Who joins Purdue on pharma's top 10 settlements list? Merck, GSK and Pfizer, for starters

FiercePharma | September 12, 2019

Purdue’s pending opioid settlement with thousands of cities and counties, worth between $10 billion and $12 billion, could rank as the largest deal ever inked by a pharma if it passes a Cleveland federal judge’s muster. But where do pharma’s other major settlements fall on that list? The top 10 largest federal settlements list is a who’s who of some of pharma’s biggest companies, including Merck, Pfizer, Johnson & Johnson and Eli Lilly. If Purdue’s deal is approved, it would more than double the amount from the closest federal settlement—Merck takes an ignoble second place with a Vioxx settlement signed in 2007—but it could be eclipsed by other drugmakers ensnared in national opioid lawsuits. Purdue’s path to the negotiating table was a long one, as the OxyContin maker and its billionaire founding family, the Sacklers, have become the face of the nation’s opioid epidemic. On Wednesday, the drugmaker reportedly inked a $12 billion deal with thousands of cities and counties and 23 states that would immediately send the drugmaker into bankruptcy and restructuring. The deal isn’t just a hit to the company: The Sacklers would be required to shell out $3 billion of their own money as part of the deal.

Spotlight

he recent evolution of Fedegari Group is present on integrated projects where various process machines interact with robotized handling systems for fully automatic high-throughput manufacturing lines. This video provides an overview of our last project: an automated production line with robotized handling solution for pharmaceutical syringes and vials. For more information, contact us: fedegari@fedegari.com


Other News
BUSINESS INSIGHTS

AustinPx Names Elizabeth Hickman Chief Business Officer

AustinPx | September 28, 2022

AustinPx, Pharmaceutics and Manufacturing, a contract development and manufacturing organization announced the appointment of Elizabeth Hickman as Chief Business Officer. In this role, Ms. Hickman will be responsible for the Company’s CDMO business operations and strategy, including building capabilities and a team to deliver high-value solutions for pharmaceutical customers. Ms. Hickman is an accomplished business leader with over 15 years of experience with small and multi-billion-dollar CDMOs. Over her career, she has held business development and market strategy positions of increasing responsibility, most recently at West Pharmaceutical Services as Senior Director of Strategic Marketing, Services and Solutions where she was responsible for market expansion of the company’s contract development, testing and manufacturing services. Prior to joining West, Ms. Hickman led sales and marketing at Pharmatek Laboratories, where she helped grow the company’s services and revenues resulting in its successful acquisition by Catalent Pharma Solutions. Following Pharmatek’s acquisition, she continued to excel in market strategy and business development leadership roles with Catalent’s oral drug development business unit. Ms. Hickman has a BA in Microbiology from the University of Texas, Austin and an MBA from San Diego State University. "Elizabeth brings a sharp skillset and a wealth of CDMO experience to AustinPx," said Tim Scott, President and CEO for AustinPx. "She has a strong history of growing CDMOs as both a strategist and a team-builder. Elizabeth is unique in her ability to foster and create a culture that excels at providing client-centric services, and that is why she is such a tremendous asset for AustinPx. We are very fortunate to have her." As CBO at AustinPx, Ms. Hickman will focus on the strategic buildout of agile, best in class operations, systems, and teams. She will be responsible for all market strategy and communications, business development, project management, systems optimization, and data-driven processes that drive growth. "I am excited to be a part of AustinPx and join its impressive team of formulation and manufacturing scientists and operations staff. They are a true scientific powerhouse for our clients. My goal is to build on the Company’s strong foundation to develop a client-centric CDMO that consistently delivers exceptional service from initial engagement to product shipment. Ultimately, my passion is for the patients of our clients – if we can help get their drug candidates to the clinic faster, with better formulations and dosage forms, we can in turn impact more patients around the world." Elizabeth Hickman About AustinPx AustinPx, Pharmaceutics and Manufacturing is a contract development and manufacturing organization providing analytical and formulation development services and cGMP manufacturing for small molecule drugs. We specialize in phase-appropriate development strategies, speed to clinic and market strategies, and bioavailability enhancement of poorly soluble molecules - including our next generation amorphous dispersion platform, KinetiSol® Technology.

