The Therapeutic Goods Administration is the regulatory body for therapeutic goods in Australia. It is a Division of the Australian Department of Health established under the Therapeutic Goods Act 1989 . The TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard and that access to therapeutic advances is in a timely manner. Wikipedia.


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News Article | February 15, 2017
Site: www.newscientist.com

Australia has become the latest country to ban over-the-counter sales of medications containing the opioid painkiller codeine. The new regulation, which will come into effect on 1 February 2018, is hoped to halt the rise in codeine-related deaths, which have more than doubled in Australia since 2000. Codeine is used to treat pain and suppress coughing, and can currently be purchased in Australia and the UK without a prescription; low doses are found in some painkillers, cough syrups, and cold and flu tablets. However, even in small doses, codeine has the potential to become addictive. Inside the body, it is partially metabolised to morphine, which can produce feelings of relaxation and euphoria. As a result, some people increase their use of codeine-containing medications. The US, Germany and Japan have already banned over-the-counter sales of the drug. Since banning such sales, these countries have seen a fall in codeine-related deaths, says Michael Vagg, a pain specialist in Geelong, Australia. “But that’s not even the most compelling argument for doing this,” he says. “It’s also a pretty rubbish drug that doesn’t actually help people as much as they think it does.” In its decision to make codeine prescription-only, Australia’s Therapeutic Goods Administration noted that codeine doesn’t provide effective pain relief at the low doses used in over-the-counter medications. Long-term codeine use has even been shown to have a pain-sensitising effect in people who take it regularly for headaches, ultimately making their pain worse. When people start taking high doses, codeine can cause severe breathing difficulties. But there is another harmful effect for people who become addicted. Over-the-counter drugs that contain codeine also often contain other drugs like paracetamol (acetaminophen) or ibuprofen, and as a person increases their use of these, they can experience liver, gut or kidney damage. A recent study found that paracetamol or ibuprofen was involved in 55 per cent of the 1200 codeine-related deaths recorded in Australia between 2000 and 2013. Every hospital in Australia will tell you stories of addiction to such combined drugs, says Vagg. “You often see it in young women. Some have to be tube-fed because their guts are so damaged,” he says. “Others have to go on dialysis because their kidneys are wrecked.” However, George Tambassis, president of the Pharmacy Guild of Australia, says that making codeine prescription-only will unfairly affect people who genuinely need it and use it safely. The issue of misuse would be better managed by a real-time monitoring system that identified people at risk of misusing codeine at the point of sale, he says. In April 2015, the UK’s Medicines and Healthcare products Regulatory Agency recommended that children under 12 shouldn’t be given over-the-counter codeine. However, no plans have been announced yet to make codeine prescription-only in the UK.


- Toujeo® provides a flatter profile than insulin degludec with less within-day fluctuations - Sanofi presented today the full results of a pharmacokinetic / pharmacodynamic (PK/PD) study with Toujeo® (insulin glargine 300 Units/mL) and insulin degludec 100 Units/mL (Deg-100) at the 16th Annual Diabetes Technology Meeting, Bethesda, Maryland, U.S.[1] In patients with type 1 diabetes, the Toujeo® PK/PD profile at a clinically relevant dose (0.4 U/kg/day, the average dose used in worldwide clinical practice)[2] was flatter and more evenly distributed over 24 hours compared with the profile of insulin degludec. The within-day fluctuation of metabolic activity was 20% lower (p=0.047) for Toujeo® than insulin degludec. An overall flat PK/PD profile and an evenly distributed exposure over 24 hours were observed for Toujeo® at both dose levels studied (0.4 and 0.6 U/kg/day). "These new findings may have clinical implications for people with type 1 diabetes on basal insulin therapy," said Dr. Timothy Bailey, Clinical Associate Professor, University of California, San Diego. "Toujeo® has already shown an improved PK/PD profile when compared to insulin glargine 100 Units/mL (Gla-100), with a flatter profile. Also in a previous CGM study[3] in adults with type 1 diabetes versus Gla-100, Toujeo showed less between-day variability and less within-day fluctuations, associated with a lower risk of nocturnal confirmed (≤54 mg/dL) or severe hypoglycemia in the first 8 weeks.