GSK receives Japanese marketing approval for Nucala to treat asthma

GlaxoSmithKline plc (GSK) announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted approval for Nucala (mepolizumab) as a treatment for bronchial asthma in patients with refractory asthma whose symptoms are inadequately controlled with standard treatment. Nucala is licensed in Japan for adults and adolescents aged 12 years or older.

Nucala is the first medicine in a new class of anti-interleukin-5 (IL-5) biologic therapies. IL-5 plays an important role in regulating the function of eosinophils, inflammatory white blood cells known to be important in asthma. The medicine is administered as a 100 mg fixed dose subcutaneous injection once every four weeks. Patients will receive the treatment in addition to their existing respiratory medication, which comprises high-dose inhaled corticosteroids plus additional medicines, and may include maintenance oral corticosteroids.

Approval in Japan comes just four months after the approval of Nucala in the US – the first approval of an anti-IL-5 treatment anywhere in the world.

Philippe Fauchet, president, GSK Japan said: "As the market leader in respiratory medicine, GSK has been focused on gaining approval and launching its new respiratory medicines to meet the needs of patients in Japan. Approval of Nucala not only complements our respiratory portfolio but also gives us the opportunity to make a difference to the lives of more patients in Japan. It is our aim to make Nucala available in Japan as soon as possible to support the needs of a significant group of severe asthma patients whose condition is driven by eosinophilic inflammation, which is difficult to control."

The MHLW assessment of mepolizumab was based on data from the global clinical development programme, including the pivotal DREAM (MEA112997), MENSA (MEA115588) and SIRIUS (MEA115575) studies, which investigated the efficacy and safety of mepolizumab in patients with severe eosinophilic asthma. All patients in the phase III MENSA and SIRIUS studies had peripheral blood eosinophil levels greater than or equal to 150 cells/µL at initiation of treatment or greater than or equal to 300 cells/µL within the past 12 months.

Nucala is a monoclonal antibody that stops IL-5 from binding to its receptor on the surface of eosinophils. Inhibiting IL-5 binding in this way reduces blood, tissue and sputum eosinophil levels.

Mylan introduces Tramadol HCl extended-release tablets in US market

Mylan N.V.,a global pharmaceutical company, announced the US launch of Tramadol hydrochloride extended-release tablets USP, 100 mg, 200 mg and 300 mg, which is the generic version of Valeant's Ultram extended-release tablets.

Mylan received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.

Tramadol hydrochloride extended-release tablets USP, 100 mg, 200 mg and 300 mg, had US sales of approximately $52.8 million for the 12 months ending December 31, 2015, according to IMS Health.

Currently, Mylan has 265 ANDAs pending FDA approval representing $110.3 billion in annual brand sales, according to IMS Health. Forty-eight of these pending ANDAs are potential first-to-file opportunities, representing $38.3 billion in annual brand sales, for the 12 months ending Dec. 31, 2015, according to IMS Health.

[tags Mylan,pharmaceutical,,regulatory,ANDAs, ]

Biocon’s insulin glargine gets regulatory nod in Japan

Biocon has announced that the Ministry of Health, Labour and Welfare (MHLW) of Japan has approved its biosimilar insulin glargine.  The company through its commercial partner, FUJIFILM Pharma Co. Ltd (FFP) will now offer  high quality, yet affordable, world class products to diabetes patients in Japan.

The product is a ready-to-use, prefilled disposable pen with 3 ml of 100IU insulin glargine, expected to be launched in Q1 FY17, aiming to capture a significant share of the Japanese glargine market of US$ 144 million, which is the second largest market outside of North America & Europe and is largely dominated by disposable pens.

The approval for insulin glargine has been obtained post successful completion of initial development by Biocon and local phase III clinical studies in over 250 type 1 diabetes patients by our partner in Japan.  Biocon's manufacturing facilities for insulin glargine, and its state-of-the-art disposable pen assembly facility, were inspected and approved by the Japanese regulatory authorities.  This pen assembly facility was inaugurated in September 2015 for the launch of Biocon's insulin glargine pen branded as 'Basalog One' in India.

"The insulin glargine approval in the highly regulated market like Japan, marks a huge credibility milestone for Biocon. We see this as a significant achievement in our journey of making global impact in diabetes management through our affordable biosimilar insulins. We hope to enable the Japanese government to bring down its healthcare expenditure on diabetes with the use of this cost effective, high quality biosimilar insulin glargine, said Kiran Mazumdar-Shaw, chairperson & managing director, Biocon.

[tags Biocon,insulins,regulatory,GermanyKiran Mazumdar-Shaw,]

Emmbi Industries to set up facility for food & pharma grade packaging materials

Emmbi Industries Limited (earlier Emmbi Polyarns Ltd), one of the leading players in the field of woven polyethylene and polypropylene product, will set up a positive pressure integrated clean room facility for manufacturing of food and pharmaceutical grade FIBC (flexible intermediate bulk containers) packaging material at Silvassa.
 
The facility, estimated to cost Rs 10 crore, will take 10-12 months to complete and start the production. Emmbi will fund the project, which will be constructed on the land already available with the company, through internal accruals and debt from the banks.
 
With the new facility, Emmbi aims to tap the exports market, especially the developed countries such as the US. "This facility will help the company to produce the food & pharma grade products for the export market. This will increase the value addition of the products, especially in the US as the new US FDA guidelines recommends the use of food grade material for packaging for the entire value chain of food and pharmaceuticals," said Emmbi Industries in a press release.

[tags Emami,Polyarns,US FDA,Industries]

Teva completes acquisition of Mexico-based pharma distribution company

Teva Pharmaceutical Industries Ltd. has successfully completed the acquisition of Representaciones e Investigaciones Médicas, S.A. de C.V. (Rimsa), a leading pharmaceutical manufacturing and distribution company in Mexico, together with a portfolio of products and companies, intellectual property, assets and pharmaceutical patents in Latin America and Europe in a set of transactions for an aggregate of $2.3 billion.

With the completion of the acquisition, Teva is now one of the leading pharmaceutical companies in Mexico, the second largest market in Latin America and one of the top five emerging markets globally.

"This acquisition delivers on our strategy of increasing our presence in key emerging markets and offers a platform for further growth in the region. Rimsa will provide Teva with a strong brand, unique portfolio of patent-protected products, a promising pipeline and significant relationships with patients, physicians and other healthcare providers," said Erez Vigodman, president and CEO of Teva. "We have a clear responsibility to turn those strengths into meaningful results for patients, customers and the communities we serve, as well as for our shareholders."

Rimsa has had annual growth, year-over-year of 10.6% since 2011. The company has an extensive portfolio of patent-protected products, including fixed-dose combination products which have fueled its growth.

[tags Teva,Pharmaceutical,Rimsa]

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