The week in industry: Another step towards patient access to medical cannabis across Europe

This week: Evotec (Hamburg, Germany) acquire Just Biotherapeutics (WA, USA) for US$90 million, ENTYVIO®, from Takeda Pharmaceutical (Tokyo, Japan), approved in Japan for Crohn’s disease and the US FDA grants Priority Review of INVOKANA® sNDA for chronic kidney disease.

May 23, 2019
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This week's industry news: 

Platform launched for the licensed import of medical cannabis across Europe
Evotec acquire Just Biotherapeutics for US$90 million
ENTYVIO® approved in Japan for Crohn’s disease
FDA grants Priority Review of INVOKANA® sNDA for chronic kidney disease


Platform launched for the licensed import of medical cannabis across Europe

Following on from the opening of The Medical Cannabis Clinics (London, UK), Britain’s first chain of specialist medical cannabis, European Cannabis Holdings (London, UK) have launched a platform, in the UK, to facilitate the licensed import of medical cannabis into Europe. The platform, Astral Health, will provide a simple and efficient system for the licensed important and distribution of approved medical cannabis products.

“The launch of Astral Health is a pioneering step forward that will support increased market access to medical cannabis across Europe. The legalization of prescription cannabis in the UK has given people with chronic illnesses hope; the next step is to ensure the availability of this medication to those who need it. By facilitating the licensed import of approved medical cannabis products on an ongoing contractual basis through Astral Health, that’s what we are working to achieve,” commented Dean Friday, CFO and Director of European Cannabis Holdings.

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Evotec acquire Just Biotherapeutics for US$90 million

Evotec SE (Hamburg, Germany) have announced the signing of a definitive agreement under which Ecotec will acquire Just Biotherapeutics (Just.Bio; WA, USA) for up to US$ 90 million. This acquisition of Just.Bios’s scientific expertise and machine learning technologies for the design, development and manufacture of biologics, will further accelerate Ecotec’s long-term plan to be the industry partner of choice for external end-to-end innovation.

“We are excited about the acquisition and warmly welcome Just.Bio’s expert team as a new part of the Evotec family and also welcome Dr Jim Thomas in his new management role EVP, Global Head, Biotherapeutics, President US Operations. Broadening our platform into biologics has always been key to our strategy. With this acquisition we finally found the perfect match to complement our leadership in small molecules,” commented Werner Lantheraler, CEO, Evotec.

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ENTYVIO® approved in Japan for Crohn’s disease

Takeda Pharmaceutical (Tokyo, Japan) has gained approval from the Japanese Ministry of Health, Labor and Welfare, for ENTYVIO® (vedolizumab) to treat adult patients with moderate to severe active Crohn’s disease. The drug was initially approved for the treatment of ulcerative colitis in July 2018 and launched in November 2018. This additional approval comes after positive results from a Phase III clinical trial investigating the efficacy, safety and pharmacokinetics of the drug in patients with Crohn’s disease.

“Crohn's disease is an inflammatory bowel disease along with ulcerative colitis. The number of patients with Crohn's disease in Japan is rapidly increasing and many patients experience difficulties in their daily lives from this chronic disease. Entyvio is a biologic medicine with a new mechanism of action that regulates the immune response selectively in the gut and was approved last year in Japan as a new treatment option for ulcerative colitis. This approval means there is now another option that can help contribute to the solution of unmet needs in the treatment of Crohn's disease,” commented Takanori Kanai, Professor of Gastroenterology and Hepatology at Keio University (Tokyo, Japan).

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FDA grants Priority Review of INVOKANA® sNDA for chronic kidney disease

From Janssen Pharmaceutical Companies (Beerse, Belgium), the sNDA for INVOKANA® (canaglifozin) has been granted Priority Review by the US FDA. The drug aims to reduce the risk of end-stage kidney disease, the doubling of serum creatine, and renal or cardiovascular death in adults with type 2 diabetes and chronic kidney disease.

“Millions of people with type 2 diabetes will develop chronic kidney disease, which leads to a high risk of progressing to kidney failure and developing CV disease. We are pleased the FDA recognizes the urgency to deliver a novel treatment that can reduce the risk of kidney failure and prevent life-threatening cardiovascular events in people with type 2 diabetes and chronic kidney disease,” commented James List, Global Therapeutic Area Head, Cardiovascular & Metabolism, Janssen Research & Development. “This Priority Review designation brings us one step closer to addressing this major unmet need and providing a new standard of care to those living with this serious condition.”

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