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."

Need of the hour

The 2012 Patient View survey of 600 international, national and regional patient groups, on the corporate reputation of pharma in general and 29 leading pharma companies in particular showed that the overall industry reputation has dropped. In terms of reputation, the pharma industry was 7th of the 8 healthcare sectors evaluated. Only 34% of respondents gave pharma a “good” or “excellent” rating for reputation. Pharma trailed retail pharmacists (62%), medical device companies (50%), private healthcare services (46%), biotech companies (44%) and generic drug makers (37%).

From a patient’s perspective this negative view of pharma is being driven by:
1)    A lack of fair pricing policies leading to unseemly profits (50%);
2)    A lack of transparency in all corporate activities (48%);
3)    Management of adverse event news (37%);
4)    Acting with integrity (32%)

Till the final quarter of the last century, the pharmaceutical industry's social, political, technological and economic credentials were unparalleled. Its range of noble and altruistic ideals attracted the best and brightest graduates who delivered an outstanding range of new medicines. Its single-minded pursuit of integrity was widely respected and its reputation, image and influence were without equal.

GanedenBC30

Ganeden Biotech’s patented probiotic ingredient is now available in six of the seven continents.

Ganeden Biotech has announced that probiotic ingredient GanedenBC30 (Bacillus coagulans GBI-30, 6086) which bagged several international regulatory approvals is now being shipped to six of the seven continents. This means that its probiotic ingredient  known for its digestive and immune benefits are now available globally for food and beverage fortification.

The company is engaged in probiotic research and product development with an extensive library of published studies and more than 100 patents for probiotic technologies in the food, beverage, animal health, and now personal care ingredients markets. It is known for its GanedenBC30), a patented, FDA GRAS which is a highly stable probiotic ingredient. Its newest ingredient, Bonicel, is the first science-backed, probiotic-derived, personal care ingredient shown to dramatically reduce signs of aging.

Pharmaceutical policy for Telangana

The pharmaceutical association of Telangana (TPA) has demanded the state government of Telangana to come up with a comprehensive pharma and biotechnology policy to attract more investors and enhance growth in this sector.





At present there are 412 pharma companies and 173 bulk drug units in Telangana state. Earlier the total count was about 1500 pharma firms in the united Andhra Pradesh. In the year 2005 about 300 firms had shifted to tax incentive states like Uttarkhand, Gujarat and Himachal Pradesh. Now that the State of Andhra Pradesh is divided into two, the Telangana Pharmaceutical Association fear that the remaining firms may also shift their bases to Andhra state, as the AP government has been luring with numerous incentives and benefit packages for the investors.

In view of this, the TPA has demanded the Telangana Medical, Health and Family welfare Minister Dr.T.Rajaiah to come out with a comprehensive pharma policy and announce incentives and tax exemptions. The association has also demanded to increase more number of public private partnership programme to attract new investor and at the same time retain the existing companies in the state.

Melgain for treatment of vitiligo

Dr Reddy’s Laboratories, an integrated global pharma company, announced the launch of Melgain, lotion that has been approved for the treatment of vitiligo, to benefit patients of the skin pigmentation disorder in India. The medication has been launched in partnership with Issar Pharmaceuticals to increase access to a novel treatment for vitiligo patients in India.

lobally, Melgain lotion (decapeptide) is the first peptide-based drug for the treatment of vitiligo. It has been indigenously developed in India. Melgain lotion is the only patented decapeptide derived from basic fibroblast growth factor, a substance the body naturally produces for maintaining the structure and function of melanin producing cells. Melgain lotion is safe and efficacious in vitiligo cases involving various areas of the body, as established by a number of clinical studies. Its safety is well established for treating children as well.

Horizon Discovery and LGC get £360,224

Horizon Discovery Group plc, the international life science supplying research tools to organisations engaged in genomics research and the development of personalised medicines, together with LGC, an international life sciences measurement and testing company have been offered a research grant of £360,224 ($608,000 USD) by the UK’s innovation agency, the Technology Strategy Board, of which Horizon will receive more than half of the funding. The grant is awarded under the Technology Strategy Board’s Collaborative Research and Development (CR&D) project ‘Improving Cell and Tissue Analysis for Stratified Medicine’ and will fund a joint project run by the Company’s Horizon Diagnostics division in partnership with LGC.

