Another busy day draws to a close. At least for now. Who knows what may turn up later? Maybe another high-ranking exec will suddenly resign? Nonetheless, we will break to entertain one of the short people and check back later. We will also compile the results of our two latest unscientific polls - one concerning Fred Hassan, and the other about Andy Bonfield at Bristol-Myers Squibb. Meanwhile, these should help you keep busy…..

Carl Icahn dumped his Genzyme shares, according to Xconomy.com. Regulatory filings posted today show that during the fourth quarter of 2007 the activist investor dumped all 1.5 million shares he bought in Genzyme during the third quarter. You may recall that Genzyme ceo Henry Termeer in December told Carl to go away, but the site speculates the real reason Carl sold the stock is because he made a tidy profit.

Caremark, the pharmacy benefits manager, has agreed to pay $38.5 million in a multistate settlement of claims that it was deceptive when it encouraged patients to switch prescription drugs under the guise of saving money, the Associated Press reports. Instead, Caremark kept rebates and discounts that it should have passed on to patients and employers, according to Pennsylvania Attorney General Tom Corbett, who adds that the PBM didn’t adequately explain to docs how switching drugs would affect what a patient would pay.

Lawmakers chastised the FDA for its failure to inspect a Chinese plant that made an ingredient for Baxter’s Heparin blood thinner. The criticism came after the FDA urged docs to limit use of the blood thinner following reports of 350 life-threatening reactions and four deaths. Regulators aren’t sure the ingredient from the Chinese supplier caused the side effects. The agency conducts annual inspections of less than 10 of overseas drugmakers that ship to the US, according to the Government Accountability Office. The letter to the FDA from the House Energy & Commerce Committee.

Warren Buffett bought a stake in Glaxo, Bloomberg News reports. His Berkshire Hathaway holds 1.51 million American depositary receipts valued at about $65.4 million. The investment follows purchases of stock in several health-care companies over the past 12 months, including Johnson & Johnson and Sanofi-Aventis, as well as two big health insureres, UnitedHealth Group and WellPoint.

A judge will decide by early next week whether to reduce a $134 million judgment against Wyeth that jurors awarded three Nevada women in October after deciding its Prempro pill caused the women’s breast cancer, the Associated Press writes. Washoe County District Court Judge Robert Perry says he’ll issue a written ruling by Tuesday on the drugmaker’s request to find the award illegally excessive and slash it to closer to $5 million.

The pill, not just the controversy, can have that affect on you. The FDA has just approved a labeling change for the cholesterol med that adds depression as a possible side effect. The same thing goes for Zetia, which along with Zocor comprises the Vytorin combo therapy.

In letters to Schering-Plough and Merck, which jointly market the meds, the agency says depression would be added to the section of the label that discusses adverse reactions in post-marketing and the new language will be included in a section of package inserts listing possible side effects. The section of the label being changed is for adverse reactions regardless of the “causality assessment.”

Here is the letter to Merck and here is the letter to Schering-Plough. This is the new Vytorin label.

A Merck spokesman told Dow Jones that the changes were made based on reports of depression by patients, which the drugmakers forwarded to the FDA, and caused them to submit proposed label changes in October.

After nearly a decade of resisting, biotech companies want a law passed this year that lets generic drug companies sell cheaper copies of their medicines. Biotechs, of course, have never had the competition from generics that brand-name drugmakers face when patents expire. While the FDA lacks authority to approve generic biotechs, several bills introduced in Congress during the past year would change that, the Associated Press writes.

Biotech companies say they are ready for that change - so much so that their main trade group is making the legislation a top priority in 2008. And the Bush administration recently said it supports that aim. The shift comes as election-year politics are expected to turn Washington away from biotech’s interests. Many political observers expect Democrats to gain more power in Congress this November, which could tilt favor to the generic drug industry.

Faced with that possibility, the biotech industry wants an agreement as soon as possible. “We’ve made good progress in having this issue understood by the people who are in place on Capitol Hill now,” Jim Greenwood, president of the BIO trade group, told reporters at a press event in Washington. “And we’d like to get it done this year so we don’t have to start all over again.”

The group spent more than $3.6 million lobbying Congress and federal agencies on issues including biogenerics in the first half of 2007. But BIO must also consider that Barack Obama, Hillary Clinton and John McCain have all advocated generic drugs as a health care cost-cutter.

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In October 2005, Wyeth filed a citizen’s petition with the FDA in an effort to stop compounding pharmacies from making bioidentical versions of Prempro, its controversial hormone replacement therapy, which some women claim in lawsuits has caused them to develop breast cancer. Last month, the FDA responded by sending warning letters to seven compounders that their claims about the safety and effectiveness of their BHRT products are unsupported by medical evidence, and are considered false and misleading.

