News Feature | September 19, 2014

EMA, EC, NICE Weekly News Roundup: Roche, GSK, Janssen, And More

By Anna Rose Welch, Director, Cell & Gene Collaborative
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Roche Receives EU Approval For RA Drug

Roche’s and Chugai Pharma’s RoACTEMRA was approved in the EU for those with severe rheumatoid arthritis (RA) that were not previously treated with methotrexate (MTX). The drug was tested in the phase 3 FUNCTION study that enrolled 4,000 patients in 41 countries with early moderate-to-severe RA. In the trial, the drug, either in combination with MTX or as a monotherapy, proved its ability to slow joint damage and to stop the disease from progressing when compared to those receiving MTX as a monotherapy. RoACTEMRA was also found to be a superior treatment option to reduce RA symptoms compared to monotherapy of adalimumab in the phase 4 ADACTA study. In Japan, the drug is available for several indications, including Castleman’s disease, active systemic juvenile idiopathic arthritis (SJIA), and polyarticular juvenile idiopathic arthritis (PJIA) in patients two years of age and older.

Lilly, Boehringer MAA Given Thumbs Up

The European Commission (EC) was granted marketing approval last week for Eli Lilly’s and Boehringer Ingelheim’s insulin glargine product. This is the first insulin glargine product to make it past the European Medicines Agency’s biosimilar pathway. So far, the Lilly and Boehringer partnership has been a fruitful one, as this approval marks the fourth diabetes drug that was approved in the EU from this particular collaboration. The drug, which will be available to control blood sugar between meals and at night for those with type 1 and 2 diabetes, is a basal insulin that shares the same amino acid sequence as Sanofi’s Lantus.  

Chinese Company Granted Generic Viagra Approval

A Chinese company, Guangzhou Baiyunshan, earned a green light from China’s State Food and Drug Administration to produce a generic version of Viagra — Pfizer’s blockbuster erectile dysfunction drug that lost its patent protection in May. The company has been one of many Chinese companies rushing to gain prominence in the prominent erectile drug sector in China, which is expected to be worth $810 million by 2018. Guangzhou Baiyunshan began developing its product in the 1990’s, but was delayed in the process of gaining a production license for sildenafil because of the existing Pfizer patent. The company plans to name its product “Jin Ge,” which translates to “Golden Dagger Ax.”

Epirus Remicade Biosimilar Granted Approval In India

Epirus Biopharmaceuticals received a nod for its marketing and manufacturing approvals of its Remicade (infliximab) biosimilar, BOW015. This approval makes BOW015 the first infliximab biosimilar approved in India for those with rheumatoid arthritis, Crohn’s Disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis, and psoriasis. The biosimilar will be manufactured in Mumbai by Reliance Life Sciences and launches in 2015 under the brand name Infimab.

UK Watchdog Backs GSK Melanoma Drug

GSK’s Tinfalar, indicated for melanoma, was recommended by NICE for inclusion on the National Health Service (NHS) after the drug maker offered to lower the medicine’s price. Tinfalar, an oral med similar to Roche’s Zelboraf, targets a gene mutation that is responsible for causing half of aggressive melanomas and, in clinical trials, has shown efficacy at shrinking tumors. GSK plans to offer the drug for an undisclosed, lower price than the list price, which currently stands at $2,280 for a 28-capsule pack of 75 mg pills. The drug is taken twice daily in a 150 mg dose.

NW Bio Immune Therapy Named Promising Innovative Medicine

U.S. Biotech, Northwest Biotherapeutics, accomplished the first step in a 2-step process for early access approval for its DCVax personalized immune therapies for malignant gliomas, including Glioblastoma multiforme. The product is the first to receive the designation “Promising Innovative Medicine,” or PIM, under the Early Access Medicines Scheme (EAMS) — a program that was launched in April in the U.K.  Attaining a PIM is necessarily in order to accomplish the second step that can provide early access to the drug while it is still in clinical development and before it is formally licensed. To garner a PIM, the drug needed to meet three criteria: it needed to be targeted towards an unmet, serious health need; offer significant treatment advantage compared to other treatments in the market; and the benefits needed to outweigh the adverse effects of the drug. The second step in this process will put the drug before the MHRA, which will not only evaluate it based on clinical data and the aforementioned qualities, but it will also determine the company’s ability to manufacture the product according to GMP standards.  

Olysio Combination Recommended By NICE For HCV

NICE has come out in favor of Janssen’s Olysio to be used in the treatment of hepatitis C on the NHS. However, there were restrictions placed on the patients that are able to receive the treatment. For one, the drug has only been endorsed to be taken in combination with peginterferon alfa and ribavirin in genotype 1 HCV. The agency however, has requested more information on whether or not the drug’s clinical effectiveness in genotype 1 patients will also be the same in those with genotype 4 HCV. In May, Olysio garnered EU approval to treat HCV genotypes 1 and 4 in combination with Gilead’s Sovaldi.