Pharmaceutical News

FDA Approves Nexavar for Advanced Thyroid Cancer

The US Food and Drug Administration (FDA) have approved Nexavar (sorafenib) to treat some people with advanced thyroid cancer. The drug was already on the market for treating some types of kidney cancer and liver cancer. The new approval is for treating differentiated thyroid cancer – the most common type – that has come back after treatment or that has spread to other parts of the body (metastasized), and is no longer responding to radioactive iodine treatment.

Thyroid cancer starts in the thyroid gland, which is located in the front part of the neck. Nexavar is a targeted therapy that can help stop the growth of cancer cells by interfering with signals that encourage them to grow. Nexavar qualified for faster review under the FDA’s priority review program for drugs that may offer a significant improvement in safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition. The drug also received orphan-product designation by the FDA because it is intended to treat a rare disease or condition.

“Differentiated thyroid cancer can be challenging to treat, especially when unresponsive to conventional therapies,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a prepared statement. “Today’s approval demonstrates the FDA’s commitment to expediting the availability of treatment options for patients with difficult-to-treat diseases.”

The FDA based its approval on a clinical study involving 417 people with advanced, differentiated thyroid cancer that was not responding to radioactive iodine treatment. Nexavar increased the length of time patients lived without the cancer growing by 41%. Half the people who received Nexavar lived without the cancer growing for at least 10.8 months compared to at least 5.8 months for those who received a placebo.

The most common side effects for Nexavar were diarrhea, fatigue, infection, hair loss, skin problems on the hands and feet, rash, weight loss, decreased appetite, nausea, gastrointestinal and abdominal pains, and high blood pressure. Thyroid stimulating hormone is more likely to become elevated while on treatment with Nexavar, requiring adjustment of thyroid hormone therapy.

Nexavar is co-marketed by Bayer HealthCare Pharmaceuticals Inc. and Onyx Pharmaceuticals.

Biocon & Mylan get approval for biosimilar of breast cancer drug

Mumbai: Biocon Ltd said on Tuesday that the Drugs Controller General of India (DCGI) has given it permission to sell a biological copy of Herceptin, the world’s best-selling breast cancer drug.

The biosimilar trastuzumab, a biological copy of Herceptin, was developed jointly by Biocon and US generic drug maker Mylan Inc., and will be sold in India under the brand name Canmab, Biocon said in a statement on Tuesday.

It will be available in India by the fourth quarter of fiscal year 2014.

Trastuzumab, a medicine originally developed and patented by Swiss drug maker Roche Holding AG, is sold by Roche in world markets, including India, under the brand name Herceptin. DCGI’s approval comes three months after Roche relinquished its Indian patent on it.

A biosimilar is equivalent to a copycat version of a biological drug. But such versions are not called generics because they are not an identical copy. Trastuzumab is used for the treatment of metastatic breast cancer.

“The regulatory approval for biosimilar trastuzumab in India is an extremely important milestone for Biocon as it is the world’s first biosimilar version of Herceptin to be brought to the market,” Biocon said on Tuesday.

“This is a major milestone for both partners as it is the world’s first biosimilar Trastuzumab to be accorded regulatory approval,” said Biocon chairman and managing director Kiran Mazumdar-Shaw in a statement.

“The Indian approval is an encouraging milepost as we plan to leverage this data to support regulatory filings in several countries across the globe,” she added.

Roche said in August that its decision to let the Indian patent for trastuzumab lapse was part of a new strategy for the high-value biological drug in the local market. It has no plans to seek a restoration of the patent.

“Regular reviews of our patent portfolio are a routine business practice. In this connection, Roche has come to the conclusion not to pursue the Indian patent for trastuzumab,” Roche India’s director corporate affairs, market access and compliance officer G.K. Raman had said in August.

Mint reported on 14 August that if Roche does not restore the patent in six months through a separate process, generic firms can legally produce the medicine in India.