The project will fund the research and development of a portfolio of novel reference standard materials in order to serve a high need area of clinical diagnostics.  The programme will establish methods and cross platform data sets to standardise existing ‘liquid biopsy’ genetic diagnostic tests, to determine test sensitivity, and to help drive the development of new more sensitive systems as well as training and proficiency testing schemes for pathology laboratories.

Minimally invasive ‘liquid biopsies’ of tumour cells and tumour DNA from the bloodstream can enable earlier primary and secondary diagnosis compared to solid tumour biopsies, as well as detection of metastasis and/or residual disease, and ‘real time’ monitoring of treatment effectiveness that isn’t possible with solid biopsy methods. Standardisation within and between facilities and across geographies will enable the uptake of minimally invasive cancer diagnostics as a routine clinical procedure

Patented probiotic ingredient BC30

Ganeden Biotech’s patented probiotic ingredient is now available in six of the seven continents.

Ganeden Biotech has announced that probiotic ingredient GanedenBC30 (Bacillus coagulans GBI-30, 6086) which bagged several international regulatory approvals is now being shipped to six of the seven continents. This means that its probiotic ingredient  known for its digestive and immune benefits are now available globally for food and beverage fortification.

The company is engaged in probiotic research and product development with an extensive library of published studies and more than 100 patents for probiotic technologies in the food, beverage, animal health, and now personal care ingredients markets. It is known for its GanedenBC30), a patented, FDA GRAS which is a highly stable probiotic ingredient. Its newest ingredient, Bonicel, is the first science-backed, probiotic-derived, personal care ingredient shown to dramatically reduce signs of aging.

Ferrer begins second phase III study of Ozenoxacinin

Ferrer, a privately-held Spanish pharmaceutical company, announces that the first patient has been recruited into a second phase III trial of Ozenoxacin, formulated as a topical treatment for infectious dermatological conditions in adult and paediatric patients with impetigo. The study is scheduled to complete in Q1, 2015.

The multicentre, randomised, double-blinded, clinical study comparing Ozenoxacin one per cent cream versus placebo will be conducted in about 412 patients aged two months and over with a clinical diagnosis of non-bullous or bullous impetigo at approximately 36 centres in the USA, South Africa, Germany, Spain, Romania, Russia and Puerto Rico, subject to completion of additional regulatory approvals

In 2013, Ferrer successfully completed a first phase III clinical trial of Ozenoxacin in adult and paediatric patients aged two years and over with impetigo. The study demonstrated the superiority of Ozenoxacin one per cent cream versus a placebo, applied topically twice daily for five days, on both the clinical and bacteriological endpoints by end of therapy visit. In addition, Ozenoxacin demonstrated a superior bacteriological cure compared to placebo by the second visit (day three-four). The trial also demonstrated that Ozenoxacin is safe and very well tolerated in the adult and paediatric populations.

GlobalData shows lucrative biosimilars space

The increasing prevalence of biosimilars will have a noticeably negative impact on the biologics market beyond 2019, despite an initial projected Compound Annual Growth Rate (CAGR) of 8.3%, taking the overall biologics market value from $162 billion in 2013 to more than $262 billion by 2019, says research and consulting firm GlobalData.







The company’s latest report states that patent expirations of branded biologics and the introduction of clearer regulatory frameworks for biosimilars after 2019 will see the latter capturing the market share from biologics.

Joshua Owide, GlobalData’s Director of Healthcare Industry Dynamics, says: “There are a number of factors driving the initiative towards the global adoption of biosimilars, from austerity measures and slow economic growth in the US, to an aging population and increasing demand for healthcare in countries such as Japan.

Eylea to treat macular edema following BRVO

Bayer HealthCare, a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials, has applied for marketing authorisation of aflibercept solution for injection for the treatment of patients with visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO) to the European Medicines Agency (EMA).

