Pharmaceutical Market Europe • September 2020 • 6-7
NEWS
UK Health Secretary Matt Hancock (pictured right) has unveiled the new body that is set to replace Public Health England (PHE), days after reports that the agency was to be axed over its coronavirus response.
The new National Institute for Health Protection (NIHP) will replace PHE, and is set to be led by Baroness Dido Harding, the current head of NHS Test and Trace in England.
It will be closely modelled on Germany’s Robert Koch Institute, a government agency which is solely focused on disease control and prevention.
According to a statement from the Department of Health and Social Care (DHSC), the NIHP will start work immediately, with a focus on the country’s response to the ongoing COVID-19 pandemic.
The organisation will then be finalised and fully operational from spring 2021. Under the new body, PHE and NHS Test and Trace will be combined, along with the Joint Biosecurity Centre, under a single leadership team.
“To give ourselves the best chance of beating this virus once and for all – and of spotting and being ready to respond to other health threats, now and in the future – we are creating a brand new organisation to provide a new approach to public health protection and resilience,” said Hancock.
Takeda is on the verge of selling its consumer health unit in Japan for up to $2.3bn to Blackstone Group, an American investment firm.
The portfolio to be divested to Blackstone includes a range of Takeda’s over-the-counter (OTC) medicines and health products, such as its regional brand Alinamin, a vitamin B1 derivative, and Benza, a cold remedy.
According to a statement from Takeda, Blackstone intends to develop the business together with Takeda Consumer Health Company’s (TCHC) current management and continue to employee existing staff members.
Last year, Takeda acquired Irish biotech company Shire for £46bn, which gave the Japanese pharma company access to a solid platform of rare diseases.
However, the takeover also meant that Takeda inherited a massive amount of debt, which the company plans to reduce by divesting up to $10bn in non-core assets.
This included offloading a number of its OTC and prescription medicines in emerging markets in Near East, Middle East and Africa (NEMEA) countries to Acino for $200m.
The Japanese pharma also entered an agreement with Stada last October to divest a portfolio of select OTC drugs for a total value of $660m.
The Stada deal includes OTC vitamins and food supplements, and select products in the cardiovascular, diabetes, general medicine and respiratory therapeutic areas.
Nestlé has announced plans to acquire allergy specialist Aimmune Therapeutics in a deal worth $2.6bn, six months after the biopharmaceutical company’s Palforzia became the first peanut allergy drug to be cleared for use in the US.
Currently, Nestlé has a 25% equity ownership stake in Aimmune, but is set to acquire the outstanding shares in an all-cash offer made through its health division, Nestlé Health Science. The deal is subject to customary closing conditions, although Nestlé expects the transaction to close in the fourth quarter of 2020.
Palforzia, previously known as AR101, was approved by the US Food and Drug Administration (FDA) in January for use in children aged four to 17 with a confirmed diagnosis of peanut allergy.
The oral immunotherapy is comprised of defatted peanut flour that is sprinkled over food and given in small but gradually increasing amounts over a six-month period, with the aim of encouraging the immune system to develop a tolerance to peanut allergies.
Aimmune’s launch of Palforzia has been hampered by the ongoing COVID-19 pandemic, as the health crisis continues to have an impact in the US.
The US Food and Drug Administration (FDA) has approved Novartis’ relapsing multiple sclerosis (MS) treatment Kesimpta, one of the company’s most promising growth drivers as identified by CEO Vas Narasimhan.
The approval is based on results from the phase 3 ASCLEPIOS I and II studies, in which Kesimpta (ofatumumab) demonstrated superiority over Sanofi’s Aubagio (teriflunomide) in reducing the number of confirmed relapses in patients with relapsing forms of MS.
Kesimpta also met the key secondary endpoints, which included delaying time to confirmed disability progression, in the head-to-head study.
The drug is already approved for the treatment of chronic lymphocytic leukaemia (CLL), with the clinical development programme in relapsing MS taking ten years from the initiation of early studies to achieving regulatory approval.
Kesimpta’s approval in relapsing MS builds on Novartis’ existing presence in the therapy area, which includes its active secondary progressive multiple sclerosis (SPMS) therapy Mayzent (siponimod).
However, the drug will have fierce competition in the market, from rivals such as Roche’s Ocrevus (ocrelizumab) and Sanofi’s Aubagio, despite touting superior efficacy data over the latter.
Both Kesimpta and Ocrevus selectively target the immune system’s CD20-positive B cells that image nerve tissue and cause disease progression.
The US Department of Justice (DoJ) has charged Teva Pharmaceuticals for conspiring with competitors in a generic drugs price-fixing probe.
The DoJ is investigating allegations that Teva conspired with other generic drugmakers to hike prices of commonly used medications, including a high cholesterol drug.
According to Reuters, a person familiar with the matter said the charges came after Teva refused to agree to a settlement and admit to wrongdoing.
However, Teva is maintaining that it did not commit any crime, and said in a statement that “it firmly rejects the allegations and will vigorously defend the Company in court”.
“Today’s charge reaffirms that no company is too big to be prosecuted for its role in conspiracies that led to substantially higher prices for generic drugs relied on by millions of Americans,” said Assistant Attorney General Makan Delrahim in a statement.
In May last year, a wide-ranging lawsuit was filed in the US by 44 states, claiming price fixing for dozens of widely used generic medicines. A total of 20 pharma companies were cited in the lawsuit – including Teva, Novartis’ Sandoz unit, Mylan and Pfizer – which are accused of ‘multi-billion dollar fraud’.
According to Teva, the company has tried to reach a resolution with the DoJ, but that the agency “has shown an unwillingness to consider alternatives that would not deeply impact Teva and the stakeholders who depend on the Company, including the patients who benefit from our medicines”.
NHS England has reached an agreement with Vertex for immediate access to the pharma company’s transformative triple combination therapy for cystic fibrosis (CF).
The landmark deal for the combination therapy, Kaftrio (ivacaftor/tezacaftor/elexacaftor), was made possible thanks to previous negotiations between Vertex, NHS England and the UK’s National Institute for Health and Care Excellence (NICE).
Last October, the three parties finally reached an agreement for access to Vertex’s other cystic fibrosis drugs Orkambi (lumacaftor/ivacaftor), Symkevi (tezacaftor/ivacaftor) and Kalydeco (ivacaftor).
Under the terms of the deal, NHS access to the pharma company’s triple therapy would be ensured as soon as it received approval from the European Medicines Agency (EMA). Vertex scored EMA authorisation on Friday, allowing for immediate access to the drug on the NHS for thousands of CF patients in England.
Through the commercial deal, NHS England has also secured equivalent terms for CF patients in Wales, Northern Ireland and Scotland. According to NHS England, the deal will span four years to allow for further data on the medication to be collected.
The terms of the deal also mean that up to 300 CF patients with rare genetic mutations, who previously were not included within the scope of the EMA’s licensing considerations, will now be able to access Kalydeco and Symkevi.
In clinical trials, Kaftrio significantly improved lung function in CF patients with two copies of the F508del mutation or one copy of the F508del mutation with a minimal function mutation.