Pharmaceutical Market Europe • January 2021 • 6-7
NEWS
Gilead set to acquire hepatitis specialist MYR for €1.15bn
Gilead will pay approximately €1.15bn to acquire MYR GmbH for access to the German biotech’s chronic hepatitis delta virus (HDV) treatment Hepcludex.
Hepcludex (bulevirtide) received a conditional approval from the European Medicines Agency (EMA) for the treatment of chronic HDV in adults with compensated liver disease in July.
HDV is a severe form of viral hepatitis that carries mortality rates as high as 50% within five years in cirrhotic patients.
Patients with HDV co-infection are at a higher risk of developing serious liver disease compared to those living with HBV infection alone. Those with HDV may also experience faster progression to liver fibrosis, cirrhosis, hepatic decompensation and an increased risk of liver cancer and death.
Hepcludex treats HDV by blocking viral entry into liver cells through binding to NTCP, which is an essential HBV and HDV receptor of hepatocytes (liver cells). It is currently the first and only drug with conditional approval in the EU for HDV.
In addition to the EMA conditional approval, MYR expects to submit Hepcludex to the US Food and Drug Administration (FDA) for accelerated approval in the second half of 2021.
Under the terms of the deal, Gilead will pay approximately €1.15bn in cash on closing the transaction, plus a potential future milestone payment of up to €300m dependent on the US approval of Hepcludex.
Boehringer spends €1.18bn to acquire NBE-Therapeutics
NBE-Therapeutics, headquartered in Switzerland, is focused on antibody-drug conjugates (ADC) for the development of targeted cancer therapies.
The biotech company’s immune stimulatory iADC platform creates ‘highly potent’ immune stimulatory ADCs with an anthracycline payload that are designed to directly target tumour cells and induce a durable immunological anti-tumour effect, according to the company.
ADCs are comprised of an antibody that specifically binds to a target on tumour cells and is linked to a cytotoxic drug intended to kill the targeted cells.
NBE’s lead candidate, NBE-002, is currently in phase 1 clinical studies for triple negative breast cancer and a number of additional solid tumours.
Following the acquisition, Boehringer will have access to this programme, as well as NBE’s iADC platform, which the company says it will use to build a ‘leading ADC portfolio’.
The €1.18bn total financial consideration also includes contingent clinical and regulatory milestone payments, Boehringer added in a statement.
Boehringer has also announced its intention to acquire German biotech company Labor Dr. Merk & Kollegen, which will give Boehringer access to its immuno-oncology therapies.
Lilly picks up gene therapy programme in $1bn Prevail Therapeutics acquisition deal
Eli Lilly has stepped into the gene therapy space after announcing a deal to acquire Prevail Therapeutics, a company focused on developing adeno-associated virus (AAV)-based gene therapies for neurodegenerative diseases.
Lilly will acquire Prevail for $22.50 per share in cash, plus one $4 contingent value right dependent on the first regulatory approval of a product from Prevail’s pipeline.
This reflects a potential consideration of up to $26.50 per share in cash for a total consideration of approximately $1.04bn.
For Lilly, the acquisition will extend its focus into developing gene therapies, establishing an in-house gene therapy programme ‘anchored’ by Prevail’s current portfolio and AAV-based technology.
Prevail’s pipeline spans clinical-stage and preclinical neuroscience assets, including lead gene therapies PR001 for patients with Parkinson’s disease with GBA1 mutations (PD-GBA) and neuronopathic Gaucher disease (nGD) and PR006 for patients with frontotemporal dementia with GRN mutations (FTD-GRN).
The company’s preclinical pipeline also includes PR004, a potential gene therapy for patients with specific synucleinopathies, as well as candidates for Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis (ALS) and other neurodegenerative disorders.
For Prevail to achieve the full value of the contingent CVR payment, the first regulatory approval arising from its current gene therapy pipeline must happen by 31 December 2024.
Failing regulatory approval by this date, Lilly said in a statement that the value of the CVR will decrease by approximately 8.3 cents per month until the expiration date on 1 December 2028.
