Jeg er nok ikke den eneste der har siddet på kanten af stolen idag op til regnskabet. Nu er det kommet og der var ingen negative overraskelse.
Hvis vi frygtede at de havde lavet rod i deres regnskab eller deres obligationsbeholdning. Kan vi ånde lettet op. Der var intet problem i deres finanser, tværtimod opskrev de med 141 mill og vigtigst af alt - måske - var at de har halvdelen i kontanter. Hele 717 mill pr. dags dato.
Hvis man som jeg havde spekuleret i at de ville benytte lejligheden til at ende deres forsøg i RA, kan man ligeledes ånde lettet op. Det sker heller ikke.
Om noget var regnskabet lidt bedre end ventet. Selve det store underskud får kun begrænset indvirkning på deres likvide beholdning da der er tale om nedskrivning af fabrikken.
Her er highlights
Genmab?s revenues were DKK 435 million (USD 86 million) for the nine month period
ended September 30, 2009. In the same period of 2008, Genmab recognized revenues of
DKK 667 million (USD 131 million).
? An operating loss of DKK 536 million (USD 105 million). This compares to an operating
loss of DKK 508 million (USD 100 million) for the corresponding period of 2008.
Despite the decrease in revenues of DKK 232 million, the operating loss has only
increased by DKK 28 million compared to the corresponding period in 2008. This is
mainly a result of our continued strong focus on cost savings and control.
? An income of DKK 141 million (USD 28 million) from net financial items for the first
nine months of 2009, compared to a loss of DKK 18 million (USD 4 million) in the same
period of 2008. The net financial items have continued to be positively impacted by the
improved market conditions which have resulted in improved fair market valuations of
our marketable securities.
? A net loss of DKK 403 million (USD 79 million) compared to a net loss of DKK 526
million (USD 104 million) for the same period in 2008. The net loss per share was DKK
8.98 (USD 1.77) for the first nine months of 2009 compared to DKK 11.81 (USD 2.32) in
the first nine months of 2008.
? Genmab ended the nine month period with a cash position of DKK 1,380 million (USD
271 million), a decrease of DKK 382 million (USD 76 million) from the end of 2008.
The decrease arises primarily from the investment in our research and development
activities.
Highlights
During the third quarter of 2009, Genmab announced a number of business and scientific
highlights, as follows:
For ofatumumab:
? Completion of patient recruitment in two ofatumumab studies: the Phase III pivotal study in
refractory chronic lymphocytic leukemia (CLL) and the Phase II study in relapsed Diffuse
Large B-cell Lymphoma (DLBCL).
? Top-line results from four ofatumumab studies: a Phase III study to treat rheumatoid arthritis
(RA) in patients refractory to methotrexate; a Phase II front line combination study in CLL; a
Phase II front line combination study in non-Hodgkin?s lymphoma (NHL) and a pivotal
Phase III study in rituximab refractory NHL. The overall response rate in this Phase III
pivotal study was 11%. Genmab and its partner GlaxoSmithKline (GSK) are continuing
ongoing plans for additional clinical studies in NHL.
For zalutumumab:
? The FDA placed a partial clinical hold on zalutumumab clinical studies being conducted
under the US Investigational New Drug (IND) application, as well as requests for new
studies in June 2009. The company met the FDA?s request for additional safety information
and the hold was lifted on July 16.
Financial guidance:
? We published revised financial guidance for 2009 to reflect the exclusion of a milestone
payment related to the Phase III NHL study under the Arzerra? (ofatumumab) collaboration
with GSK.
Subsequent to the balance sheet date:
In October, we announced that GSK had filed a declaratory judgment action seeking a
declaration that the US Patent 6,331,415 (the ?Cabilly? patent) is invalid, unenforceable and
not infringed by Arzerra.
? In October, we received accelerated approval for Arzerra from the FDA for CLL that is
refractory to fludarabine and alemtuzumab. The FDA approval triggered a milestone
payment of DKK 116 million from GSK.
? In November, we announced a reorganization plan to match resources to ongoing and future
needs, sell our US manufacturing facility and reduce headcount by approximately 300
positions. We will retain a core staff with critical development skills. We do not intend to
discontinue any of our ongoing development programs as a result of this reorganization and
look forward to data from the zalutumumab pivotal study in head and neck cancer, now
expected in 2010, as overall patient survival is longer than anticipated.
In November, we published revised financial guidance for 2009 to reflect the financial
impact of the reorganization plan.
