Q&A with Amy Barzdukas, Executive Vice President & Chief Marketing Officer at Poly

MEDIA 7 | November 21, 2019

Amy Barzdukas, EVP and Chief Marketing Officer at Poly is a marketing and communications leader with extensive experience in setting strategy, shifting perceptions, advising customers, digital marketing, revenue marketing, integrated marketing communications, and public relations in highly competitive product arenas.

Amy is known for her ability to create and execute winning turnarounds on a global scale.

MEDIA 7: What inspired you to get into marketing?
AMY BARZDUKAS:
I was always destined for marketing, even if I didn’t know it. As a child, I collected promotional brochures. I was fascinated by how the words and pictures were used to drive action. My first job was as an advertising copywriter, and I’ve never looked back.

M7: How is Poly redefining the video conferencing experience for modern businesses?
AB:
 We’re in an unprecedented time of change in our industry. Voice and video services are moving to the cloud, and companies are changing how they approach their communications needs. Poly is the largest provider of the devices – video conferencing, audio conferencing, headphones and desk phones – you use to connect to these services so you can collaborate with your colleagues. That uniquely positions us to shape the video conferencing experience, and we’re doing so in four ways.

First, Poly has made both the Zoom Rooms and the Microsoft Teams video conferencing experience better than ever with our radically simple Poly Studio X video bars that deliver these experiences with no PC or Mac required. We’ve got decades of experience in understanding what makes meetings more human – for everyone in the room and those dialing in from other locations – and we’ve packed all of that into easy-to-install, easy-to-manage, and easy-to-use all-in-one powerhouses.

Second, we are bringing the world of AV and video conferencing into the modern app economy. Our Studio X series and Poly G7500 video conferencing devices run a common platform that can be updated and enhanced through a series of regular software updates. This Poly platform, built on Android, can run applications like a smartphone does today.

Third, Poly has introduced innovation that makes any video conference better. Our new Poly MeetingAI features use AI and machine learning to address the distractions that hit your senses in a meeting. We make it easier to hear what’s being said by blocking out the annoying noises that people make while talking, and we make it easier to see what’s going on in the room with the most advanced speaker tracking and framing, and our built-in production rules.

Finally, we are pricing our solutions in a way that completely resets the calculations on what it costs to outfit a room. The Studio X30, for huddle room and smaller spaces, costs just about $2,100, including the Poly TC8 touch controller. All you add is the cloud service and a monitor, and you have a room up and running for under $2,500. That’s easily under the cost of other solutions and with better audio and video quality.


"Baby Boomers and more than half of Gen Z say they are most productive when they were working around noise."

M7: As the CMO of Poly, what were the major challenges in rebranding and transforming two separate organizations (Plantronics and Polycom) under a single brand Poly?
AB:
One of the greatest challenges of bringing together Plantronics and Polycom was doing so in a way that honored their brand equity, history, and positive associations while establishing a new story for the new company. Plantronics was already an audio pioneer– the first headset that transmitted Neil Armstrong’s famous words during the first moon landing. Polycom was the leader in audio and video conferencing – the conference phone used by business leaders and industry captains.
We had to figure out how to build a stand-out narrative in a crowded space for the general market. For customers and partners, we found a way to carry through the legacies and histories of both companies into the new brand. And for our employees, we had to inspire them to believe in the new brand and the new combined mission. These different challenges with different stakeholders took different approaches to confront, but in the end, we brought everyone to the same conclusion that Poly was moving forward, unified and stronger.

And like any acquisition, integration takes time. We’re proud of our accomplishments since rebranding to Poly in March 2019. Since then, we’ve refreshed our video conferencing line of products, broken new ground with a mobile phone station called Elara 60 Series and showcased our continued commitment to expanding the ecosystem with partners such as Zoom, Microsoft, Google, Amazon and more. As Poly, we bring a new level of quality, simplicity, and flexibility so that every communication can easily become a place for collaboration and innovation for the enterprise.


"Gen Z and Millennials came up in an era of digitization, so they are more accustomed to the tools and technology to deal with distractions in the workplace."

