This document contains forward-looking statements about Impax Laboratories' presentation at the 33rd Annual J.P. Morgan Healthcare Conference on January 13, 2015. The summary discusses Impax's focus on quality improvements, commercial success in 2014, proposed acquisition of CorePharma, and multiple opportunities to drive growth through their generic pipeline, RYTARY, business development, and a strong balance sheet. The acquisition of CorePharma is highlighted as expanding Impax's generic and branded portfolios and pipeline while growing and diversifying its revenue base.
Cowen & co health care conference march 2 2015impax-labs
- Impax provides a presentation summarizing its business, including an overview of its generic and branded pharmaceutical platforms, key areas of focus, and growth opportunities.
- It discusses its recent financial performance and growth, the approval and commercialization plans for its Parkinson's drug RYTARY, and a proposed acquisition of CorePharma that would expand its generic and branded portfolios.
- The presentation includes financial projections for RYTARY sales, pro forma financials assuming the CorePharma acquisition, and reconciliations of GAAP to non-GAAP financial metrics.
This document contains forward-looking statements from Impax Laboratories regarding their financial projections, product pipeline and opportunities for growth. Some of the key points include:
- Impax expects revenue growth from the commercialization of their Parkinson's drug RYTARY, with projections of $275-350M in US sales by 2019.
- Their generics division has 30-48% potential for first-to-file or first-to-market opportunities among pending ANDAs, with expected product launches in 2015 addressing $1.6B in total market sales.
- Following the acquisition of CorePharma, Impax estimates their revenue mix will shift to 75-80% generics and 20-25% branded products, divers
Jp morgan 34th annual healthcare conferenceimpax-labs
Impax provides a cautionary statement regarding forward-looking statements in their presentation at the J.P. Morgan Healthcare Conference. They discuss key priorities for 2016 including maintaining quality and compliance across facilities, optimizing existing generic opportunities and launching up to 16 new generics, effectively utilizing an expanded specialty sales force, optimizing R&D through new product development, and pursuing value-enhancing business development opportunities including licensing for NUMIENT outside the US. Impax is well-positioned for future growth through their dual generic and specialty platforms and established core competencies.
Raymond james insitutional investors conference march 7 2016impax-labs
1) Impax provides a forward-looking statement regarding risks and uncertainties that could impact future results.
2) Impax is well-positioned for future growth with a generic pipeline targeting $18B in sales and a specialty pipeline focused on next-generation opportunities.
3) Impax highlights its established competencies in generic and specialty commercialization, complex formulation and development expertise, and profitability to support growth.
Impax laboratories credit suisse conference nov 11 2014impax-labs
Impax provides a summary of its dual generic and branded business model, focusing on resolving FDA issues, maximizing both platforms, optimizing R&D, and accelerating business development. It highlights recent generic and branded product launches contributing over $190 million and the growth of Zomig Nasal Spray sales. Impax also outlines its reorganization of R&D to strengthen infrastructure, leverage internal strengths, improve efficiencies, and prioritize quality initiatives within scientific operations.
Impax Laboratories Credit Suisse 2013 Healthcare Conference November 14, 2013impax-labs
1) The document contains a "Safe Harbor Statement" noting that statements in the presentation contain forward-looking information and are subject to risks and uncertainties.
2) It discusses Impax Laboratories' positioning for future growth through its generic and branded platforms, established core competencies, and strong financial profile.
3) It provides an overview of Impax's two growth platforms - generics and brands, noting key areas of focus and pipeline products for each.
Impax acquires tower holdings inc and lineage therapeutics inc oct 9 2014impax-labs
Impax to acquire Tower Holdings Inc. and Lineage Therapeutics Inc. for $700 million in cash. The acquisition adds a portfolio of growing branded and generic products that are expected to generate $215-225 million in revenue and $80-85 million in EBITDA in 2014. The deal provides strategic benefits like diversifying Impax's product portfolio and expanding its manufacturing capabilities. It is also expected to be immediately accretive to Impax's earnings per share.
Impax Announces Agreement to Acquire Generic Products - June 21, 2016impax-labs
Impax announces it has agreed to acquire a portfolio of 18 generic products from an undisclosed party for $586 million in cash. The acquisition expands Impax's portfolio of solid oral, injectable, inhalable, and topical generic drugs. It is expected to add $80 million in revenue and $50 million in EBITDA in the second half of 2016 and be immediately accretive to earnings per share. Impax provides updated 2016 financial guidance incorporating the acquisition, projecting at least 15% revenue growth over 2015 to over $860 million.
Cowen & co health care conference march 2 2015impax-labs
- Impax provides a presentation summarizing its business, including an overview of its generic and branded pharmaceutical platforms, key areas of focus, and growth opportunities.
- It discusses its recent financial performance and growth, the approval and commercialization plans for its Parkinson's drug RYTARY, and a proposed acquisition of CorePharma that would expand its generic and branded portfolios.
- The presentation includes financial projections for RYTARY sales, pro forma financials assuming the CorePharma acquisition, and reconciliations of GAAP to non-GAAP financial metrics.
This document contains forward-looking statements from Impax Laboratories regarding their financial projections, product pipeline and opportunities for growth. Some of the key points include:
- Impax expects revenue growth from the commercialization of their Parkinson's drug RYTARY, with projections of $275-350M in US sales by 2019.
- Their generics division has 30-48% potential for first-to-file or first-to-market opportunities among pending ANDAs, with expected product launches in 2015 addressing $1.6B in total market sales.
