|Update on VioPharma's Vancocin Capsules; Court Rules Pfizer Can Face Asbestos Suits|
|By Staff and Wire Reports|
|Tuesday, 10 April 2012 18:32|
ViroPharma Incorporated (Nasdaq: VPHM) announced the U.S. FDA denied the citizen petition (Docket # FDA-2006-P-0007) filed by ViroPharma on March 17, 2006 related to the FDA's proposed in vitro method for determining bioequivalence of abbreviated new drug applications (ANDAs) referencing Vancocin® (vancomycin hydrochloride, USP) Capsules.
In the FDA's response to the citizen petition, the agency denied ViroPharma's citizen petition and also informed the company that a final guidance for vancomycin bioequivalence consistent with the FDA's citizen petition response is forthcoming.
ViroPharma intends to file a complaint in the United States District Court for the District of Columbia, seeking an injunction to set aside the FDA's approval of ANDA's for generic versions of Vancocin. While the courts dismissed ViroPharma's prior lawsuit on the procedural basis of standing, the substance of the company's bioequivalence arguments and the arguments regarding Vancocin's eligibility for exclusivity have not been litigated before the Court.
As it has since 2006, the company will actively pursue a legal remedy in these matters in order to ensure the safety of patients. ViroPharma's efforts to date have already helped make FDA's approval standards for generic vancomycin capsules more patient-protective. FDA's 2006 in vitro bioequivalence method did not protect patients from the risks of inactive ingredient differences, but after ViroPharma filed its petition FDA in 2008 determined that generic products would not be eligible for the in vitro method unless they have the same inactive ingredients in the same quantities as Vancocin. And in yesterday's petition response FDA further tightened the standards to require that generics use a particular grade of polyethylene glycol.
ViroPharma believes that FDA is incorrect in interpreting its bioequivalence regulations in a manner that provides it with broad discretion to permit in vitro bioequivalence testing in the absence of a waiver of in vivo testing. ViroPharma believes that the FDA's position is not supported by its regulations, or by FDA's stated interpretation of those regulations at the time of their enactment.
A federal appellate court ruled on drugmaker Pfizer (NYSE:PFE) can face asbestos liability suits in state court over products once manufactured by a bankrupt subsidiary, dragging out a dispute that has already lasted more than 30 years.
At issue is insulating products made by Pfizer unit Quigley Co Inc that contained asbestos. Quigley, which Pfizer bought in 1968, at one time faced suits by more than 160,000 plaintiffs. It filed for bankruptcy in 2004.
Pfizer reached a deal that year with lawyers representing more than 80 percent of claimants, which provided for about $430 million in settlement payments. Quigley filed for bankruptcy protection as part of that arrangement, which was aimed at resolving cases dating back to the late 1970s.
The bankruptcy court later ruled that an injunction it issued in the case stayed some suits that were still pending against Pfizer. In May 2011, a federal judge in New York reversed that order, and the U.S. 2nd Circuit Court of Appeals upheld that ruling Tuesday.
Pfizer said in a statement it was evaluating its options.
"It is important to note that the court's ruling is procedural and does not address the merits of the underlying claims, which we strongly dispute," the company said. "In the history of this litigation, Pfizer has never been found derivatively or directly liable for injuries allegedly caused by Quigley's asbestos-containing products."
The suits in question were filed starting in 1999 by plaintiffs lawyer Peter Angelos in Pennsylvania state court. Angelos, one of the best-known asbestos lawyers in the country, also owns the Baltimore Orioles baseball team.
Angelos, according to the 2nd Circuit, had argued Pfizer was liable because the company allowed its label to be put on Quigley's asbestos-contaminated products, and therefore was not covered by the injunction protecting Quigley from lawsuits.
The appellate court ruled that Angelos was correct under the language of what is known as "524(g)," the section of the bankruptcy code that deals specifically with asbestos liability cases.
"We are confident that the Angelos reading of the statutory language at issue here is the correct one," the court's three judges said in the 34-page ruling.
Acorda Therapeutics, Inc. (Nasdaq: ACOR) will host a Research and Development Day for the investment community on Tuesday, April 17, 2012 from 10:00 a.m. to 1:00 p.m. at The Four Seasons Hotel in New York City.
Advaxis, Inc., (OTCBB: ADXS), a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that Dr. John Rothman, EVP of Science & Operations at Advaxis, and Dr. Robert Petit, VP of Clinical Operations at Advaxis, will present at the World Vaccine Congress 2012 at the Gaylord National Hotel and Convention Center in Washington, DC on April 10-12, 2012.
