-force last year, the drug-maker is set to add another 100 people, said GSK's Managing Director in India, Dr Hasit Joshipura, responding to reports of the parent company cutting jobs to re-focus.
Two vaccines
The company is also set to bring in two vaccines, Infanrix-Hexa (a six-component vaccine) and pneumococcal vaccine Synflorix over the next 12-18 months, he told Business Line. The regulatory filings with the Drug Controller General of India have been completed, he added.
Three drugs, including blood-platelet boosting drug Promacta, leukaemia drug Arzerra and renal cancer drug Votrient are also to be brought into the local market, he said. Two of the drugs are patented and the medicines will be priced differently in the local market, he said, adding that the price had not yet been decided. The high price of patented drugs, specially in the cancer segment have been a concern locally.
Stiefel consolidation
The global acquisition of Stiefel Laboratories Inc will translate in India giving GSK over 90 per cent presence in the dermatology segment, he said. Having got the board's approval, GSK will now look at its products and local distribution, he added. The products include acne, sun protection and moisturisers, to name a few.
Commenting on the company's dip in net profit, he said that there was a one-time gain in the quarter last year, from the sale of shares and other income from investments. The management was ?comfortable? about GSK's performance in the year under review, he added. The year ahead would grow on the back of its regular products, new launches, vaccines and products brought in through licensing pacts signed in the recent past, he added. More such pacts would happen, he added.
Vaccines contribute about 10 per cent of sales, he said. And the company expects its total business to grow ahead of the local market in the present year, he added.
GSK Pharma's shares were marginally down at Rs 1,576 on the BSE.http://www.thehindubusinessline.com/2010/02/16/stories/2010021652670200.htm
1. Rituxian har intet salg i indien
2. Arzerra er super stærk....
Hvis Arzerra begynder at køre på 3 kontinenter kan det altså godt blive rigtigt stort.
P.T. Jyothi Datta
Mumbai, Feb. 15
Multinational drug-maker GlaxoSmithKline Pharmaceuticals Ltd is set to increase its field-force, and introduce several products including patent-protected ones, over the next 12-18 months.
Having added about 200 people to its field-force last year, the drug-maker is set to add another 100 people, said GSK's Managing Director in India, Dr Hasit Joshipura, responding to reports of the parent company cutting jobs to re-focus.
Two vaccines
The company is also set to bring in two vaccines, Infanrix-Hexa (a six-component vaccine) and pneumococcal vaccine Synflorix over the next 12-18 months, he told Business Line. The regulatory filings with the Drug Controller General of India have been completed, he added.
Three drugs, including blood-platelet boosting drug Promacta, leukaemia drug Arzerra and renal cancer drug Votrient are also to be brought into the local market, he said. Two of the drugs are patented and the medicines will be priced differently in the local market, he said, adding that the price had not yet been decided. The high price of patented drugs, specially in the cancer segment have been a concern locally.
Stiefel consolidation
The global acquisition of Stiefel Laboratories Inc will translate in India giving GSK over 90 per cent presence in the dermatology segment, he said. Having got the board's approval, GSK will now look at its products and local distribution, he added. The products include acne, sun protection and moisturisers, to name a few.
Commenting on the company's dip in net profit, he said that there was a one-time gain in the quarter last year, from the sale of shares and other income from investments. The management was ?comfortable? about GSK's performance in the year under review, he added. The year ahead would grow on the back of its regular products, new launches, vaccines and products brought in through licensing pacts signed in the recent past, he added. More such pacts would happen, he added.
Vaccines contribute about 10 per cent of sales, he said. And the company expects its total business to grow ahead of the local market in the present year, he added.
GSK Pharma's shares were marginally down at Rs 1,576 on the BSE.http://www.thehindubusinessline.com/2010/02/16/stories/2010021652670200.htm
16/2 2010 00:35 collersteen 0
25939 Der er røget en generisk variant af Rituximab (Mabthera) på markedet derovre allerede - Reditux fra Dr. Reddys.
Der står lidt om prisniveauet i denne artikel. Nu har jeg ikke styr på doser eller noget som helst, men hvordan ligger prisniveauet i Indien (ift USA/Europa) hvis 100mg dose af Mabthera vil koste Rs20,000 eller ca. 500usd ?
http://livemint.com/2007/05/02004327/Dr-Reddys-generic-of-Roches.html
Reddy?s Reditux is priced at Rs10,000 ($243) for a 100mg dose in a 10ml vial, or about half the price Roche charges for Mabthera, Dr. Reddy?s Mamidanna said. A 500mg dose will cost Rs40,000, she added.
Artiklen er også fra 2007, så der kan jo være sket en del siden.
Der står lidt om prisniveauet i denne artikel. Nu har jeg ikke styr på doser eller noget som helst, men hvordan ligger prisniveauet i Indien (ift USA/Europa) hvis 100mg dose af Mabthera vil koste Rs20,000 eller ca. 500usd ?
http://livemint.com/2007/05/02004327/Dr-Reddys-generic-of-Roches.html
Reddy?s Reditux is priced at Rs10,000 ($243) for a 100mg dose in a 10ml vial, or about half the price Roche charges for Mabthera, Dr. Reddy?s Mamidanna said. A 500mg dose will cost Rs40,000, she added.
