Category Archives: Infectious Disease

GSK’s blockbuster HIV drug linked with birth defects

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Regulators in Europe and the US have issued warnings about a link between GlaxoSmithKline’s blockbuster HIV drug Tivicay (dolutegravir) and birth defects of the brain and spine.

The European Medicines Agency’s safety committee has said it is evaluating preliminary results from a study which found four cases of birth defects such as spina bifida – a malformed spinal cord – in babies born to mothers who became pregnant while taking Tivicay (dolutegravir).

The Pharmacovigilance Risk Assessment Committee (PRAC) has issued precautionary advice while assessing the study, saying Tivicay should not be prescribed to women seeking to become pregnant.

Women who can become pregnant should use effective contraception while taking Tivicay-based medicines, the PRAC said.

In a separate announcement the FDA said it was also issuing a warning following preliminary results of an ongoing observational study in Botswana, suggesting women who took Tivicay at the time of becoming pregnant, or early in the first trimester, appear to be at higher risk for these birth defects.

The US regulator warned against stopping Tivicay-containing regiments without first switching to alternative HIV medicines, as this could cause the virus to spread to the unborn baby.

Women of childbearing age should talk to healthcare professionals about other non-Tivicay containing medicines.

Tivicay, an integrase strand transfer inhibitor (INSTI) is an important drug for GlaxoSmithKline, which produces the drug through its ViiV joint HIV venture with Pfizer and Shionogi.

Tivicay (dolutegravir) is sold on its own for use as a component of combinations involving other drugs, and generated sales of £1.4 billion,

And Triumeq, which combines dolutegravir with nucleoside reverse transcriptase inhibitors abacavir and lamivudine, brings in sales of more than £2.4 billion.

There are alternatives from the same class such as Merck & Co’s Isentress (raltegravir) and combinations, and combinations containing Gilead’s elvitegravir.

These are still preliminary findings, and the warnings have been issued purely as a precaution.

But preventing HIV spreading to unborn children is important to the medical community, and if there is stronger evidence of a link with birth defects, doctors will surely look for alternative therapies.

SOURCE: www.pharmaphorum.com/news

Experimental vaccine to be used against Ebola outbreak in the DRC

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campaign to vaccinate people at risk of developing Ebola in the latest outbreak in the Democratic Republic of the Congo could begin by the end of this week, Tedros Adhanom Ghebreyesus, the director-general of the World Health Organization, said Sunday.

Tedros said the government of the DRC has formally asked to use an experimental vaccine being developed by Merck. The WHO has a stockpile of 4,300 doses of the vaccine in Geneva; the company also has 300,000 doses of the vaccine stockpiled in the United States. Merck has given its permission for the vaccine to be used in this outbreak.

“Everything is ready for the vaccine. They want it,”  Tedros, who goes by his first name, told STAT in an interview from Kinshasa.

The WHO and its partners are responding quickly, concerned that this outbreak has the potential to spread because of its location. The epicenter, a town called Bikoro, is difficult to reach by vehicle because of poor roads between it and the regional capital, Mbandaka. Tedros and his party traveled there by helicopter.

But the town is a port, on Lake Tumba. And it feeds into the Congo and Ubangi rivers — major waterways that connect to several large centers.

To the south is the DRC capital, Kinshasa (population 11.5 million), as well as Brazzaville (population 1.9 million), the capital of the neighboring Republic of the Congo. To the north is Bangui (population 800,000), the capital of the Central African Republic. Mbandaka, with a population of about 1 million people, is also reachable from Bikoro by water.

The World Food Program has established an air bridge, a costly undertaking but one that is essential for moving people and materiel into Bikoro.

The equipment needed to keep the vaccine at subzero temperatures — the so-called cold chain — was arriving in the DRC on Sunday and would be set up in the next couple of days, he said. By Wednesday or Thursday, the vaccines in Geneva will be sent to the DRC, said Tedros. After that, vaccination of health care workers and people who have been in contact with cases will begin.

“That’s our plan. And so far things are going as planned,” he said, expressing hope that the quick response will speed containment of the outbreak. “We have better weapons this time.”

The outbreak, which is believed to have started at least five weeks ago, was officially declared on May 8 after the DRC health ministry confirmed two positive tests from among a number of suspected Ebola cases in Bikoro and a village called Ikoko-Impenge, about 40 miles away.