[3] The results observed in the current PK/PD study comparing Toujeo® versus Deg-100 confirm that Toujeo has an interesting profile with the potential to help the people with diabetes to reach their targets with less risk of hypoglycemia." "In this PK/PD study, we observed a more favorable profile for Toujeo® compared to insulin degludec," said Riccardo Perfetti, Head of Global Diabetes Medical Team, Sanofi. "The clinical implications of these findings are currently being investigated." Although basal insulin injections cannot perfectly replicate endogenous insulin production, the 'ideal' basal insulin for diabetes therapy would have stable pharmacodynamic (PD) and pharmacokinetic (PK) profiles. Smaller and less variable glucose excursions may result in more predictable 24hour profiles and less hypoglycemia, and could translate into an improved experience for people on basal insulin and better adherence to therapy. This was a randomized, double-blind, 2x2, crossover, euglycemic-clamp study in two parallel cohorts of people with type 1 diabetes (48 people in total) to compare the pharmacodynamic and pharmacokinetic properties of 0.4 and 0.6 U/kg/day insulin glargine 300 Units/mL (Toujeo®, Gla-300) with the same dose levels of insulin degludec 100 Units/mL (Deg-100) in steady state after 8 days multiple dosing regimen. Within-day fluctuation of the smoothed glucose infusion rate (GIR-smFL0-24) was significantly lower with Gla-300 versus Deg-100 at the 0.4 U/kg dose level. At the 0.4 U/kg dose level, relative 6-hour fractions of GIR-AUC0-24 were more evenly distributed with Gla-300 versus Deg-100. GIR-smFL0-24 and 6-hour fractions of GIR-AUC0-24 were similar between insulins at the supra-therapeutic 0.6 U/kg dose level. At both dose levels, GIR-AUC0-24 and GIRmax were lower for Gla-300 versus Deg-100, while T50%-GIR-AUC0-24 and duration of BG control were similar foreach insulin. Both dose levels of Gla-300 provided plateau-like insulin profiles up to 16 hours post-dose, followed by a subsequent slow decline. For Deg-100, insulin increased at both dose levels from the time of injection until ~10 hours after dosing, with subsequent slow decline. Exposure of both insulins was measurable until clamp end (30 hours). At both dose levels the 6-hour fractions of INS-AUC0-24 were more evenly distributed with Gla-300 versus Deg-100. Continuous glucose monitoring (CGM), is a valuable way to confirm whether the differences observed in the PK and PD properties of insulins under experimental condition translate to clinically relevant differences in their 24-hour glucose profiles and other parameters of glycemic control, including hypoglycemia. This was a multicenter, 16-week, open-label, Phase II, parallel-group, two-period crossover study including 59 people with type 1 diabetes (PDY12777; NCT01658579). The primary endpoint was the mean percentage of time within the glucose range of 4.4-7.8 mmol/L (80-140 mg/dL) during the last 2 weeks of treatment in each treatment period (Weeks 7-8 and Weeks 15-16). The main secondary endpoints were the average 24-hour glucose profiles based on CGM (mmol/L) for the last 2 weeks of treatment in each treatment period and the incidence of participants experiencing at least one hypoglycemic event (defined by American Diabetes Association criteria) in either study period. The percentage of time within the glucose range of 4.4-7.8 mmol/L (primary endpoint) was similar for participants receiving Gla-300 vs Gla-100 (LS mean difference 0.75%, p=0.73). Average 24-hour glucose profiles showed a more constant glucose level with Gla-300 vs. Gla-100. Toujeo® is a once-daily basal insulin based on a broadly-used molecule (insulin glargine). Toujeo has been approved by the U.S. Food and Drug Administration (FDA), the European Commission, Health Canada, the Therapeutic Goods Administration in Australia, and the MHLW in Japan (where its approved brand name is Lantus® XR), and is under review by other regulatory authorities around the world. Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Merial.


