Alimera Sciences and Knight Therapeutics Announce Filing of New Drug Submission for Iluvien® in Canada
http://ih.advfn.com/p.php?pid=nmona&article=73923580
[-chart]resource.globenewswire.com/Resource/Download/a0fc0818-863a-4533-89c5-56e1bff5632e?size=2[/chart]
Date : 02/22/2017 @ 8:00AM
Source : GlobeNewswire Inc.
Stock : Alimera Sciences, Inc. (MM) (ALIM)
Quote : 1.25 0.0 (0.00%) @ 8:11AM
Alimera Sciences and Knight Therapeutics Announce Filing of New Drug Submission for Iluvien® in Canada
Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a leader in research, development and commercialization of prescription ophthalmic pharmaceuticals, and Knight Therapeutics Inc. (TSX:GUD) (Knight), a leading Canadian specialty pharmaceutical company, today announced that Knight’s New Drug Submission (NDS) for ILUVIEN® has been accepted for review by Health Canada. ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is Alimera's sustained release intravitreal implant approved in the U.S. to treat diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure
“ILUVIEN is a unique and innovative product that is available in different markets around the world, including the U.S. and Europe,” said Jonathan Ross Goodman, CEO of Knight. “We are happy to continue advancing ILUVIEN and our portfolio of novel therapeutics that improve the health of Canadian patients.”
“This is another important milestone for ILUVIEN,” said Dan Myers, CEO of Alimera. “We believe ILUVIEN is the only therapy that treats DME consistently every day due to its continuous microdosing for up to three years, and we look forward to working with Knight and Health Canada to make ILUVIEN available to Canadian patients.”
Knight and Alimera signed an agreement in July 2015 granting Knight the exclusive right to distribute ILUVIEN in Canada.
About ILUVIEN
http://www.ILUVIEN.com.
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant approved in the U.S. to treat diabetic macular edema in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. Each ILUVIEN implant is designed to release submicrogram levels of fluocinolone acetonide, a corticosteroid, for 36 months.
About Diabetic Macular Edema (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 associated with diabetic retinopathy results in swelling of the macula, the condition is called DME. The onset of DME is painless and may go unreported 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% of people with diabetes included in the study were diagnosed with DME. All people with type 1 or type 2 diabetes are at risk of developing DME.
About Alimera Sciences, Inc.
http://www.alimerasciences.com
Alimera, founded in June 2003, is a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Alimera is presently focused on diseases affecting the back of the eye, or retina, because these diseases are not well treated with current therapies and will affect millions of people in our aging populations. Alimera’s commitment to retina specialists and their patients is manifest in Alimera’s product and development portfolio designed to treat early- and late-stage diseases. For more information, please visit
http:// www.alimerasciences.com.
Alimera Forward Looking Statements
This press release contains “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, Alimera’s plans to make ILUVIEN available to Canadian patients. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ include, but are not limited to, Knight’s ability to obtain approval from Health Canada and to launch ILUVIEN in Canada, as well as other factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Alimera’s Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarters ended June 30, 2016 and September 30, 2016, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at http://www.sec.gov. Additional factors may also be set forth in those sections of Alimera's Annual Report on Form 10-K for the year ended December 31, 2016, to be filed with the SEC in the first quarter of 2017. In addition to the risks described above and in Alimera’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Alimera’s results. There can be no assurance that the actual results or developments anticipated by Alimera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Alimera. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.
All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. Alimera cautions investors not to rely too heavily on the forward-looking statements Alimera makes or that are made on its behalf. These forward-looking statements speak only as of the date of this press release (unless another date is indicated). Alimera undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
About Knight Therapeutics Inc.
Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian and select international markets. Knight's shares trade on TSX under the symbol GUD. For more information about Knight, please visit the company's web site at www.gud-knight.com or www.sedar.com.
Knight Forward-Looking Statement
This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2015. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events, except as required by law.
