ANDA approves Glenmark Pharmaceuticals for Sirolimus Tablets, 0.5 mg, 1 mg and 2 mg

Glenmark Pharmaceuticals Inc | October 19, 2020

Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Sirolimus Tablets, 0.5 mg, 1 mg and 2 mg, the generic version of Rapamune®1 Tablets, 0.5 mg, 1 mg and 2 mg, of PF Prism CV. According to IQVIATM sales data for the 12 month period ending August 2020, the Rapamune® Tablets, 0.5 mg, 1 mg and 2 mg market2 achieved annual sales of approximately $119.7 million*. Glenmark's current portfolio consists of 165 products authorized for distribution in the U.S. marketplace and 45 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

Spotlight

With over 260,000 health apps worldwide and 70% of patient groups using at least one app to manage their condition, it’s clear that a digital ecosystem has developed within healthcare. New research released by the Deloitte Centre for Health Solutions explores how digital technology can help pharma embrace patient centricity to remain relevant, profitable, and to deliver better health outcomes. Based on extensive literature reviews, new primary research on the production and utilisation of health apps by 12 major pharma companies and a survey of 190 patient groups, as well as our experience working across the healthcare and life sciences sector, our report examines the barriers that pose a threat to pharma’s transformation as well as the strategies being used to achieve patient centricity.


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Standigm names Carl Foster chief business officer to expand strategic partnerships for AI drug discovery

Standigm | August 19, 2022

Standigm Inc. the leading workflow artificial intelligence (AI) drug discovery company, announced the appointment of Chief Business Officer Carl Foster. Based in our U.S. office, Foster will be responsible for expanding strategic partnerships for novel drug target discoveries and first-in-class lead candidate identifications. "Carl has established a reputation for increasing company value. He has significant experience building and growing biotech companies, like Standigm, through creative deal-making. We're confident Carl can help us meet our aggressive goals." Jinhan Kim, CEO of Standigm Foster spent over 30 years working for drug and platform technology companies in various areas including genomics, proteomics and antibodies. Throughout his career, he has built a strong track record of business planning, establishing strategic relationships and financial modeling. Foster began his career with Merck and Co., Inc. where he had spent nine years in business development, marketing, and sales. Most recently, he was executive vice president, business development for Cempra Pharmaceuticals. Prior to that, he was CEO of Jurilab, a European-based genomics company. Foster has also held vice president-level positions at Nanogen, King Pharmaceuticals, Oxford GlycoSciences and Praecis Pharmaceuticals. In addition, he was general manager of Intracel BV, a Netherlands-based immunology company and managing director of Ferghana Partners, a New York-based investment banking group. Foster holds an MBA in marketing and an M.S. in biochemistry from the University of Kansas. "Our goal is to shorten the drug discovery process, reduce costs and increase the probability of success by combining the Standigm AI platform with disease-specific data from our strategic partners," said Foster. "I believe combining AI with drug discovery will result in major advances in how we understand diseases and create solutions. Standigm's first-class AI platform is backed by a strong team of biologists, chemists and AI engineers who have collectively created a tremendous opportunity for me. I look forward to helping them build a novel and industry-leading company." About Standigm Standigm is a workflow AI-driven drug discovery company headquartered in Seoul, South Korea and subsidiarized in Cambridge, U.K. and Cambridge, MA. Standigm has proprietary AI platforms encompassing novel target identification to compound design, to generate commercially valuable drug pipelines. Founded in 2015, Standigm has established an early-stage drug discovery workflow AI to generate multiple First-in-Class compounds within average seven months. Pursuing full-stack, AI-driven industrializing drug discovery, Standigm has achieved the automation of molecular design workflow, and the automation effort has been expanding to the whole drug discovery process based on Standigm AI platforms, including Standigm ASK™ for novel target discovery, Standigm BEST™ for novel compound generation and Standigm Insight ™ for novel indication.

