ALIM-Alimera Sciences, Inc. / PSDV-Psivida Corp. FDA 11 Novembre 2011

s&d · 24-10-11, 21:32

ALIM sta conducendo i test per l'approvazione mentre PSDV detiene i diritti sul principio attivo.

Rapporto tra le due società tratto dall'ultimo 10-K di PSDV:

Under our original collaboration agreement entered into in February 2005, we and Alimera agreed to collaborate on the development of ILUVIEN for DME and share the development expenses equally. In connection with the March 2008 Restated Alimera Agreement, we received consideration of $12.0 million in cash, and Alimera cancelled $5.7 million of accrued development cost liabilities, including related penalties and accrued interest, we owed Alimera as of March 14, 2008. In addition, Alimera gave us an interest-bearing $15.0 million conditional note, agreed to pay us a $25.0 million milestone payment upon FDA approval of ILUVIEN for DME and assumed all financial responsibility for the development of licensed products under the Restated Alimera Agreement (including reimbursement of approved development costs incurred by us in support of the ongoing clinical studies of ILUVIEN) and anticipated regulatory submissions. In exchange, we decreased our share in any future profits, as defined, on sales of ILUVIEN by Alimera from 50% to 20%, subject to an offset of 20% of pre-profitability commercialization costs, as defined, incurred by Alimera. In the event Alimera sublicenses commercialization, we are entitled to receive 20% of royalties and 33% of non-royalty consideration received by Alimera, less certain permitted deductions. Alimera has indicated that it intends to commercialize ILUVIEN, if approved, through a direct sales force in the United States and to seek marketing collaboration partners for the commercialization of ILUVIEN outside of the United States.

Farmaco in attesa di approvazione:
About ILUVIEN®

ILUVIEN is an investigative, extended release intravitreal insert that Alimera is developing for the treatment of DME. Each ILUVIEN insert is designed to provide a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of FA. ILUVIEN is inserted in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The insertion device employs a 25-gauge needle, which allows for a self-sealing wound.

Disturbo per il quale è stato sviluppato

About DME

DME, the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina responsible for central vision. When the blood vessel leakage of diabetic retinopathy causes swelling in the macula, the condition is called DME. The onset of DME is painless and may go undetected by the patient until it manifests with the blurring of central vision or acute vision loss. The severity of this blurring may range from mild to profound loss of vision. The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that over a 10-year period approximately 19 percent of people with diabetes studied were diagnosed with DME. As the population of people with diabetes increases, Alimera expects the annual incidence of diagnosed DME to increase, as well.

Mercato potenziale

The macular edema therapeutics market is forecast to show significant growth until 2018, according to a new report from GlobalData, which valued the global sector at $1.29 billion in 2010 and expects this to grow at a compound annual growth rate (CAGR) of 8.9%, and reach $2.57 billion by 2018.

In attesa di approvazione da parte della FDA il prossimo 11 Novembre 2011 in seguito a:
Alimera Sciences, Inc. (Nasdaq:ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced the resubmission on May 12, 2011 of its New Drug Application for the investigational drug ILUVIEN® to the U.S. Food and Drug Administration (FDA). The resubmission addresses questions raised in the Complete Response Letter (CRL) received in December 2010.

According to the FDA's classification, this will be a Class 2 resubmission. Under the Prescription Drug User Fee Act (PDUFA), FDA review of a Class 2 resubmission is expected to be completed within a six-month period beginning on the date that the resubmission is received.

This resubmission addresses the FDA's request for analyses of the safety and efficacy data through month 36 of Alimera's FAME Study, and includes the data from the subgroup population that was presented last week at the 2011 Association for Research in Vision and Ophthalmology Annual Meeting. In addition, the resubmission includes further information regarding controls and specifications about the manufacturing, packaging and sterilization of ILUVIEN, which was requested by the FDA.

"We believe that the resubmission package sent to the FDA will demonstrate the safety and efficacy of ILUVIEN and address the FDA's additional issues," said Dan Myers, Alimera's president and CEO. "We look forward to working with the FDA for a prompt review and response."