In July, Roche had also decided not to pursue two of its applications for patenting new variants of Herceptin in India. This followed Roche’s decision to partner with local drug maker Emcure Pharmaceuticals Ltd for producing this drug in India and making it available at a lower price.

Breast cancer is one of the most common cancers in India, with over 100,000 patients diagnosed with it every year. The cost of biologics in cancer treatment is extremely high, which makes access to drugs unaffordable to many patients. The biosimilar is expected to offer an affordable alternative in India and other countries.

The global sales for trastuzumab were $6.4 billion in 2012, while in India it recorded sales of $21 million, according to data available with the industry.

Since 2009, Biocon and Mylan have been co-developing a high value portfolio of biosimilar monoclonal antibodies and complex biologics, comprising five drugs, including trastuzumab.

The global market in biosimilars will be worth $22 billion by 2020, according to industry estimates.

Source: live mint

Cadila launches Mycidac-C : World’s first drug for lung cancer

Cadila Pharmaceuticals has announced the launch of Mycidac-C, an affordable, unique and innovative drug for the treatment of lung cancer.

Mycidac-C is an innovative research product for the patients suffering from Non Small Cell Lung Cancer (NSCLC). The drug has been approved for launch in India by the Drug Controller General of India (DCGI). It targets Desmocolin-3, a novel target, said the company in a statement.

According to the statement, Mycidac-C is a first in the class active immunotherapy as well as drug targeting Desmocollin-3. It is a breakthrough in the management of squamous cell NSCLC. There has been no significant innovation in management of squamous NSCLC since the introduction of platinum containing doublet in 1983. Besides affordability and other advantages, Mycidac-C has no systemic side effects during the treatment. Mycidac-C is to be used with platinum containing doublet therapy.

As per the World Health Organisation (WHO) report, approximately 1.25 million people are diagnosed with lung cancer every year worldwide. Around 30 per cent of them suffer from squamous NSCLC. Lung cancer kills more people than the three next commonest cancers combined.

Mycidac-C can be administered easily by trained paramedics, thus further reducing the cost of hospitalisation associated with other cancer therapy, according to the statement.

Rajiv I Modi, chairman and managing director, Cadila Pharmaceuticals, said, “It has taken us over a decade, a huge investment and a dedicated research and development team to develop this unique drug. We expect it to be available in the Indian market by December 2013. Thereafter, we will introduce it in other regions like SAARC countries and European markets over the next five years.”

Source: India Medical Times

The curious case of Pentavalent vaccine

With the number of cases related to the deaths of children, most recently in Jammu and Kashmir, because of apparent administration of Pentavalent vaccine continues to rise, the vaccine is once again mired in controversy as the issue comes up for hearing in the Supreme Court on November 26 questioning its safety and demand to impose a ban.

Earlier this year, a PIL (public-interest litigation) was filed by a doctor in the Supreme Court alleging that the vaccine, which provides protection against the five life threatening diseases — Diphtheria, Pertussis, Tetanus, Hepatitis B and Hib (Haemophilus influenza type B), had serious adverse effects on children. Subsequently, the court issued a notice to the government, which in turn gave a clean chit to the vaccine.

The Pentavalent vaccine, which has claimed over 21 deaths in Tamil Nadu and Kerala, was introduced in Jammu & Kashmir in February 2013, as a part of the Universal Immunization Programme (UIP). In Srinagar eight infant deaths were reported during Sep-Oct this year following immunization with this vaccine.

Soon after the report of deaths, the union health ministry deputed a team of expert doctors, headed by Dr N K Arora, additional professor, department of paediatrics, All India Institute of Medical Sciences (AIIMS), New Delhi, to investigate into these deaths.

While the final report of this team is still awaited, their preliminary report has stated that the children died from causes like septicaemia and pneumonia, and are unrelated to the vaccine. The team denied any link of Pentavalent vaccine with the death of the children.

Disappointed by the findings of the government team, a team from Peoples Union for Democratic Rights (PUDR) visited the affected families in Jammu and Kashmir from November 8 to 10.

