This week, Pharmaceutical
Whispers (Phispers) looks at Ranbaxy whistleblower’s public interest litigation (PIL) against the Indian government, Bristol-Myers’ clampdown on doctor payments in China and how Jimmy Carter won the battle against cancer. Ranbaxy whistleblower
takes government to court over harmful drugs being sold in India Dinesh Thakur got almost US
$ 48 million as a whistleblower award, when American regulators fined
Ranbaxy US $ 500 million for violating federal drug safety laws and making
false statements to the Food and Drug Administration (FDA). Thakur has now filed a fresh case – a public interest litigation (PIL) alleging responses provided to him by the Indian government show how lax regulation can lead to potentially harmful medicines being sold in India without proper approvals. Thakur's
suit refers to the case of Buclizine, a drug made
by Belgian firm UCB, but since sold to Mankind Pharma for marketing in India. The Central Drugs Standard Control Organization (CDSCO) allowed UCB to sell Buclizine as an appetite stimulant in 2006, though it wasn’t approved for the purpose in Belgium and is banned in many other countries. The case is scheduled for a Supreme Court hearing on March 11. Evergreen pharma
sector is facing some serious headwindsLast week, we heard some not-so good news about the
pharmaceutical sector. First, Moody's Investors Service reduced its outlook from ‘positive’ to ‘stable’ for both the pharmaceutical and medical device industries. The reasons cited are: One, a strong dollar is reducing company sales outside of the US. Two, there is pressure on drug-makers to reduce price in the US. And three, drug-makers have also been hurt by slower uptake of many drugs. Back in India, there was news that pharma
companies in the state of Gujarat have witnessed a dip in exports to the African countries. Most of the countries in Africa have seen their currencies depreciate against the dollar, making imports costlier. As a result, Gujarat’s pharma exports dipped 40 percent in the last six months. And then there was news that Venezuela
settled debts with at least three global drug companies by giving them
bonds that trade at a heavy discount. Merck claims US $ 3
billion from Gilead as patent royalties from Hepatitis C franchise Gilead
Sciences is trying to fend off an
over US $ 3 billion demand by Merck in a patent dispute over the treatment
of hepatitis C, a disease for which the former had pioneered a cure. Last month, a judge found a compound in Gilead's blockbuster
drugs Sovaldi
and Harvoni
may have infringed Merck's patents. A jury will now decide whether those patents are valid or not. In case they are valid, how much does Gilead owe Merck in royalties? Gilead, on the other hand, plans to show jurors that scientists were working on the medicine as early as 2001, a year before Merck got the patent rights it’s seeking to enforce in this case. According to Gilead’s lawyer, the company owes the success of its drug not to Merck but to laboratory research done 15 years ago by Pharmasset, a company Gilead acquired in 2011 for US $ 11 billion. Bristol-Myers curbs
doctor payments in China Novartis got raided in
Korea over bribery concerns two weeks ago, and now Bristol-Myers Squibb has clamped down on the use of
expenses and speaker fees for doctors, after the issue got reported in Chinese social
media. Although
the news could not be confirmed, an emailed statement to Reuters said “Bristol-Myers Squibb has voluntarily stopped certain initiatives in China as the company continues to review its activities and build upon its business model in China.” In October 2015, Bristol-Myers had agreed to pay US $ 14 million to resolve allegations
that it violated the Foreign Corrupt Practices Act. Government’s authority to override patents makes headlines in India, US and ColombiaOf
late, the authority to override patents in order to make medicines accessible to
more people has been making headlines across the world. In
a stunning revelation, the US-India
Business Council (USIBC), in a report, said the Indian government had “privately reassured” them it would not use compulsory licences (CLs) for commercial purposes. This indicates that India’s patent office will take a more restrained approach in handing out licences to domestic players to produce cheaper versions of patented drugs. A CL allows a company to make a patent-protected product without the consent of the patent holder. This news comes at a time when the
