Would Trumps new drug-imports plan do much to prices, or to pharma?

Fiercepharma | July 31, 2019

The Pharma industry cheered when the Trump administration introduced a proposal putting drug pricing rebates in the crosshairs. But like so many other drug pricing ideas over the years, the measure didnt go anywhere. Now, the administration is switching gears to importation. HHS on Wednesday presented a plan for bringing in cheaper drugs from Canada, an approach the industry staunchly opposes. It marks a major shift from previous policies on imports, but the plan itself might not do much to lower prices—or hurt pharma, according to one industry watcher. The plan would allow imports through two pathways. The first would let states, wholesalers or pharmacists launch pilot projects to import drugs from Canada that are approved in the U.S. and “manufactured consistent with the FDA approval.” Under the second, the FDA could allow manufacturers to import drugs under new national drug codes, potentially allowing for lower prices than those stipulated by existing contracts. The drugs would have to be identical to their U.S. counterparts and have appropriate labeling. HHS says the pathway could work for insulins, rheumatoid arthritis drugs, cardiovascular meds and more. While the news may have sent concerns around the halls at top drugmakers, one analyst quickly responded that he isn’t worried. In a note to clients titled “SNOOZE?”, Evercore ISI’s Umer Raffat dug into the plan’s details and outlined some shortfalls—or positives from a pharma industry perspective. Digging into the first pathway, Raffat pointed out that many of pharma's most costly products—biologics such as AbbVie's Humira; IV drugs, a category that would include many pricey cancer treatments; and inhaled products, such as respiratory therapies from GlaxoSmithKline and AstraZeneca, are all excluded. So are meds that require Risk Evaluation and Mitigation Strategies at the FDA—a group that comprises many expensive and newer drugs, such as multiple sclerosis treatments.

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The European regulators therefore considered that a change was needed. Following recent scandals such as the Poly Implant Prothese ("PIP”) scandali, certain initiatives were having already been taken under the current regime (a) to minimise the risk to patients' and (b) to reduce so called “notified body tourism” by increasing scrutiny on notified bodiesii; further harmonisation measures to improve patient safety were nonetheless deemed necessary.

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The European regulators therefore considered that a change was needed. Following recent scandals such as the Poly Implant Prothese ("PIP”) scandali, certain initiatives were having already been taken under the current regime (a) to minimise the risk to patients' and (b) to reduce so called “notified body tourism” by increasing scrutiny on notified bodiesii; further harmonisation measures to improve patient safety were nonetheless deemed necessary.

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Atomwise Signs Strategic Multi-Target Research Collaboration with Sanofi for AI-Powered Drug Discovery

Atomwise | August 22, 2022

Atomwise, a leader in using artificial intelligence (AI) for small molecule drug discovery, announced that it has established a strategic and exclusive research collaboration with Sanofi that will leverage its AtomNet® platform for computational discovery and research of up to five drug targets. The Atomwise approach shifts the mode of drug discovery away from serendipitous discovery and toward search based on structure, making the drug discovery process more rational, effective, and efficient. The AtomNet platform incorporates deep learning for structure-based drug design, enabling the rapid, AI-powered search of Atomwise’s proprietary library of more than 3 trillion synthesizable compounds. “At Sanofi, we are committed to bringing higher quality medicines to patients faster, empowered by our advanced AI drug discovery engine. We are excited to partner with Atomwise, given their leadership in the field of virtual screening and AI-based molecular design. Together, we aim at making the drug discovery process more efficient and effective in particular when very limited information is available to support drug design.” Frank Nestle, Global Head of Research and Chief Scientific Officer at Sanofi As part of this agreement, Sanofi will pay Atomwise $20 million upfront to identify, synthesize, and advance lead compounds for up to five targets which will be exclusive to Sanofi. Subsequent payments pegged to key research, development, and sales milestones could total more than $1 billion. In addition, tiered royalties have been established for products developed through the collaboration. “At Atomwise, our mission is to use our unique technology to make better medicines, faster, by unlocking targets that have been inaccessible to traditional small molecule discovery approaches,” said Abraham Heifets, co-founder and CEO of Atomwise. “We are pleased to enter into this collaboration with Sanofi, which serves as continued validation of the important role that AI-powered platforms will play in accelerating the discovery of new therapies for diseases and conditions that may have gone untreated due to challenging or uncharacterized drug targets.” About Atomwise Atomwise is a technology-enabled pharmaceutical company leveraging the power of AI to revolutionize small molecule drug discovery. The Atomwise team invented the use of deep learning for structure-based drug design; this technology underpins Atomwise’s best-in-class AI discovery engine, which is differentiated by its ability to find and optimize novel chemical matter. Atomwise has extensively validated its discovery engine, having demonstrated the ability to find compounds with therapeutic potential for biological targets in 90% of internal programs and more than 70% of the company’s 270 academic collaborations, including across a wide variety of protein types and multiple “hard to drug” targets. Atomwise is building a wholly-owned pipeline of small-molecule drug candidates, with three programs in lead-optimization and over 30 programs in discovery. The company has raised over $194 million from leading venture capital firms and collaborations to advance its mission to make better medicines, faster.

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Societal CDMO Selected To Provide Tech Transfer And Manufacturing Services To Support Clinical Development Of An Oral Solid Dose Product In Europe

Societal CDMO, Inc. | July 21, 2022

Societal CDMO, Inc. a contract development and manufacturing organization dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced that it has been selected to provide CDMO services to support the ongoing clinical development of a novel drug candidate in Europe. The compound is an oral solid dose anti-viral therapy product approved for the prevention and treatment of human immunodeficiency virus in select countries in Europe and Societal’s work is focused on supporting the expansion of the product’s indications. Under terms of the new agreement, Societal CDMO will execute appropriate technology transfer activities, followed by cGMP manufacture of clinical trial material to support the initiation and execution of Phase 2 studies of the drug candidate. This work will include production, packaging and labeling of both the active compound and matching placebo for the study. “This is a key new agreement for Societal CDMO as it is a clear demonstration of the company’s ability to capitalize on the increasing interest of drug developers in the onshoring and reshoring of contract manufacturing activities to the U.S. from other regions around the globe. We are proud to be trusted by our partner to execute the tech transfer, manufacturing and packaging services that will be necessary for the initiation of its planned Phase 2 study in Europe. We continue to be pleased with our progress in leveraging our end-to-end CDMO service offerings to grow our business and expand our client base.” David Enloe, chief executive officer of Societal CDMO About Societal CDMO Societal CDMO is a bi-coastal contract development and manufacturing organization with capabilities spanning pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms with a primary focus in the area of small molecules. With an expertise in solving complex manufacturing problems, Societal CDMO is a leading CDMO providing therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market. In addition to our experience in handling DEA controlled substances and developing and manufacturing modified-release dosage forms, Societal CDMO has the expertise to deliver on our clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. We do all of this in our best-in-class facilities, which total 145,000 square feet, in Gainesville, Georgia and San Diego, California.

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QHP Capital Acquires Lexitas Pharma Services

Lexitas and QHP Capital | July 08, 2022

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

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