After forfeiting two board seats and undertaking a strategic review, AMAG Pharmaceuticals is saying goodbye to its CEO and two of its drugs.But with another medlikely being pulled from the market, AMAG's sudden decision to cut ties with its chief executive could be akin to shifting "deck chairs on the Titanic," one analyst said.

AMAG CEO William Heiden has agreed to step downfollowing a strategic review spurred by activist investor Caligan Partnersthat also recommended the sale or spinoff of two women's healthdrugs, female libido treatment Vyleesi and painful sex med Intrarosa, the company said Thursday.

Heiden will stay on with AMAG through the successor search, which the company expects to wrap upby mid-2020, it said.

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It has been an honor and a privilege to lead the team at AMAG," Heiden said in a release."As we implement the strategic shift announced today, my fellow directors and I believe that this is the right time for the board to identify a new CEO for the next leg of AMAGs journey.

RELATED:FDA experts vote to pull AMAG's premature-birth med Makena from the market

Heiden's planned departure comes more than two months after an FDA advisory committee recommended AMAG pullpremature birth med Makena from the market in a 9-7 vote after confirmatory testing showed little clinical benefit in patients.

Piper Jaffray analyst Christopher Raymond called the panel'srecommendation "surprisingly definitive" in a note to investors at the time and forecastthat the FDA would likely pull Makena's marketing approval and structure a phaseout through mid-2020.

With Makena likely being taken off the market, AMAG said it would focus on the success of its iron deficiency medFeraheme as it moves ahead and has already received tentative interest from buyers for both Vyleesi and Intrarosa. With Heiden departing, Chief Financial Officer Ted Myles will assume the additional role of chief operating officer, and general counsel Joseph Vittiglio will assume the additional role of chief business officer.

In a note to investors Thursday, Raymond said the "handwriting was on the wall' inHeiden's departure and the Vyleesi and Intrarosa divestures after both drugs showed little market impact in their short commercial lives. AMAG hasn't yet disclosed revenue contributions from Vyleesi, which the FDA approved in Juneand AMAG launched in September. And Intrarosa, approved in 2017, hit just $21 million in sales in 2019 despite promise of a more than$500 million market for the drug.

Worse times could be coming, Raymond said, comparing AMAG's plight to shifting "deck chairs on the Titanic"particularly with Feraheme soon to face generic competition.

"While (Feraheme)has been a stalwart, recall that beginning (around)July 2021, Sandoz can launch its generic version of Feraheme," Raymond wrote. "Combining this with a substantial debt burden from the acquisitions of these and other assets, we would avoid the stock."

RELATED:AMAG bails on proxy fight standoff with settlement for 2 board seats

Just weeks before the FDA committee vote, AMAG opted to give two board seats to activist investor Caligan after the venture capital firm pushed for change at the top. The move temporarily expanded AMAGs board to 11 seats before the companys 2020 annual meeting, when nine permanent directors will be chosen.

Caliganacquired10.3% of AMAGs shares in early August, aimingto push the company to find an international marketing partner forFeraheme and investigate opportunities for its womens health business. Caligan alsofloated the idea ofsplitting upthe drugmaker.

In mid-September, in a proposal seeking to take four of AMAGs board seats, Caliganlambasted AMAGs share priceand what it called the failure of the drugmakers five-year strategic plandespite the immense value of some of its pharmaceutical portfolio. The firm said AMAGs board, recently elected in May, was approved because shareholders lacked options.

Read more here:
'Deck chairs on the Titanic'?: AMAG's CEO departure, drug dumps may not right the ship, analyst says - FiercePharma

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January 13, 2020 at 2:45 pm by Mr HomeBuilder
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