FDA Approves Major New Lung Cancer Medication

Health regulators in the United States have indicated that they have granted approval to an advanced lung cancer medication.

The drug in question is produced by the pharmaceutical manufacturer Roche Holding, and addresses lung cancer in patients with a specific genetic mutation.

Roche Holding will be selling the drug, alectinib, under the brand name Alecensa.

The medication has been approved with the intention of treating patients with advanced ALK-positive non-small cell lung cancer (NSCLC).

Alecensa will be particularly effective in treating those patients within whom this disease has worsened after, or who could not tolerate, treatment with competitor Pfizer’s Xalkori.

There are hopes that the drug will now be approved for wider marketplaces as well, as Roche Holding looks to increase its share of the lung cancer pharmaceutical marketplace.

“Today’s approval provides a new therapy for a group of patients who would have few treatment options once their disease no longer responds to treatment with Xalkori,” Richard Pazdur, head of the Food and Drug Administration’s Hematology and Oncology Products division, commented in an official statement.

Xalkori was seen as an advance in the field of personalised medicine as it was designed to treat only patients with the ALK genetic mutation.

This is a relatively tiny portion of overall cancer sufferers, with this specific group accounting for only 4% of NSCLC patients.

As competition hots up in this particular area of pharmaceuticals, it has been reported that Pfizer is also developing a drug for ALK.

The pharmaceutical heavyweight has had to acknowledge that many patients have stopped responding to its own products Xalkori, and Pfizer is attempting to develop an alternative remedy.

Pfizer has established itself as one of the 50 largest corporations in the world according to Forbes magazine, with a market capitalisation in excess of $200 billion.

The pharmaceutical lobby is famously one of the most influential groupings in the United States, and indeed the industry spends more on lobbying government than any other comparable industrial sector.

While the United States pharmaceutical industry unquestionably produces many valuable medicines, the country has also been criticised for its reliance on responding to illnesses with drugs, as opposed to addressing the cause of problems.

Indeed, the US has something of an addiction to popping pills, with the country one of only two in the world that allows the television advertising of drugs (the other being New Zealand).

The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition based on early evidence of clinical benefit.

A confirmatory study is required to verify the benefit of Alecensa for it to gain full approval, the agency revealed.

There are an estimated 158,040 deaths from lung cancer annually in the United States (86,380 in men and 71,660 among women).

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European Court of Justice Makes Key Pharma Ruling

A European Court ruling is expected to have a significant influence over the pharmaceutical industry.

The decision of the of Court of Justice of the European Union in favour of Seattle Genetics will be welcomed by pharmaceutical companies all over the world.

Seattle Genetics went before the European court regarding the duration of supplementary patent protection afforded to the pharmaceutical industry.

EU legislation provides the possibility of a supplementary protection certificate to compensate a patent holder.

This is necessary due to the erosion of patent protection suffered due to the lengthy regulatory process leading to the grant of marketing authorisation.

However, it is currently European law that no medicinal product may be commercially exploited before the relevant authority has issued marketing authorisation.

Prior to the Seattle Genetics case, there was confusion regarding the duration and calculation of a supplementary protection certificate.

EU legislation suggests that the certificate should be calculated on the basis of “the date of first authorisation to place the product on the market in the Community”.

But confusion reigned regarding what constitutes the date of the first authorisation.

The ruling thus addresses this issue and creates a president in European law.

The Court of Justice ruled that “Article 13(1) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that the ‘date of the first authorisation to place the product on the market in the [European Union]’ is determined by EU law.”

Although this may seem an extremely technical and obscure issue, the ruling is nonetheless expected to have a significant influence over the pharmaceutical industry in the foreseeable future.

The court decision puts an end to any uncertainty faced by both innovative and generic pharmaceutical industry companies regarding the duration of effective patient protection, which will have potentially significant effect on the industry.

This is due to the fact that the marketing of medicinal products will often reach its peak towards the end of the patent term.

When one considers the vast number of pharmaceutical products that this ultimately relates to to, the potential delays involved are certainly not insignificant.

Additionally, following the Court of Justice’s ruling, divergence should no longer exist between member states regarding the relevant date for calculation.

This will enable patent holders to be certain of a uniform duration throughout the EU.

Commenting on the court ruling, Mark Sandbaken, VP, Intellectual Property for Seattle Genetics, was naturally pleased with the decision:

“The CJ’s ruling will benefit all those at Seattle Genetics, its partner Takeda, and other companies who have invested significant time and efforts in the development of many innovative products that benefit patients. Seattle Genetics is grateful to the Commission and those member states that submitted written observations in support of Seattle Genetics’ position and for the timely response from both the Advocate General and CJ on this matter.”

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HIV Drug Truvada Impresses in Clinical Trials

A new tablet intended to prevent HIV infections in individuals at particularly high risk appears to provide a large success rate.

Two new studies that assess the efficacy of Truvada, manufactured by Gilead, conclude that the medicine is positively impacting on the development of HIV.

The first of the two studies was conducted in the San Francisco area, and researchers found that 657 people who consumed Truvada on a daily basis did not contract HIV.

Truvada’s efficacy was also tested in another study in the UK, in which it was found that people taking the drug had a significantly lower risk of HIV diagnosis.

The pill in question has already been approved in the U.S. for “pre-exposure prophylaxis” (PrEP) of HIV.

And the U.S. Centers for Disease Control and Prevention has suggested that Truvada can reduce the risk of HIV infection by up to 92%.

It is notable, though, that the drug provides no protection against other forms of sexually transmitted diseases.

