GSK Biologicals gets patent nod for pneumonia vaccine

GlaxoSmithKline Biologicals SA has received a favorable order from Indian Patent Office (IPO) for an invention related to improved Streptococcus Pneumonia vaccine. Patent Office, that has found out the company has removed all objections raised against the application stated ten claims submitted on 2nd June, 2015 stand granted for patent.

The company filed the application for "Comprising Streptococcus Pneumoniae Capsular Polysaccharide Conjugates' in June, 2008 and it was published on January, 2009, following which a first examination report was issued on March, 2011.In the first examination report, the Patent Office raised objections including 'claims lack novelty, inventive step and conflict with another application among others'.

The company argued claims in the application is different from that in other application it filed earlier and the claimed composition is new and provides an improved technical effect. The present invention optimises immune response elicited by different components in a pneumococal multivalent conjugate vaccine, argued the company.

The company also argued it is an object of the present invention to develop an improved formulation of a multiple serotype Streptococcus pneumoniae polysaccharide conjugate vaccine and the prior documents would not lead the skilled person to consider the particular composition of the claim to improve it and thus, the composition is novel and inventive.

After considering submissions during the hearing, Assistant Controller of Patents and Designs Abhijit Das issued an order granting the patent for ten claims submitted.
According to the documents, Streptococcus pneumoniae is the most common cause of invasive bacterial disease and Otitis media in infants and young children. Children less than two years of age do not mount an immune response to most polysaccharide vaccines, so it has been necessary to render the polysaccharides immunogenic by chemical conjugation to a protein carrier, it added.

GSK completes divestment rights of ofatumumab to Novartis

GlaxoSmithKline Plc announced the completion of its transaction to divest its rights to ofatumumab for auto-immune indications to Novartis Pharma AG (“Novartis Pharma”), a subsidiary of Novartis AG, following regulatory approval.

The consideration payable by Novartis Pharma to GSK may reach up to $1,034 million and comprises a series of milestone payments as: $300 million paid at closing; $200 million payable subject to the start of a phase III study in relapsing remitting multiple sclerosis by Novartis; further contingent payments of up to $534 million payable on the achievement of certain other development milestones.

Novartis Pharma will also pay royalties of up to 12 per cent to GSK on any future net sales of ofatumumab in auto-immune indications. Income generated from the divestment will be treated as non-core in line with the accounting policies outlined in the third quarter financial results announcement of 28 October 2015.

 

GSK acquires BMS's R&D HIV assets

GlaxoSmithKline plc announced that its global HIV business, ViiV Healthcare, has reached two separate agreements with Bristol-Myers Squibb, to acquire its late-stage HIV R&D assets; and to acquire Bristol-Myers Squibb’s portfolio of preclinical and discovery stage HIV research assets.

These potential therapies have novel modes of action and would offer significant new treatment options to patients with HIV. In addition to being developed as standalone treatment options, these new assets complement ViiV Healthcare’s existing portfolio and therefore offer multiple opportunities for development as combination therapies.

The late-stage asset purchase comprises an upfront payment of $317 million, followed by development and first commercial sale milestones of up to $518M, and tiered royalties on sales. The purchase of preclinical and discovery stage research assets comprises an upfront payment of $33 million, followed by development and first commercial sales milestones of up to $587M, and further consideration contingent on future sales performance.
 

GSK announces positive results of Benlysta

GSK announced results from the BLISS-SC Phase III pivotal study in patients with active, autoantibody-positive systemic lupus erythematosus (SLE). These results, which are being presented at the American College of Rheumatology/Association for Rheumatology Health Professionals Annual Meeting, showed that Benlysta^® (belimumab) 200mg administered weekly via subcutaneous injection plus standard of care (SoC), showed significantly greater reductions in disease activity compared to placebo plus SoC.

BLISS-SC builds on a robust clinical trial programme for belimumab, which is the largest conducted in SLE to date. BLISS-SC is a Phase III, multi-centre, randomised, double-blind, placebo-controlled, 52-week study to evaluate the efficacy and safety of belimumab administered subcutaneously to patients with active, autoantibody-positive SLE who are receiving standard therapy. The primary efficacy endpoint is the SRI response rate at Week 52.

Benlysta is the first medicine specifically developed and approved for SLE in over 50 years. It is a human monoclonal antibody that selectively targets B-lymphocyte stimulator (BLyS), an important factor in the survival of B cells

GSK and Theravance announce results from the SUMMIT COPD CV Survival Study

GlaxoSmithKline plc and Theravance, Inc. announced initial results from the Study to Understand Mortality and MorbidITy in COPD (SUMMIT) for Relvar®/Breo® Ellipta® 100/25mcg (fluticasone furoate ‘FF’/vilanterol ‘VI’ or ‘FF/VI’). The study involved 16,485 patients from 43 countries who had chronic obstructive pulmonary disease (COPD) with moderate airflow limitation (FEV1 50-70% predicted) and either a history or increased risk of cardiovascular disease (CVD). 

For the primary endpoint of the study, the risk of dying on FF/VI 100/25mcg was 12.2% lower than on placebo* over the study period, which was not statistically significant (p=0.137).

For the first of two secondary endpoints, FF/VI 100/25mcg reduced the rate of lung function decline (as measured by forced expiratory volume in one second, ‘FEV1’) by 8mL per year compared with placebo (p=0.019). As the primary endpoint was not met, statistical significance cannot be inferred from this result. For the other secondary endpoint, the risk of experiencing an on-treatment cardiovascular (CV) event (CV death, myocardial infarction, stroke, unstable angina and transient ischemic attack [TIA]) at any time was 7.4% lower in patients taking FF/VI 100/25mcg versus placebo which was not statistically significant (p=0.475).

The study also formally analysed a number of additional COPD endpoints assessing the efficacy of FF/VI relative to placebo, which included FEV1 (post-bronchodilator), rate of moderate/severe exacerbations, time to first moderate/severe exacerbation, time to first severe (hospitalised) exacerbation, rate of severe (hospitalised) exacerbation, health related quality of life (as measured by the St George’s Respiratory Questionnaire-COPD total score at 12 months) and health status as measured using the COPD Assessment Tool (CAT) at 12 months. Against these endpoints FF/VI demonstrated an improvement compared to placebo with a nominal P-value of<0.002 for each.  As the primary endpoint was not met, statistical significance cannot be inferred from these results. 

Chronic obstructive pulmonary disease (COPD) is a disease of the lungs that includes chronic bronchitis, emphysema or both. COPD is characterised by obstruction to airflow that interferes with normal breathing. Cigarette smoke, breathing in second-hand smoke, air pollution including biomass fuels, chemical fumes and dust from the environment or workplace can all contribute to COPD.

COPD mortality is increasing and is the third leading cause of death globally. COPD often coexists with other chronic diseases and epidemiological data suggests that CVD or CV risk occurs in nearly half of all patients with COPD. CVD is the number one killer of mild to moderate COPD patients and patients with both COPD and CVD or CV risk were observed to have a mortality rate double that of COPD patients without CVD in studies of up to 15 years in duration.