- Following the acquisition of CorePharma, Impax estimates their revenue mix will shift to 75-80% generics and 20-25% branded products, divers
Jp morgan 34th annual healthcare conferenceimpax-labs
Impax provides a cautionary statement regarding forward-looking statements in their presentation at the J.P. Morgan Healthcare Conference. They discuss key priorities for 2016 including maintaining quality and compliance across facilities, optimizing existing generic opportunities and launching up to 16 new generics, effectively utilizing an expanded specialty sales force, optimizing R&D through new product development, and pursuing value-enhancing business development opportunities including licensing for NUMIENT outside the US. Impax is well-positioned for future growth through their dual generic and specialty platforms and established core competencies.
Raymond james insitutional investors conference march 7 2016impax-labs
1) Impax provides a forward-looking statement regarding risks and uncertainties that could impact future results.
2) Impax is well-positioned for future growth with a generic pipeline targeting $18B in sales and a specialty pipeline focused on next-generation opportunities.
3) Impax highlights its established competencies in generic and specialty commercialization, complex formulation and development expertise, and profitability to support growth.
Impax laboratories credit suisse conference nov 11 2014impax-labs
Impax provides a summary of its dual generic and branded business model, focusing on resolving FDA issues, maximizing both platforms, optimizing R&D, and accelerating business development. It highlights recent generic and branded product launches contributing over $190 million and the growth of Zomig Nasal Spray sales. Impax also outlines its reorganization of R&D to strengthen infrastructure, leverage internal strengths, improve efficiencies, and prioritize quality initiatives within scientific operations.
Impax Laboratories Credit Suisse 2013 Healthcare Conference November 14, 2013impax-labs
1) The document contains a "Safe Harbor Statement" noting that statements in the presentation contain forward-looking information and are subject to risks and uncertainties.
2) It discusses Impax Laboratories' positioning for future growth through its generic and branded platforms, established core competencies, and strong financial profile.
3) It provides an overview of Impax's two growth platforms - generics and brands, noting key areas of focus and pipeline products for each.
Impax acquires tower holdings inc and lineage therapeutics inc oct 9 2014impax-labs
Impax to acquire Tower Holdings Inc. and Lineage Therapeutics Inc. for $700 million in cash. The acquisition adds a portfolio of growing branded and generic products that are expected to generate $215-225 million in revenue and $80-85 million in EBITDA in 2014. The deal provides strategic benefits like diversifying Impax's product portfolio and expanding its manufacturing capabilities. It is also expected to be immediately accretive to Impax's earnings per share.
Impax Announces Agreement to Acquire Generic Products - June 21, 2016impax-labs
Impax announces it has agreed to acquire a portfolio of 18 generic products from an undisclosed party for $586 million in cash. The acquisition expands Impax's portfolio of solid oral, injectable, inhalable, and topical generic drugs. It is expected to add $80 million in revenue and $50 million in EBITDA in the second half of 2016 and be immediately accretive to earnings per share. Impax provides updated 2016 financial guidance incorporating the acquisition, projecting at least 15% revenue growth over 2015 to over $860 million.
The document is a presentation from Impax Laboratories' management at the Cowen and Company 34th Annual Health Care Conference on March 3, 2014.
In 3 sentences:
1) Impax Laboratories has leveraged its dual generic and brand business model and significant investments to drive 21% revenue growth over 7 years and create resources for business development and M&A.
2) The company is focused on growing its generic and brand pipelines through internal R&D, partnerships, and M&A, while continuing to implement a quality improvement program and commercialize new products.
3) Impax provided 2014 objectives including resolving its manufacturing warning letter, commercializing potential new generics, resubmitting its RYTARY N
Impax provides concise summaries of forward-looking statements and highlights its focus on four key areas:
1) Continued focus on quality to resolve regulatory issues and gain approvals of generic products.
2) Maximization of its generic and specialty pharmaceutical platforms through pipeline of potential launches representing billions in sales.
3) Optimization of its generic research and development pipeline including first-to-file opportunities representing $19 billion in potential sales.
4) Pursuit of business development to accelerate growth including advancement of its next-generation brand pipeline programs.
Deutsche Bank Health Care Conference May 30 2013impax-labs
Impax Laboratories provided a "Safe Harbor" statement noting that statements in the presentation involving the future are forward-looking and actual results could differ. Impax is committed to improving operations by addressing FDA issues, implementing quality enhancements, and moving in the right direction. The company is positioned for future growth through two platforms - generics targeting $25B in U.S. sales and brands focused on central nervous system conditions. Impax has a diversified generic pipeline, established competencies, and financial flexibility to support growth strategies including organic growth, partnerships, and M&A.
Jefferies Global Healthcare Conference June 5 2013impax-labs
This document contains a "Safe Harbor" statement regarding forward-looking statements in the presentation. It notes several risks and uncertainties that could cause the company's future results to differ from forward-looking statements, including economic conditions, issues raised by the FDA in warning letters and observations, developing and commercializing pharmaceutical products, reductions in business with significant customers, the impact of competition, and other regulatory, legal and operational risks. It also provides an overview of the company's generic and branded product pipelines and growth strategies focusing on organic growth, partnerships, and M&A.
UBS Global Healthcare Conference May 22 2013impax-labs
- The document contains forward-looking statements about the company's future performance that involve known and unknown risks and uncertainties.
- The company has submitted responses to recent FDA observations and requested a meeting to ensure regulatory alignment. Significant improvements have been made to quality systems over the past two years.
- The company is committed to improving operations and moving in the right direction.
Bank of America Merrill Lynch Health Care Conferene May 16 2013impax-labs
- The document is a presentation by Impax Laboratories at a health care conference discussing its business strategies and outlook.
- Impax has two platforms for growth - generics targeting $25B in US sales and brands focused on central nervous system drugs.
- Its strategies include organic growth of its generic and brand pipelines, strategic partnerships mainly in alternative dosage forms, and mergers and acquisitions mainly in alternative dosage forms.
Bank of America Merrill Lynch Healthcare ConferenceImpaxLaboratories
- The document is a presentation by Impax Laboratories at a health care conference discussing its business strategies and outlook.
- Impax has two platforms for growth - generics targeting $25B in US sales and brands focused on central nervous system drugs.
- Its strategies include organic growth of its generic and brand pipelines, strategic partnerships mainly for alternative dosage forms, and mergers and acquisitions mainly for alternative dosage forms.
Impax Laboratories presented at the Cowen & Co Health Care Conference on March 6, 2013. They discussed their progress in improving quality operations and resolving FDA observations. They are committed to improving operations but have more work to do to fully address issues. Impax also outlined their strategy to create long-term growth through diversifying their generic product mix, building their branded neurology pipeline, and pursuing business development opportunities, supported by their strong financial position with $299 million in cash.
1) Impax reported financial results for the third quarter of 2016 with generic revenue down 3% year-over-year due to price erosion, partially offset by growth in epinephrine auto-injector and oxymorphone sales.
2) The company provided a business update on growing market share for key generic and brand products through marketing initiatives and new launches, while also facing challenges from industry-wide price declines.
3) Impax discussed its pipeline of generic opportunities and investments in research and development, focusing on expanding its central nervous system franchise and growing products like Rytary, Zomig nasal spray, and Emverm.
Impax Labs - 35th Annual JP Morgan Healthcare Conferenceimpax-labs
1) Impax provides a forward-looking statement regarding risks and uncertainties that could impact future performance.
2) Impax operates both a generic pharmaceutical division and specialty pharmaceutical division focused on central nervous system disorders.
3) Impax is focusing on growth opportunities including product development and approvals, marketing execution, and business development activities while also improving operations and reducing debt.
Impax reported its fourth quarter and full year 2016 financial results. Revenue declined year-over-year due to continued pricing pressures and volatility in the generic drug market. The company reported a net loss for the year due to non-cash impairment charges related to intangible assets. Looking ahead, Impax expects the challenging market conditions to continue but believes its specialty drug portfolio and generic pipeline can drive growth. Key priorities for 2017 include reducing debt, improving efficiency, and investing in R&D and generic launches.
Cowen and Company 37th Annual Health Care Conference Presentationimpax-labs
Impax provides a forward-looking statement regarding risks and uncertainties for its business. It discusses various risks including fluctuations in revenues and operating income, reliance on key customers and products, supply chain risks, competition, product development risks, and regulatory risks. Impax also outlines steps it has taken to reduce costs and optimize operations, with estimated annual savings of $40-50 million by 2018. Its priorities for 2017 include focusing on quality, executing specialty product growth, maximizing generics profits, and exploring more efficiencies.
Impax provides an overview of its growth strategy, operations, generic and branded businesses, and 2014 financial outlook. The company's growth strategy focuses on internal and external R&D opportunities, M&A, and business development to drive revenue growth. Key generic products launched in 2013 include oxymorphone ER and authorized generics of Zomig and Trilipix. The branded pipeline includes RYTARY for Parkinson's disease and a bupivacaine patch for postherpetic neuralgia. For 2014, Impax forecasts adjusted gross margins in the low 50% range and expenses of $82-88M for generic R&D and $36-39M for branded R&D.
Raymond james 38th annual institutional investor conferenceimpax-labs
Impax provides a summary of its business operations and growth priorities. It discusses its specialty pharmaceutical and generic drug portfolios, highlighting products that delivered strong growth in 2016 such as Rytary, Zomig Nasal Spray, and Albenza. Impax also summarizes its pipeline of generic ANDAs pending approval and in development, which could provide future growth opportunities. It reviews cost optimization efforts undertaken to reduce expenses and debt levels. Priorities for 2017 include focusing on quality, executing specialty product growth plans, maximizing profitability within generics, and continuing to diversify its product portfolio.
ISR interviewed 13 experienced Regulatory Affairs professionals at 11 of the Top 50 pharmaceutical companies to better understand the Regulatory Affairs function. ISR has designed this report to be used as a benchmarking tool for companies to compare their Regulatory Affairs functions to those of other organizations. Key takeaways include:
Identify how your company’s approach to Regulatory Affairs may be different from a typical industry approach and the benefits and drawbacks that may result
Gather information on unique Regulatory Affairs structures and best practices employed by other organizations, which may be used to improve or streamline the function
Compare your company’s Regulatory Affairs department size, structure, resources and approach to those of other companies
Learn more: https://goo.gl/
Impax Laboratories is focused on improving health through developing generic and branded pharmaceutical products. For generics, Impax has a portfolio of 45 applications pending FDA approval and 24 products under development, targeting high value opportunities. For brands, Impax's Parkinson's drug Rytary was filed for approval in 2012 and Phase II trials are underway for restless leg syndrome treatment IPX159. Impax also has drug delivery expertise and manufacturing expansion underway to support its growth initiatives.
Bank of america merrill lynch 2014 health care conferenceimpax-labs
This document contains forward-looking statements from Impax Laboratories regarding their business strategies and goals. It discusses leveraging their dual generic and brand business model, with a focus on first-to-file generic opportunities and developing a portfolio of specialty branded products. It outlines their priorities of resolving FDA issues, optimizing brand and generic strategies, analyzing their product pipelines, and pursuing expansion opportunities through partnerships or acquisitions. The overall message is that Impax is positioned for future growth by leveraging their core competencies in generics and specialty brands.
Regulatory Affairs Excellence: Staffing and Performance in Medical Device Com...Best Practices
Regulatory affairs group ensure that medical device companies comply with volatile regulatory environment pertaining to developing and marketing medical device products. These specialized groups rely on their own internal effectiveness and efficiencies for enhanced performance under stringent compliance norms. Also, optimal resourcing and staffing helps Regulatory Affairs groups in the medical device industry prioritize roles and responsibilities that will be most beneficial to growth.
Best Practices, LLC conducted this benchmarking study to establish meaningful metrics and insights around the structure, activities, roles and responsibilities of Regulatory Affairs groups at medical device companies. The study also provides recent spend and staffing trends of regulatory affairs in medical device sector, including the use of outsourcing and off-shoring.
Medical device regulatory leaders can use this study to align their staff as per strategies of best in class companies for an increased performance delivery.
Regulatory affairs professionals ensure public health by controlling the safety and efficacy of products. They keep track of changing legislation and advise their company on legal and scientific requirements. They collect and evaluate scientific data, present registration documents to regulatory agencies, and obtain marketing authorization for products. A good regulatory affairs professional helps maximize resources and serves as the first point of contact between a company and government authorities.
RedLotus is a pharma technical services company that provides consulting services to help pharmaceutical companies achieve and maintain GMP compliance. It has experts with regulatory and manufacturing experience who can assist companies at various stages, from facility design and process validation to responding to regulatory issues. RedLotus' services include quality audits, regulatory inspections preparation, qualification and validation activities, and training. The company aims to help clients develop robust quality systems and avoid compliance problems.
Cowen & company health care conference march 7 2017 presentationimpax-labs
Impax provides a summary of its business operations and priorities for 2017. The company operates both specialty pharmaceutical and generic drug divisions. For its specialty division, Impax focuses on growing its Parkinson's drug Rytary and developing a next generation version. Its generic division has a diversified portfolio of 72 approved products and a pipeline of 43 potential products, including several opportunities for first-to-file or first-to-market generics. For 2017, Impax priorities include executing on specialty growth, maximizing generic profits, launching new generics, finding cost savings, and diversifying its portfolio.
Impax provides a summary of its business and priorities for 2017. It has a specialty pharmaceutical division focused on branded CNS products including Rytary for Parkinson's disease. Its generics division has a diversified portfolio of 72 commercial products. For 2017, Impax aims to focus on quality, execute growth initiatives for specialty products, maximize profits from generics, launch new generics, and further diversify and reduce expenses.
The document is a presentation from Impax Laboratories' management at the Cowen and Company 34th Annual Health Care Conference on March 3, 2014.
In 3 sentences:
1) Impax Laboratories has leveraged its dual generic and brand business model and significant investments to drive 21% revenue growth over 7 years and create resources for business development and M&A.
2) The company is focused on growing its generic and brand pipelines through internal R&D, partnerships, and M&A, while continuing to implement a quality improvement program and commercialize new products.
3) Impax provided 2014 objectives including resolving its manufacturing warning letter, commercializing potential new generics, resubmitting its RYTARY N
Impax provides concise summaries of forward-looking statements and highlights its focus on four key areas:
1) Continued focus on quality to resolve regulatory issues and gain approvals of generic products.
2) Maximization of its generic and specialty pharmaceutical platforms through pipeline of potential launches representing billions in sales.
3) Optimization of its generic research and development pipeline including first-to-file opportunities representing $19 billion in potential sales.
4) Pursuit of business development to accelerate growth including advancement of its next-generation brand pipeline programs.
Deutsche Bank Health Care Conference May 30 2013impax-labs
Impax Laboratories provided a "Safe Harbor" statement noting that statements in the presentation involving the future are forward-looking and actual results could differ. Impax is committed to improving operations by addressing FDA issues, implementing quality enhancements, and moving in the right direction. The company is positioned for future growth through two platforms - generics targeting $25B in U.S. sales and brands focused on central nervous system conditions. Impax has a diversified generic pipeline, established competencies, and financial flexibility to support growth strategies including organic growth, partnerships, and M&A.
Jefferies Global Healthcare Conference June 5 2013impax-labs
This document contains a "Safe Harbor" statement regarding forward-looking statements in the presentation. It notes several risks and uncertainties that could cause the company's future results to differ from forward-looking statements, including economic conditions, issues raised by the FDA in warning letters and observations, developing and commercializing pharmaceutical products, reductions in business with significant customers, the impact of competition, and other regulatory, legal and operational risks. It also provides an overview of the company's generic and branded product pipelines and growth strategies focusing on organic growth, partnerships, and M&A.
UBS Global Healthcare Conference May 22 2013impax-labs
- The document contains forward-looking statements about the company's future performance that involve known and unknown risks and uncertainties.
- The company has submitted responses to recent FDA observations and requested a meeting to ensure regulatory alignment. Significant improvements have been made to quality systems over the past two years.
- The company is committed to improving operations and moving in the right direction.
Bank of America Merrill Lynch Health Care Conferene May 16 2013impax-labs
- The document is a presentation by Impax Laboratories at a health care conference discussing its business strategies and outlook.
- Impax has two platforms for growth - generics targeting $25B in US sales and brands focused on central nervous system drugs.
- Its strategies include organic growth of its generic and brand pipelines, strategic partnerships mainly in alternative dosage forms, and mergers and acquisitions mainly in alternative dosage forms.
Bank of America Merrill Lynch Healthcare ConferenceImpaxLaboratories
- The document is a presentation by Impax Laboratories at a health care conference discussing its business strategies and outlook.
