Pharmaceutical Market Europe • September 2023 • 6-7
NEWS
Merck and Ginkgo Bioworks enter biologic manufacturing collaboration worth up to $490m
Merck & Co – known as MSD outside the US and Canada – and Ginkgo Bioworks have announced a new biologic manufacturing collaboration worth up to $490m.
The partnership will utilise Ginkgo’s capabilities in cell engineering, ultra high-throughput multiplexed screening, protein characterisation and process optimisation to improve production efficiency and increase yields.
In exchange, Ginkgo could receive up to $490m in upfront research fees, research milestone fees, option licence payments and commercial milestone payments.
The deal marks the second collaboration between Merck and Ginkgo, after the companies signed a deal worth up to $144m in October last year to improve Merck’s active pharmaceutical ingredient manufacturing.
The contract includes up to four enzyme biocatalysts, which are hoped to decrease production costs by reducing costly synthesis and purification steps.
Ginkgo also recently secured a deal with the US Defense Advanced Research Projects Agency. The four-year contract, which is worth up to $18m, will see the company research the manufacturing of complex therapeutic proteins.
Prior to this, Ginkgo signed a multi-year collaboration with Novo Nordisk to “unlock the potential” of expression systems that could accelerate and enhance the discovery and development of Novo’s biological medicines.
Novo Nordisk to acquire metabolic disorders specialist Inversago Pharma for $1bn
Novo Nordisk has said it will be acquiring Canada-based Inversago Pharma, a specialist in metabolic disorders, in a deal worth $1.075bn.
The transaction gives the Danish drugmaker access to Inversago’s lead asset, INV-202, a CB1 receptor blocker being developed to treat metabolic syndrome and its associated complications.
Inversago recently announced positive results from a phase 1b trial evaluating the candidate in 37 adults with features of metabolic syndrome.
Over a 28-day treatment period, clinically significant and progressive weight loss of an average decline of 3.5kg was shown for the INV-202-treated patients, compared with an average gain of 0.55kg for those receiving placebo.
The candidate has already advanced into mid-stage development for diabetic kidney disease, and Novo has outlined its plans to investigate the potential of INV-202 for obesity and obesity-related complications.
Martin Holst Lange, executive vice president for development at Novo, said: “The acquisition of Inversago will further strengthen our clinical development pipeline in obesity and related disorders.
“This promising class of medicine pioneered by the Inversago team could lead to life-changing new treatment options for those living with a serious chronic disease and, in particular, may offer alternative or complementary solutions for people living with obesity.”
Biogen to acquire Reata for approximately $7.3bn
Biogen has entered into a definitive agreement to acquire rare disease specialist Reata Pharmaceuticals for approximately $7.3bn.
The deal, which is expected to close in the fourth quarter of this year, would give the biotech access to Skyclarys (omaveloxolone), the only treatment approved in the US for the rare and inherited neurologic disorder Friedreich’s ataxia.
There are approximately 5,000 patients in the US diagnosed with the debilitating neuromuscular disease that results in loss of coordination, muscle weakness and fatigue.
Skyclarys was approved by the US Food and Drug Administration in February this year to slow or prevent the progression of the disease, with sales of the drug expected to touch $1.3bn by 2029, according to Refinitiv data.
An application for Skyclarys has also already been filed in Europe, with a decision expected early next year.
Biogen’s president and chief executive officer, Christopher Viehbacher, said the company believes it has the foundation in place to “accelerate the delivery of Skyclarys to patients around the world”.
Though Skyclarys is the main asset included in the acquisition, Biogen would also gain access to a portfolio of products that Reata is currently developing for a range of neurological diseases.
Pfizer’s RSV vaccine granted EC approval to protect infants and older adults
Pfizer’s respiratory syncytial virus (RSV) vaccine has been approved by the European Commission (EC) to protect both infants and older adults against RSV-caused lower respiratory tract disease (LRTD).
The EC’s decision allows Abrysvo to be given as a single dose to adults aged 60 years and older, and to those who are 24 to 36 weeks into their pregnancy to protect their babies from birth until they are six months old.
In the EU, about 245,000 yearly hospital admissions have been associated with RSV in children aged under five years, while the virus is estimated to cause more than 270,000 hospitalisations in older adults each year.
The EC’s decision, which follows a recent recommendation from the European Medicines Agency’s human medicines committee, was supported by positive results from the late-stage MATISSE and RENOIR trials.
In MATISSE, the vaccine demonstrated 81.8% efficacy in preventing severe medically attended lower respiratory tract illness in infants in the first 90 days after birth, and 69.4% efficacy within 180 days.
At an interim analysis of the ongoing RENOIR trial, the vaccine was 85.7% effective among older adults with two or more symptoms of RSV, and 66.7% for two or more symptoms.
Roche’s spinal muscular atrophy therapy Evrysdi approved by EC for newborns
Roche’s spinal muscular atrophy (SMA) therapy has been approved by the European Commission (EC) to treat infants aged under two months, the company announced.
Evrysdi (risdiplam), which is already authorised for use in patients aged two months or older, can now be used to treat infants from birth to below two months with a clinical diagnosis of SMA type 1, 2 or 3, or with one to four SMN2 copies.
SMA is a severe and progressive neuromuscular disease affecting approximately one in every 10,000 babies.
Those living with the condition have insufficient levels of the SMN protein, which is essential to the function of nerves that control muscles and other functions such as swallowing, speaking, breathing and movement.
Roche’s Evrysdi, which can be administered at home in liquid form by mouth or by feeding tube, is designed to treat the disease by increasing and sustaining the production of SMN protein in the central nervous system and peripheral tissues.
The EC’s decision is supported by an interim analysis of the ongoing RAINBOWFISH study, which included six babies with two or three copies of the SMN2 gene.
After one year of treatment with Evrysdi, all six infants were able to sit, four could stand, and three could walk independently.
Sandoz’s Tyruko approved by FDA as first biosimilar for relapsing multiple sclerosis
Sandoz, a Novartis division, has announced that its biosimilar Tyruko (natalizumab-sztn) has been approved by the US Food and Drug Administration (FDA) to treat adults with relapsing forms of multiple sclerosis (MS).
The disease-modifying therapy, developed by Polpharma Biologics, is a version of Tysabri (natalizumab) and is now the first FDA-approved biosimilar for this patient population.
A biosimilar is a biological product that is highly similar to one already approved in the US. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product, but may potentially benefit from lower healthcare costs.
Tyruko, which is administered as an injection, is approved as a monotherapy to treat all indications covered by Tysabri for relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting MS and active secondary progressive disease, as well as Crohn’s disease.
The FDA’s decision was supported by evidence confirming similarity of the biosimilar with the reference biologic in terms of efficacy, safety and immunogenicity.
Sandoz and Polpharma Biologics signed a global commercialisation agreement for the biosimilar in 2019. As part of the deal, Polpharma Biologics will develop, manufacture and supply the biosimilar, while Sandoz will commercialise and distribute the biosimilar in all markets.
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