Biological E’s Japanese Encephalitis vaccine prequalified by WHO

Biological E (BioE) and European biotech company Valneva SE (Valneva) are now prequalified by the World Health Organization (WHO) for the global use in adults of the former Japanese Encephalitis vaccine. This is the first prequalification of a Japanese Encephalitis vaccine, and is a key step in ensuring the vaccine can be distributed to developing countries.

The company also expects the pediatric indication to be prequalified by the end of the year.

In 2005, Biological E and Valneva inked a partnership for the development and commercialization of a Japanese encephalitis vaccine for endemic regions, based on latter’s JEV technology. The vaccine, which was successfully developed under this partnership, is being marketed in India under the trade name JEEV and commercialization in other JE-endemic countries is planned.

Valneva is a new European biotech company focused on vaccine development and antibody discovery. It was created in 2013 through the merger between Intercell AG and Vivalis SA.

Mahima Datla, MD of Biological E Limited, said that it was an extremely important achievement for the vaccines community. Our vaccine’s prequalification is well in time to support GAVI’s plans of introducing the JE vaccine in several developing countries.

 “We share the excitement for this great achievement and are pleased that our technology used for IXIARO which is FDA and EMA approved will now help introducing an excellent vaccine in countries of substantial needs, stated Thomas Lingelbach, Valneva’s president and CEO and Franck Grimaud, Valneva’s president and chief business officer.

Biological E has emerged as a fast growing company. Early this year, the company also entered into a five year pentavalent supply arrangement with GAVI. In this regard, it has entered into a joint venture with GSK to develop a six-in-one paediatric vaccine combining the latter’s IPV It had also entered into a licensing pact with Novartis’s phase II typhoid conjugate vaccine.

Japanese encephalitis caused by a flavivirus that affects the membranes around the brain. Approximately one in 200 infections results in severe disease characterized by rapid onset of high fever, headache, neck stiffness, disorientation, coma, seizures, spastic paralysis and death. The case fatality rate can be as high as 60 per cent among those with disease symptoms; 30 per cent of those who survive suffer from lasting damage to the central nervous system. The severity of JE infections has been recognized by the medical community and the global health authorities have emphasized the need for routine vaccination, campaigns and travelers vaccine for endemic countries. The disease is endemic to many regions in Asia and South East Asia including in India, Bangladesh, Bhutan, Myanmar, Cambodia, Indonesia, Laos, Malaysia, Nepal, Pakistan, Philippines, Sri Lanka, Thailand and Vietnam.

Sun Pharma recalls brain haemorrhage treatment drug in US

Drug major Sun Pharma has recalled certain lots of Nimodine capsules, a drug indicated to treat brain haemorrhage, in the United States market due to crystal formation.

As per the US Food and Drug Administration ( USFDA) website, the company is recalling the Nimodine capsules, 30 mg, due to " crystallisation".

The recall falls under Class II category, and it is done in a situation in which the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

As per the USFDA, 46,387 cartons of the drug have been distributed in the US market. The recall has been initiated voluntarily by the drug maker and the same was intimated to the drug regulator through a letter on May 21.

Comments from the company could not be obtained immediately.

Last year, the Mumbai-based firm had recalled one lot of the drug as a precautionary measure due to the presence of crystals of nimodipine within the capsule solution.

Nimodipine Capsules, 30 mg, are used to decrease problems due to subarachnoid haemorrhage (bleeding in the brain).

Shares of Sun Pharma on Friday closed at Rs 1,080.25 apiece on the BSE, down 3.35 per cent down from the previous close.

Health Ministry to check if Pharma FDI policy mars public health

The health ministry will hold an inter-ministerial meeting on Monday 15,july to ensure that the existing foreign direct investment policy in the pharmaceutical sector is not at variance with the public health goals of the country.

Besides the Department of Industrial Policy & Promotion (DIPP), the nodal ministry for framing FDI policy, and the Department of Pharmaceuticals, a range of other stakeholders, including healthcare experts from the Public Health Foundation of India, will participate in the deliberations.

DIPP may float a discussion on how multinationals in the last few years have targeted specific therapeutic verticals such as injectables and cancer therapy for takeovers here, which has significantly eroded the strength of Indian drug makers to provide low-cost alternatives in these affected segments.

This comes in the wake of commerce and industry minister Anand Sharma requesting Prime Minister Manmohan Singh to revisit the FDI policy for brownfield investments in the pharmaceutical sector by calling a high-level meeting with the Finance, Health and Family Welfare, and Fertilizer and Chemicals Ministers. Sharma cautioned that the present policy may weaken domestic capabilities, compelling India to depend on imports or on domestic facilities owned by MNCs for life-saving drugs.

