Sucampo Announces Approval for Updates to AMITIZA; Endo Health Solutions Stock Halted Following News Print E-mail
By Staff and Wire Reports   
Friday, 30 November 2012 19:53
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 30, 2012.

Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP)
announced the Company received a supplement approval from the U.S. Food and Drug Administration (FDA) that removes pregnancy “warnings and precautions” and clarifies information regarding the use of AMITIZA^® (lubiprostone) by pregnant and/or nursing women. In addition, the FDA expanded the labeling text of the Mechanism of Action section in the prescribing information for AMITIZA. AMITIZA is approved for the treatment of chronic idiopathic constipation (CIC) in adults (24 mcg twice daily) and irritable bowel syndrome with constipation (IBS-C) in women 18 years of age and older (8 mcg twice daily).

The Company also announced today that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date for the Agency's priority review of the supplemental new drug application (sNDA) filing seeking approval for an additional indication for lubiprostone for the treatment of opioid-induced constipation (OIC) in patients with chronic, non-cancer pain. Sucampo was notified that its November 16, 2012 submission of FDA-requested supportive analyses has been designated as a major amendment to the application. Since the receipt date of this additional information is within three months of the PDUFA date, the FDA has decided to extend the goal date by three months to provide time for a full review of the submission. The extended user fee goal date is late April, 2013. No new clinical trials or studies have been requested by the FDA.

Sucampo has accepted the following FDA-approved labeling changes, which will be effective immediately:

1. All pregnancy-related Warnings and Precautions (Section 5.1 of the label) have been removed. This includes deletion of the sentence: “Women who could become pregnant should have a negative pregnancy test prior to beginning therapy with AMITIZA and should be capable of complying with effective contraceptive measures.”  2. Section 8 of the product labeling, “Use in Specific Populations,” was updated to include additional animal data and a Clinical Consideration section, with the pregnancy category remaining unchanged.  3. Previous labeling statements regarding the potential for serious adverse reactions in nursing infants have been removed. The revised label states that caution should be exercised when AMITIZA is administered to a nursing mother and advises “lactating women to monitor their human milk-fed infants for diarrhea while taking AMITIZA.”  4. The Mechanism of Action section (Section 12.1) of the label now reads as follows: “Lubiprostone is a locally acting chloride channel activator…activation of ClC-2 by lubiprostone has been shown to stimulate recovery of mucosal barrier function and reduce intestinal permeability (bolding added to indicate label addition) via the restoration of tight junction complexes in ex vivo studies of ischemic porcine intestine.”


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Endo Health Solutions Inc. (Nasdaq: ENDP)
announced its subsidiary, Endo Pharmaceuticals Inc., has filed suit against the U.S. Food and Drug Administration (FDA) seeking a formal determination whether the original formulation of OPANA® ER (oxymorphone HCl) was voluntarily removed from the market in 2012 for reasons of safety involving the misuse of the drug; and FDA's immediate suspension of any abbreviated new drug applications (ANDAs) for generic versions of non-tamper resistant formulations of extended-release oxymorphone HCl until FDA has made a determination as to whether the original formulation of OPANA ER was withdrawn from sale for safety reasons.  There is currently a non-tamper resistant generic of extended-release oxymorphone available in 7.5mg and 15mg dosage strengths, and if the FDA does not promptly suspend the approval of all non-tamper resistant formulations, all doses of the product will be available in non-tamper resistant versions in January 2013.

Endo reformulated OPANA ER to a version designed to be crush-resistant and launched this reformulated version in March 2012.  Current data monitoring abuse rates show a substantial decrease in abuse since the launch of the reformulated product, while simultaneously showing a more than 122 percent increase in abuse rates of the 7.5mg and 15mg non-tamper resistant extended release oxymorphone HCl.

The lawsuit, filed in the U.S. District Court for the District of Columbia, is based on the failure of the FDA to meet its legal obligation to determine in a timely manner whether the old formulation of OPANA ER was withdrawn from the market for reasons of safety.  Since its launch, Endo has collected surveillance data on the rates of abuse of oxymorphone HCl from two national programs – the first includes surveillance of substance abusers and the second collects data from U.S. Poison Control Centers.  The data show a 59 percent drop in abuse rates of the reformulated OPANA ER which is designed to be crush-resistant. The same data demonstrate a 122 percent increase in abuse rates of non-tamper resistant extended-release oxymorphone HCl.



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Also Friday:



On November 28, 2012, a class action lawsuit was filed in the United States District Court for the Northern District of California against Align Technology, Inc. (NASDAQ: ALGN).

AMRI (NASDAQ: AMRI)
announced today that as a next step in its SMARTSOURCING™ strategy it has taken further actions to expand and better integrate its in vitro biology services with its total drug discovery service platform.

BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX)
and privately held Presidio Pharmaceuticals, Inc. today announced the mutual termination of the Merger Agreement and the related Investor Financing Agreement entered into on October 17, 2012.

BioLineRx Ltd. (NASDAQ:BLRX) (TASE:BLRX)
, a biopharmaceutical development company, today announced that its management team will be presenting at the 2012 Fifth Annual LD MICRO Conference at the Luxe Sunset Bel Air Hotel in Los Angeles.

The first patient has been enrolled in the Boston Scientific Corporation (NYSE: BSX) EVOLVE II clinical trial, which is designed to further assess the safety and effectiveness of the SYNERGYStent System and support U.S. Food and Drug Administration and Japanese regulatory approvals for the treatment of atherosclerotic coronary lesions.

Celldex Therapeutics, Inc. (NASDAQ: CLDX)
announced today that Anthony Marucci, President and Chief Executive Officer, is scheduled to present at the Deutsche Bank 2012 dbAccess BioFEST on Monday, December 3, 2012 at 2:50 pm ET at the Four Seasons Hotel in Boston, MA.

China Jo-Jo Drugstores, Inc. (NASDAQ:CJJD)
(the “Company”), a retail and wholesale distributor of pharmaceutical and other healthcare products in Zhejiang and Shanghai, today announced the appointment of Ms. Zhimin Su to the Company’s board of directors and its audit committee as its chairperson, effective November 30, 2012.

Connectyx Technologies Holdings Group, Inc. (PINKSHEETS: CTYX)
, www.connectyx.com, a Healthcare BPO that provides unique products for the healthcare market including MedFlash®, the electronic Personal Health Manager (ePHM), Medical Transcription, Disease Management, Revenue Cycle Management, and Medical Consulting -- Billing and GuardianOne in the Personal Emergency Response Systems/Services (PERS) market, announced today the company has become a marketing partner with ProMAC, LLC.

CytoSorbents Corporation (OTCBB: CTSO)
, a critical care-focused company using blood purification to reduce inflammation as a means to prevent or treat organ failure caused by life-threatening illnesses, announced today that it has appointed Thomas Bocchino as Chief Financial Officer.

eHealth, Inc. (NASDAQ: EHTH), which operates PlanPrescriber (www.planprescriber.com) and eHealthMedicare (www.eHealthMedicare.com), released a list of helpful tips for people comparing Medicare Advantage plans and stand-alone Medicare Part D prescription drug plans during the 2012/2013 Medicare Annual Enrollment Period (AEP).

FluoroPharma Medical, Inc. (OTCQB: FPMI)
, a company specializing in the development of novel diagnostic imaging products that utilize positron emission tomography (PET) technology for the detection and assessment of disease before clinical manifestation, today announced that they have received a second round of high quality images in an investigator-sponsored clinical trial in China where patients with CAD were given BFPET™(18)F-TPP, its imaging agent under evaluation, for measuring cardiovascular blood flow.

Hi-Tech Pharmacal Co., Inc. (NASDAQ:HITK)
announced that it will pay a special one-time dividend of $1.50 per share. The dividend will be payable on December 28, 2012 to shareholders of record on December 13, 2012.

Panacea Global, Inc. ("Panacea") (OTCBB:PANG)
a biotechnology company focused on the discovery, development and commercialization of diagnostic products for the management of cancer, announced today that Dr. Mahmood Moshiri, President and CEO of Panacea is scheduled to present its cancer detection technology and chair a session at BIT's 3rd Annual World Congress of Biomarkers held December 2-4, 2012 in Guangzhou, China.

Revolutions Medical Corporation (OTCQB: RMCP)
experienced its largest turnout ever at any trade show to date when the Company exhibited at the recent Medica Show in Dusseldorf, Germany.

Santeon Group, Inc. (OTC.BB: SANT)
today announced that Dr. Ashraf Rofail Chairman of the Board and CEO, will present at RetailInvestorConferences.com.

Spectrum Pharmaceuticals (NasdaqGS: SPPI)
, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that an overview of the Company's business strategy and commercial and development-stage programs will be given at Deutsche Bank’s 2012 dbAccess BioFEST being held at the Four Seasons Hotel in Boston.

Synthetic Biologics, Inc. (NYSE MKT: SYN)
, a developer of synthetic biologics and innovative medicines for serious infections and diseases, announced today that Jeffrey Riley, CEO, will present at the Fifth Annual LD MICRO Conference on Thursday, December 6, 2012 at 9:00 a.m. (PT).

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA)
provided its current outlook for non-GAAP financial performance for the full year ending December 31, 2013.

University General Health System, Inc. (OTCQB: UGHS)
, a diversified, integrated multi-specialty health care delivery system, today announced that it has acquired a sleep and imaging center from Jacinto Medical Group in Baytown, Texas.



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