Phispers, our news capsule, brings you the latest recap from the world of pharma, such as up to 20 percent drugs sold in India could be counterfeit, Reckitt Benckiser’s killer disinfectants, after $200 million fine Gilead accuses Merck lawyer of lying, China’s multi-billion pharma opportunity and more.
FDA Compliance Director’s pay package pales in comparison with Clinton’s DCAT speaking fee
PharmaCompass noticed a job opening at the US Food and Drug Administrations (FDA) – Director, Office of
Compliance. The annual salary for this post mentioned was US $ 123,175 to
US $ 185,100.
Now compare this to what Hillary Clinton was paid to speak
at DCAT’s Annual Dinner in 2014 – US $ 250,000. Or with Valeant’s new CEO Joseph Papa’s US
$ 67 million package which could be worth US $ 500 million if Valeant
shares reach their previous record high levels.
The price that the department pays for a post that ‘touches the lives of every American’ certainly seems measly!
IMS Health in US $ 9
billion merger deal with Quintiles
In an announcement which caught the market by surprise,
industry leaders, contract medical research provider Quintiles
Transnational announced
a merger with healthcare information company IMS Health Holdings in a deal
worth about US $ 9 billion.
The combined company, which will have a market value of
nearly US $ 18 billion, will offer
services to drug and medical device makers, ranging from helping run
clinical trials to tracking sales once a product has hit the market.
The combined company – Quintiles IMS Holdings – will be led by IMS Health chief executive Ari Bousbib.
China’s blood plasma shortage throws opportunities for pharma companies
While China’s blue-chip firms maybe sinking at the bourses, Shanghai RAAS Blood Products, a seller of treatments made from human blood plasma, is rallying
new highs. It’s now China’s largest healthcare company by valuation with a market cap of almost US $16 billion (compare that with an IMS & Quintiles combination which is worth $ 18 billion).
The big driver of growth is China’s surging demand for plasma-based therapies. Even though millions in China need these treatments, there’s scarcity of the blood plasma used to make them, partly because Beijing strictly controls the number of companies that have licenses to collect blood.
GSK should
definitely look into this opportunity as its sales
in China have been tumbling. At the same time Biogen considers
hemophilia to be a serious
opportunity and plans to spin the division into a separate entity
Up
to 20 percent drugs sold in India could be counterfeit
In a special report, the office of the US
Trade Representative (USTR) has raised major concerns about counterfeit drugs and devices. According to the report, 97 percent of all counterfeit pharmaceuticals seized at the US border in 2015 were shipped from four economies – China, Hong Kong, India and Singapore. Particularly, the USTR has raised concern about the proliferation of counterfeit pharmaceuticals manufactured, sold, and distributed in trading partners such as Brazil, China, Guatemala, India, Indonesia, Lebanon, Peru and Russia.
While it is impossible to determine an
exact figure, studies have suggested that up to 20
percent of drugs sold in the Indian market are
counterfeit and could represent a serious threat to patient health and safety.
Court orders J&J
to pay US $ 55 million to woman who alleged talc caused cancer
In February, J&J
was ordered
to pay US $ 72 million, in a St. Louis courthouse, to the family of a woman who died of ovarian cancer after having used J&J’s baby powder and another talc-based product for years.
In another loss, Johnson & Johnson needs to pay US $55
million to a 62-year-old
South Dakota woman who put the blame for her ovarian cancer on the company’s talcum powder. In the US, J&J is accused in more than 1,000 lawsuits in state and federal courts of ignoring studies linking its Shower-to-Shower product and Johnson’s Baby Powder to ovarian cancer. Women contend the company knew the risk and failed to warn
customers. J&J, on the other hand, has denied any link between talc and
ovarian cancer or any need to warn women.
After US $200 million
fine, Gilead accuses Merck lawyer of lying
In March, a federal jury in San Jose ordered Gilead to
pay Merck US $200 million after finding that two US patents held by Merck and
its partner, Ionis Pharmaceuticals, were valid and infringed by Gilead’s multibillion-dollar hepatitis C drugs – Sovaldi
and Harvoni.
The patents cover a range of compounds treating hepatitis C. Merck recently
began selling its own hepatitis C drug – Zepatier.
After the jury verdict, Gilead argued it shouldn’t have had to pay Merck because Merck was dishonest in obtaining its patents. Gilead said in 2004, Merck patent attorney Philippe Durette had a conference call with employees of Pharmasset, in which he learned the chemical structure of an experimental hepatitis C drug being developed by Pharmasset, code-named PSI-6130.
Gilead later spent
more than US$11 billion to acquire Pharmasset and its hepatitis C drugs. Gilead said Durette misused what he learned on the call to subsequently change claims in pending Merck patent applications in a way that would cover Pharmasset’s technology.
Reckitt Benckiser apologizes for killer disinfectants, even as it misled patients in Australia
Ataur Safdar, head of the Reckitt Benckiser’s Korean division, apologized for selling deadly disinfectants that killed or injured hundreds of people, five years after
the government ordered the company to remove the products from shelves for
health risks. Safdar said the company wanted to make amends, even as he was interrupted
by angry and tearful victims and their family members.
Meanwhile, an Australian court has ordered Reckitt
Benckiser to pay 1.7
million Australian dollars in penalties after a ruling that the company
misled consumers about the effectiveness of a popular painkiller.
Eli Lilly warns of job
losses due to ban on carcinogen used to produce raloxifene
Eli
Lilly, one of Ireland’s largest pharmaceutical employers, has warned of job
losses at its Kinsale plant if the EU does not exempt it from a forthcoming
ban on ethylene
dichloride (EDC) – a carcinogenic chemical.
Eli Lilly uses the chemical to produce raloxifene,
marketed as Evista,
a prescription drug to prevent osteoporosis in post-menopausal women. The drug
is currently used by 1.7 million patients worldwide.
EDC will be banned within the EU from November 2017.
Goggles, hair, insects,
dirt in APIs, reveals FDA warning letter to Polydrug Labs
Polydrug
Laboratories has been on FDA’s Import Alert List since September 2015. The warning
letter issued by the FDA was posted on the regulator’s website and it talks about all kinds of uninvestigated complaints found on a torn sheet of paper recovered during the inspection.
Amongst these were complaints like low assay value in API and particles and hair, insect and dirt and safety googles found in API. According to the FDA, Polydrug failed to comply with current good manufacturing practices for the manufacture of APIs and also failed to record and investigate all quality-related customer complaints according to an established procedure. More details are available at Barbara Unger’s blog
entry.
Effort to regulate drug
pricing reaches G7 Summit
In March, the French President Francois Hollande had said he
would push for international regulation of drug prices when he meets leaders
from other G7 countries in Ise-Shima (Japan) on May 26-27. News reports point that the issue
is now on the agenda for the G7 Summit and health ministers will continue work
on it in Kobe in September when other parties, such as the pharmaceutical
companies themselves, could potentially be involved.
France plans to press its G7 partners to launch an ‘irreversible’ process to control the prices of new medicines as part of a global drive to make life-saving drugs more affordable.
This news has come at a time when the UK too (like the US)
is witnessing debates on price gouging, after the price
of eye-drops used for bacterial conjunctivitis underwent a 14-fold price
increase recently.
FDA’s generic drug approval report card
For the past few weeks, we have been mentioning an
acceleration in the review process of generic drug applications filed with the
FDA. The FDA recently released its Generic
Drug Review Dashboard for the first quarter of 2016.
It wasn’t surprising that the review process has been accelerated as the number of applications pending with the FDA have reduced by almost 10 percent with the burden of work now shifting to the industry which has to respond to the FDA’s comments or concerns.
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