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DeepIntent Adds More Leading Data Providers to its Audience Marketplace, Simplifying Pharma Campaign Planning and Optimization

DeepIntent | July 14, 2022

DeepIntent, the leading healthcare advertising technology company built to influence better patient health and business outcomes announced the addition of audience segments from Redi-Data, MedFuse, HealthWise Data, Prognos Health, and TV viewership data from LG Ads Solutions to the DeepIntent Audience Marketplace. These segments are directly integrated into DeepIntent's demand side platform for immediate activation, with the ability to optimize campaigns in real-time toward audience quality and script performance using DeepIntent Outcomes™. Launched in September 2021, Audience Marketplace remains the industry's first and only healthcare-specific data marketplace with ready-to-activate and custom audience segments powered by a variety of medical and pharmacy claims, lab, genomic, contextual, and wellness data providers. In total, DeepIntent now offers hundreds of patients and HCP segments from leading digital health data providers and publishers, including HealthLink Dimensions, Fluent, Doc Delta, and ShareThis. Additionally, over two dozen leading pharmaceutical brands and advertising agencies have made use of custom or ready-to-activate segments available on the marketplace to simplify their campaign planning and tap into Outcomes to optimize their third-party segments. "Audience Marketplace meets an important need to have unique healthcare audience segments included in a healthcare-focused DSP with the ability to optimize towards pharma-specific KPIs, such as Audience Quality, all within a single platform. Many of our customers already use audience segments from our new partners, and their direct integration will make it much easier to execute, measure, and optimize campaigns." Jen Werther, chief strategy officer at DeepIntent Audience Marketplace users benefit from greater convenience, faster time-to-activation, and improved data integrity and reporting compared with conventional methods, which require the use of costly and time-consuming third-party platforms. Segments within the Audience Marketplace are also matched with DeepIntent's industry-leading identity graph to prepare advertisers for the cookieless future, and provide daily physician-level data reporting for healthcare provider audiences. "Using integrated health data and Prognos Clinical Truths™ to ensure relevancy, healthcare marketers can rest easy knowing their messages are reaching the right physicians at the right time. Our partnership with DeepIntent makes the process of onboarding and activating HCP segments from Prognos seamless, and segments can further be optimized toward script performance in real-time when leveraging the advanced machine learning capabilities of DeepIntent Outcomes," said Matt Apprendi, vice president of marketing and media solutions at Prognos Health. About DeepIntent DeepIntent is leading the healthcare advertising industry with data-driven solutions built for the future. Built purposefully for healthcare marketers, DeepIntent's platform is proven to drive higher audience quality and script performance. It enables marketers to plan, activate, measure, and optimize their campaigns all within a single platform. Conceived by former Memorial Sloan Kettering data scientists, DeepIntent empowers nine of the top ten pharmaceutical companies and the leading healthcare advertising agencies to improve patient outcomes through the artful use of advertising, data science, and real-world health data.

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Love Pharmas Investment in US Biotech Offers Strategic Industry Advantages and Enhanced Shareholder Value