A section of the government is concerned that Indian generic drug industry is losing its edge in some of the highly-specialized and complex niche therapies such as oncology and injectables verticals, where only a few domestic players have been able to build capacities. If MNCs swallow these select players, this could mark the end of cheaper generic version of these drugs, these officials fret.

"Whenever a buy-out is proposed, we must thoroughly analyse the ramification on public health. To do that, we must look at the therapy competencies of the target Indian drugmaker, how much market share the company's drugs command in its relevant vertical in the domestic market and compare the prices of its products to the competition products to get a clear understanding of what the country may lose," said an official, who didn't wish to be identified

A DIPP official confirmed participation for Monday's meeting.

"We should be in a position to produce a drug in an emergency. If all the front-end facilities are gone, you cannot compel foreign entities to produce it for your domestic market," said another government official, adding that during the formulation of the pharma FDI policy, no one imagined companies specializing in drugs other than just solid formulations, like vaccines and injectables, could be taken over like this. Similar concerns led DIPP to raise objections on US-based Mylan Inc's plan to acquire Agila Specialties, the injectable division of Bangalore-headquartered Strides Arcolab. This deal worth $1.6 billion, which was deferred by the Foreign Investment Promotion Board, is one of the largest in the pharma space in recent years after Abbott's takeover of Piramal Healthcare in 2010 and Daiichi Sankyo's acquisition of Ranbaxy Labs in 2008.

It cited the instance of Shantha Biotechnics, which was bought over by the French drug innovator Sanofi Aventis in 2009. It was the only facility to manufacture the Hepatitis B vaccine in the country and it supplied this vaccine at a fraction of the cost in India against prices in other markets of the world, an official had pointed out. The highly specialised state-of-the-art facilities for oncology drugs and injectables in India have been the targets of MNCs. Mylan, just before announcing the Agila deal, bought over Hyderabad-based SMS Pharma's manufacturing plants, including some of its advanced oncology units in late 2012.

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Falling standards of pharma companies is industry's big bane: GV Prasad, Chairman, Dr Reddy’s Lab

The pharmaceutical industry is facing pressure from regulators in the US because companies have allowed standards to decline, the head of one of India's biggest drug makers has said.

GV Prasad, who took over as chairman of Dr Reddy's Laboratories in April from the company's late founder Anji Reddy, said the increased scrutiny is good for the industry and will help it get its act together.

"Increasing regulatory pressures are largely because the companies have slipped off in terms of quality, in terms of systems, in terms of integrity. And we are feeling the pressure of that," he told ET in an interview, his first to an Indian publication since becoming chairman. "In the long run it is good for the industry to get its act together and comply with the regulations."

Prasad's statement comes in the backdrop of a record $500-million ( Rs 3,000 crore) fine imposed by the US on Ranbaxy Laboratories BSE 0.77 %. Now owned by Japan's Daiichi Sankyo, Ranbaxy pleaded guilty to violating manufacturing norms and falsifying statements to US drug regulator FDA.

Prasad, whose company sold drugs worth over Rs 11,600 crore in 2012-13, said Ranbaxy under its new owners has improved and adopted an "uncompromising approach towards quality". India has emerged as an important global supplier of low-cost generic medicines, helping to drive down prices of drugs that were hitherto inaccessible to low-income patients.

In 2012-13, Indian pharmaceutical companies are estimated by the government to have exported drugs worth over Rs 90,000 crore.

Following such success, multinational pharmaceutical companies have in recent years acquired Indian generics makers, among them Ranbaxy and Piramal Healthcare Solutions (bought by American firm Abbott). This has prompted tighter rules from the government, which says its approval is required if a foreign firm is to buy an Indian pharma company. The government's argument is that it is trying to balance public health concerns with strengthening domestic manufacturing capacity.

Prasad, who said Dr Reddy's has no intention of being sold, was, however, of the view that hurdles in the way of acquisitions are not right. "Today nobody restricts us from buying their companies anywhere in the world. Why should we put all these things? Competition will take care of pricing."

The government's decision to impose price caps on essential drugs, he observed, is not ideal but better than the earlier cost-based pricing system. "I think the government has a role to keep prices affordable and we take it in our stride. It's not something we are happy about, but what can we do?"

On the other hand, Prasad, a chemical engineer, said complaints from multinationals about violation of intellectual property rights and weak patent protection are misplaced. In the most high-profile case on the issue, patent authorities and the Supreme Court rejected an application by NovartisBSE 2.09 % claiming protection for its cancer drug Glivec by saying innovation was only incremental.

"I think we are on that path of giving full respect to all intellectual property. That doesn't mean we will blindly follow everything that is there and that is what has been demonstrated in the Glivec case."

