DID - Oct. 3, 2007 Issue

Vol. 6 No. 194

FDA Reviewing Cardiovascular Effects of Osteoporosis Drugs

The FDA is reviewing new safety data on reports of atrial fibrillation in patients taking bisphosphonates, which are typically used to treat osteoporosis, the agency announced. 

A study in the May 3 issue of the New England Journal of Medicine (NEJM) reported increased rates of serious atrial fibrillation in patients taking Merck’s Fosamax (alendronate sodium) and Novartis’ Reclast (zoledronic acid), the agency said. However, after an initial review of safety data, the FDA does not recommend that healthcare professionals change their prescribing habits of bisphosphonates and patients should not change their use of the drugs.

After reviewing spontaneous postmarketing reports, the FDA did not identify a population of bisphosphonate users who are at an increased risk of atrial fibrillation, the agency said.

Atrial fibrillation is common in individuals 65 years and older, the same age range as many of the patients studied in the NEJM article, according to the FDA. The agency recently evaluated the risk of atrial fibrillation in patients taking Reclast during its review for the approval of once-yearly Reclast. Most cases of atrial fibrillation occurred more than a month after taking the drug, the agency said.

There was no significant difference in occurrence of atrial fibrillation in patients taking Reclast compared with those taking placebo in the subgroup of patients who were monitored by electrocardiogram, the FDA added.

The FDA is seeking additional data to perform an in-depth review of the issue with all bisphosphonates. The review could take up to 12 months, the agency said. Patients and healthcare professionals should report any side effects from bisphosphonates to the agency’s MedWatch Adverse Event Reporting program.

The seven FDA-approved bisphosphonates are Procter & Gamble’s Didronel (etidronate disodium) and Actonel (risedronate sodium), Roche’s Boniva (ibandronate sodium), Novartis’ Aredia (pamidronate disodium), sanofi-aventis’ Skelid (tiludronate disodium), Fosamax and Reclast.

The agency said it would continue to make any recommendations on use of the drugs available to the public during its review.

More information on the FDA’s early communication can be seen at www.fda.gov/cder/drug/early_comm/bisphosphonates.htm. — Emily Ethridge


Supreme Court Turns Down Two Drug Patent Cases

The U.S. Supreme Court will not hear appeals filed by Dr. Reddy’s Laboratories and Teva Pharmaceuticals seeking to overturn lower court rulings that upheld the validity of Eli Lilly’s Zyprexa patent, according to court records.

The U.S. District Court for the Southern District of Indiana ruled in 2005 that Eli Lilly’s ’382 patent covering Zyprexa (olanzapine) was valid and infringed on by abbreviated new drug applications (ANDAs) filed by Dr. Reddy’s and Teva (DID, April 20, 2005). The ’382 patent covers olanzapine and its use in treating schizophrenia.

On appeal, the U.S. Court of Appeals for the Federal Circuit upheld the decision in a December 2006 ruling. The court agreed with the lower court that the patent was not obvious and that Eli Lilly did not engage in inequitable conduct in not disclosing some prior art.

Teva and Dr. Reddy’s filed petitions for writs of certiorari with the Supreme Court in July, which the Supreme Court denied Oct. 1.

An Eli Lilly spokesman said the company agrees with the court’s decision. “From the initial court ruling and through the subsequent appeals, the courts have consistently upheld the validity of Lilly’s Zyprexa patent,” he said.

Teva declined to comment on the ruling. Dr. Reddy’s could not be reached for comment by press time.

The Supreme Court also declined to hear Pfizer’s appeal of a federal circuit court ruling that favored Apotex and invalidated Pfizer’s Norvasc (amlodipine besylate) patent due to obviousness (DID, March 23). Previously, the U.S. District Court for the District of Northern Illinois had sided with Pfizer and upheld the ’303 patent.

The appeals court ruling prompted Mylan Laboratories to launch its generic Norvasc product at risk (DID, March 26). Apotex had not yet received final approval for its product, but it did launch its generic Norvasc in May (DID, May 25).

A spokesman for Apotex said the company believes the Supreme Court made the right decision.

“It’s clear that Pfizer’s efforts to overturn this case were not focused solely on its Norvasc drug, which no longer had patent protection,” Robert Breisblatt, attorney with Welsh & Katz and lead trial lawyer in the case, said. “Its intent was to remove this decision so that the ruling couldn’t be used in future pharmaceutical patent disputes.”

Pfizer did not return a request for comment by press time. — Breda Lund


NIH Posts Open-Access Genetic and Clinical Data Database

The NIH is posting a free online database, touting it as one of the most extensive collections of genetic and clinical data ever made freely available to researchers worldwide.

Called SNP Health Association Resource (SHARe), the web-based dataset enables qualified researchers to access data from large population-based studies, starting with the Framingham Heart Study. SNP stands for single nucleotide polymorphism.

