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FDA approves Gilead’s Harvoni in two new indications

The hepatitis C treatment battle had its latest development yesterday, with the FDA awarding Gilead Science’s market-leading drug Harvoni (ledipasvir/sofosbuvir) approval in two new indications and bringing it to an even broader group of patients.

The new approvals mean liver transplant hep C patients, as well as those with decompensated cirrhosis can now be treated with 12 weeks of all-oral therapy.

MSD’s Zepatier approval could spell end of Gilead’s Hep C dominance, says analyst

The introduction of MSDs’ recently FDA-approved drug Zepatier (elbasvir/grazoprevir) to the hepatitis C treatment space will shake up a market long-dominated by Gilead, according to an analyst with research and consulting firm GlobalData.

Daian Cheng, GlobalData’s infectious diseases analyst, says the combination of Zepatier’s strong clinical profile and competitive pricing- revealed by the company last month to be a surprisingly low $54,600 for a 12-week treatment course (compared to Harvoni’s $94,500)- will play a major role in encouraging its uptake.

Revenues down at MSD

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Caption: Merck is known as MSD outside of the US and Canada

MSD (Merck, Sharpe and Dohme) reported a mixed bag of financial figures today, as the company announced full-year 2015 revenues down 6% to $39.5 billion, hit by negative currency impact as well as acquisitions and divestitures.

The Q4 decline was only half as bad, with revenues for the last three-month period down 3% to $10.2 billion, this time including a 4% net favourable impact from acquisitions and divestitures.

Non-GAAP earnings per share, however, rose 7% to $0.93 for the quarter and 3% to $3.59 for the year.

MSD gets FDA approval for hepatitis C drug Zepatier

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MSD is known as Merck in the United States, where Zepatier has FDA approval

The competitive hepatitis C market is to get another contender, with FDA approving MSD’s new combo treatment Zepatier (elbasvir and grazoprevir) to treat genotypes one and four of the virus, with or without ribavirin.

In the short-term, Zepatier (elbasvir and grazoprevir) will compete with such therapies as Gilead Science’s Solvadi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir), as well as AbbVie’s Viekira Pak (ombitasvir/paritaprevir/ritonavir/dasabuvir) and Technivie (ombitasvir, paritaprevir and ritonavir).

MSD and GAVI agree Ebola vaccine deal

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MSD and the global vaccine alliance Gavi have agreed a deal to provide 300,000 dosesof  an Ebola virus vaccine, to continue trials and begin preparation for future outbreaks of the deadly virus.

The deal, announced today at the World Economic Forum in Davos, establishes an Advance Purchase Commitment between Gavi that provides $5 million towards the development of MSD’s rVSV-G-ZEBOV-GP live attenuated Ebola Zaire vaccine, on the understanding that it will be submitted for

MSD sues German Merck for using name in US

Merck MSD
MSD operates under the name Merck in the US and Canada

MSD says it is filing a lawsuit against the German company Merck “regarding their improper use of the name 'Merck' in the United States.”

MSD, which has operated under the name Merck in the US and Canada for 125 years, says it is taking the legal action to “protect our long-established brand rights in the United States.” The US lawsuit is being filed in the United States District Court for the District of New Jersey.

BioLineRx to test lead candidate with MSD’s Keytruda in pancreatic cancer

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Israeli biopharma company BioLineRx has announced a collaboration with MSD on a Phase II study investigating its lead oncology candidate, BL-8040, in combination with MSD’s immunotherapy Keytruda to treat metastatic pancreatic cancer.

BL-8040 has been shown in several clinical trials to be effective at inducing direct tumour cell death. Immuno-oncology studies suggest that drugs of this type – called CXCR4 antagonists – may stimulate anti-tumour T cells.

MSD to acquire Scottish firm IOmet Pharma

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US pharma company MSD is to buy Edinburgh based IOMet Pharma to expand its existing R&D programme, exploring the development of new immuno-oncology treatments for cancer.

Financial terms for the deal have not been made public, but IOMet is known to focus on the development of innovative medicines for the treatment of cancer, with a particular emphasis on the fields of cancer immunotherapy and cancer metabolism. The firm was established in 2008, and has shareholders including the Scottish Investment Bank.

MSD chooses partner to develop ‘game-changing’ cancer therapies

Merck/MSD

MSD has entered a research collaboration with biopharma company Complix, using the company’s proprietary technology to develop new treatments for cancer. 

The collaboration will make use of Complix’s Cell-Penetrating Alphabodies (CPABs) platform, with which the company is developing a pipeline of proteins, called Alphabodies, for investigation as treatments for cancer, and also severe autoimmune diseases. 

WHO to review MSD’s Ebola vaccine for emergency use

Ebola virus
Credit: National Institute of Allergy and Infectious Diseases

The World Health Organisation (WHO) has accepted MSD’s application for the company’s investigational Ebola vaccine, V920 (Zebov), to be reviewed as a drug for Emergency Use Assessment and Listing (EUAL).

WHO says the EUAL process is designed to expedite the availability of vaccines needed for public health emergencies, such as another outbreak of the Ebola virus. The procedure assists United Nations’ procurement agencies and Member States on which vaccine candidates to use in an emergency-use setting.

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