ResQ Pharma Receives FDA Orphan Drug Designation for LipidRescue™ Therapy for the Treatment of Local Anesthetic Systemic Toxicity

CHICAGO–(BUSINESS WIRE)–ResQ Pharma, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for LipidRescue™ Therapy (LRT) for the indication of local anesthetic systemic toxicity (LAST). ResQ Pharma is a biopharmaceutical company focused on ensuring reliable global access to (LRT), a treatment for various drug overdoses and poisonings.

In addition, the company recently received an Advice Letter from the FDA guiding the company to prepare a new drug application (NDA) based on the existing literature, case reports and new manufacturing specifics via the 505(b)2 pathway (“paper NDA”). The company is on track to file the NDA in the first half of 2018. Given this accelerated path to potential regulatory approval, the company is currently soliciting commercialization partners. ResQ Pharma’s CEO, Paul Burton, will be attending BIO 2017 in San Diego June 19th thru 23rd.

According to the Centers for Disease Control and Prevention (CDC), 52,404 people died in 2015 from drug overdoses in the US alone. Approximately half of those, over 25,000, involved non-opioid drugs.

“ResQ Pharma is energized about the opportunity to better address the global problem of severe drug overdoses by commercializing a life-saving therapy for this category of overdoses,” said Paul Burton, CEO, ResQ Pharma. “Currently, there is no FDA approved treatment for LAST and other severe non-opioid, lipophilic drug overdoses.”

About LipidRescueTM Therapy (LRT)

ResQ Pharma’s lead product candidate is LRT, which refers to the administration of a lipid emulsion with the intent of reducing the life-threatening clinical manifestations of toxicity from excessive doses of certain lipophilic drugs. It is already the opinion of the American Heart Association and American College of Medical Toxicology that where there is serious hemodynamic instability from local anesthetic drugs with high lipid solubility, LRT is a reasonable consideration for therapy, even if the patient is not in cardiac arrest.

About ResQ Pharma

ResQ Pharma, Inc., is a biopharmaceutical company created to ensure access to reliable, global use of LRT, a treatment for various lipophilic drug overdoses and poisonings. For more information on ResQ Pharma, please visit www.LipidRescue.com. We are members of iBIO’s PROPEL, EnterpriseWorks Chicago, Chicago Founders Circle, The BUNKER and MATTER! We are also a Qualified New Business Venture for the Illinois Investment Tax Credit Program. For more information, please visit www.ResQPharma.com.

About Paul Burton, J.D., M.B.A.

Mr. Paul Burton has served as the CEO of ResQ Pharma since July 2015. He is a former investment banker having started his career as an investment banking associate with Salomon Brothers/Salomon Smith Barney in New York City in 1998 upon completion of both law school and business school at the University of Illinois at Urbana-Champaign. More recently he has worked with several entrepreneurial ventures in healthcare. Mr. Burton is also a former U.S. Regular Army Commissioned Officer (Infantry).

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “believes,” “potential,” “proposed,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, analyses or current expectations concerning, among other things: our expectations regarding the clinical effectiveness and safety of our product candidates and results of studies; and the timing of and our ability to obtain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, our product candidates and advancing studies for LRT. Any forward-looking statements in this press release speak only as of the date of this press release.

Contacts

ResQ Pharma, Inc.
Jacque Eneliko, 224-880-6001
Executive Assistant
Jacque@LipidRescue.com
or
For Media:
Beck Media & Marketing
Todd Beck, 310-300-4800
Todd@BeckMedia.com

ResQ Pharma’s CEO, Paul Burton to Present at Biotech Showcase

ResQ Pharma’s CEO, Paul Burton, to Present at Biotech Showcase

 

January 10, 2017
CHICAGO–(BUSINESS WIRE)–Paul Burton, the CEO of ResQ Pharma, Inc., a biopharmaceutical company focused on enabling reliable, global use of LipidRescue™ Therapy (LRT), which is a treatment for various drug overdoses and poisonings is scheduled to present at Biotech Showcase as part of the J.P. Morgan 35th Annual Healthcare Conference Week in San Francisco. The presentation will take place on Wednesday January 11, 2017 at 3:30 pm PT at the Hilton San Francisco Union Square, 333 O’Farrell Street at the Ballroom Level. Mr. Burton will be discussing ResQ Pharma’s plans to attain regulatory market approval for LRT by 2018.

