Archive: May, 2008
Surprise! A Food and Drug Administration advisory panel is backing approval for a blood-clotting drug being developed by GlaxoSmithKline and a San Diego firm.
The advisors voted unanimously today to recommend approval for Promacta to treat an immune system disorder. That's a bit of a surprise given that the FDA staff said the data indicated that the drug didn't work any better than a placebo in clinical testing.
After the staff report was released earlier in the week, the stock price of GlaxoSmithKline's development partner, Ligand Pharmaceuticals, plummeted to its lowest level in a decade. Today, Ligard shares popped up by more than 50 percent.
Shares of GlaxoSmithKline, which is a much bigger company, also rose on the action by the Oncologic Drugs Advisory Committee, rising little more than 1 percent.
The full FDA generally follows the recommendations of its advisory panels, but nothing requires it to do so. The key date for FDA action is June 19.
“It’s Always Sunny in Philadelphia” is not just the name of a cable-TV show.
It describes the positive thinking that seems to be catching in the executive suites of Philadelphia-area companies.
A new survey by KPMG LLP shows local executives to be fairly bubbly about their companies’ prospects and the city’s business climate.
A whopping 90 percent of the 106 senior executives polled said the Nutter administration will have a positive impact on business conditions here.
Given that the survey was conducted in February and March, some of those good feelings could just reflect the honeymoon the new mayor is enjoying.
Jerry Maginnis, managing partner of KPMG’s Philadelphia office, said he thinks there’s more to it. “It’s one thing to be a cheerleader for the city,” he said, but Nutter has an ambitious agenda that has kindled a “sense of optimism” that the challenging business environment will change.
You and I could predict that the biggest thing businesses want is lower city taxes. But the KPMG survey also asked businesspeople what they would do to help the city. Forty-eight percent said they would hire summer interns, one of Nutter’s pet programs.
In February, the mayor challenged the business community to double its commitment to hire summer interns. The Greater Philadelphia Chamber of Commerce, which has been championing the effort, set a goal of 2,000 internships compared with the 1,049 provided by employers in 2007.
Given the downshift in the U.S. economy, I thought it would be really tough to nail that. As of Wednesday, the chamber had identified 1,039 internships, which will start June 30.
Maginnis said KPMG is doing it part, doubling its summer internships this year to four. But its survey makes it clear that the chamber has its work cut out to meet its goal:
Forty-six percent have not hired summer interns in the past, and 29 percent said it would be hard to raise their paid-intern ranks this year.
But maybe next year. The survey indicates that 60 percent of these regional companies expect better company performance a year from now. They say this even though 68 percent think it’s likely the United States will slide into recession in the 12 months.
Maginnis noted that dichotomy. One possible explanation is that the Philadelphia economy is such a diverse one with a substantial number of jobs tied to education and medicine — sectors that weather downturns well.
I take every survey with a canister of salt. What people say and what they do are often very different things.
But we’ve been fairly insulated from the housing market collapse and job destruction being experienced in other areas of the country.
Philadelphia’s been a good place to be for these executives. No wonder they see even better times ahead.
Redlasso Inc. will not acquiesce to several broadcasters’ request that it cease and desist in providing their video content over its Web site.
In fact, the King of Prussia company has added a high-powered broadcast industry executive to help make its case to the broadcasters.
Redlasso retained Michael H. Jordan, former CEO of CBS Corp., as a senior advisor. Until August, Jordan was the CEO of Electronic Data Systems Corp., of Plano, Texas.
One of his roles for Redlasso will be as chief liaison to the networks. In a statement, Jordan said he had “the greatest belief in the solution offered by the company and its long-term viability.”
NBC, Fox, CBS and two other broadcasters sent a letter May 19 to Redlasso expressing concern over its “unauthorized copying and distribution” of copyrighted content. That letter went on to demand that it stop doing it.
Redlasso operates a password-protected site that enables bloggers to search for TV and radio segments that they can then clip and add to their blog posts. Since launching it in November, Redlasso has usage of the site skyrocket with 24 million unique visits in April. Bloggers love it, even Philadelphia's own Philebrity.
Redlasso chief operating officer Al McGowan said in the statement:
Our goal was always, and continues to be, the development of a platform that would be beneficial both to the content providers and the blogging community. And we’re hopeful for constructive negotiations with the content providers.
