Content about Cephalon

August 10, 2012

Mylan has launched a generic drug used to treat sleep disorders, the company said Friday.

PITTSBURGH — Mylan has launched a generic drug used to treat sleep disorders, the company said Friday.

The generic drug maker announced the launch of modafinil tablets in the 100-mg and 200-mg strengths. The drug is a generic version of Provigil, made by Cephalon — a company that Teva Pharmaceutical Industries acquired last year — and used to treat narcolepsy, obstructive sleep apnea and shift work disorder.

May 15, 2012

Net revenues for Teva rose more than 24% for the first quarter ended March 31, thanks to new drug launches and the company's acquisition of drug maker Cephalon.

JERUSALEM — Net revenues for Teva rose more than 24% for the first quarter ended March 31, thanks to new drug launches and the company's acquisition of drug maker Cephalon.

First-quarter net revenues totaled $5.1 billion, compared with $4.1 billion in the year-ago period, while net income and earnings per share totaled $1.3 billion and $1.47 diluted earnings per share, an increase of 39% and 41%, respectively, compared with first quarter 2011.

April 30, 2012

Mylan plans to start selling a generic version of a drug for sleep disorders starting in June 2016, under a deal with Teva announced Monday.

PITTSBURGH — Mylan plans to start selling a generic version of a drug for sleep disorders starting in June 2016, under a deal with Teva announced Monday.

Mylan said it had settled with Teva over the former's generic version of Nuvigil (armodafinil) tablets, a drug used to treat sleepiness related to sleep apnea, narcolepsy and shift work disorder.

April 6, 2012

Par Pharmaceutical has started shipping its generic version of a drug for sleep disorders, the company said Friday.

WOODCLIFF LAKE, N.J. — Par Pharmaceutical has started shipping its generic version of a drug for sleep disorders, the company said Friday.

Par announced the launch of a generic version of Provigil (modafinil), used to treat such sleep disorders as narcolepsy and work shift sleep disorder.

April 5, 2012

Teva is the first company to file for a generic version of a drug to treat sleep disorders, the Food and Drug Administration has determined.

JERUSALEM — Teva is the first company to file for a generic version of a drug used to treat sleep disorders, the Food and Drug Administration has determined, though Mylan is contesting the FDA decision.

March 30, 2012

Teva Pharmaceutical Industries has launched an authorized generic version of Cephalon's Provigil, used for conditions like shift work sleep disorder and narcolepsy, the company said Friday.

JERUSALEM — Teva Pharmaceutical Industries has launched an authorized generic version of Cephalon's Provigil, used for conditions like shift work sleep disorder and narcolepsy, the company said Friday.

Teva acquired Cephalon for $6.8 billion in October 2011. An authorized generic is the branded drug marketed under its generic name at a reduced price.

Provigil had annual sales of about $1.1 billion, according to IMS Health.

 

January 23, 2012

The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said.

SUPPLIER NEWS — The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said. The FDA announced the approval of a single REMS for transmucosal immediate-release fentanyl drugs. The new system, which takes effect in March, will allow prescribers and pharmacies to enroll into one system instead of individual systems for each product.

January 3, 2012

The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said Tuesday.

SILVER SPRING, Md. — The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said Tuesday.

November 21, 2011

Drug maker Impax Labs is looking to challenge the patent protection on a drug used to treat pain related to cancer, the company said Monday.

HAYWARD, Calif. — Drug maker Impax Labs is looking to challenge the patent protection on a drug used to treat pain related to cancer, the company said Monday.

Impax said it had filed a regulatory approval application with the Food and Drug Administration for a generic version of Cephalon's Fentora (fentanyl) buccal tablets in the 100 mcg, 200 mcg, 400 mcg, 600 mcg and 800 mcg strengths. The drug is used to treat breakthrough cancer pain, defined as pain related to cancer that can't be controlled by other drugs.

October 10, 2011

The Federal Trade Commission has given Teva Pharmaceutical Industries the green light to acquire Frazer, Pa.-based drug maker Cephalon, but with some restrictions, Teva said.

JERUSALEM — The Federal Trade Commission has given Teva Pharmaceutical Industries the green light to acquire Frazer, Pa.-based drug maker Cephalon, but with some restrictions, Teva said.