M7: A recent study by Poly reveals that employees prefer noisier open offices to closed, quiet spaces. What do you think is responsible for driving these unique demands in the workplace today?
AB:
Our research shows that Gen Z and Millennials tend to prefer open offices compared to Gen X and Baby Boomers and that more than half of Gen Z say they are most productive when they were working around noise. What we’re seeing is that Gen Z and Millennials came up in an era of digitization, so they are more accustomed to the tools and technology to deal with distractions in the workplace. For example, they’re used to wearing noise-canceling headphones to block out the background noise, and similarly at home with video. They’ve been doing it all their lives!

Now that we can work from anywhere – coffee shops, airports, waiting rooms – we are more accustomed to dealing with distractions and working through them. We take that mindset into the office along with the tools we may use to address distraction, from a pair of comfortable headphones with ANC to deciding to do different types of work in different settings.

M7: What features have made Poly Studio win the 'Best of Enterprise Connect' award in the '2019 Communication/Collaboration Device'?
AB: 
Poly Studio is our answer to the need for easy-to-use video conferencing devices for smaller spaces called huddle rooms. Poly Studio is a video USB bar with premium audio and video capabilities. Its standout features include NoiseBlock, which mutes distracting background noises, Automatic Group Framing and Speaker Tracking, which zooms in to focus on the speaking participant. This board-room like audio and video transforms small meeting rooms into a center for collaboration. We’re also pleased that it was recently certified for Zoom Rooms and Microsoft Teams. The device also works with Skype for Business, Google Meet, Cisco WebEx and Amazon Chime, and virtually any cloud-based video collaboration service.


"Poly combines legendary audio expertise with powerful video and conferencing capabilities to help our users overcome the distractions, complexity, and distance, making communication in and out of the workplace challenging."

M7: What traits make Poly a global leader in communications and a leading choice for every kind of workspace?
AB:
Our in-depth expertise, tireless innovation, and emphasis on partnership make Poly a global leader in communications and a leading choice for every kind of workspace.

Poly combines legendary audio expertise with powerful video and conferencing capabilities to help our users overcome the distractions, complexity, and distance, making communication in and out of the workplace challenging. When the world was on a race to space in the ’60s, NASA approached us—Plantronics back then—with a seemingly impossible task: create a headset that would equip astronauts to communicate with Mission Control from the earth to the moon, and back again.

Fifty years later, we share the same mission today: to create powerful connections that unify people the world over. We’re designing technology for the different ways people work – open offices, remote locations, mobile-first workers. We are the largest provider of headsets, video and audio-conferencing devices that you use to communicate and collaborate for your work, whatever that may be. And we continue to innovate with products like Poly Studio X that change how people collaborate.
Through partnerships with industry leaders like Microsoft, Amazon, Google, and Zoom, Poly takes an open-architecture approach that allows users to seamlessly connect across all the best technologies. Whenever and wherever people connect with these services, we will be there to provide the best-in-class audio, video and voice technology to make the experience that much better.

M7: What’s your superpower or spirit animal?
AB: 
My superpower is the ability to read amazingly quickly, thanks to the experimental elementary school I attended. I don’t know how anyone gets through their workload without it, honestly. My spirit animal? I told my husband the other day that I think it is Tom Petty. I’m a huge fan. If you have a problem, there is a Tom Petty song that can solve it, or at least make it more fun.

ABOUT POLY

Plantronics, Inc. (“Poly” – formerly Plantronics and Polycom) (NYSE: PLT) is a global communications company that powers meaningful human connection and collaboration. Poly combines legendary audio expertise and powerful video and conferencing capabilities to overcome the distractions, complexity, and distance that make communication in and out of the workplace challenging. Poly believes in solutions that make life easier when they work together and with our partner’s services. Our headsets, software, desk phones, audio and video conferencing, analytics and services are used worldwide and are a leading choice for every kind of workspace.

