Cephalon

Biopharmaceutical maker Cephalon Inc., of Frazer, said Thursday that stockholders approved the company's proposed $6.8 billion acquisition by Teva Pharmaceutical Industries Ltd. Teva, based in Israel but with large operations in the region, in May offered $81.50 a share for Cephalon. At the time, Cephalon was trying to ward off a $73-a-share hostile-takeover attempt by Canadian firm Valeant Pharmaceuticals International. The deal remains under review by the U.S. Federal Trade Commission and the European Commission.

IN THE REGION Teva settles Nuvigil patent litigation Drugmaker Teva Pharmaceutical Industries Ltd. said it settled patent infringement litigation over Nuvigil and will allow rival generic drugmaker Mylan Inc. to sell generic versions of the sleep-disorder drug. Teva, of Israel, has its Americas headquarters in North Wales. The deal allows Mylan to start selling three doses of Nuvigil by June 2016. Mylan, based in Canonsburg, Pa., expects to have six months of marketing exclusivity on the generic doses of 50, 150 and 250 milligrams.

Teva Pharmaceutical Industries Ltd., which is based in Israel but has operations in North Wales, completed its $6.8 billion acquisition of Frazer-based Cephalon Inc. The combined company, which will make and distribute branded and generic drugs, will have a presence in more than 60 countries. Cephalon Inc. became a wholly owned subsidiary of Teva and ceased to be traded on NASDAQ. Under the deal, each share of Cephalon common stock has been converted into the right to receive $81.50 in cash.

Cephalon Inc. said yesterday that a late-stage clinical trial of its recently approved cancer-pain drug Fentora worked for patients suffering from chronic lower-back pain. The Frazer biotechnology company said results from a Phase 3 trial showed the lozenge, which dissolves in the mouth, had a statistically significant effect in relieving pain within 10 minutes compared with a placebo. Cephalon will present the data at the annual meeting of the American Society of Regional Anesthesia and Pain Medicine next month in San Francisco.

SmithKline Beecham said yesterday that it would invest up to $25 million in a West Chester firm that specializes in developing drugs to treat neurological problems. The agreement with Cephalon Inc. will focus on discovering potential medicines to reduce the debilitating effects of such conditions as stroke and traumatic injury. More than 500,000 cases of stroke occur in the United States annually, and few treatment options now are available, the companies said. Under terms of the agreement, SmithKline will pay the funds to Cephalon over a period of up to five years and allow the West Chester firm to help promote any jointly developed drugs in some major markets.

Cephalon Inc. yesterday reported a 54 percent increase in second-quarter revenue on strong sales of its biggest-selling sleep-disorder drug, Provigil, beating analysts' expectations. The Frazer company said it earned $55.4 million, or 83 cents a share, in the quarter ended June 30, compared with a loss of $249 million, or $4.29 a share, in the year-earlier period, when Cephalon took large acquisition-related charges. Revenue was $440.1 million, up from $286 million. "The quality of our earnings is strong because of the Provigil sales growth," said Frank Baldino Jr., founder and chief executive officer of Cephalon, referring to the company's treatment for narcolepsy, obstructive sleep apnea, and night-shift-work sleep disorder.

Cephalon Inc. received clearance from regulators yesterday to begin selling Treanda as a treatment for a rare form of leukemia. The medicine will be a new option for about 15,000 people in the United States diagnosed annually with the slow-progressing form of leukemia known as chronic lymphocytic leukemia, or CLL. The Frazer, Pa., biotech company said it hoped to make Treanda the foundation for a growing oncology business. "We are extremely excited about the future of our oncology business, particularly Treanda, which is a much-needed alternative for patients," chairman and chief executive officer Frank Baldino Jr. said after word of the approval by the Food and Drug Administration.