No immediate reaction from those broadcasters.
When it comes to lobbying and the pharmaceutical industry, apparently you can never have too many voices.
The Center for Responsive Politics says the pharmaceutical industry spent $150 million on lobbying in 2007.
The Pink Sheet trade publication says that Frazer’s Cephalon Inc. and Chadds Ford’s Endo Pharmaceuticals Holdings Inc. have teamed with five other drug makers to form America’s Specialty Medicines Companies.
Cephalon’s vice president of public affairs Sheryl Williams confirms the companies have been talking for months, but that right now it’s an “informal working group.”
I can’t imagine that Washington really needs another group calling on Congress on behalf of the drug industry.
After all, the Pharmaceutical Research & Manufacturers Association, one of the most powerful trade associations, spent $22.7 million on lobbying last year.
And the Biotechnology Industry Organization, which has become the biggest advocate for biotech companies, spent $7.2 million.
But Williams said Cephalon and the other six companies involved in this working group are not giants like those in Big Pharma. (The other members are Celgene, Cubist, Millennium, Purdue and Sepracor.) They’re also not development-stage firms working on biologics.
Each of these seven has at least one or two drugs that provide most of their revenue, Williams said. As a result, their situation can be more tenuous than a Big Pharma company that can rely on dozens of products, including the billion-dollar-selling blockbusters.
She said the group sees its concerns as different from those of Big Pharma and traditional biotech even if it hasn’t been able to articulate exactly what it will stand for. The companies just know that when it comes to federal legislation “it’s not one size fits all,” Williams said.
Maybe these companies are what parents say about teenagers: They’re at an awkward age. Too old to play with the kids, but not old enough to hang with the adults.
Still, let’s hope they don’t start hanging out on the corners outside the Capitol.
How many voices does an industry need?
When it comes to the pharmaceutical industry, apparently you can never have too many.
A couple of drug industry trade publications say that Frazer's Cephalon and Chadds Ford's Endo Pharmaceuticals have teamed with five other drug makers to form America's Specialty Medicines Companies.
The In Vivo blog cites a report in The Pink Sheet trade publication that the organization is still being formed, so it's not clear what its main priorities are. (I can't afford $1,900 a year to subscribe to The Pink Sheet. Those who can obviously can afford to belong to multiple trade associations. But it looks as if the item has been reprinted at FDALegislativeWatch.com.)
But the founding members indicated to the trade pub that they're not dissatisfied with the alphabet soup that is Washington's other advocacy organizations:
* PhRMA, the Pharmaceutical Research & Manufacturers Association, one of the most powerful trade associations in the nation. The Washington-based group represents dozens of pharmaceutical and biotechnology companies.
* GPhA - Generic drug makers have their own group called the Generic Pharmaceutical Association.
* And BIO, the Biotechnology Industry Organization, which has become the biggest trade association for biotech companies.
Besides the two Philadelphia-area drug companies, the ASMC would include Celgene, Cubist, Millennium, Purdue and Sepracor.
Sheryl Williams, Cephalon's vice president of public affairs, described the effort as an "informal working group" that had been talking for a few months trying to identify common ground. Legislation that might affect sales and marketing or changes at the Food and Drug Administration are some of the issues they've discussed.
What they do have in common is that each has at least one or two drugs that provide most of their revenue, Williams said. As a result, their situation can be more tenuous than a Big Pharma company that has dozens of products, including the blockbuster medicines that draw most of the public's attention.
She said the group sees its concerns as different from those of Big Pharma and traditional biotech even if it hasn't been able to articulate exactly what it will stand for. The companies just know that when it comes to legislation "it's not one size fits all," Williams said.
But one thing Cephalon does not want to see is the formation of a new trade association, she said. Because the lobbyists for these companies had been meeting and discussing issues, the group had to file paperwork with regulators disclosing that. She described the effort as "early in its development."
While it was founded as a biotechnology company, Cephalon isn't now. Provigil, which treats various sleep disorders, is its biggest-selling drug. Cephalon executives were key to Philadelphia's attracting the big BIO convention in 2005. But Cephalon became a full-fledged member of PhRMA in the last year. This is the first year Cephalon has not been a member of BIO, Williams said. (The company remains a member of Pennsylvania Bio, a statewide organization.)