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Q&A with Sangram Vajre, Co-founder & Chief Evangelist at Terminus

MEDIA 7 | January 9, 2020

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MEDIA 7 | December 5, 2019

Andrea Lechner-Becker, Chief Marketing Officer at LeadMD is an experienced Marketing and Sales Executive with a demonstrated history of working in the marketing and advertising industry. Skilled in Business Process, Marketo, Sales, Customer Relationship Management (CRM), and IT Service Management, Andrea is also a strong business development professional and a storyteller. MEDIA 7: What inspired you to get into marketing? ANDREA LECHNER: Frankly, not having better options. I originally attended the University of Wisconsin-La Crosse thinking I’d major in Archaeology. I wanted to be Indiana Jones! But, after visiting the archaeology building – i.e. the cold, dark basement of the science building – where a girl sat to piece together pieces of an old Native American vase, I knew archaeology was not going to be the right path for me. And so, without being good at science and a major in art or art history was unlikely to pay my bills, I decided to go into “business”. I originally registered as a management major, but took my first marketing class and thought it was more interesting and switched my sophomore year. That was pretty much it. I’d never been involved in business classes or DECA in high school – I didn’t really know what to do or what jobs in marketing were even possible. I dumb lucked myself into it really. M7: As a storyteller, do you relate the brand to a story or story to the brand? AL: Both? Neither? I think there are stories in every brand, because there are people working on the brand and people engaging with the brand and people using what the brand creates. People, most often a single person, are at the heart of great stories. You can start with the “point” of the story you’re trying to tell. Say you have a software that help accountants better create reports for board meetings. It’s likely you’ll want to tell a success story about an accountant getting promoted to CFO in part because your software helped better communicate their work product to the board. You could have the idea for that and go looking for that story in your customers. OR, you could hear that story, and say, “That’s amazing!” and share it with customers, partners and internal people. Stories are all around us – the most important thing is to keep your ears and eyes open for finding them.

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Q&A with Ed Breault, Chief Marketing Officer at Aprimo

MEDIA 7 | November 28, 2019

Ed Breault, Chief Marketing Officer at Aprimo is a marketer with over 18 years of industry experience. At Aprimo, Ed is responsible for the global brand and growth which includes all Paid/Owned/Earned media, Brand Experience, Product Marketing, Industry Marketing, Influencer Marketing, Strategic Communications, Content Marketing, Analyst Relations, Alliance Marketing, Public Relations, Events, Demand Generation and Account-Based Marketing. MEDIA 7: What’s your superpower? ED BREAULT: I would say it’s applying the full spectrum of art and science that is required in marketing today. Not just left or right brained, but whole-brained strategy. Being human yet data-driven and really understanding numbers and (the right) metrics to make connections to business drivers. Add storytelling to that, so I can effectively communicate to my team, the CEO and CFO as well as my Board of Directors on those metrics, and connecting all that we are doing in marketing to the mission of the business. Then quickly shifting gears to the art and creative aspects of marketing that are required to engage an audience and tell great commercial stories that take complex concepts and craft them in a way that is interesting for people to pay attention to. I have to be the ultimate point of truth for the brand. M7: At Aprimo, how have marketing leadership roles and responsibilities evolved over the past few years? EB: There are so many dimensions needed by marketing leaders today. There are several elements driving this evolution, it’s the new experience battlefront that is emerging and also marketers themselves driving changes. From a market perspective, there is a clear appetite for disruption and consumers are wanting more experiential elements to their buying experience and interactions with brands. Take a few direct to consumer disruptions like trialing products in-home, purchasing directly from a brand or even wanting to ensure that the producer’s trade practices are in line with the buyer’s or even a regulator’s for that matter. Then we want to try before we buy, and we emotionally care about the supply chain of products. Do we TRUST this brand to do business with them? Behind all of this is a story that needs to be told, and it is those marketers who know their audience well and make connections that will win the commercial game. Back to the marketer, there are so many diverse backgrounds that marketers bring now and I’m really intrigued by those who have unconventional backgrounds because they contribute something uniquely new to the field. I love hearing about the marketer’s journey.