In the CRL, the FDA also indicated that it had observed deficiencies in current good manufacturing practices (cGMP) during its facility inspections of two of Alimera's third-party manufacturers. Alimera believes the deficiencies have been resolved and no further action is required because the FDA has issued letters to both of these third-party manufacturers indicating that the inspections are now closed

La principale delle obiezioni sollevate dalla FDA sembra essere stata superata:

pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, including the investigational drug ILUVIEN® for the treatment of Diabetic Macular Edema (DME), today announced month 36, top-line readout results for the FAME™ Study prepared by its licensee, Alimera Sciences, Inc. (Alimera).

Alimera previously presented the month 24, top-line results from the now completed FAME Study. The FAME Study consisted of two 3-year, Phase 3 pivotal clinical trials (Trial A and Trial B) to assess the safety and efficacy of ILUVIEN in the treatment of DME. Patients in the trials were randomized to receive either high dose ILUVIEN, low dose ILUVIEN or control treatment. The primary endpoint for efficacy in the trials was the difference in the percentage of patients whose best corrected visual acuity (BCVA) improved by 15 or more letters from baseline on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart at month 24 between the treatment and control groups. Alimera presented data for both the low and high dose patient results at 24 months. Based on these data, Alimera submitted a New Drug Application (NDA) on June 29, 2010 for approval of only the low dose. Therefore, only the low dose data from the 36 month readout is being released by Alimera and is discussed in this release.

Alimera reported that data through month 36 for the Full Analysis Set in Trial A demonstrated statistically significant therapeutic effects of 28.9% at month 30 (p= 0.011) and 28.4% at month 33 (p= 0.042) of ILUVIEN patients gaining 15 or more letters compared to the control group, in which fewer than 17% of patients gained 15 or more letters. The therapeutic effect was maintained at month 36 (with 28.4% of patients gaining 15 or more letters); however, as 18.9% of the control group gained 15 or more letters, the p value increased to p=0.106.

Results from Trial B reported by Alimera were similar. Statistically significant therapeutic effects of 33.9% at month 30 (p=0.002) and 29.6% at month 33 (p=0.046) of ILUVIEN patients gaining 15 or more letters over baseline were reported compared to the control group, which had fewer than 18% of patients making such gains. At month 36, 29.0% of ILUVIEN patients gained 15 or more letters compared with 18.9% of control patients (p=0.086).

By comparison, in the month 24 data earlier reported by Alimera, 26.8% of ILUVIEN patients and 14.7% of control patients had gained 15 or more letters (p=0.029) at month 24 in Trial A. In Trial B at month 24, 30.6% of ILUVIEN patients and 17.8% of control patients (p=0.030) had gained 15 letters or greater over baseline.

As reported by Alimera, Trial A and B data combined demonstrated a statistically significant effect at week three, and this effect was maintained throughout the 36 months. On a combined basis, 28.7% of ILUVIEN patients and 16.2% of control patients (p = 0.002) had an improvement in BCVA of 15 letters or greater over baseline at month 24, 31.4% versus 15.1% at month 30 (p=<0.001), 29.0% versus 17.3% at month 33 (p=0.004) and 28.7% versus 18.9% at month 36 (p=0.018).

“We believe this data is very promising, and look forward to the response from the FDA. If approved, pSivida will be entitled to a $25.0 million milestone payment from Alimera and 20% of profits (as defined) on sales of ILUVIEN by Alimera,” said Paul Ashton, president and CEO of pSivida.

The Full Analysis Set includes 376 patients in the ILUVIEN arm and 185 patients in the control arm with data imputation employed using last observation carried forward (LOCF) only for missing data. Data for the Full Analysis Set includes 190 patients in Trial A and 186 patients in Trial B randomized to the ILUVIEN arm.

Alimera reported safety data for all patients treated with ILUVIEN low dose and control group in the study. Increases in intraocular pressure (IOP) to 30 millimeters of mercury (mmHg) or greater at any time point were reported in 18.4% of the patients by month 36 compared to 16.3% by the month 24 readout. By month 36, 4.8% of patients had undergone an incisional surgical procedure to reduce elevated pressure versus 3.7% of patients by month 24. The incidence of cataract among patients with a natural lens in their eye at the start of the trial was 81.7% at month 36, with 80% undergoing a cataract operation, compared to 80% and 74.9%, respectively, by the time of the month 24 readout.