Artiklen er også fra 2007, så der kan jo være sket en del siden.
16/2 2010 16:14 125962 Safety data from Part 1 of the trial will be evaluated to determine if it is safe to begin Part 2. There will be two treatment groups in Part 2 of the study. Patients will receive either 2 cycles of induction chemotherapy in combination with weekly doses of up to 16 mg/kg of HuMax-EGFr followed by 7 weekly doses of HuMax-EGFr in combination with chemo-radiation or 2 cycles of induction chemotherapy followed by chemo-radiation alone.
In both parts of the study, patients will be evaluated every 3 months until disease progression and every 4 weeks thereafter until death in accordance with the general methodology of trials in cancer patients.
The objective of the study is to evaluate the safety and efficacy of HuMax-EGFr in combination with chemo-radiation versus chemo-radiation alone in the treatment of advanced NSCLC. The primary endpoint of the study is progression free survival from randomization until disease progression or death.
NSCLC is the leading cause of cancer deaths in both men and women, with approximately 172,000 patients being diagnosed annually in the US. Almost 25% of newly diagnosed patients will have advanced (stage IIIA or IIIB) disease for which effective treatment options are few.
In both parts of the study, patients will be evaluated every 3 months until disease progression and every 4 weeks thereafter until death in accordance with the general methodology of trials in cancer patients.
The objective of the study is to evaluate the safety and efficacy of HuMax-EGFr in combination with chemo-radiation versus chemo-radiation alone in the treatment of advanced NSCLC. The primary endpoint of the study is progression free survival from randomization until disease progression or death.
NSCLC is the leading cause of cancer deaths in both men and women, with approximately 172,000 patients being diagnosed annually in the US. Almost 25% of newly diagnosed patients will have advanced (stage IIIA or IIIB) disease for which effective treatment options are few.
VI kan jo ikke have at vi taber penge pga. fejlagtig information. Nej det er den rigtige information man taber penge på.
Nedenfor de studier der ifølge genmabs hjemmeside er aktive i EGFR. Sorry.
Nedenfor de studier der ifølge genmabs hjemmeside er aktive i EGFR. Sorry.
he complex monoclonal antibody manufacturing process is also expensive, leading to the sometimes controversially high price of biologics products. For example, a month's supply of Rituxan costs at least $4,200 in the US (USA Today, November 2006). In India, Reditux has been priced 50% lower than the original product. This would translate to a saving of at least $25,200 a year, should Dr Reddy succeed in its plans to bring the product to the US. Although this price level may not be sustainable if the company has to pay for clinical trials to support its case for approval, the scope for large savings with even a slight discount would make a generic version attractive.
16/2 2010 00:48 collersteen 025941 Og lidt om RA
http://www.pharmabiz.com/article/detnews.asp?articleid=36161§ionid=45
7 mio mennesker med RA i Indien. Der må vel være et par 1000 patienter til overs der har råd til at prøve Arzerra til sin tid.
(hvis altså det bliver til noget i RA med arzerra)
Man kan også se at Rituxan har været på markedet i Indien i NHL siden 2001.
(2006 minus 5 år)
Mabthera is approved and available in India for the last 5 years for the treatment of Non-Hodgkin's Lymphoma. It is now recently approved for the treatment of Rheumatoid Arthritis. The official availability of the product is expected on 24 November 2006. Currently it is available in four Indian cities namely: Lucknow, Hyderabad, Chennai, and Chandigarh.
RA is one of the most common forms of autoimmune disease globally, 1 per cent of the population suffer from RA. In India around more than 7 million patients are suffering from this disease.
http://www.pharmabiz.com/article/detnews.asp?articleid=36161§ionid=45
7 mio mennesker med RA i Indien. Der må vel være et par 1000 patienter til overs der har råd til at prøve Arzerra til sin tid.
(hvis altså det bliver til noget i RA med arzerra)
Man kan også se at Rituxan har været på markedet i Indien i NHL siden 2001.
(2006 minus 5 år)
Mabthera is approved and available in India for the last 5 years for the treatment of Non-Hodgkin's Lymphoma. It is now recently approved for the treatment of Rheumatoid Arthritis. The official availability of the product is expected on 24 November 2006. Currently it is available in four Indian cities namely: Lucknow, Hyderabad, Chennai, and Chandigarh.
RA is one of the most common forms of autoimmune disease globally, 1 per cent of the population suffer from RA. In India around more than 7 million patients are suffering from this disease.
16/2 2010 01:24 collersteen 025942 http://www.roche.com/gb09e.pdf side 22 og frem
CEMAI står for ca. 8 % af Roche's totale salg af pharmaceuticals (som dog er på gigantiske 38 mia CHF - hvoraf Mabthera-salget er ca. 6 mia CHF)
CEMAI: Central and Eastern Europe, Middle East, Africa,
Central Asia, Indian Subcontinent.
