Cephalon

Specialty drugmakers lobbying together

Tracy Staton — Wed, 28 May 2008 10:30:00 -0400

Here's a quandary: You're a good-sized drugmaker, but not a behemoth able to throw your weight around the industry's big trade associations. So how do you get your voice heard in our nation's capital? Form your own association, of course. That's exactly what Celgene, Cephalon, Cubist, Endo, Millennium, Purdue and Sepracor are doing: Banding together under the name America's Specialty Medicines Companies, and hiring a D.C. law firm for help getting organized.

What might this assortment's key issues be? That's unclear as yet. But you can bet we'll hear more from them as time goes by.

- read the item at In Vivo

Cephalon's Frank Baldino - CEO Pay

Tracy Staton — Mon, 19 May 2008 14:48:49 -0400

Frank Baldino- Cephalon

Total Compensation: $13.5M

2007 Revenue: $1.8B
2006 Revenue: $1.76B
Change: 2.2%

Details: Baldino's pay includes $1.2 million salary, $2.2 million in bonus, and $10.1 million in stock and options. In total, it rose about $2 million from 2006 levels. Another interesting fact: According to the Wall Street Journal, Baldino makes 140 percent of the median among his peers.

Cephalon News:
Cephalon pays CEO more than hefty rivals
FTC sues Cephalon for blocking generics
Cephalon to pay $425M settlement

Public Citizen joins FDA review

Tue, 13 May 2008 06:59:57 -0400

When Cephalon asked the FDA to expand the use of its opioid painkiller Fentora, did it see the shape of things to come at the agency? In Vivo says yes, the "challenging" regulatory environment was on display during last week's advisory committee meeting. In fact, the drugmaker may have faced the embodiment of FDA's apparent caution: Sidney Wolfe, M.D., of the consumer group Public Citizen, a frequent pharma critic, was a "temporary voting member" of the committee hearing the Fentora request.

Agency observers tell In Vivo that Wolfe will be at that table more often in the months to come--and the blog thinks that's a good thing, now that FDA has more post-marketing enforcement tools at its disposal, because Wolfe will push the agency "to use its new tools aggressively." Plus, his presence would be an added stamp of credibility: "If his opinions are built into the standard risk management reviews, then his concurrence should shield the agency (and drug sponsors) from further criticism." We'll be watching this one closely.

- see the item at In Vivo

ALSO: "New" CDER chief Janet Woodcock has been busy weighing in on risk-management plans, too--and trying to figure out how to implement other measures of the FDA Amendments Act, too. Report

FDA panel rejects broader Fentora use

Wed, 07 May 2008 06:59:57 -0400

No go, Fentora. An FDA advisory panel voted against broadening the use of Cephalon's painkiller, citing worries that it would in fact be misused. Already the potent drug has caused overdoses and death when it was improperly substituted for another painkiller. Plus, the panel said it could be more attractive to potential abusers because it's stronger than other opioids. The expert advisers told Cephalon to get more data on a proposed risk-management plan for the drug.

The FDA doesn't have to follow the panel's recommendations, but usually does. And an FDA briefing document raised these concerns in advance of the panel meeting. A final decision is expected in mid-September. If the FDA decides to go ahead and approve the expanded label, Fentora could have a potential market of more than 10 million patients, the panel estimated.

After yesterday's meeting, analysts said even if Fentora doesn't get the FDA go-ahead this time around, the drug may still be approved for broader use: It's "a matter of when--not if," one said.

- see Cephalon's release
- see the story in BusinessWeek
- check out the AP article

ALSO: The FDA's decision to reject Merck's new cholesterol med Cordaptive is further proof that the agency is remaining cautious, according to the Star-Ledger. Report

Expert panel to mull broader Fentora use

Fri, 02 May 2008 06:59:55 -0400

Everyone suddenly has an opinion on Fentora. Good opinion: The Cephalon painkiller got European approval a couple of weeks ago, after two years on the market in the U.S. Another good opinion, in the imitation-is-flattery department: Watson Pharmaceuticals filed for the FDA OK on its copycat version of the oral med. In good opinion number three, analysts pooh-poohed Watson's generic challenge, saying, "Fentora is a novel invention and the patents are strong."

Then there's one not-so-sure opinion, from none other than the FDA. As the anesthetic drug advisory committee prepares to discuss broadening usage of Fentora at next week's meeting, an agency staffer raised the twin specters of drug abuse and adverse events in briefing documents. Fentora's current risk-management programs have already failed in a few instances, the documents state, leading to serious adverse events, including overdose deaths. You'll recall that the company strengthened warnings on Fentora's label to help prevent those problems, which seem to stem from prescribing the med inappropriately and from substitution errors.

Given these problems, the documents say, expanding Fentora's indication beyond breakthrough cancer pain could lead to more misuse. And it could make the med more accessible to potential abusers. Key to approval, the staffer wrote, would be an effective risk management program. Is this possible? We'll see what the advisory committee says next week.

- read the FDA briefing
- see the Euro OK piece at Motley Fool
- check out Watson's release
- read the patent coverage in the Chester Daily Local

Cephalon pays CEO more than hefty rivals

Wed, 26 Mar 2008 07:59:58 -0400

Which drug exec gets paid 140 percent more than the median among his peers? Hint: His company makes the anti-narcolepsy med Provigil. And he made a cool $13.5 million last year (the AP says $16 million). That paycheck included a $1.2 million salary, $2.2 million in bonus, and $10.1 million in stock and options.

