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Domestic Growth Helped Pharma Companies to Offset Pricing Pressure in the US

moneylife | June 03, 2019

Rising revenues in the domestic market helped Indian pharmaceutical companies counterbalance the ongoing pricing pressure on generic drugs in the US in the financial year ended 31 March 2019 (FY19), says Fitch Ratings. The US and India are the two key markets served by Indian pharmaceutical companies, which sell predominantly generic drugs. Many of the leading pharmaceutical companies - including Glenmark Pharmaceuticals Ltd, Lupin Ltd and Dr Reddy's Laboratories Ltd (DRL) - reported double-digit growth in their domestic sales, supported by robust growth in chronic categories such as cardiac, anti-diabetics and respiratory, which in turn supported overall industry growth of 11% during FY19. By contrast, Fitch says, growth in the US market remained subdued for many Indian drug-makers, as consolidation of pharma distributors and a faster pace of approvals of new generic drugs by the US Food and Drug Administration (USFDA) has resulted in continued pressure on generic drug pricing over the last few years.  "Companies with a solid record of compliance with the current good manufacturing practices (CGMP) of the USFDA - such as Glenmark - have experienced less severe revenue pressure as they managed to avoid regulatory disruption to existing business, and launched new products leveraging on timely approvals from their abbreviated new drug application (ANDA) pipeline. Similarly, the ramp-up of speciality portfolio and generic launches with 'first-to-file' exclusivity helped some of the larger companies boost their US revenues in fourth quarter (4Q) of FY19," the ratings agency added.

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Methods for deformulating drugs

The FDA has a number of regulatory routes through which a company can seek approval for a generic drug. The most notable is the Abbreviated New Drug Application (ANDA) route whereby a generic company develops an exact copy of the innovator product and can use the safety and efficacy data from the innovator in their submission. This route was facilitated in the 1980s through the Drug Price Competition and Patent Term Restoration Act, informally known as the Hatch-Waxman Act after Senator Orrin Hatch and Representative Henry Waxman who sponsored it. The US government at the time were concerned about the low number of generic drug approvals. Before the Hatch-Waxman act, innovator companies could easily create legal obstacles for companies looking to develop generic medicines; this made generic drug development an unattractive industry. The Hatch-Waxman Act removed many of these obstacles, successfully incentivising generics companies to produce affordable generic medicines, whilst simultaneously protecting innovator companies by allowing them a sufficient exclusivity period after the initial release of their drug and keep innovation profitable.

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Spotlight

Methods for deformulating drugs

The FDA has a number of regulatory routes through which a company can seek approval for a generic drug. The most notable is the Abbreviated New Drug Application (ANDA) route whereby a generic company develops an exact copy of the innovator product and can use the safety and efficacy data from the innovator in their submission. This route was facilitated in the 1980s through the Drug Price Competition and Patent Term Restoration Act, informally known as the Hatch-Waxman Act after Senator Orrin Hatch and Representative Henry Waxman who sponsored it. The US government at the time were concerned about the low number of generic drug approvals. Before the Hatch-Waxman act, innovator companies could easily create legal obstacles for companies looking to develop generic medicines; this made generic drug development an unattractive industry. The Hatch-Waxman Act removed many of these obstacles, successfully incentivising generics companies to produce affordable generic medicines, whilst simultaneously protecting innovator companies by allowing them a sufficient exclusivity period after the initial release of their drug and keep innovation profitable.

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QHP Capital Acquires Lexitas Pharma Services

