Pfizer increased Jeff’s pay package by 10 percent to $12.6 million last year, even though the drugmaker’s earnings plunged. Kindler’s salary was increased to nearly $1.5 million in 2007. His bonus, however, was reduced to $3.1 million, from $3.3 million in 2006. The Pfizer ceo also received stock and option awards that were valued by the company at about $7.6 million on the day they were granted.

His other compensation totaled about $440,000, which included nearly $175,000 for using company aircraft, more than $42,000 for a car and $10,000 for financial counseling, according to the proxy statement filed with the Securities and Exchange Commission. Apart from his 2007 compensation, Kindler also realized more than $750,000 on vesting restricted stock units, the Associated Press writes.

The bigger pay package was awarded despite a plunge in Pfizer’s earnings last year to $8.3 billion, while revenue barely rose 1 percent. Meanwhile, Pfizer suffered from increased generic competition, the embarassing end to sales of the Exubera insulin inhaler and a loss of confidence on Wall Street. As the AP reminds us, Pfizer shares climbed to a high of $27.73 last June before dropping back to end the year at $22.73.

Read more »

As promised last month, Anna Eshoo, a Democrat from California - specifically, the region where many biotechs and venture capitalists are based - has now introduced legislation that would create a so-called pathway for FDA approval while offering brand-name companies 12 years of exclusivity, plus an extra two years for a medically significant innovation. That adds up to, yes, 14 years. (This is the bill and this is the summary).

Not surprisingly, the BIO trade group was ecstatic in its praise for Eshoo and Joe Barton, a Texas Republican who joined her in sponsoring the bill, which calls for studies to demonstrate safety and efficacy; requires the FDA to create a mechanism to determine whether products are interchangeable and also requires the agency to issue guidances for biosimilar approvals.

“Some special interests publicly say they want to delay follow-ons legislation until next year or beyond,” says BIO ceo Jim Greenwood in a statement. “We urge Congress to pass the right bill as soon as possible. It is time all parties work together to place patient needs before political gamesmanship. The time is now to pass a pro-patient, pro-innovation, pro-science follow-on biologics bill.”

Conversely, the Generic Pharmaceutical Association was distressed and argued the lengthy exclusivity provision will deny patients access to lower-cost meds for years. “‘The Pathway for Biosimilars Act’ is a pathway to the wrong destination for patients in need of safe and affordable biogenerics. This new bill, at best, is a disappointing distraction that does nothing to advance legislation. At worst, it’s a step backwards that puts brand company profits before patient needs,” says GPHA ceo Kathleen Jaeger, in a statement. “For a pathway to work, it must ensure patient access. Unfortunately, this new proposal creates a pathway filled with needless roadblocks to access.

John Lechleiter, who is about to be elevated to ceo, wrote e-mail in March 2003 to other Lilly execs that appears to have encouraged the drugmaker to promote its antipsychotic for an unapproved use, The New York Times reports. His remarks were sent after he traveled to Cincinnati to watch Lilly sales reps talk to doctors.

The e-mail message was discussed earlier this week in an Anchorage courtroom in a lawsuit against Lilly by the state of Alaska. The suit seeks reimbursement for the medical costs of Medicaid patients who developed diabetes while taking Zyprexa, which drug causes severe weight gain and cholesterol problems in many patients and has been linked to diabetes, the paper notes.

In the message, Lechleiter, who was then executive vp for pharmaceutical products, noted to other Lilly execs that sales reps were already promoting Strattera, a second Lilly psychiatric drug, to pediatricians and child psychiatrists. The reps, he wrote, could also discuss Zyprexa with such doctors. However, Zyprexa was not approved for children.

“The fact we are now talking to child psychs and peds and others about Strattera means that we must seize the opportunity to expand our work with Zyprexa in this same child-adolescent population,” he wrote, while encouraging Lilly to get data on the use of Zyprexa in treating “disruptive kids” in order to increase sales. UPDATE: To see a lengthy response from Lilly that was issued at about 9:30 pm EST, keep reading….

Read more »

The drugmaker’s former ceo, who retired last year but remains chairman received total compensation valued at $20.09 million in 2007, his last year at the helm, amounting to a 9 percent raise, the Associated Press reports.

Despite repeated rejections and delays in winning FDA approval, Bob received a base salary of $1.73 million in 2007, up 4 percent from the prior year. He received no bonus, but got $3.2 million from Wyeth’s nonstock incentive plan. Then there were restricted stock shares and options awarded him last April, when the company valued them at $14.93 million.