- Impax has two platforms for growth - generics targeting $25B in US sales and brands focused on central nervous system drugs.
- Its strategies include organic growth of its generic and brand pipelines, strategic partnerships mainly for alternative dosage forms, and mergers and acquisitions mainly for alternative dosage forms.
Impax Laboratories presented at the Cowen & Co Health Care Conference on March 6, 2013. They discussed their progress in improving quality operations and resolving FDA observations. They are committed to improving operations but have more work to do to fully address issues. Impax also outlined their strategy to create long-term growth through diversifying their generic product mix, building their branded neurology pipeline, and pursuing business development opportunities, supported by their strong financial position with $299 million in cash.
1) Impax reported financial results for the third quarter of 2016 with generic revenue down 3% year-over-year due to price erosion, partially offset by growth in epinephrine auto-injector and oxymorphone sales.
2) The company provided a business update on growing market share for key generic and brand products through marketing initiatives and new launches, while also facing challenges from industry-wide price declines.
3) Impax discussed its pipeline of generic opportunities and investments in research and development, focusing on expanding its central nervous system franchise and growing products like Rytary, Zomig nasal spray, and Emverm.
Impax Labs - 35th Annual JP Morgan Healthcare Conferenceimpax-labs
1) Impax provides a forward-looking statement regarding risks and uncertainties that could impact future performance.
2) Impax operates both a generic pharmaceutical division and specialty pharmaceutical division focused on central nervous system disorders.
3) Impax is focusing on growth opportunities including product development and approvals, marketing execution, and business development activities while also improving operations and reducing debt.
Impax reported its fourth quarter and full year 2016 financial results. Revenue declined year-over-year due to continued pricing pressures and volatility in the generic drug market. The company reported a net loss for the year due to non-cash impairment charges related to intangible assets. Looking ahead, Impax expects the challenging market conditions to continue but believes its specialty drug portfolio and generic pipeline can drive growth. Key priorities for 2017 include reducing debt, improving efficiency, and investing in R&D and generic launches.
Cowen and Company 37th Annual Health Care Conference Presentationimpax-labs
Impax provides a forward-looking statement regarding risks and uncertainties for its business. It discusses various risks including fluctuations in revenues and operating income, reliance on key customers and products, supply chain risks, competition, product development risks, and regulatory risks. Impax also outlines steps it has taken to reduce costs and optimize operations, with estimated annual savings of $40-50 million by 2018. Its priorities for 2017 include focusing on quality, executing specialty product growth, maximizing generics profits, and exploring more efficiencies.
Impax provides an overview of its growth strategy, operations, generic and branded businesses, and 2014 financial outlook. The company's growth strategy focuses on internal and external R&D opportunities, M&A, and business development to drive revenue growth. Key generic products launched in 2013 include oxymorphone ER and authorized generics of Zomig and Trilipix. The branded pipeline includes RYTARY for Parkinson's disease and a bupivacaine patch for postherpetic neuralgia. For 2014, Impax forecasts adjusted gross margins in the low 50% range and expenses of $82-88M for generic R&D and $36-39M for branded R&D.
Raymond james 38th annual institutional investor conferenceimpax-labs
Impax provides a summary of its business operations and growth priorities. It discusses its specialty pharmaceutical and generic drug portfolios, highlighting products that delivered strong growth in 2016 such as Rytary, Zomig Nasal Spray, and Albenza. Impax also summarizes its pipeline of generic ANDAs pending approval and in development, which could provide future growth opportunities. It reviews cost optimization efforts undertaken to reduce expenses and debt levels. Priorities for 2017 include focusing on quality, executing specialty product growth plans, maximizing profitability within generics, and continuing to diversify its product portfolio.
ISR interviewed 13 experienced Regulatory Affairs professionals at 11 of the Top 50 pharmaceutical companies to better understand the Regulatory Affairs function. ISR has designed this report to be used as a benchmarking tool for companies to compare their Regulatory Affairs functions to those of other organizations. Key takeaways include:
Identify how your company’s approach to Regulatory Affairs may be different from a typical industry approach and the benefits and drawbacks that may result
Gather information on unique Regulatory Affairs structures and best practices employed by other organizations, which may be used to improve or streamline the function
Compare your company’s Regulatory Affairs department size, structure, resources and approach to those of other companies
Learn more: https://goo.gl/
Impax Laboratories is focused on improving health through developing generic and branded pharmaceutical products. For generics, Impax has a portfolio of 45 applications pending FDA approval and 24 products under development, targeting high value opportunities. For brands, Impax's Parkinson's drug Rytary was filed for approval in 2012 and Phase II trials are underway for restless leg syndrome treatment IPX159. Impax also has drug delivery expertise and manufacturing expansion underway to support its growth initiatives.
Bank of america merrill lynch 2014 health care conferenceimpax-labs
This document contains forward-looking statements from Impax Laboratories regarding their business strategies and goals. It discusses leveraging their dual generic and brand business model, with a focus on first-to-file generic opportunities and developing a portfolio of specialty branded products. It outlines their priorities of resolving FDA issues, optimizing brand and generic strategies, analyzing their product pipelines, and pursuing expansion opportunities through partnerships or acquisitions. The overall message is that Impax is positioned for future growth by leveraging their core competencies in generics and specialty brands.
Regulatory Affairs Excellence: Staffing and Performance in Medical Device Com...Best Practices
Regulatory affairs group ensure that medical device companies comply with volatile regulatory environment pertaining to developing and marketing medical device products. These specialized groups rely on their own internal effectiveness and efficiencies for enhanced performance under stringent compliance norms. Also, optimal resourcing and staffing helps Regulatory Affairs groups in the medical device industry prioritize roles and responsibilities that will be most beneficial to growth.