- Toujeo® provides a flatter profile than insulin degludec with less within-day fluctuations - Sanofi presented today the full results of a pharmacokinetic / pharmacodynamic (PK/PD) study with Toujeo® (insulin glargine 300 Units/mL) and insulin degludec 100 Units/mL (Deg-100) at the 16th Annual Diabetes Technology Meeting, Bethesda, Maryland, U.S.[1] In patients with type 1 diabetes, the Toujeo® PK/PD profile at a clinically relevant dose (0.4 U/kg/day, the average dose used in worldwide clinical practice)[2] was flatter and more evenly distributed over 24 hours compared with the profile of insulin degludec. The within-day fluctuation of metabolic activity was 20% lower (p=0.047) for Toujeo® than insulin degludec. An overall flat PK/PD profile and an evenly distributed exposure over 24 hours were observed for Toujeo® at both dose levels studied (0.4 and 0.6 U/kg/day). "These new findings may have clinical implications for people with type 1 diabetes on basal insulin therapy," said Dr. Timothy Bailey, Clinical Associate Professor, University of California, San Diego. "Toujeo® has already shown an improved PK/PD profile when compared to insulin glargine 100 Units/mL (Gla-100), with a flatter profile. Also in a previous CGM study[3] in adults with type 1 diabetes versus Gla-100, Toujeo showed less between-day variability and less within-day fluctuations, associated with a lower risk of nocturnal confirmed ( 54 mg/dL) or severe hypoglycemia in the first 8 weeks.[3] The results observed in the current PK/PD study comparing Toujeo® versus Deg-100 confirm that Toujeo has an interesting profile with the potential to help the people with diabetes to reach their targets with less risk of hypoglycemia." "In this PK/PD study, we observed a more favorable profile for Toujeo® compared to insulin degludec," said Riccardo Perfetti, Head of Global Diabetes Medical Team, Sanofi. "The clinical implications of these findings are currently being investigated." Although basal insulin injections cannot perfectly replicate endogenous insulin production, the 'ideal' basal insulin for diabetes therapy would have stable pharmacodynamic (PD) and pharmacokinetic (PK) profiles. Smaller and less variable glucose excursions may result in more predictable 24hour profiles and less hypoglycemia, and could translate into an improved experience for people on basal insulin and better adherence to therapy. This was a randomized, double-blind, 2x2, crossover, euglycemic-clamp study in two parallel cohorts of people with type 1 diabetes (48 people in total) to compare the pharmacodynamic and pharmacokinetic properties of 0.4 and 0.6 U/kg/day insulin glargine 300 Units/mL (Toujeo®, Gla-300) with the same dose levels of insulin degludec 100 Units/mL (Deg-100) in steady state after 8 days multiple dosing regimen. Within-day fluctuation of the smoothed glucose infusion rate (GIR-smFL0-24) was significantly lower with Gla-300 versus Deg-100 at the 0.4 U/kg dose level. At the 0.4 U/kg dose level, relative 6-hour fractions of GIR-AUC0-24 were more evenly distributed with Gla-300 versus Deg-100. GIR-smFL0-24 and 6-hour fractions of GIR-AUC0-24 were similar between insulins at the supra-therapeutic 0.6 U/kg dose level. At both dose levels, GIR-AUC0-24 and GIRmax were lower for Gla-300 versus Deg-100, while T50%-GIR-AUC0-24 and duration of BG control were similar for each insulin. Both dose levels of Gla-300 provided plateau-like insulin profiles up to 16 hours post-dose, followed by a subsequent slow decline. For Deg-100, insulin increased at both dose levels from the time of injection until ~10 hours after dosing, with subsequent slow decline. Exposure of both insulins was measurable until clamp end (30 hours). At both dose levels the 6-hour fractions of INS-AUC0-24 were more evenly distributed with Gla-300 versus Deg-100. Continuous glucose monitoring (CGM), is a valuable way to confirm whether the differences observed in the PK and PD properties of insulins under experimental condition translate to clinically relevant differences in their 24-hour glucose profiles and other parameters of glycemic control, including hypoglycemia. This was a multicenter, 16-week, open-label, Phase