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MEDIA 7 | December 5, 2019

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MEDIA 7 | November 28, 2019

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Aquestive Therapeutics Receives FDA Acceptance of New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film in Pediatric Patients

globenewswire | September 12, 2023

Aquestive Therapeutics, Inc. a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today announced acceptance by the U.S. Food and Drug Administration (FDA) of the Company’s NDA for Libervant™ (diazepam) Buccal Film in pediatric patients between two and five years of age and the assignment of a PDUFA goal date of April 28, 2024. Aquestive’s NDA for approval of Libervant™ Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients between two and five years of age has been accepted by the FDA. Diastat® (diazepam) Rectal Gel is the only treatment currently available to this patient population for this indication. The Company received tentative approval for Libervant for the treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients 12 years of age and older in August 2022, but Libervant is currently under an orphan drug block to market access until January 2027. “The FDA’s acceptance of our most recent filing for Libervant is another step forward in bringing this important treatment option to patients,” said Daniel Barber, Chief Executive Officer of Aquestive. “When it comes to the treatment of seizure clusters in pediatric patients with epilepsy five years of age and under, physicians and caregivers have limited options. We believe Libervant, as an oral alternative to existing device-based products, will be well-received by this patient population, if approved with market access.” About Libervant Libervant is a buccally, or inside of the cheek, administered film formulation of diazepam, a benzodiazepine intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern. Aquestive developed Libervant as an alternative to the device-based products currently available for patients with refractory epilepsy, including a rectal gel and nasal spray products. The FDA has granted tentative approval for Libervant for treatment of these epilepsy patients 12 years of age and older, with U.S. market access for Libervant for this age group of patients subject to the expiration of the existing orphan drug market exclusivity of a previously FDA approved drug scheduled to expire in January 2027. The NDA submitted today for Libervant for epilepsy patients between two and five years of age is subject to FDA approval, including for U.S. market access. About Aquestive Aquestive is a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has five commercialized products marketed by its licensees in the U.S. and around the world, and is the exclusive manufacturer of these licensed products. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven drug development and commercialization capabilities. Aquestive is advancing a late-stage proprietary product pipeline focused on treating diseases of the central nervous system and an earlier stage pipeline for the treatment of severe allergic reactions, including anaphylaxis.

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Pharmacy Market

Halozyme Announces Approval of Roche's Tecentriq® Subcutaneous (SC) with ENHANZE® in Great Britain

prnewswire | August 29, 2023

Halozyme Therapeutics, Inc. announced the approval of Roche's Tecentriq® SC (atezolizumab), using Halozyme's ENHANZE® drug delivery technology, by the Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain. Tecentriq® subcutaneous (SC) is co-formulated with Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20, allowing for subcutaneous delivery, which takes approximately seven minutes, compared with 30-60 minutes for intravenous (IV) infusion. Tecentriq® SC will be available to patients in Great Britain for certain types of lung, bladder, breast, and liver cancer.7 Multiple oncology studies suggest that most cancer patients prefer to receive their treatments via subcutaneous delivery, instead of intravenous infusion because of reduced discomfort, ease of administration, and shorter duration of treatment.2,4,11 "We are delighted that Roche has received approval of Tecentriq SC in Great Britain. Subcutaneous delivery of Tecentriq provides cancer patients a faster and more flexible treatment option and may alleviate pressure on healthcare system resources," said Dr. Helen Torley, president and chief executive officer of Halozyme. "We look forward to additional regulatory approvals of our partner products utilizing ENHANZE." Tecentriq® SC is the first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain and is Roche's fourth subcutaneous cancer therapy using Halozyme's ENHANZE® drug delivery technology.8-10 The approval is based on clinical data from the Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq® in the blood when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation.12 While the IMscin001 trial was conducted within the hospital setting, the SC formulation may be suitable for out-of-hospital administration by a healthcare professional. The U.S. Food and Drug Administration (FDA) is currently evaluating Tecentriq® SC for regulatory approval. About Halozyme Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. As the innovators of the ENHANZE® technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the delivery of injected drugs and fluids in order to reduce the treatment burden to patients. Having touched more than 700,000 patient lives in post-marketing use in six commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, AbbVie, Eli Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare and Chugai Pharmaceutical. Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technology that are designed to provide commercial or functional advantages such as improved convenience and tolerability, and enhanced patient comfort and adherence. The Company has a commercial portfolio of proprietary products including XYOSTED®, TLANDO® and NOCDURNA® and partnered commercial products and ongoing product development programs with several pharmaceutical companies including Teva Pharmaceuticals and Idorsia Pharmaceuticals.

