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Amgen expects FDA decision on new indication for cancer drug by next April

BY Alaric DeArment

THOUSAND OAKS, Calif. — The Food and Drug Administration will decide whether or not to approve a new usage for a cancer drug made by Amgen by next year, the drug maker said.

Amgen said the FDA would seek to take action by April 26 on its application seeking approval for Xgeva (denosumab) for preventing prostate cancer that has persisted despite castration surgery from spreading to the bones, also known as bone metastasis, one of the most common places for cancer to spread. The action date is an estimate made under the terms of the Prescription Drug User Fee Act of 2007, also known as a PDUFA date, meaning that the agency will try to complete its review of Amgen’s application and make a decision by then.

Xgeva originally received approval in November 2010 for preventing skeletal injuries in patients whose cancer has spread to the bones.

The drug maker is seeking the new approval based on results of a 1,432-patient late-stage clinical trial announced in May that showed the drug reduced chances of prostate-resistant prostate cancer spreading to the bones by 15%, compared with placebo.

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Sandoz announces FDA approval, U.S. launch of chemotherapy drug

BY Alaric DeArment

PRINCETON, N.J. — The Food and Drug Administration has approved a chemotherapy drug made by Sandoz, the drug maker said Tuesday.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval and launch of docetaxel, an injectable chemotherapy drug that the company said was the 11th cancer drug it has launched in the United States.

The drug is a ready-to-use formulation of Sanofi’s Taxotere in a single vial.* Various versions of Taxotere had sales of about $1.1 billion during the 12-month period ended in June, according to IMS Health. The drug is used to treat cancers of the lung, breast, prostate, stomach, head and neck, in combination with various other drugs.

* CORRECTION: An earlier version of this story referred to the drug as a generic version of Taxotere, based on an error in Sandoz’s original press release. The drug was approved under an FDA New Drug Application, as opposed to an Abbreviated New Drug Application, as is the case with generic drugs, so Sandoz’s product is not technically a generic drug.

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CVS Caremark announces receipt of requisite consents, termination of replacement capital covenant, expiration of consent solicitation

BY Antoinette Alexander

WOONSOCKET, R.I. — CVS Caremark has announced the results of its previously announced solicitation of consents from the registered holders as of 5 p.m. Eastern time on Aug. 8 of its 6.125% senior notes due Aug. 15, 2016, to terminate the replacement capital covenant — which was entered into on May 25, 2007 — for the benefit of the holders of the notes in connection with the issuance of its 6.302% enhanced capital advantaged preferred securities due 2062.

Under the replacement capital covenant, CVS Caremark was prohibited from repurchasing, redeeming or repaying its ECAPS on or before June 1, 2047, unless a specified portion of the funds used to repay, redeem or repurchase the ECAPS were obtained by CVS Caremark through the sale of common stock or certain other equity or equity-like securities.

The consent solicitation expired at 5 p.m. Eastern time on Aug. 22. The termination of the replacement capital covenant required the consent of the holders of a majority in aggregate principal amount of the outstanding notes. Based on the final tabulation provided by the information and tabulation agent for the consent solicitation, D.F. King & Co., Inc., the holders of approximately 619,838,000 notes, or approximately 88.55% of the aggregate principal amount outstanding, delivered duly executed consents prior to the expiration of the Consent Solicitation.

CVS Caremark has executed a termination of the replacement capital covenant and will make a cash payment to each holder of the notes of $15 per $1,000 in principal amount of the notes as to which a duly executed consent was delivered and not revoked on or prior to the expiration of the consent solicitation.

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