Sanofi, Eisai join Lillys SCOTUS bid to save Cialis from overly broad patent claims

fiercepharma | July 09, 2019

Eli Lilly has a message for the U.S. Supreme Court- We arent going to take a $20 million patent loss for Cialis sitting down. Now, Lilly can count on a couple of friends ready to join the fight—and it's a fight that the rest of pharma might want to watch. On Monday, Sanofi and Eisai Pharma threw their weight behind a lawsuit seeking to overturn a claim by Erfindergemeinschaft Uropep GBR (EUG) that ended Cialis’ patent protection in benign prostatic hyperplasia (BPH), a $20 million indication. Lilly called EUG’s original claim a “particularly egregious example of functional claiming,” in the suit (PDF). Both Sanofi and Eisai doubled down on Lilly’s “functional claim” argument, saying EUG’s claim effectively roped off any drug formulations used to treat BPH through an enzyme inhibitor, a category Cialis falls under. It's the sort of broad patent claim at issue in a variety of outstanding court cases, so it's no surprise other drugmakers want in. Lilly's lawsuit could have big implications for companies who've fallen prey to claims that rely on results rather than precise formulations. In fact, fighting "overly broad" patent claims is at the heart of Sanofi and Regeneron's fight to market PCSK9 inhibitor Praluent, which a California jury said in February infringed on Amgen's older patent for Repatha.

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Federal prosecutors charged executives of the Rochester Drug Cooperative Tuesday, the first criminal charges against a drug distributor in the nation's ongoing opioid crisis.

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Federal prosecutors charged executives of the Rochester Drug Cooperative Tuesday, the first criminal charges against a drug distributor in the nation's ongoing opioid crisis.

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PHARMA TECH

MyMD Pharmaceuticals Announces Issuance of U.S. Patent Covering Lead Drug Candidate MYMD-1 in a Method of Extending Lifespan

MyMD | November 24, 2021

MyMD Pharmaceuticals, Inc. a clinical stage pharmaceutical company committed to extending healthy lifespan by delaying aging, announced that the U.S. Patent and Trademark Office (USPTO) today issued U.S. Patent 11,179,382 B2, titled “Methods of Reversing Normal Aging Process and Extending Lifespan.” The allowed claims protect the use of MYMD-1 in a method designed to extend the lifespan of an individual. “This patent is a timely addition to our IP portfolio as we advance toward the launch of our fully funded Phase 2 trial of MYMD-1 for aging. After a comprehensive review by USPTO, we are pleased with the broad scope of the granted claims which offer further protection for our lead drug candidate, which we believe has the potential to become the first and only FDA-approved therapeutic solution for delaying aging and prolonging healthy lifespan,” Chris Chapman, M.D., President, Director and Chief Medical Officer of MyMD “Our primary focus for MYMD-1 is to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan,” Dr. Chapman added. “It’s also important to note that MYMD-1 shows promise in pre-clinical studies as a treatment for immune diseases including rheumatoid arthritis, multiple sclerosis, and Hashimoto’s thyroiditis, and as an anti-fibrotic and anti-proliferation therapeutic.” The latest patent adds to MyMD’s intellectual property portfolio of 14 granted patents (12 U.S. and two foreign) covering MYMD-1 in methods of treating chronic inflammation, autoimmune disorders, diabetes, multiple sclerosis, viral infections, addictions, fibrosis, asthma, and other disorders. MyMD also holds two patents for its synthetic cannabidiol (CBD) derivative Supera-CBD. An additional 30 patent applications are pending worldwide. About MYMD-1 Originally developed for autoimmune diseases, MYMD-1’s primary purpose is to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan. Because it can cross the blood-brain barrier and gain access to the central nervous system (CNS), MYMD-1 is also positioned to be a possible treatment for brain-related disorders. Its mechanism of action and efficacy in diseases including multiple sclerosis (MS) and thyroiditis have been studied through collaborations with several academic institutions. MYMD-1 is also showing promise in pre-clinical studies as a potential treatment for post- COVID-19 complications and as an anti-fibrotic and anti-proliferation therapeutic. MYMD-1 has shown effectiveness in pre-clinical studies in regulating the immune system by performing as a selective inhibitor of tumor necrosis factor-alpha (TNF-α), a driver of chronic inflammation. Unlike other therapies, MYMD-1 has been shown to selectively block TNF-α when it becomes overactivated in autoimmune diseases and cytokine storms, but not block it from doing its normal job of being a first responder to any routine type of moderate infection. MYMD-1’s ease of oral dosing is another differentiator compared to currently available TNF-α blockers, all of which require delivery by injection or infusion. No approved TNF inhibitor has ever been dosed orally. In addition, the drug is not immunosuppressive and has not been shown to cause the serious side effects common with traditional therapies that treat inflammation. About MyMD Pharmaceuticals, Inc. MyMD Pharmaceuticals, Inc. a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1 is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to delay aging, increase longevity, and treat autoimmune diseases and COVID-19- associated depression. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs.

