22 September 2020

Bausch Health to acquire ophthalmology assets of Allegro

Bausch Health has signed an agreement to acquire an option to buy biopharmaceutical company Allegro Ophthalmics’ ophthalmological assets.

The option will include worldwide rights to Allegro’s lead experimental candidate risuteganib (Luminate).

Allegro focuses on developing therapies that modulate integrin functions for ocular disease treatment.

Risuteganib is a retina compound, which targets the angiogenic, inflammatory and mitochondrial metabolic pathways linked to various diseases, including intermediate dry age-related macular degeneration (AMD).

The integrin-regulating therapy candidate could mitigate mitochondrial dysfunction associated with intermediate dry AMD.

Risuteganib’s action on multiple pathways may decrease the cellular burden of oxidative stress and restore retinal homeostasis.

Two concurrent Phase III trials to understand the use of intravitreal risuteganib in treating intermediate dry AMD should begin in a year.

Statistics show that nearly 16 million people in the US receive an AMD diagnosis. Globally, the figures could hit 196 million this year and increase to 288 million by 2040.

Dry AMD, detected in about 90% of AMD patients, currently lacks therapies.

Bausch Health anticipates that Allegro’s ophthalmic assets will complement its portfolio of AMD products.

Bausch Health CEO and chairman Joseph Papa said: “If approved, risuteganib may be the first treatment indicated to help reverse vision loss due to dry AMD and would address a significant unmet medical need affecting millions of people globally.”

Allegro’s other ophthalmology assets include ALG-1007, a topical integrin regulator candidate for the treatment of dry eye disease. The candidate is in Phase II development outside the US.

The terms of the deal include an option payment of $50m completed in two instalments, the first payment of $10m made upon signing and the second payment of $40m next year after Allegro’s plans to raise additional funding, with further instalments made if Bausch Health decides to exercise the option.

In February, Bausch Health won a bid to acquire certain assets of Synergy Pharmaceuticals for $195m.

21 September 2020

Sanofi and GSK agree to supply Covid-19 vaccine doses to EU

Sanofi and GlaxoSmithKline (GSK) have signed an advanced purchase agreement with the European Commission (EC) to supply up to 300 million doses of their potential Covid-19 vaccine, following regulatory approval.

The vaccine candidate leverages Sanofi’s recombinant protein-based technology, along with GSK’s adjuvant technology. Earlier this month, the companies initiated a Phase I/II clinical trial of the vaccine.

With a Phase III trial scheduled to start by the end of this year, submission for regulatory approval should take place in the first half of next year.

Under the terms of the agreement, the EC will be able to purchase the vaccine for all European Union (EU) Member States, which can choose to donate reserved doses to lower and middle-income markets.

The EU agreed to provide upfront funding to help scale-up the companies’ manufacturing capabilities in Europe. The aim is to manufacture up to one billion doses annually to meet global demand.

Sanofi and GSK said they will produce the antigen and final vaccine doses at their industrial sites in Belgium, Italy, Germany and France.

European Commission president von der Leyen said: “With today’s contract with Sanofi-GSK, the European Commission shows once again its commitment to ensuring equitable access to safe, effective and affordable vaccines not only for its citizens but also for the world’s poorest and most vulnerable people.

“Agreements with other companies will be concluded soon and build a diversified portfolio of promising vaccines, based on various types of technologies, increasing our chances to find an effective remedy against the virus.”

The EC signed the first vaccine supply contract with AstraZeneca for 300 million doses of the company’s vaccine, with an option to buy an additional 100 million doses.

Furthermore, the agency confirmed its participation in the COVAX Facility and will initially provide €230 in cash, equivalent to reserves or options to purchase 88 million vaccine doses.

21 September 2020

Russia authorises first Covid-19 drug Coronavir for sale in pharmacies

Russia has granted marketing authorisation for R-Pharm’s Covid-19 prescription drug, Coronavir, to treat outpatients with mild to moderate infection.

The antiviral drug became the first coronavirus drug distributed in pharmacies in Russia. A favipiravir product, Coronavir directly targets the virus and blocks its replication.

Coronavir’s approval comes from the final data obtained during a Phase III clinical trial performed in patients with mild to moderate Covid-19 in community and hospitalised settings.

In the 168-participant trial, the drug led to a decrease in median time to clinical improvement in Covid-19 patients by four days and in a cohort of outpatients by eight days.

On day seven, more than 50% of patients on Coronavir experienced clinical improvement, 1.5 times higher compared to the reference arm of standard treatment.

R-Pharm’s drug also demonstrated statistically significantly more frequent SARS-CoV-2 elimination from the oropharyngeal mucous membrane at the early stages of the disease.

On day three, researchers observed viral elimination in 71.4% of patients in the study drug group compared to 57.1% in the reference arm, and on day five, in 81.2% versus 67.9%, respectively.

Furthermore, Coronavir showed a favourable safety profile, with most participants tolerating the treatment well. The only specific adverse effect related to the drug was an asymptomatic uric acid elevation.

R-Pharm medical department director Mikhail Samsonov said: “According to the clinical trial evidence, Coronavir, when administered in a timely manner early during the disease course, has demonstrated the best efficacy among all medicines used by now.”