Alimera reported that the statistical significance observed in both trials at month 33 met the criteria for replication of two studies and that Alimera will provide the 36 month safety and efficacy data to the FDA in connection with the pending NDA for ILUVIEN.

Webcast slides prepared by Alimera containing more detailed information with respect to the 36 month data are being filed by pSivida with the Securities & Exchange Commission on Form 8-K. The information in this press release is qualified in its entirety by the more detailed information contained in those slides.

Additional data and analysis of the FAME Study will be presented by Peter Campochiaro, M.D., on February 12, 2011, at 1:40 p.m. at the Angiogenesis, Exudation and Degeneration 2011 Meeting in the Mandarin Oriental Hotel, Miami, FL. Dr. Campochiaro is a professor in the Department of Ophthalmology at The Wilmer Eye Institute, Retina Division at Johns Hopkins.

About the FAME Study

Alimera conducted two 36-month, Phase 3 pivotal clinical trials (collectively known as the FAME Study) for ILUVIEN involving 956 patients in sites across the United States, Canada, Europe and India to assess the efficacy and safety of ILUVIEN with two doses of the corticosteroid fluocinolone acetonide (FA), a high and low dose, for the treatment of DME. The primary efficacy endpoint for the FAME Study was the difference in the percentage of patients whose best corrected visual acuity improved by 15 or more letters from baseline on the ETDRS eye chart at month 24 between the treatment and control groups. The study concluded in October 2010 with the final patient visit at the three-year data point. Alimera prepared the analyses of the data from the FAME Study.

Following its NDA submission to the FDA, Alimera submitted a Marketing Authorization Application to the Medicines and Healthcare products Regulatory Agency in the United Kingdom. Applications have also been submitted to regulatory agencies in Austria, France, Germany, Italy, Portugal and Spain. Based upon the analysis of the FAME Study, all filings included the 24-month data. The FDA, in a December 2010 Complete Response Letter, requested further information, including the month 36 data from the FAME Study.

Io non azzardo nè previsioni nè pronostici però i presupposti non sembrano malvagi

topolino99 · 24-10-11, 22:13

provo a dare uno sguardo!

s&d · 24-10-11, 22:31

Articolo intero sul mercato di riferimento del farmaco in questione:
This growth is primarily attributed to the increase in the prevalence and incidence rates of diabetes across the seven major markets such as the USA, the UK, Japan, Germany, Spain, Italy and France.

Macular edema is a slowly progressing disease, and diabetes is cited as the main cause of the condition. The growth in the market will be supported and driven by the increased use of off-label drugs such as Roche’s Avastin (bevacizumab), the introduction of new drugs and the two newly approved drugs Ozurdex (dexamethasone) from Allergan and Lucentis (ranibizumab) from Roche and Novartis - for the treatment of macular edema following retinal vein occlusion (RVO).

Current treatment options moderately successful in meeting market demand

GlobalData has found that the current competition in the macular edema therapeutics market is intense, due to the increased use of off-label products by the physicians. This is due to lack of approved drugs in the market, which forces physicians to use off-label drugs to treat patients.

Currently, there are only two approved products available in the market - Lucentis and Ozurdex - for the treatment of macular edema following RVO are available in the market. The competition in the market is expected to increase as the newly approved products compete with the off-label products and capture market share. This is likely to drive the growth in the market in the next few years.

Strong pipeline candidates expected to intensify future competition

There are 30 products in different stages of development, according to GlobalData. The late stage pipeline of macular edema seems very promising. There are approximately 13 first-in-class molecules in different stages of development. Iluvien (fluocinolone acetonide intravitreal insert) is currently in the New Drug Application filing stage by Alimera Sciences, while VEGF Trap-Eye, Lucentis and Ozurdex are currently in Phase III for the treatment of DME. As there is no approved drug for the treatment of diabetic macular edema (DME), these products are expected to fulfill the unmet needs and will provide physicians with a better choice in treating diabetic as well as non-diabetic macular edema.

GlobalData also found that the available treatment options are moderately successful in meeting the market demand. There is a high unmet need in the macular edema market. The high unmet need shows that the market is underserved by the currently available products. There are only two approved products in the market for macular edema following RVO - Ozurdex and Lucentis.