Paul Burton presenting @ Biotech Showcase 2017

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According to the Center for Disease Control and Prevention (CDC) 47,055 people died in 2014 from drug overdoses in the US. ResQ Pharma is energized about the opportunity to better address the situation by commercializing a life-saving therapy.

About LipidRescueTM Therapy (LRT)

ResQ Pharma’s lead product candidate is LRT, which refers to the administration of a lipid emulsion with the intent of reducing the life-threatening clinical manifestations of toxicity from excessive doses of certain lipophilic drugs. It is already the opinion of the American Heart Association and American College of Medical Toxicology that where there is serious hemodynamic instability from local anesthetic drugs with high lipid solubility, LRT is a reasonable consideration for therapy, even if patient is not in cardiac arrest.

About ResQ Pharma

ResQ Pharma, Inc., is a biopharmaceutical company created to ensure reliable, global use of LRT, a treatment for various lipophilic drug overdoses and poisonings. For more information on ResQ Pharma, please visit www.LipidRescue.com. We are members of iBIO’s PROPEL, EnterpriseWorks Chicago, Chicago Founders Circle, The BUNKER and MATTER! We are also a Qualified New Business Venture for the Illinois Investment Tax Credit Program. DLA Piper, LLP provided legal counsel for the financing.

About Paul Burton, J.D., M.B.A.

Mr. Paul Burton has served as the CEO of ResQ Pharma since July 2015. He is a former investment banker having started his career in corporate finance with Salomon Brothers / Salomon Smith Barney in New York City in 1998 upon completion of both law school and business school at the University of Illinois at Urbana-Champaign. More recently he has worked with several entrepreneurial ventures in healthcare. Mr. Burton is also a former U.S. Regular Army Commissioned Officer (Infantry).

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “believes,” “potential,” “proposed,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, analyses or current expectations concerning, among other things: our expectations regarding the clinical effectiveness and safety of our product candidates and results of studies; and the timing of and our ability to obtain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, our product candidates and advancing studies for LRT. Any forward-looking statements in this press release speak only as of the date of this press release.

Contacts

ResQ Contact:
Jacque Eneliko| Executive Assistant
224-880-6001 | Jacque@LipidRescue.com
For Media:
Todd Beck | Beck Media
310-300-4800 | Todd@BeckMedia.com

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RT Gareth Menagh @drgmenagh: Tricyclic Antidepressant Overdose in a Toddler Treated With Intravenous…

RT Gareth Menagh @drgmenagh: Tricyclic Antidepressant Overdose in a Toddler Treated With Intravenous Lipid Emulsion Dr Gareth Menagh -...

RT Gareth Menagh @garethmenagh: Lipid emulsion saves child’s life https://t.co/BCFEsKi0ct #Pediatric…

RT Gareth Menagh @garethmenagh: Lipid emulsion saves child's life https://t.co/BCFEsKi0ct #Pediatrics...

RT Dr. Guy Weinberg @lipidguy: Veterinary, equine lipid rescue. Lidocaine-induced asystolic arrest u…

RT Dr. Guy Weinberg @lipidguy: Veterinary, equine lipid rescue. Lidocaine-induced asystolic arrest unresponsive to epi and atropine. https://t.co/ohwzVk9woH...

Excellent podcast 30: Intravenous lipid emulsion for the treatment of drug toxicity https://t.co/ynv…

Excellent podcast 30: Intravenous lipid emulsion for the treatment of drug toxicity https://t.co/ynvnFPdLz5

Thanks @iBIOPROPEL ! https://t.co/3ZXFLAcGZc

Thanks @iBIOPROPEL ! https://t.co/3ZXFLAcGZc

RT BluePrint Orphan @BluePrintOrphan: ResQ Pharma granted #OrphanDrug status for #LipidRescue therap…

RT BluePrint Orphan @BluePrintOrphan: ResQ Pharma granted #OrphanDrug status for #LipidRescue therapy for local anesthetic systemic toxicity. Expect an N…...