II, parallel-group, two-period crossover study including 59 people with type 1 diabetes (PDY12777; NCT01658579). The primary endpoint was the mean percentage of time within the glucose range of 4.4-7.8 mmol/L (80-140 mg/dL) during the last 2 weeks of treatment in each treatment period (Weeks 7-8 and Weeks 15-16). The main secondary endpoints were the average 24-hour glucose profiles based on CGM (mmol/L) for the last 2 weeks of treatment in each treatment period and the incidence of participants experiencing at least one hypoglycemic event (defined by American Diabetes Association criteria) in either study period. The percentage of time within the glucose range of 4.4-7.8 mmol/L (primary endpoint) was similar for participants receiving Gla-300 vs Gla-100 (LS mean difference 0.75%, p=0.73). Average 24-hour glucose profiles showed a more constant glucose level with Gla-300 vs. Gla-100. Toujeo® is a once-daily basal insulin based on a broadly-used molecule (insulin glargine). Toujeo has been approved by the U.S. Food and Drug Administration (FDA), the European Commission, Health Canada, the Therapeutic Goods Administration in Australia, and the MHLW in Japan (where its approved brand name is Lantus® XR), and is under review by other regulatory authorities around the world. Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Merial.


News Article | November 29, 2016
Site: www.prweb.com

AxioMed is pleased to announce the success of the first viscoelastic Freedom cervical case in Australia. Dr. Richard Laherty of Queensland Neurosurgery & Spine Surgery completed the procedure on Monday, November 28th at the Princess Alexandria Hospital in Brisbane, Australia. The procedure was performed on a 47-year-old male patient suffering from degenerative disc disease with radiculopathy, as a result of degenerative cervical discs at levels C5-7. The patient failed conservative treatments prior to undergoing surgery. The AxioMed viscoelastic disc is a next-generation disc replacement that restores natural disc height, lordosis, stability, and motion in the human spine. AxioMed was approved in September to market and sell their viscoelastic cervical and lumbar Freedom total disc replacements in Australia by the Therapeutic Goods Administration. Dr. Richard Laherty spoke to the advantages of the AxioMed cervical disc after the operation: “The Freedom cervical disc is extremely easy to implant and has a great anatomical fit for restoring disc height and lordosis in the cervical spines of my patients. I am excited to have this viscoelastic technology that mimics the natural motion of a healthy human disc, and to make this solution available to my patients. It will provide a faster surgical recovery time and increase a patient’s overall health and satisfaction.” AxioMed CEO Dr. Kingsley Chin explained how an experience like Dr. Laherty’s aligns with AxioMed’s vision: “AxioMed believes it can replicate the success of total joint restoration in the spine with our innovative and advanced viscoelastic total disc replacements with a high degree of patient satisfaction.” Dr. Chin added, “With the addition of the lateral lumbar technique, we expect AxioMed to be the worldwide leader in disc replacement surgery.” Dr. Laherty currently practices general neurosurgery with a special interest in minimally invasive surgical techniques for management of complex spine conditions. Dr. Laherty graduated from University of Queensland and completed postgraduate fellowship training at Princess Alexandra Hospital, Brisbane and St. Vincents and Concorde Hospitals in Sydney. He is extensively involved in both research and training young neurosurgeons in the latest technologies via his roles at both Princess Alexandra Hospital and the University of Queensland. About AxioMed Founded in 2001, AxioMed (http://www.axiomed.com/) began its journey of exhaustively proving the Freedom® Disc through clinical studies in the USA and Europe, research, development and testing. In 2014, KICVentures recognized the disc’s enormous potential and acquired the company into their healthcare portfolio. AxioMed owns an exclusive viscoelastic material license on its proprietary Freedom Disc technology.


