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BIOCAD’s rituximab biosimilar to receive MA soon in India

On June 20, 2017 Biocad reported that the Central Drugs Standard Control Organization (CDSCO) has recommended Acellbia, the first rituximab biosimilar made in Russia, for approval in India (Press release, Biocad, JUL 4, 2017, View Source [SID1234527808]).

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In August 2017, BIOCAD will receive permanent market authorization in India, which represents a strategic milestone for BIOCAD’s international expansion.

Today, the Indian market for rituximab exceeds $40 m, with an annual growth of 8%. According to experts, this volume may reach $58 million in the next five years.

Meanwhile, India experiences low rituximab availability. Therefore, the Russian biosimilar marketed here will not only boost competition among the existing players, but will make this product available for larger numbers of patients with certain types of lymphomas and autoimmune disorders.

"We are happy to see Acellbia, our first biosimilar drug product to receive MA in India, but our efforts to register more products there will continue. In the first quarter of 2018 we plan to obtain MA for Herticad, BIOCAD’s trastuzumab biosimilar which is used to treat certain types of breast cancer, and is already supplied to Syria, Sri Lanka and other countries," says Mr. Dmitry Morozov, BIOCAD’s CEO.

The quality of Acellbia manufactured by BIOCAD, including the API, was clearly demonstrated in sizeable international clinical trials, parts of which were conducted in India. The trials were conducted in accordance with the EMA’s guidelines for the non-clinical and clinical development of biosimilar monoclonal antibodies. They demonstrated similar efficacy and safety of Acellbia in a head-to-head comparison with the original drug product by F. Hoffmann-La Roche, Ltd.

BIOCAD’s rituximab has already been authorized in seven countries, including Bolivia and Honduras, with the registration pending in 27 countries.

Since 2014, over twenty-six thousand patients in Russia and other countries were treated with rituximab produced by BIOCAD.

The first shipment of BIOCAD’s Acellbia to India is scheduled for September 2017.

Sumitomo Dainippon Pharma Announces Change in Name of Consolidated Subsidiary Based in U.S.

On July 4, 2017 Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; President: Masayo Tada; "Sumitomo Dainippon Pharma") reported that the Board of Directors of Dainippon Sumitomo Pharma America Holdings, Inc. ("DSPAH"), a holding company in the United States wholly-owned by Sumitomo Dainippon Pharma, decided on July 4, 2017 (US time) that DSPAH will change its name as following (Press release, Dainippon Sumitomo Pharma, JUL 4, 2017, View Source [SID1234519748]).

1. New name
Sumitomo Dainippon Pharma America, Inc.
(Former name: Dainippon Sumitomo Pharma America Holdings, Inc.)

2. Reason for name change
To unify the brand of Sumitomo Dainippon Pharma group by aligning the subsidiary’s name with the parent Company’s name Sumitomo Dainippon Pharma Co., Ltd.

3. Date of the change July 5, 2017 (US time)

4. Outline of DSPAH Company name Dainippon Sumitomo Pharma America Holdings, Inc. Representative Hiroshi Nomura (Chair) Business description Holding company Address of headquarters Wilmington, Delaware, U.S. Capital US1,000$

Somatuline® Autogel® 120 mg receives Japanese approval for a new indication for the treatment of gastro-entero-pancreatic neuroendocrine tumors

On July 3, 2017 Ipsen (Euronext: IPN; ADR: IPSEY) and Teijin Pharma Limited, the core company of the Teijin Group’s healthcare business, reported that Teijin Pharma has received approval from the Japanese Ministry of Health, Labour and Welfare for Ipsen’s subcutaneous drug Somatuline (lanreotide) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP NET) (Press release, Ipsen, JUL 3, 2017, View Source [SID1234519744]). The drug is approved in Japan for the treatment of acromegaly and pituitary gigantism since 2012.

The request for the additional approval was filed in July 2016, based on Ipsen’s investigational, pivotal phase III randomised placebo-controlled trial (CLARINET) in 204 patients with GEP NET conducted in 14 countries, and an open-label single group multicenter Phase II trial (J-001) in 32 patients with NET that Teijin Pharma conducted in Japan. This approval establishes Somatuline as the first drug available in Japan for the treatment of pancreatic NET.