UK selects Shionogi’s Fetcroja for antimicrobial reimbursement scheme
Shionogi’s novel antibiotic Fetcroja has been selected for inclusion in a pilot subscription reimbursement scheme, launched by the UK’s National Institute for Health and Care Excellence (NICE) and NHS England and Improvement (NHSE&I).
The scheme – first announced by Health Secretary Matt Hancock in 2019 – will pilot a model that reimburses pharma companies for antimicrobials based on a health technology value assessment of their value to the NHS, as opposed to the volumes of the drug used.
This pilot is intended to encourage drug developers to resume and increase research and development into new antibiotic medications, given that this area is lacking in innovation due to the economic challenges associated with it.
This is due in large part to the fact that the newest antibiotic drugs are reserved as last-line treatments, and are often only used when all other treatment options have been exhausted.
“Low use leads to limited revenues, which in turn restricts continued commercialisation and new product research,” Shionogi said in a statement.
“Shionogi strongly supports the introduction of new incentives, funding and value assessment models for reimbursement to restore a viable commercial environment to address the economic challenge faced in bringing novel antibiotics to market,” the company added.
Fetcroja was launched in the UK in September and treats infections caused by aerobic Gram-negative bacteria in adults.
In the UK, over 5,000 deaths per year are attributed to antimicrobial resistance (AMR), with over 25,000 deaths per year attributed to AMR in the EU.
EU authorises Aimmune’s peanut allergy treatment Palforzia
Aimmune Therapeutics’ Palforzia has received approval from the European Commission (EC) for the treatment of a peanut allergy.
The EC has approved Palforzia for use in children aged four to 17 with a confirmed diagnosis of a peanut allergy.
The treatment must be accompanied by a diet that avoids peanuts. It is not intended for, and does not provide, immediate relief of allergic symptoms.
In Europe, 17 million people are affected by food allergies, with a peanut allergy being one of the most common. It is thought that around 1.6% of European children live with a peanut allergy, with estimations ranging from 0.24% to 2% depending on the diagnostic methods used.
The oral immunotherapy – previously known as AR101 – takes the form of defatted peanut flour that is sprinkled over food, given in tiny but gradually increasing amounts over a six-month period, to encourage the immune system to develop a tolerance to peanut antigens.
The EU approval, which comes nine months after authorisation in the US, is based on a range of data including results from two pivotal phase 3 trials, PALISADE and ARTEMIS.
In the ARTEMIS trial, the oral immunotherapy met the primary objective, outperforming placebo when it came to inducing a tolerance to a single 1,000mg dose of peanut protein – equivalent to three to four peanut kernels.
The earlier PALISADE study also found that 50.3% of Palforzia-treated patients tolerated a single highest dose of 1,000mg of peanut protein compared to 2.3% of placebo patients.
FDA approves Myovant’s oral pill Orgovyx for prostate cancer
The US Food and Drug Administration (FDA) has approved Myovant’s once-daily pill Orgovyx for prostate cancer.
Orgovyx (relugolix), which will become available for advanced prostate cancer patients in the US, offers a new option that enables at-home administration.
This is a particularly attractive option for patients looking to avoid travelling for in-person injections, especially in light of the ongoing COVID-19 pandemic.
The phase 3 HERO study enrolled 934 men with advanced prostate cancer, assigning them in a 2:1 ratio to receive either Orgovyx or depot injections of Lupron (leuprolide) – a standard-of-care treatment for prostate cancer patients.
In this study, Orgovyx achieved sustained testosterone suppression to castrate levels in 96.7% of patients from week five to week 48, in comparison to 88.8% for those receiving leuprolide acetate injections.
Secondary endpoints from the study showed that relugolix was better than Lupron at suppressing testosterone quickly (four to 15 days after dosing started), suppressing prostate-specific antigen PSA at day 15 and reducing levels of follicle-stimulating hormone (FSH), which can drive tumour growth in prostate cancer.
Orgovyx is the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist to receive FDA approval for the treatment of advanced prostate cancer.
It is designed to block the GnRH receptor, which in return reduces the production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer.