Replies to post #96182 on Biotech Values

[DewDiligence]

These are ABT’s webcast slides re the Piramal acquisition:

http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9MzgzNjI2fENoaWxkSUQ9Mzg0ODgwfFR5cGU9MQ==&t=1

[ilpapa]

We found that 7% of all tested samples were substandard and 3.6% were likely counterfeit.

Frankly that seems low to me, almost reassuring. Not that I'll specify Indian drugs just yet, though.

I'm probably just expressing a cultural bias.

[DewDiligence]

More on ABT’s phenomenal success with branded generics:

http://prescriptions.blogs.nytimes.com/2012/01/25/despite-generic-rivals-branded-drugs-still-sell-well

[DewDiligence]

If you think the FDA has problems, take a look at India’s CDSCO:

http://in.reuters.com/article/2012/05/09/us-india-drugs-idINBRE8480BG20120509

[DewDiligence]

More ammunition for branded generics from reputable companies:

http://online.wsj.com/article/SB10001424127887323320404578211492452353034.html

In 2010, 80 patients taking part in a clinical trial in Shanghai developed acute inflammation of the eye after doctors inadvertently gave them counterfeit Avastin, according to a 2011 report in the New England Journal of Medicine.

According to the Shanghai government, 17 of the patients required surgery to fix the problem. The fake Avastin vials contained saline that was contaminated with bacterial endotoxin, the Shanghai government said.

[DewDiligence]

Bookend to #msg-50473238 on India’s drug-quality problems:

http://in.reuters.com/article/2013/09/12/us-india-drugs-analysis-idINBRE98B17C20130912

U.S. inspectors visiting a factory in India owned by drugmaker Wockhardt Ltd in March found torn data records in a waste heap and urinals that emptied into an open drain in a bathroom six meters from the entrance to a sterile manufacturing area.

…when an inspector asked about the contents of unlabelled vials in the laboratory glassware washing area, a plant worker dumped them down a sink and said the contents could not be determined…

The more Indian drugs continue have issues with quality, the better it is for ABT.

p.s. Unlabeled vials can be a serious problem, as depicted in #msg-50231017 :- )

[DewDiligence]

India’s Fake Drugs Are a Real Problem—Part Deux

This is a cover story in today’s NY Times; the title above is mine, not theirs, but I think it applies. (The 2010 article in #msg-50473238 is “part one.”)

The problem described in this article is the premise for ABT’s (not ABBV’s) becoming the leading supplier of branded generic drugs in India, a business that has a very high profit margin, according to ABT’s most recent quarterly CC.

http://www.nytimes.com/2014/02/15/world/asia/medicines-made-in-india-set-off-safety-worries.html

“If I have to follow U.S. standards in inspecting facilities supplying to the Indian market,” G. N. Singh, India’s top drug regulator, said in a recent interview with an Indian newspaper, “we will have to shut almost all of those.”

…The World Health Organization estimated that one in five drugs made in India are fakes. A 2010 survey of Delhi pharmacies found that 12 percent of sampled drugs were spurious. [These factoids are consistent with what was stated in #msg-50473238.]

In one recent example, counterfeit medicines at a pediatric hospital in Kashmir are now suspected of playing a role in hundreds of infant deaths there in recent years. One widely used antibiotic was found to contain no active ingredient after being randomly tested in a government lab. The test was kept secret for nearly a year while some 100,000 useless pills continued to be dispensed.

…Investigations of the deaths are continuing, but convictions of drug counterfeiters in India are extremely rare.

…India’s Central Drugs Standard Control Organization, the country’s drug regulator, has a staff of 323, about 2% [!] the size of the F.D.A.'s, and its authority is limited to new drugs. The making of medicines that have been on the market at least four years is overseen by state health departments, many of which are corrupt or lack the expertise to oversee a sophisticated industry. Despite the flood of counterfeit drugs, Mr. Singh, India’s top drug regulator, warned in meetings with the F.D.A. of the risk of overregulation.

[DewDiligence]

FDA fooled by counterfeit Cialis:

http://blogs.wsj.com/pharmalot/2015/01/13/fda-bans-cialis-from-a-plant-where-lilly-says-drugs-arent-made/

[DewDiligence]

(ABT)—

Fake drugs are expected to generate $95 billion in global sales this year, up 26% from $75 billion in 2010, according to the Center for Medicine in the Public Interest, a New York-based research group partly funded by the pharmaceutical industry. In many developing countries…counterfeit drugs account for about 30% of…pharmaceutical sales…

Hence the strong allure of drugs made by companies with a respected name.

http://www.wsj.com/articles/call-centers-new-battle-front-for-fake-drugs-1433712783

See #msg-114019677, #msg-50473238 and #msg-97351346 for related stories.