HEALTH

Sorry, FTC: ‘Pay-for-delay’ isn’t going away

BY Alaric DeArment

WHAT IT MEANS AND WHY IT’S IMPORTANT This week’s decision by the U.S. Second Circuit Court of Appeals could make political efforts to ban generic-branded patent settlements a lot more difficult.

(THE NEWS: Appeals court upholds decision to OK ‘pay-for-delay’ deals. For the full story, click here)

The Federal Trade Commission in particular, not to mention some members of Congress like Sen. Herb Kohl, D-Wis., has fought hard against so-called “pay-for-delay” settlements between branded and generic drug companies, contending that they delay patients’ access to generic drugs and cost consumers billions of dollars every year.

The concerns of opponents are understandable. Because generic and branded drug makers are supposed to be competitors, what seem on the surface like sweetheart deals must look positively Faustian to many people. But the judges in the appeals court affirmed that whatever their appearance, patent settlements don’t violate antitrust laws.

And the facts seem to support that decision. According to a report released in January by RBC Capital Markets, generic drug companies prevailed in 76% of cases that included settlements, but only in 48% of cases that went to trial. Meanwhile, according to a report released the same month by securities and investment banking firm Jefferies & Co., on average, patent settlements result in generic launch three years before patent expiration. Legally, a generic drug company must launch its version of a drug before or at the time of patent expiration.

While patent settlements often involve some type of monetary transaction, in many cases, the “pay” is in the form of a promise by the branded drug company not to launch an authorized generic, which is the branded drug sold under its generic name at a lower price. Under the Hatch-Waxman Act, the first generic drug maker to launch a knockoff of a branded drug is entitled to six months in which to compete directly with the branded version, but the authorized generic allows the branded drug maker to undercut the generic drug maker by marketing a supposedly “generic” version of its own.

Authorized generics have seen a bit of a pickup as well, and more activity on that front can be expected. On Tuesday, Greenstone, the generics arm of Pfizer, announced that it would create a new business called the Authorized Generics Alliance in order to market authorized generics under the Greenstone label.

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Kiwi Shoe Care goes back to basics with new ad campaign

BY Allison Cerra

EXTON, Pa. Sara Lee’s Kiwi Shoe Care is looking to educate consumers on how to care for their shoes with a back-to-basics approach.

Kiwi’s new campaign focuses on taking care of what consumers already have without breaking the bank, the company said.

"Our new ads will take a unique approach to drive home the concept of caring for one’s shoes and demonstrate the value and savings it can bring to one’s household," said Bob Clark, marketing director of Kiwi Shoe Care.

Kiwi’s line of products include shoe inserts, boot and suede protectors, shine sponges and women’s comfort cushions.

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FDA approves expanded use of Saphris

BY Allison Cerra

WHITEHOUSE STATION, N.J. Merck’s supplemental drug applications for its atypical antipsychotic received approval from the Food and Drug Administration, the drug maker said.

Saphris now is indicated for the treatment of schizophrenia in adults, as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, and as adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, Merck said.

Saphris initially was approved by the FDA last summer for the acute treatment of schizophrenia in adults and as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults.

 

“These FDA approvals demonstrate our active commitment to further understand how our medicines can be used to help physicians help their patients, and we look forward to discussing these new uses for Saphris with the mental health community,” said David Michelson, VP neuroscience clinical research at Merck.

 

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