Pharmaceutical Market Europe • April 2023 • 6-7

NEWS

Sanofi to acquire Provention Bio in deal worth $2.9bn

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Sanofi has announced that it will acquire US-based Provention Bio for $2.9bn, strengthening the French drugmaker’s portfolio of diabetes medicines.

Through the acquisition, Sanofi will gain access to recently approved type 1 diabetes prevention therapy Tzield (teplizumab-mzwv), for which the companies already have a co-promotion agreement.

The deal also adds certain early drug development assets in immune-mediated diseases, Sanofi said.

Tzield was approved in the US in November last year as the first and only immunomodulatory treatment to delay the onset of stage 3 type 1 diabetes in adults and paediatric patients aged eight years and older who have stage 2 type 1 diabetes.

This was supported by clinical trial results showing that, after an average follow-up of 51 months, only 45% of the 44 patients treated with Tzield went on to develop stage 3 type 1 diabetes, compared with 72% of the 32 patients in the placebo group.

Under the terms of the agreement, Sanofi will initiate a cash tender offer to acquire all outstanding shares of Provention Bio for $25 per share in cash.

Subject to the satisfaction or waiver of customary closing conditions, Sanofi said it currently expects to complete the acquisition in the second quarter of this year.


Merck signs $922m deal with Opko Health’s ModeX Therapeutics

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Merck & Co – known as MSD outside the US and Canada – has signed a worldwide licensing deal worth up to $922.5m with Opko Health’s ModeX Therapeutics unit for its experimental Epstein-Barr virus (EBV) vaccine.

The partnership will see both companies advance MDX-2201 to an Investigational New Drug application filing, after which Merck will be responsible for clinical and regulatory activities, as well as product commercialisation.

In exchange, Opko will receive an upfront payment of $50m and will be eligible for milestone payments of up to $872.5m plus royalties on global sales.

There are currently no approved vaccines or treatments in the US for EBV, a virus that infects most people at some point during their lives.

Most can recover in a few weeks without treatment, and the virus usually does not cause health issues other than infectious mononucleosis.

After infection however, the virus becomes latent in the body and can be a cause for some specific types of cancer and multiple sclerosis.

Based on ModeX’s ferritin nanoparticle vaccine platform, MDX-2201 presents antigens from four viral proteins involved in viral entry into host cells. These include a recombinant antigen designed from the proteins gH, gL and gp42, as well as an antigen derived from gp350.


Pfizer to acquire Seagen for $43bn in biggest pharma deal since 2019

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Pfizer has announced that it will acquire Seagen for a total enterprise value of $43bn, which will be a significant boost to the US pharma’s oncology pipeline.

Under the terms of the agreement, which marks the biggest pharma deal since AbbVie agreed to acquire Allergan for $63bn in 2019, Pfizer will pay $229 in cash per Seagen share.

Dr Albert Bourla, chairman and chief executive officer of Pfizer, said: “Oncology continues to be the largest growth driver in global medicine, and this acquisition will enhance Pfizer’s position in this important space and contribute meaningfully to the achievement of Pfizer’s near- and long-term financial goals.”

Pfizer’s oncology portfolio currently includes 24 approved drugs, while Seagen’s includes Adcetris for lymphomas, Padcev for bladder cancers, Tivdak for cervical cancer, and Tukysa for breast and colorectal cancers.

As well as the four approved medicines, which are all currently being assessed for potential new tumour types or expanded indications, Pfizer will also gain access to Seagen’s drug development pipeline and have the option to explore combinations across its own pipeline.

The deal also includes Seagen’s proprietary antibody-drug conjugate (ADC) technology, Pfizer said.

The companies expect to complete the transaction in late 2023 or early 2024.


Eli Lilly announces 70% cut to US insulin prices while also capping out-of-pocket costs

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In a very welcome move, Eli Lilly and Company (Lilly) has announced it is cutting the US prices of its most commonly prescribed insulins by 70%.

The prices of Humalog and Humulin will be cut by 70% from the fourth quarter of this year. The company will also be lowering the US price of its non-branded insulin, Lispro, to $25 a vial from the beginning of May.

Lilly also said it will be automatically capping the out-of-pocket costs for its US insulin products at $35 a month for those with commercial insurance, and expanding its Insulin Value Program to ensure those without insurance can benefit from the cap as well.

Around 8.4 million of the 37 million people in the US with diabetes use insulin, but the rising cost of the life-saving medicine has been a pressing concern for many patients.
Sanofi, Novo Nordisk and Eli Lilly produce over 90% of the US insulin supply and have come under recent fire over the rising costs of their products.

In January this year, California attorney general Rob Bonta filed a lawsuit against the three drugmakers and leading pharmacy benefit managers for allegedly using their market power to overcharge patients for insulin.


Novo Nordisk to cut US insulin prices by up to 75% in January 2024

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Following the news from Eli Lilly, Novo Nordisk has said it too will be significantly lowering the US list prices for several of its insulin products.

The changes will come into effect in January 2024 and include a 75% reduction to the list price of its NovoLog insulin and a 65% reduction for Novolin and Levemir.

The drugmaker will also be reducing the list price of unbranded biologics to match the lowered price of each respective branded insulin.

Steve Albers, senior vice president, market access and public affairs at Novo Nordisk, said: “We have been working to develop a sustainable path forward that balances patient affordability, market dynamics and evolving policy changes.

“Novo Nordisk remains committed to ensuring patients living with diabetes can afford our insulins, a responsibility we take seriously.”

The American Diabetes Association’s (ADA’s) chief advocacy officer, Lisa Murdock, said: “We are pleased that more manufacturers are continuing to take steps to make insulin more affordable, and we hope others follow suit.

“ADA will keep working to make sure drug rebates are not inflating costs for patients at the pharmacy counter, and we will continue to support efforts to provide affordable insulin to everyone with diabetes who relies on it to survive.”


Sanofi to cut US insulin prices by up to 78% in January 2024

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Sanofi has said it will cut the US list price of its most widely prescribed insulin by 78%, following the earlier price cuts from Eli Lilly and Novo Nordisk.

The changes will come into effect in January 2024 and will also include a $35 price cap on the same insulin, Lantus (insulin glargine injection), for those with commercial insurance.

Olivier Bogillot, head, US general medicines, Sanofi, said: “Sanofi believes that no one should struggle to pay for their insulin and we are proud of our continued actions to improve access and affordability for millions of patients for many years.

“Our decision to cut the list price of our lead insulin needs to be coupled with broader change to the overall system to actually drive savings for patients at the pharmacy counter.”

The American Diabetes Association issued a statement in response to the latest cuts, with chief advocacy officer, Lisa Murdock, saying: “We are encouraged that all of the major manufacturers have taken steps to make insulin more affordable, but the fight is not over.

“We will continue advocating for efforts in Congress and states across the country to ensure insulin is affordable to everyone with diabetes who relies on it to survive.”