Harout Semerjian, Executive Vice-President & President, Specialty Care International & Global Franchises said: "We are pleased that Somatuline is now also available for Japanese patients suffering from gastrointestinal and pancreatic neuroendocrine tumors. In line with our commitment to serve NET patients worldwide, this is a significant step after our partner Teijin launched Somatuline for the treatment of acromegaly and pituitary gigantism in Japan in January 2013."

Akihisa Nabeshima, President of Teijin Pharma said: "It is our great pleasure to now have the capacity to provide a new therapeutic option to NET patients in Japan. We will continue to focus on drug discovery and improve the quality of life of patients by offering them new treatment options to fulfill unmet medical needs."

About Neuroendocrine Tumors

NETs are malignant tumors arising from neuroendocrine cells. Most of the NET tumors present with metastasis and are discovered fortuitously. In some patients, excess hormones secreted from a NET can lead to severe diarrhea, peptic ulcers or hypoglycemia. While incidence rates are relatively rare, at about 3.5 gastrointestinal NET patients and 1.3 pancreatic NET patients per 100,000 people in Japan, the number of patients has been increasing year by year due to disease awareness and better diagnosis[1].

The primary treatment for NETs is removal by surgery, but if this is not possible as the disease is usually disseminated, or if a tumor relapses following surgery, another option is a medical treatment.

About Somatuline

The active substance in Somatuline is lanreotide acetate, a somatostatin analogue that inhibits the secretion of several endocrine, exocrine and paracrine functions. It has been shown to be effective in inhibiting the secretion of GH and certain hormones secreted by the digestive system. Somatuline is marketed as Somatuline Depot within the United States and as Somatuline Autogel in other countries where it has marketing authorization. Somatuline is indicated for the treatment of acromegaly and neuroendocrine tumors in 70 countries.

Immunocore Announces Third Oncology Target Selected in Discovery Collaboration with GlaxoSmithKline

On July 3, 2017 Immunocore Limited, the world’s leading TCR company developing biological drugs to treat cancer, infectious diseases and autoimmune diseases, reported that GlaxoSmithKline (GSK) has selected a third target as part of their ongoing oncology discovery collaboration for multiple novel targets not addressable with antibody-based technologies. Immunocore will generate a novel ImmTAC molecule against the selected target which is relevant in multiple cancers.

This is the third programme to be initiated as part of the discovery collaboration with GSK, announced in 2013. Immunocore is currently working on two other ImmTAC programmes under the agreement. The lead programme is on track for an Investigational New Drug (IND) this year with potential application in Non-Small Cell Lung Cancer (NSCLC), bladder cancer, synovial sarcoma, melanoma and ovarian cancer.

Dr Bent Jakobsen, Chief Scientific Officer at Immunocore, commented: "The initiation of this new programme adds to a growing body of evidence that our ImmTAC technology has real potential to generate novel, potent drug candidates against disease targets which are difficult to address with other biologic platforms. ImmTAC molecules are relevant across a wide range of cancer types and have the ability to tackle solid ‘cold’, low mutation rate tumours – the majority of tumours which are difficult for other immuno-oncology drugs to address. We look forward to beginning work on this additional programme with GSK in oncology."

Dr Axel Hoos, Senior Vice President Therapeutic Area Head Oncology R&D Head, Immuno-Oncology at GSK, added: "We are pleased with the progress made in our ongoing collaboration with Immunocore and are excited to add a yet another target to the programme. ImmTAC molecules have great potential among the third generation of immuno-oncology agents and we look forward to seeing this promising program progress."

India Patent Office Granted AskAt a Substance Patent of EP4 antagonist(AAT-007)

On June 30, 2017 AskAt Inc. reported that AskAt received a notice of allowance dated June 30, 2017 from Office of the Controller General of Patent, Designs & Trade Marks in connection with the Application No. 817/DELNP/2006, a substance patent for its EP4 antagonist(AAT-007) (Press release, AskAt, JUN 30, 2017, View Source [SID1234535062]).