With more than $1 billion in cash, "we might do something that is larger scale, if there is a chance," says Emmens. "But the
bread and butter of our business is going to be bringing in projects that are in Phase II or Phase III."
The company says its current pipeline can produce up to 11 launches by 2007. Six drugs are currently at registration, and
Shire expects approval of several products any day. (See "Loaded in Late Stage," page 54.) To chart the company's pipeline
progress, it is helpful to review it by therapeutic area.
CNS. In addition to seeking an adult indication for Adderall XR, Shire has several follow-on products to bolster its ADHD franchise.
The first, MethyPatch (methyl-phenidate)-licensed from Noven Pharmaceuticals and based on the same molecule as Ritalin and
Concerta-is before FDA. The product will be the only ADHD transdermal patch on the market, a feature expected to promote compliance.
Adderall XR and MethyPatch are psychostimulants, which are classified as controlled substances. But Shire also has several
noncontrolled entities in the pipeline. The first, SPD503 (guanfacine), currently in Phase III, was originally FDA approved
as a hypertensive agent and is already used off label in adults and children with ADHD. Shire also filed a new drug application
(NDA) with FDA for the anti-epileptic Carbatrol for bipolar disease under the name Bipotrol. "That helps to support the CNS
business and continues growth," says Flexter. "But it also reaches into adult psychiatry, which will overlap to some extent
with the adult ADHD business."
Renal. Of the six products at registration, only Fosrenol (lanthanum) is a new chemical entity. Fosrenol treats patients who have
high blood phosphate levels as a result of chronic kidney failure. The product has already been approved in Sweden and is
in the final stages of FDA review.
Fosrenol will compete directly with Genzyme's Renagel (sevelamer), which commands just less than half the market and has the
advantage of a lengthy clinical track record and lipid-lowering qualities. But Fosrenol's chewable tablets may be easier to
take-an advantage for patients who often must limit their fluid intake. Datamonitor predicts Fosrenol will reach sales of
$101 million by 2008.
GI. A double-strength formulation of Shire's ulcerative colitis (UC) therapy Pentasa, called Pentasa 500 mg, awaits FDA approval.
Another UC candidate, SPD476 (mesalazine MMX), uses a proprietary system that releases the drug in high concentrations in
the lower part of the small bowel, followed by a gradual release in the large bowel.
In addition, Janssen has filed for FDA approval of a once-daily version of Reminyl, and GlaxoSmithKline has filed for a new
HIV fixed-dose combination therapy that uses 3TC, entitling the company to additional royalties.
Despite the filled pipeline, a commitment to growth by acquisition, when everybody is growing by acquisition, has its dangers:
"There are more late-stage deals going on, but the opportunity to find good candidates is getting much smaller," says Jim
Hall, president of life sciences at Wood Mackenzie. "There is probably not a lot of low-hanging fruit."
Looking ahead, says Wahl, "the most important and, as yet, unfulfilled goal is the licensing in of the next round of products."
At press time, the role of head of business development was still vacant.
Although much of the talk at Shire these days is about new products, Adderall XR is far from a dead issue. "Few companies
are as in as good a position as Shire is to overcome the patent exclusivity challenges," notes Wahl. For one thing, they've
done it before. Shire's campaign to switch patients from Adderall to Adderall XR has been acknowledged as one of the most
successful and fastest in the industry.
To encourage patients to switch, Shire priced Adderall XR at a 14 percent discount to standard Adderall and used DTC advertising.
A quick start paid off: Barr launched a generic version in February 2002, four months earlier than expected.