News Article | October 28, 2016
Site: www.prweb.com

Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that it is to provide fill-finish production services for the commercial supply of SB4, a biosimilar referencing Enbrel® [1] (etanercept), on behalf of the Korea-based biopharmaceutical company Samsung Bioepis Co., Ltd. The services will be provided at Catalent’s flagship sterile pre-filled syringe facility in Brussels, Belgium. Used in the treatment of adults with moderate to severe rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis, SB4 is the first etanercept biosimilar to receive regulatory approval by the European Commission (EC), as Benepali®. [2] SB4 has also received regulatory approvals from Korea’s Ministry of Food and Drug Safety (MFDS), Australia’s Therapeutic Goods Administration (TGA), and Canada’s Health Canada, as BRENZYS™. [3,4] “We are proud to have partnered with Samsung Bioepis on the launch of this biosimilar therapy, which was the first etanercept biosimilar to receive European Commission approval, and look forward to a continued partnership as we continue to commercial supply,” commented Jonathan Arnold, Vice President & General Manager, Drug Delivery Solutions at Catalent. Catalent’s 265,000 square foot Brussels facility offers the latest in innovative pre-filled syringe fill-finish processing and associated packaging. With experts in technology transfer, scale-up and life-cycle management, its annual syringe filling capacity is more than 200 million units. 1 Enbrel is a registered trademark of Immunex Corp. 2 Benepali® is a registered European trademark of Biogen Idec International Holding Ltd. 3 BRENZYS™ has not been approved for the treatment of patients with psoriatic arthritis and plaque psoriasis in Canada 4 BRENZYS™ is a trademark of Merck Sharp & Dohme Corp. About Samsung Bioepis Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of 13 biosimilar candidates that include six first-wave candidates that cover the therapeutic areas of immunology, oncology and diabetes. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: http://www.samsungbioepis.com About Catalent Catalent is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 9,200 people, including over 1,400 scientists, at more than 30 facilities across five continents, and in fiscal 2016 generated $1.85 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit http://www.catalent.com


IRVINE, Calif., Dec. 19, 2016 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today that the Australian Therapeutic Goods Administration (TGA) has approved the AFX®2 Bifurcated Endograft System for inclusion on the Australian Register of Therapeutic Goods. The TGA has approved the use of AFX2 for the treatment of abdominal aortic aneurysms (AAAs). Vikram Puttaswamy, MD, vascular surgeon at Sydney Vascular Surgery in Sydney, Australia, commented, “We are pleased with the approval of AFX2 in Australia and look forward to providing this new technology to our patients.  AFX2 and its unique ability to preserve the aortic bifurcation represents an important addition to our endovascular AAA treatment options.” AFX2 reduces procedure steps for the delivery and deployment of the bifurcated endograft.  The new device also facilitates percutaneous endovascular aneurysm repair, or PEVAR, by providing the lowest profile contralateral access through a 7F introducer. These improvements bring together Endologix's ActiveSeal™ technology and DuraPly™ ePTFE graft material into an integrated new EVAR system. John McDermott, Chief Executive Officer of Endologix, said, “The original concept of anatomical fixation was first introduced in 1999 and has been used to treat over 75,000 patients worldwide with AAA. Over the years we have collaborated with physicians to make design improvements and procedural enhancements to treat more patients more effectively. The latest version of the device, AFX2, was designed to incorporate 17 years of clinical experience together with rigorous testing to provide physicians and their patients with excellent long-term clinical outcomes.” Mr. McDermott added, “The TGA approval of AFX2 in Australia will allow us to begin offering the latest version of our unique anatomical fixation system to physicians and patients beginning in 2017. It also provides additional third party support on the safety and efficacy of the AFX2 system, reinforcing the positive clinical results we have seen with AFX and AFX2 since launching the system in other parts of the world earlier this year.” About Endologix, Inc. Endologix, Inc., develops and manufactures minimally invasive treatments for aortic disorders. The Company's focus is endovascular stent grafts for the treatment of abdominal aortic aneurysms (AAA). AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAA is approximately 80%, making it a leading cause of death in the United States. Additional information can be found on Endologix's website at www.endologix.com. Forward-Looking Statements This communication includes statements that may be "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to the benefits of the AFX2 system and the anticipated market release and commercial launch of the AFX2 system, the accuracy of which are necessarily subject to risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Endologix. Many factors may cause actual results to differ materially from anticipated results, including delays in the market release and commercial launch of the AFX2 system, unanticipated clinical results for the AFX2 system and clinician acceptance of the AFX2 system.  Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Endologix undertakes no obligation to update any forward looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Endologix's Annual Report on Form 10-K for the year ended December 31, 2015, and Endologix's subsequent filings with the Securities and Exchange Commission, for more detailed information regarding these risks and other factors that may cause actual results to differ materially from those expressed or implied.