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PHARMACY MARKET

Ascentage Pharma Announces its 9th Orphan Drug Designation from the US FDA in 2020

Ascentage Pharma | January 05, 2021

Ascentage Pharma (6855.HK), an internationally engaged, clinical-stage biotechnology organization occupied with creating novel treatments for malignancies, persistent hepatitis B (CHB), and age-related sicknesses, today reported that the US Food and Drug Administration (FDA) has allowed an Orphan Drug Designation (ODD) to the organization's novel Bcl-2 inhibitor, APG-2575, for the therapy of patients with intense myeloid leukemia (AML). This is the fourth ODD allowed to APG-2575 by the US FDA, following the past ODDs for the therapy of Waldenström macroglobulinemia (WM), ongoing lymphocytic leukemia (CLL), and numerous myeloma (MM). Until this point, four of Ascentage Pharma's investigational drug up-and-comers have been allowed an aggregate of nine ODDs by the US FDA, a record number for any Chinese biopharmaceutical organization. AML is an exceptionally heterogenous hematologic threat that is more normal in the old populace with a middle age at analysis of 68 years1. The latest information from the Surveillance, Epidemiology, and End Results Program (SEER) of the US National Cancer Institute (NCI) assessed 19,940 new instances of AML and 11,180 passings from this infection in the United States in 2020. Notwithstanding the critical advances in therapeutics as of late, the 5-year endurance pace of AML stays at 25%–30%, which actually speaks to a huge neglected clinical requirement for treatments with more solid viability and a superior wellbeing profile. The expression "vagrant medications" alludes to drug items produced for the counteraction, finding, and treatment of uncommon illnesses or conditions. In the United States, a vagrant sign is characterized as a sickness or condition with a pervasiveness of under 200,000 patients in the nation. Since the Orphan Drug Act was passed in 1983, the US government has given motivators and strategy backing to support advancement of vagrant medications. Treatments conceded ODDs by the FDA are equipped for different advancement motivators, including a tax break on consumptions brought about in clinical examinations, a waiver of the New Drug Application (NDA) charge, conceivable exploration award granted by the FDA, and above all, 7 years of US market restrictiveness upon endorsement.

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BUSINESS INSIGHTS

InDex Pharmaceuticals strengthens the clinical development organization in preparation of the start of the phase III study CONCLUDE with cobitolimod

InDex Pharmaceuticals | August 23, 2021

InDex Pharmaceuticals Holding AB today announced that two new employees have been appointed in the clinical development organisation in preparation of the start of the phase III study CONCLUDE with cobitolimod. Anders Bröijersén is joining InDex as Senior Medical Director Clinical Operations and Johan Levin as Project Manager Clinical Operations. Anders Bröijersén is a medical doctor and PhD with 15 years of experience in Clinical Development, Medical Affairs and Drug Safety at leading pharmaceutical companies such as Boehringer Ingelheim and MSD. Anders joins InDex from Sobi where he currently serves as Medical Director, Global Pharmacovigilance & Patient Safety. Johan Levin is a trained nurse and has more than 20 years of experience in Clinical Development at leading pharmaceutical companies and clinical research organizations (CROs) such as MSD and Covance. He currently works as senior Clinical Research Associate (CRA) at PRA Health Sciences. "I am pleased that InDex has been able to attract two highly qualified new employees and welcome Anders and Johan to the team," said Peter Zerhouni, CEO of InDex Pharmaceuticals. "We are expanding the organisation in preparation of the start of our global phase III study CONCLUDE with cobitolimod to be able to be active towards the study sites in collaboration with our CRO. This was a successful model for patient recruitment in our previous study CONDUCT." The phase III study CONCLUDE with cobitolimod will include 440 patients and be conducted at several hundred clinics in over 30 countries. It is a randomised, double-blind, placebo-controlled, clinical study to evaluate cobitolimod as a novel treatment for patients with moderate to severe left-sided ulcerative colitis. Cobitolimod Cobitolimod is a first-in-class Toll-like receptor 9 (TLR9) agonist that can provide an anti-inflammatory effect locally in the large intestine, which may induce mucosal healing and relief of the clinical symptoms in ulcerative colitis. Cobitolimod met the primary endpoint in the phase IIb study CONDUCT and demonstrated an outstanding combination of efficacy and safety. The results have been published in the reputable medical journal, The Lancet Gastroenterology & Hepatology. Data from four previous completed placebo-controlled clinical trials support the efficacy and safety demonstrated in the CONDUCT study. InDex Pharmaceuticals InDex is a pharmaceutical development company focusing on immunological diseases where there is a high unmet medical need for new treatment options. The company's lead asset is the drug candidate cobitolimod, which is in late stage clinical development for the treatment of moderate to severe ulcerative colitis – a debilitating, chronic inflammation of the large intestine. InDex has also developed a platform of patent protected discovery stage substances, so called DNA based ImmunoModulatory Sequences (DIMS), with the potential to be used in the treatment of various immunological diseases.

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