? In November, we announced the initiation of a Phase III study of ofatumumab plus
chemotherapy versus rituximab plus chemotherapy to treat patients with relapsed or
refractory DLBCL.
Hvis vi frygtede at de havde lavet rod i deres regnskab eller deres obligationsbeholdning. Kan vi ånde lettet op. Der var intet problem i deres finanser, tværtimod opskrev de med 141 mill og vigtigst af alt - måske - var at de har halvdelen i kontanter. Hele 717 mill pr. dags dato.
Hvis man som jeg havde spekuleret i at de ville benytte lejligheden til at ende deres forsøg i RA, kan man ligeledes ånde lettet op. Det sker heller ikke.
Om noget var regnskabet lidt bedre end ventet. Selve det store underskud får kun begrænset indvirkning på deres likvide beholdning da der er tale om nedskrivning af fabrikken.
Her er highlights
Genmab?s revenues were DKK 435 million (USD 86 million) for the nine month period
ended September 30, 2009. In the same period of 2008, Genmab recognized revenues of
DKK 667 million (USD 131 million).
? An operating loss of DKK 536 million (USD 105 million). This compares to an operating
loss of DKK 508 million (USD 100 million) for the corresponding period of 2008.
Despite the decrease in revenues of DKK 232 million, the operating loss has only
increased by DKK 28 million compared to the corresponding period in 2008. This is
mainly a result of our continued strong focus on cost savings and control.
? An income of DKK 141 million (USD 28 million) from net financial items for the first
nine months of 2009, compared to a loss of DKK 18 million (USD 4 million) in the same
period of 2008. The net financial items have continued to be positively impacted by the
improved market conditions which have resulted in improved fair market valuations of
our marketable securities.
? A net loss of DKK 403 million (USD 79 million) compared to a net loss of DKK 526
million (USD 104 million) for the same period in 2008. The net loss per share was DKK
8.98 (USD 1.77) for the first nine months of 2009 compared to DKK 11.81 (USD 2.32) in
the first nine months of 2008.
? Genmab ended the nine month period with a cash position of DKK 1,380 million (USD
271 million), a decrease of DKK 382 million (USD 76 million) from the end of 2008.
The decrease arises primarily from the investment in our research and development
activities.
Highlights
During the third quarter of 2009, Genmab announced a number of business and scientific
highlights, as follows:
For ofatumumab:
? Completion of patient recruitment in two ofatumumab studies: the Phase III pivotal study in
refractory chronic lymphocytic leukemia (CLL) and the Phase II study in relapsed Diffuse
Large B-cell Lymphoma (DLBCL).
? Top-line results from four ofatumumab studies: a Phase III study to treat rheumatoid arthritis
(RA) in patients refractory to methotrexate; a Phase II front line combination study in CLL; a
Phase II front line combination study in non-Hodgkin?s lymphoma (NHL) and a pivotal
Phase III study in rituximab refractory NHL. The overall response rate in this Phase III
pivotal study was 11%. Genmab and its partner GlaxoSmithKline (GSK) are continuing
ongoing plans for additional clinical studies in NHL.
For zalutumumab:
? The FDA placed a partial clinical hold on zalutumumab clinical studies being conducted
under the US Investigational New Drug (IND) application, as well as requests for new
studies in June 2009. The company met the FDA?s request for additional safety information
and the hold was lifted on July 16.
Financial guidance:
? We published revised financial guidance for 2009 to reflect the exclusion of a milestone
payment related to the Phase III NHL study under the Arzerra? (ofatumumab) collaboration
with GSK.
Subsequent to the balance sheet date:
In October, we announced that GSK had filed a declaratory judgment action seeking a
declaration that the US Patent 6,331,415 (the ?Cabilly? patent) is invalid, unenforceable and
not infringed by Arzerra.
? In October, we received accelerated approval for Arzerra from the FDA for CLL that is
refractory to fludarabine and alemtuzumab. The FDA approval triggered a milestone
payment of DKK 116 million from GSK.
? In November, we announced a reorganization plan to match resources to ongoing and future
needs, sell our US manufacturing facility and reduce headcount by approximately 300
positions. We will retain a core staff with critical development skills. We do not intend to
discontinue any of our ongoing development programs as a result of this reorganization and
look forward to data from the zalutumumab pivotal study in head and neck cancer, now
expected in 2010, as overall patient survival is longer than anticipated.