Interestingly, Cephalon doesn't like, or use, the phrase "specialty pharmaceutical" company. But that's exactly how Endo describes itself. The company focuses on pain management drugs, and its top-selling drug is Lidoderm, a patch that contains lidocaine.
(Thanks to the FiercePharma newsletter for flagging this development.)
Can the CEO of a publicly held company be a whistleblower?
Well, that’s what Louis D. Paolino Jr. seems to be claiming in a letter filed with the Securities and Exchange Commission on Friday.
Paolino was terminated as CEO of Mace Security International Inc., of Fort Lauderdale, Fla., May 20, for what the board described as willful misconduct.
Lots of CEOs not only keep their jobs but get raises when their companies perform poorly. Even when a CEO gets ousted, he often leaves with a generous severance package.
Then there’s the situation between Paolino and Mace, the maker of self-defense sprays that used to be based in Mount Laurel.
Mace, which has not been profitable since 2001, dumped Paolino after the board said he was not following its instructions. The company will not pay him any severance.
Not so fast, according to a “statement of disagreement” written by Paolino and filed with the Securities and Exchange Commission.
The ex-CEO says he’ll seek arbitration for more than $4 million in damages for the breach of his employment contract and more than $6 million for defamation of character.
But more intriguing is Paolino’s statement that he’ll file a claim with the federal Labor Department as a whistleblower. Why would he do that? Paolino claims the board was requesting him to take actions “in violation of my obligations under Sarbanes-Oxley.”
That’s the law, passed after the collapse of WorldCom, that tightened public companies’ oversight of their accounting practices.
Paolino is going to have a tough time convincing regulators that he’s the underdog. Far from being a powerless worker bee in a sprawling enterprise, Paolino was in charge of Mace for nearly nine years. Plus, he certified Mace’s latest 10-Q, under a provision of the Sarbanes-Oxley law. Why’d he sign if he had some concerns about disclosure?
For its part, Mace said it disagrees with the statements made by Paolino in his letter and that it “intends to vigorously defend any litigation he initiates.”
More details have emerged about the rift between Mace Security International Inc. and its CEO that led to his ouster last week for misconduct.
Mace, which is now based in Fort Lauderdale, Fla., but had been in Mount Laurel, terminated Louis D. Paolino Jr. at a special board meeting May 20. In its statement, the maker of personal defense spray and hidden cameras said that Paolino did not follow board instructions or perform his supervisory duties sufficiently.
A filing Friday with the Securities and Exchange Commission contains Paolino's response to the board's allegations. He told Inquirer staff Bob Fernandez last week that he would fight, and the letter makes it clear he's not going quietly:
The Board's "belief" that I have not followed its instructions or sufficiently performed my supervisory duties is patently false and misleading.
Paolino goes on in the "statement of disagreement" to list areas where he and the board disagreed over disclosure of certain events, including:
... the notice of resignation of key officers of the Digital Media Marketing segment, the changes (or potential changes) in the business plan of the Company as previously established, the change in the overall strategic direction of the company, and the disagreements between management of the Company and its Board of Directors relative to the above.
Paolino writes that he hired his own lawyer (at Greenberg Traurig) to "review and evaluate some of the disclosures and risk factors" in a quarterly financing filing called a Form 10-Q. What happened next?
I forwarded the recommendations of my counsel to the Company on May 14, 2008. Within days of my taking this action and, in blatant violation of corporate law and MSI's by-laws, the other five members of the Board called and held a secret Board meeting without providing me with any notice that it would be held. Decisions were made by the Board in my absence at this unlawful meeting which, in direct retaliation for my intent to make certain disclosures to the shareholders, led to my subsequent wrongful termination.
Mace's board issued "patently false statements defaming my character," Paolino writes.
As he told the Inquirer last week, he will seek arbitration for more than $4 million in damages for the breach of his employment contract. Today's letter adds that he will seek more than $6 million for defamation of character.
But more intriguing is Paolino's statement that he'll file a claim with the federal Labor Department as a whistleblower. Why would he do that? Paolino claims the board was requesting him to take actions "in violation of my obligations under Sarbanes-Oxley." That's the post-Worldcom law governing corporate disclosure and documentation of financial controls by public companies.
So Paolino, the former CEO, is claiming whistleblower status under a law that was passed to clean up the accounting shenanigans of many companies in the late '90s and early '00s. Can a CEO be a whistleblower? We'll find out.