Essner also received perks and other compensation totaling $232,057, including $95,246 for the use of a corporate jet, $15,096 for personal auto use, $51,855 in company matches to two retirement plans, $39,460 for legal fees regarding ending his employment and $13,139 for reimbursement of taxes he paid, according to the proxy filed with the Securities and Exchange Commission.

Meanwhile, Bernard Poussot, who was promoted to ceo, received compensation totaling $11.85 million in 2007. His salary was $1.05 million, and last April, Wyeth gave him restricted stock and options it valued at $8.54 million. Poussot got $2 million from Wyeth’s nonstock incentive plan, plus $263,845 in other compensation, including $173,770 for corporate aircraft use, $5,596 for personal auto use, $50,165 for reimbursement of taxes he paid and $31,512 in matching contributions to two retirement plans.

Read more »

A controversial New Jersey bill to require informed consent from a minor’s parent before a doc, nurse practitioner and other healthcare providers can write a prescription for any psychotropic that already carries a Black Box warning was approved overwhelmingly by the state assembly yesterday in a 72-to-3 vote. You can read the bill here. Now, an identical Senate version heads for what may be a fractious debate in the Senate health committee.

This a big leap from just three months ago, when the bill appeared to be dead after a year-long fight by a pair of New Jersey moms and their allies, who argue that informed consent is the only way to make sure info is passed from docs to patients. In particular, they’re concerned that side effects, such as suicidal behavior and thoughts, that are linked to antidepressants can be misconstrued as part of the illness. As a result, they maintain parents may not have sufficient info to recognize troubling signals.

The legislation is being closely watched by the medical community and other legislators. But what do you think?

 Loading …

How is this for a boast? “It’s hard to compare us with other companies. Since in some respects, there’s not even anyone to compare us with. There is no company like Teva, nor will there be another company on the planet that will produce drugs in the quantities we will in a few years time, or that it will have a generic R&D operation the size of Teva’s.”

Would you say Shlomo Yanai is confident? The former major general in the Israel Defense Forces is finishing his first year as ceo of Teva Pharmaceuticals, the big generic drugmaker, and in an interview with Globes, the Israeli business newspaper, Yanai deflects speculation about Teva execs who are coming and going, and his ability to lead in the corporate world. Of course, if the questions weren’t so breathless…

Globes: People often talk about the secret of Teva’s success. Have you, as someone who came from the outside, managed to crack it?
Yanai: “Maybe. It’s a combination of several things. Firstly, Teva is outstanding in that it has a long-term strategy, in the real sense of the word, and not in the way it is bandied about all the time. The second thing is that it has a practical attitude. This does not mean there’s no internal criticism. There certainly is. Go out into the yard and take a look, there’s no shortage of gossip in Teva either, but everything is businesslike. The third thing is that there are some fantastic people here, and the fourth thing is modesty. We’re not ascetics and we haven’t made an ideology out of it. We don’t get up in the morning and pour a bit of sand on ourselves to make us feel humble, but look around - we don’t have swank offices, the modesty impacts on all our decision making. We have not let ourselves become dazzled, and the sense of pride is in the right place.”

You can read the rest here…

As the Lilly ceo heads toward retirement, he gave a little talk at the Wharton School of Business about the issues confronting the pharmaceutical industry. There was apparently no mention of Zyprexa or marketing issues, in general, because all that is the subject of litigation. Why risk time-consuming depositions when so many stock options are waiting?

But Sid did opine about the future. “I believe that the years ahead will amount to revolution much more than evolution,” he said during his keynote address at the recent 2008 Wharton Health Care Business Conference. “It will not happen overnight, but we are already moving toward the barricades and headed toward a new business model.”

Drugmakers, he offered, will move away from blockbusters and instead focus on highly individualized solutions for patients, which is generally called personalized medicine, although Sid prefers “tailored therapeutics.” To him, this is a larger concept that encompasses the many different types of personalized approaches to medicine. “A good tailor’s abilities go well beyond alteration,” he said. “The custom-made suit is his ultimate creation.”

And he maintained targeted treatments have the potential to increase repeat prescriptions, as opposed to the current trend away from repeat prescriptions due to the lack of efficacy, according a Wharton summary. Tailoring also bodes well for reducing costs and thus contributing to the bottom line. “The net result of sales can be quite virile. Instead of getting a relatively small slice of a large pie, the tailored model promises a larger share of a more segmented pie.”

Sid doesn’t address safety issues, but his comments sound similar to recent remarks by another outgoing ceo, Glaxo’s JP Garnier: “The development of new chemical entities and new biologicals is going to change. One way is to slice the patient populations, not to try to put the drug on the market for all the patients that could benefit, but focus on the easiest slice, the ones where they would be the least amount of controversy from a safety efficacy standpoint.”

