According to National Society of Health, approximately 26 million patients are suffering from heart failure worldwide, with the increased economic burden of USD 30.7 billion each year. The advent of a novel class of drugs, i.e., the angiotensin receptor-neprilysin inhibitor, gives hope to the patients.
Neprilysin is a zinc-dependent metallopetidase enzyme that helps breakdown of the biologically active natriuretic peptides and several other vasoactive compounds. It catalyses the degradation of various peptides including atrial natriuretic peptide, brain natriuretic peptide, and bradykinin, as well as contributes to the breakdown of angiotensin II. Inhibition of neprilysin is a promising target in cardiovascular disease as it increases circulating levels of Natriuretic peptides.
The first neprilysin inhibitor, Candoxatril, was developed by Pfizer during 1998. However, the drug was discontinued in Phase III stage due to lack of efficacy and side effects. Then, in year 2000, Bristol-Myers Squibb developed Omapatrilat, but the drug was also not able to pass FDA review due to lack of efficacy. In the year 2001, Bayer discontinued the development of Ecadotril in Phase II stage after disappointing results. Around 2004-2005, Pharmacia’s RAAS-NEP inhibitor, Eplerenone (Inspra), did not receive FDA approval due to angioedema side effects.
After 10 years, Novartis Pharmaceuticals’ drug LCZ696 found success in Phase III trials. It has demonstrated greater efficacy than enalapril in a phase 3 trial assessing heart failure with reduced ejection fraction. It is composed of 2 molecular moieties in a single crystalline complex—and possessed the ability to inhibit the renin-angiotensin-aldosterone axis and augment the endogenous natriuretic peptide system to provide a distinctive mechanism of action in cardiovascular disease. Theravance Biopharma is also working on developing TD-0714 neprilysin inhibitor product. The company has completed Phase I trial of TD-0714.
The market of neprilysin inhibitor is gaining success from year 2014, after long time of failure since 1990s. The hope is still present that it can be a new era of treatment in heart failure therapy.
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Boston Biomedical starts phase III study of Napabucasin
Boston Biomedical, an industry leader in the development of novel compounds designed to target cancer stemness pathways, announced dosing of the first patient in CanStem303C, a new global phase III study investigating napabucasin in combination with standard of care (Folfiri) in patients with previously treated metastatic colorectal carcinoma (mCRC). Napabucasin is an orally-administered investigational agent designed to inhibit cancer stemness pathways by targeting STAT3.
Martindale Pharma’s clobazam oral suspension receives approval from seven European countries
Martindale Pharma, UK-based international specialty pharmaceutical company, announced the regulatory approval of its clobazam oral suspension product, Epaclob. The suspension has received approval in France, Ireland, Germany and Italy and Silocalm in Denmark, Spain and Iceland following the successful completion of a decentralised procedure (DCP). Epaclob/Silocalm are based on Tapclob, and are approved in two strengths, 5mg/5ml and 10mg/5ml. They will be supplied in packs containing dosing syringes and dosage cups to facilitate accurate dosing and aid adherence to treatment.
Merck snagged a green light for Zinplava
The anti-infectives field is heating up–and Merck’s the latest Big Pharma player to win approval for a new entrant. The medicine meant to reduce resistance of Clostridium difficile infection in adults. Zinplava will join a Merck anti-infectives portfolio that took shape with its early 2015 purchase of Cubist Pharmaceuticals. Zinplava also faces the prospect of competition not only from other drugs, but also from vaccines that might prevent C. Diff altogether. Pfizer and Sanofi are each working on versions, and smaller vaccine makers are in the mix, too.
Nanotechnology to improve HIV drug therapies
Researchers at the University of Liverpool, UK, are exploring the use of nanotechnology to improve administration and availability of drug therapies to HIV patients. A recent investigation conducted by Pharmacologist professor Andrew Owen and Materials Chemist professor Steve Rannard, has discovered that HIV patient groups have shown their desire to switch to nanomedicine alternatives. They are working on the development of new oral therapies, by using solid drug nanoparticle (SDN) technology. The SDN technology is anticipated to reduce both the dose and the cost per dose.
Biocon’s Malaysia insulin plant will be ready for commercial production in H2
India’s Biocon has been working for six years on a massive, $250 million facility to manufacture insulin in Malaysia and says it will soon produce commercial product there. The company’s plant is in Nusajaya, which was certified by authorities this year, and has 400 employees and represents the largest foreign investment made in Malaysia’s biotech sector to date. It also is Biocon’s first overseas biopharma manufacturing and research facility.
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