IRVINE, Calif., Dec. 19, 2016 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today that the Australian Therapeutic Goods Administration (TGA) has approved the AFX®2 Bifurcated Endograft System for inclusion on the Australian Register of Therapeutic Goods. The TGA has approved the use of AFX2 for the treatment of abdominal aortic aneurysms (AAAs). Vikram Puttaswamy, MD, vascular surgeon at Sydney Vascular Surgery in Sydney, Australia, commented, “We are pleased with the approval of AFX2 in Australia and look forward to providing this new technology to our patients.  AFX2 and its unique ability to preserve the aortic bifurcation represents an important addition to our endovascular AAA treatment options.” AFX2 reduces procedure steps for the delivery and deployment of the bifurcated endograft.  The new device also facilitates percutaneous endovascular aneurysm repair, or PEVAR, by providing the lowest profile contralateral access through a 7F introducer. These improvements bring together Endologix's ActiveSeal™ technology and DuraPly™ ePTFE graft material into an integrated new EVAR system. John McDermott, Chief Executive Officer of Endologix, said, “The original concept of anatomical fixation was first introduced in 1999 and has been used to treat over 75,000 patients worldwide with AAA. Over the years we have collaborated with physicians to make design improvements and procedural enhancements to treat more patients more effectively. The latest version of the device, AFX2, was designed to incorporate 17 years of clinical experience together with rigorous testing to provide physicians and their patients with excellent long-term clinical outcomes.” Mr. McDermott added, “The TGA approval of AFX2 in Australia will allow us to begin offering the latest version of our unique anatomical fixation system to physicians and patients beginning in 2017. It also provides additional third party support on the safety and efficacy of the AFX2 system, reinforcing the positive clinical results we have seen with AFX and AFX2 since launching the system in other parts of the world earlier this year.” About Endologix, Inc. Endologix, Inc., develops and manufactures minimally invasive treatments for aortic disorders. The Company's focus is endovascular stent grafts for the treatment of abdominal aortic aneurysms (AAA). AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAA is approximately 80%, making it a leading cause of death in the United States. Additional information can be found on Endologix's website at www.endologix.com. Forward-Looking Statements This communication includes statements that may be "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to the benefits of the AFX2 system and the anticipated market release and commercial launch of the AFX2 system, the accuracy of which are necessarily subject to risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Endologix. Many factors may cause actual results to differ materially from anticipated results, including delays in the market release and commercial launch of the AFX2 system, unanticipated clinical results for the AFX2 system and clinician acceptance of the AFX2 system.  Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Endologix undertakes no obligation to update any forward looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Endologix's Annual Report on Form 10-K for the year ended December 31, 2015, and Endologix's subsequent filings with the Securities and Exchange Commission, for more detailed information regarding these risks and other factors that may cause actual results to differ materially from those expressed or implied.