In November, we published revised financial guidance for 2009 to reflect the financial
impact of the reorganization plan.
? In November, we announced the initiation of a Phase III study of ofatumumab plus
chemotherapy versus rituximab plus chemotherapy to treat patients with relapsed or
refractory DLBCL.
10/11 2009 20:55 1
21645 Jo måske skal man lige sige at der en information er at salget begynder midt november af arzerra refrac...
10/11 2009 21:05 Solsen 021646 Kunne ProInvestor ikke abonnere på "prescriptions" fra US.
Den information kan være guld værd
Den information kan være guld værd
10/11 2009 21:14 Solsen 021648 Har nogen en statistik fra de sidste 3-4 handelsdage så kan I analysere ENS´s smarte short med CSFB som hjælper....CH har du data ?
Fredag og mandag sælger de stort og imod luk i dag begynder de lukning (inden regnskabsoffentliggørelse) og tjener vel 1-2 mio DKK (mindst)
Fredag og mandag sælger de stort og imod luk i dag begynder de lukning (inden regnskabsoffentliggørelse) og tjener vel 1-2 mio DKK (mindst)
10/11 2009 22:00 tumult 021653 ENS køb salg
5/11 158.000 117.000
6/11 48.000 81.000
9/11 9.000 84.000
10/11 144.000 94.000
5/11 158.000 117.000
6/11 48.000 81.000
9/11 9.000 84.000
10/11 144.000 94.000
11/11 2009 10:06 JørgenVarnæs 021673 Hvis/når fabrikken bliver solgt, så må vi vel formode, at der kommer et solidt skud cash i kassen - mon ikke det er Lisa's plan for en skjult kapitalrejsning, nu de dkk 400 mio (eller hvor meget det nu var) for refrac NHL udeblev?
Og der er jo rigeligt cash i kassen til at udforske markedet for købere i et stykke tid.
Og der er jo rigeligt cash i kassen til at udforske markedet for købere i et stykke tid.
11/11 2009 10:54 tumult 021676 Telefonkonference
Genmab afholder en telefonkonference for at præsentere periodens resultat i morgen onsdag den
11. november 2009 klokken:
15.00 CEST
14.00 BST
9.00 EDT
Telefonkonferencen vil foregå på engelsk.
Ring venligst på følgende telefonnumre:
+1 877 941 2333 (i USA) og oplys følgende kode: 4181679
+1 480 629 9724 (uden for USA) og oplys følgende kode: 4181679
Det er muligt at høre en live webcast af telefonkonferencen på www.genmab.com og relevante
slides til telefonkonferencen vil være tilgængelige på Genmabs hjemmeside www.genmab.com.
Efterfølgende vil en kopi af webcasten endvidere kunne findes på Genmabs hjemmeside.
Genmab afholder en telefonkonference for at præsentere periodens resultat i morgen onsdag den
11. november 2009 klokken:
15.00 CEST
14.00 BST
9.00 EDT
Telefonkonferencen vil foregå på engelsk.
Ring venligst på følgende telefonnumre:
+1 877 941 2333 (i USA) og oplys følgende kode: 4181679
+1 480 629 9724 (uden for USA) og oplys følgende kode: 4181679
Det er muligt at høre en live webcast af telefonkonferencen på www.genmab.com og relevante
slides til telefonkonferencen vil være tilgængelige på Genmabs hjemmeside www.genmab.com.
Efterfølgende vil en kopi af webcasten endvidere kunne findes på Genmabs hjemmeside.
11/11 2009 17:53 121691 Mange forstår nok ikke præcis hvor langt genmab er i sin udvilking. Der er tale om det biotek selskab der i Danmark er længst fremme i sin udvikling mod markedet.
Fra chatten - skal læses nedefra
11/11 16:55
af akademikeren yes men selve historiefortællingen ændrer jo ikke noget ved den kliniske fremskredenthed?
11/11 16:54
af Hya men er en KRIG om at komme først til markedet - hvor alle svinske trix benyttes
11/11 16:54
af akademikeren hya nu har jeg uploadet i 21691
11/11 16:54
af Hya det handler slet ikke om GEN eller deres FA situation
11/11 16:53
af Hya forstå - skal du aka
11/11 16:53
af Hya ER de fnidder spil jeg tit har henvist til sker når stoffer er ved at ramme markedet og de slås om at komme først
11/11 16:52
af akademikeren ja men jeg lytter og jo jeg tror der manipuleres vildt med genmab...men hvad fanden skal jeg gøre
11/11 16:52
af Hya Genmab this summer reported positive results from a Phase III trial in RA, but said next steps were still under discussion with GSK.