Lexitas and QHP Capital | July 08, 2022

QHP Capital the management company for NovaQuest Private Equity announced its acquisition of Lexitas Pharma Services a full-service ophthalmology contract research organization supporting biopharmaceutical and medical device clinical trials. Since 2011, Lexitas has provided clinical trial and medical strategy solutions to biopharmaceutical and medical device companies developing ophthalmic products. The Company provides end-to-end support and development expertise in the anterior and posterior segments of ophthalmology. Lexitas has conducted clinical trials for dry eye disease, glaucoma, cataract, uveitis, pediatric myopia, diabetic macular edema, age-related macular degeneration, and retinitis pigmentosa, among others. The Company’s therapeutic area expertise, relationships with ophthalmic KOLs, and network of high-performing research sites has led to strong outcomes for its international customer base. “For the past decade, Lexitas has had the incredible opportunity and privilege to partner with talented companies with amazing science as they develop their ophthalmic drugs and devices. Partnering with the QHP team brings deep expertise and domain knowledge that is going to allow Lexitas to improve and increase the scope, quality, and efficiency of our capabilities. We couldn’t be more thrilled to be working with QHP and are excited at the prospect of getting safe and efficacious ophthalmic drugs to patients efficiently and quickly,” George Magrath, M.D., CEO of Lexitas “Lexitas is an excellent fit with QHP’s philosophy and strategy of providing strategic capital to growing clinical trial services providers in niche, specialized therapeutic areas,” said Vern Davenport and Jeff Edwards, Partners at QHP. “We look forward to supporting the Lexitas team as they continue to build out their capabilities and provide best-in-class ophthalmic drug development services.” Additionally, Lexitas appointed Jeanne Hecht as Executive Chairwoman of the Board. Jeanne is a seasoned ophthalmology CRO industry executive having previously served as CEO of Ora, an ophthalmic CRO, where she expanded Ora’s international presence, introduced new lines of business, and furthered its goals along numerous strategic paths. About Lexitas Lexitas is a full-service ophthalmic biopharmaceutical solutions company focused on providing end-to-end eyecare support and exceptional service to biopharma and medical device clients globally. About QHP Capital QHP Capital, L.P. is the management company for NovaQuest Private Equity NQPE is a private equity firm that invests in lower middle market healthcare companies primarily in North America. The Firm invests in services and technology companies where a strategic partner and operating resources can accelerate growth, targeting companies in healthcare and pharmaceutical services industries. NQPE invests in the form of buyouts, growth equity, and recapitalizations.

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ILC Dover Becomes a Provider of Ascent / Entry Spacesuits for Boeing's Starliner

ILC Dover | May 27, 2022

ILC Dover, the leading provider of spacesuits since the Apollo era, announced that it was selected to be one of two providers of Boeing's Ascent/Entry Suit for the company's Commercial Crew Program and has developed a bespoke AES spacesuit for CST-100 Starliner crews. "We are proud to utilize our expertise to create a new AES for the Starliner spacecraft. Having worked with the Boeing team on the Starliner's landing airbags, which provide a safe, cushioned arrival to Earth from space, we understood the importance of delivering another quality product for this program." Patty Stoll, President of Space Systems and Engineered Solutions at ILC Dover The Boeing AES is based off ILC Dover's commercial Launch, Entry, and Abort suit, SOL™. ILC Dover worked with Boeing to tailor SOL for the Starliner spacecraft to provide protection for astronauts during the most critical phases of spaceflight, including launch, docking, re-entry and landing. With over 50 years of spacesuit experience, the AES suit was designed to provide maximum mobility to operate, enter and exit the spacecraft, as well as provide protection for astronauts in case of an emergency. "Our success is measured by those we've helped return to Earth safely for over 50 years of space travel and we will continue to provide spacesuits and soft solutions that will keep astronauts safe in the harsh environment of space," said Stoll. Working with ILC Dover's in-house fashion designer, the cover layer of the spacesuit was designed with a unique look for Starliner crew members. A replica of the Starliner AES will be on display on Florida's Space Coast at the Kennedy Space Center Visitor Complex's new attraction called Gateway: The Deep Space Launch Complex. ILC Dover and Boeing worked with Adam Savage, television personality and longtime special effects designer and fabricator, to create the replica. About ILC Dover ILC Dover is a world-leader in the innovative design and production of solutions for biopharmaceutical, pharmaceutical, medical device markets as well as a leading supplier for the space industries. Our customers will attest to our relentless dedication to high value products, advanced technology, and responsive service, as our visionary solutions have improved efficiency while safeguarding people, product, and infrastructure in hazardous conditions through flexible protective solutions since 1947.

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Aditxt, Inc. Successfully Completes Preclinical Toxicity Study of Its Psoriasis Drug Candidate ADI™-100 Advancing it Closer to First-in-Human Trials

