Schering-Plough Gears Up For Possible Antipsychotic Launch
13 5월 2009 - 4:36AM
Dow Jones News
Schering-Plough Corp. (SGP) is gearing up for the potential
launch of a new antipsychotic drug.
The Kenilworth, N.J., drug maker recently told employees it will
probably hire a small number of new workers for the launch of
asenapine - under the proposed brand name Saphris - which is
currently under review by U.S. regulators. Merck & Co. (MRK),
Whitehouse Station, N.J., which agreed in March to acquire
Schering-Plough in a cash-and-stock deal then valued at about $41
billion, disclosed Schering's hiring plans in a regulatory filing
Friday.
The hirings would be notable because the merger partners said in
March they would institute hiring freezes in connection with their
pending combination, which is expected to close by the end of this
year. Merck has said it expects to then reduce the combined
entity's work force by about 15%, or nearly 16,000 employees.
The exception to the current hiring freeze is for "critical
business needs," according to Merck's regulatory filing, and
Schering's potential new hires for asenapine would fall into this
category.
"There are various positions you might need to fill even in the
planning, pre-launch" phase, said Schering-Plough spokesman Robert
Consalvo, who declined to specify the number of positions in
question, or say when Schering expects a regulatory decision.
Just four months ago, the U.S. Food and Drug Administration
declined to approve asenapine for treatment of schizophrenia and
bipolar disorder, and asked Schering for more information from
existing clinical databases. The FDA proposed language for a
prescribing label, and didn't request additional clinical trials -
which some analysts saw as a good sign. Schering responded to the
FDA's request in February, and an agency decision is pending.
Schering inherited asenapine with its 2007 acquisition of
Organon BioSciences from Akzo Nobel NV (AKZOY). Akzo had previously
been in a partnership with Pfizer Inc. (PFE) to develop and
commercialize the drug, but Pfizer backed out of the alliance in
2006 for commercial reasons.
Schering believes asenapine is effective but with a less severe
side effect of weight gain that is associated with some other
antipsychotics. Schering has predicted the drug's peak annual sales
could exceed $1 billion.
But some analysts have had low expectations, citing unimpressive
clinical data and the perception that a cautious FDA had raised the
bar for approval of mental-health drugs. Even if the drug gets
approved, it would enter a crowded antipsychotic market dominated
by AstraZeneca PLC's (AZN) Seroquel and relatively cheap generic
versions of Johnson & Johnson's (JNJ) Risperdal.
Doubts about asenapine's prospects were reinforced last year
when the FDA rejected another experimental antipsychotic,
iloperidone from Vanda Pharmaceuticals Inc. (VNDA), signaling the
FDA was taking a tough stance toward new antipsychotics.
But last week the FDA reversed course and approved Vanda's drug,
which will be sold under the brand Fanapt. The Fanapt approval
doesn't guarantee the FDA will do the same for Schering's
asenapine, but it does show that the FDA's bar for new
antipsychotics isn't insurmountable.
Schering-Plough shares rose 32 cents to $23.00 Tuesday. Merck
shares rose 57 cents to $24.97.
-Peter Loftus; Dow Jones Newswires; 215-656-8289;
peter.loftus@dowjones.com