D Manjit and Asish Gupta, secretaries of PUDR, said, “This conclusion by the central team in J&K fails to explain why or how the babies were administered the vaccine in the first place if they were seriously ill at the time of immunization.”

“This vaccine is being promoted vigorously by several international agencies, specifically the World Health Organization (WHO) and the Global Alliance for Vaccines and Immunization (GAVI), an international network of vaccine manufacturers and philanthropic organizations such as the Gates Foundation. Concerns regarding the safety and efficacy of this vaccine, as well as the very need for it, have been repeatedly pointed out by public health professionals to the health authorities, which have been brushed aside. Given these problems with this vaccine, one is left questioning the wisdom and this urgency in promoting this vaccine, especially through ill-equipped peripheral health facilities such as dispensaries and sub-centres, which cannot manage the adverse reactions in the immunized infants. A detailed report of the fact finding team will be released soon,” added Manjit and Gupta.

Dr Jacob Puliyel, head of paediatrics at St Stephen’s Hospital, New Delhi told India Medical Times, “The safety of Pentavalent vaccine is in question for a long time because of apparent adverse effects and deaths related to it. The Pentavalent vaccine has caused deaths in different countries. This is across brands as different countries using the vaccine from different manufacturers have had the same problem.

“There are at least 80 deaths now that have been investigated and which must have been due to vaccine as there is no alternate explanation for the deaths so soon after vaccination in children who seemed perfectly well before vaccination. India has had over 38 deaths. There are at least 10 deaths in Kashmir. There are some 15 deaths in Kerala. The deaths appear like allergic reactions and only a few children react to the vaccine. This type of death is seen with drugs like Penicillin. Thousands of people can receive the drug and be helped by the drug but one person who is allergic can die of the drug.

“From data now available 1 in 10,000 to 1 in 100,000 children vaccinated die as a reaction to the vaccine. The 1 in 10,000 is a better figure as there is under reporting. This means that if the birth cohort of 25 million is vaccinated we will have 300 to 3,000 deaths. The death rate is seen in all the states where the vaccine has been introduced. In Kashmir and Kerala the people are more aware and so they are reported better.

“The fact that the vaccine has not been banned is a problem that is impossible to answer. Sri Lanka, Bhutan, Viet Nam had banned the vaccine but later were forced to resume the use of the vaccine under severe international pressure. In Sri Lanka the WHO report altered the Brighton Classification, which was earlier used by the WHO to classify adverse reactions following the vaccination. If the classification were not altered they would have had to report that the deaths were probably due to the vaccine.

“After the Kashmir deaths the central team went there for two days and reported in the press that the children died of septicaemia and pneumonia. A fact finding team recently visited some of these families and performed a detailed verbal autopsy. They have reported that the children were in perfect health before vaccination and the reaction in terms of fever, continuous crying and convulsions started within half an hour (of the vaccination) in some cases. They died in the hospital and some died before reaching the hospital in Srinagar. The matter is coming up for hearing. Unlike in other countries, the international organizations will not be able to pressurize the Supreme Court of India. We expect the full truth to come out here.

“It is time we stopped playing with the lives of these children. There is no way to check which child is going to react adversely to the vaccine. Unless we have a means to determine this before vaccination the vaccine must not be used. This vaccine is not used in the USA, as the FDA has not licensed it there. They use the components separately. This is safe. We can use the components separately,” added Dr Puliyel.

Dr Vinod K Paul, head of the paediatrics department at AIIMS New Delhi, who is also a member of the National Technical Advisory Group on Immunisation (NTAGI), told India Medical Times, “I stand by the NTAGI recommendation for a national scale-up and that the Pentavalent vaccine is safe and effective. It is an important tool to reduce under-five mortality in India.”

The Pentavalent vaccine, which was recommended by the NTAGI in 2008 to be added to the universal immunisation programme, was introduced in Kerala and Tamil Nadu in December 2011. After an evaluation of the vaccination in the two states in August 2012, the decision to expand it in other states was taken. The Pentavalent vaccine was then introduced in phases in Haryana, Puducherry, Goa, Gujarat and Karnataka, with Jammu and Kashmir being the latest to join the list.

