Otsuka appoints new president to replace Taro Iwamoto, who died of heart failure

SINGAPORE--On Feb. 11, Otsuka Pharmaceutical appointed a new president, Tatsuo Higuchi, already president and CEO of the parent holding company, to replace Taro Iwamoto, who died two days earlier. The death was another blow to a Japan drugmaker that faces steep sales losses for its best-selling drug in three months.

Iwamoto was a 20-year veteran of the company, and he served as president since 2008. He was 54 years old and reportedly died of heart failure, but no other information was forthcoming and no obituary was available.

Just two weeks earlier, Higuchi, as head of Otsuka Holdings, announced the 2014 sales figures for Abilify (aripiprazole), the generic version of Bristol-Myers Squibb's ($BMY) drug that Otsuka had been marketing in the United States under a collaborative agreement. Higuchi reported preliminary fourth-quarter net sales of just over $1.3 million and $4.9 million for the year, a 5.8% increase over 2013.

Bristol-Myers forecast a huge decline in sales this year because of the pending loss of IP protection loss of its branded version. The company already had reported a 25% decline in 2014 fourth-quarter sales, to $475 million, and a 12% decline in annual sales, to $2.02 billion.

Abilify, which is prescribed for bipolar disorder and schizophrenia, also had accounted for 40% of Otsuka Holdings income in 2013 when its global sales amounted to nearly $4.84 billion, a quarter of the company's total sales that year. Iwamoto had presided over the deal that gave Otsuka exclusive rights for the generic version.

FiercePharma placed Abilify on its list of the top 10 patent losses set for this year in the pharmaceutical industry.

Otsuka has a patent suit pending against Sciegen Pharmaceuticals for filing for a generic before the May 15 expiration of the BMS patent for Abilify. Meanwhile, Otsuka mulled filing with the FDA to block an application from Alkermes for a another competing generic, arguing Alkermes had conducted only one of the two Phase III clinical trials the agency usually requires.

In December, Iwamoto presided over Otsuka's purchase of another drug maker, Avanir Pharmaceuticals and access to its Neudexta (pseudobulbar) drug for neurologic diseases. The drug garnered $94 million in sales during the year ending last June. Otsuka paid $3.5 billion for Avanir.

Along with BMS, Otsuka faces the loss of protection for four versions of Abilify this year: a 1-mg oral solution that expires May 15; an intramuscular 9.75-mg injectable that expires June 15; Discmelt 10-mg orally disintegrating tablets, which expire July 15; and the 15-mg version of Discmelt, which expires at the end of November.

- read releases from Otsuka here, here and here
- read MPR's take on the situation here
- here's what Law360 had to say (sub. req.)

Special Report: The top 10 patent losses of 2015