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Pharmacy Market

European Medicines Agency Accepts Novaliq’s Marketing Authorization Application for CyclASol® 0.1% for the Treatment of Dry Eye Disease

businesswire | August 25, 2023

Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for CyclASol (ciclosporin ophthalmic solution) for regulatory review. CyclASol is an investigational new drug treatment for dry eye disease in patients not responding to tear substitutes. The Committee for Medicinal Products for Human Use (CHMP) of the EMA will start its review of the MAA under the centralized procedure for all 27 member states of the European Union (EU). Dry eye disease (DED) affects millions of people in Europe and is one of the most common ocular surface disorders. A leading cause of DED is inflammation of the ocular surface. The chronic inflammatory nature causes progressive corneal surface damage that can lead to direct or indirect visual impairment. In the EU only one drug therapy limited to a subset of DED patients with severe keratitis is currently approved. CyclASol is ciclosporin, solubilized in a novel, water-free excipient and was designed to address unmet needs, providing patients with a fast acting and well tolerable dry eye drug therapy. Dispensed in a unique 10 microliter small drop the solution does not contain water or anti-microbial preservatives, oils or surfactants. As a water-free product, there is no associated pH and no osmolarity. “Our in Heidelberg, Germany, invented water-free technology was designed to unfold the full potential of pharmaceuticals on the ocular surface,” said Christian Roesky, Ph.D., Chief Executive Officer of Novaliq. “The acceptance of the EU Marketing Authorization Application is a key milestone in our global efforts to address high unmet needs to better serve patients suffering from dry eye disease. We look forward to collaborating with the CHMP throughout the review process and hope to make CyclASol available for patients in Europe.” The clinical development program for the MAA is based on six clinical studies, which evaluated the safety and efficacy of CyclASol in a total of 1,575 patients with dry eye disease. Results from the two registrational studies, ESSENCE-1 and ESSENCE-2 consistently demonstrated that the product is effective for the treatment of DED. Continued improvement under therapy in both signs and symptoms of DED has been clinically demonstrated over a period of up to 56 weeks in an extension study of ESSENCE‑2. With its early onset of effect and its good tolerability profile CyclASol addresses unmet medical needs in DED. CyclASol was approved by the U.S. Food and Drug Administration (FDA) as VEVYE™ (cyclosporine ophthalmic solution) 0.1% for the treatment of the signs and symptoms of dry eye disease on May 30, 2023. VEVYE is the first and only FDA approved cyclosporine solution indicated for the treatment of signs and symptoms of dry eye disease with efficacy demonstrated after 4 weeks of treatment and is commercialized in Northern America by Harrow Health Inc, a leading U.S. eyecare pharmaceutical company. About Novaliq Novaliq is a private biopharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol® the worldwide first water-free ophthalmic technology. Novaliq offers an industry-leading portfolio addressing today's unmet medical needs of millions of patients with eye diseases based on its proprietary water-free eyedrop technology. On May 18th, 2023, U.S. Food and Drug Administration (FDA) approved MIEBO™ (perfluorohexyloctane ophthalmic solution; formerly known as NOV03) followed by the approval of VEVYE™ (cyclosporine ophthalmic solution, development name CyclASol®) 0.1% on May 30th, 2023.