Best Practices, LLC conducted this benchmarking study to establish meaningful metrics and insights around the structure, activities, roles and responsibilities of Regulatory Affairs groups at medical device companies. The study also provides recent spend and staffing trends of regulatory affairs in medical device sector, including the use of outsourcing and off-shoring.
Medical device regulatory leaders can use this study to align their staff as per strategies of best in class companies for an increased performance delivery.
Regulatory affairs professionals ensure public health by controlling the safety and efficacy of products. They keep track of changing legislation and advise their company on legal and scientific requirements. They collect and evaluate scientific data, present registration documents to regulatory agencies, and obtain marketing authorization for products. A good regulatory affairs professional helps maximize resources and serves as the first point of contact between a company and government authorities.
RedLotus is a pharma technical services company that provides consulting services to help pharmaceutical companies achieve and maintain GMP compliance. It has experts with regulatory and manufacturing experience who can assist companies at various stages, from facility design and process validation to responding to regulatory issues. RedLotus' services include quality audits, regulatory inspections preparation, qualification and validation activities, and training. The company aims to help clients develop robust quality systems and avoid compliance problems.
Cowen & company health care conference march 7 2017 presentationimpax-labs
Impax provides a summary of its business operations and priorities for 2017. The company operates both specialty pharmaceutical and generic drug divisions. For its specialty division, Impax focuses on growing its Parkinson's drug Rytary and developing a next generation version. Its generic division has a diversified portfolio of 72 approved products and a pipeline of 43 potential products, including several opportunities for first-to-file or first-to-market generics. For 2017, Impax priorities include executing on specialty growth, maximizing generic profits, launching new generics, finding cost savings, and diversifying its portfolio.
Impax provides a summary of its business and priorities for 2017. It has a specialty pharmaceutical division focused on branded CNS products including Rytary for Parkinson's disease. Its generics division has a diversified portfolio of 72 commercial products. For 2017, Impax aims to focus on quality, execute growth initiatives for specialty products, maximize profits from generics, launch new generics, and further diversify and reduce expenses.
Cowen Co Health Care Conference March 6 2013impax-labs
Impax Laboratories is committed to improving its quality operations and resolving an FDA warning letter. It has made significant improvements over the past two years through changes to quality management and increased quality staffing. However, more work remains to be done to complete its quality improvement program and address recent FDA observations. Impax is also focused on growing its generic and branded drug pipelines to target sustainable markets. It has established competencies in complex drug development and delivery and seeks to diversify its generic portfolio and build its neurology-focused branded pipeline.
Impax third quarter 2017 earnings call presentation impax-labs
Impax reported third quarter 2017 results and provided a business update. Key points include:
- Revenues declined year-over-year due to lower generic pricing, but increased sequentially driven by cost savings initiatives. Adjusted EBITDA and EPS also increased quarter-over-quarter.
- Generic division revenues declined year-over-year due to lower pricing, partially offset by higher volumes. Pricing declines moderated sequentially. The specialty pharmaceutical division saw revenue growth driven by higher product sales.
- Phase 2b results for Parkinson's treatment IPX203 showed significant reduction in "off time" compared to an immediate-release competitor, supporting advancement to Phase 3.
- Impax remains on track or ahead of
Shire - Jefferies 2014 Global Healthcare ConferenceCompany Spotlight
This document provides an overview of Shire's strategy and performance in Q1 2014. Shire has repositioned itself around four focused business units and an integrated R&D organization to drive sustainable growth. In Q1 2014, Shire delivered strong results including 19% revenue growth, 41% EBITDA growth, and upgraded full-year guidance. Shire has leading positions in attractive therapeutic areas such as Rare Diseases, Neuroscience, and GI, and is pursuing a pipeline of innovative treatments.
The document discusses Impax Laboratories' strategy to grow through both generic and brand drug opportunities. For generics, Impax focuses on developing complex generic drugs that are difficult to formulate and can provide exclusivity opportunities. Impax has 45 generic drug applications pending FDA approval and 24 more in development. For brands, Impax is preparing to launch Rytary for Parkinson's disease in early 2013 and has IPX159 in Phase II trials for restless leg syndrome. Impax also has manufacturing facilities in Taiwan capable of supporting future growth.
In this case study, WGroup collaborated with business and IT stakeholders to build and compare business scenarios to evaluate in-house and third-party Pharmacy applications to support the client’s strategic, operational, and technical objectives, which resulted in estimated savings of $80M over 5 years. WGroup helped the client work through a complex analysis and evaluation process in just a few months. The client’s commercial pharmacy package will return value in a much shorter time than could be achieved by continuing with their internal solution development.
This project report discusses drug regulatory affairs and its importance. It provides an overview of regulatory departments and professionals, their roles, and necessary qualities. Regulatory authorities from India, the US, European Union, and Japan are examined. The report outlines the drug approval process in each region and highlights literature on regulatory issues faced by pharmaceutical companies. In conclusion, the report emphasizes that regulatory affairs has become essential for pharmaceutical companies due to globalization and the need to navigate varying international regulations and authorities.
