DID - Nov. 9, 2009 Issue

Vol. 8 No. 217

Whistle-Blower Sues Cancer Research Clinic Over Firing

The Carle Clinic Association is facing a lawsuit from a whistle-blower who alleges she was fired for reporting violations that led to an investigation by the HHS Office for Human Research Protections (OHRP).

Earlier this year, OHRP found that the clinic failed to prepare and maintain adequate documentation of institutional review board (IRB) activities for 11 cancer trials. In one of the studies, a clinical investigator made changes to the protocol without informing the IRB.

Suzanne Stratton, the former vice president for research at the Carle Foundation Hospital, filed suit last week in the U.S. District Court for the Central District of Illinois, Urbana Division. The defendants are hospital CEO James Leonard; the Carle Clinic Association; Kendrith Rowland, a lead physician at the Carle Clinic; and Carle Clinic CEO Bruce Wellman.

Stratton alleges that she was fired in retaliation for her repeated warnings that the Carle Hospital and the Carle Clinic had violated federal regulations intended to protect cancer patients enrolled as subjects in clinical trials.

Stratton “made repeated attempts to stop the violations, which were repeatedly ignored by Dr. Leonard and others, including the Carle Clinic Cancer Center director,” according to a statement Friday from Katz, Marshall & Banks, the law firm representing Stratton.

An outside audit that Stratton alleges was withheld from her found that multiple Carle Clinic trials had deficiencies, resulting in what Stratton said she believed were risks to patient safety, including incorrect drug dosages and enrollment of ineligible patients, according to her law firm.

The trials for which OHRP cited the clinic in a June determination letter include a Phase II study of epratuzumab and rituximab in patients with previously untreated, diffuse, large B-cell lymphoma and a separate Phase III trial comparing adjuvant temozolomide with dose-intensive temozolomide in patients with newly diagnosed glioblastoma.

As the result of a July on-site evaluation, OHRP sent the Urbana, Ill., clinic a second letter, dated Sept. 21, detailing ongoing problems and acknowledging the “enthusiastic and sincere concern for the protection of human subjects” the IRB members, staff and investigators displayed. The second letter says the clinic has addressed IRB documentation failures and other problems.

“We anticipate successfully refuting claims as we believe the allegations are without merit, and we intend to vigorously defend the organization and its physicians,” Jennifer Hendricks Kaufmann, a spokeswoman for the Carle Clinic, told DID. “Dr. Wellman and Dr. Rowland each have an outstanding reputation for the highest degree of integrity and commitment to clinical excellence.”

With regard to the OHRP investigation, Hendricks Kaufmann said, “Concerns have been largely administrative and procedural. We are pleased that the majority of issues involving Carle Clinic have been unsubstantiated or adequately addressed. Most significantly, this review has found that no patients have been harmed as a result of clinical studies at Carle Clinic.”

In a separate statement, Gretchen Robbins, a spokeswoman for the Carle Foundation Hospital, told DID, “We believe the allegations in the lawsuit are without merit and we intend to vigorously defend the organization and its CEO. We believe this filing is in response to the defendant’s recent refusal to pay Mimi Suzanne Stratton and her counsel the money they demanded to avoid this lawsuit.

“The leaders of Carle Foundation Hospital place the highest priority on being compliant with all state and federal regulations, including those that govern research activities and patient protection, and employees are expected to bring concerns to light,” Robbins added.

OHRP did not respond to a request for comment by press time. The suit, M. Suzanne Stratton, Ph.D. v. The Carle Clinic Association, James Leonard, M.D., Chief Executive Officer, Carle Foundation Hospital, Bruce Wellman, M.D., Chief Executive Officer, Carle Clinic Association, and Kendrith Rowland, M.D., Cancer Center Program Director, Carle Clinic Association, was filed in the U.S. District Court for the Central District of Illinois.

The June determination letter from OHRP can be seen at www.hhs.gov/ohrp/detrm_letrs/YR09/jun09b.pdf, the September letter is at www.hhs.gov/ohrp/detrm_letrs/YR09/sep09b.pdf, and Stratton’s complaint is at www.fdanews.com/ext/files/Stratton-v.-Carle.pdf. — Martin Berman-Gorvine


Healthcare Overhaul Bill Slated to Be Considered by Full House

The House scheduled a vote over the weekend on healthcare overhaul legislation that includes a 12-year exclusivity period for manufacturers of brand biologics and several other measures important to drugmakers.

The Affordable Health Care for America Act, H.R. 3962, which was introduced by House Speaker Nancy Pelosi (D-Calif.) at a news conference last month, combines the healthcare overhaul legislation passed by the House Energy and Commerce, Ways and Means and Education and Labor committees earlier this year (DID, Oct. 30).

In addition to the biologic exclusivity period, the legislation also incorporates a provision to ban agreements between brand and generic drug manufacturers that limit, delay or prevent competition from generic drugs.

The bill contains another addition — a provision that would allow Medicare Advantage prescription drug plans to waive copayments for first fills of generic prescription drugs as an incentive for beneficiaries to try less expensive formulations. The bill also maintains a provision that would help eliminate the drug coverage gap for Medicare Part D beneficiaries in stages, beginning in 2011. Drugmakers would be required to provide 50 percent discounts on brand drugs during the phase-out period (DID, July 15).

House Republicans introduced an alternative to the bill last week, the Common Sense Health Care Reform and Affordability Act, that also includes the 12-year exclusivity period (DID, Nov. 6). Unlike the House Democrats’ bill, however, the Republican bill does not have language that would enable innovator and generic biologics to be billed under the same payment code to Medicare and Medicaid.