The FDA explained that the drugs made by the compounding pharmacies contain hormones such as estrogen, progesterone and estriol, which the agency made a point of noting isn’t a component of any approved drug and hasn’t been proven safe and effective for any use. And this makes for a little bit of irony. In its petition, Wyeth harps on the presence of estriol in these BHRTs as a prime reason the FDA ought to yank the compounded drugs from the market.

The “FDA should…initiate enforcement action against compounded BHRT products containing Estriol and the pharmacies manufacturing them on the grounds that the products are adulterated and misbranded, and that their sale without prior FDA approval of an NDA (new drug application) violates the
new drug provisions of the (Food Drug & Cosmetic) Act and poses a serious threat to public health.” (See pages 18 and 19 of the petition).

At the same time the petition was filed, however, Wyeth was selling Cyclo-Menorette, a menopausal drug in four European countries - Estonia, Germany, Latvia and Poland - that contained, yes, estriol. (This is the package insert from Germany). The drug was since discontinued due to “limited sales,” according to a Wyeth spokesman. So how does the drugmaker reconcile what appears to have been a contradiction?

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Who says we only tell you about layoffs? Shire plans to expand its operations in the greater Boston area by adding the 680 jobs over the next eight years, the Associated Press reports.

A Shire unit, Shire Human Genetic Therapies, says it expects to invest $394 million to construct a new manufacturing plant in Lexington. The drugmaker already employs 675 people in nearby Cambridge, but has transferred some operations to Lexington Technology Park. That shift will accelerate with construction of the manufacturing plant.

Shire, by the way, considered expanding out of state, since other states offered incentive packages to compete with Massachusetts. But Shire was swayed by state tax and other incentives totaling more than $40 million, plus another $7 million offered by the town of Lexington itself.

In recent months, China has caused tremendous consternation. A Chinese facility that wasn’t inspected by the FDA made the active ingredient in Baxter’s Heparin blood thinner, which is now being reviewed after 350 reports of allergic reactions and four deaths. A big state-owned Chinese drugmaker, Shanghai Hua Lian, that exports to dozens of countries, including the US, caused a scandal after nearly 200 Chinese cancer patients were paralyzed or otherwise hurt last year by contaminated leukemia drugs. The company supplies the active ingredient for the RU-486 abortion pill.

However, Michael Santoro, an associate professor of business ethics at Rutgers Business School, believes pharma should get out of China and Congress ought to impose an embargo on drugs made there. Santoro, who co-edited ‘Ethics and the Pharmaceutical Industry’ and next month presents a paper at Stanford University entitled ‘Flight of the Toxic Dragon: The Global Threat to Safety Posed by China’s Underdeveloped Drug Regulation Regime,’ says the American public is increasingly at risk because of abysmal oversight. If action isn’t taken now, he warns, the number of serious incidents and fatalities will only increase.

Pharmalot: The Heparin story seems to have focused still more attention on problems in China, but how bad is it?
Santoro: Let me state this in no uncertain terms - the pharmaceutical companies should not be there. China is not ready to be a chemical manufacturing hub for the United States and the rest of the world. There’s far too great a safety danger. We’re getting too many safety signals in recent months. This isn’t a catastrophe waiting to happen. This is a catastrophe that is happening. The warnings signals are cleare for this than they were for 9/11.

Pharmalot: How’d we get to this point?
Santoro: The problem has been evolving and taking on a life of its own but no one has asked whether pharma should be there. The issue is that China is learning on the job, which is fine for China, but not for the US. This isn’t about bashing China or pharma. But China is fundamentally incapable of safeguarding the safety and efficacy of the products they make. There are insufficients control and incentives. A lot of politicans in Beijing are giving speeches this past year about the need for concern over safety. But that doesn’t translate well in the provinces. To get away from regulators, factories are moved further away from the centers of commerce, where local authorities aren’t paying attention or can be corrupted. That’s standard operating procedure over there….

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The battle among prostate-cancer patients and investors to have the FDA approve Dendreon’s Provenge suffered a setback yesterday when a congressional committee declined to hold a hearing into the agency’s handling of the controversial vaccine. Today, however, the drugmaker released some news that it hopes will convince regulators that their decision to delay approval should be reversed.

At the American Society of Clinical Oncology meeting in San Francisco, Dendreon researchers presented data demonstrating the correlation of a measure of the cumulative potency of the vaccine with overall survival. And they claim this is “the first time that an association between higher potency of an active immune therapy and increased patient survival has been reported.”