Cephalon Inc., a Frazier-based global biopharmaceutical company, said it is suspending its 2010 financial projections for the year based on preliminary second-quarter results that vastly exceed expectations. The company expects sales for the second quarter to be $705 million to $715 million. That is up from a previous projection of $645 million to $670 million. Projected income per share is expected to be $2.17 to $2.22, up from the estimated range of $1.65 to $1.75 The company said it will release its earnings Tuesday, when it also will update its guidance for the year.

Teva Pharmaceutical Industries Ltd. said Thursday the European Commission had approved its planned $6.8 billion purchase of Cephalon Inc., after agreeing to sell the generic rights to Cephalon's narcolepsy drug Provigil and agree not to sue the acquiring company. Teva is based in Israel, but it has operations in North Wales and recently broke ground on new facility in Northeast Philadelphia. Cephalon's headquarters is in Frazer. The U.S. Federal Trade Commission approved the deal on Oct. 7, with the condition that Teva divest other products.

In what prosecutors called the largest health-care settlement in federal court here, Cephalon Inc. will pay $425 million to settle criminal and civil charges that it illegally marketed three of its drugs. The Frazer company is expected to plead guilty in U.S. District Court to one misdemeanor criminal charge, the U.S. Attorney's Office in Philadelphia announced yesterday. Cephalon, a biopharmaceutical company based in Chester County, previously announced last November an "agreement in principle" with the U.S. attorney and Justice Department over an investigation that began in 2003 of its "off-label" promotion and sales of pain medication Actiq, Provigil for sleep disorders, and Gabitril for epilepsy.

IN THE REGION Teva settles Nuvigil patent litigation Drugmaker Teva Pharmaceutical Industries Ltd. said it settled patent infringement litigation over Nuvigil and will allow rival generic drugmaker Mylan Inc. to sell generic versions of the sleep-disorder drug. Teva, of Israel, has its Americas headquarters in North Wales. The deal allows Mylan to start selling three doses of Nuvigil by June 2016. Mylan, based in Canonsburg, Pa., expects to have six months of marketing exclusivity on the generic doses of 50, 150 and 250 milligrams.

Without actually saying "Iran," Teva Pharmaceutical Industries Ltd.'s chief executive officer said Wednesday that the Israel-based company was prepared as best as possible to deal with potential manufacturing disruptions if Israel is attacked by Iran or its allies. Tensions have risen in recent weeks over Iran's nuclear program and whether Israel might launch a military strike to disable the program before Iran can make a weapon. The assumption is that Iran and its allies would attack Israel in retaliation.

Before I leave 2011 behind, I must come clean about a column from last January in which I picked stories to watch involving local businesses. They weren't predictions. Just six things to keep in mind as the year unfolded. With the benefit of hindsight, I made some good choices, even if I provided the wrong reasons for them. The biggest no-brainer was to pay attention to Comcast Corp.'s acquisition of NBC Universal . The $30 billion transaction did indeed close and has profoundly changed Philadelphia's most valuable company, which started as a little cable TV operator in Tupelo, Miss., in the early '60s.

Phillip Frost wants a bigger bite of the global drug market for Teva Pharmaceutical Industries, which is why the board chairman and other directors hired Jeremy Levin to be the next chief executive officer of the world's largest generic manufacturer. Levin leaves Bristol-Myers Squibb, where he helped engineer the company's "string-of-pearls strategy," in which it forged successful partnership and licensing agreements with other companies. In choosing a doctor with a scientific and dealmaking background, Frost said, the Teva board wants to profit more from its move into different areas, including more branded drugs and over-the-counter products through a marketing deal with Procter & Gamble, while squeezing more out of its long-held global lead in the generic-drug market.

An Israeli media report Wednesday said that Teva Pharmaceutical Industries Ltd. could fire 1,000 workers in the United States and Europe in the wake of its acquisition of Cephalon Inc., which is based in Frazer, Chester County. Teva's $8.6-billion deal for Cephalon closed in October. Responding to the report, Teva spokeswoman Denise Bradley said the integration of the two companies has only recently begun and will include employee cutbacks. "At this point, we cannot comment on the number of employees or the fields in which changes will take place," she said in an e-mail.