Illumina Announces Outcome of Its Patent Litigation; FDA Approves Two New Pancreatic Enzyme Products Print E-mail
By Staff and Wire Reports   
Thursday, 01 March 2012 19:42
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 1, 2012.
Illumina, Inc. (NASDAQ: ILMN) announced a federal jury in Wilmington, Delaware, found that certain of Illumina’s TruSeq sample preparation and cluster generation kits and products infringe U.S. Patent No. 6,107,023, owned by LadaTech LLC, a patent holding company. Other Illumina sample preparation kits, such as its Nextera kits, were not accused of infringement in the lawsuit. In addition, United States District Court Judge Sue L. Robinson in an earlier order granted summary judgment that Illumina cluster generation kits and products, when used with sample preparation kits made or sold by third parties, do not infringe the patent.

The case will now proceed to its next phase in which Illumina will have the opportunity to demonstrate that the jury’s verdict should not stand because the patent is unenforceable. The jury’s verdict is therefore preliminary, and in the meantime Illumina plans to support its customers with the products that are the subject of the suit. In addition, the damages phase of the case has not been scheduled and will not proceed, if at all, until at least 2013, after all appropriate appeals of the jury verdict have been taken. Illumina does not expect that damages, if any, resulting from this lawsuit would have a significant effect on its consolidated financial position, liquidity or results of operations.

Jay Flatley, Illumina’s President and CEO, stated:  “We disagree with and plan to appeal the present finding of infringement in this lawsuit, and note that this finding was made without consideration of the enforceability of the patent asserted by LadaTech. We continue to feel very strongly about our position that LadaTech’s allegations are without merit and we look forward to presenting our unenforceability defense, and ultimately to obtaining a favorable result to that effect. Like many other companies, we respect valid and enforceable intellectual property rights of others. Consistent with our policy, we believe we acted properly with respect to the LadaTech patent and that, ultimately, our position will be vindicated.”


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Two new pancreatic enzyme products used to help aid food digestion, Ultresa (pancrelipase) and Viokace (pancrelipase), were approved today by the U.S. Food and Drug Administration.


Ultresa is a delayed-release capsule used to treat children and adults with cystic fibrosis, a serious genetic disorder affecting the lungs and other organs, or other conditions who cannot digest food normally because their pancreas does not make enough pancreatic enzymes.

Viokace, in combination with a proton pump inhibitor, is used to treat adults who cannot digest food normally. Adults with chronic pancreatitis, a continuing, chronic inflammatory process of the pancreas, or those who have had some or all of their pancreases removed (pancreatectomy) may not digest food normally because they lack needed enzymes or because their enzymes are not released into the bowel (intestine). Viokace’s safety and efficacy in children has not been established.

“The approvals of Ultresa and Viokace, along with the other approved pancreatic enzyme products, allow health care providers to prescribe the product that is most appropriate for the estimated 200,000 patients in the United States who have pancreatic insufficiency,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research.

Ultresa and Viokace are the fourth and fifth pancreatic enzyme products approved by FDA. Other FDA-approved pancreatic enzyme products include Creon (2009), Zenpep (2009) and Pancreaze (2010). Approved pancreatic enzyme products meet FDA standards for safety, efficacy and product quality.

Unapproved pancreatic enzyme products had been available for many years. FDA established a date of April 28, 2010 for the makers of pancreatic enzyme products to stop manufacturing and distributing unapproved products.  Ultresa and Viokace are marketed by Bridgewater, N.J.-based Aptalis Pharma U.S. Inc.



Also Thursday:



Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY)
, a leading RNAi therapeutics company, and the University of Massachusetts Medical School (UMMS) reported today that the European Patent Office (EPO) has upheld the Tuschl I ’726 patent (EP 1309726) in oral opposition proceedings held in Munich, Germany.

ArQule, Inc. (NASDAQ: ARQL)
today announced its financial results for the year and for the fourth quarter ended December 31, 2011.

Bio-Reference Laboratories, Inc. (NASDAQ: BRLI)
announces best-ever first quarter results for revenues, earnings and cash.