Dr Ashok Kumar Gupta, a paediatrician from Jammu, told India Medical Times, “The vaccine is doing more than good for children of J&K and such major cases of deaths related to it have been noticed. The vaccine is safe and helpful in controlling mortality. There are only mild side effects such as fever, pain, swelling and redness at the site of injection. Millions of doses have been administered to children since the vaccine was launched in eight Indian states. A meagre percentage of reaction and deaths due to it cannot overshadow the positive aspect of the vaccine that saves children from preventable diseases.”

Though no causative link between the vaccine and child has been established by the government but in the face of stiff resistance to the vaccine its continued use and nationwide rollout has been questioned. A clearer picture is expected to emerge after the Supreme Court gives a conclusive judgment on the future administration of the vaccine.

Source: India Medical Times

Sandoz recalls wrongly-packed TB drug batch from 5 States

Drug-maker Sandoz has been asked to recall a batch of wrongly-packaged tuberculosis (TB) drugs from the market. The incorrect packaging was first discovered in Mumbai and the recall will cover five States.

Maharashtra Food and Drug Administration (FDA) Joint Commissioner S. D. Patil said Sandoz has been asked to recall all 4D and 4D-Plus batches of the tuberculosis combination product after a Mumbai-based doctor complained that his patient suffered from stomach ache and vomiting.

“There has been a mix up in the packaging of two products (4D and 4D-Plus), and so all stocks from the private market, stockists and retailers have been recalled,” said Patil. The products have been made by a third-party manufacturer, Themis Medicare of Haridwar. The State FDA in Uttarakhand has also been alerted, he added.

A Sandoz spokesperson said that while 4D was marketed across India, “according to our records, this particular batch is restricted to the domestic private market in the five States of Gujarat, Madhya Pradesh, Maharashtra, Bihar and Chhattisgarh.”

Confirming that the third-party drug maker was Themis, the spokesperson added that as investigations were still on, more details were not being shared.

Themis representatives were not willing to comment on the development.

As a precautionary measure, Sandoz is recalling one batch of the product (No DD 4670) pending further investigation. “In addition, we are investigating a potential second fault related to 4D-Plus, also used to treat tuberculosis, and of a higher strength,” the spokesperson said.

RESISTANCE CONCERNS

Though details on the quantum of stocks recalled are not available, the FDA official clarified that the problem did not relate to all stocks. But they were being recalled “as you cannot take a chance with TB drugs”.

India faces a huge problem of resistance to tuberculosis drugs, wherein medicines become ineffective in treating patients. Resistance occurs when patients do not follow a doctor’s advice and discontinue the medicine or take it erratically.

Source: Business Line

 

U.S. FDA approves J&J, Pharmacyclics lymphoma drug

U.S. health regulators on Wednesday approved a drug to treat a rare and aggressive form of non-Hodgkin lymphoma developed by Johnson & Johnson and Pharmacyclics Inc, becoming the second drug that had received the FDA’s new breakthrough therapy designation to gain approval.

The drug, to be sold under the brand name Imbruvica, and known chemically as ibrutinib, was approved to treat mantle cell lymphoma in patients who have received prior treatment with at least one other medicine, such as Celgene Corp’s Revlimid. It works by inhibiting an enzyme needed by the cancer to multiply and spread.

Mantle cell lymphoma, which represents about 6 percent of non-Hodgkin lymphoma cases in the United States, has typically spread to lymph nodes, bone marrow and other organs by the time it is diagnosed, the Food and Drug Administration said.

The FDA earlier this month approved Roche’s Gazyva to treat chronic lymphocytic leukemia (CLL), another type of blood cancer, making it the first drug approved after receiving the breakthrough designation.

The FDA gives a breakthrough designation when it believes a medicine may offer a substantial improvement over existing therapies for serious or life-threatening diseases.