For Alimera Sciences:
Katie Brazel
404-317-8361
kbrazel@bellsouth.net
For Knight Therapeutics:
Jeffrey Kadanoff, P.Eng., MBA
Chief Financial Officer
514-484-GUD1 (4831)
info@gud-knight.com
Primary Logo
///////////////////////////////////////////////////////////////
previous/
good morning, news/ Alimera Sciences Begins Selling ILUVIEN® in the Middle East
http://finance.yahoo.com/news/alimera-sciences-begins-selling-iluvien-113000658.html
GlobeNewswire•October 26, 2016
ATLANTA, Oct. 26, 2016 (GLOBE NEWSWIRE)
-- Alimera Sciences, Inc. (ALIM) (Alimera), a leader in research, development and commercialization of prescription ophthalmic pharmaceuticals,
today announced that its subsidiary, Alimera Sciences B.V.,
has begun shipping ILUVIEN®,
an eye implant for the treatment of diabetic macular edema (DME),
to MEAgate International FZLLC, headquartered in Dubai, for Named Patient Sales in the Middle East.
MEAgate is the ILUVIEN distributor for
Bahrain,
Egypt,
Iraq,
Jordan,
Kuwait,
Lebanon,
Oman,
Qatar,
Saudi Arabia,
UAE, and
Yemen,
where combined an estimated 16 million people today are living with diabetes.
Following the successful completion of a technical review,
the Health Authority
- Abu Dhabi (HAAD) code for ILUVIEN was published on October 11, 2016.
The HAAD code allows for the reimbursement of ILUVIEN by HAAD.
In addition, some large Middle East institutions are finalizing compassionate use programs in order to include ILUVIEN in their available treatment options.
The first DME patient in the region was treated with ILUVIEN
under the Named Patient Sales program,
an early access program whereby health authorities allow selected institutions to provide globally approved innovative medications
to their patients while the products are still in the process of approval and full registration.
“Diabetes and its complications have been listed among the top priorities of health authorities across the region,”
said Dream Samir, MEAgate’s chief executive officer.
“In several Middle-East countries,
prominent ophthalmologists have confirmed that ILUVIEN will address
an unmet need for a significant number of their patients with diabetes.”
“We are pleased to begin providing ILUVIEN to this population,”
said Dan Myers,
Alimera’s chief executive officer.
“Given the high incidence of diabetes in the region,
we believe a continuous microdosing delivery system will be welcomed
by both retinal specialists and their patients with diabetic macular edema.”
About ILUVIEN
www.ILUVIEN.com.
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is
a sustained release intravitreal implant approved in the U.S.
to treat diabetic macular edema in patients who have been
previously treated with a course of corticosteroids and did
not have a clinically significant rise in intraocular pressure.
Each ILUVIEN implant is designed to release submicrogram levels
of fluocinolone acetonide, a corticosteroid, for 36 months.
About Diabetic Macular Edema (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 associated with diabetic retinopathy results in swelling of the macula, the condition is called DME.
The onset of DME is painless and may go unreported 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% of people
with diabetes included in the study were diagnosed with DME.
All people with type 1 or type 2 diabetes are at risk of developing DME.
About Alimera Sciences, Inc.
www.alimerasciences.com
Alimera, founded in June 2003, is a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals.
Alimera is presently focused on diseases affecting the back of the eye, or retina,
because these diseases are not well treated with current therapies
and will affect millions of people in our aging populations.
Alimera’s commitment to retina specialists and their patients is manifest in Alimera’s product and development portfolio designed
to treat early- and late-stage diseases.
For more information, please visit
http://www.alimerasciences.com.
About MEAgate International FZ LCC
The management team of MEAgate includes seasoned pharmaceutical
and
life sciences executives with over 35 years combined experience
in selling pharmaceuticals and medical devices in much of the Middle East.
They have developed a Middle East hub to address the needs of small
to medium innovative companies,
and become the partner of choice that ensures highest scientific
and compliant standards while managing
– on behalf of the company
– a network of carefully chosen country distributors.
