Category Archives: Nephrology

Merck, Eisai sign deal to further develop, sell Eisai cancer drug

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Merck & Co and Japan’s Eisai Co Ltd on Wednesday announced a potential multibillion-dollar collaboration to develop and sell Eisai’s cancer drug Lenvima, which is already approved in many countries for two uses.

The deal, under which Lenvima will be developed for several types of cancer alone and in combination with Merck’s immunotherapy Keytruda, could be worth up to $5.76 billion to Eisai, but most of that would be contingent on eventual sales.

Meanwhile, Merck will be entitled to half of all global Lenvima sales, even for its already-approved uses for thyroid cancer and in combination with another drug for kidney cancer.

The deal is similar to a multibillion-dollar oncology collaboration Merck struck with AstraZeneca Plc last July.


Improving healthcare has led to a higher salt requirement

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The number of dialysis treatments is increasing across the globe, mainly due to an increasing number of patients and improved healthcare in many developing countries.

The main market for pharmaceutical grade salt lies in dialysis solutions. Supply has struggled to keep up with demand, which led to AkzoNobel expanding its production site in Denmark.

AkzoNobel’s Specialty Chemicals business completed the expansion of its production site, which supplies pharmaceutical grade salt to the healthcare industry, increasing capacity by 60%.

Located in Mariager, the products supplied by the facility are used as an active pharmaceutical ingredient in various applications, including intravenous solutions, insulin and baby food.

“Our facility produces the purest salt in the world,” said Nils van der Plas, General Manager of AkzoNobel’s Salt business, “this expansion will now enable us to serve a strong growing market worldwide.

“Following a year of detailed engineering, construction and testing, the Mariager site is now well positioned to continue capturing the organic dialysis market developments. This specific market is growing globally by 7 to 8% per year and is expected to continue growing at this pace for at least another generation.”

In addition to dialysis, pharmaceutical grade salt is also used as a base material for liquid medications and dietary formulations.


J&J seeks US OK to add cardiovascular claim to Invokana label

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Johnson & Johnson has moved swiftly ahead with a filing for its diabetes drug Invokana that would include a claim that it can reduce major adverse cardiovascular events (MACE).

The filing is based on the results of the CANVAS trial, which showed that its SGLT2 inhibitor Invokana (canagliflozin) was able to reduce the combined risk of cardiovascular death, myocardial infarction and stroke by 14% compared to placebo in at-risk patients with type 2 diabetes, and also cut the risk of hospitalisation for heart failure by a third.

J&J’s pharma division Janssen is trying to get the cardiovascular outcome claim added to Invokana and its combination products Invokamet and Invokamet XR (canagliflozin and metformin), and if it succeeds will be able to make a strong case for its product to prescribers and payers. Adults with type 2 diabetes are four times more likely to develop cardiovascular disease, and this is the leading cause of death in these patients.

If the FDA approves the label, Invokana could be able to match rival SGLT2 inhibitor Jardiance (empagliflozin) from Eli Lilly and Boehringer Ingelheim, which had cardiovascular outcomes data added to its label in the wake of the EMPA-REG study, as well as Novo Nordisk’s GLP-1 agonist Victoza (liraglutide) which was given a cardiovascular disease reduction indication in August.

“People with type 2 diabetes have a substantially increased risk of developing cardiovascular disease, and it’s encouraging that we now have data to show Invokana may help address this challenge,” said Janssen’s head of cardiovascular and metabolism James List. “Invokana has shown a clear benefit in reducing cardiovascular risk in adults with type 2 diabetes and we look forward to working with FDA as it reviews our filing.”

One issue that could hold back J&J’s Invokana franchise is that of a higher risk of leg and foot amputations, with the FDA requiring a black box warning – its most prominent – on the products’ label earlier this year. The US regulator’s current thinking is that this has only been confirmed with canagliflozin, although the EMA recently suggested that while this has not been seen with other SGLT2 inhibitors, doctors and patients should be vigilant with all drugs in the class.

Analysts have suggested that cardiovascular outcomes data could boost peak sales of Jardiance by up to $1.7bn, and that the amputation issue with Invokana could mean that Lilly and Boehringer’s drug has the most to gain from cardiovascular labelling, threatening Invokana’s current market-leading position. J&J counters that it was only because CANVAS was such a big programme that the safety signal was able to be observed

J&J is hoping to tilt the balance in its favour with a large-scale trial called CREDENCE that will try to show a benefit for Invokana on renal damage in type 2 diabetes – something that was shown in the CANVAS-R companion trial – but Lilly and Boehringer have designs in that area too with an outcomes trial planned for Jardiance in chronic kidney disease patients both with and without diabetes.

AstraZeneca and Pfizer/Merck & Co are the laggards in the category, with AZ not expecting prospective cardiovascular outcomes data for Farxiga(dapagliflozin) until 2019 and Pfizer and Merck still waiting for approval of their ertugliflozin-based products.