Truvada has typically worked extremely well in laboratory conditions compared to a placebo, but prior to real-world surveys, there were concerns about the ability of the drug to operate outside of clinical trials.

However, the San Francisco study, which was published in Clinical Infectious Diseases, seems to provide the strongest evidence yet that Truvada is indeed effective in overcoming HIV.

In mitigation, it should be noted that the relatively small incidence of HIV cannot be entirely  confidently attributed to the usage of Truvada.

Other factors such as regular GP visits, enabling more opportunities for doctors to locate infections, could also have played a significant part in the results.

The UK study of Truvada was published in the renowned Lancet, and found that gay men who consumed the drug experienced significantly fewer new HIV infections than those who went without.

There was quite a significant gulf between the two control groups as well, with those not taking the drug apparently nine times more likely to contract the deadly HIV virus.

Founder and co-chair and medical research director of the Fenway Institute, Dr. Kenneth Mayer, commented on the findings, suggesting that the research represented serious vindication for the effectiveness of the drug.

“I don’t think PrEP is the magic bullet, but we know that it does work really well,” Mayer said. “It’s great to know we have options.”

Based on estimates from clinical trial data, as many as 35 new HIV infections may have been prevented among the PrEP users.

The number of people living with HIV in the UK has doubled in the last 10 years, with around 100,000 people currently thought to be living with the illness.

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Moody’s Report Paints Optimistic Picture of Global Pharma Industry

According to a newly released report from Moody’s, the industrial outlook for the global pharmaceutical industry looks to be extremely healthy.

Although the pharmaceutical industry will experience pricing pressure over the next 12 to 18 months, the success of new products will more than offset this issue.

Key European pharmaceutical manufacturers such as AstraZeneca are predicted to play a major role in the industry going forward.

Moody’s also suggests that oncology will be the largest growth opportunity in the entire industry.

Newly launched cancer drugs, such as Bristol-Myers Squibb’s Opdivo and Merck & Co.’s Keytruda have significant upside according to the financial analysis and credit ratings agency.

In addition, according to Michael Levesque, Moody’s Senior Vice President and lead author for the report, “innovation, alongside research and development productivity improvements, has also produced stronger late-stage pipelines, which means other new products will be launched over the next 12 to 18 months.”

Moody’s projects that the majority of pharmaceutical products in the United States will rise, and this will be a major driver of global growth.

Meanwhile, another factor supporting overall global growth in the pharmaceutical sector throughout the next financial year will be synergies from acquisitions.

This will particularly be the case within the speciality pharmaceutical categories, in which acquirers such as Allergan and Valeant Pharmaceuticals will obtain lasting cost reductions.

“We expect acquisition activity to remain strong, given the cost-saving opportunities, the emergence of high-potential pipeline drugs, and companies’ desire for greater scale and diversification,” Levesque asserted.

But the picture painted by the report is not entirely rosy. Moody’s projects that the global pharmaceutical industry will face longer-term challenges relating to the sustainability of drug prices.

The profitability of pharmaceuticals is being influenced by consumer behaviour in Europe and Japan, where the use of unbranded, generic drugs is becoming increasingly common.

It is also predicted by the report that upcoming launches of biosimilar products will begin to have a negative impact on the sales of major biotech products, such as Amgen’s Neulasta and Pfizer’s Enbrel. 

Moody’s projects 4-5 percent annualised growth in the pharmaceutical marketplace over the next 12 to 18 months, with improved drug pipelines contributing to this positive overall picture.

“Most rated companies will continue to benefit from modest top-line growth, supported by lower sales erosion from generic competition, first product revenues from recently launched drugs and continued robust growth in emerging markets,” commented Stanislas Duquesnoy, Moody’s Vice President and Senior Analyst.

“Pricing trends should remain positive, although certain therapeutic areas, such as treatments for respiratory illnesses and diabetes, will continue to face increased payor scrutiny, especially in the US, for the remainder of 2015,” Duquesnoy added.

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One third of pharmaceutical sector know nothing about new data protection regulations finds new survey

Pharmaceutical professionals across the UK are in danger of underestimating the huge changes that lie ahead in data protection – after a survey revealed almost one third aren’t even aware of the forthcoming European General Data Protection Regulation.

Carried out by information management experts Crown Records Management, the survey of IT decision-makers at UK companies with more than 200 employees tested how well prepared businesses are for the changes.

The results found that: (i) almost one third of IT decision-makers in the pharmaceutical sector (28 percent) are totally unaware of the changes – only the insurance sector came out worse; (ii) almost one third say they are waiting for the final details of the Regulation before taking any action; (iii) only one in three (33 percent) say their company is looking a staff training to prepare for the new Regulation – the lowest across all sectors; and (iv) 6 percent are not planning to make any changes at all.

“The results show that UK businesses, and particularly those in the pharmaceutical industry, are worryingly uninformed when it comes to preparing for the EU General Data Protection Regulation”, said John Culkin, Director of Information Management at Crown Records Management.

“It’s a concern that a third of businesses in the pharmaceutical sector are unaware of the big changes ahead. But the important question is not just whether businesses are worried or not, but whether they are being proactive and taking early action to prepare for the Regulation.”

However, there was some good news as Mr Culkin relates: “The results did show that more than half in the sector are planning to review information policies, and that’s important. Also 45 per cent have already appointed a Data Protection Officer, which is likely to be compulsory for many companies in future, and that’s the best figure across all sectors.

“Overall, our advice is that companies should begin an information audit as soon as possible and make positive changes as early as possible.

“With big fines for data breaches in future and strict guidelines on how quickly breaches should be reported there is work to do for many businesses across all sectors.”

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