Enterprise Labeling for the Pharmaceutical IndustryLoftware
For the pharmaceutical industry, the focus is on patient safety and improved patient outcomes. It’s also on driving greater efficiencies, cost reductions, and collaboration with contract manufacturers throughout the supply chain. In this environment, labeling is growing in importance, and there are a number of reasons why.
shire-to-acquire-dyax-presentation-final-02-nov-2015Aaron Sato
Shire will acquire Dyax Corp. to expand its leadership position in treating rare diseases like hereditary angioedema (HAE). Dyax's Phase 3-ready therapy, DX-2930, is a long-acting injectable drug for HAE prophylaxis that could generate $2 billion in annual sales if approved. The acquisition enhances Shire's growth by adding an innovative late-stage asset with potential for greater efficacy and more convenient dosing than current HAE treatments. The transaction delivers substantial value for shareholders of both companies by expanding Shire's HAE franchise and rare disease pipeline.
Maetrics: The ROI of Good Quality & ComplianceGeneris
The document discusses investing in quality and compliance programs to justify costs. It outlines how to quantify direct and indirect quality costs, examines the FDA's increasing focus on medical devices, and explores the impacts of non-compliance. Proactive quality systems can reduce costs compared to reactive systems. Good investments include dedicated CAPA resources, risk management programs, quality metrics, and harmonizing quality systems during acquisitions.
1. The document analyzes Pfizer's internal and external environments using various matrices to identify strengths, weaknesses, opportunities, and threats. It also outlines key assumptions made in the analysis.
2. The internal factor evaluation matrix finds Pfizer has strengths in brand recognition and R&D capabilities, but also faces challenges from generic competition and regulatory hurdles.
3. The competitive profile matrix shows Pfizer leads competitors in several factors but still has room for improvement. Overall, the analysis seeks to help Pfizer enhance its competitiveness and sustainability in the pharmaceutical industry.
Targeted Medical Pharma Innovating Healthcare for Better Patient Health IP 2014Targeted Medical Pharma
Targeted Medical Pharma (OTCQB: TRGM) is a small cap biotechnology company that specializes in manufacturing of medical foods for a vareity of disease states. Innovators in the growing medical food sector, The Company has developed products that improve back pain, sleep disorders, hypertension, peripheral neuropathy, fibromyalgia, PTSD and cognitive dysfunction. The Company has recently launched Clearwayz (www.clearwayz.com), the first in a line of proprietary dietary supplements.
The document discusses trends in GMP (good manufacturing practices) compliance in the pharmaceutical industry from 2012. The top six trends are: 1) Increasing number of inspections, 2) Increasing number of warning letters, 3) Increasing enforcement penalties, 4) Increasing harmonization between regulatory agencies, 5) Increasing use of science and technology, and 6) Increasing use of subject matter experts. The document emphasizes that knowledge of these compliance trends can help companies improve processes, avoid citations, and strengthen standard operating procedures.
SQUARE Pharmaceuticals Ltd Wholly owned subsidiary entry mode Africa Country ...Shorab Hossain
SQUARE Pharmaceuticals Ltd. is the largest pharmaceuticals company in Bangladesh. The company was established in 1958 by Samson H. Chowdhury along with his three friends. At the beginning, the company was a private firm. In 1964 the company converted into a Private Limited Company. The company was converted into a public limited company in 1991 and listed with Dhaka Stock Exchange in 1995. It has been continuously in the 1st position among all national and multinational pharmaceuticals companies since 1985. According to their annual report (April 2014 – March 2015), the turnover of SQUARE Pharmaceuticals was BDT. 30.28 billion (US$ 385.22 million) with about 18.64% market share having a growth rate of about 25.36%.
Similar to 33rd Annual J.P. Morgan Healthcare Conference (15)
3. Integrated Specialty Pharmaceutical Company
Targeting complex, high-value, solid
oral and alternative dosage form
ANDAs
Focused on developing products for
unmet needs in the treatment of
Central Nervous System disorders
and other select specialty segments
Generic Pharmaceuticals
Branded Pharmaceuticals
3
4. Business Update - Four Core Areas of Focus
Resolving FDA issues
Fully implementing industry-best Quality Improvement Program
Generic and Brand commercial success in 2014
Revenue up 13% and EPS up 39% YTD September 2014
Optimized resources by leveraging shared services
Refocused internal Brand and Generic pipeline
Proposed acquisition of CorePharma*
Increased efficiency of the Balance Sheet
Focus on
Quality
Maximize
Dual Platform
Optimize
R&D
Business
Development
Acceleration
4
*CorePharma, LLC, Amedra Pharmaceuticals LLC, Lineage Therapeutics Inc. and Trail Services, Inc. (collectively CorePharma)
5. Multiple Opportunities to Drive Growth
5
Supported by
Strong Cash
Flow and
Balance Sheet
RYTARYTM
Generic
Pipeline
Proposed
Acquisition of
CorePharma*
Additional
Business
Development
and M&A
*CorePharma, LLC, Amedra Pharmaceuticals LLC, Lineage Therapeutics Inc. and Trail Services, Inc. (collectively CorePharma)
6. • Approved by FDA January 7th 2015
• Three years Hatch-Waxman exclusivity
• Four issued U.S. formulation patents
− One expires May 2022
− Three expire December 2028
6
RYTARY for Treatment of Parkinson’s Disease
7. RYTARY Attributes
7
Efficacy Clinical benefits include:
• Reduction in “OFF” time by 1.2 hours
• Increase in “ON” time without troublesome dyskinesia by 1.0 hour
• Significant improvement in motor function and Activities of Daily
Living (ADL)
Dosing • Oral capsule with 3x daily starting dose
• Ability to sprinkle contents of capsule on soft foods
PK
Characteristics
• RYTARY provides both an initial and extended levodopa plasma
concentrations after a single dose.
