Prosecutors strike yet another pharma kickback settlement, this time with Almirall

fiercepharma | May 30, 2019

One by one, drugmakers have been handing over millions of dollars to the U.S. government to settle kickback allegations. And Almirall is the latest.The Spain-based drugmaker agreed to pay $3.5 million to the Department of Justice (DOJ) and $3.1 million to the California Department of Insurance to wrap up claims that it paid doctors to prescribe more of its skin drugs. Based on allegations outlined in a whistleblower lawsuit, the government said that Almirall's Aqua Pharmaceuticals business wined, dined, entertained and gave gifts to dermatologists to boost scripts. Almirall bought Aqua in 2013, and the alleged kickbacks extended from 2012 to 2017, the DOJ said.  The company also used speaking events, advisory boards and more to influence prescribing habits, the feds alleged, focusing on three meds Monodox, Cordran and Acticlate Almirall’s wrap-ups are the latest in a string of pharma kickbacks settlements, many of them related to charity contributions. The Justice Department has said certain donations actually served as kickbacks designed to boost sales. At least 10 drugmakers have settled those claims with the DOJ: Astellas, Amgen, Actelion, Aegerion, Jazz, Alexion, Lundbeck, Pfizer, Novartis and United Therapeutics.

Spotlight

Disorders of the peripheral and central nervous system are very severe in nature. They may lead to the complete degeneration of the neurological system and permanently incapacitate an individual. These disorders are observed mainly after the age of 65. But in recent years, young adults and even small children are being diagnosed with neurological diseases. The most common form of the neurological disease is “brain diseases” that is affecting the lives of millions worldwide. According to the global estimates by the World Health Organization, 1 out of every 6 people in any country suffers from one or the other type of brain disease. This has resulted in reduced life expectancy all over the world and demands attention from global health organizations.


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VIEWS AND ANALYSIS

CHMP Recommends Approval of Dupixent® (dupilumab) for Children Aged 6 to 11 Years with Severe Asthma with Type 2 Inflammation

Regeneron Pharmaceuticals, Inc | January 31, 2022

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending to extend the approval of Dupixent® (dupilumab) in the European Union (EU) to include add-on maintenance treatment for children aged 6 to 11 years with severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO) who are inadequately controlled on two maintenance therapies. The European Commission is expected to announce a final decision on the Dupixent application in the coming months. The CHMP positive opinion is supported by Phase 3 data recently published in the New England Journal of Medicine showing that Dupixent added to standard of care significantly reduced the rate of severe asthma attacks and rapidly improved lung function within two weeks, with sustained improvement up to 52 weeks, in children with uncontrolled moderate-to-severe asthma. The safety results from the trial were generally consistent with the known safety profile of Dupixent in patients aged 12 years and older with uncontrolled moderate-to-severe asthma. Adverse events more commonly observed with Dupixent compared to placebo included injection site reactions, viral upper respiratory tract infections and eosinophilia. Helminth infections were also more commonly observed with Dupixent compared to placebo in patients aged 6 to 11 years. Asthma is one of the most common chronic diseases in children. Up to 85% of children with asthma may have type 2 inflammation and are more likely to have higher disease burden. Despite treatment with current standard-of-care inhaled corticosteroids (ICS) and bronchodilators, these children may continue to experience serious symptoms such as coughing, wheezing and difficulty breathing. Severe asthma may impact children's developing airways and cause potentially life-threatening exacerbations. Children with severe asthma also may require the use of multiple courses of systemic corticosteroids that carry significant risks. Uncontrolled severe asthma can interfere with day-to-day activities like sleeping, attending school and playing sports. On October 20, 2021, Dupixent was approved by the FDA as an add-on maintenance treatment for patients aged 6 to 11 years with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid-dependent asthma. The use of Dupixent in children aged 6 to 11 years with uncontrolled severe asthma is investigational in the EU and is not yet approved. About Dupixent Dupixent, which was invented using Regeneron's proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP). About Regeneron Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite technologies, such as VelocImmune, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. About Sanofi Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

