Rarely do we experience a court ruling that could benefit a Big Pharma and a generics maker at the same time. But as the Wall Street Journal points out, both Teva Pharmaceutical Industries and Merck are likely to cheer an appeals court decision on the blood pressure drugs Cozaar and Hyzaar.

The new ruling awards 180-day exclusivity to Teva on its versions of both drugs, reversing a lower court’s decision to deny that first-to-market advantage. Clearly, that’s a win for Teva; it will have six months as the only copycat provider of two of the most popular hypertension meds on the market.

But it could be a win for Merck, too. Ever since the district court ruled last July that Teva had forfeit its exclusivity rights, Merck has been expecting a whole slew of Cozaar and Hyzaar copycats to hit the market at once. Scads of competition tends to bring drug prices down fast, so Merck would have suffered lots of lost sales on both meds. Now that Teva has its exclusivity back, Merck’s branded meds will only be competing against one rival apiece.

That means Teva can charge more, enriching its own income statement. And it means that fewer users of the branded versions will switch to generics, because the price advantage won’t be nearly so big. Expect both meds to launch next month.

Source: FiercePharma

Popularity: 2% [?]

In what could be a win-win decision for both Teva Pharmaceutical and Merck, a federal court said that Teva was entitled to six months of exclusivity to sell generic versions of two hypertension medicines made by Merck.

A district court ruled in July that Teva, the largest of the generic drug makers, had forfeited the 180 days of exclusivity that usually goes to the first applicant seeking FDA approval to make a generic versions of drugs — in this case, copycats of Merck’s Cozaar and Hyzaar.

But Teva said today an appeals court found the Israeli company should get the exclusive sales period once its gets the FDA go-ahead to market the drugs. Teva said it would be eligible to begin sales in April.

Merck benefits because it was expecting a gaggle of generics for the two drugs to hit the market right away, according to Reuters. The U.S. company said its lawyers were reviewing the decision, the report said.

World-wide sales of the hypertension drugs were $3.6 billion in 2009. The exclusive-sales period allows a generic maker to charge a little more for having the first copycat version on the market, Reuters notes.

Source: The Wall Street Journal

Popularity: 2% [?]

Drugmaker Merck & Co. said Wednesday it will slash 7,200 jobs as part of a new restructuring program that comes as its third-quarter profit plunged 28 percent, due to a hefty restructuring charge and flat sales.

The maker of allergy and asthma treatment Singulair and cervical cancer vaccine Gardasil said it will cut nearly 13 percent of its work force, including many executives, to lower overhead and become more competitive, in its second major restructuring in less than three years.

Whitehouse Station, N.J.-based Merck & Co. said that because of a $612 million charge for restructuring, net income for its third quarter amounts to $1.09 billion, or 51 cents per share. That’s down from $1.53 billion, or 70 cents per share, a year earlier.

The $612 million charge, after taxes, includes a $720 million pretax charge for the new restructuring program, plus $127 million in costs related to the prior restructuring program, announced in December 2005.

Excluding the restructuring charge, which amounts to 29 cents per share, Merck would have posted earnings of 80 cents, 1 cent better than Wall Street was expecting.

The company narrowed its 2008 earnings forecast, to $3.28 to $3.32 per share excluding one-time items. The prior forecast, issued in April, was for $3.28 to $3.38 per share.

Third-quarter revenue was down 2 percent at $5.9 billion, from $6.07 billion in 2007. Analysts surveyed by Thomson Reuters were expecting sales of $6.1 billion.

Sales were hurt by a further decline in Merck’s cholesterol franchise, lower sales for nearly all its vaccines and generic competition for former blockbuster osteoporosis drug Fosamax, which lost U.S. patent protection in February and saw sales cut in half this quarter to $354 million.

The cholesterol drugs Vytorin and Zetia, which Merck jointly markets with partner Schering-Plough Corp., saw sales dip about 15 percent to $1.1 billion in the quarter, cutting Merck’s equity income from the joint venture by 17 percent, to $400 million.

Singulair sales edged up 1 percent, to $1.03 billion, and blood pressure drugs Cozaar and Hyzaar rose 9 percent to $888 million. Some new products, including HIV drug Isentress and diabetes drugs Januvia and Janumet, also sold well.

The new restructuring program announced Wednesday aims to eliminate about 7,200 jobs, 400 of them currently vacant, across the company worldwide by the end of 2011. As part of the program, Merck will streamline management layers by eliminating about 25 percent of senior and mid-level executives. The company currently has a total of about 56,700 employees.

The new job cuts come on top of a massive December 2005 restructuring program, just about completed, that eliminated 10,400 jobs.

The company said the new cuts are expected to produce cumulative pretax savings of $3.8 billion to $4.2 billion from 2008 to 2013, but it will cost between $1.6 billion and $2 billion through the end of 2011, when the program is expected to be completed.

For the first nine months, net income jumped nearly 26 percent to $6.16 billion, or $2.86 per share, compared with $4.9 billion, or $2.24 per share, in the January-September period of 2007. Much of that improvement was due to one-time items this year, particularly a $2.2 billion gain related to Merck’s partnership with AstraZeneca LP. Sales for the first nine months were down about 1 percent, to $17.82 billion from $17.94 billion.

Source: Merck & Co.

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