Aditxt | July 11, 2022

Aditxt, Inc. a biotech innovation company developing and commercializing technologies focused on monitoring and reprogramming the immune system, today announces that its therapeutic program Adimune™, has successfully completed a toxicology study that indicates the safety profile of ADI™-100, the Company’s immunotherapeutic technology drug that addresses rejection of transplanted organs, skin allografting, autoimmune diseases and allergies. The toxicology findings will provide vital supporting evidence when the Company files an Investigational New Drug application with the regulatory agencies. “Our drug is truly antigen-specific in the treatment of autoimmune diseases. In preparation of the clinical study, we performed a toxicology study and found: no premature death, no signs of local intolerance, no test item-related influence on clinical signs, body weight and body weight gains, food consumption, biochemistry or urinalysis. No anti-nuclear antibodies, no macroscopic post-mortem findings, no changes in histopathology were noted, confirming the safety profile of our drug product, which we have seen in all pre-clinical experiments before.” Joachim-Friedrich Kapp, M.D., Ph.D., Aditxt senior vice president of Clinical Development-Autoimmunity ADI™-100 consists of two DNA molecules, which together restore immune tolerance in autoimmune disease and establish tolerance in allogeneic skin transplantation applied in large skin wounds. Modulating the immune system by restoring/inducing tolerance is a unique mechanism of action, with a potentially huge efficacy and safety benefit for the patients affected because there is no immunosuppression involved. “These findings are very promising,” said Dr. Kapp. Amro Albanna, co-founder and CEO of Aditxt, said the encouraging toxicology results of ADI™-100 illustrate the Company’s commitment to advancing promising technologies to address rising unmet needs of patients with autoimmune diseases and those needing life-saving organ transplantation procedures. “We are excited about the progress Adimune™ is making towards human trials, which represents a significant inflection point for the program and Aditxt as a whole,” Albanna said. “Adimune™ is an example of our business model accelerating promising innovation into commercialization and monetization.” “In addition, and separately, we clearly demonstrated that our drug does not display any general immunosuppressive effect,” Dr. Kapp explains. “This was shown in safety studies, when using a Listeria model for infection and a melanoma model for potential effects on tumor growth. As one could have predicted, considering the mechanism of action, there was no interference with the immune system and its capacity to fight infection or tumor disease, at all. These findings are very promising and certainly will support our story when filing the IND.” About Aditxt Aditxt is a biotech innovation company developing and commercializing technologies focused on monitoring and reprogramming the immune system. Aditxt’s immune monitoring technologies are designed to provide a personalized immune profile. Aditxt’s immune reprogramming technologies, currently preclinical, are being developed to retrain the immune system to induce tolerance to address rejection of transplanted organs, autoimmune diseases, and allergies.

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QHP Capital Acquires Lexitas Pharma Services

Lexitas and QHP Capital | July 08, 2022

QHP Capital the management company for NovaQuest Private Equity announced its acquisition of Lexitas Pharma Services a full-service ophthalmology contract research organization supporting biopharmaceutical and medical device clinical trials. Since 2011, Lexitas has provided clinical trial and medical strategy solutions to biopharmaceutical and medical device companies developing ophthalmic products. The Company provides end-to-end support and development expertise in the anterior and posterior segments of ophthalmology. Lexitas has conducted clinical trials for dry eye disease, glaucoma, cataract, uveitis, pediatric myopia, diabetic macular edema, age-related macular degeneration, and retinitis pigmentosa, among others. The Company’s therapeutic area expertise, relationships with ophthalmic KOLs, and network of high-performing research sites has led to strong outcomes for its international customer base. “For the past decade, Lexitas has had the incredible opportunity and privilege to partner with talented companies with amazing science as they develop their ophthalmic drugs and devices. Partnering with the QHP team brings deep expertise and domain knowledge that is going to allow Lexitas to improve and increase the scope, quality, and efficiency of our capabilities. We couldn’t be more thrilled to be working with QHP and are excited at the prospect of getting safe and efficacious ophthalmic drugs to patients efficiently and quickly,” George Magrath, M.D., CEO of Lexitas “Lexitas is an excellent fit with QHP’s philosophy and strategy of providing strategic capital to growing clinical trial services providers in niche, specialized therapeutic areas,” said Vern Davenport and Jeff Edwards, Partners at QHP. “We look forward to supporting the Lexitas team as they continue to build out their capabilities and provide best-in-class ophthalmic drug development services.” Additionally, Lexitas appointed Jeanne Hecht as Executive Chairwoman of the Board. Jeanne is a seasoned ophthalmology CRO industry executive having previously served as CEO of Ora, an ophthalmic CRO, where she expanded Ora’s international presence, introduced new lines of business, and furthered its goals along numerous strategic paths. About Lexitas Lexitas is a full-service ophthalmic biopharmaceutical solutions company focused on providing end-to-end eyecare support and exceptional service to biopharma and medical device clients globally. About QHP Capital QHP Capital, L.P. is the management company for NovaQuest Private Equity NQPE is a private equity firm that invests in lower middle market healthcare companies primarily in North America. The Firm invests in services and technology companies where a strategic partner and operating resources can accelerate growth, targeting companies in healthcare and pharmaceutical services industries. NQPE invests in the form of buyouts, growth equity, and recapitalizations.