Teams are centrally selected, hired and trained, ensuring that the same high standards are applied across the region.
http://ih.advfn.com/p.php?pid=nmona&article=73923580
[-chart]resource.globenewswire.com/Resource/Download/a0fc0818-863a-4533-89c5-56e1bff5632e?size=2[/chart]
Date : 02/22/2017 @ 8:00AM
Source : GlobeNewswire Inc.
Stock : Alimera Sciences, Inc. (MM) (ALIM)
Quote : 1.25 0.0 (0.00%) @ 8:11AM
Alimera Sciences and Knight Therapeutics Announce Filing of New Drug Submission for Iluvien® in Canada
Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a leader in research, development and commercialization of prescription ophthalmic pharmaceuticals, and Knight Therapeutics Inc. (TSX:GUD) (Knight), a leading Canadian specialty pharmaceutical company, today announced that Knight’s New Drug Submission (NDS) for ILUVIEN® has been accepted for review by Health Canada. ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is Alimera's sustained release intravitreal implant approved in the U.S. to treat diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure
“ILUVIEN is a unique and innovative product that is available in different markets around the world, including the U.S. and Europe,” said Jonathan Ross Goodman, CEO of Knight. “We are happy to continue advancing ILUVIEN and our portfolio of novel therapeutics that improve the health of Canadian patients.”
“This is another important milestone for ILUVIEN,” said Dan Myers, CEO of Alimera. “We believe ILUVIEN is the only therapy that treats DME consistently every day due to its continuous microdosing for up to three years, and we look forward to working with Knight and Health Canada to make ILUVIEN available to Canadian patients.”
Knight and Alimera signed an agreement in July 2015 granting Knight the exclusive right to distribute ILUVIEN in Canada.
About ILUVIEN
http://www.ILUVIEN.com.
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant approved in the U.S. to treat diabetic macular edema in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. Each ILUVIEN implant is designed to release submicrogram levels of fluocinolone acetonide, a corticosteroid, for 36 months.
About Diabetic Macular Edema (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 associated with diabetic retinopathy results in swelling of the macula, the condition is called DME. The onset of DME is painless and may go unreported 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% of people with diabetes included in the study were diagnosed with DME. All people with type 1 or type 2 diabetes are at risk of developing DME.
About Alimera Sciences, Inc.
http://www.alimerasciences.com
Alimera, founded in June 2003, is a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Alimera is presently focused on diseases affecting the back of the eye, or retina, because these diseases are not well treated with current therapies and will affect millions of people in our aging populations. Alimera’s commitment to retina specialists and their patients is manifest in Alimera’s product and development portfolio designed to treat early- and late-stage diseases. For more information, please visit
http:// www.alimerasciences.com.
Alimera Forward Looking Statements
This press release contains “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, Alimera’s plans to make ILUVIEN available to Canadian patients. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ include, but are not limited to, Knight’s ability to obtain approval from Health Canada and to launch ILUVIEN in Canada, as well as other factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Alimera’s Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarters ended June 30, 2016 and September 30, 2016, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at http://www.sec.gov. Additional factors may also be set forth in those sections of Alimera's Annual Report on Form 10-K for the year ended December 31, 2016, to be filed with the SEC in the first quarter of 2017. In addition to the risks described above and in Alimera’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Alimera’s results. There can be no assurance that the actual results or developments anticipated by Alimera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Alimera. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.
All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. Alimera cautions investors not to rely too heavily on the forward-looking statements Alimera makes or that are made on its behalf. These forward-looking statements speak only as of the date of this press release (unless another date is indicated). Alimera undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
About Knight Therapeutics Inc.
Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian and select international markets. Knight's shares trade on TSX under the symbol GUD. For more information about Knight, please visit the company's web site at www.gud-knight.com or www.sedar.com.
Knight Forward-Looking Statement
This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared, but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report and in Knight Therapeutics Inc.'s Annual Information Form for the year ended December 31, 2015. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events, except as required by law.
