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Drug maker Barr's Plan B efforts blocked by regulatory politics

TRENTON, N.J. (AP) _ Maybe the maker of Plan B, the aptly named morning-after pill, needs its own backup plan.

For years, Barr Pharmaceuticals Inc. has been trying to get its controversial contraceptive approved for sale without a prescription. Named for its purpose _ to prevent pregnancy after contraceptive failure or unprotected intercourse _ Plan B reduces chances of pregnancy 89 percent if taken within 72 hours after sex.

But amid political pressure from conservatives, the Food and Drug Administration has put off a decision indefinitely.

Meanwhile, Woodcliff Lake-based Barr _ a former generics-only drug maker that branched out into brand-name drugs five years ago _ continues to grow.

It has 34 drugs awaiting FDA approval: four new brand-name medicines, including Bijuva estrogen cream and a low-dose version of contraceptive Seasonale, and 30 generic versions of other companies' drugs, including long-acting versions of allergy medicine Allegra and Adderall for attention deficit/hyperactivity disorder, plus Evista for osteoporosis and Ortho Tri-Cyclen Lo, one of the most popular birth control pills.

Revenues are expected to rise about 20 percent a year the next couple years, and the company is gunning for the titans of women's medicines, Johnson & Johnson and Wyeth.

``We want to establish ourselves as the leading company in women's health care,'' said Bruce Downey, Barr's chief executive and chairman.

Specialty pharmaceuticals analyst Robert H. Uhl of Freedman, Billings, Ramsey & Co. calls that ``perhaps a lofty long-term goal'' for a company with barely 300 sales representatives. In comparison, top drug makers have 1,000 sales reps just for their women's health products.

``They (Barr) could get there, but it's still years away in our view,'' Uhl said.

Still, Barr already is the No. 1 supplier of oral contraceptives, both brand name and generic, including Seasonale, which limits periods to four times per year. Nearly half of Barr's revenues come from women's health products, including Cenestin, a synthetic estrogen pill for hot flashes and other menopause symptoms; new versions of both Cenestin and Seasonale are in the pipeline, too.

Uhl said the company made a smart deal in buying the maker of the ParaGard copper IUD, a nonhormonal birth control option with about $50 million in annual sales, which he thinks Barr could quadruple with enough promotion.

The Plan B contraceptive pill, with only about $25 million in annual revenues, still gets the most attention.

Available by prescription since 1999, Barr wants to sell Plan B _ two high-dose pills of the contraceptive levonorgestrel _ over the counter.

The Center for Reproductive Rights and similar groups have been pushing for over-the-counter status since February 2001, arguing that a delay in getting the pill can lead to unplanned pregnancies.

Conservative groups and several congressmen have pressed the Bush administration to block over-the-counter approval, while reproductive rights groups say wider availability would reduce the number of U.S. abortions, now about 1.5 million per year.

``This application basically got caught up in the abortion wars,'' said Dr. Michael Greene, a member of the FDA advisory panel that in December 2003 voted 23-4 to allow nonprescription sales. People at FDA were told, he said, ``that this approval was not to happen on the Bush administration's watch.''

Senior FDA officials overruled staff experts and the advisory panel, kept extending deadlines to act and, after promising a decision late last summer, decided to start a rulemaking process that can take up to a decade. Requests to interview FDA officials were turned down and agency spokeswoman Julie Zawisza could not say how long just the first step, reviewing thousands of public comments, will take.

Barr, meanwhile, has persuaded eight states to let pharmacists sell Plan B without a prescription with some restrictions, and continues to lobby others to do so.

In its generic drug business, the company likewise tends to choose the more difficult path. It focuses on bringing to market generic versions of brand-name drugs that were never blockbusters and that have what it calls ``barriers to entry.'' Those are drugs that are especially difficult to manufacture, have supply problems with key raw ingredients, or are still under relatively secure patents, including Barr's 22 oral contraceptives and generic versions of blood thinner Coumadin and Accutane for severe acne.

``We're a pretty plucky group. We take on hard challenges,'' said Downey, the CEO.

He said that limits the amount of competition Barr gets from other generic manufacturers, which often forces them all to slash their prices. Barr focuses on smaller drugs hard to bring to market and usually ends up with little to no competition from other generic companies, said Downey. That gives Barr a higher profit margin _ key because all its generic drugs have annual sales below $100 million.

With 12 to 15 new generics coming on the market every year, Barr's revenues totaled $1.05 billion in the fiscal year ending last June, down from $1.3 billion the year before because a short-term distribution deal ended. Revenues in the quarter through September totaled $310 million.

Barr should reach $1.3 billion in sales this year and $1.4 billion the next, according to analyst Dimi Ntantoulis of UBS Securities LLC. She expects net income to jump from $215 million in the year ending last June to $359 million in fiscal 2007.

``They really are very well run,'' said Ntantoulis, who has increased her 12-month price target for Barr shares from $60 last fall to $78. Shares have climbed from about $45 to $65 since September.

She said Barr has been one of the more successful companies using the generic-brand name hybrid model, partly by choosing a niche that permits highly focused marketing to gynecologists. Several generic companies have abandoned the brand business as unprofitable.
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