11/11 16:52
af Hya for at gøre det mere troværdigt
11/11 16:52
af Hya og der henvises enda til en gammel artikel
11/11 16:52
af Hya trods VI VED at det er de
11/11 16:51
af Hya fordi man i artiklen lader det fremstå som om at gen ikke er gået i fase 3 endnu
11/11 16:51
af Hya at der manipuleres med info mellem de 3 konkurenter i det stof
11/11 16:51
af Hya MEN
11/11 16:51
af Hya jeg siger ikke at det du fortæller er forkert
11/11 16:50
af Hya og lyt
11/11 16:50
af Hya aka - rens lige hjernen
11/11 16:50
af akademikeren EGFR er sat til 0
11/11 16:50
af akademikeren hele pipelinen udenom er sat til 0
11/11 16:50
af akademikeren alt udover CLL er sat til 0 p.t.
11/11 16:49
af akademikeren hvis analytikerne skal regne RA med i ligningen så skal kursen i 900
11/11 16:49
af Hya Genmab this summer reported positive results from a Phase III trial in RA, but said next steps were still under discussion with GSK.
11/11 16:49
af akademikeren men der er i RA, hvor ingen regner rigtigt med Genmab så det er bare en af indikationerne
11/11 16:48
af akademikeren jeg loader det lige op til dig
11/11 16:48
af Hya ka du ik se det? konkurencen er skarp mellem de 3 - og alle rævestreger bruges!
11/11 16:47
af Hya så falder GEN igen - og dennegang på fejlinfo!
11/11 16:47
af Hya aka - men DET STÅR I DET LINK TIL ARTIKLEN DU SENDTE FØR - så der kommer en fejlinfo til markedet DER - hvis artiklen er NY
11/11 16:46
af akademikeren eller i regnskabet fra igår
11/11 16:45
af akademikeren hya du kan se deres pipeline på hjemmesiden
11/11 16:45
af Gobe Sidste chance for at skubbe til Topsil. Rapport i morgen
11/11 16:45
af akademikeren de er ikke på vej i fase 3....de er på vej ud af fase 3 og i et enkelt tilfælde altså godkendt
11/11 16:45
af Hya i artiklen står der da noget andet
11/11 16:44
af nohope Jeg købte 1.000 stk. ekstra i kurs 100 det giver sådan nogen nemme tal at regne med når man skal opgøre sine tab.
11/11 16:44
af akademikeren jeg tror den store misforståelse når man vurdere genmab er hvor langt de er nået....
11/11 16:44
af akademikeren nej gen er i fase 3
11/11 16:43
af Hya aka vil det sige at der er 3 firmaer der bejler til samme produkt? og at gen fortsat ikke er gået i fase 3 forde de diskuterer med gsk?
11/11 16:43
af akademikeren nope...jeg holder
11/11 16:43
af nohope Nå Aka, vakler du i troen ?
11/11 16:40
af akademikeren hvad gør de kloge analytikere efter i dag......det er det gode spørgsmål
11/11 16:39
af akademikeren http://www.therapeuticsdaily.com/news/article.cfm?contentValue=1944414&contentType=sentryarticle&channelID=29
11/11 16:37
af Stinker Aka, hvilket link taler du om?
username :
password :
Remember me
Newsletter Overviews | Newsletter Archive Wednesday, November 11, 2009
Cardiovascular | Oncology | Pain & Inflammation | Central Nervous System | Infectious Disease
Article Preview
Yeastward Ho! Alder's Antibody Method Nets Jumbo BMS Deal
BioWorld Today - Nov. 11, 2009
Alder Biopharmaceuticals Inc.'s yeast-based way of making a fast follower - or eventual follower - to the FDA-stalled rheumatoid arthritis candidate Actemra helped the firm pull down a whopper deal with Bristol-Myers Squibb Co., which is shelling out $85 million up front for what could become a rival to Roche's FDA-stalled therapy, already cleared in Europe.
"It depends on how long their delay is at the FDA, which we don't know at this point," said Randall C. Schatzman, president and CEO of Bothell, Wash.-based Alder. "But I suspect they will launch in 2010, and we'll be several years behind that."