Before it can complete the $6.8 billion deal, Teva must sell to Par Pharmaceutical Cos. its generic versions of two Cephalon drugs, namely generic versions of the cancer pain drug Actiq (fentanyl citrate) and the muscle relaxant drug Amrix (cyclobenzaprine), which have combined sales of $298 million per year, according to IMS Health.

August 24, 2011

The final outcome of the battle between Israel’s Teva Pharmaceutical Industries and Canada’s Valeant Pharmaceuticals International to buy Cephalon serves as a good illustration of why it helps to have a plan B.


The final outcome of the battle between Israel’s Teva Pharmaceutical Industries and Canada’s Valeant Pharmaceuticals International to buy Cephalon serves as a good illustration of why it helps to have a plan B.


In May, Teva beat out Valeant’s $5.7 billion offer to buy Frazier, Pa.-based Cephalon with a $6.8 billion offer of its own, acquiring Cephalon’s hefty pipeline in the process. And last month, Teva bought Taiyo Pharmaceutical Industry, Japan’s third-largest generics company, for $934 million.


July 21, 2011

The Food and Drug Administration has approved a risk evaluation and mitigation strategy for two painkillers made by Cephalon, the drug maker said Thursday.

FRAZER, Pa. — The Food and Drug Administration has approved a risk evaluation and mitigation strategy for two painkillers made by Cephalon, the drug maker said Thursday.

The FDA approved a REMS for Fentora (fentanyl) buccal tablets and Actiq (oral transmucosal fentanyl citrate). Both drugs are used for managing breakthrough pain in cancer patients who have become tolerant of opioid drugs.

July 15, 2011

Teva Pharmaceutical Industries got the go-ahead from Cephalon’s shareholders to acquire the Frazer, Pa.-based company in a deal worth $6.8 billion.

FRAZER, Pa. — Teva Pharmaceutical Industries got the go-ahead from Cephalon’s shareholders to acquire the Frazer, Pa.-based company in a deal worth $6.8 billion.

Teva came out as the front-runner to purchase Cephalon in May, when the drug maker spurned a takeover bid by Mississauga, Ontario-based Valeant Pharmaceuticals, which had offered $5.7 billion in March.

June 14, 2011

Before they can move ahead with their deal, drug makers Teva and Cephalon must provide the Federal Trade Commission with additional information related to Teva's pending acquisition of Cephalon.

JERUSALEM and FRAZER, Pa. — Before they can move ahead with their deal, drug makers Teva and Cephalon must provide the Federal Trade Commission with additional information related to Teva's pending acquisition of Cephalon.

May 16, 2011

Drug maker Mylan has launched a generic treatment for muscle spasms, the company said Friday.

PITTSBURGH — Drug maker Mylan has launched a generic treatment for muscle spasms, the company said Friday.

Mylan announced the launch of cyclobenzaprine hydrochloride, a once-daily muscle relaxant, in the 15-mg and 30-mg strengths. The drug is a generic version of Cephalon’s Amrix, which had sales of about $125 million during the 12-month period ended in March, according to IMS Health.

May 2, 2011

Cephalon has another suitor in the form of the world’s largest generic drug company.

JERUSALEM — Cephalon has another suitor in the form of the world’s largest generic drug company.

Teva Pharmaceutical Industries said Monday that it would buy Frazer, Pa.-based Cephalon for $6.8 billion, undercutting efforts by Valeant Pharmaceuticals International, which had offered $5.7 billion in March.

The boards of both companies have agreed to the acquisition, equal to $81.50 per share. Cephalon previously had turned down Valeant’s offer, prompting the Mississauga, Ontario-based company to take its case directly to Cephalon’s shareholders.

April 22, 2011

Valeant Pharmaceuticals International is taking its case directly to Cephalon’s shareholders in its effort to acquire the Frazer, Pa.-based drug maker.

MISSISSAUGA, Ontario — Valeant Pharmaceuticals International is taking its case directly to Cephalon’s shareholders in its effort to acquire the Frazer, Pa.-based drug maker.

In a letter to the shareholders Thursday, Valeant said its $73-per-share offer, totaling $5.7 billion, was a 29% premium over the 30-day stock price of Cephalon, noting that the price had declined over the last five years and that the average stock price in the month before the offer was $57, which Wall Street analysts didn’t expect to rise above $60.