The dataset is funded by the NIH’s National Heart, Lung and Blood Institute (NHLBI) and is intended to accelerate discoveries linking genes and health, thereby advancing scientists’ understanding of the causes and prevention of cardiovascular disease and other disorders. Researchers can use the database to search for information such as summary data on study participants’ average blood pressure, which can be linked with the associated protocol for measuring blood pressure.

Framingham SHARe has data on more than 9,300 participants spanning three generations who had their DNA tested for 550,000 genetic variations. More than 900 families are represented. The database also features clinical data gathered on participants during the study, such as test results and weight, which will enable researchers to relate participants’ genetic variations to their clinical and laboratory test results. All personal identifying information has been removed.

The Framingham Heart Study is funded by NHLBI in collaboration with the Boston University School of Medicine and the Boston University School of Public Health.

“SHARe represents a major milestone in moving toward an era of personalized healthcare — a future in which the ways we prevent, diagnose and treat health problems are tailored to an individual’s genetic makeup,” HHS Secretary Mike Leavitt said.

Although summary data and analyses are available to any researcher, individual-level data can be used only by NIH-authorized investigators. Researchers interested in access to individual-level Framingham SHARe data can find application instructions at www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?id=phs000007. — Martin Gidron


WLF Petitioning Supreme Court to Hear Experimental Drugs Access Case

Washington Legal Foundation (WLF) has petitioned the U.S. Supreme Court to review a recent circuit court decision that said patients do not have a fundamental right to experimental drugs.

The foundation is asking the Supreme Court to reinstate a May 2006 U.S. Court of Appeals for the District of Columbia Circuit panel decision that said when there are no other FDA-approved treatment options, a terminally ill patient has a “fundamental right” to investigational new drugs.

However, the court reversed the panel decision by an 8-2 vote in August, ruling against the Abigail Alliance for Better Access to Developmental Drugs and WLF (DID, Aug. 9). The court ruled that terminally ill patients do not have a fundamental right to access experimental drugs, affirming a 2004 ruling by the U.S. District Court for the District of Columbia.

WLF is asking the Supreme Court to consider whether the due process clause of the U.S. Constitution “protects the right of a terminally ill patient with no remaining approved treatment options to attempt to save her own life by deciding, in consultation with her own doctor, whether to seek access to investigational medications that the FDA concedes are safe and promising enough for substantial human testing,” according to the petition.

The petition adds that the circuit court made a “profound and important error” in determining that FDA regulations do not implicate a patient’s fundamental rights.

The Supreme Court is likely to decide by January whether to hear the case, according to WLF.

WLF’s petition can be viewed at www.wlf.org/upload/09-28-07Abigail%20ceriorari%20petition.pdf. — Emily Ethridge


Pfizer Prevails in Viagra Patent Challenge

Pfizer announced last week that the Canadian Federal Court has ruled that one of the company’s patents on Viagra would be infringed on by Apotex’s proposed generic product.

The court granted Pfizer’s request for an order preventing Apotex from launching a generic version of Viagra (sildenafil citrate) until expiration of the ’446 medical use patent in 2014.

An Apotex spokesman said the company plans to appeal the ruling, which could take roughly one year.

The same Canadian court recently ruled in favor of Pfizer in a Lipitor (atorvastatin calcium) patent suit the company brought against Ranbaxy Laboratories (DID, Sept. 14). The court ruled that the patent covering a crystalline form of atorvastatin would be infringed on by Ranbaxy Laboratories’ process for making generic Lipitor, Pfizer said.

Ranbaxy announced it would appeal the decision. — Breda Lund

Customer Service
(888) 838-5578 • 1 (703) 538-7600
(703) 538-7600
Ad Sales: Andrew McSherry
(703) 538-7643
Content Sales: Alka Desai
(703) 538-7669

300 N. Washington St., Suite 200 • Falls Church, VA 22046-3431
Phone: (888) 838-5578 • 1 (703) 538-7600 • Fax: 1 (703) 538-7676

Reporters: Martin Gidron, Emily Ethridge, April Astor, Breda Lund, Christopher Hollis

President: Cynthia Carter; Publisher: Matt Salt; Editorial Director: Christopher Changery; Executive Editor: Steve Brown

Copyright © 2007 by Washington Business Information Inc. All rights reserved. Drug Industry Daily (ISSN 1541-6607), an executive briefing on the regulation of pharmaceuticals, is published daily, 250 issues, for $1,895. Photocopying or reproducing in any form, including electronic or facsimile transmission, scanning or electronic storage is a violation of federal copyright law and is strictly prohibited without the publisher’s express written permission. Subscribers registered with the Copyright Clearance Center (CCC) may reproduce articles for internal use only. For more information, contact CCC at www.copyright.com or call (978) 750-8400. For site licenses for multiple users or to purchase multiple copies, contact Content Sales Manager Alka Desai at (703) 538-7669.