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PHARMACY MARKET

Aquestive Therapeutics Receives FDA Acceptance of New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film in Pediatric Patients

globenewswire | September 12, 2023

Aquestive Therapeutics, Inc. a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives, today announced acceptance by the U.S. Food and Drug Administration (FDA) of the Company’s NDA for Libervant™ (diazepam) Buccal Film in pediatric patients between two and five years of age and the assignment of a PDUFA goal date of April 28, 2024. Aquestive’s NDA for approval of Libervant™ Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients between two and five years of age has been accepted by the FDA. Diastat® (diazepam) Rectal Gel is the only treatment currently available to this patient population for this indication. The Company received tentative approval for Libervant for the treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients 12 years of age and older in August 2022, but Libervant is currently under an orphan drug block to market access until January 2027. “The FDA’s acceptance of our most recent filing for Libervant is another step forward in bringing this important treatment option to patients,” said Daniel Barber, Chief Executive Officer of Aquestive. “When it comes to the treatment of seizure clusters in pediatric patients with epilepsy five years of age and under, physicians and caregivers have limited options. We believe Libervant, as an oral alternative to existing device-based products, will be well-received by this patient population, if approved with market access.” About Libervant Libervant is a buccally, or inside of the cheek, administered film formulation of diazepam, a benzodiazepine intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern. Aquestive developed Libervant as an alternative to the device-based products currently available for patients with refractory epilepsy, including a rectal gel and nasal spray products. The FDA has granted tentative approval for Libervant for treatment of these epilepsy patients 12 years of age and older, with U.S. market access for Libervant for this age group of patients subject to the expiration of the existing orphan drug market exclusivity of a previously FDA approved drug scheduled to expire in January 2027. The NDA submitted today for Libervant for epilepsy patients between two and five years of age is subject to FDA approval, including for U.S. market access. About Aquestive Aquestive is a pharmaceutical company advancing medicines to solve patients’ problems with current standards of care and provide transformative products to improve their lives. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has five commercialized products marketed by its licensees in the U.S. and around the world, and is the exclusive manufacturer of these licensed products. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven drug development and commercialization capabilities. Aquestive is advancing a late-stage proprietary product pipeline focused on treating diseases of the central nervous system and an earlier stage pipeline for the treatment of severe allergic reactions, including anaphylaxis.

Read More

Pharmacy Market

Halozyme Announces Approval of Roche's Tecentriq® Subcutaneous (SC) with ENHANZE® in Great Britain

prnewswire | August 29, 2023

Halozyme Therapeutics, Inc. announced the approval of Roche's Tecentriq® SC (atezolizumab), using Halozyme's ENHANZE® drug delivery technology, by the Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain. Tecentriq® subcutaneous (SC) is co-formulated with Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20, allowing for subcutaneous delivery, which takes approximately seven minutes, compared with 30-60 minutes for intravenous (IV) infusion. Tecentriq® SC will be available to patients in Great Britain for certain types of lung, bladder, breast, and liver cancer.7 Multiple oncology studies suggest that most cancer patients prefer to receive their treatments via subcutaneous delivery, instead of intravenous infusion because of reduced discomfort, ease of administration, and shorter duration of treatment.2,4,11 "We are delighted that Roche has received approval of Tecentriq SC in Great Britain. Subcutaneous delivery of Tecentriq provides cancer patients a faster and more flexible treatment option and may alleviate pressure on healthcare system resources," said Dr. Helen Torley, president and chief executive officer of Halozyme. "We look forward to additional regulatory approvals of our partner products utilizing ENHANZE." Tecentriq® SC is the first subcutaneous anti-PD-(L)1 cancer immunotherapy available to patients in Great Britain and is Roche's fourth subcutaneous cancer therapy using Halozyme's ENHANZE® drug delivery technology.8-10 The approval is based on clinical data from the Phase IB/III IMscin001 study, which showed comparable levels of Tecentriq® in the blood when administered subcutaneously, and a safety and efficacy profile consistent with the IV formulation.12 While the IMscin001 trial was conducted within the hospital setting, the SC formulation may be suitable for out-of-hospital administration by a healthcare professional. The U.S. Food and Drug Administration (FDA) is currently evaluating Tecentriq® SC for regulatory approval. About Halozyme Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. As the innovators of the ENHANZE® technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the delivery of injected drugs and fluids in order to reduce the treatment burden to patients. Having touched more than 700,000 patient lives in post-marketing use in six commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, AbbVie, Eli Lilly, Bristol-Myers Squibb, Alexion, argenx, Horizon Therapeutics, ViiV Healthcare and Chugai Pharmaceutical. Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technology that are designed to provide commercial or functional advantages such as improved convenience and tolerability, and enhanced patient comfort and adherence. The Company has a commercial portfolio of proprietary products including XYOSTED®, TLANDO® and NOCDURNA® and partnered commercial products and ongoing product development programs with several pharmaceutical companies including Teva Pharmaceuticals and Idorsia Pharmaceuticals.