ALD518 shows the potential for dosing three or four times per year rather than once monthly, like Actemra, and could be given at about one-tenth the dose. The latter's half-life is about six days, ALD518's about a month. "And this will be a much better molecule than Actemra," Schatzman pledged, and should beat the latter's safety as well as efficacy.
BMS, of New York, apparently believes it. The firm is buying exclusive rights to develop and commercialize the drug for everything except cancer, for which Alder keeps rights while giving BMS an option to co-develop and commercialize outside the U.S. Anemia and fatigue are cancer indications at which Alder is taking aim.
Up to $764 million in milestone payments based on progress across various indications come with the BMS collaboration, along with sales-based rewards that could pass $200 million. Royalties are part of the deal, and Alder has an option to require that BMS make an equity investment of up to $20 million if Alder goes public.
Alder's manufacturing approach means the firm can make drugs more quickly and cheaper with fewer immune reactions at less frequent dosing. Development happens faster, too: Generating a commercial antibody strain using mammalian cell cultures takes about a year, on average. Alder's yeast-based cultures take about five weeks.
"We're able to save six-month intervals in multiple places," noted John A. Latham, chief scientific officer. Interleukin-6-targeting ALD518 went from disease antigen to first dose in humans in 18 months. "We knew we needed a molecule that displayed much higher potency, and we wanted to get into the landscape much more quickly," he said.
BMS - nontypically among big pharmas, lately busying themselves with mergers and acquisitions to build their companies - has taken aim at specific compounds to beef up its pipeline. "They're going to take this as a franchise opportunity," said Mark J. Litton, Alder's chief business officer.
With IL-6, "the nice thing is the broad-based biology," Schatzman said, ideal for the plan. "Where the guys at BMS want to take this immediately is farther in RA," he added. After that, "the first on their list is probably Crohn's [disease]."
ALD518 has finished one Phase II RA trial and will enter another dose-finding study next year in "several hundred patients," Schatzman said. Results from the first experiment will be disclosed in the coming months at a scientific meeting or in a journal.
Roche Holding AG, of Basel, Switzerland, submitted its biologics license application for mammalian-made Actemra (tocilizumab) about two years ago, and said in December 2008 that the FDA wanted more animal data plus a risk evaluation and mitigation strategy.
An advisory panel in the summer of 2008 blessed Actemra with a 10-1 vote in favor of approval for RA, and European regulators let the drug onto the market as RoActemra in January. (See BioWorld Today, July 30, 2008.)
Already Actemra is fondly looked upon by rheumatologists, according to a recent Decision Resources poll. Ninety-eight percent of specialists surveyed said they would prescribe the drug, with 60 percent pointing to the drug's efficacy, proven comparable to anti-TNF blockbusters Enbrel (etanercept), from Thousand Oaks, Calif.-based Amgen, and Humira (adalimumab), from Abbott, of Abbott Park, Ill.
ALD518, if it works better and proves safer, "has the potential to take the market by storm," Schatzman said.
As for reimbursement, 75 percent of managed care organizations said they would likely cover Actemra, while 80 percent said they would cover anti-CD20 competitor Arzerra (ofatumumab) from Copenhagen, Denmark-based Genmab A/S, and 85 percent liked same-class ocrelizumab, from Biogen Idec Inc., of Cambridge, Mass.
Arzerra, not yet approved in RA, recently won the FDA's nod in chronic lymphocytic leukemia, and is made by Genmab partner GlaxoSmithKline plc, of London. Genmab this summer reported positive results from a Phase III trial in RA, but said next steps were still under discussion with GSK. (See BioWorld Today, July 31, 2009, and Oct. 28, 2009.)
Genmab's study with Arzerra in TNF-alpha refractory RA patients is not expected to yield data until next year, and analysts suspect the focus has shifted to development of a subcutaneous formulation, with a Phase I study due to complete by the end of this year. The idea is to differentiate the product from chimeric antibody Rituxan (rituximab) and its humanized successor ocrelizumab, in Phase III trials. Both are given intravenously.
With ALD518, Alder and partner BMS also are mulling a subcutaneous RA therapy that patients could self-administer once per month, Schatzman said.
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11/11 16:55
af akademikeren yes men selve historiefortællingen ændrer jo ikke noget ved den kliniske fremskredenthed?