According to the latest market report published by Persistence Market Research titled ‘Global Market Study on Compounding Pharmacies: Asia Pacific is expected to witness highest growth by 2021’, the global compounding pharmacies market is projected to expand at a CAGR of 6% during the forecast period (2015 - 2021). Compounding pharmacies accounted for market revenue worth US$ 6.5 Bn in 2014 and the revenue is expected to increase to US$ 9.75 Bn by 2021. Compounding pharmacies produce personalized medicines, which can be altered by dosages, medicinal strengths, forms, and medium of administration, under the guidance of licensed pharmacists and physicians. The market for compounding pharmacies – though shrouded by regulatory restrictions and product quality conformations – presents a lucrative opportunity as compounded drugs offer ease of accessibility, affordability, and administration to potential customers. The report analyzes the global compounding pharmacies market in terms of market value by end use, product, region, and therapeutic area; and provides information regarding regional market dynamics, regulations, PEST analysis, competitive landscape, current trends, market estimations, and forecast. Among therapeutic segments, compounding pharmacies find largest application in the pain management industry followed by hormone replacement therapy and others. The hormone replacement therapy segment is expected to gain traction in the near future due to increasing demand for anti-ageing solutions. Increasing demand for high-quality dermatological products is also influencing manufacturers to opt for better quality active pharmaceutical ingredients and maintain a sterile microbial contamination-free manufacturing space. Creams and gels are the most popular products in dermatology, followed by transdermal application products, largely popular in tropical countries. By end use type, the compounding pharmacies market is segmented into medications for adults, children, and geriatric population along with veterinary drugs. Medications for the adult segment is expected to dominate the overall compounding pharmacies market by the end of the forecast period. The segment is projected to register an above average growth rate over the forecast period. However, veterinary compounded drugs are also gaining traction as these drugs are available in alternate forms and in varying strengths not commercially available. Globally, Asia Pacific is expected to dominate the market throughout the forecast period, driven by the promotion of innovative therapies and product formulations by major players in the market. Singapore and Australia are the two major growth promoting countries for compounding pharmacies in Asia Pacific. The compounding pharmacies market in Singapore is expected to increase from a current estimated value of US$ 204.9 Mn in 2015 to US$ 387.2 Mn by 2021, registering a CAGR of 11% over the forecast period. Increase in demand for drugs prone to medicinal drought, personalized dosages, and innovative therapeutic areas is expected to boost overall demand for compounding pharmacies worldwide. Upcoming regulatory harmonization and the need for manufacturing facilities to adhere to good manufacturing practices listed under the U.S. and EU pharmacopeias are set to standardize the compounding pharmacies market. Compounded drug manufacturers in Australia have been mandated to adhere by rules listed under the Australian Therapeutic Goods Administration (TGA). Latin America and Europe are the subsequent lucrative destinations for compounding pharmacies. Key market players covered in the report include B. Braun Melsungen AG Company, Fagron, PharMEDium Services LLC, Institutional Pharmacy Solutions, Cantrell Drug Company, Triangle Compounding Pharmacies, Lorraine’s Pharmacy, and Fresenius Kabi AG.


IRVINE, Calif., Dec. 19, 2016 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today that the Australian Therapeutic Goods Administration (TGA) has approved the AFX®2 Bifurcated Endograft System for inclusion on the Australian Register of Therapeutic Goods. The TGA has approved the use of AFX2 for the treatment of abdominal aortic aneurysms (AAAs). Vikram Puttaswamy, MD, vascular surgeon at Sydney Vascular Surgery in Sydney, Australia, commented, “We are pleased with the approval of AFX2 in Australia and look forward to providing this new technology to our patients.  AFX2 and its unique ability to preserve the aortic bifurcation represents an important addition to our endovascular AAA treatment options.” AFX2 reduces procedure steps for the delivery and deployment of the bifurcated endograft.  The new device also facilitates percutaneous endovascular aneurysm repair, or PEVAR, by providing the lowest profile contralateral access through a 7F introducer. These improvements bring together Endologix's ActiveSeal™ technology and DuraPly™ ePTFE graft material into an integrated new EVAR system. John McDermott, Chief Executive Officer of Endologix, said, “The original concept of anatomical fixation was first introduced in 1999 and has been used to treat over 75,000 patients worldwide with AAA. Over the years we have collaborated with physicians to make design improvements and procedural enhancements to treat more patients more effectively. The latest version of the device, AFX2, was designed to incorporate 17 years of clinical experience together with rigorous testing to provide physicians and their patients with excellent long-term clinical outcomes.” Mr. McDermott added, “The TGA approval of AFX2 in Australia will allow us to begin offering the latest version of our unique anatomical fixation system to physicians and patients beginning in 2017. It also provides additional third party support on the safety and efficacy of the AFX2 system, reinforcing the positive clinical results we have seen with AFX and AFX2 since launching the system in other parts of the world earlier this year.” About Endologix, Inc. Endologix, Inc., develops and manufactures minimally invasive treatments for aortic disorders. The Company's focus is endovascular stent grafts for the treatment of abdominal aortic aneurysms (AAA). AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAA is approximately 80%, making it a leading cause of death in the United States. Additional information can be found on Endologix's website at www.endologix.com. Forward-Looking Statements This communication includes statements that may be "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to the benefits of the AFX2 system and the anticipated market release and commercial launch of the AFX2 system, the accuracy of which are necessarily subject to risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Endologix. Many factors may cause actual results to differ materially from anticipated results, including delays in the market release and commercial launch of the AFX2 system, unanticipated clinical results for the AFX2 system and clinician acceptance of the AFX2 system.  Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Endologix undertakes no obligation to update any forward looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Endologix's Annual Report on Form 10-K for the year ended December 31, 2015, and Endologix's subsequent filings with the Securities and Exchange Commission, for more detailed information regarding these risks and other factors that may cause actual results to differ materially from those expressed or implied.


