DID - Dec. 22, 2009 Issue

Vol. 8 No. 247

Abbott to Pay $175 Million in Interest on Humira Patent Case Award

Abbott Laboratories will end up paying Centocor Ortho Biotech more than $1.8 billion for infringing the company’s Humira patent, including more than $175 million in interest, based on a district court decision.

The U.S. District Court for the Eastern District of Texas added the interest to the jury award Centocor is due in the dispute in which it alleged that Abbott willfully infringed its patent by manufacturing Humira (adalimumab), a tumor necrosis factor alpha blocker.

A jury awarded Centocor, a Johnson & Johnson unit, $1.7 billion in a trial in June (DID, July 1). The drugmaker will receive about $1.2 billion in lost profits and $504 million in royalties, in addition to the interest payment ordered by the court. Centocor owns the patent with New York University and Centocor holds an exclusive license. The patent lawsuit was filed in the District Court in 2007.

The District Court, which upheld the judgment in a ruling last month, based the interest payment amount on what would have been payable to Centocor on the date the ’775 patent was first infringed in 2006, the court says in its judgment (DID, Nov. 9).

In May, the court ordered that the case’s equitable issues be split from the jury trial issues. In a pre-trial brief, Abbott argued that Centocor had misrepresented and omitted information during the jury trial regarding the patent.

The court found that Abbott didn’t prove material misrepresentation or omission during prosecution and the same was found true of the inventors, attorneys or anyone else associated with the prosecution of the ’775 patent.

Abbott did not respond by press time to a request for comment on the interest payment.

The case filed in 2007 is Centocor, Inc. and New York University v. Abbott Laboratories.

Abbott intends to appeal the case, Scott Stoffel, a spokesman for Abbott, told DID Monday.

"We believe this verdict is out of step with the law, the facts and the scope of prior patent damage awards," Stoffel said. "The trial court's judgment represents solely the end of the first round." — David Belian


Pfizer to Develop IBD Treatment With Athersys

Pfizer will pay Athersys $6 million upfront to collaborate on developing and commercializing Athersys’ MultiStem stem cell therapy to treat inflammatory bowel disease (IBD).

Under the agreement, Pfizer also will provide the Ohio biopharmaceutical company with research funding and support during the initial phase of collaboration on MultiStem, Athersys said Monday. Pfizer will be responsible for developing and commercializing the product.

Athersys also is eligible for milestone payments of up to $105 million and royalties on MultiStem products for IBD. The agreement gives Athersys the option of forgoing royalties and co-developing MultiStem products with Pfizer. The companies would share development and commercialization costs on an agreed upon basis beginning at Phase III clinical development, Athersys said.

MultiStem also is being developed to treat conditions including heart attack and ischemic stroke, Athersys added. — Owen Skoler


Lilly, Incyte to Collaborate on Anti-Inflammatory, Autoimmune Therapies

Eli Lilly has agreed to give Incyte an upfront payment of $90 million and as much as $665 million in milestone payments in return for the global rights to develop and commercialize Incyte’s lead compound, INCB28050, as an oral treatment for all inflammatory conditions.

The exclusive licensing and collaboration deal also covers Incyte’s oral JAK1/JAK2 inhibitors and certain follow-on compounds for inflammatory and autoimmune diseases. Incyte will receive potential royalty payments of as much as 20 percent of sales, according to the companies. The lead compound is in a six-month, dose-ranging Phase II trial for rheumatoid arthritis.

The agreement gives Incyte the option to co-develop its JAK1/JAK2 inhibitors on a “compound-by-compound and indication-by-indication basis” with initiation of a Phase IIb trial, of which Incyte would fund 30 percent, the companies add.

Incyte also has the option to co-promote products using the JAK1/JAK2 inhibitors in the U.S.

