PharmExec Blog

Pfizer Adds FoldRx to its Specialty Care Unit

Pfizer on Wednesday announced that it acquired a small rare-disease drug firm, FoldRx, for an undisclosed sum of money.

Pfizer spokeswoman Gwen Fischer told Pharm Exec that the deal came together in a matter of weeks, and that FoldRx will be fully incorporated into Pfizer’s research division. All of FoldRx’s employees are expected to become Pfizer employees when the deal is completed.

FoldRx made its name—literally—by discovering compounds that treat diseases related to protein misfolding, using a proprietary yeast-based target discovery platform. Its pipeline leader is tafamidis meglumine, a treatment for TTR amyloid polyneuropathy, which is a genetic neurodegenerative disease.

“Over the past five years the FoldRx team has successfully developed tafamidis from the bench stage to MAA submission,” stated Richard Labaudiniere, president and CEO of FoldRx, in a release. “Pfizer’s strong clinical and regulatory resources, global marketing reach, and commitment to the treatment of rare diseases will significantly enhance the ability to pursue the goal of efficiently bringing tafamidis to all patients affected by this devastating neurodegenerative disease.” Read More »

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Baxter Receives Third FDA Warning for Misleading Promotional Material

FDA issued a warning letter to Baxter International for making “misleading efficacy claims” about its lung drug Araplast NP, which is contraindicated in individuals with selective IgA deficiencies and prescribed to patients who are at increased risk of emphysema. FDA’s letter, dated Aug. 3, takes issue with claims in a brochure aimed at physicians that “overstates” the drug’s efficacy—specifically that it elevates blood levels of AAT above the protective threshold recommended by ATS/ERS standards when given at certain does levels. The brochure’s claims, the letter states, “misleadingly imply that there is substantial evidence or substantial clinical experience that this threshold is clinically meaningful when such is not the case.”

In the last two years, FDA has twice cited Baxter for similar violations. In April 2009, it sent the company a warning letter indicating that select promotional materials created in support of Tisseel (a fibrin sealant) were false or misleading. In July 2008, the Agency’s Office of Compliance and Biologics Quality (OCBQ) issued an untitled letter to the company over claims about its anti-inhibitor coagulant complex, Feiba VH. The letters are not legally binding, but FDA can follow them up with litigation if they are ignored. Read More »

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Genzyme Snubs Sanofi Offer

Less than 24 hours after offering to purchase Genzyme for $18.5 billion, Sanofi-Aventis was sent a letter of rejection from the biotech firm’s board of directors stating that the offer just wasn’t worth it.

“Without exception, each member of the Genzyme board believes this is not the right time to sell the company, because your opportunistic takeover proposal does not begin to recognize the significant progress under way to rectify our manufacturing challenges or the potential for our new product pipeline,” Genzyme CEO Henri Termeer wrote.

The letter goes on to state that the company outlined a laundry list of improvements it plans to make in its manufacturing facilities—an area that Genzyme has been chastised for recently—as well as future earnings from its much lauded multiple sclerosis treatment alemtuzumab, currently in development. Read More »

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New Study Shows Spike in Branded Drug Prices (Updated 8/26)

The retail price of branded pharmaceuticals spiked 8.3 percent in 2009, according to a new report released by AARP on Wednesday.

This is the first time AARP has measured the retail price of Rx drugs. In the past, the lobby group only tracked the wholesale manufacturers’ price of generic, branded, and specialty drugs, which is traditionally considered to be much higher than the retail price.

The brand name pharma firms had criticized those reports for not taking into account rebates and couponing offered to pharmacies and hospitals.

“What we found was that the prices are still trending way up, and for the most part they are relatively similar increases that we received when we were measuring the manufacturer prices,” AARP spokesperson Jordan McNerney told Pharm Exec in an interview. “Those discounts and rebates aren’t making much of a difference on the bottom line as far as the consumer is concerned.” Read More »

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And What Exactly is a Stakeholder?

Pharma’s uncritical use of the word ‘stakeholder’ has increased to the point where it can refer to almost anyone connected to the industry. But this can have serious consequences, warns Reflector.

EU-flagLike it or not (and frankly, I don’t), stakeholders are here to stay in European pharmaceutical affairs. Don’t get me wrong. I’ve no objection to democratic engagement, or to giving people with a legitimate interest a legitimate voice. It’s the word I object to. Partly on aesthetic grounds, because it is an ugly coining. But much more because it is one of these words that has now been appropriated by everyone to mean exactly what they want it to mean, irrespective of what it means to anyone else. Consequently, despite its almost mandatory inclusion in every discussion of contemporary pharmaceutical affairs, it has largely lost its meaning.

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