Aflibercept solution for injection into the eye has already been approved under the brand name Eylea for the treatment of patients with neovascular age-related macular degeneration (wet AMD) and the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO). Bayer has already filed for marketing authorisation for the treatment of diabetic macular edema (DME).

Inovio Pharmaceuticals

Inovio Pharmaceuticals, Inc has initiated a phase I/IIa clinical trial to evaluate safety, immunogenicity and clinical responses of its immunotherapy product, INO-3112, in treating human papillomavirus (HPV)- associated head and neck cancer. INO-3112 is a combination of Inovio's lead active immunotherapy product, VGX-3100, and its proprietary immune activator expressing interleukin-12 (IL-12). VGX-3100 is currently being evaluated in a randomised phase II efficacy trial for the treatment of high grade cervical dysplasia (pre-cancer).

Strike in Kerala protesting DMO's raid of Ayurveda hospital

The ayurvedic medical association of India (AMAI) has decided to paralyze the medical services of the Ayurveda hospitals and clinics in Kerala from June 9 till the state government takes action against the Thiruvananthapuram district allopathic medical officer (DMO) who had on last Saturday raided and sealed an Ayurveda hospital, and arrested the doctor there with the support of police and excise officials.

Member doctors of the association, UG and PG students at various Ayurveda medical colleges and all other big and small Ayush healthcare establishments will join the strike and abstain from work from June 9 in protest against the allopathic DMO’s illegitimate and unwise raid on the decade old ayurvedic hospital in the city.

New certified Snap-N-Spike solutions of NBOMe

Sigma-Aldrich Corporation, a leading life science and high technology company, has announced that the Cerilliant brand within its applied diagnostics and testing business segment has introduced six new certified Snap-N-Spike reference standards of designer psychedelics in the NBOMe (N-methoxybenzyl-substituted) class of phenethylamines. New products include 25I-NBOMe HCl, 25C-NBOMe HCl, and 25B-NBOMe HCl and their deuterium labeled internal standards.

Bayer HealthCare appoints Dieter Weinand as president

Bayer HealthCare Pharmaceuticals appoints Dieter Weinand as president effective from August 1, 2014. Presently, Dieter Weinand is the president - global commercialisation & portfolio management at Otsuka Pharmaceutical Development & Commercialisation Inc., Princeton, New Jersey.

FDCs licenced prior to Sept 21

Thousands of FDC drug manufacturers in the country engaged in production of drugs licensed prior to September 21, 1988, can now heave a sigh of relief as the Drugs Controller General of India (DCGI) has excluded such drugs from the requirement of proving the safety and efficacy of FDC drugs licenced by the SLAs without due approval from the DCGI.

On January 15 last year, the DCGI had asked the manufacturers to prove the safety and efficacy of the FDCs approved before October 1, 2012 and had made it clear that those FDCs approved by the State licencing authorities (SLAs) from October without the permission of the DCGI will be considered for ban.

Dr Edmundo Muniz appointed as new CEO of Certara

Certara, the leading global technology-enabled drug development and drug safety consultancy, announced the appointment of new chief executive officer Dr. Edmundo Muniz.

Dr. Muniz joins Certara from Kirax Corporation, where he had served as president and chief executive officer, since 2005. In that role, he focussed on acquiring, developing and commercialising innovative specialty care therapies for oncology, pain, inflammation, acute and supportive care. Prior to that position, Dr. Muniz held several senior executive roles at Eli Lilly and Company, including Head of Worldwide Pharmacovigilance and Epidemiology, Cardiovascular Business Unit Leader, and vice president of Oncology Clinical Development.

Boston Scientific begins RESPOND Registry

Boston Scientific Corporation has initiated the RESPOND Post Market Registry to assess real world performance of the Lotus Valve System.  The RESPOND Registry will collect data on clinical outcomes and device performance in 1,000 patients implanted at 50 centres around the world.

Three patients enrolled in the RESPOND Registry thus far have been successfully implanted with the Lotus Valve System.  Dr. Nicolas Van Mieghem and Prof. Peter De Jaegere led the first transcatheter aortic valve implantation (TAVI) procedure at Erasmus Medical Centre in Rotterdam, the Netherlands using the Boston Scientific Safari Pre-Shaped TAVI Guidewire.  The Safari Guidewire, which received FDA clearance and CE Mark in 2013, is compatible with the Lotus Valve System and other TAVI devices and is designed to facilitate stable, atraumatic valve placement.

