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Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: Wyeth

Dreaming of REMS: A Second Reason Why FDAAA Risk Evaluation and Mitigation Strategies Might Be a Benefit to Drug Developers

Over at The In Vivo Blog, Michael McCaughan has another thought-provoking piece on REMS — the FDA’s Risk Evaluation and Mitigation Strategies that impose tight controls on the distribution channels for certain drugs.

Michael compares two drugs for the same indication — opioid-induced constipation therapy, if you must know — and though they have similar mechanisms of action and were both developed by small biotechs and picked up by big pharmas, they met different ends (har).

Wyeth gave Progenics back the rights to Relistor last week, paying $10 million to do so; but GSK is continuing to market Adolor’s Entereg.

The difference? According to Michael, Wyeth was facing big marketing commitments, but GSK was not. Here’s the rub: GSK’s marketing commitments were limited because Entereg is marketed under a REMS that limits its use to an “ultra-restrictive indication.”

So, we now have two situations where REMS confer an unexpected benefit:

  1. Limiting marketing expenditures for a marginally successful partnered drug (the partnered part is key — without that, marketing budgets can be adjusted at-will, without regard to minimums); and
  2. As previously noted by Michael and discussed here, limiting generic competition for off-patent drugs (REMS don’t die or fade away, they just complicate life for generics).

In each case, I’d leave it to the math guys to calculate whether the benefits outweigh the costs of the sales limitations that come with a REMS (not to mention the direct compliance costs); but if your partnered product isn’t looking like a blockbuster or is closer than you’d like to patent expiration, maybe it’s a good time to look over the FDA’s recent draft REMS guidance — a “useful blueprint for how to develop these important safety strategies.”

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Corporate Liability Journal Article on Wyeth v. Levine, Reigel v. Medtronic and Medtronic v. Lohr

Check out Jeremy’s latest article, published in the current issue of Corporate Liability Journal.

In The Changing Landscape of U.S. State Tort Liability for FDA-Approved Drugs and Medical Devices (pdf), Jeremy and his co-author, Alison Varga, take a more detailed look at this year’s U.S. Supreme Court decisions in Wyeth v. Levine and Reigel v. Medtronic, which Jeremy has been following on the blog.

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Post-Vacation Brain Dump: Deal Developments

Some exciting deal news from the week:

And some interesting company news:

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Wednesday Brain Dump: Two of Everything! Edition

Two Camels!  Dolly the cloned sheep, meet Injaz the cloned camel.

Two R&D Heads!  The combined Pfizer-Wyeth will have Mikael Dolsten heading up the newly created BioTherapeutics Research Group and Martin Mackay heading up the small molecule PharmaTherapeutics Research Group.  (Two CapitalLetters!)  The In Vivo Blog has a podcast interviewing both.

Two VA Initiatives!  In addition to the electronic medical records initiative we mentioned earlier this week, the Department of Veterans Affairs is also setting up a large cohort genetic study that will establish a database of genetic information from patients that will be linked to the participants’ electronic health records.  This is great news for personalized medicine because it will ensure that the EHR standard that comes out of the VA project will accomodate and utilize individualized genotypic data.

Two R’s, Two L’s, Two B’s!  G. Steven Burrill (two r’s, two l’s, one b) says he’s confident he can raise $1 billion (there it is!) to develop the Pine Island biotechnology project and a private equity/venture capital fund, which will support development of new technologies out of the Mayo Clinic and the University of Minnesota, among others.

Two Guidance…s!  Health Canada issued a finalized version of a Guidance Document on data protection (only applicable to qualifying innovative drugs that received an NOC on or after June 17, 2006) AND a revised version of the draft Guidance Document on Subsequent Entry Biologics, (which includes a 6-year data protection period).  More to come on this.

Two Border Crossings!  Simponi, a biologic developed by Johnson & Johnson and Schering-Plough, crossed the border Northbound — gaining approval from Health Canada before the FDA; and Molecular Templates Inc. crossed the border Southbound — leaving Ontario for the Texas Life-Sciences Collaboration Center.