Columbia Laboratories Inc. (Nasdaq: CBRX)
will hold a conference call on March 8, 2012, to discuss financial results of the three- and twelve-month periods ended December 31, 2011.

Digirad Corporation (NASDAQ: DRAD)
today announced it has adopted a series of new corporate governance policies aimed at strengthening the Company's high standard of corporate governance practice.

Exelixis, Inc. (NASDAQ:EXEL)
today announced that Michael M. Morrissey, Ph.D., the company’s president and chief executive officer, will present at the 2012 Cowen Health Care Conference at 10:00 a.m. EST / 7:00 a.m. PST on Tuesday, March 6, 2012 in Boston.

Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY)
, today announced that it has begun shipping Fabrazyme® (agalsidase beta) produced at its newly approved plant in Framingham, Massachusetts.

Human Genome Sciences, Inc. (NASDAQ: HGSI)
announced today that its presentation at the Cowen & Company 32nd Annual Healthcare Conference will be webcast and may be accessed at www.hgsi.com.

Impax Laboratories, Inc. (NASDAQ: IPXL)
today announced that the Company will present at the Cowen and Company Health Care Conference on Tuesday, March 6, at 11:20 a.m. ET.

Integrated Management Information, Inc. (IMI Global) (OTCBB: INMG)
, a leading provider of verification and Internet solutions for the agricultural/livestock industry under the Where Food Comes From® brand, today announced it has acquired controlling interest in International Certification Services, Inc. (ICS), a leading provider of organic and sustainable certification services to agricultural operations and the food industry

Medical technology company iSonea Ltd. (ASX: ISN; OTCQX: ISOAY) today announced that Lynn M. Taussig, M.D., Special Advisor to the Provost for the Life Sciences at the University of Denver and the retired president and CEO of National Jewish Medical and Research Center, has been named Chairman of iSonea’s Medical Advisory Board (MAB).

mPhase Technologies, Inc. (OTCBB: XDSL)
today announced that it has extended the engagement of FIRST PRINCIPALS, INC. (FPI), a world-class technology appraisal and commercialization enterprise located in Cleveland, Ohio, to continue its complete economic and strategic evaluation of mPhase's Patent Portfolio and identify a broad array of potential innovative products for "smart surfaces."

Novadaq® Technologies Inc. (TSX:NDQ) (NASDAQ:NVDQ), a developer of real-time imaging systems for use in the operating room, today announced that its common shares have been approved for listing on the NASDAQ Global Market (NASDAQ) under the ticker symbol "NVDQ".

Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, today provided additional details based on the Goldman Small Cap Research report issued February 29, 2012, that highlighted the company’s cell encapsulation technology and its benefits for treating chronic diseases such as diabetes.

POZEN Inc. (NASDAQ: POZN)
, a pharmaceutical company committed to transforming medicine that transforms lives, announced today that John R. Plachetka, Pharm.D., the Company’s Chairman, President and Chief Executive Officer, will present at the 24th Annual ROTH Conference on Wednesday, March 14, 2012 at 12:30 p.m. (PT), at the Ritz Carlton Hotel in Laguna Nigel, CA.

Senesco Technologies, Inc. (NYSE AMEX: SNT)
today announced that it has received Institutional Review Board approval and has finalized a clinical trial research agreement with the University of Arkansas for Medical Sciences (“UAMS”) in Little Rock, Arkansas to evaluate SNS01-T, the Company’s lead therapeutic candidate for the treatment of multiple myeloma in the on-going Phase 1b/2a study.

SGI (NASDAQ:SGI), the trusted leader in technical computing, announced today that Japan’s National Institute of Genetics, an information and systems research organization located in Mishima, Shizuoka, under the leadership of Director-General Yuji Kohara, has selected an SGI® UVTM 1000, the top model in the SGI UV series, for a new supercomputer system.

Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of simulation and modeling software for pharmaceutical discovery and development, today announced that a member of its Board of Directors has elected to retire from the board and a new, outside member has been elected to fill the vacancy.

Tikcro Technologies Ltd. (OTC PK: TIKRF)
today reported results for the fourth quarter and year ended December 31, 2011.



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