Supported by the Industrial Developmental Fund, the drug’s manufacturing takes place at R-Pharm site in Yaroslavl city.

In June, Russia granted temporary approval to Covid-19 treatment, Avifavir, produced by the Russian Direct Investment Fund (RDIF) and ChemRar Group.

Separately, the European Medicines Agency’s human medicines committee (CHMP) recommended dexamethasone as a treatment option for adult and adolescent Covid-19 patients needing oxygen therapy.

The CHMP recommendation comes after a review of results from the RECOVERY trial. The UK Government already authorised the use of dexamethasone to treat Covid-19 on the National Health Service (NHS) in June.

18 September 2020

J&J faces $2bn insurance fraud charges over opioid claims

The New York State Department of Financial Services (DFS) has filed a $2bn lawsuit against Johnson & Johnson (J&J) for its alleged role in the opioid crisis in the US.

New York Governor Andrew Cuomo announced that the DFS has filed charges and launched administrative proceedings against the company and its subsidiaries Janssen Pharmaceutica, Janssen Pharmaceuticals and Ortho-McNeil-Janssen Pharmaceuticals.

J&J manufactured multiple opioid products in the state such as the fentanyl patch Duragesic and a tapentadol drug Nucynta.

Furthermore, its ‘Norman Poppy’ was said to be associated with up to 80% of the global supply for oxycodone raw materials. Oxycodone is the main ingredient of opioid painkiller OxyContin manufactured by Purdue Pharma.

According to the lawsuit, J&J downplayed the risks of its opioids drugs and continued to promote the medicines even after government officials warned about the potential threat caused by opioids.

The company and its subsidiaries were accused of targeting elderly patients for opioid treatment despite the risks of side effects.

Also, the company allegedly used branded marketing and the support of ‘key opinion leaders’ to characterise opioid addiction as a myth.

Cuomo said: “The opioid crisis has taken too many lives and New York State will continue to take action against those who helped fuel this public health catastrophe and bring a measure of justice to families who have lost loved ones.

“Misrepresentation of opioids to consumers for profit is inexcusable and we will use every tool necessary to help ensure those responsible are held fully accountable.”

According to the DFS statement, the company violated two insurance laws, with penalties of up to $5,000 per violation.

Commenting on the charges, J&J said that its marketing and promotion of opioids were ‘appropriate and responsible’, according to Reuters.

J&J was quoted by the news agency as adding: “Janssen provided these medicines for doctors treating patients suffering from pain and worked with regulators to provide appropriate information about their risks and benefits.”

The hearing in the case will be held at the New York State DFS office on 25 January.

Previously, the DFS filed similar charges against Teva Pharmaceutical Industries and Allergan, Endo International and Mallinckrodt.

Last month, the US Department of Justice sought $13bn in criminal and civil penalties from Purdue Pharma over opioid claims filed against the company.

16 September 2020

US researchers identify tiny molecule to neutralise Covid-19 virus

A research team at the University of Pittsburgh School of Medicine in the US has isolated a tiny biological molecule that could completely neutralise SARS-CoV-2, the virus that causes Covid-19.

Researchers noted that the discovered antibody component was ten times smaller compared to a full-sized antibody, used to create a drug named Ab8 to potentially treat and prevent Covid-19.

In mice and hamsters, Ab8 proved effective in preventing and treating the disease; the journal Cell published the findings.

According to researchers, the small size of the molecule rises its potential for diffusion in tissues to better neutralise the virus causing Covid-19, as well as enables alternative routes of administration, such as inhalation.

Furthermore, the antibody component does not bind to human cells and hence may not have negative side-effects.

Researchers collaborating to test on Ab8 hailed from the University of North Carolina at Chapel Hill (UNC) and University of Texas Medical Branch (UTMB) at Galveston, along with the University of British Columbia and the University of Saskatchewan.

University of Pittsburgh Medical Center Division of Infectious Diseases chief John Mellors said: “Ab8 not only has potential as therapy for Covid-19, but it also could be used to keep people from getting SARS-CoV-2 infections.

“Antibodies of larger size have worked against other infectious diseases and have been well-tolerated, giving us hope that it could be an effective treatment for patients with Covid-19 and for protection of those who have never had the infection and are not immune.”

The antibody component consists of a variable, heavy chain (VH) domain of an immunoglobulin, a type of antibody present in the blood. It was identified by analysing more than 100 billion potential candidates.

Ab8, constructed by fusing the VH domain to part of the immunoglobulin tail region, incorporates the immune functions of a full-size antibody.

UPMC-backed company Abound Bio licensed Ab8 for development globally.

14 September 2020

US President Trump signs new executive order to reduce US drug prices

US President Donald Trump has signed a new executive order to reduce prescription drug prices in the country by linking them to those of other developed countries.

The aim of the policy is that the US would not pay more than the ‘most-favoured-nation price’ for specific Medicare Part B or Part D prescription drugs or biological products.

Most-favoured-nation price is the lowest price for a drug that the manufacturer sells in an Organisation for Economic Co-operation and Development (OECD) member country with the comparable per-capita gross domestic product to the US.

