* Says 1 million U.S. patients want to stay on brand
* Sees quick 20-30 pct fall in price of Lipitor, generics
* U.S. patent of top-selling drug lapses after 14 years
* Watson confirms it begins shipping generic Lipitor
By Ransdell Pierson
Nov 30 As cholesterol fighter Lipitor goes
generic, its maker Pfizer Inc is hoping to hold onto
perhaps a third of the 3 million Americans who take the
biggest-selling drug of all time.
Lipitor, which became available in 1997 and generated
annual sales of $13 billion at its peak, reduces "bad" LDL
cholesterol and the risk of heart attack and stroke. It loses
U.S. patent protection on Wednesday.
"More than one-third of patients currently taking Lipitor
would like to stay on Lipitor," David Simmons, president of
emerging markets and established products for Pfizer, said on
Tuesday, citing internal company research.
Pfizer is employing unprecedented tactics to hold onto as
many Lipitor prescriptions as it can during the first six
months of generic competition, when only two copycat versions
will be on the market. It plans to pull back on the aggressive
marketing plan afterward, when a slew of other generics will be
Watson Pharmaceuticals Inc will sell an "authorized
generic" form of Lipitor made by Pfizer, with an estimated 70
percent of its sales going to Pfizer. Watson said early on
Wednesday it has begun shipping the pills, calling it the
"largest generic product launch in U.S. history."
Indian drugmaker Ranbaxy Laboratories Ltd is also
ready to sell its copycat Lipitor as the result of a settlement
reached with Pfizer in 2008. But the actual launch depends on
whether U.S. regulators lift a ban that has kept Ranbaxy from
exporting some products to the United States following quality
control lapses at the company's Indian factories.
Analysts said on Wednesday there was no sign Ranbaxy had
begun shipping its version of Lipitor to pharmacies to be sold
under its chemical name atorvastatin, a delay that could
Ranbaxy officials did not return calls. A U.S. Food and
Drug Administration spokeswoman declined comment on the status
of Ranbaxy's generic Lipitor, saying the agency did not discuss
pending drug applications.
Some industry watchers expected Israel's Teva
Pharmaceutical Industries Ltd to step in and help
supply Ranbaxy if the FDA did not approve shipments from its
main facility in Paonta Sahib, India.
"It's hard to know whether the FDA will approve Ranbaxy's
product, or whether Teva will become involved, but we should
know by midnight," Sanford Bernstein analyst Aaron Gal said.
Teva officials could not immediately be reached for comment.
Teva shares were up 3 percent on the Nasdaq in afternoon
trading, while Ranbaxy closed down 3.9 percent in India. Watson
shares slid 0.7 percent, while Pfizer rose 2.8 percent, both on
the New York Stock Exchange, amid sharp gains for the broader
PROTECTING THE BRAND
Watson has forecast branded Lipitor will keep 40 percent of
its prescription volume in the next six months. That is about
twice as much as brand companies typically retain in the
initial 180-day period, according to Leerink Swann analyst
Why would patients prefer Lipitor even though Watson's
generic is identical to the branded product and Ranbaxy's
generic has the same active ingredient?
"When I go into a pharmacy and if I'm going to be dispensed
a generic, I have no idea where it is coming from," Simmons
said. "I know if I get Lipitor, I know it's coming from
Pfizer said it reached deals with some health insurers and
pharmacy benefit managers (PBMs) -- firms that negotiate drug
prices for companies and health plans -- that will allow
patients to obtain branded Lipitor at similar or even lower
co-payments than those assigned for Lipitor generics.
The arrangements also mean health insurers working with
Pfizer will pay no more for branded Lipitor than for the
generics, Simmons said.
He forecast the cost of the generics would likely be 20
percent to 30 percent lower than the original price of Lipitor
during the first six months and fall dramatically afterward.
Pfizer is offering patients a card that covers all but $4
of their co-payment for Lipitor, up to a maximum discount of
$50. It can be ordered at the website LipitorForYou.com.
Lipitor has chalked up more than $130 billion in sales
during its 14 years on the market and many investors doubt
another drug of its magnitude is likely any time soon.
But industry experts say a major advance in treating
diabetes, obesity or Alzheimer's disease would have a good shot
at matching or even eclipsing Lipitor's gargantuan sales.