same issue is being debated in the United States and even in Colombia. Last week, Obama administration rejected a request from dozens of Congressional Democrats to develop guidelines that would require drug makers to license their patents and put a lid on “price gouging.” Similarly, in Colombia, a government committee in February-end recommended that a CL should be issued for a cancer treatment drug – Gleevec – sold by Novartis. Across the world, several patients turn to countries like India for cheaper, generic versions of life-saving
patented drugs. Billions worth of cancer
drugs wasted due to their packagingPackaging plays a large role in determining how drugs get
used. A new study (undertaken by researchers at Memorial Sloan Kettering Cancer
Center and the University of Chicago) projects US
$ 3 billion worth of the most common cancer medicines will go to waste this
year in the US. According to the study, the drugs are wasted because
manufacturers sell
them in vials that are not practical to reuse. Experts have asked for
policies that require pharmaceutical companies to package drugs differently or
buy back unused drugs. Jimmy Carter says his
cancer has gone into remission, thanks to immunotherapyIf you are one of those who is skeptical of immunotherapy,
think again. Recently, former US President Jimmy
Carter said he will no longer need treatment for melanoma, a type of skin
cancer that had spread to his liver and brain. The 91-year-old Nobel Peace
Prize winner will continue to be observed by doctors, but will not need
treatment. The reason – a promising immunotherapy drug has helped his body’s immune system target cancer cells. Ten years back, Japan’s Ono
Pharmaceutical had tried convincing doctors to test a drug that helped the body’s immune system fight cancer. No one got convinced back then. They had dismissed immunotherapy as a fad. But now, Ono’s CEO Gyo Sagara says he received plenty of apologies when Opdivo – the drug the Japanese company worked on with Bristol-Myers Squibb – got the green light from regulators. Prostate cancer drug
to fund UCLA scholarships, stipendsThe University of California, Los Angeles (UCLA) took US $
520 million pay-out as part of a deal announced last week that transferred
royalty rights for a prostate cancer drug originally discovered in one of its
science laboratories. The UCLA innovation is transforming cancer treatments. UCLA
says it will spend the money until 2027 supporting research, scholarships for
undergraduates, and stipends for graduate students. Khloé Kardashian to promote Allergan’s double-chin treatment KybellaReality TV star Khloé Kardashian hosted the kick-off event for Allergan’s Live Chin Up campaign. Khloé moderated a panel of experts who talked about how Allergan's injection -- Kybella – can treat chin fat. We hope her involvement with the pharma company doesn’t trigger a warning letter from the FDA, akin to how her sister Kim received one when her media posts promoted Diclegis, a prescription-only drug used to treat nausea and vomiting during pregnancy. Kim
Kardashian had shared a selfie on Instagram and Twitter, holding a bottle
of Diclegis, which invited a warning letter issued to Duchesnay USA, the
company which produces the drug. The FDA’s warning letter said the media posts did not communicate the medical risks of the drug. Deal round-up: Sanofi-Merck,
Alvogen-County Line, AbbVie-Boehringer & Amgen Alvogen
has signed an agreement to acquire
County Line Pharmaceuticals, a specialty generic pharma company based in
Wisconsin. The transaction is likely to provide annual revenues of more than US
$ 100 million per year for Alvogen.AbbVie
will pay Boehringer Ingelheim nearly US $ 595 million to collaborate in developing drugs aimed at treating psoriasis, Crohn’s disease, asthma and other diseases affecting the immune system.After sitting out for most of the biotech acquisition frenzy
of 2015, Amgen
is ready to do a deal. According to Amgen’s Chief
Financial Officer David Meline, the time is ripe for bigger targets. Sanofi and Merck ended a 22-year-old joint venture to sell vaccines in Europe, arguing they would do better by managing their product portfolios independently. Sanofi and Merck
said they expected the unwinding of the vaccines joint venture to be completed by
2016-end.
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