RT Biotech 365 @Biotech365: ResQ Pharma Receives FDA Orphan Drug Designation for LipidRescue Therapy…

RT Biotech 365 @Biotech365: ResQ Pharma Receives FDA Orphan Drug Designation for LipidRescue Therapy https://t.co/kKuH952lWP #pharma #biotech #biopharma #science...

ResQ Pharma Receives FDA Orphan Drug Designation for LipidRescue™ Therapy for the Treatment of Local Anesthetic Systemic Toxicity

ResQ Pharma Receives FDA’s ODD status for LipidRescue Therapy (LRT) for LAST and on track to file NDA in first half of 2018

ResQ Pharma Raises $725,000

ResQ Pharma Raises $725,000

September 27, 2017
CHICAGO–(BUSINESS WIRE)–ResQ Pharma, Inc., a biopharmaceutical company focused on enabling reliable, global use of LipidRescue™ Therapy (LRT), which is a treatment for various drug overdoses and poisonings, announces the completion of a second seed-round of equity financing of $725,000.00. This financing brings their total seed financing to $1,050,000.00. The company is scheduled to meet the U.S. Food & Drug Administration (FDA) on September 29th 2016 regarding an application for LRT as a treatment for local anesthetic systemic toxicity (LAST). The company also filed for Orphan Drug Designation applications in both the US and European Union.

@LipidResQ completes 2nd #Seedround of $725k & meets #FDA 9/29/16 for confirmation of reg path

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According to the Center for Disease Control and Prevention (CDC) 47,055 people died in 2014 from drug overdoses in the US. ResQ Pharma is excited about the opportunity it has to attain regulatory market approval for LRT and better address the situation by commercializing a potentially life-saving therapy.

About LipidRescueTM Therapy (LRT)

ResQ Pharma’s lead product candidate is LRT, which refers to the administration of a lipid emulsion with the intent of reducing the life-threatening clinical manifestations of toxicity from excessive doses of certain lipophilic drugs. It is already the opinion of the American Heart Association and American College of Medical Toxicology that where there is serious hemodynamic instability from local anesthetic drugs with high lipid solubility, LRT is a reasonable consideration for therapy, even if patient is not in cardiac arrest.

About ResQ Pharma

ResQ Pharma, Inc., is a biopharmaceutical company created to ensure reliable, global use of LRT, a treatment for various lipophilic drug overdoses and poisonings. For more information on ResQ Pharma, please visit www.LipidRescue.com. We are members of iBIO’s PROPEL, EnterpriseWorks Chicago, Chicago Founders Circle, The BUNKER and MATTER/CIMs! We are also a Qualified New Business Venture for the Illinois Investment Tax Credit Program. DLA Piper, LLP provided legal counsel for the financing.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “believes,” “potential,” “proposed,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding our intentions, beliefs, analyses or current expectations concerning, among other things: our expectations regarding the clinical effectiveness and safety of our product candidates and results of studies; and the timing of and our ability to obtain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, our product candidates and advancing studies for LRT. Any forward-looking statements in this press release speak only as of the date of this press release.

Contacts

ResQ Contact:
Paul Burton, JD,MBA | Chief Executive Officer
224-880-6001 | Paul@LipidRescue.com
or
For Media:
Todd Beck | Beck Media
310-300-4800 | Todd@BeckMedia.com

RT Todd Beck @ToddBeck: In my spare time, I keep tabs on these #pharmaTech geniuses who are using sc…

RT Todd Beck @ToddBeck: In my spare time, I keep tabs on these #pharmaTech geniuses who are using science to prevent/reverse countless avoi…...