Because INCB28050 has potential applications in many treatment areas, Incyte needed Lilly’s help with large trials and infrastructure, Paul Friedman, Incyte’s president and CEO, told DID.— Owen Skoler


Seattle Genetics, GSK Agree to $12 Million Drug Collaboration

GlaxoSmithKline (GSK) has agreed to pay $12 million for rights to use Seattle Genetics’ antibody-drug conjugate technology with multiple antigens.

GSK is responsible for research, product development, manufacturing and commercialization of all antibody-drug conjugate products under the collaboration, Seattle Genetics said Monday.

The technology is designed to spare nontargeted cells and thus reduce many of the toxic effects of traditional chemotherapy, Seattle Genetics said.

Seattle Genetics may receive up to $390 million in milestone payments from GSK if all antibody-drug conjugate products in the collaboration are commercialized. The company also is eligible to receive certain royalties on net sales of any resulting products.

The company will receive material supplies, annual maintenance fees and research funding for assistance given to GSK. — April Hollis


Ligand, GSK Get Positive Opinion in EU for Revolade

Ligand Pharmaceuticals and GlaxoSmithKline (GSK) have received a positive opinion for Revolade in the EU for oral treatment of thrombocytopenia in adults with chronic immune thrombocytopenic purpura (ITP).

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended Revolade (eltrombopag) for adult ITP patients who have had their spleen removed and who do not respond to other treatments, such as corticosteroids and immunoglobulin products. Revolade also may be considered as a second-line treatment for adult patients when spleen removal is contraindicated, Ligand says.

The CHMP opinion is based on two Phase III randomized, double-blind, placebo-controlled clinical trials and two open-label studies in adults who previously received treatment for chronic ITP, the company adds.

The studies showed patients treated with Revolade, plus the standard of care, experienced significant increases in platelet counts, fewer bleeding incidents and improved quality of life compared with those receiving placebo with the standard of care. Revolade also allowed patients to reduce the dose of their other medications, such as steroids.

ITP patients experience bruising and bleeding and sometimes serious hemorrhages, which can be fatal, the company says.

Ligand notes GSK plans to develop Revolade, sold in the U.S. as Promacta, for other indications but did not provide details by press time. — April Hollis


UK’s NICE Recommends Use of Cancer Drug Yondelis

PharmaMar’s cancer treatment Yondelis has received a positive recommendation from the UK’s National Institute for Health and Clinical Excellence (NICE).

The drug was recommended for the treatment of advanced soft-tissue sarcoma, a rare form of cancer. The treatment received the positive opinion after Madrid-based drugmaker PharmaMar agreed to cover the cost of Yondelis when a patient needs it after the fifth cycle of therapy, NICE said Monday.

NICE issued a draft guidance earlier this year that did not recommend Yondelis (trabectedin) because of its cost. The company’s offer to cover some of the price changed the decision, the agency says.

“Treatment options for this type of cancer are limited and in the last 20 years there have been no major developments to treat the advanced stages of this disease,” Carole Longson, Health Technology Evaluation Centre director at NICE said Monday.

The agency recommends the use of Yondelis for people with advanced soft-tissue sarcoma when treatment with anthracyclines and ifosfamide has failed, patients can’t tolerate the treatment or there are contraindications against the use of anthracyclines and ifosfamide.

Soft-tissue sarcomas are tumors that develop in supporting tissues in the body — such as fat, muscle and blood vessels — and can occur anywhere in the body, NICE says. Trabectedin works by damaging the DNA in cancer cells, making them unable to grow and spread. Research shows the drug can extend life by at least three months more than other treatments currently available on the National Health Service, according to NICE. — David Belian

Customer Service: Kim Williams
(888) 838-5578 • +1 (703) 538-7600
Editorial: David Grant
(703) 538-7600
Ad Sales: Matt Salt
(703) 538-7642
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: David Belian, April Hollis, Owen Skoler

President: Cynthia Carter; Publisher: Matt Salt; Editorial Director: David Grant; Executive Editor: Theresa Barry

Copyright © 2009 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.