“The agency worked cooperatively with the companies to expedite the drug’s development, review and approval, reflecting the promise of the breakthrough therapy designation program,” Richard Pazdur, director of the FDA’s Office of Hematology and Oncology Products, said in a statement.

Imbruvica is also awaiting an approval decision to treat CLL, which some analysts believed would come at the same time as the U.S. lymphoma approval.

“This is a relative short-time disappointment versus Wall Street expectations for simultaneous approval in both indications with a broad label,” RBC Capital Markets analyst Michael Yee said in a research note.

Yee, in an email, said RBC is forecasting long-term annual worldwide sales of $5 billion for Imbruvica.

Pharmacyclics shares were up $3.20, or 2.6 percent, at $122.87 on Nasdaq. Shares of Johnson & Johnson were down 85 cents, or 0.9 percent, at $92.71 on the New York Stock Exchange.

Source: Thomson Reuters foundation

GlaxoSmithKline heart drug misses goal in major study

An experimental GlaxoSmithKline drug, designed to fight heart disease in a new way, failed to meet its main goal in a major late-stage clinical study, dealing a blow to one of the company’s biggest new treatment hopes.

Darapladib’s inability to reduce the overall risk of heart attacks and strokes in the first of two big Phase III studies is disappointing, but not a huge surprise. Many analysts already had low expectations for the project.

Shares in Britain’s biggest drugmaker had fallen 1.2 percent on the news by 1050 GMT on Tuesday, and Deutsche Bank analyst Mark Clark said failure of the drug removed some “blue sky fantasy” about potential multibillion-dollar sales.

GSK obtained full rights to darapladib, along with lupus drug Benlysta, when it bought U.S. biotech firm Human Genome Sciences last year for $3 billion.

The once-daily pill did produce statistically significant reductions in serious coronary events in some of the pre-defined secondary endpoints of the trial, which GSK said required more analysis.

Darapladib is designed to prevent heart attacks and strokes in a completely different way from cholesterol-lowering statin drugs by targeting an enzyme called Lp-PLA2 that is linked to artery-clogging plaques.

While some industry analysts have suggested it could become a $10 billion-a-year seller, if it works, few have pencilled in significant sales forecasts so far, given uncertainty about the product.

Current consensus forecasts point to annual sales of only $605 million in 2018, according to Thomson Reuters Pharma.

Panmure Gordon downgraded GSK shares to “hold” from “buy” on the latest news, which it said was the second big disappointment in the year, following similarly negative results with the company’s MAGE-A3 cancer vaccine for melanoma in September.

It also predicted GSK would write down 150 million pounds ($240 million) of its investment in darapladib in the fourth quarter, even though a second Phase III trial is continuing.

“Even if that trial was successful, we believe it will be difficult to gain market registration on one trial alone,” said Panmure analyst Savvas Neophytou.

Patrick Vallance, GSK’s head of pharmaceuticals R&D, said the group would continue to investigate the role of Lp-PLA2 inhibition in coronary heart disease and other conditions, while also poring over the latest trial results.

“We will now work to better understand the data, including evaluation of the patient sub-groups, and await the outcome of a second Phase III study of darapladib in acute coronary syndrome,” he said in a statement.

The first trial, known as STABILITY, enrolled nearly 16,000 patients with chronic coronary heart disease in 39 countries and measured the differences in outcomes between giving them darapladib or a placebo pill, in addition to standard drugs such as statins, aspirin and blood pressure medicines.

A second 13,000-patient study, called SOLID-TIMI 52, is due to complete in March 2014 and is looking at patients who have already suffered an acute coronary event. It will assess if darapladib can prevent a secondary attack.

Some medical experts believe darapladib may have a better chance of success in the second study.

GSK has had some notable successes with its new drugs this year, including approvals of medicines for cancer, lung disease and HIV. But its failure to deliver positive results in more ambitious projects like darapladib and MAGE-A3 may cast doubt over its prowess in the most cutting-edge science.

Source: Zee News

 

Colds and sore throats not helped by ibuprofen

If you have a cold or sore throat, you might want to opt for the acetaminophen over the ibuprofen for symptom relief, a new study suggests.