If you said Cephalon CEO Frank Baldino (photo), you're correct. Baldino beat out Big Pharma chiefs Jeff Kindler ($9.5 million, according to the WSJ) and Bristol-Myers Squibb's Jim Cornelius ($11.3 million). That's saying something, considering the fact that Cephalon's $1.8 billion in revenues is dwarfed by Pfizer's $48.6 billion and Bristol's $19 billion.

Actually, Baldino qualified for an even bigger bonus, the company said, but its compensation committee decided to shave a bit off the top because of Cephalon's recent $425 million settlement with the U.S. Attorney's office in Philadelphia. The company was under investigation for off-label marketing violations.

- read the item at the WSJ Health Blog
- check out the AP's figures here

Related Articles:
FTC sues Cephalon for blocking generics. Report
Cephalon to pay $425M settlement. Report
Cephalon takes heat for off-label narcotic promotion. Report

FTC sues Cephalon for blocking generics

Thu, 14 Feb 2008 06:59:57 -0500

Here's one way generics might pay off. The feds are accusing Cephalon of bribing drugmakers to keep copycat Provigil off the market. According to an FTC lawsuit against the company, Cephalon paid four generics makers $200 million to stop selling their versions of the narcolepsy drug until 2012. With $800 million in annual sales, Provigil accounts for about half of Cephalon's revenues.

Using words like "monopoly," an FTC official said Cephalon agreed to share profits with the generics firms in exchange for their staying out of the fray. "Such conducts is at the core of what the antitrust laws proscribe," the official said. But Cephalon defended its agreements with the other companies, which settled patent litigation. "We believe they fully comply with both the spirit and letter of the antitrust laws," the company said in a statement. And Barr Pharmaceuticals, one of the generics firms, said that it believes the deals are legal and that they serve consumers' best interests.

- find Cephalon's release about the FTC suit
- read the story in BusinessWeek
- check out more details in the Wall Street Journal

Related Articles:
Cephalon to pay $425M settlement. Report
Cephalon takes heat for off-label narcotic promotion. Report

ALSO NOTED: Nigeria wants to extradite U.S. Pfizerites; PDI BioPharma sells cardio drugs;

Tue, 05 Feb 2008 06:59:50 -0500

> Just weeks after Nigerian officials sent local Pfizer officials scurrying to avoid arrest, the Kano state government is asking that three Americans be extradited and tried in the ongoing court battle over a meningitis drug trial there. Report

> PDI BioPharma agreed to sell its FDA-approved cardiovascular meds Cardene and Retavase for up to $170 million; the deal also includes an in-development drug called ularitide. Report

> In 2007, Cephalon spent $160,000 lobbying for the approval and insurance reimbursement of Vivitrol, a treatment for alcoholism, according to Senate documents. Report

> Alkermes announced that its Risperidone antipsychotic drug helps to prevent relapse in patients with bipolar disorder, according to a new study. Report

> Though nearly one in four primary care docs prescribe antidepressants for lower back pain, there's no evidence the drugs offer relief, according to a new study. Report

> Extending antiretroviral treatment to HIV-positive moms who are breastfeeding helps keep babies from contracting the virus via their mothers' milk. Report

> Researchers have overcome one of the chief obstacles to developing a vaginal gel to protect poor women from HIV infection. Report

> Researchers targeting new treatments for the common cold can now look forward to getting help from a new mouse model for the ailment. Report

> Struggling under the weight of falling anemia drug sales, Amgen is selling the Japanese rights to a slate of some 13 experimental therapies to Takeda in a deal that may be worth more than $1 billion. Report

> Wanted: Biotech companies with no cash flow, facing a high risk and in need of money to back translational development efforts. Report

And Finally... Eat your veggies, avoid saturated fat, and take aspirin? New research shows that long-term use of the pain killer cut the risk of colon cancer by up to 70 percent. Report

ALSO NOTED: Sepracor chair to retire in May; Study shows Glaxo drug outpacing Pfizer's Spiriva;

Wed, 02 Jan 2008 06:59:50 -0500

> Sepracor chairman Timothy Barberich will retire by May, according to a disclosure filed with the Securities and Exchange commission; Barberich is the drug maker's former CEO. Report

> A GlaxoSmithKline-funded study showed that chronic obstructive pulmonary disease patients using its asthma drug Seretide (Advair) were half as likely to die as those using Pfizer's Spiriva. Release

> Pfizer India sold several of its brands, including Listerine and Benadryl, to Johnson & Johnson for $55 million. Report

> Cephalon is asking the FDA to extend the use of its chemo drug Treanda to lymphatic cancer in patients who have stopped responding to Genentech's Rituxin. Release

> India-based Wockhardt got U.S. FDA approval to sell its copycat form of Zyrtec, the allergy med. Report

And Finally... Researchers have identified the reasons why fish oil protects people from Alzheimer's disease. Report

10. Fentora - Top 10 Warnings and Recalls

Tracy Staton — Thu, 29 Nov 2007 10:17:50 -0500

Drug: Fentora

2006 sales: $370 million

Manufacturer: Cephalon

Safety concern: Warning; improper dosing leading to death

Related Articles:
> New warning for off-label Fentora. Report
> Red flags raised on Fentora misuse. Report
> FDA approves Fentora for cancer pain. Report
> Cephalon shares jump on Fentora decision. Report
> Cephalon takes heat for off-label narcotic promotion. Report