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BUSINESS INSIGHTS

Oramed Completes Patient Enrollment in Phase 2 Oral Insulin NASH Trial

Oramed Pharmaceuticals Inc. | March 17, 2022

Oramed Pharmaceuticals Inc. a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, announced it has completed enrollment of all patients in a Phase 2 trial of its oral insulin capsule ORMD-0801 for the treatment of non-alcoholic steatohepatitis. An estimated 1.5% to 6.5% of adults in the U.S., or between 4 million and 17 million people, have NASH and about half of these also have diabetes, according to the National Institute of Diabetes and Digestive and Kidney Diseases. The double-blind, multi-center trial with clinical sites in the U.S. and Israel is assessing the safety and potential efficacy of ORMD-0801 in Type 2 diabetes patients with NASH. Efficacy endpoints including safety and percentage change in liver fat content, liver fibrosis, and liver steatosis from baseline are measured via MRI-PDFF following 12 weeks of dosing. "There is currently no drug approved to treat this disease, leaving NASH with a serious unmet medical need. With direct action on the liver, we believe that ORMD-0801 has the potential to address over 50% of people with diabetes who also suffer from NASH, a population with unfortunately increased mortality. We look forward to analyzing and reporting topline data, which we expect will confirm our prior pilot study's efficacy and safety results," Oramed Chief Executive Officer, Nadav Kidron The global market for drugs to treat NASH is expected to reach $84 billion by 2029, according to a publication by Research and Markets on the Global Non-Alcoholic Steatohepatitis (NASH) Drugs Market. About NASH Non-alcoholic steatohepatitis is a serious, progressive liver disease caused by a buildup of fat in the liver and accompanied by inflammation, liver cell damage, and in some cases, scarring of the liver. Over time, NASH may progress to cirrhosis, liver cancer, liver failure, and even death. Currently, no pharmacotherapy is globally approved for the treatment of NASH, and people with NASH are left with very few treatment options. About Oramed Pharmaceuticals Oramed Pharmaceuticals is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, with offices in the United States and Israel, Oramed has developed a novel Protein Oral Delivery (POD™) technology. Oramed is seeking to transform the treatment of diabetes through its proprietary lead candidate, ORMD-0801, which is being evaluated in two pivotal Phase 3 trials and has the potential to be the first commercial oral insulin capsule for the treatment of diabetes. In addition, Oramed is developing an oral GLP-1.

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BUSINESS INSIGHTS

Angelini Pharma, a New Partner in Epilepsy

Angelini Pharma | March 26, 2022

On the occasion of Purple Day an annual international event aimed at raising awareness of epilepsy, Angelini Pharma, international Italian pharmaceutical company, is committed to provide patients and healthcare professionals with innovative solutions improving the care of patients with epilepsy. Epilepsy is a common neurological disorder that typically results in seizures of various types, with focal seizures being the most common one.1 The essential treatment goal of epilepsy therapy is seizure freedom.2 The global disease burden of epilepsy is high. 3,4 A diagnosis of epilepsy confers significant disability on the individual, including physical, psychological, and social issues that negatively impact self-esteem, family environment, relationships, leisure and working life. 3,5 Long-term outcomes for patients who have not responded to at least 2 antiepileptic drugs remain without significant improvement for more than 2 decades despite the availability of many new antiepileptic drugs. 6,7 Indeed, even today 40% of all patients with epilepsy do not achieve seizure freedom despite treatment with 2 different drugs.6,8 The probability of achieving the therapeutic goal of seizure freedom decreases significantly with each failed treatment. 6 Aware of the existence of an unmet medical need, Angelini Pharma is committed to make available a new anti-epileptic drug. The product received the Market Authorization from the European Medicines Agency in March 2021 and many Early Access Program authorization across European countries, including in France. The product is already marketed in Germany, Austria, United Kingdom, Sweden, and Denmark. About Angelini Pharma Angelini Pharma is an international pharmaceutical company, part of the Italian privately group owned Angelini Industries. Angelini Pharma is committed to helping patients in the therapeutic areas of Mental Health Rare Diseases and Consumer Healthcare. In particular, Angelini Pharma is committed to brain health working every day to reduce and mitigate neurological disorders, while restoring and protecting mental health and cognitive function.

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BUSINESS INSIGHTS

PhaseBio Pharmaceuticals to Participate in the Cowen 42nd Annual Health Care Conference

PhaseBio Pharmaceuticals, Inc. | February 25, 2022

PhaseBio Pharmaceuticals, Inc. a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiovascular diseases, today announced that Chief Executive Officer Jonathan P. Mow will participate in a panel discussion during Cowen’s 42nd Annual Health Care Conference taking place virtually on Tuesday, March 8, 2022 from 12:50 pm – 1:50 pm ET. Interested parties can access the live and archived webcasts of the virtual session on the “Events and Presentations” page of the “Investors” section of the company’s website at www.phasebio.com. The webcast replay will be available for 90 days after the conclusion of the live presentation. About PhaseBio PhaseBio Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiovascular and cardiopulmonary diseases. PhaseBio’s pipeline includes: bentracimab (PB2452), a novel reversal agent for the antiplatelet therapy ticagrelor; pemziviptadil (PB1046), a once-weekly VIP receptor agonist for the treatment of pulmonary arterial hypertension; and PB6440, an oral agent for the treatment of resistant hypertension. PhaseBio’s proprietary elastin-like polypeptide technology platform enables the development of therapies with potential for less-frequent dosing and improved pharmacok

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Spotlight

Disorders of the peripheral and central nervous system are very severe in nature. They may lead to the complete degeneration of the neurological system and permanently incapacitate an individual. These disorders are observed mainly after the age of 65. But in recent years, young adults and even small children are being diagnosed with neurological diseases. The most common form of the neurological disease is “brain diseases” that is affecting the lives of millions worldwide. According to the global estimates by the World Health Organization, 1 out of every 6 people in any country suffers from one or the other type of brain disease. This has resulted in reduced life expectancy all over the world and demands attention from global health organizations.

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