LOVE Pharma | September 09, 2022

Love Pharma Inc. an international mental health and sexual wellness company, remains extremely active in shaping itself into a real competitor in the biotech/pharmaceutical space. The company’s growth and development plan took a major leap forward this week with the announcement that Love Pharma is establishing a “strategic alliance” with Starton Therapeutics a leading clinical-stage biotechnology company in the United States. It’s a relationship that finds Starton ideally aligned with Love Pharma’s mission of improving “quality of life” for its customers. And the benefit to Love Pharma is that Starton is well on its way to transforming standard of care therapies with its proprietary dermal drug delivery technology that allows cancer patients to receive continuous treatment so they can live better, longer. Love Pharma’s investment in Starton Therapeutics is primarily based upon “the company’s interest in innovative drug delivery technology, such as transdermal patches that can reduce side effects, transforming patient outcomes with established, approved medicines allowing for streamlined market entry with long-term IP protections.” A partnership with Starton offers a host of advantages to Love Pharma and its shareholders, including a wealth of experience from industry leaders, proven clinical trials using its proprietary technology, and a “continuous drug delivery” platform that Love Pharma could exploit in the development of its own clinical portfolio—especially in the “addiction” space. The company’s strategic investment certainly makes a lot of sense for the future of this young global brand. “This investment provides our shareholders with exposure to a rapidly developing therapeutics business, which just reported positive data from a phase 1 clinical trial evaluating the pharmacokinetics and safety of the company’s continuous delivery lenalidomide program. Starton is also entering a phase 2 trial, which the U.S. Food and Drug Administration has already cleared an Investigational New Drug application for STAR-OLZ in Chemotherapy Induced Nausea and Vomiting (CINV). Love Pharma’s Chief Executive Officer (CEO), Zachary Stadnyk, said of the relationship “With this investment in Starton, we are building our relationship, forming an alliance, and look to Starton’s expert management team to reduce risk in our own portfolio of clinical pursuits and focus more on the addiction space.” So, what made Starton Therapeutics an attractive investment now? Well, earlier this year, Love Pharma partnered with researchers at Johns Hopkins University. This research initiative aligns with key principles in Love Pharma’s strategy as it aims to develop innovative products that establish new consumer applications based upon science and efficacy. And to further its meticulous plan, the company likely sees a much smoother path forward by expanding its development strategy to include guidance from a vast selection of industry and clinical experts and a highly de-risked avenue into the clinic by way of this strategic alliance with Starton. It's no secret that Love Pharma wants to develop its own clinical portfolio, and specifically, has its eye on developing therapeutic treatments for addiction. Pharmaceutical applications for addiction and recovery treatment are an unmet need and represent a growing market, including in the cannabis space where the Johns Hopkins research initiative is focused. With Starton’s mission of delivering meaningful patient outcomes by leveraging the untapped potential of continuous delivery and dermal technology, it’s obvious that Love Pharma sees this platform technology and its endless opportunities for expansion, as an ideal platform on which it can develop its own therapeutic treatment(s) for addiction. The benefit to partnering with Starton and having access to its platform technology is that the “proof of concept” is complete, and the technology has proven it can address unmet medical needs using already FDA-approved drugs to transform patient outcomes. For Love Pharma and its shareholders, this means much of the hard work is already done. Starton’s proprietary continuous delivery technology can increase efficacy of approved drugs, make them more tolerable, and expand their potential use. Starton uses three different delivery technologies to provide continuous, low-dose delivery as part of its strategic platform that provides a controlled, sustained release over multiple days. Starton uses proven transdermal and subcutaneous technologies to transform approved medicines–establishing superiority or new indications. It is the potential to establish a new indication/use for already approved drugs using the delivery technology, namely in the addiction space that is enticing to Love Pharma. And Love Pharma isn’t stopping there. The company announced that “to further accelerate its planned strategic alliance with Starton, and to bolster the company’s own biotech initiatives in the area, Love Pharma is in discussions with TRPL Laboratory, the lab that develops and supports Starton’s transdermal drug delivery programs and is a global leader in transdermal delivery systems.” Investors in Love Pharma couldn’t ask for a better way to reduce the risk associated with the company developing its own clinical portfolio than by surrounding itself with a plethora of industry and clinical leaders. That expertise begins with Pedro Lichtinger, the CEO and Chairman of the Board at Starton. Lichtinger has spent almost 40-years in the biotechnology arena, including 16 years at Pfizer as President of Global Primary Care and as Pfizer’s President of Europe. Additionally, Love Pharma can draw from the experiences of the former Global Lead, Multiple Myeloma at Celgene, world-renowned scientific leaders in their field leading each program at Dana Farber/Harvard, Mayo Clinic, and Moffitt Cancer Center, and a breadth of operational expertise in regulatory, clinical development, manufacturing, and intellectual property. The company stated that it is currently identifying and assessing disruptive opportunities within the transdermal biotechnology field, which it believes can be a superior delivery system in many cases for new and existing pharmaceutical therapeutic drugs. With its initial investment in Starton, the company believes it can leverage their expertise and proven success to credibly evaluate potential acquisitions in the transdermal field of advanced drug delivery systems. This news should be seen as extremely encouraging by the company’s investors as it could dramatically accelerate Love Pharma’s path to the clinic and the development of its own clinical portfolio. After all, it is these relationships in the biopharma industry that can lead to promising results and real shareholder value. About Love Pharma Inc. With a focus on the global sexual Health and Wellness markets, Love Pharma Inc. was founded in 2020, with a mission to bring to market innovative products that enhance sexual health and wellness while providing an improved quality of life. Love Pharma holds exclusive licenses to produce, market, package, sell, and distribute patent-protected therapeutic and pharmaceutical products throughout Europe, the United Kingdom, and North America. About Starton Therapeutics A clinical-stage biotechnology company focused on transforming standard of care therapies with proprietary dermal technology, so people with cancer can receive continuous treatment to live better, longer. Starton’s proprietary transdermal technology is intended to increase efficacy of approved drugs, to make them more tolerable and expand their potential use. About Stock Market Media Group Stock Market Media Group is a News and Media content development IR firm offering a platform for corporate stories to unfold in the media with press releases, feature news articles, research reports, corporate videos, and radio-style CEO interviews.

