Source:
IMS
MIDAS
*Note: Pro-forma data for Sanofi-Aventis based on global
sales for 2003. During the period, IMS assigned Sanofi-Synthelabo
approximately $1.1 billion in sales ("consolidated")
for Plavix from total global sales of $3.6 billion ("developed")
for the drug, which is co-marketed worldwide by Bristol-Myers
Squibb. MIDAS assigns North American sales to BMS.
Sanofi-Aventis
will be ranked third in the global drug league table,
according to IMS data, overtaking Merck & Co based
on 2003 sales, but still some way behind GlaxoSmithKline.
Aventis is currently ranked number seven, and Sanofi number
14.
Novartis
backs away
The three months
between the two bids from Sanofi were certainly eventful.
Aventis revealed a plan to issue warrants that would benefit
its shareholders if Sanofi's number two product, Plavix
(clopidogrel), a platelet anti-aggregant for the
reduction of atherosclerotic events associated with stroke,
heart attack etc., lost exclusivity in the US before 2007.
It also put out the call for a 'white knight' to step
in with an improved bid. Novartis duly responded, but
said it would only make a formal bid if invited to do
so by Aventis and if the French government remained neutral.
The first condition was met, but not the second.
After weeks
of wrangling, on April 23 French Finance Minister Nicolas
Sarkozy succeeded in bringing Aventis CEO Igor Landau
and his Sanofi counterpart Jean-Francois Dehecq together
for their first direct talks since January. Two days later,
Aventis agreed to a new bid, 14% higher than the original.
It values Aventis at approximately €54 billion. Shareholders
will receive five Sanofi shares and €120 cash for
six Aventis shares; or 1.1739 Sanofi shares for each Aventis
share; or €68.93 in cash for each Aventis share.
Dehecq
persistence pays off
Dehecq will
lead the enlarged group, which will be known as Sanofi-Aventis.
He expects cost savings of €1.6 billion by 2006.
The improved bid was supported by Total and L'Oreal: the
oil and cosmetics firms together own 44% of Sanofi. Their
shareholder pact, however, ends in December - thought
to be a major spur to Dehecq's bold move, as Sanofi could
have become a vulnerable takeover target itself.
Dehecq anticipates
only minor regulatory hurdles at antitrust authorities.
Sanofi has already agreed to divest two antithrombotics,
Fraxiparine (nadroparin) and Arixtra (fondaparinux),
which would compete with Aventis' top product, Lovenox
(enoxaparin), to GlaxoSmithKline.
Sanofi-Aventis
would have a varied portfolio, with leading franchises
in three areas according to IMS:
-
B1 Antithrombotics (Lovenox, Plavix)
-
L1 Antineoplastics (Taxotere, Eloxatin)
-
C9 Agents acting on the renin-angiotensin system (Triatec,
Delix Plus, Aprovel, Coaprovel)
Patent
problems?
Some analysts
believe Sanofi-Aventis will have its challenges. Two generic
manufacturers, Apotex and Dr Reddy's, have filed ANDAs
for clopidogrel products, equivalent to Plavix.
Sanofi has sued both, and a court decision is expected
before the end of the year. Aventis' antihistamine Allegra
(fexofenadine) now has competition from both over-the-counter
and generic versions of the former leading
allergy drug in the US, Schering-Plough's Claritin
(loratadine). Moreover, in September 2004, Aventis
is due to go to court in its patent litigation against
generic manufacturers that have filed fexofenadine ANDAs.
Aventis' leading
drug, Lovenox, is also facing a patent fight
and there is a possibility that the low molecular weight
heparin could lose US exclusivity from 2005; however,
it is a difficult product to make due to its biological
nature, so any generic manufacturer would face a number
of hurdles.
Sanofi-Aventis'
top 10 products
(Pro forma, based on global sales data for 2003)
| Product
|
Indication |
Sales
($m) |
| Lovenox
(enoxaparin) |
DVT,
angina |
2,066 |
| Allegra
(fexofenadine) |
Allergy |
1,815 |
| Ambien/Stilnox
(zolpidem) |
Insomnia |
1,770 |
| Taxotere
(docetaxel) |
Cancer |
1,356 |
| Plavix
(clopidogrel) |
Thrombosis,
stroke |
1,120* |
| Triatec/Delix
(ramipril) |
Hypertension |
935 |
| Eloxatin
(oxaliplatin) |
Colorectal
cancer |
755 |
| Amaryl
(glimepiride) |
Diabetes |
696 |
| Lantus
(insulin glargine) |
Diabetes |
547 |
| Nasacort/Azmacort
(triamcinolone) |
Allergic
rhinitis |
523 |
Source:
IMS MIDAS (Sanofi-Synthelabo products in bold)
*Note: Consolidated sales figure assigned to Sanofi-Synthelabo - MIDAS does not include sales in North America, which are
assigned to BMS.
US
sales boost for rimonabant
Aventis' pipeline
is generally considered weak, though its new antibiotic
Ketek (telithromycin) and rapid-acting insulin
analogue Apidra both received FDA approval in
early 2004, and Sculptra, an injectable filler
for facial lipoatrophy in HIV patients, was backed by
an FDA advisory panel. In general, analysts view Sanofi's
pipeline as having more depth.
Aventis COO
Richard Markham, however, told IMS
Company Profiles it has a number of interesting
projects, including MDL 100907, currently in Phase II
studies for the improvement of sleep quality; unlike Sanofi's
Ambien it is not a hypnotic, but patients wake
less frequently in the night. And teriflunomide, which
could become the first oral therapy for multiple sclerosis,
began Phase III trials in early 2004. The new group will
have almost 60 projects in late-stage (Phase II and above)
clinical development.
One
of Aventis' main attractions for Sanofi is its strong
presence in the all-important US market. This could prove
invaluable to boost the launch of Sanofi's most important
pipeline drug, the obesity treatment Acomplia
(rimonabant), which was in Phase III trials in early 2004.
Who
will be next?
It
seems likely that a fresh wave of consolidation could
sweep through the industry. Novartis has increased its
voting
stake in neighbour Roche to 33.3% - less than
500 shares short of being required to launch a formal
takeover bid. Family-owned Roche is resistant to such
a move, and Novartis seems prepared to wait until it has
a change of heart; combined, they would create a Swiss
giant whose sales would exceed GSK's.
Barring
a major calamity with Lipitor, no one is likely to overtake
Pfizer for some time. But the likes of GSK and AstraZeneca
could well be tempted to move in on one of the struggling
US firms to keep their place in the rankings. After a
period of being overshadowed by their US peers, European
drugmakers could be looking to stamp their authority on
the global pharmaceutical market once again.
This
article was written by Selena Class, Deputy Executive
Editor of IMS Company Profiles.
Information
was sourced from our new web site, IMS Knowledge Link,
which integrates detailed data from a number of publications
covering sales, R&D, news, patents and strategic issues.
The extensive coverage includes more than 100 of the top
pharmaceutical and biotechnology companies as well as
300 therapeutic areas and 36 countries. Analysis for mergers
and acquisitions is only one of the service's many applications.
For
more information, visit IMS
knowledgelink or contact Stephanie Earle via e-mail
or +44 207 393 5515.