The WHO said on Saturday the case estimate is up to 39 — two confirmed, 20 probable cases, and 17 suspected. At least 18 of those people have died. Three health care workers are among the cases and one has died.

The plan is to employ a ring vaccination approach, vaccinating anyone who has been in contact with a case to prevent continuing spread of the virus. Contact tracing efforts are already underway. To date, 382 contacts have been identified, Tedros said.

SOURCE: www.statnews.com

Emergex wins Innovate UK grant to advance universal flu vaccine

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A UK biotech developing a pioneering a new approach to developing vaccines for infectious diseases has been awarded a grant of £979,318 by Innovate UK.

Emergex Vaccines says the funds will help fuel progress of its universal flu vaccine programme through preclinical development.

The vaccine is designed to target components of the influenza virus that are common to all strains, and will therefore also be suitable to target the outbreak of a new flu pandemic caused by the emergence of a novel form of the virus at the time it moves from an animal species into humans, according to the firm.

The vaccine is 100 percent synthetic and delivers “highly conserved immunogenic peptide fragments from the flu virus to antigen presenting cells in the skin, eliciting a strong and long-lasting T-cell immune response,” it said.

The grant should cover 70 percent of the cost of developing the flu vaccine programme over a period of two years, and will be used to complete preclinical toxicology and validation studies and the manufacturing of the vaccine, so that clinical batches are ready for Phase I clinical testing in the first half of 2020.

“This Innovate UK grant provides endorsement of our flu vaccine programme and reinforces our belief that an innovative approach, using the very latest technologies, could help protect the public from this inevitable epidemic or pandemic health threat,” noted Professor Thomas Rademacher, co-founder, chief executive and chief scientific officer at Emergex.

SOURCE: www.pharmatimes.com/news

Sanofi, Evotec in major infectious disease R&D transfer and license deal

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Big Pharma Sanofi and German CRO-biotech drug discovery hybrid Evotec are penning a deal that will see Sanofi license out a host of infectious disease assets to the biotech, with 100 staffers also moving into its R&D engine.

Sanofi is paying a one-time, upfront fee of €60 million ($74 million) to Evotec, a small sum, but one backed up with a promise to “provide significant further long-term funding to ensure support and progression of the portfolio,” although exact financial details were not shared.

The deal drills down like this: Sanofi will license most of its infectious disease (ID) research and early-stage portfolio (around 10 assets all-told) and move this unit, with around Sanofi 100 staffers alongside it, into Evotec (although this does not include the French pharma’s vaccine R&D unit).

Evotec, which does its own research and also relies heavily on external collaborations with biopharmas and academic biomedical research, will run this “open innovation platform” near Lyon, France, where Sanofi Pasteur is HQ’d.

Sanofi holds on to certain option rights on the development, manufacturing, and commercialization of anti-infective products and will “continue to be involved in infectious disease through its vaccines research and development and its global health programs,” it says in a statement.

The focus of the Evotec drug discovery will be on “new mode-of-action antimicrobials,” the pair say.

Werner Lanthaler, Ph.D., CEO of Evotec, said: “Since the acquisition of Euprotec (UK) in 2014, Evotec has had a significant strategic interest and demonstrated expertise in infectious diseases research, with an ambition to grow and become the drug discovery and development leader in this space together with its partners.

“We are pleased to be working and expanding our strategic relationship with Sanofi, which has a long history in providing novel anti-infective agents to markets globally. Finding a way to motivate more public funding and academic initiatives for the progress of novel anti-infectives on Evotec’s platform will be a key success factor for this initiative.”

The deal is still being talked over, but should be done in the coming months.

Evotec already has a series of deals with the likes of Eli Lilly, Tesaro, Oxford University, and even has its own spin-out in the form of Topas Therapeutics.

Elias Zerhouni, M.D., president of global R&D for Sanofi, adds: “Research in the field of anti-infectives is an area where building critical mass through partnering is particularly important. This new French-based open innovation center will benefit from the high-quality science ecosystem. Evotec is a trusted partner in drug discovery and has the ambition and capacity to become a real leader in the fight against infectious diseases.”

This also comes as Sanofi continues to retool its R&D, getting back into cancer as well as blood disorders via its $11.6 billion deal for Biogen spin-out Bioverativ.

SOURCE: www.fiercebiotech.com/biotech