Read More

BUSINESS INSIGHTS

Inversago Pharma Raises $95 million CAD in Series C Financing

Inversago Pharma Inc. | October 18, 2022

Inversago Pharma Inc. a clinical stage biotech company with a unique portfolio of peripherally-acting CB1 inverse agonists, announced the completion of a Series C funding of $95 million CAD led by New Enterprise Associates. Additional new investors Forbion’s Growth Opportunities Fund and Amgen Ventures joined current investors including Forbion’s Ventures Fund IV Fonds de solidarité FTQ, Genesys Capital, AmorChem, JDRF T1D Fund and adMare BioInnovations in the financing round. Proceeds from the Series C financing will be used to move Inversago’s lead program, INV-202, into a Phase 2 clinical trial in Diabetic Kidney Disease in Q4 2022. This follows the previously announced IND clearance from the FDA and the upcoming promising Phase 1b topline results in subjects with metabolic syndrome. Additionally, the funds will accelerate the Company’s other key programs currently in pre-clinical development, while establishing its leadership in the field of CB1 blockers. “We are privileged to have the support and commitment of such an impressive investor syndicate at this critical stage of the Company’s development. This new round of financing is a strong endorsement of the whole Inversago team, who have carried the vision to leverage the potential of the CB1 blockade in developing potent treatments for a growing number of patients suffering from metabolic conditions, such as Diabetic Kidney Diseases and other diabetes-related conditions”. François Ravenelle, PhD, Chief Executive Officer of Inversago Pharma Commenting on the investment, Ed Mathers, General Partner at NEA, said: “Inversago has demonstrated that peripherally-acting CB1 blockers have an untapped potential to create a new class of target therapies that serve diabetic patient populations. Today’s financing reflects our shared vision and collaboration with the Company’s management as they initiate a Phase 2 clinical trial with INV-202”. Nanna Lüneborg, General Partner at Forbion Growth, added: “We are delighted to join this Series C financing of Inversago, and support the Company to develop a pipeline of new therapies which promise to make a profound impact on the lives of patients with cardiometabolic diseases. We have been impressed by the terrific progress of Inversago since Forbion led the Company’s Series B round two years ago and are excited to further support the Company from both Forbion Growth and Forbion Ventures”. About NEA New Enterprise Associates, Inc. is a global venture capital firm focused on helping entrepreneurs build transformational businesses across multiple stages, sectors and geographies. With nearly $24 billion in cumulative committed capital since the firm's founding in 1977, NEA invests in technology and healthcare companies at all stages in a company's lifecycle, from seed stage through IPO. The firm's track record of investing includes more than 260 portfolio company IPOs and more than 440 mergers and acquisitions. About Forbion Forbion is a dedicated life sciences venture capital firm with offices in The Netherlands, Germany and Singapore. Forbion invests in life sciences companies that are active in the (bio-) pharmaceutical space. Forbion manages well over EUR 2 billion across multiple fund strategies that cover all stages of pharmaceutical drug development. Forbion’s current team consists of over 30 life sciences investment professionals that have built an impressive performance track record since the late nineties with investments in 92 companies. Besides financial objectives, Forbion selects investments that will positively affect the health and well-being of patients. The firm is a signatory to the United Nations Principles for Responsible Investment. Forbion operates a joint venture with BGV, the manager of seed and early-stage funds, especially focused on Benelux and Germany. About Amgen Ventures Amgen Ventures is Amgen's corporate venture capital fund, dedicated to investing in emerging companies and technologies to advance promising new medicines and solutions to healthcare’s biggest challenges. About Inversago Pharma Located in Montreal, Inversago Pharma is a privately owned Canadian biotech company at clinical stage, specialized in the development of new therapies focusing on CB1 blockade, based on first-in-class, peripherally-acting CB1 inverse agonists. Inversago aims to provide new treatment options that improve the lives of patients affected by metabolic conditions such as Diabetic Kidney Disease including Diabetic Nephropathy Type 1 and Type 2 Diabetes Non-Alcoholic Steatohepatitis complications of obesity and hypertriglyceridemia as well as fibrotic indications like Progressive Fibrosis-Interstitial Lung Disease including Idiopathic Pulmonary Fibrosis and other conditions.

Read More

PHARMACY MARKET

Astellas Announces Topline Results from Phase 3 Long-Term Safety Study of Fezolinetant in Mainland China