When Japanese health officials learned of serious health complications with Zyprexa in 2002, they forced the drugmaker to put a strong warning on its label: Do not give to patients with diabetes. Sales took an immediate dive. So did Lilly’s reputation and not just with the Japanese health ministry, the Anchorage Daily News reports from Anchorage Superior Court.

Japan made Lilly send a “Dear Doctor” letter in response to nine reported cases of serious diabetic complications, including two deaths “for which causal relationship with this product cannot be denied,” according to the letter. That was out of an estimated 137,000 patients, the paper writes, adding that, as a result, Lilly had to put new warnings on the drug label, and doctors weren’t pleased.

“Market research shows we have also lost quite a bit of credibility with prescribers and opinion leaders, basically because they felt left in the dark with what they perceived as the late sharing of safety information,” two Lilly execs wrote that year in a memo to John Lechleiter, who was Lilly’s chief operating officer and president at the time.

Meanwhile, in the US, Zyprexa’s label, which guides doctors and other prescribers, has gradually been strengthened since the drug was first approved in 1996, the paper notes. Doctors now are told to closely monitor patients with diabetes. But they are not told diabetics should never be given Zyprexa.

The state of Alaska, you may recall, sued Lilly in 2006, alleging the drugmaker failed to warn of weight gain and diabetes caused by Zyprexa, and wants Lilly to cover treatment costs of Medicaid patients who suffered serious health problems. The civil suit is being closely watched by state and federal prosecutors investigating the drugmaker, because this is the first lawsuit filed by a state against Lilly to make it to trial.

Read more »

In a surprise move, the Ontario government announced yesterday it will begin covering the cost of an expensive drug to treat macular degeneration, a leading cause of blindness, even though an alternative is widely available at a fraction of the cost, The Globe and Mail reports.

It will cost the province’s drug benefit plan roughly $100 million over the next three years to pay for Lucentis, a breakthrough drug that has been on the Canadian market since last September. The decision will give eligible Ontarians - primarily seniors - suffering from wet macular degeneration access to this new drug for the first time, the province’s Ministry of Health and Long-Term Care said in a statement. But the paper reports thousands of Canadians already have access to a similar drug that is much cheaper than Lucentis and that many ophthalmologists say is equally effective. That drug, Avastin, and Lucentis, are both made by Genentech.

The problem is that Avastin was developed to fight colorectal cancer and isn’t approved for use in the eye by Health Canada. Although many ophthalmologists in Canada regularly use Avastin to treat wet macular degeneration, the fact it doesn’t have government approval gives significant leverage to Novartis, which sells Lucentis in Canada, to lobby governments to fund the high-priced drug.

“It’s a very unusual situation,” said Keith Gordon, head of research at the Canadian National Institute for the Blind. The situation is similar to what took place in the US, which you can read about here.

Read more »

A Philadelphia judge ruled this week that federal law can’t preempt a state product-liability claim concerning Glaxo’s alleged failure to warn about increased suicide risk of its Paxil antidepressant, The Legal Intelligencer reports.

Judge Allan Tereshko, the coordinating judge of Philadelphia Common Pleas Court’s Complex Litigation Program, denied a defense motion for summary judgment, ruling that federal preemption doesn’t preclude the plaintiffs from arguing Glaxo failed to fulfill its duty to warn users of Paxil of an alleged association between the use of the drug and suicidality. The drugmaker argued that the plaintiffs should be precluded from making that argument in state court under implied preemption.

“Defendant asserts that such inquiry is precluded by federal law since the content of the drug’s label is governed by federal law and the duty to supplement the label is somehow subsumed into the (FDA) regulatory scheme,” wrote Tereshko. “Defendant’s position is clearly not sustainable. Federal law in question unquestionably places the duty upon the manufacturer and does not preempt a state’s ability to allow one of its citizens to inquire whether the manufacturer breached that duty.”

This is the ruling. Last month, by the way, Glaxo won a Paxil case when a federal judge in California ruled that preemption trumped state courts.

According to attorney Bijan Esfandiari, who reps the family of Bobby Collins, a detective who committed suicide in 2002 while on Paxil: “Naturally, this is a significant ruling in the preemption battle and will benefit all of the plaintiffs in Pennsylvania’s Mass Tort Paxil Program. We further hope that Judge Tereshko’s scholarly decision will be relied upon as persuasive authority by courts in other jurisdictions.”

Read more »