Research published in the British Medical Journal shows that taking ibuprofen (commonly known by the brand name Advil) doesn’t seem to relieve symptoms of upper respiratory tract infections as well as acetaminophen (commonly known by the brand name Tylenol).

Taking ibuprofen along with acetaminophen also didn’t provide as many symptomatic benefits as taking acetaminophen alone, the University of Southampton researchers found.

Interestingly, people who took ibuprofen or ibuprofen with acetaminophen were more likely to come back to the doctor with new or worse symptoms, than those who took acetaminophen alone.

“This may have something to do with the fact the ibuprofen is an anti-inflammatory. It is possible that the drug is interfering with an important part of the immune response and leads to prolonged symptoms or the progression of symptoms in some individuals,” study researcher Paul Little, a professor at the University of Southampton, said in a statement. “Although we have to be a bit cautious since these were surprise findings, for the moment I would personally not advise most patients to use ibuprofen for symptom control for coughs colds and sore throat.”

The findings are based on data from 899 patients who had symptoms of a respiratory tract infection. They were prescribed either acetaminophen, ibuprofen, or both ibuprofen and acetaminophen, and were instructed to take it either as needed, or four times a day. Some patients were also told to try steam inhalation to relieve symptoms.

Researchers also found that steam inhalation didn’t seem to provide any symptomatic benefits — and in fact led to mild scalding among 2 percent of people observed in the study who used this method.

Source: Huffington post

 

Methadone reducing drug use in India

Anti-addictive drug Methadone has been found to be effective in reducing drug use in India, says a study released on Thursday.

Methadone is a drug that can be taken orally or injected. It helps people dependent on morphine, heroin and other substances to reduce and stop their drug usage.

“Currently, five centres across India are offering methadone maintenance treatment. When the methadone treatment was used as a pilot project, it was found to be more effective with results of reduced drug use, injecting episodes and criminal behaviour amongst drug users,” said Christina Albertin, UN Office on Drugs and Crime (UNODC)representative for South Asia.

“The treatment using Methadone will also be a vital option for HIV prevention. So there is a need to scale up the process in India,” Albertin added.

The pilot study was conducted by the UNODC in collaboration with the National Drug Dependence Treatment Centre and the All India Institute of Medical Sciences

Source: IANS Live

Apollo Hospitals launches web-based Personal Health Record

Hyderabad: Apollo Hospitals, in association with HealthHiway, on Tuesday launched Apollo Prism, a web-based personal health record (PHR) that would enable patients to receive, create and manage their health information such as lab test results, discharge summary, medical history, medications and other health interventions. The patients can then choose to share all or part of their health information with their loved ones and Apollo hospital.

Apollo Prism has been launched across all Apollo Hospitals locations. It has been tightly integrated with the hospital information system across locations, thus providing clinically validated information to patients, who come to Apollo Hospitals. Information is entirely patient controlled and completely confidential. Patients can also download the mobile application of Apollo Prism that lets them receive their lab test results on their phone. Apollo Prism is also an interface for diabetic patients, for managing their diabetes. Thus, beyond helping a patient to track and manage their health information, the PHR enables continuous, preventive and wellness support, according to a statement by Apollo Hospitals.

Sangita Reddy, executive director, Apollo Hospitals, said, “Apollo Prism is a significant step forward in our mission to further engage, involve and create a more delightful experience for our patients. When our patients have easy and secure access to their medical information, it reduces costs, improves outcomes and enables superior care.”

Madhu Aravind, CEO, HealthHiway, said, “Traditionally, care provided by a hospital was inward focused and physician centric. A PHR is a first step in involving and engaging the patient and makes the care delivery centered on the needs of the patient.”

Headquartered in Bangalore, HealthHiway is a cloud-based health information network that enables seamless exchange of health information – data sharing and transactional – between hospitals, clinics, diagnostics, insurers, doctors and patients.

Source: Indian Medical Times