IRVINE, Calif., Dec. 19, 2016 (GLOBE NEWSWIRE) -- Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today that the Australian Therapeutic Goods Administration (TGA) has approved the AFX®2 Bifurcated Endograft System for inclusion on the Australian Register of Therapeutic Goods. The TGA has approved the use of AFX2 for the treatment of abdominal aortic aneurysms (AAAs). Vikram Puttaswamy, MD, vascular surgeon at Sydney Vascular Surgery in Sydney, Australia, commented, “We are pleased with the approval of AFX2 in Australia and look forward to providing this new technology to our patients.  AFX2 and its unique ability to preserve the aortic bifurcation represents an important addition to our endovascular AAA treatment options.” AFX2 reduces procedure steps for the delivery and deployment of the bifurcated endograft.  The new device also facilitates percutaneous endovascular aneurysm repair, or PEVAR, by providing the lowest profile contralateral access through a 7F introducer. These improvements bring together Endologix's ActiveSeal™ technology and DuraPly™ ePTFE graft material into an integrated new EVAR system. John McDermott, Chief Executive Officer of Endologix, said, “The original concept of anatomical fixation was first introduced in 1999 and has been used to treat over 75,000 patients worldwide with AAA. Over the years we have collaborated with physicians to make design improvements and procedural enhancements to treat more patients more effectively. The latest version of the device, AFX2, was designed to incorporate 17 years of clinical experience together with rigorous testing to provide physicians and their patients with excellent long-term clinical outcomes.” Mr. McDermott added, “The TGA approval of AFX2 in Australia will allow us to begin offering the latest version of our unique anatomical fixation system to physicians and patients beginning in 2017. It also provides additional third party support on the safety and efficacy of the AFX2 system, reinforcing the positive clinical results we have seen with AFX and AFX2 since launching the system in other parts of the world earlier this year.” About Endologix, Inc. Endologix, Inc., develops and manufactures minimally invasive treatments for aortic disorders. The Company's focus is endovascular stent grafts for the treatment of abdominal aortic aneurysms (AAA). AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAA is approximately 80%, making it a leading cause of death in the United States. Additional information can be found on Endologix's website at www.endologix.com. Forward-Looking Statements This communication includes statements that may be "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to the benefits of the AFX2 system and the anticipated market release and commercial launch of the AFX2 system, the accuracy of which are necessarily subject to risks and uncertainties, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Endologix. Many factors may cause actual results to differ materially from anticipated results, including delays in the market release and commercial launch of the AFX2 system, unanticipated clinical results for the AFX2 system and clinician acceptance of the AFX2 system.  Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Endologix undertakes no obligation to update any forward looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Endologix's Annual Report on Form 10-K for the year ended December 31, 2015, and Endologix's subsequent filings with the Securities and Exchange Commission, for more detailed information regarding these risks and other factors that may cause actual results to differ materially from those expressed or implied.

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