11/11 16:54
af Hya men er en KRIG om at komme først til markedet - hvor alle svinske trix benyttes
11/11 16:54
af akademikeren hya nu har jeg uploadet i 21691
11/11 16:54
af Hya det handler slet ikke om GEN eller deres FA situation
11/11 16:53
af Hya forstå - skal du aka
11/11 16:53
af Hya ER de fnidder spil jeg tit har henvist til sker når stoffer er ved at ramme markedet og de slås om at komme først
11/11 16:52
af akademikeren ja men jeg lytter og jo jeg tror der manipuleres vildt med genmab...men hvad fanden skal jeg gøre
11/11 16:52
af Hya Genmab this summer reported positive results from a Phase III trial in RA, but said next steps were still under discussion with GSK.
11/11 16:52
af Hya for at gøre det mere troværdigt
11/11 16:52
af Hya og der henvises enda til en gammel artikel
11/11 16:52
af Hya trods VI VED at det er de
11/11 16:51
af Hya fordi man i artiklen lader det fremstå som om at gen ikke er gået i fase 3 endnu
11/11 16:51
af Hya at der manipuleres med info mellem de 3 konkurenter i det stof
11/11 16:51
af Hya MEN
11/11 16:51
af Hya jeg siger ikke at det du fortæller er forkert
11/11 16:50
af Hya og lyt
11/11 16:50
af Hya aka - rens lige hjernen
11/11 16:50
af akademikeren EGFR er sat til 0
11/11 16:50
af akademikeren hele pipelinen udenom er sat til 0
11/11 16:50
af akademikeren alt udover CLL er sat til 0 p.t.
11/11 16:49
af akademikeren hvis analytikerne skal regne RA med i ligningen så skal kursen i 900
11/11 16:49
af Hya Genmab this summer reported positive results from a Phase III trial in RA, but said next steps were still under discussion with GSK.
11/11 16:49
af akademikeren men der er i RA, hvor ingen regner rigtigt med Genmab så det er bare en af indikationerne
11/11 16:48
af akademikeren jeg loader det lige op til dig
11/11 16:48
af Hya ka du ik se det? konkurencen er skarp mellem de 3 - og alle rævestreger bruges!
11/11 16:47
af Hya så falder GEN igen - og dennegang på fejlinfo!
11/11 16:47
af Hya aka - men DET STÅR I DET LINK TIL ARTIKLEN DU SENDTE FØR - så der kommer en fejlinfo til markedet DER - hvis artiklen er NY
11/11 16:46
af akademikeren eller i regnskabet fra igår
11/11 16:45
af akademikeren hya du kan se deres pipeline på hjemmesiden
11/11 16:45
af Gobe Sidste chance for at skubbe til Topsil. Rapport i morgen
11/11 16:45
af akademikeren de er ikke på vej i fase 3....de er på vej ud af fase 3 og i et enkelt tilfælde altså godkendt
11/11 16:45
af Hya i artiklen står der da noget andet
11/11 16:44
af nohope Jeg købte 1.000 stk. ekstra i kurs 100 det giver sådan nogen nemme tal at regne med når man skal opgøre sine tab.
11/11 16:44
af akademikeren jeg tror den store misforståelse når man vurdere genmab er hvor langt de er nået....
11/11 16:44
af akademikeren nej gen er i fase 3
11/11 16:43
af Hya aka vil det sige at der er 3 firmaer der bejler til samme produkt? og at gen fortsat ikke er gået i fase 3 forde de diskuterer med gsk?
11/11 16:43
af akademikeren nope...jeg holder
11/11 16:43
af nohope Nå Aka, vakler du i troen ?
11/11 16:40
af akademikeren hvad gør de kloge analytikere efter i dag......det er det gode spørgsmål
11/11 16:39
af akademikeren http://www.therapeuticsdaily.com/news/article.cfm?contentValue=1944414&contentType=sentryarticle&channelID=29
11/11 16:37
af Stinker Aka, hvilket link taler du om?
username :
password :
Remember me
Newsletter Overviews | Newsletter Archive Wednesday, November 11, 2009
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Yeastward Ho! Alder's Antibody Method Nets Jumbo BMS Deal
BioWorld Today - Nov. 11, 2009
Alder Biopharmaceuticals Inc.'s yeast-based way of making a fast follower - or eventual follower - to the FDA-stalled rheumatoid arthritis candidate Actemra helped the firm pull down a whopper deal with Bristol-Myers Squibb Co., which is shelling out $85 million up front for what could become a rival to Roche's FDA-stalled therapy, already cleared in Europe.