Since companies investing in such diseases face a higher risk of being denied an approval, not many products have entered the market over the last decade. This explains the lack of safe and efficacious drugs in the market. Newer molecules in the late stage pipeline are few in number but novel drug delivery systems to deliver drugs at a constant rate to the back-of-the-eye (BOTE) (retinal) diseases are emerging in the market, which is likely to increase patient compliance. This is likely to marginally fulfill the unmet need through the forecast period 2018.

Fonte: Macular edema therapeutics market set to reach $2.57 billion by 2018 - Pharmaceutical and Biotechnology News - Pharma Letter

skicross · 11-11-11, 19:04

-75%

skicross · 11-11-11, 19:19

Alimera Sciences Receives Complete Response Letter From FDA for ILUVIEN(R) - Yahoo! Finance

skicross · 11-11-11, 19:19

Dentro 2k a 1,9!

Mi sembra esagerato!!!!

aioico · 11-11-11, 19:25

cosa ti sembra esagerato??

skicross · 21-11-11, 17:42

Ero poi uscito a 2,15....

Ora mi sembra il momento di rientrare,voi che dite?

1,15 adesso,capitalizza 36mio ed ha una cassa di 38mio,voi che dite?

skicross · 22-11-11, 18:09

1,28 ora capitalizza poco piu' della cassa!40mio

Se solo uscisse una news questa esplode!

Sempre in a 1,15....

