Sunday, August 9, 2009

Where Is the EU Antitrust Filing for Merck/Schering-Plough?


I did a little digging, and the most-recent record of a filing with the EU Competition Commission which includes both Merck and Schering was from March of 2006 -- and it was a withdrawal of a notice:

. . . .On 16 March 2006, the Commission of the European Communities received notification of a proposed concentration between Merck KgaA ("Merck", Germany) and Schering Aktiengesellschaft ("Schering", Germany). On 27 March 2006, the notifying parties informed the Commission that they withdrew their notification. . . .

So far, my research has revealed no current EU filing for the proposed transaction. Given the European Competition Commission's recent announcement of stepped-up scrutiny of pharmaceutical sector consolidation (both in transactional terms, and in agreements to restrict generics entries -- in already highly-concentrated markets), I would think this just became the "critical path" -- or limiting variable, as to the timing of a close of the Merck/Schering-Plough bust-up reverse merger. Take a look at this, from page 19, of a July 9, 2009 Commission Final Report (analogous to a working paper, under our regulatory schema):
. . . .4.1. Intensify Competition Law Scrutiny

Where appropriate, the Commission will make full use of its powers under antitrust rules (Articles 81, 82 and 86 of the EC-Treaty), merger control (Regulation (EC) No 139/2004)38 and State aid control (Articles 87 and 88 of the EC-Treaty). The Commission, in close cooperation with the National Competition Authorities, will pursue any antitrust infringement in the sector, wherever required by the Community interest. Action can also be taken at national level and in areas which were not the primary focus of the inquiry or are outside its scope.

Market Concentration

As described in the Final Report, the pharmaceutical industry is currently going through a significant phase of consolidation. This includes, on the one hand, an increasing concentration among (large) originator companies as well as the acquisition of biotech companies.

On the other hand, the generic landscape is undergoing substantial changes also, in the form of acquisitions of generic companies by originator companies and through merger & acquisition activities within the generic industry.

The trend towards increased market concentration is followed with attention by the Commission and analysis of these merger cases will benefit from the insights gained through the sector inquiry so as to preserve a competitive structure and process in the market. . . .

So, it will not just include a review of the transaction itself, that the EU authorities are certain to undertake -- but also, very likely, a reviews of the many patent settlement agreements Schering-Plough (and, to a lesser degree, Merck) have signed -- with would-be generic manufacturers, to effectively delay the introduction of generic versions of franchise drugs, as the EU Commission's adopting press release indicates.

This, I think, is clearly the "time-line-bottleneck" -- for any closing this proposed transaction -- the one the shareholders just approved, on Friday past.

As backround information, here is a handy-table of some of the threatened, and pending, generic introduction dates -- at least on Schering-Plough's side of the house:



Branded NameSales ($M/Yr)Compound NameFirst Suit Filed30 Month Expiry/
"At Risk" Date
Likely Competitor
Clarinex®$800 MillionDescloratadineSeptember 2006May 2009*Orchid Pharma*
Zetia®$900 MillionEzetimibeMarch 2007October 2009Glenmark Pharma
Temodar®$950 MillionTemozolomideJuly 2007January 2010Barr Labs (Teva Pharma)
Integrilin®$300 MillionEptifibatideFebruary 2009November 2011Teva Pharma
Levitra®$430 MillionVardenafil HClJuly 2009April 2012Teva Pharma
Total:$3.38 Billion........

~~~~~~~~~~~~~


* All but two potential generic Descloratadine manufacturers have agreed to a standstill until January 2012, for generic launches. I believe the two remaining are Orchid Pharmaceuticals, out of India, and Orgenus Pharma, Inc.

2 comments:

Anonymous said...

Condor,

Not to dismiss your point but I believe Merck KgaA ("Merck", Germany) is a different company than the US Merck that SP is merging with. I checked and the US Merck was split off from Merck KgaA after WWI. Schering AG of Germany is also a different company than Schering-Plough of the US.

Salmon

Condor said...

That is absolutely right, Salmon -- and my point in quoting the 2006 filing was to make clear (as you know) that Schering-Plough and Merck have not yet filed for approval of the transaction in the EU.

Importantly, with over 70 percent of revenue at Schering-Plough originating outside the US, and mist of that being generated inside Europe, the EU antitrust authorities will have an important role in potentially modifying the deal(s).

Namaste