In two Phase III trials, D9901 and D9902A, researchers evaluated cumulative product release parameters of Provenge, including CD54 upregulation, which is a measure of product potency. The results showed that Provenge patients experienced improved survival if they received more cells across the three doses of Provenge or higher cumulative CD54 upregulation values.

“We have been able to show a correlation between patient survival and a measure of the cumulative potency of Provenge; such a correlation between product potency and clinical outcome has not been previously demonstrated with an active immunotherapy,” Mark Frohlich, Dendreon’s chief medical officer, says in a statement. “These data provide further evidence that (Provenge) is actively engaging the immune system in a clinically meaningful way that prolongs patient survival.”

Last week, the drugmaker disclosed it took action after reporting an eye-opening $275 million charge for investing in sub-prime securities, which contributed to a loss in the fourth quarter. Jim Cornelius, the ceo, announced that he is now out recruiting. “I’m a big believer in accountability, and we’re looking for a new corporate treasurer and a couple of people under him,” he told Merrill Lynch conference in New York.

But one wag says that was the wrong move. In the latest Seeking Alpha column called 10Q Detective, David Phillips, says Cornelius should have fired Andy Bonfield, the cfo.

“Although the treasury department invests corporate funds, in the hierarchy of the company, the treasurer reports directly to the CFO (who has the fiduciary responsibility to analyze and review all the financial data and performance of the company),” he writes. “In other words, the ultimate responsibility of the CFO is to routinely check the corporation’s financial health and integrity. Think of it this way - if Bristol-Myers Squibb had reported an investment gain of $275 million…the individual standing front-and-center, crowing about his investment acumen would have been…Bonfield!

“But here’s a thought, maybe Bonfield could spend some of the $10,000 he receives annually for financial planning (as part of his compensation package) on an investment class, schooling him on the downside risk of investing in auction rate securities,” he concludes. Actually, page 32 of the last proxy lists $7,688 for financial counseling. However, the point is well taken. But what do you think?

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After all the rain that fell on the nation’s medicine chest, the shining sun is a welcome sight here at the Pharmalot corporate campus. We apologize for what appears to be a later start than usual, but we were shuttling short people to various schools. Now, though, the time has come for a hot cup of coffee. We hope you’ll join us and, while you do, take a peek at a few items that should help you with your day…

Smaller biotechnology companies are ready to take the lead away from big pharma in developing antibiotics that can take on a new generation of deadly superbugs, writes CNNMoney.com. Targanta Therapeutics just submitted its application to the FDA. Cethromycin from Advanced Life Sciences finished late-stage studies and is on track for FDA submission. Faropenem, from Replidyne, is in early-stage tests for MRSA. And an antibiotic from privately held Paratek Pharmaceuticals is in early-stage tests for community and hospital infections.

A greater percentage of patients than previously thought may develop heart failure when taking Pfizer’s Sutent cancer drug, HealthDay News writes. The drug was approved for advanced kidney cancer and a rare form of gastrointestinal cancer. The Pfizer-funded study looked at 48 patients and found that 15 percent experienced heart conditions such as symptomatic left ventricular dysfunction or heart failure. This was almost double the 8 percent rate seen in clinical trials. Two recent studies also found that use of Sutent can boost patients’ blood pressure and add to their risk of heart failure.

The Rituxan cancer drug from Genentech and Biogen reduced brain lesions in multiple sclerosis patients and cut their risk of relapse, offering a potential new way to slow the disease, Bloomberg News reports. About one in five patients on Rituxan relapsed, while twice as many on a placebo had a recurrence during a 48-week clinical trial, researchers said in this week’s New England Journal of Medicine. The drug significantly reduced the number of brain lesions on MRI scans after 12 weeks, and the benefit was sustained during the rest of the study.

AstraZeneca is spinning off some of its gastrointestinal research operations into a new biotech company backed by a trio of private equity firms, Reuters reports. The new venture, called Albireo, will be financed by a syndicate led by Nomura Phase4 Ventures, and joined by TVM Capital and Scottish Widows Investment Partnership. AstraZeneca will retain a significant minority stake in Albireo, in exchange for transferring the R&D assets into the new business. It will also have a seat on its board.

Pfizer is in talks to acquire a stake in Imaginatik, an idea management technology and services company Imaginatik, which develops collaborative software that allows ideas and insights from employees in large organizations to be shared, providing input for possible additional revenue streams or cost savings, PLC Digital writes. As well as Pfizer, Imaginatik’s clients include Georgia-Pacific, W. R. Grace, ChevronTexaco, Bayer and Goodyear Tire & Rubber.