Roman66 · 29-11-11, 17:37

Sembra che stia ripartendo anche senza news

24-10-11, 21:32	#1 (permalink)
s&d Member Data registrazione: Jan 2009 Messaggi: 1,198 Popolarità: 40500758	ALIM-Alimera Sciences, Inc. / PSDV-Psivida Corp. FDA 11 Novembre 2011 ALIM sta conducendo i test per l'approvazione mentre PSDV detiene i diritti sul principio attivo. Rapporto tra le due società tratto dall'ultimo 10-K di PSDV: Under our original collaboration agreement entered into in February 2005, we and Alimera agreed to collaborate on the development of ILUVIEN for DME and share the development expenses equally. In connection with the March 2008 Restated Alimera Agreement, we received consideration of $12.0 million in cash, and Alimera cancelled $5.7 million of accrued development cost liabilities, including related penalties and accrued interest, we owed Alimera as of March 14, 2008. In addition, Alimera gave us an interest-bearing $15.0 million conditional note, agreed to pay us a $25.0 million milestone payment upon FDA approval of ILUVIEN for DME and assumed all financial responsibility for the development of licensed products under the Restated Alimera Agreement (including reimbursement of approved development costs incurred by us in support of the ongoing clinical studies of ILUVIEN) and anticipated regulatory submissions. In exchange, we decreased our share in any future profits, as defined, on sales of ILUVIEN by Alimera from 50% to 20%, subject to an offset of 20% of pre-profitability commercialization costs, as defined, incurred by Alimera. In the event Alimera sublicenses commercialization, we are entitled to receive 20% of royalties and 33% of non-royalty consideration received by Alimera, less certain permitted deductions. Alimera has indicated that it intends to commercialize ILUVIEN, if approved, through a direct sales force in the United States and to seek marketing collaboration partners for the commercialization of ILUVIEN outside of the United States. Farmaco in attesa di approvazione: About ILUVIEN® ILUVIEN is an investigative, extended release intravitreal insert that Alimera is developing for the treatment of DME. Each ILUVIEN insert is designed to provide a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of FA. ILUVIEN is inserted in the back of the patient's eye to a position that takes advantage of the eye's natural fluid dynamics. The insertion device employs a 25-gauge needle, which allows for a self-sealing wound. Disturbo per il quale è stato sviluppato About DME DME, the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina responsible for central vision. When the blood vessel leakage of diabetic retinopathy causes swelling in the macula, the condition is called DME. The onset of DME is painless and may go undetected by the patient until it manifests with the blurring of central vision or acute vision loss. The severity of this blurring may range from mild to profound loss of vision. The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that over a 10-year period approximately 19 percent of people with diabetes studied were diagnosed with DME. As the population of people with diabetes increases, Alimera expects the annual incidence of diagnosed DME to increase, as well. Mercato potenziale The macular edema therapeutics market is forecast to show significant growth until 2018, according to a new report from GlobalData, which valued the global sector at $1.29 billion in 2010 and expects this to grow at a compound annual growth rate (CAGR) of 8.9%, and reach $2.57 billion by 2018. In attesa di approvazione da parte della FDA il prossimo 11 Novembre 2011 in seguito a: Alimera Sciences, Inc. (Nasdaq:ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced the resubmission on May 12, 2011 of its New Drug Application for the investigational drug ILUVIEN® to the U.S. Food and Drug Administration (FDA). The resubmission addresses questions raised in the Complete Response Letter (CRL) received in December 2010. According to the FDA's classification, this will be a Class 2 resubmission. Under the Prescription Drug User Fee Act (PDUFA), FDA review of a Class 2 resubmission is expected to be completed within a six-month period beginning on the date that the resubmission is received. This resubmission addresses the FDA's request for analyses of the safety and efficacy data through month 36 of Alimera's FAME Study, and includes the data from the subgroup population that was presented last week at the 2011 Association for Research in Vision and Ophthalmology Annual Meeting. In addition, the resubmission includes further information regarding controls and specifications about the manufacturing, packaging and sterilization of ILUVIEN, which was requested by the FDA. "We believe that the resubmission package sent to the FDA will demonstrate the safety and efficacy of ILUVIEN and address the FDA's additional issues," said Dan Myers, Alimera's president and CEO. "We look forward to working with the FDA for a prompt review and response." In the CRL, the FDA also indicated that it had observed deficiencies in current good manufacturing practices (cGMP) during its facility inspections of two of Alimera's third-party manufacturers. Alimera believes the deficiencies have been resolved and no further action is required because the FDA has issued letters to both of these third-party manufacturers indicating that the inspections are now closed La principale delle obiezioni sollevate dalla FDA sembra essere stata superata: pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, including the investigational drug ILUVIEN® for the treatment of Diabetic Macular Edema (DME), today announced month 36, top-line readout results for the FAME™ Study prepared by its licensee, Alimera Sciences, Inc. (Alimera). Alimera previously presented the month 24, top-line results from the now completed FAME Study. The FAME Study consisted of two 3-year, Phase 3 pivotal clinical trials (Trial A and Trial B) to assess the safety and efficacy of ILUVIEN in the treatment of DME. Patients in the trials were randomized to