In a statement, Trump said: “Americans pay more per capita for prescription drugs than residents of any other developed country in the world. It is unacceptable that Americans pay more for the exact same drugs, often made in the exact same places.

“In addition to being unfair, high drug prices in the US also have serious economic and health consequences for patients in need of treatment. High prices cause Americans to divert too much of their scarce resources to pharmaceutical treatments and away from other productive uses.”

The new order will test a payment model where no more than the most-favoured-nation price will be paid for select expensive prescription drugs and biological products covered under Medicare Part B.

Furthermore, another payment model will pay no more than the most-favoured-nation price for Medicare Part D prescription drugs or biological products associated with inadequate competition and high prices compared to OECD member countries.

These payment models will be investigated for their ability to reduce poor clinical outcomes for patients, along with increased expenditures for high drug costs.

Trade group Pharmaceutical Research and Manufacturers of America (PhRMA) said that the most favoured nation policy would allow foreign governments a say in how the US provides access to treatments and cures.

PhRMA president and CEO Stephen Ubl said: “What’s worse is that they are now expanding the policy to include medicines in both Medicare Part B and Part D, an overreach that further threatens America’s innovation leadership and puts access to medicines for tens of millions of seniors at risk.”

Trump also revoked the executive order signed in July, when the federal government was asked to purchase some essential medicines from domestic manufacturers.

11 September 2020

Boehringer partners with Click Therapeutics on schizophrenia therapeutic

Boehringer Ingelheim has teamed up with Click Therapeutics to develop and commercialise a new prescription digital therapeutic, CT-155, to treat schizophrenia.

CT-155 will leverage cognitive and neurobehavioral mechanisms provided via Click’s engagement platform. It aims to mitigate cognitive deficits and impaired social functioning in schizophrenia patients.

The companies will work together to develop the new therapeutic as a mobile application, which integrates various clinically validated therapeutic interventions to help patients alter their behaviour.

Boehringer noted that its digital therapeutic could enable positive clinical outcomes alone and in combination with pharmaceutical therapies.

Boehringer Ingelheim CNS Diseases Research director Cornelia Dorner-Ciossek said: “CT-155 is an excellent addition to our CNS pipeline portfolio; it reflects our patient-centric approach and translates evidence showing how behavioural modification can induce positive neuronal changes into a widely accessible solution.

“Further it has the potential to be prescribed together with Boehringer Ingelheim’s schizophrenia pipeline compounds possibly enhancing the benefit of pharmacotherapy for patients.”

As part of the collaboration, Click Therapeutics will primarily carry out research and development activities while Boehringer will be responsible for global commercialisation activities.

Click Therapeutics will receive an upfront payment, funding for research and development activities, along with clinical, regulatory and commercial milestones, as part of a deal valued at a total of more than $500m.

Furthermore, Click will get tiered royalties on annual net sales of CT-155 globally.

Click Therapeutics CEO David Benshoof Klein said: “Partnering with Boehringer Ingelheim allows us to leverage their considerable experience in the clinical development and global commercialisation of new treatment options for neuropsychiatric diseases to improve the efficacy and reach of our digital therapeutic software.”

The partners intend to assess CT-155 in a pivotal clinical study and potentially obtain regulatory authorisations worldwide, including the US.

In 2018, Novartis partnered with Pear Therapeutics for the development of new prescription software applications ‘digital therapeutics’ to help patients with schizophrenia and multiple sclerosis.

10 September 2020

French authority orders €444m fine on Novartis, Roche over Lucentis

The French competition authority has imposed a total fine of €444m on Novartis, Roche and Genentech for allegedly following abusive practices to push more sales of eye disease drug Lucentis than a cheaper drug.

Genentech developed Lucentis for the treatment of age-related macular degeneration. The drug is co-commercialised by Roche and Novartis.

The company also developed an anti-cancer drug, Avastin, observed to have positive effects in AMD patients but lacking marketing approval in the eye disease indication.

Genentech did not intend to apply for marketing authorisation of Avastin in ophthalmology and hence its use has been off label. A Lucentis injection costs approximately €1,161, while Avastin is nearly 30 times cheaper at €30/€40.

According to the competition watchdog in France, Genentech, Novartis and Roche have used abusive practices to maintain the position and price of Lucentis by restricting off-label use of Avastin.

Based on price differences between the two medicines, the use of Avastin rather than Lucentis would have resulted in a significant loss of income for each of the three laboratories, added the authority.

In a statement, the authority said: “Novartis, Roche and Genentech have also been sanctioned for colluding in obstructive behaviour and spreading an alarmist and sometimes for having misleading discourse, before the public authorities, regarding the risks related to the use of Avastin to treat of AMD.

“These practices aimed at obstructing or unduly slowing down initiatives taken by the public authorities to authorise the off-label use of Avastin to treat AMD.”

Of the total €444m, Novartis has to pay €385m, while Roche/Genentech will pay the remaining €59m.

Novartis said it would appeal the decision, while Roche intends to assess its next steps, reported Reuters.

The news agency quoted Novartis as saying: “This decision relies on a gross misinterpretation of the facts and a distortion of previous case law.”

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