Sun agrees to FTC conditions on Taro acquisition
NEW YORK Mumbai, India-based Sun Pharmaceutical Industries has agreed to the Federal Trade Commission’s conditions for allowing it to buy Israeli drug maker Taro Pharmaceutical Industries, according to reports.
The FTC filed a complaint Wednesday challenging Sun’s acquisition, alleging that it would take control of three generic drugs that it already controls, making the deal anticompetitive.
The products are three formulations of carbamazepine, an anticonvulsant drug. Both companies either manufacture the formulations and sell them in the United States or will soon enter them the market, pending Food and Drug Administration approval.
The FTC conditions require Sun to sell the rights and assets for the three drugs.
Sun mounted a hostile takeover of Taro after its $454 million bid in May failed.
FDA new response procedure could confuse investors
WASHINGTON The Food and Drug Administration’s decision to change how it responds to drug companies’ submissions for drug applications is not only affecting the companies, but investors as well, according to Reuters.
The approach could cloud a drug review process already growing less predictable as global pharmaceutical companies find less success winning U.S. approval for new products. The policy “may not give as much visibility to the direction the FDA is going,” Morningstar analyst Damien Conover said.
In the past, an approvable letter told companies their applications could be cleared if certain conditions were met. A not-approvable letter was seen as a sign of more serious problems.
The complete response letters will spell out what drugmakers could do to win approval, the FDA said.
But the agency by law must keep the letters confidential. Investors must rely on the companies, which often disclose only the type of letter received and give little detail about the FDA’s complaints. Manufacturers typically do not release a letter’s actual text.
Based on those facts, investors will now be guided by the companies as to what happens to a drug that could be a potential blockbuster on the market.
Insmed ceo lobbies for follow-on biologics rule
WASHINGTON The chief executive of a biotech company in Richmond, Va., wants to make it possible to get generic biologic drugs approved, the Washington Post reported Wednesday.
Geoffrey Allan, chief executive officer of Insmed, has been lobbying members of Congress in an effort to teach them the differences between chemical and biotech drugs. Allan hopes his company will become the first United States company to develop generic biologic drugs, also called “biosimilars.”
While the market for generic chemical drugs is expanding, there is no way to get generic biologic drugs approved. Allan hopes that Congress will change the laws to make generic biologic drug competition possible.