Based in Hyderabad, Dr Reddy's operates plants in India, the US, UK and Mexico. It has technology development centres in Hyderabad, Cambridge in the UK, and the Netherlands. In Russia, an important emerging market for the company, Prasad said the company would set up a local manufacturing facility if it makes a "significant

Generic Pharma Association study says patent settlements netted $25.5 bn in savings for US health system

Generic pharmaceuticals launched prior to patent expiration due to a patent settlement helped the US health system save $25.5 billion from 2005-2012 and brought generic medicines to market on average 81 months sooner than patent expiry, according to a new analysis conducted for the Generic Pharmaceutical Association (GPhA) by the IMS Institute for Healthcare Informatics. An additional $61.7 billion will be saved if the current level of savings continues through to patent expiry for each molecule analysed, the study projects.

“For years, opponents of pharmaceutical patent settlements with consideration have stated that settlements create a cost for consumers, the government and others. This new analysis provides the most current, complete and transparent estimate of the impact of patent settlements on health costs, and it shows that the opposite is true,” said Ralph G Neas, president and CEO of the Generic Pharmaceutical Association.

“In particular, the new analysis estimates that patent settlements – including those with consideration – have led to billions in savings. For example, the settlement involving Lipitor alone will save $22 billion over the next four years. This is critical for lawmakers to understand, because any further restrictions on settlements will put these savings at risk.”

The study analysed a set of 33 molecules subject to patent settlements between 2005 and 2012 and measured the savings resulting from lower cost generics entering the market in advance of the each molecule’s patent expiration date as recorded in the FDA’s Orange Book. In addition, arithmetic modeling was used to estimate the proportion of patent settlements with consideration to derive estimated savings.

Generic pharmaceuticals launched prior to patent expiry as a result of a patent settlement reduced drug costs by $25.5 billion from 2005-2012. The Federal government benefits from almost one-third ($8.3 billion) of these savings. Savings from patent settlements with consideration, those at issue in the Court and legislation, would be between $11.8 and $13.6 billion if these settlements are typical of all settlements. The Federal government’s share of such savings would be between $3.8 and $4.4 billion.

Further, in addition to the $25.5 billion saved by patent settlements from 2005 to 2012, the study projects an additional $61.7 billion saved if the current level of savings continues through to patent expiry for each molecule analysed. That equates to more than $87 billion in savings from settlements.

The study also looked at the savings that would have been negated if patent settlements had not been an available course of action. Applying the success rate of 48 per cent, derived from a separate Royal Bank of Canada analysis of patent challenges from 2000-2009, the IMS Institute found that realized (from 2005-2012) and projected (from 2013 until each molecule’s patent expiry) savings of $87 billion would have been reduced by nearly half, to only $45 billion.

“Recent IMS Institute and Department of Labour studies have shown the first decline in drug expenditures in 55 years. We believe generic medicines, including those that come to market through settlements and settlements with consideration, have contributed to this historic success,” said Neas.

Govt may ban sale of TB drugs in open market

Sale of Tuberculosis drug could be prohibited in open market as part of efforts to ensure calibrated and monitored administration of these medicines which would then only be given on daily basis free of cost by government registered outlets to patients.

The Health Ministry is proposing changes in view of irregularity in administration of these drugs to patients and lack of proper monitoring which is hindering efforts to check the disease, sources said.

According to a WHO estimate, India is home to the largest number of TB patients, 2.2 million of the world's 8.7 million.

Patients are administered TB medicines either through government-run hospitals and clinics free of cost or by private practitioners.

According to the Health Ministry, about 65 per cent of the TB patients avail these drugs under the government's DOT (Daily Observed Therapy) System while the rest opt for treatment by private practitioners and buy drugs from the chemists based on their prescription.

The latter results in irregularity of treatment which leads to relapse of the ailment as there is lack of proper monitoring, the sources said citing experts.

To address this, the government is planning to prohibit sale of drugs in open market.

Under the new initiative, patients going to private practitioners for treatment will get medicines free of cost from chemists but only after the doctor informs them through a dedicated call center

The changes are being brought to ensure that all TB patients are administered the drugs on daily basis instead of intermittently as at present.

Recently, Health Minister Gulam Nabi Azad had expressed concern on the issue saying that the irregular regime is leading to growing resistance to anti-TB drugs.

The Health Ministry officials recently had held a meeting with WHO and other experts who had emphasised on changing intermittent dosage system to daily regime.

During the meeting, it was informed that many other countries including Brazil, China, which were following the intermittent dosage system, have now turned to daily regime.

to be set up by the government.