Thanks @CuresWReach ! From @lipidguy @SmartMoneyPaul @ToddBeck @AntoinetteGawin @thewizkid50 @paul…

Thanks @CuresWReach ! From @lipidguy @SmartMoneyPaul @ToddBeck @AntoinetteGawin @thewizkid50 @paulhertz...

RT Gareth Menagh @drgmenagh: Tricyclic Antidepressant Overdose in a Toddler Treated With Intravenous…

RT Gareth Menagh @drgmenagh: Tricyclic Antidepressant Overdose in a Toddler Treated With Intravenous Lipid Emulsion Dr Gareth Menagh -...

RT Gareth Menagh @garethmenagh: Lipid emulsion saves child’s life https://t.co/BCFEsKi0ct #Pediatric…

RT Gareth Menagh @garethmenagh: Lipid emulsion saves child's life https://t.co/BCFEsKi0ct #Pediatrics...

RT Dr. Guy Weinberg @lipidguy: Veterinary, equine lipid rescue. Lidocaine-induced asystolic arrest u…

RT Dr. Guy Weinberg @lipidguy: Veterinary, equine lipid rescue. Lidocaine-induced asystolic arrest unresponsive to epi and atropine. https://t.co/ohwzVk9woH...

Excellent podcast 30: Intravenous lipid emulsion for the treatment of drug toxicity https://t.co/ynv…

Excellent podcast 30: Intravenous lipid emulsion for the treatment of drug toxicity https://t.co/ynvnFPdLz5

Thanks @iBIOPROPEL ! https://t.co/3ZXFLAcGZc

Thanks @iBIOPROPEL ! https://t.co/3ZXFLAcGZc

RT BluePrint Orphan @BluePrintOrphan: ResQ Pharma granted #OrphanDrug status for #LipidRescue therap…

RT BluePrint Orphan @BluePrintOrphan: ResQ Pharma granted #OrphanDrug status for #LipidRescue therapy for local anesthetic systemic toxicity. Expect an N…...

RT Biotech 365 @Biotech365: ResQ Pharma Receives FDA Orphan Drug Designation for LipidRescue Therapy…

RT Biotech 365 @Biotech365: ResQ Pharma Receives FDA Orphan Drug Designation for LipidRescue Therapy https://t.co/kKuH952lWP #pharma #biotech #biopharma #science...

ResQ Pharma Receives FDA Orphan Drug Designation for LipidRescue™ Therapy for the Treatment of Local Anesthetic Systemic Toxicity

ResQ Pharma Receives FDA’s ODD status for LipidRescue Therapy (LRT) for LAST and on track to file NDA in first half of 2018

Guy Weinberg Presents at EAPCCT

Guy Weinberg Presents at EAPCCT

 

May 25, 2016
CHICAGO–(BUSINESS WIRE)–ResQ Pharma, Inc., a biopharmaceutical company focused on ensuring reliable, global use of LipidRescue™ Therapy (LRT), a treatment for various lipophilic drug overdoses & poisonings, today announced that Guy Weinberg, M.D., its co-founder and inventor of LRT will be presenting this Friday, May 27th at the Congress Of The European Association Of Poisons Centres And Clinical Toxicologists or EAPCCT in Madrid, Spain on advances in critical care of poisoned patients.

#Lipidrescue to treat acute poisonings: the fundamentals and the future @lipidguy #EAPCCT #CriticalCare #lifesaver

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About Guy Weinberg, M.D.

Dr. Guy Weinberg is Perioperative Care Specialist with over 30 years of experience as an Anesthesiologist. He is currently a professor of Anesthesiology at the University of Illinois at Chicago College of Medicine and a staff member at Jesse Brown VA Medical Center. In addition, he serves on the board of directors of ResQ Pharma, Inc.

About LipidRescue Therapy (LRT)

LRT is ResQ Pharma’s lead product candidate which refers to the administration of a lipid emulsion with the intent of reducing the life-threatening clinical manifestations of toxicity from excessive doses of certain lipophilic drugs. It is already the opinion of the American Heart Association and American College of Medical Toxicology that where there is serious hemodynamic instability from local anesthetic drugs with high lipid solubility, LRT is a reasonable consideration for therapy, even if patient is not in cardiac arrest.