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Pharmacy Market

European Medicines Agency Accepts Novaliq’s Marketing Authorization Application for CyclASol® 0.1% for the Treatment of Dry Eye Disease

businesswire | August 25, 2023

Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, announced that the European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for CyclASol (ciclosporin ophthalmic solution) for regulatory review. CyclASol is an investigational new drug treatment for dry eye disease in patients not responding to tear substitutes. The Committee for Medicinal Products for Human Use (CHMP) of the EMA will start its review of the MAA under the centralized procedure for all 27 member states of the European Union (EU). Dry eye disease (DED) affects millions of people in Europe and is one of the most common ocular surface disorders. A leading cause of DED is inflammation of the ocular surface. The chronic inflammatory nature causes progressive corneal surface damage that can lead to direct or indirect visual impairment. In the EU only one drug therapy limited to a subset of DED patients with severe keratitis is currently approved. CyclASol is ciclosporin, solubilized in a novel, water-free excipient and was designed to address unmet needs, providing patients with a fast acting and well tolerable dry eye drug therapy. Dispensed in a unique 10 microliter small drop the solution does not contain water or anti-microbial preservatives, oils or surfactants. As a water-free product, there is no associated pH and no osmolarity. “Our in Heidelberg, Germany, invented water-free technology was designed to unfold the full potential of pharmaceuticals on the ocular surface,” said Christian Roesky, Ph.D., Chief Executive Officer of Novaliq. “The acceptance of the EU Marketing Authorization Application is a key milestone in our global efforts to address high unmet needs to better serve patients suffering from dry eye disease. We look forward to collaborating with the CHMP throughout the review process and hope to make CyclASol available for patients in Europe.” The clinical development program for the MAA is based on six clinical studies, which evaluated the safety and efficacy of CyclASol in a total of 1,575 patients with dry eye disease. Results from the two registrational studies, ESSENCE-1 and ESSENCE-2 consistently demonstrated that the product is effective for the treatment of DED. Continued improvement under therapy in both signs and symptoms of DED has been clinically demonstrated over a period of up to 56 weeks in an extension study of ESSENCE‑2. With its early onset of effect and its good tolerability profile CyclASol addresses unmet medical needs in DED. CyclASol was approved by the U.S. Food and Drug Administration (FDA) as VEVYE™ (cyclosporine ophthalmic solution) 0.1% for the treatment of the signs and symptoms of dry eye disease on May 30, 2023. VEVYE is the first and only FDA approved cyclosporine solution indicated for the treatment of signs and symptoms of dry eye disease with efficacy demonstrated after 4 weeks of treatment and is commercialized in Northern America by Harrow Health Inc, a leading U.S. eyecare pharmaceutical company. About Novaliq Novaliq is a private biopharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol® the worldwide first water-free ophthalmic technology. Novaliq offers an industry-leading portfolio addressing today's unmet medical needs of millions of patients with eye diseases based on its proprietary water-free eyedrop technology. On May 18th, 2023, U.S. Food and Drug Administration (FDA) approved MIEBO™ (perfluorohexyloctane ophthalmic solution; formerly known as NOV03) followed by the approval of VEVYE™ (cyclosporine ophthalmic solution, development name CyclASol®) 0.1% on May 30th, 2023.

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