receive either high dose ILUVIEN, low dose ILUVIEN or control treatment. The primary endpoint for efficacy in the trials was the difference in the percentage of patients whose best corrected visual acuity (BCVA) improved by 15 or more letters from baseline on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart at month 24 between the treatment and control groups. Alimera presented data for both the low and high dose patient results at 24 months. Based on these data, Alimera submitted a New Drug Application (NDA) on June 29, 2010 for approval of only the low dose. Therefore, only the low dose data from the 36 month readout is being released by Alimera and is discussed in this release. Alimera reported that data through month 36 for the Full Analysis Set in Trial A demonstrated statistically significant therapeutic effects of 28.9% at month 30 (p= 0.011) and 28.4% at month 33 (p= 0.042) of ILUVIEN patients gaining 15 or more letters compared to the control group, in which fewer than 17% of patients gained 15 or more letters. The therapeutic effect was maintained at month 36 (with 28.4% of patients gaining 15 or more letters); however, as 18.9% of the control group gained 15 or more letters, the p value increased to p=0.106. Results from Trial B reported by Alimera were similar. Statistically significant therapeutic effects of 33.9% at month 30 (p=0.002) and 29.6% at month 33 (p=0.046) of ILUVIEN patients gaining 15 or more letters over baseline were reported compared to the control group, which had fewer than 18% of patients making such gains. At month 36, 29.0% of ILUVIEN patients gained 15 or more letters compared with 18.9% of control patients (p=0.086). By comparison, in the month 24 data earlier reported by Alimera, 26.8% of ILUVIEN patients and 14.7% of control patients had gained 15 or more letters (p=0.029) at month 24 in Trial A. In Trial B at month 24, 30.6% of ILUVIEN patients and 17.8% of control patients (p=0.030) had gained 15 letters or greater over baseline. As reported by Alimera, Trial A and B data combined demonstrated a statistically significant effect at week three, and this effect was maintained throughout the 36 months. On a combined basis, 28.7% of ILUVIEN patients and 16.2% of control patients (p = 0.002) had an improvement in BCVA of 15 letters or greater over baseline at month 24, 31.4% versus 15.1% at month 30 (p=<0.001), 29.0% versus 17.3% at month 33 (p=0.004) and 28.7% versus 18.9% at month 36 (p=0.018). “We believe this data is very promising, and look forward to the response from the FDA. If approved, pSivida will be entitled to a $25.0 million milestone payment from Alimera and 20% of profits (as defined) on sales of ILUVIEN by Alimera,” said Paul Ashton, president and CEO of pSivida. The Full Analysis Set includes 376 patients in the ILUVIEN arm and 185 patients in the control arm with data imputation employed using last observation carried forward (LOCF) only for missing data. Data for the Full Analysis Set includes 190 patients in Trial A and 186 patients in Trial B randomized to the ILUVIEN arm. Alimera reported safety data for all patients treated with ILUVIEN low dose and control group in the study. Increases in intraocular pressure (IOP) to 30 millimeters of mercury (mmHg) or greater at any time point were reported in 18.4% of the patients by month 36 compared to 16.3% by the month 24 readout. By month 36, 4.8% of patients had undergone an incisional surgical procedure to reduce elevated pressure versus 3.7% of patients by month 24. The incidence of cataract among patients with a natural lens in their eye at the start of the trial was 81.7% at month 36, with 80% undergoing a cataract operation, compared to 80% and 74.9%, respectively, by the time of the month 24 readout. Alimera reported that the statistical significance observed in both trials at month 33 met the criteria for replication of two studies and that Alimera will provide the 36 month safety and efficacy data to the FDA in connection with the pending NDA for ILUVIEN. Webcast slides prepared by Alimera containing more detailed information with respect to the 36 month data are being filed by pSivida with the Securities & Exchange Commission on Form 8-K. The information in this press release is qualified in its entirety by the more detailed information contained in those slides. Additional data and analysis of the FAME Study will be presented by Peter Campochiaro, M.D., on February 12, 2011, at 1:40 p.m. at the Angiogenesis, Exudation and Degeneration 2011 Meeting in the Mandarin Oriental Hotel, Miami, FL. Dr. Campochiaro is a professor in the Department of Ophthalmology at The Wilmer Eye Institute, Retina Division at Johns Hopkins. About the FAME Study Alimera conducted two 36-month, Phase 3 pivotal clinical trials (collectively known as the FAME Study) for ILUVIEN involving 956 patients in sites across the United States, Canada, Europe and India to assess the efficacy and safety of ILUVIEN with two doses of the corticosteroid fluocinolone acetonide (FA), a high and low dose, for the treatment of DME. The primary efficacy endpoint for the FAME Study was the difference in the percentage of patients whose best corrected visual acuity improved by 15 or more letters from baseline on the ETDRS eye chart at month 24 between the treatment and control groups. The study concluded in October 2010 with the final patient visit at the three-year data point. Alimera prepared the analyses of the data from the FAME Study. Following its NDA submission to the FDA, Alimera submitted a Marketing Authorization Application to the Medicines and Healthcare products Regulatory Agency in the United Kingdom. Applications have also been submitted to regulatory agencies in Austria, France, Germany, Italy, Portugal and Spain. Based upon the analysis of the FAME Study, all filings included the 24-month data. The FDA, in a December 2010 Complete Response Letter, requested further information, including the month 36 data from the FAME Study. Io non azzardo nè previsioni nè pronostici però i presupposti non sembrano malvagi