For Alimera Sciences:
Katie Brazel
404-317-8361
kbrazel@bellsouth.net
For Knight Therapeutics:
Jeffrey Kadanoff, P.Eng., MBA
Chief Financial Officer
514-484-GUD1 (4831)
info@gud-knight.com
Primary Logo
///////////////////////////////////////////////////////////////
previous/
good morning, news/ Alimera Sciences Begins Selling ILUVIEN® in the Middle East
http://finance.yahoo.com/news/alimera-sciences-begins-selling-iluvien-113000658.html
GlobeNewswire•October 26, 2016
ATLANTA, Oct. 26, 2016 (GLOBE NEWSWIRE)
-- Alimera Sciences, Inc. (ALIM) (Alimera), a leader in research, development and commercialization of prescription ophthalmic pharmaceuticals,
today announced that its subsidiary, Alimera Sciences B.V.,
has begun shipping ILUVIEN®,
an eye implant for the treatment of diabetic macular edema (DME),
to MEAgate International FZLLC, headquartered in Dubai, for Named Patient Sales in the Middle East.
MEAgate is the ILUVIEN distributor for
Bahrain,
Egypt,
Iraq,
Jordan,
Kuwait,
Lebanon,
Oman,
Qatar,
Saudi Arabia,
UAE, and
Yemen,
where combined an estimated 16 million people today are living with diabetes.
Following the successful completion of a technical review,
the Health Authority
- Abu Dhabi (HAAD) code for ILUVIEN was published on October 11, 2016.
The HAAD code allows for the reimbursement of ILUVIEN by HAAD.
In addition, some large Middle East institutions are finalizing compassionate use programs in order to include ILUVIEN in their available treatment options.
The first DME patient in the region was treated with ILUVIEN
under the Named Patient Sales program,
an early access program whereby health authorities allow selected institutions to provide globally approved innovative medications
to their patients while the products are still in the process of approval and full registration.
“Diabetes and its complications have been listed among the top priorities of health authorities across the region,”
said Dream Samir, MEAgate’s chief executive officer.
“In several Middle-East countries,
prominent ophthalmologists have confirmed that ILUVIEN will address
an unmet need for a significant number of their patients with diabetes.”
“We are pleased to begin providing ILUVIEN to this population,”
said Dan Myers,
Alimera’s chief executive officer.
“Given the high incidence of diabetes in the region,
we believe a continuous microdosing delivery system will be welcomed
by both retinal specialists and their patients with diabetic macular edema.”
About ILUVIEN
www.ILUVIEN.com.
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is
a sustained release intravitreal implant approved in the U.S.
to treat diabetic macular edema in patients who have been
previously treated with a course of corticosteroids and did
not have a clinically significant rise in intraocular pressure.
Each ILUVIEN implant is designed to release submicrogram levels
of fluocinolone acetonide, a corticosteroid, for 36 months.
About Diabetic Macular Edema (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 associated with diabetic retinopathy results in swelling of the macula, the condition is called DME.
The onset of DME is painless and may go unreported 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% of people
with diabetes included in the study were diagnosed with DME.
All people with type 1 or type 2 diabetes are at risk of developing DME.
About Alimera Sciences, Inc.
www.alimerasciences.com
Alimera, founded in June 2003, is a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals.
Alimera is presently focused on diseases affecting the back of the eye, or retina,
because these diseases are not well treated with current therapies
and will affect millions of people in our aging populations.
Alimera’s commitment to retina specialists and their patients is manifest in Alimera’s product and development portfolio designed
to treat early- and late-stage diseases.
For more information, please visit
http://www.alimerasciences.com.
About MEAgate International FZ LCC
The management team of MEAgate includes seasoned pharmaceutical
and
life sciences executives with over 35 years combined experience
in selling pharmaceuticals and medical devices in much of the Middle East.
They have developed a Middle East hub to address the needs of small
to medium innovative companies,
and become the partner of choice that ensures highest scientific
and compliant standards while managing
– on behalf of the company
– a network of carefully chosen country distributors.
Teams are centrally selected, hired and trained, ensuring that the same high standards are applied across the region.
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