8. Two Clinical Phase III Studies Support Approval
In levodopa naïve patients RYTARY demonstrates significant improvements in:
• Combined scores of activities of daily living and motor function as measured by the
Unified Parkinson's Disease Rating Scale (UPDRS) Parts II and III
When studied against immediate-release carbidopa and levodopa comparator, RYTARY:
• Reduced mean “OFF” time by 1.2 hours
• Increased mean “ON” time with no or non-troublesome dyskinesia by 1.0 hour from
baseline to end of study compared with IR CD-LD
8
APEX-PD (N=381)
ADVANCED-PD (N=393)
9. The Parkinson’s Disease Market
$ millions; TRx millions; Source: IMS National Prescription Audit (NPA
Market Dynamics
9
Sales by Region
Sources: IMS; Decision Resources
• Significant global market with strong
future growth
• Carbidopa-Levodopa (CD-LD) is the
primary therapy for Parkinson’s
disease
• Significant unmet need for improved
CD-LD product that produces
relatively constant LD concentrations
• 87% of Parkinson’s disease patients
are taking CD-LD products
Parkinson’s Disease Sales and TRx
MAT Nov. 2014
$180
$67
$149
$296
Sales
CD/LD* COMT-I
Dopamine Agonists MAO-I
5.1
0.2
2.8
0.6
TRx
Sales
$700MM
TRx
8.7MM
10. Planning a Two Phase U.S. Product Launch
Phase 1
• Soft launch mid February 2015
• Product in distribution channel
• Limited samples to former clinical investigators and trained speakers
• Start Medicare Part D reimbursement process
• Initiate commercial coverage and reimbursement with managed care
Phase 2
• Full launch beginning early April 2015
• Field force promotion begins with 77 sales reps
• Focus on Top Tier Neurologists – approximately 8,100
10
11. Source: IMS NPA
Successfully Commercializing Zomig® Nasal Spray
+70% Revenue Growth
Nine Months Ended Sept. 2014 vs. Sept. 2013
Product
Nasal Triptan National Segment
Prescription Share
Share Growth
Since Impax
PromotionAug. 2012 Nov. 2014
Zomig® 23% 30% 28%
Imitrex® 5% 5% 5%
Generic Sumatriptan 72% 65% (9%)
A Track Record of Branded Commercial Success
11
12. RYTARY U.S. Market Assumptions and Growth
12
2015
• Full launch in 2Q
• Increase Sales Force to 77 reps from 64
• Marketing costs of approximately $13 million
• 8,100 target physicians
• Primary focus is existing carbidopa-levodopa patients
• Tier 2 or tier 3 formulary positioning with managed care
• Wholesale price between $15 to $17 per day
Critical U.S. Market Assumptions
*Projected based on current forecasts as of December 31, 2014.
2015E 2016E 2017E 2018E 2019E
RYTARY Projected U.S. Revenue Growth*
$275MM to $350MM
13. RYTARY Global Development Status
• Submitted Marketing Authorization Agreement on Nov. 7th 2014
‒ Deemed eligible as a “therapeutic innovation”
‒ Approval entitles the product to 10-year regulatory
exclusivity in Europe
‒ Accepted Nov. 26th 2014
• Active dialogue with potential ex-U.S. partners
13
14. A single integrated specialty pharmaceutical company
that builds on our collective strengths
14
Business Development Acceleration
Proposed Acquisition Adds Growth and Provides
Strategic and Financial Benefits
CorePharma, LLC, Amedra Pharmaceuticals LLC, Lineage Therapeutics Inc. and Trail Services, Inc. (collectively CorePharma)
15. 18
Other SOD
9
Controlled-
Release SOD
10
Alternative
Dosage Form
Impax
37 Currently Marketed Products
Expands Generic Commercialized Portfolio
15
CorePharma/Lineage Therapeutics
11 Currently Marketed Products
9
Other SOD
1
Controlled-
Release SOD
1
Alternative
Dosage Form
Source: Data as of December 31, 2014
SOD = Solid Oral Dosage Form
16. Expands Generic Pipeline Opportunities
8
10
2
4
8
Impax CorePharma
22
10
ANDAs Pending at FDA Various Stages of Development
Current U.S. Brand/Generic market $13B sales
4
6
13
12
25
Impax CorePharma
22
38
Current U.S. Brand/Generic market $16B sales
12 Products Potential FTF or FTM
Source of sales data: IMS October 2014; Pipeline data as of December 31, 2014
FTF = First-to-File; FTM = First-to-Market; SOD = Solid Oral Dosage Form
2 Products Confirmed FTF or FTM
10 Products Potential FTF or FTM
Other SOD Controlled-Release SOD Alternative Dosage Form
16
17. Expands Potential Generic Launches in 2015
Assuming acquisition closes in First Quarter 2015
Current U.S. Brand/Generic market $2.2B sales
17
Source of sales data: IMS October 2014
*Requires approval from Hayward facility currently under a Warning Letter.
** Impax and CorePharma external partnered products
3* 3
2
1
4
4
Impax CorePharma External Partners**
Pending Approval Approved/Re-introduction
4
7
6
19. Acquisition Delivers in Primary Areas of Focus
FDA approved and DEA licensed manufacturing facility
Successful implementation of a Quality Improvement Program
Lead Brand in a new therapeutic area
High value Generic product line with near term new launches
Focus on late stage & life cycle management Brand projects
Significant near-term Generic opportunities
Opportunity for optimization of combined R&D portfolio
Strategic M&A transaction intended to enhance Shareholder value
Balance sheet remains flexible for additional opportunities
Focus on
Quality
Maximize
Dual Platform
Optimize
R&D
Business
Development
Acceleration
19
20. Well Positioned for Growth
Targeting
Sustainable Generic
and Specialized
Brand Markets
Established Core
Competencies
Strong and Flexible
Financial Profile
20