April 13, 2011

Cephalon has lodged a bidder’s statement to acquire Australian drug maker ChemGenex Pharmaceuticals for $167 million, Cephalon said Wednesday.

FRAZER, Pa. — Cephalon has lodged a bidder’s statement to acquire Australian drug maker ChemGenex Pharmaceuticals for $167 million, Cephalon said Wednesday.

Cephalon, which said its offer of 70 Australian cents per share represented a premium of nearly 60% over ChemGenex’s stock price as of March 29, said the Australian company’s directors had unanimously recommended approval of the acquisition. ChemGenex specializes in developing treatments for cancer.

March 30, 2011

Canadian drug maker Valeant Pharmaceuticals has proposed to buy Cephalon for $5.7 billion, Valeant said Tuesday.

MISSISSAUGA, Ontario — Canadian drug maker Valeant Pharmaceuticals has proposed to buy Cephalon for $5.7 billion, Valeant said Tuesday.

The buyout offer, equal to $73 per share, includes a 29% premium over Cephalon’s stock price. Valeant noted it had made previous offers, but was “disappointed by Cephalon’s unwillingness to engage in discussions in a timely manner.”

March 25, 2011

A generic painkiller made by Watson Pharmaceuticals infringes a patent covering the branded version, a U.S. District Court ruled.

MORRISTOWN, N.J. — A generic painkiller made by Watson Pharmaceuticals infringes a patent covering the branded version, a U.S. District Court ruled.

Watson said Friday that the U.S. District Court for the District of Delaware decided that Watson’s generic version of Cephalon’s Fentora (fentanyl) buccal tablets infringes U.S. Patent No. 6,264,981, though the Food and Drug Administration had approved Watson’s version of the drug.

March 24, 2011

The Consumer Healthcare Products Association may not be painting pink Pepto-Bismol mustaches on a group of Hollywood celebrities and professional athletes as part of the new campaign it plans to fully unveil in June, but the goal is more or less the same as the “Got Milk?” ads.

“Got milk?” has become ubiquitous. There is 100% clarity of message. The milk mustache says it all: Milk is an essential food and an integral part of a healthy diet; it HAS TO BE in your refrigerator, on your breakfast table and in your lunch box.

March 22, 2011

Cephalon plans to acquire a privately owned company developing treatments for cancer, Cephalon said Monday.

FRAZER, Pa. — Cephalon plans to acquire a privately owned company developing treatments for cancer, Cephalon said Monday.

The Frazer, Pa.-based drug maker said it would pay $225 million upfront for Malvern, Pa.-based Gemin X, and Gemin X stockholders would be eligible to receive up to $300 million in milestone payments related to products under development.

Gemin X specializes in cancer treatments that target and kill cancer cells. Its lead product is GX15-070 (obatoclax), currently in phase-2b clinical development as a treatment for small cell lung cancer.

March 15, 2011

A generic painkiller made by Watson Pharmaceuticals does not infringe on the patent covering the branded version, a U.S. District Court has ruled.

MORRISTOWN, N.J. — A generic painkiller made by Watson Pharmaceuticals does not infringe on the patent covering the branded version, a U.S. District Court has ruled.

Watson said the U.S. District Court for the District of Delaware ruled that Watson’s generic version of Cephalon’s Fentora (fentanyl buccal tablets) does not infringe on two patents that were set to expire in March 2019, according to Food and Drug Administration records.

February 1, 2011

SUPPLIER NEWS — The Food and Drug Administration has approved a generic drug made by Watson Pharmaceuticals for cancer-related breakthrough pain, Watson said. The drug is a generic version of Cephalon’s Fentora, which had sales of around $179 million during the 12-month period ended in November 2010, according to IMS Health.


January 10, 2011

The Food and Drug Administration has approved a generic drug made by Watson Pharmaceuticals for cancer-related pain, Watson said Monday.

MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic drug made by Watson Pharmaceuticals for cancer-related pain, Watson said Monday.

Watson announced the approval of fentanyl buccal tablets in the 0.1-mg, 0.2-mg, 0.6-mg and 0.8-mg strengths.