Zydus pioneers a breakthrough with LIPAGLYN, India’s first NCE to reach the market

The Zydus Group announced a breakthrough in its research efforts with LipaglynTM (Saroglitazar), a novel drug targeted at bridging an unmet healthcare need for treating Diabetic Dyslipidemia or Hypertriglyceridemia in Type II diabetes, not controlled by statins alone. The drug has been approved for launch in India by the Drug Controller General of India (DCGI). With a novel action that offers lipid and glucose lowering effects in one molecule, LipaglynTM is the first Glitazar to be approved anywhere in the world.
“LipaglynTM provides patients suffering from diabetic dyslipidemia the option of a once-daily oral therapy that has a beneficial effect on both lipid parameters as well as glycemic control,” said Mr. Pankaj R. Patel, Chairman and Managing Director, Zydus Cadila. "It has always been our dream to take a molecule right from the concept stage up to its launch. Today, we have realized this dream. It is an important breakthrough and I would like to dedicate this to all the Indian research scientists in the field of drug discovery,” Mr. Patel added.
Diabetic Dyslipidemia is a condition where a person is diabetic and has elevated levels of the total cholesterol, the "bad" low-density lipoprotein (LDL) cholesterol and the triglycerides and a decrease in the "good" high-density lipoprotein (HDL) cholesterol concentration in the blood. Optimal LDL cholesterol levels for adults with diabetes are less than 100 mg/dL, optimal HDL cholesterol levels are equal to or greater than 40 mg/dL, and desirable triglycerides levels are less than 150 mg/dL. LipaglynTM , a non-thiazolidinedione, is the first therapy to be approved for this condition.
World over, it is estimated that 30% of all deaths occur due to cardiovascular diseases (CVD). In India, one out of every five persons is at serious risk of developing CVD. Research has shown that diabetes is one of the major risk factors of CVD. India has a population of nearly 65 million diabetics and 77 million pre-diabetics. 85 - 97% of the diabetes patients suffer from dyslipidemia or lipid abnormalities. Hence, addressing the problem of diabetes and dyslipidemia is crucial in tackling the health risk posed by CVD.
Discovered by the Zydus Research Centre, the dedicated NCE research arm of the Zydus group, LipaglynTM is a best-in-class innovation, designed to have a unique cellular mechanism of action following an extensive structure-activity relationship study initiated in the year 2000. LipaglynTM has a predominant affinity to PPAR alpha isoform and moderate affinity to PPAR gamma isoform of PPAR nuclear receptor subfamily. The molecule has shown beneficial effects on lipids and glycemic control without side effects. This molecule underwent extensive pre-clinical characterisation and the IND was submitted in the year 2004.
As a part of the clinical development programme, extensive Phase-I, Phase-II and Phase-III clinical trials were conducted to evaluate the phamacokinetics, pharmacodynamics, efficacy and safety of LipaglynTM. The new drug application for LipaglynTM was based on a comprehensive clinical development programme spanning eight years.
Results from the first Phase III programme with Pioglitazone as a comparator drug in diabetes patients showed that the 4 mg dose of LipaglynTM led to a reduction of triglycerides and LDL (bad) cholesterol, and an increase in HDL (good) cholesterol and also showed a reduction in Fasting Plasma Glucose and glycosylated haemoglobin (HbA1c) thereby confirming its beneficial effects of both lipid and glycemic control in diabetic patients.
In the second Phase III study, LipaglynTM was studied in diabetic dyslipidemic patients insufficiently controlled with statin therapy. The results from this study confirmed that LipaglynTM had a pronounced beneficial effect on both the lipid and glycemic parameters in these subjects.
In both the studies, LipaglynTM was well tolerated and had a better safety profile than the comparators. Importantly LipaglynTM has a non-renal route of elimination, and did not show adverse events like edema, weight gain, myopathies or derangement of liver and/or kidney functions, thus making it safe and efficacious. LipaglynTM is recommended for once daily administration as 4 mg tablets.
Zydus will offer a dedicated LipaglynTM support programme to patients and caregivers. The programme shall provide important support and information regarding access, adherence, education and thereby help patients to start and appropriately manage their disease and therapy over time.
About Zydus Cadila
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. From a turnover of Rs. 250 crore in 1995, the group posted revenues of over Rs. 6300 crore in FY2013. With 20 discovery research programmes under various stages of clinical development, the group invests over 7% of its turnover in research. At the group’s state-of-the-art research arm, the Zydus Research Centre, over 400 research scientists are engaged in NCE research alone. The group employs over 15,000 people worldwide and is dedicated to creating healthier communities globally. It aims to be a leading global healthcare provider with a robust product pipeline; achieve sales of over $3 billion by 2015 and be a research-based pharmaceutical company by 2020.