Akorn, Inc. (NASDAQ: AKRX), a niche specialty pharmaceutical company, today announced that it has launched Vancomycin Hydrochloride USP 125mg and 250mg capsules, the generic version of ViroPharma’s Vancocin®, which is indicated for the treatment of Clostridium difficile-associated diarrhea (CDAD).
ArQule, Inc. (NASDAQ: ARQL) today announced its intention to offer, subject to market and other conditions, 6 million shares of its common stock in an underwritten public offering.
Biovest International, Inc. (OTCQB: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI), today announced that Biovest is seeking marketing approval in Canada for BiovaxID®, its personalized cancer vaccine for the treatment of follicular non-Hodgkin’s lymphoma, an incurable cancer of the immune system.
Enzo Biochem Inc. (NYSE: ENZ) today announced the launch of the ColonSentry™ test for assessing a patient’s risk of having colorectal cancer, the first in a pipeline of new molecular diagnostic products the Company plans for the medical community.
Incyte Corporation (Nasdaq: INCY) announced today that it has scheduled its first quarter 2012 financial results conference call for 8:30 a.m. ET on Thursday, April 26, 2012.
Mallinckrodt, the pharmaceuticals business of Covidien (NYSE: COV), today joined The Partnership at Drugfree.org in supporting the “Wake Up to Medicine Abuse” campaign.
MannKind Corporation (Nasdaq: MNKD), focused on discovering, developing and commercializing treatments for diabetes and cancer, announced today that it will present at the Imperial Capital 2012 Healthcare Investor Forum on Tuesday, April 17, 2012 at 9:00 am Eastern Time at the New York Palace in New York.
Medtronic, Inc. (NYSE: MDT) today announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for its cardiac resynchronization therapy with implantable cardioverter defibrillator (CRT-D) devices.
The Multiple Myeloma Research Consortium (MMRC) today announced the start of a clinical trial evaluating ganetespib, a second generation Hsp90 inhibitor being developed by Synta Pharmaceuticals (NASDAQ: SNTA), as a single agent and in combination with the proteasome inhibitor bortezomib (VELCADE®) for the treatment of relapsed multiple myeloma.
NeuroMetrix, Inc. (Nasdaq: NURO), a medical device company focused on the diagnosis and treatment of the neurological complications of diabetes reported today that it will exhibit at the Midwest Podiatry Conference on April 19-22, 2012 in Chicago.
Provectus Pharmaceuticals, Inc. (OTCBB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announces that data from its Phase 2 study of PV-10 for metastatic melanoma will be presented at the HemOnc Today – Melanoma and Cutaneous Malignancies Conference on April 13, 2012.
Rentech Nitrogen Partners, L.P. (NYSE: RNF) and ClimeCo America Corporation (ClimeCo America) jointly announced today that ClimeCo America will deliver 120,000 Climate Reserve Tonnes (CRT) to Just Energy (NYSE:JE and TSX:JE), a leading competitive North American green energy retailer.
Safeguard Scientifics, Inc. (NYSE: SFE), a holding company that builds value in growth-stage life sciences and technology companies, today announced that it expects to receive an additional $5.6 million in proceeds from Eli Lilly and Company’s (NYSE: LLY) acquisition of former partner company Avid Radiopharmaceuticals, Inc., which took place in December 2010.
Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of simulation and modeling software for pharmaceutical discovery and development, today reported financial results for its second quarter of fiscal year 2012 ended February 29, 2012 (2QFY12).
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced it has posted information from the MAUDE database showing 377 deaths associated with the Medtronic Quattro Secure lead, rather than the 62 that was reported by Dr. Robert Hauser in a manuscript published online last week by the Heart Rhythm Journal.
Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR Therapeutics™, today announced revised top-line results from its exploratory Phase 2 clinical study of TC-6987 in asthma.
A new Walgreens (NYSE: WAG) (NASDAQ:WAG) study comparing utilization rates of patients filling 90-day prescription medications using community and mail order pharmacies found that when co-pay costs are similar, patients preferred the community pharmacy channel option by a ratio of four to one.
ZOLL Medical Corporation (NasdaqGS: ZOLL), a manufacturer of medical devices and related software solutions, announced today that it recently provided an educational grant to sponsor the second annual “Chilling at the Beach─Therapeutic Hypothermia and Temperature Management: Current and Future Directions” conference hosted by the University of Miami Miller School of Medicine.