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24-10-11, 22:13	#2 (permalink)
topolino99 Member Data registrazione: Nov 2010 Messaggi: 1,902 Popolarità: 24947183	provo a dare uno sguardo!

24-10-11, 22:31	#3 (permalink)
s&d Member Data registrazione: Jan 2009 Messaggi: 1,198 Popolarità: 40500758	Articolo intero sul mercato di riferimento del farmaco in questione: This growth is primarily attributed to the increase in the prevalence and incidence rates of diabetes across the seven major markets such as the USA, the UK, Japan, Germany, Spain, Italy and France. Macular edema is a slowly progressing disease, and diabetes is cited as the main cause of the condition. The growth in the market will be supported and driven by the increased use of off-label drugs such as Roche’s Avastin (bevacizumab), the introduction of new drugs and the two newly approved drugs Ozurdex (dexamethasone) from Allergan and Lucentis (ranibizumab) from Roche and Novartis - for the treatment of macular edema following retinal vein occlusion (RVO). Current treatment options moderately successful in meeting market demand GlobalData has found that the current competition in the macular edema therapeutics market is intense, due to the increased use of off-label products by the physicians. This is due to lack of approved drugs in the market, which forces physicians to use off-label drugs to treat patients. Currently, there are only two approved products available in the market - Lucentis and Ozurdex - for the treatment of macular edema following RVO are available in the market. The competition in the market is expected to increase as the newly approved products compete with the off-label products and capture market share. This is likely to drive the growth in the market in the next few years. Strong pipeline candidates expected to intensify future competition There are 30 products in different stages of development, according to GlobalData. The late stage pipeline of macular edema seems very promising. There are approximately 13 first-in-class molecules in different stages of development. Iluvien (fluocinolone acetonide intravitreal insert) is currently in the New Drug Application filing stage by Alimera Sciences, while VEGF Trap-Eye, Lucentis and Ozurdex are currently in Phase III for the treatment of DME. As there is no approved drug for the treatment of diabetic macular edema (DME), these products are expected to fulfill the unmet needs and will provide physicians with a better choice in treating diabetic as well as non-diabetic macular edema. GlobalData also found that the available treatment options are moderately successful in meeting the market demand. There is a high unmet need in the macular edema market. The high unmet need shows that the market is underserved by the currently available products. There are only two approved products in the market for macular edema following RVO - Ozurdex and Lucentis. Since companies investing in such diseases face a higher risk of being denied an approval, not many products have entered the market over the last decade. This explains the lack of safe and efficacious drugs in the market. Newer molecules in the late stage pipeline are few in number but novel drug delivery systems to deliver drugs at a constant rate to the back-of-the-eye (BOTE) (retinal) diseases are emerging in the market, which is likely to increase patient compliance. This is likely to marginally fulfill the unmet need through the forecast period 2018. Fonte: Macular edema therapeutics market set to reach $2.57 billion by 2018 - Pharmaceutical and Biotechnology News - Pharma Letter

11-11-11, 19:04	#4 (permalink)
skicross Member Data registrazione: Aug 2003 Messaggi: 7,016 Popolarità: 42949681	-75%

11-11-11, 19:19	#5 (permalink)
skicross Member Data registrazione: Aug 2003 Messaggi: 7,016 Popolarità: 42949681	Alimera Sciences Receives Complete Response Letter From FDA for ILUVIEN(R) - Yahoo! Finance

11-11-11, 19:19	#6 (permalink)
skicross Member Data registrazione: Aug 2003 Messaggi: 7,016 Popolarità: 42949681	Dentro 2k a 1,9! Mi sembra esagerato!!!!

11-11-11, 19:25	#7 (permalink)
aioico Member Data registrazione: Nov 2011 Messaggi: 39 Popolarità: 858994	cosa ti sembra esagerato??

21-11-11, 17:42	#8 (permalink)
skicross Member Data registrazione: Aug 2003 Messaggi: 7,016 Popolarità: 42949681	Ero poi uscito a 2,15.... Ora mi sembra il momento di rientrare,voi che dite? 1,15 adesso,capitalizza 36mio ed ha una cassa di 38mio,voi che dite?

22-11-11, 18:09	#9 (permalink)
skicross Member Data registrazione: Aug 2003 Messaggi: 7,016 Popolarità: 42949681	1,28 ora capitalizza poco piu' della cassa!40mio Se solo uscisse una news questa esplode! Sempre in a 1,15....

29-11-11, 17:37	#10 (permalink)
Roman66 no chem-trails Data registrazione: Jun 2001 Messaggi: 2,391 Popolarità: 42949683	Sembra che stia ripartendo anche senza news

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