Probe Ionic Liquid Acidity

ionic liquids (ILs) can facilitate a number of reactions, including proton transfer, which is very common in industry. The reactivity of proton transfer is highly dependent on the acidity of the ILs, a property yet to be well characterized.

Tom Welton and co-workers, Imperial College London, UK, have reported a convenient method to measure IL acidity between –1 to –9 of the Hammett scale with NMR technique using mesityl oxide as a probe. They relied on the ¹³C chemical shift difference (∆δ) between the α- and β-carbons of mesityl oxide to extrapolate deduce IL acidity from IL-acid systems

Provence Technologies

The deal opens up new development opportunities for the Provence Technologies Group in the area of biologically active pharmaceuticals. Synprosis has a ten-year history of producing active principles in the field of vaccines under development (for malaria, cancer, and allergies, etc.), as well as in other therapeutic fields (for neurogenerative diseases and the treatment of pain). The company was first recognised for its expertise in creating synthetic vaccines for HIV and malaria. The technology developed by Synprosis offers significantly increased peptide production yields with a cost reduction of 30 to 40 per cent.

The Group’s new entity has adopted the name Provepep. Synprosis will be the division specialized in pharmaceutical-standard production, in keeping with good manufacturing practices. Jean-Pierre Salles, who founded Synprosis, will remain in the Provepep executive management team.

Generic Celebrex patent litigation with Pfizer

Under the terms of the agreement, Mylan will begin selling product at the earliest market formation, however in any case not later than December 2014. All other terms and conditions of the settlement and license agreement are confidential, and the agreement itself is subject to review by the US Department of Justice and the Federal Trade Commission.

Genia Technologies for US$ 350 mn

Roche, a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics, announced the acquisition of Genia Technologies, Inc. (Genia), a privately held company, based in Mountain View, California, USA. Genia is developing a single-molecule, semiconductor based, DNA sequencing platform using nanopore technology.







Under the terms of the agreement, Roche will pay Genia’s shareholders USD 125 million in cash. In addition to this payment from Roche, Genia’s shareholders may receive up to USD 225 million in contingent payments depending on the achievement of certain milestones. Genia’s proprietary technology is expected to reduce the price of sequencing while increasing speed and sensitivity.

SKYNDEX Pro120

The SKYNDEX Pro120 comes with an iOS app that automatically records the skinfold site measurements and calculates both the body fat percentage and fat free mass. An optional Bluetooth Weight Scale communicates with the app and provides a fast, easy and highly accurate body composition measurement system. The app can print a professional custom report that includes skinfold site readings, body weight, body fat percentage and client information based on American College of Sports Medicine guidelines. Reports can be emailed to the client directly from the iOS app, which also features trending, filtering and group reporting capabilities to help manage client contact and communication.

The new Pro120 calipers and accompanying iOS app will be available in early summer. An Android app is planned for release this fall. SKYNDEX will begin accepting orders on June 15, 2014 through SKYNDEX.com, the SKYNDEX catalog and existing distributors. The entire system will be priced at approximately $1,495.

CDSCO rebuts concern over quality of Indian made drugs

Reiterating his commitment to ensure best healthcare services to the patients, Drug Controller General of India (DCGI) Dr GN Singh has stressed that Indian drug regulators have always maintained a strict vigil in ensuring quality of the drugs that are manufactured throughout the country.  Dr Singh strongly defended that there have been no lapse or compromise on quality parameters from the Indian drug regulators as efficacy of the drugs and safety of the patients have always remained to be the top priority.

Rubbishing claims levelled by media expressing growing concern among overseas regulators over the quality of Indian made drugs, Dr Singh pointed out that Indian drug regulatory norms are amongst one of the stringent regulatory norms followed across the globe. Which again is painstakingly implemented through professional expertise leaving no place for error because it is the life of the patients at risk.