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Monday Deal Review: April 6, 2009

One complex arrangement, two clinical trial updates, three commercial deals and other bits of Canadian deal and company miscellany after the jump…

Preemption Update: Waxman and Pallone Hit the Ground Running

When we reported on the Supreme Court’s decision in Wyeth v. Levine, we wondered what the effect would be on legislation proposed by Reps. Waxman and PalloneWe did not have to wonder long — they introduced legislation yesterday, with a parallel effort from Sens. Kennedy and Leahy, to moot the Supreme Court’s decision in Reigel v. Medtronic and reinstate (har) state tort liability for PMA-approved medical devices.

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Supreme Court Rules 6-3 Against Preemption in Wyeth v Levine

The Wyeth v. Levine opinion (pdf) was handed down this morning, holding that state tort law claims (in this case, inadequate warning) are not preempted by the FDCA.  Justice Thomas’ concurring opinion starts at page 30 of the pdf.  Alito and Scalia’s dissent starts at page 54 of the pdf.

Now we have different preemption rules for PMA-approved devices (Reigel v. Medtronic), where state tort law is preempted, than for 510(k) devices (Medtronic v. Lohr) and for drugs (Wyeth v. Levine) where state law claims are still available.

Let’s see where Waxman and Pallone head with this.

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More Waxman-Pallone Reporting on State Tort Liability, Preemption, Medical Devices and FDA Approval

The NY Times Business section (and the WSJ Health Blog) this morning picked up the story — that we noted last week — that Waxman and Pallone plan to reintroduce legislation essentially reversing the Supreme Court’s ruling in Reigel v. Medtronic.  Those stories also note a Senate version to be introduced by Sen. Kennedy and Sen. Leahy.

The basis for the Supreme Court’s decision in Reigel v. Medtronic is the interpretation of the Medical Devices Amendments of 1976, so by enacting changes that specifically disclaim preemption of state tort law, Congress could effectively moot the Supreme Court’s ruling. 

However, two state-level developments may change the debate:

  1. The Wisconsin Supreme Court’s decision this week in Blunt v. Medtronic, which was dictated by Reigel v. Medtronic, may create additional pressure in favor of federal action and maintaining state tort liability (although note that only two of seven justices signed on to the Wisconsin concurring opinion decrying the result); but on the other hand
  2. The Georgia Senate Economic Development Committee held its first hearing yesterday on legislation protecting Georgia-based businesses or companies with more than 200 employees headquartered out of state from liability for defects in any drug or medical device that has been approved by the FDA.  If this initiative is successful, and is replicated in other states, both the Supreme Court’s ruling(s) and the federal legislation would be moot, since there would be no underlying state tort liability.

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Rep. Waxman, Reigel v Medtronic and Wyeth v Levine

Last Summer, the U.S. Supreme Court held in Reigel v. Medtronic that the premarket approval (PMA) process for medical devices pre-empts liability under State common law for claims challenging the safety or effectiveness of medical devices.  Wyeth v. Levine, which the U.S. Supreme Court heard last Fall, but has not decided, makes a parallel argument with respect to labelling of FDA-approved drugs. Together, these two cases could reshape liability for products under the FDA’s purview in a way that looks very much like tort reform, and therefore, have seemed ripe for a legislative response.  A story in yesterday’s Minneapolis-St.Paul Star Tribune includes a statement from Rep. Henry Waxman, D- Calif. that

Waxman and Rep. Frank Pallone Jr., D-N.J., plan to introduce legislation that would circumvent the Supreme Court ruling and “protect Americans from dangerous medical devices.”

and notes that Barack Obama was one of the cosponsors of the Senate bill introduced last year to address the issue. more analysis after the jump…

It’s Raining M&A: Update

Canadian developments first:

The committee is comprised of William Anderson, Robert Luba, James MacDonald and Gregory Spivy, each of whom is independent of management. James MacDonald will act as Chair of the committee. Goldman, Sachs & Co and RBC Capital Markets are assisting the Company and the Board of Directors as financial advisors.

More news on Pfizer-Wyeth, NitroMed, Sanofi, Crucell and Amylin after the jump…

It’s Raining M&A

Pfizer-Wyeth in Canada

Following today’s developments, some Canadian stats from the Pfizer Canada and Wyeth Canada web sites:

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