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ILC Dover Becomes a Provider of Ascent / Entry Spacesuits for Boeing's Starliner

ILC Dover | May 27, 2022

ILC Dover, the leading provider of spacesuits since the Apollo era, announced that it was selected to be one of two providers of Boeing's Ascent/Entry Suit for the company's Commercial Crew Program and has developed a bespoke AES spacesuit for CST-100 Starliner crews. "We are proud to utilize our expertise to create a new AES for the Starliner spacecraft. Having worked with the Boeing team on the Starliner's landing airbags, which provide a safe, cushioned arrival to Earth from space, we understood the importance of delivering another quality product for this program." Patty Stoll, President of Space Systems and Engineered Solutions at ILC Dover The Boeing AES is based off ILC Dover's commercial Launch, Entry, and Abort suit, SOL™. ILC Dover worked with Boeing to tailor SOL for the Starliner spacecraft to provide protection for astronauts during the most critical phases of spaceflight, including launch, docking, re-entry and landing. With over 50 years of spacesuit experience, the AES suit was designed to provide maximum mobility to operate, enter and exit the spacecraft, as well as provide protection for astronauts in case of an emergency. "Our success is measured by those we've helped return to Earth safely for over 50 years of space travel and we will continue to provide spacesuits and soft solutions that will keep astronauts safe in the harsh environment of space," said Stoll. Working with ILC Dover's in-house fashion designer, the cover layer of the spacesuit was designed with a unique look for Starliner crew members. A replica of the Starliner AES will be on display on Florida's Space Coast at the Kennedy Space Center Visitor Complex's new attraction called Gateway: The Deep Space Launch Complex. ILC Dover and Boeing worked with Adam Savage, television personality and longtime special effects designer and fabricator, to create the replica. About ILC Dover ILC Dover is a world-leader in the innovative design and production of solutions for biopharmaceutical, pharmaceutical, medical device markets as well as a leading supplier for the space industries. Our customers will attest to our relentless dedication to high value products, advanced technology, and responsive service, as our visionary solutions have improved efficiency while safeguarding people, product, and infrastructure in hazardous conditions through flexible protective solutions since 1947.

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Aditxt, Inc. Successfully Completes Preclinical Toxicity Study of Its Psoriasis Drug Candidate ADI™-100 Advancing it Closer to First-in-Human Trials

Aditxt | July 11, 2022

Aditxt, Inc. a biotech innovation company developing and commercializing technologies focused on monitoring and reprogramming the immune system, today announces that its therapeutic program Adimune™, has successfully completed a toxicology study that indicates the safety profile of ADI™-100, the Company’s immunotherapeutic technology drug that addresses rejection of transplanted organs, skin allografting, autoimmune diseases and allergies. The toxicology findings will provide vital supporting evidence when the Company files an Investigational New Drug application with the regulatory agencies. “Our drug is truly antigen-specific in the treatment of autoimmune diseases. In preparation of the clinical study, we performed a toxicology study and found: no premature death, no signs of local intolerance, no test item-related influence on clinical signs, body weight and body weight gains, food consumption, biochemistry or urinalysis. No anti-nuclear antibodies, no macroscopic post-mortem findings, no changes in histopathology were noted, confirming the safety profile of our drug product, which we have seen in all pre-clinical experiments before.” Joachim-Friedrich Kapp, M.D., Ph.D., Aditxt senior vice president of Clinical Development-Autoimmunity ADI™-100 consists of two DNA molecules, which together restore immune tolerance in autoimmune disease and establish tolerance in allogeneic skin transplantation applied in large skin wounds. Modulating the immune system by restoring/inducing tolerance is a unique mechanism of action, with a potentially huge efficacy and safety benefit for the patients affected because there is no immunosuppression involved. “These findings are very promising,” said Dr. Kapp. Amro Albanna, co-founder and CEO of Aditxt, said the encouraging toxicology results of ADI™-100 illustrate the Company’s commitment to advancing promising technologies to address rising unmet needs of patients with autoimmune diseases and those needing life-saving organ transplantation procedures. “We are excited about the progress Adimune™ is making towards human trials, which represents a significant inflection point for the program and Aditxt as a whole,” Albanna said. “Adimune™ is an example of our business model accelerating promising innovation into commercialization and monetization.” “In addition, and separately, we clearly demonstrated that our drug does not display any general immunosuppressive effect,” Dr. Kapp explains. “This was shown in safety studies, when using a Listeria model for infection and a melanoma model for potential effects on tumor growth. As one could have predicted, considering the mechanism of action, there was no interference with the immune system and its capacity to fight infection or tumor disease, at all. These findings are very promising and certainly will support our story when filing the IND.” About Aditxt Aditxt is a biotech innovation company developing and commercializing technologies focused on monitoring and reprogramming the immune system. Aditxt’s immune monitoring technologies are designed to provide a personalized immune profile. Aditxt’s immune reprogramming technologies, currently preclinical, are being developed to retrain the immune system to induce tolerance to address rejection of transplanted organs, autoimmune diseases, and allergies.

Read More

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