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TMCNet: FDA OK of GSK's Promacta Triggers Windfall for Ligand

[November 21, 2008]

FDA OK of GSK's Promacta Triggers Windfall for Ligand

(BioWorld Today Via Acquire Media NewsEdge) Ligand Pharmaceuticals Inc. said that the FDA has granted accelerated approval of GlaxoSmithKline plc's Promacta for a disorder called idiopathic thrombocytopenic purpura (ITP), which can cause bruising and bleeding.

As a result, San Diego-based Ligand will be entitled to a $2 million milestone payment from GSK. In addition, Ligand will earn tiered royalties in the range of 5 percent to 10 percent on annual net sales of Promacta (eltrombopag), an oral drug that will compete with Amgen Inc.'s injectable Nplate (romiplostim).

Promacta, expected to launch this week, marks the third drug that Ligand has discovered and has been approved, noted CEO John Higgins.

"For a small research company down in San Diego, this is a fantastic track record," he said

FDA approval decisions are pending for two other Ligand products, both for osteoporosis: Fablyn (lasofoxifene), partnered with Pfizer Inc., and Viviant, partnered with Wyeth.

The FDA originally was scheduled to make a decision on Promacta Sept. 19, but the agency missed its action date. During the delay, GSK had indicated that the process was going well. One reason for the delay may be that GSK had quietly submitted additional data to the FDA seeking to use Promacta for chronic as well as short-term use, Higgins told BioWorld Today.

"We think that was one factor" contributing to the delay, Higgins said. In the end, there was "a very good outcome" for both companies. As a treatment for chronic ITP, Promacta will compete with Amgen Inc.'s Nplate.

Like Promacta, Amgen's Nplate is intended for long-term use in patients with chronic ITP and could be used for short-term use as well.

Both products would be subject to a risk-management program to ensure safe use of the drugs.

Approved in August, Nplate was the first treatment specifically developed for the bleeding disorder ITP. However, Ligand's Promacta is the first oral treatment for the disorder.

Besides their route of administration - a daily pill vs. a weekly subcutaneous injection - there are other key differences between the two products, Ligand and Amgen representatives said.

While both products are designed to boost platelet production, Higgins said that there may be dosing differences that favor GSK's drug.

He said that patients on Nplate may require dose titration, or customization, and close monitoring at the outset while they reach the target dose level. The overstimulation of platelet production could result in unwanted clotting, he said.

GSK's product also could have an advantage if it is priced lower than Nplate. Pricing information for Promacta is imminent, said GSK spokesman Ken Inchausti.

Dietmar Berger, executive medical director of global development for Amgen, said that there are differences in how the two products were tested. "Ours was tested for longer-term use; theirs was tested for shorter-term use."

According to London-based GSK, the Promacta approval is based on data from two pivotal studies in the short-term treatment and one ongoing long-term treatment study of patients with chronic ITP.

GSK's Inchausti said that the company has agreed to conduct post-market approval studies that could provide the basis for labeling updates.

Berger also pointed out the black-box warning for liver toxicity for Promacta, an issue that he said has not been linked to Amgen's product.

GSK also has reported positive Phase II Promacta data in patients with thrombocytopenia (low platelet count) associated with hepatitis C and initiated two Phase III trials in patients with hepatitis C in the fourth quarter of 2007.

A Phase II study of Promacta in patients with chemotherapy-induced thrombocytopenia has been completed, a Phase III study is ongoing in chronic liver disease and a Phase I study is ongoing in patients with sarcoma receiving a regimen of adriamycin and ifosfamide.

GSK also expects a marketing authorization application submission for the long-term treatment of ITP by year-end.

Also, Amgen announced that the European Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorization for Nplate in the European Union.

The committee recommended Nplate for adult chronic ITP splenectomized patients who are refractory to other treatments such as corticosteroids and immunoglobulins.

Nplate may be considered as second-line treatment for adult nonsplenectomized patients where surgery is contra-indicated, Amgen said.

According to Amgen, currently available treatments for ITP have limited application due to poor tolerability or transient effects.

Surgical therapy (removal of the spleen) also is available to adult patients with chronic ITP, but does not work in all cases.

Currently, there are 140,000 treated chronic ITP patients in Europe and the U.S. ITP affects about twice as many adult women as men.

Shares in Ligand (NASDAQ:LGND) were up 67 cents or 50.4 percent, closing at $2, while shares in GSK (NYSE:GSK) were up 31 cents, closing at $32.85.

Shares in Amgen (NASDAQ:AMGN) were up $4.77, or 9.5 percent, closing at $54.90. n

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Copyright ? 2008 Thomson BioWorld, All Rights Reserved.

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