In the meantime, Mace said it disagrees with the statements made by Paolino in his letter and that it "intends to vigorously defend any litigation he initiates."
Unisys Corp. is losing one of its senior executives.
Randy J. Hendricks, president of Unisys' Global Industries business unit, will step down from the Blue Bell computer services company on June 15. The company reported it in an 8-K filing with the Securities and Exchange Commission today.
Hendricks is joining Electronic Data Systems Corp. to lead that Texas company's Applications Services and Systems Integration unit.
Hendricks, who was listed in the 2007 proxy statement as one of Unisys' most highly compensated officers, was promoted in January to executive vice president and his other current title. He's been an officer at Unisys since 2003.
Unisys, which was being been pressured by a big shareholder to break up the company, last week agreed to add representatives of that investor to its board and to hire Goldman Sachs to help it evaluate alternatives.
Hendricks must be comfortable with the situation that he's going to join at EDS. Hewlett-Packard Co. agreed to buy EDS on May 13 for about $13.9 billion.
Reaction to my recent column about the economic-stimulus payments ran the gamut.
Several people said I erred in the amount of the check. I used the maximum $600 per person but neglected to point out caveats that may lower the amount you receive. Too many, in fact, to list here. But they boil down to how much you make in a year.
For example, if you are single with adjusted gross income of more than $75,000, you’ll get less than the $600.
The IRS will send a letter telling you how it calculated your payment. I got mine last week and it was very clear.
Other people called with specific questions about how their personal situations might affect the amount of their check. One woman said her husband died in March but the IRS sent her a check that contained payments for both of them. Did she have to give his share back?
Good question and I found a clue to the answer on the IRS’ Web sit where it prominently lists “Rebate Payment Questions.”
But I’m not the taxman and I don’t even play one on TV, so I advised her to call the IRS’ toll-free number (1-800-829-1040).
She called me back to say that she was told she does get to keep that money because her husband was alive during the 2007 tax filing year.
Finally, one reader took issue with my calling this “found” money. His point was that the government isn’t really giving us anything, it’s simply taking less.
And he called it what is: a massive redistribution scheme to funnel money from those who will not receive checks (because they make too much money) to those who will get checks.
He’s right, and that’s exactly the intention: Get billions of dollars into the hands of people more likely to spend it than to save it.
Will the average American do that? Probably. After all, the warm weather is here, the kids are getting out of school. Buying new patio furniture sure sounds a lot more fun than paying off that credit-card balance from the last Christmas shopping season.
As for me, the IRS last week directly deposited my payment into my checking account, but I’ll be moving it into a money market fund this week.
When it comes to drug development, every decision the Food and Drug Administration makes (or does not make) can have big-money implications.
Case in point: The FDA’s approval of Adolor Corp.’s first drug last week triggered a $20 million payment to the Exton drug company.
GlaxoSmithKline PLC has been Adolor’s partner in developing Entereg, a treatment for constipation related to bowel surgery, since April 2002.
Their agreement then called for GlaxoSmithKline to pay as much as $270 million to co-develop and market Entereg. Adolor got $50 million upfront; the rest would only be paid after reaching certain milestones.
Adolor received $10 million during 2004 when the FDA accepted the new drug application for Entereg, the beginning of the regulatory review process. Nearly four years later, Entereg narrowly won approval and will be restricted for use only in hospitals.
So if you’re keeping score, Adolor has received $80 million from GlaxoSmithKline from a deal first announced six years ago.
But starting in June, when the two drug companies expect to launch Entereg, Adolor will begin to see something it has never seen in 15 years: sales revenue.
Philly Ticker
Bank stocks have done little but gurgle since the credit crisis began to rage. But there’s nothing like a little acquisition to stoke the stock price.
Shares of Willow Financial Bancorp Inc. soared 21 percent last week after Harleysville National Corp. agreed to acquire it for $162 million. That made Willow the biggest mover among local stocks. It closed Friday at $9.30.
Companies making acquisitions rarely see their shares rise. And Harleysville fell 4 percent last week to close at $13.46 on Friday.
Annual Meetings
This week’s shareholders meetings:
* MEDecision (Tuesday.)
* Vishay Intertechnology (Wednesday.)
* Pennsylvania Real Estate Investment Trust, Genaera (Thursday.)
* Aetna, ICT Group (Friday.)
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