ZS-9 in Hyperkalemia patients

ZS Pharma, a biopharmaceutical company developing novel treatments for kidney, cardiovascular, liver and metabolic disorders, has begun enrolling patients in ZS005, a Phase 3 open-label, 12-month, long-term maintenance studyof ZS-9, an investigational treatment for hyperkalemia. This Phase 3 trial is designed to further add to the clinical experience to date by demonstrating the safety and tolerability of ZS-9 and its ability to restore and maintain normal serum potassium levels in patients with hyperkalemia over at least one year of dosing.The Company plans to file a New Drug Application with the United States Food and Drug Administration and a Marketing Authorisation Application with the European Medicines Agency in the first half of 2015.

The ZS-9 clinical programme is designed to investigate the treatment of acute and chronic hyperkalemia, regardless of underlying cause. ZS Pharma recently completed a 753-patient Phase 3 study, ZS003, which showed that ZS-9 rapidly reduced serum potassium in hyperkalemic patients to normal levels within the 48-hour Induction Phase and then controlled potassium in the normal range throughout the 12-day Extended Treatment Phase. In addition, the study provided evidence suggesting that ZS-9 is safe and well-tolerated with an adverse event profile similar to placebo.

Eisai submits first marketing authorisation for anti-cancer

Eisai Co., Ltd. announced that it has submitted its first marketing authorisation application for its novel in-house developed anti-cancer agent lenvatinib mesylate (“lenvatinib”) for the treatment of thyroid cancer in Japan. This application for Japan marks the first submission for lenvatinib in the world following the completion of a global clinical trial.

Lenvatinib is an oral multiple receptor tyrosine kinase (RTK) inhibitor with a novel binding mode that selectively inhibits the kinase activities of various RTKs including VEGFR, FGFR, PDGFRa, KIT and RET, involved in angiogenesis and tumour proliferation.

The application submitted in Japan was based on a Phase III clinical study known as the SELECT (Study of (E7080) LEnvatinib in Differentiated Cancer of the Thyroid) trial which was a multicentre, randomised, double-blind, placebo-controlled study of lenvatinib in patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC) and radiographic evidence of disease progression within the prior 13 months (patients may have received =1 prior VEGFR-targeted therapies).

Bristol-Myers

Bristol-Myers Squibb announced a collaboration with Duke University through its Duke Clinical Research Institute (DCRI) focused on clinical trial transparency. Bristol-Myers Squibb will expand access to a broader set of clinical trial information from in-scope company-sponsored studies and enable an independent scientific review through DCRI of requests from researchers that meet pre-specified requirements.

The collaboration with DCRI is one of a series of initiatives by Bristol-Myers Squibb to support data sharing and enhance the company’s existing policies on transparency and disclosure of clinical trial information. Clinical trial information being made available for scientific research will include protocols, full clinical study reports (CSR) and de-identified patient-level data and study-level data for medicines and indications approved in the U.S. and/or Europe for trials completed after January 2008. Information from terminated programs will be available two years after discontinuation.

“Bristol-Myers Squibb’s collaboration with DCRI reflects our commitment to providing broader, more timely access to important clinical trial information and serves as a catalyst to strengthening public confidence in medicines, advancing science and improving public health,” said Francis Cuss, MB BChir, FRCP, executive vice president and chief scientific officer, Bristol-Myers Squibb.

BAL101553 - Basilea Pharmaceutical

Basilea Pharmaceutica reports that it initiated a phase 2a study with its investigational oncology drug BAL101553. The study is designed to further characterise safety and tolerability, and to obtain efficacy data in adult patients with advanced or recurrent solid tumours who have failed standard therapy or for whom no effective standard therapy is available. Tumour types were selected based on clinical observations in the phase 1 study and a detailed analysis of potential patient stratification biomarkers across tumour indications. The study will also continue the extensive biomarker testing initiated in Phase 1, to further evaluate dose and patient populations most likely to respond.

BAL101553 is an intravenous and oral small-molecule microtubule-targeting agent (MTA) with a dual action against human tumours, targeting tumour cells refractory to standard MTAs as well as tumour blood supply. In preclinical studies the investigational drug demonstrated potent anti-cancer activity in a broad panel of treatment-resistant tumour models. Tumour cell proliferation was arrested and tumour cell death was induced through a destabilising effect on microtubules, an intracellular network essential for cell division. In addition, tumour-specific vascular disruption activity was observed in preclinical cancer models. First evidence of clinical antitumour activity has been seen in a recently completed phase 1 study.

DBT invites fresh proposals from biotech

he Department of Biotechnology (DBT) has invited fresh proposals from biotech companies for providing support on a cost sharing basis targeted at development of novel and high risk futuristic technologies mainly for viability gap funding and enhancing existing R&D capacities of start-ups and SMEs in key areas of national importance and public good.

Under this advanced technology scheme Biotechnology Industry Partnership Programme (BIPP), the DBT supports large, medium, small scale companies as well as start-up on cost sharing basis. It would push for high risk, discovery linked innovation and accelerated technology development. Varying models of grants, loans or grant plus loans will be made available under the scheme.  It will be one of the most enabling mechanisms to promote R&D in biotech industry and public private partnership programmes.

It will also focus on the evaluation and validation of biotech products and indigenous discovery, innovation and technology to products with focus on the products of national relevance or public benefit. BIPP is an advanced technology initiative by the DBT for supporting innovative and challenging R&D in industry.

Vertex Pharmaceuticals

Vertex Pharmaceuticals Incorporated announced results from two Phase 3 studies of lumacaftor in combination with ivacaftor that showed statistically significant improvements in lung function (percent predicted forced expiratory volume in one second, or ppFEV1) in people ages 12 and older with cystic fibrosis (CF) who have two copies (homozygous) of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. All four 24-week combination treatment arms in the studies, known as TRAFFIC and TRANSPORT, met their primary endpoint of mean absolute improvement in ppFEV1 from baseline compared to placebo at the end of treatment. Mean absolute improvements in ppFEV1 of between 2.6 and 4.0 percentage points from baseline compared to placebo were observed across the studies (p=0.0004), with mean relative improvements of 4.3 percent to 6.7 per cent (p=0.0007).

The combination regimens were generally well tolerated. The most common adverse events, regardless of treatment group, were infective pulmonary exacerbation, cough, headache and increased sputum. 4.2 per cent of patients who received the combination regimens discontinued treatment because of adverse events compared to 1.6 percent of those who received placebo. More than 1,000 patients have entered a rollover study to receive a combination regimen.

Pharmerging markets fuel high barrier

With blockbuster drugs going off patent along with increasing healthcare costs, pharma sector is now waking up to meet the numerous demands for packaging of various generic products in India and globally.

The evolving complex regulatory environment in regulated and pharmerging markets is fuelling the demand of high barrier pharma packaging for protecting molecule sensitivity of various drugs to achieve quality, according to experts.

High barrier pharma packaging holds a lot of relevance as sales of big pharma companies like Sanofi, Novartis, Roche, Astrazeneca and Pfizer are threatened in 2014 through patent cliff.

Speaking on the trends in pharma packaging, Johannes Giessler, director, Sales & Marketing, Perlen Packaging recently said, "There is a growth in demand of high barrier specifications, standardized specifications for numerous applications, individual patient packages and counterfeit resistant packaging. Besides this, new legislations are being framed which are increasing costs of products i.e. European falsified medicine directive, ePedigree law etc."