GlaxoSmithKline Kills U.S. Part of Eczema Treatment Deal With Basilea

GlaxoSmithKline Kills U.S. Part of Eczema Treatment Deal With Basilea
January 22, 2016
By Mark Terry, BioSpace.com Breaking News Staff

GlaxoSmithKline , headquartered in Basel, Switzerland, announced yesterday that it had ended its deal with Swiss company Basilea Pharmaceutica Ltd. to develop alitretinoin in the U.S.

In June 2012, the two companies, both headquartered in Basel, Switzerland, entered into an exclusive global agreement for Toctina. The drug was at that time being marketed in 14 countries and approved in an additional 15 for the treatment of adults with severe chronic hand eczema. At that time it was in Phase III trials in the U.S. as an oral formulation.

Stiefel was responsible for development, manufacturing, commercialization, and distribution of the drug, which had existing distribution deals in Europe, Canada, Mexico, Israel, and the Republic of Korea, all of which were assigned to Stiefel, a GSK company.

Basilea received GBP 146 million up front (about $225 million U.S.) and was eligible for milestone payments for between GBP 30 to GBP 50 million ($43 million and $72 million, U.S., respectively). The current conversion rate for British Pounds per U.S. dollar is one GBP is equal to $1.43 (US).

Basilea now has the option to re-acquire the U.S. rights to alitretinoin, although a specific price tag was not mentioned. GSK will continue to market Toctino in its current markets.

Toctino (alitretinoin) is a derivative of vitamin A and belongs to a class of drugs called retinoids. Retinoids are typically used to treat skin disorders. Toctino is generally used to treat severe chronic hand eczema that has not responded to other treatments, such as high potency topical corticosteroids. It has not been approved for use in the U.S.

In December 2015, Basilea provided a clinical update of its drug programs. The company indicated it had discussions with the U.S. Food and Drug Administration (FDA) regarding a Phase III trial of a broad-spectrum antibiotic, Ceftobiprole (ceftobiprole medocaril) for intravenous administration against Gram-positive and Gram-negative bacteria associated with pneumonia, including methicillin-resistant Staphylococcus aureus (MRSA) and susceptible Pseudomonas species.

It also discussed BAL101553, a novel small molecule tumor checkpoint controller (TCC), which is being studied in a Phase I/IIa clinical trial, and its oral formulation in a Phase I trial. It is being evaluated in solid tumors.

There was a rumor that Allschwil, Switzerland-based Actelion was considering buying Basilea, but Jean-Paul Clozel, Actelion’s chief executive officer, recently indicated it had no plans to acquire Basilea. “Since we’re interested in active substances and not financial opportunities,” Clozel told Finanz und Wirtschaft, “it wouldn’t make sense for us to buy Basilea.”

For its part, GSK is involved in yet another China-related scandal, of sorts. Two of the company’s scientists are being charged along with three others, of attempting to steal trade secrets from the company, which they then planned to use to create their own company and sell the drugs in China. According to the U.S. Attorney’s Office of the Eastern District of Pennsylvania, three of the individuals involved, Yu Xue, Tao Li, and Yan Mei, created a corporation in China called Renopharma to go through with their scheme.

The GSK employees involved were Yu Xue, 45, of Wayne, Pa. and Lucy Xi, 38, of West Lake Village, Calif. All five are being charged with conspiracy to steal trade secrets, conspiracy to commit wire fraud, conspiracy to commit money laundering, theft of trade secrets, and wire fraud. Xue and Xi were at GSK’s facility in Upper Merion, Pa. Also indicted was Tian Xue, 45, of Charlotte, N.C.

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