Saturday, June 29, 2013

Merck Declined Friday -- On News Of Pending EU Approvals For Generic/"Biosimilar" Versions Of Infliximab

As many here well-know, J&J and Merck -- via the (pre bust up transaction) joint venture with legacy Schering-Plough -- used to jointly sell Remicade® and Simponi® -- in various geographies around the globe. Yesterday, the EMEA recommended approved the first "biosimilars" ever -- and these "sort of genericized" versions of Remicade (Infliximab) clearly mean that Merck's share of royalties in Europe on the branded version of infliximab will decline.

That is so, because Merck's biggest retained geography, after the settlement of the 2010 arbitration proceedings is Europe -- right where these first approvals were just granted.

Thus the Friday decline of Merck's common stock, on the NYSE.


Anonymous said...

Any interest in covering the current story in Denmark where msd and other pharma payed a consultant at the national hospital directly into his (Peer Grande) private account rather than the official hospital account for medical trial work?

Condor said...

For my English only friends -- here is a not too awkward Google trnaslation of the article Anon. mentions, above.

I will wait to comment on any of these published reports, until more is known. That weems prudent.

Here's the trnaslation:

. . . .Rigshospitalet expects to increase its control over the millions of dollars that pharmaceutical companies and others each year supports the hospital's research.

It says the National Hospital medical director Jannik Hilsted to after a consultant at the hospital's heart center has been released and police for fraud with research

"I think we are going to make some additional control functions. It's too bad for everyone. It is always a balancing act, how much you will annoy all the employees who do as they are told," said Jannik Hilsted. . . .

[Continued, next post. . .]

Condor said...

. . .Got £ 933,000 on his private account

It's Jyllands-Posten, which in its Sunday edition reveals how the consultant at the hospital's heart center Peer Grande for many years seems to have received large sums from pharmaceutical company MSD, who have put money into the 62-year-old heart doctor's private bank account.

Peer Grande has denied the allegations, but according to letters that Jyllands-Posten present in the paper, the MSD for a period from July 2009 to October 2012 apparently transferred at least 933,126.60 kroner to Peer Grandes private account in Danish Bank.

This has been done as part of a study of cholesterol-lowering medication that Peer Grande has spearheaded.

Remittances to the doctor's private bank account is in direct conflict with hospital policy for external forksningsbevillinger where companies like MSD will need a special account that the hospital has in Nordea.

Rigshospitalet has by his own admission not been familiar with the cash to Peer Gardes private account and Jannik Hilsted rejects the doctor's behavior, which he calls "utterly unacceptable".

He believes that Peer Grande have known that he broke the rules.

'The rules have been announced in as many laps and have been common known in every possible way, so it can not have gone anyone's nose over. And certainly not when you are a senior official in an academic position, "said Jannik Hilsted.

Police Reviewed by meeting
The hospital was on Wednesday contacted by Jyllands-Posten on the matter.

Peer Grande was called for an interview with the center manager at the heart center, and his explanation - or lack thereof - was the day after the National Hospital management to send him home and police report him for fraud.

"We have reason to believe that there has been economic crime. Therefore, we have reported the matter to the police. As long as it runs, we have no further comment, "said Jannik Hilsted.

He explains, however, that the hospital in the coming days also will contact the pharmaceutical company MSD and ask for an explanation. Until then, he does not want to comment on the company's actions in the case.

Cheating can never be prevented
Rigshospitalet administered in 2012 external research for totaling 479 million to about 2,300 projects involving 800 researchers. . . .

[Continued, next post.]

Condor said...

. . . .Against this background, Jannik Hilsted not mean that you can protect yourself 100 percent against cheating.

"You will always be a victim of cheating. That is what we have been, and therefore we must see if we need to make some tightening, but it is annoying for more bureaucracy also means that we put more obstacles in the way of our scientists, "said Jannik Hilsted.

He believes that the hospital has done what it could in the case.

"It is clear that we would rather have been the case here as well. There can be no talk about. But when it is, as it seems to be, then we have done what we need to do, "said Jannik Hilsted. since this morning unsuccessfully tried to get a comment from Peer Grande, but the consultant did not respond to our inquiries.

Before the article's publication, the Jyllands-Posten twice got hold of Peer Grande on the phone. The first time, he rejects that he received money outside the system of MSD.

"I have no private bank account where I get money from MSD," he told the newspaper.

When the newspaper makes him aware of the letters that make up the key evidence in the case, he asks the newspaper to call back the following day.

Next day slamming Peer Grande pipe in when the newspaper reporter who agreed to call you back.

MSD will wait for the investigation
MSD want at this stage not to comment on the case, says the press officer, Anders Schiermer.

He says that the company has set an accountant and lawyer investigation in light of Jyllands-Posten detection.

"It is essential for MSD that all rules and laws are observed. Therefore, we have a full investigation underway. Until it is completed, we would like to wait to comment on the allegations that are new to us, "says Anders Schiermer to . . .

So sorry -- but I don't have even a rudimentary/passing familiarity with basic Danish, so I cannot clean it up for you all.