In the Senate, Majority Leader Harry Reid (D-Nev.) is leading the effort to combine the healthcare overhaul bill passed by the Senate Finance Committee with the Affordable Health Choices Act to create the legislation that will go to the Senate floor for debate.

The survival of several provisions unique to the Finance Committee’s bill will be determined during the process, including the $2.3 billion in annual fees imposed on drugmakers as a means of financing the healthcare changes (DID, Sept. 10).

The Affordable Health Choices Act won approval from the Health, Education, Labor and Pensions Committee in July (DID, July 16). Like the House legislation, the measure includes a provision to create a regulatory pathway for follow-on biologics that would give innovator biologics 12 years of exclusivity (DID, July 15).

The Affordable Health Care for America Act can be found at docs.house.gov/rules/health/111_ahcaa.pdf. The Republican House measure, can be found at www.fdanews.com/ext/files/RepublicanAlternative3962_9.pdf.

The America’s Healthy Future Act can be found at www.fdanews.com/ext/files/HealthyFutureAct.pdf. The Affordable Health Choices Act can be found at help.senate.gov/BAI09A84_xml.pdf. — David Belian


Federal Court Upholds $1.7 Billion Patent Award to Centocor

In a victory for Centocor Ortho Biotech, a district court has upheld the company’s $1.7 billion jury award for Abbott Laboratories’ infringement on its Humira patent.

The U.S. District Court for the Eastern District of Texas found that Abbott did not prove that the ‘775 patent in question is unenforceable or invalid, according to court records posted online last week.

The lawsuit Centocor filed in the District Court in 2007 alleges that Abbott willfully infringed the plaintiffs’ patent by manufacturing Humira (adalimumab), a tumor necrosis factor (TNF) alpha blocker. New York University and Centocor own the patent together and Centocor holds an exclusive license.

A Texas jury awarded Centocor, a Johnson & Johnson (J&J) unit, $1.7 billion in a trial in June (DID, July 1). Centocor will receive about $1.2 billion in lost profits and $504 million in royalties.

On May 13, the court ordered that the equitable issues be bifurcated from the trial of jury issues. In a pre-trial brief, Abbott argued that Centocor had misrepresented and omitted information during the jury trial regarding the patent.

Based on the evidence of record, the arguments of counsel and applicable law, the court found that Abbott didn’t prove material misrepresentation or omission during prosecution. The same was found true of the inventors, attorneys or anyone else associated with the prosecution of the ‘775 patent. “Abbott has not shown any direct evidence of intent and instead asks the Court to infer intent,” the court says.

Abbott did not prove it was appropriate for the court to infer Centocor’s intent, according to the court.

Also, evidence presented didn’t meet Abbott’s burden to show by clear and convincing evidence that representations made to the PTO were false, the court says in the filing. And Centocor’s statements to the examiners did not prove it was trying to deceive the PTO or misrepresent or omit material facts.

“The Court finds that Abbott has failed to provide clear and convincing evidence of any material misrepresentation or omission during prosecution of the applications in the ‘775 patent family,” according to court documents. “Evidence was presented showing that the prosecuting attorney’s arguments to the U.S. [Patent and Trademark Office] were correct.”

Abbott did not respond by press time to a request for comment.

Centocor, Inc. and New York University v. Abbott Laboratories was filed April 16, 2007. — David Belian


FDA Approves Gloucester’s Cancer Drug Istodax

The FDA has approved Gloucester Pharmaceuticals’ Istodax to treat cutaneous T-cell lymphoma (CTCL) in patients who have received at least one systemic therapy.

Istodax (romidepsin) is expected to be available in January, according to the company’s website.

Last month, the Oncologic Drugs Advisory Committee voted 10–0 with one abstention to tell the FDA that Gloucester Pharmaceuticals’ romidepsin cancer drug represents a favorable risk-benefit profile for patients, Gloucester President Jean Nichols told DID Friday. She added the agency is not requiring any follow-up clinical studies.

The company based its NDA on two open-label, single-arm, multicenter, international Phase II studies enrolling 167 patients with CTCL. Agency staff noted in briefing documents that the response rates — the primary endpoint in both studies — were similar in the trials. “While partial response was more common, complete responses did occur,” the agency says in briefing documents posted online before the meeting. — April Hollis


GSK’s Synflorix Vaccine Gets WHO Pre-Qualification

The World Health Organization (WHO) has “pre-qualified” GlaxoSmithKline’s (GSK) pneumococcal disease vaccine Synflorix, a step that allows UN agencies to buy it on behalf of developing countries

This is the first pneumococcal disease vaccine the world body has pre-qualified, GSK says in a statement Friday.

The vaccine has been approved in more than 40 countries over the past year. It is a complex, 10-valent conjugate vaccine to protect children age six weeks to two years from invasive pneumococcal disease and acute otitis media caused by Streptococcus pneumoniae.

The vaccine is expected to guard against about 80 percent of invasive pneumococcal disease in children younger than age five worldwide, including strains 1, 5 and 7F, which account for 3 percent to 23 percent of invasive pneumococcal diseases around the world, GSK says. — Martin Berman-Gorvine


FDA Approves Caraco’s Generic Acular

Caraco Pharmaceutical Laboratories has received FDA approval for a generic version of Allergan’s Acular.

Caraco, a unit of Sun Pharmaceutical Industries, will market ketorolac tromethamine ophthalmic solution 0.5 percent, indicated for temporary relief of ocular itching from seasonal allergic conjunctivitis. The solution also is used to treat postoperative inflammation in cataract extraction patients, Sun says in a statement Friday.

Ketorolac tromethamine ophthalmic solution had annual U.S. sales of about $40 million, Sun says. — April Hollis

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