About ResQ Pharma

ResQ Pharma, Inc., is a biopharmaceutical company created to ensure reliable, global use of LRT, a treatment for various lipophilic drug overdoses & poisonings. For more information on ResQ Pharma, please visit www.LipidRescue.com. We are a member of iBIO’s PROPEL, EnterpriseWorks Chicago, Chicago Founders Circle, The BUNKER and MATTER! We are also a Qualified New Business Venture for the Illinois Investment Tax Credit Program.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future outcomes to identify these forward-looking statements. the ability and willingness of ResQ Pharma to continue research and development activities relating to LRT; our expectations regarding the clinical effectiveness and safety of our product candidates and results of studies; Any forward-looking statements in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after this press release.

Contacts

ResQ Pharma, Inc.
Paul Burton, JD, MBA, Chief Executive Officer
224-880-6001
Paul@LipidRescue.com
or
For Media:
Beck Media
Todd Beck
310-300-4800
Todd@beckmedia.com

RT Todd Beck @ToddBeck: In my spare time, I keep tabs on these #pharmaTech geniuses who are using sc…

RT Todd Beck @ToddBeck: In my spare time, I keep tabs on these #pharmaTech geniuses who are using science to prevent/reverse countless avoi…...

Thanks @CuresWReach ! From @lipidguy @SmartMoneyPaul @ToddBeck @AntoinetteGawin @thewizkid50 @paul…

Thanks @CuresWReach ! From @lipidguy @SmartMoneyPaul @ToddBeck @AntoinetteGawin @thewizkid50 @paulhertz...

RT Gareth Menagh @drgmenagh: Tricyclic Antidepressant Overdose in a Toddler Treated With Intravenous…

RT Gareth Menagh @drgmenagh: Tricyclic Antidepressant Overdose in a Toddler Treated With Intravenous Lipid Emulsion Dr Gareth Menagh -...

RT Gareth Menagh @garethmenagh: Lipid emulsion saves child’s life https://t.co/BCFEsKi0ct #Pediatric…

RT Gareth Menagh @garethmenagh: Lipid emulsion saves child's life https://t.co/BCFEsKi0ct #Pediatrics...

RT Dr. Guy Weinberg @lipidguy: Veterinary, equine lipid rescue. Lidocaine-induced asystolic arrest u…

RT Dr. Guy Weinberg @lipidguy: Veterinary, equine lipid rescue. Lidocaine-induced asystolic arrest unresponsive to epi and atropine. https://t.co/ohwzVk9woH...

Excellent podcast 30: Intravenous lipid emulsion for the treatment of drug toxicity https://t.co/ynv…

Excellent podcast 30: Intravenous lipid emulsion for the treatment of drug toxicity https://t.co/ynvnFPdLz5

Thanks @iBIOPROPEL ! https://t.co/3ZXFLAcGZc

Thanks @iBIOPROPEL ! https://t.co/3ZXFLAcGZc

RT BluePrint Orphan @BluePrintOrphan: ResQ Pharma granted #OrphanDrug status for #LipidRescue therap…

RT BluePrint Orphan @BluePrintOrphan: ResQ Pharma granted #OrphanDrug status for #LipidRescue therapy for local anesthetic systemic toxicity. Expect an N…...

RT Biotech 365 @Biotech365: ResQ Pharma Receives FDA Orphan Drug Designation for LipidRescue Therapy…

RT Biotech 365 @Biotech365: ResQ Pharma Receives FDA Orphan Drug Designation for LipidRescue Therapy https://t.co/kKuH952lWP #pharma #biotech #biopharma #science...

ResQ Pharma Receives FDA Orphan Drug Designation for LipidRescue™ Therapy for the Treatment of Local Anesthetic Systemic Toxicity

ResQ Pharma Receives FDA’s ODD status for LipidRescue Therapy (LRT) for LAST and on track to file NDA in first half of 2018