Kan man overføre det direkte er der således knap 500 mio CHF i årligt Mabthera-salg i CEMAI. Der er derfor således nok ikke så forfærdelig mange Arzerra-kroner i det indiske marked.
Nu har jeg absolut ingen ide om procedurer osv, men man kunne vel forestille sig at det går relativt nemt med at få det hele godkendt. Ligeledes er det måske også sådan at off-label use er noget nemmere?
(hvis man kan købe en lever på et gadehjørne er det måske også et pænt offlabel-salg i de rige kredse) Der er jo ihvert fald en ganske pæn overklasse der svømmer i helt ufattelige pengesummer.
I genmab-casen pt. er sentimentet vel også næsten sådan at enhver ny patient man kan finde kan øge kursmålet....
CEMAI står for ca. 8 % af Roche's totale salg af pharmaceuticals (som dog er på gigantiske 38 mia CHF - hvoraf Mabthera-salget er ca. 6 mia CHF)
CEMAI: Central and Eastern Europe, Middle East, Africa,
Central Asia, Indian Subcontinent.
Kan man overføre det direkte er der således knap 500 mio CHF i årligt Mabthera-salg i CEMAI. Der er derfor således nok ikke så forfærdelig mange Arzerra-kroner i det indiske marked.
Nu har jeg absolut ingen ide om procedurer osv, men man kunne vel forestille sig at det går relativt nemt med at få det hele godkendt. Ligeledes er det måske også sådan at off-label use er noget nemmere?
(hvis man kan købe en lever på et gadehjørne er det måske også et pænt offlabel-salg i de rige kredse) Der er jo ihvert fald en ganske pæn overklasse der svømmer i helt ufattelige pengesummer.
I genmab-casen pt. er sentimentet vel også næsten sådan at enhver ny patient man kan finde kan øge kursmålet....
16/2 2010 09:43 Stinker 025946 Det her er gode nyheder. Den dårlige nyhed som måtte kunne indlægges, er ikke nogen nyhed: Patentkrænkelser og generisk konkurence er hvad man hele tiden har kunnet forvente fra denne front. Nyt er det til gengæld hvis Arzerra allerede skal på markedet Indien, og glædeligt at det i givet fald sker inden introduktionen af kopier samt at det sker i et lavere prisleje som vanskeliggør kopivirksomhed i det hele taget.
Så vidt jeg kan se har Rituxan til en pris på det dobbelte af 243$/100mg ikke været solgt med en lokal discount, jfr prisen på Arzerra 4,4$/mg, som blev angivet som svarende til prisen på Rituxan.
Så vidt jeg kan se har Rituxan til en pris på det dobbelte af 243$/100mg ikke været solgt med en lokal discount, jfr prisen på Arzerra 4,4$/mg, som blev angivet som svarende til prisen på Rituxan.
16/2 2010 10:41 hall 025947 Indien og områderne deromkring har længe haft stor fokus på kraftbehandlinger.
For det geografiske område gælder det generelt, at penge kan afgøre, hvilke behandlingsform man får, men det er et kæmpe marked, hvor mellemklassen og rigmandsklubberne daglig vokser med stor hast, så der er enorm potentiale (hvilket også har grunden til at Topos partner har ville have rettighed til Indien).
Med en befolkningstal på over 1 Mia og flere hundrede millioner der kan karakteriseret som mellemklasse/velhavende, er det et marked, som især kraftmiddelbranchen meget gerne vil komme ind på.
Samtidig skal man være opmærksom på er det er et marked hvor korruption er stor, så profitten bliver mindre pr. solgt enhed, ligesom der ikke behøver at være sammenhæng mellem solgt enhed og antal behandlet patienter ;(
For det geografiske område gælder det generelt, at penge kan afgøre, hvilke behandlingsform man får, men det er et kæmpe marked, hvor mellemklassen og rigmandsklubberne daglig vokser med stor hast, så der er enorm potentiale (hvilket også har grunden til at Topos partner har ville have rettighed til Indien).
Med en befolkningstal på over 1 Mia og flere hundrede millioner der kan karakteriseret som mellemklasse/velhavende, er det et marked, som især kraftmiddelbranchen meget gerne vil komme ind på.
Samtidig skal man være opmærksom på er det er et marked hvor korruption er stor, så profitten bliver mindre pr. solgt enhed, ligesom der ikke behøver at være sammenhæng mellem solgt enhed og antal behandlet patienter ;(
16/2 2010 13:41 Sibelius 025954 Forstår ikke helt - kan de sælge på baggrund af FDA godkendelse, eller skal der ske en godkendelse i Indien etc. før man kan sælge på de kanter?
16/2 2010 13:48 125956 De skal sælges på baggrund af en indisk godkendelse og jeg forstår også at sigtet er at bringe dem ind indenfor de næste 12-18 måneder. Men vi har ikke hørt noget om filing.
16/2 2010 15:11 hall 025959 På de kanter, har man en anden tilgang til godkendelser.
En indisk godkendelser er typisk meget mere lemplig end en FDA
En indisk godkendelser er typisk meget mere lemplig end en FDA