"It depends on how long their delay is at the FDA, which we don't know at this point," said Randall C. Schatzman, president and CEO of Bothell, Wash.-based Alder. "But I suspect they will launch in 2010, and we'll be several years behind that."
ALD518 shows the potential for dosing three or four times per year rather than once monthly, like Actemra, and could be given at about one-tenth the dose. The latter's half-life is about six days, ALD518's about a month. "And this will be a much better molecule than Actemra," Schatzman pledged, and should beat the latter's safety as well as efficacy.
BMS, of New York, apparently believes it. The firm is buying exclusive rights to develop and commercialize the drug for everything except cancer, for which Alder keeps rights while giving BMS an option to co-develop and commercialize outside the U.S. Anemia and fatigue are cancer indications at which Alder is taking aim.
Up to $764 million in milestone payments based on progress across various indications come with the BMS collaboration, along with sales-based rewards that could pass $200 million. Royalties are part of the deal, and Alder has an option to require that BMS make an equity investment of up to $20 million if Alder goes public.
Alder's manufacturing approach means the firm can make drugs more quickly and cheaper with fewer immune reactions at less frequent dosing. Development happens faster, too: Generating a commercial antibody strain using mammalian cell cultures takes about a year, on average. Alder's yeast-based cultures take about five weeks.
"We're able to save six-month intervals in multiple places," noted John A. Latham, chief scientific officer. Interleukin-6-targeting ALD518 went from disease antigen to first dose in humans in 18 months. "We knew we needed a molecule that displayed much higher potency, and we wanted to get into the landscape much more quickly," he said.
BMS - nontypically among big pharmas, lately busying themselves with mergers and acquisitions to build their companies - has taken aim at specific compounds to beef up its pipeline. "They're going to take this as a franchise opportunity," said Mark J. Litton, Alder's chief business officer.
With IL-6, "the nice thing is the broad-based biology," Schatzman said, ideal for the plan. "Where the guys at BMS want to take this immediately is farther in RA," he added. After that, "the first on their list is probably Crohn's [disease]."
ALD518 has finished one Phase II RA trial and will enter another dose-finding study next year in "several hundred patients," Schatzman said. Results from the first experiment will be disclosed in the coming months at a scientific meeting or in a journal.
Roche Holding AG, of Basel, Switzerland, submitted its biologics license application for mammalian-made Actemra (tocilizumab) about two years ago, and said in December 2008 that the FDA wanted more animal data plus a risk evaluation and mitigation strategy.
An advisory panel in the summer of 2008 blessed Actemra with a 10-1 vote in favor of approval for RA, and European regulators let the drug onto the market as RoActemra in January. (See BioWorld Today, July 30, 2008.)
Already Actemra is fondly looked upon by rheumatologists, according to a recent Decision Resources poll. Ninety-eight percent of specialists surveyed said they would prescribe the drug, with 60 percent pointing to the drug's efficacy, proven comparable to anti-TNF blockbusters Enbrel (etanercept), from Thousand Oaks, Calif.-based Amgen, and Humira (adalimumab), from Abbott, of Abbott Park, Ill.
ALD518, if it works better and proves safer, "has the potential to take the market by storm," Schatzman said.
As for reimbursement, 75 percent of managed care organizations said they would likely cover Actemra, while 80 percent said they would cover anti-CD20 competitor Arzerra (ofatumumab) from Copenhagen, Denmark-based Genmab A/S, and 85 percent liked same-class ocrelizumab, from Biogen Idec Inc., of Cambridge, Mass.
Arzerra, not yet approved in RA, recently won the FDA's nod in chronic lymphocytic leukemia, and is made by Genmab partner GlaxoSmithKline plc, of London. Genmab this summer reported positive results from a Phase III trial in RA, but said next steps were still under discussion with GSK. (See BioWorld Today, July 31, 2009, and Oct. 28, 2009.)
Genmab's study with Arzerra in TNF-alpha refractory RA patients is not expected to yield data until next year, and analysts suspect the focus has shifted to development of a subcutaneous formulation, with a Phase I study due to complete by the end of this year. The idea is to differentiate the product from chimeric antibody Rituxan (rituximab) and its humanized successor ocrelizumab, in Phase III trials. Both are given intravenously.
With ALD518, Alder and partner BMS also are mulling a subcutaneous RA therapy that patients could self-administer once per month, Schatzman said.
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