Astellas Pharma Inc. | September 05, 2022

Astellas Pharma Inc. announced topline results from the Phase 3 MOONLIGHT 3™ clinical trial in women in mainland China evaluating the long-term safety and tolerability of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms associated with menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause. MOONLIGHT 3 is a 52-week single-arm Phase 3 clinical trial investigating the long-term safety and tolerability of fezolinetant 30 mg taken once daily in 150 women in mainland China seeking treatment for relief of VMS associated with menopause. The study's primary endpoint is the frequency and severity of adverse events which were generally consistent with previous Phase 3 studies of fezolinetant. Detailed results will be submitted for publication in the near future. "The topline results from the MOONLIGHT 3 study are very encouraging and, upon initial review, further support the long-term safety of fezolinetant. We are evaluating the full MOONLIGHT data sets and remain committed to developing innovative treatments in this therapeutic area with the hope of delivering a first-in-class, nonhormonal treatment option for women with moderate to severe VMS." Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas Fezolinetant is an investigational selective neurokinin-3 receptor antagonist and is not approved anywhere in the world. In the U.S., a New Drug Application for fezolinetant for the treatment of moderate to severe VMS associated with menopause is under review. The NDA submission is based on results from two pivotal Phase 3 clinical trials, SKYLIGHT 1™ and SKYLIGHT 2™, and the Phase 3 long-term safety study, SKYLIGHT 4™. About the MOONLIGHT Phase 3 Clinical Trials MOONLIGHT 1™ is designed to investigate the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS associated with menopause in women in Asia. The study is double-blinded and placebo-controlled for the first 12 weeks, followed by a 12-week non-controlled extension treatment period. A total of 302 women with moderate to severe VMS associated with menopause were enrolled at nearly 60 sites in mainland China, Korea and Taiwan. MOONLIGHT 3™ is a 52-week single-arm Phase 3 clinical trial designed to investigate the long-term safety and tolerability of fezolinetant in women in mainland China with VMS associated with menopause. A total of 150 women were enrolled at 34 sites in mainland China. About the BRIGHT SKY™ Phase 3 Program The BRIGHT SKY pivotal trials, SKYLIGHT 1™ and SKYLIGHT 2™ enrolled over 1,000 women with moderate to severe VMS. The trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. Women were enrolled at over 180 sites within the U.S., Canada and Europe. SKYLIGHT 4™ is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within the U.S., Canada and Europe. About VMS Associated with Menopause VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2 Worldwide, more than 50% of women 40 to 64 years of age experience VMS and, in East Asia, the prevalence of VMS has been estimated to be around 80% of women 40 to 65 years of age, with 55% having moderate to severe VMS.3,4 VMS can have a disruptive impact on women's daily activities and overall quality of life.1 About Fezolinetant Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause. Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron to moderate neuronal activity in the thermoregulatory center of the brain (the hypothalamus) to reduce the frequency and severity of moderate to severe VMS associated with menopause.5,6,7 The safety and efficacy of fezolinetant are under investigation and have not been established. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. About Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients.

Read More

PHARMA TECH

AeroRx Partners with HCmed to Develop a Nebulized LABA/LAMA Combination Solution for the Treatment of Chronic Obstructive Pulmonary Disease

AeroRx Partners | October 03, 2022

AeroRx Therapeutics, LLC. and HCmed Innovations Co., Ltd. have initiated a collaboration, introducing a LABA/LAMA combination solution for delivery with a breath-actuated nebulizer. This collaboration sets forth the framework by which both companies will work together to develop a new nebulized combination formulation for the treatment of chronic obstructive pulmonary disease. According to market reports, it is estimated that there would be close to 34.5 million COPD patients worldwide by 2028, accounting for treatment global sales that could reach up to 19.3 billion USD. AeroRx is currently developing the first nebulized LABA/LAMA combination solution, which could benefit 7-19% of the COPD population. This population group is characterized for suffering from moderate to severe airflow obstruction, which creates difficulties to achieve the inspiratory flow rate required to use most dry powder inhalers optimally. Under this partnership, AeroRx will be responsible for the formulation development, clinical trials, and commercialization of the drug product, while HCmed will be responsible for the customization of the AdheResp breath-actuated nebulizer platform, analyzing and optimizing the formulation's aerosol characterization performance to accommodate the various stages of drug development process and the final combination product. The project will follow a 505(b)2 regulatory pathway, and the corresponding PK/PD study is expected to be conducted with HCmed's nebulizer in 2023. "We are excited to announce our partnership with AeroRx. The AeroRx team has extensive experience in the development of respiratory drugs, while at HCmed we can support our partners to develop drug-nebulizer combination products with our proprietary breath-actuated mesh nebulizer platform. The product of our collaboration will provide COPD patients with an effective inhaled LABA/LAMA combination drug, which will reinforce patients' treatment adherence and improve their quality of life." Jason Cheng, CEO and founder of HCmed Keith Ung, President and co-founder of AeroRx also commented, "We too are enthusiastic about this partnership. Breath-actuated vibrating mesh delivery of inhaled therapeutics is the wave of the future for many therapeutics and HCmed has become one of the leaders in this elegant inhaler device technology." About HCmed Founded in 2014, HCmed Innovations Co., Ltd. is a contract development and manufacturing organization that provides high-quality and cost-effective vibrating mesh nebulizer technology and services to support global pharmaceutical partners in the development of drug-nebulizer combination products for inhalation therapy. HCmed offers a mature customizable mesh nebulizer platform to enhance drug delivery. This technology enables efficient and reliable nebulization of different types of medication, ranging from small molecule synthetics to large molecule biologics, as either solutions, suspensions, or even difficult-to-deliver high viscosity drugs. About AeroRx Founded in 2022, AeroRx Therapeutics, LLC. is a spin-off of iPharma Lab's inhalation CDRO business which was recently acquired by Kindeva Drug Delivery. AeroRx is developing proprietary inhaled products for the treatment of COPD and asthma. The company is led by industry veterans with extensive expertise in inhaled drug delivery and development as well as a track record in building new pharmaceuticals organizations from the ground up.

Read More

Spotlight

he recent evolution of Fedegari Group is present on integrated projects where various process machines interact with robotized handling systems for fully automatic high-throughput manufacturing lines. This video provides an overview of our last project: an automated production line with robotized handling solution for pharmaceutical syringes and vials. For more information, contact us: fedegari@fedegari.com

Resources