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Aquestive Therapeutics Receives FDA Tentative Approval for Libervant™ (diazepam) Buccal Film

Aquestive Therapeutics, Inc. | August 31, 2022

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, announced today that the U.S. Food & Drug Administration has granted tentative approval for Libervant™ Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in patients with epilepsy 12 years of age and older. "Tentative approval" means the FDA has concluded that Libervant has met all required quality, safety, and efficacy standards for approval but, due to an existing FDA regulatory grant of orphan drug market exclusivity for Valtoco®, a diazepam nasal spray product, Libervant is not yet eligible for marketing in the United States. As a result of the FDA determination, the Agency cannot give final approval for Libervant until the expiration or inapplicability of the orphan drug market exclusivity, including, for example, by court order, a selective waiver of the orphan drug exclusivity, or a reversal of the FDA’s decision and determination that Libervant is “clinically superior” to Valtoco. “The FDA’s decision provides welcome clarity to our business. The tentative approval of Libervant is a significant achievement that brings us one step closer to bringing this important medicine to patients who are unable or choose not to use the current standards of care. Libervant has the potential to offer these patients a treatment option that is simple, portable, and precise. A significant unmet need exists for additional alternate delivery options given the ongoing shortage of diazepam rectal gel, which continues to represent a substantial portion of the current diazepam rescue market. This FDA action further validates our ability to gain FDA approval of our pipeline programs. We look forward to continuing the rapid progression of AQST-109 for the treatment of severe allergic reactions, including anaphylaxis, towards a filing with the FDA.” Daniel Barber, Chief Executive Officer of Aquestive “We continue to examine the FDA’s determination on Libervant market access and plan to request a meeting with the Agency as soon as possible. We disagree with the FDA’s determination on the various points presented by the Agency and believe that, particularly in the case of our submitted studies on the effect of food on the absorption of diazepam formulations, Libervant has the distinct advantage of being able to be readily administered when needed without regard to food, providing an important benefit to patients. This is important to patients as rapid and extensive drug absorption is critical in a rescue situation. We will continue to vigorously engage with the FDA on the need for these data to be carefully considered.” During the review process, the Company submitted to the FDA the results of a 2021 Aquestive sponsored randomized, open-label, two-sequence, two-period, two-treatment crossover study to evaluate the effect of food on the pharmacokinetics of Valtoco in healthy adult subjects. The results of this study indicated that, when Valtoco is administered after a high fat meal, the maximum drug concentration (Cmax) was reduced by 48% compared to Valtoco administered to subjects in a fasted state. The study also showed that the time to maximum drug concentration (Tmax) of Valtoco doubled from 2 hours to 4 hours when administered after a high fat meal. Aquestive provided the data along with a cross-study comparison to a similar study performed with Libervant, to FDA during the review process. The FDA’s decision concluded that the information Aquestive submitted was not sufficient to overturn the Agency's previous conclusion regarding the lack of food effect for Valtoco. Specifically, the FDA stated that “[a] cross-study comparison is not considered [by the reviewer] to be a suitable approach for making a quantitative comparison of plasma concentrations between different products because of the lack of a common reference standard between the two studies.” Aquestive will seek to gain alignment with the Agency on a reasonable path to appropriately characterize the food effect of Valtoco including potentially conducting a comparative study as indicated by the FDA. 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 that are distinct from a patient’s usual seizure pattern in patients with epilepsy 12 years of age and older. 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. Approximately 1.0 million patients with epilepsy suffer from uncontrolled refractory seizures, approximately 85% of whom will not interact with the available treatments. About Aquestive Therapeutics Aquestive Therapeutics, Inc. 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 on the U.S. market, four licensed products and one stand-alone proprietary product to date, Sympazan® (clobazam) oral film for the treatment of seizures associated with Lennox-Gastaut syndrome. Our licensees market their products in the U.S. and around the world. 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, or CNS, and an earlier stage pipeline for the treatment of severe allergic reactions, including anaphylaxis.

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Spotlight

With over 260,000 health apps worldwide and 70% of patient groups using at least one app to manage their condition, it’s clear that a digital ecosystem has developed within healthcare. New research released by the Deloitte Centre for Health Solutions explores how digital technology can help pharma embrace patient centricity to remain relevant, profitable, and to deliver better health outcomes. Based on extensive literature reviews, new primary research on the production and utilisation of health apps by 12 major pharma companies and a survey of 190 patient groups, as well as our experience working across the healthcare and life sciences sector, our report examines the barriers that pose a threat to pharma’s transformation as well as the strategies being used to achieve patient centricity.

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