Insmed to Report Top-Line Results From Phase 3 Clinical Trial of ARIKACE; Hospira's Inflectra to Get Positive Opinion From EMA's CHMP Print E-mail
By Staff and Wire Reports   
Friday, 28 June 2013 20:00
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 28, 2013.

Insmed Incorporated (NASDAQ: INSM)
, a biopharmaceutical company focused on developing and commercializing an inhaled anti-infective to treat patients battling serious lung diseases that are often life-threatening, announced the Company will report top-line results from its European and Canadian Phase 3 study of ARIKACE® (liposomal amikacin for inhalation) to treat cystic fibrosis patients with Pseudomonas aeruginosa lung infections on Monday, July 1, 2013 at 7:00 a.m. Eastern time.

Insmed management will hold a conference call to discuss the results and answer questions on Monday, July 1, 2013 beginning at 8:00 a.m. Eastern time. Shareholders and other interested parties may participate in the call by dialing 888-803-5993 (domestic) or 706-634-5454 (international) and referencing conference ID number 13711485. The press release and several data slides will be posted at 7:15 a.m. Eastern time on July 1, 2013 on the homepage of the Company's website at www.insmed.com. The call will also be webcast live and archived on the Company's website at http://investor.insmed.com/events.cfm.


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Hospira (NYSE: HSP)
, the world's leading provider of injectable drugs and infusion technologies, received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending the European Commission (EC) approval of Inflectra (infliximab) for rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis.

Inflectra (infliximab) is a biosimilar medicine to the reference medicinal product, Remicade® (infliximab), and is the first monoclonal antibody therapy to reach a positive opinion following review via the EMA biosimilars regulatory pathway. A biosimilar developed in-line with EU requirements can be considered a therapeutic alternative to an existing biologic, with comparable quality, efficacy and safety to the reference product.[1] Remicade® had European sales of over USD 2bn in 2012.[2]

"Today's announcement is confirmation that Inflectra has met the very rigorous quality, safety and efficacy requirements that have been established by the EMA, and provides the next step toward Inflectra being approved for use in Europe," said Dr. Stan Bukofzer, Corporate Vice President and Chief Medical Officer, Hospira.

Biologic medicines have led to vast improvements in the treatment of conditions such as rheumatoid arthritis and inflammatory bowel disease, but they also represent one of the biggest medical expenditures in many countries.[3]

"In a time when there is mounting pressure on healthcare budgets worldwide, Inflectra provides an opportunity to increase patient access to more affordable biologic therapy while maintaining high quality standards," said Richard Davies, Senior Vice President and Chief Commercial Officer, Hospira.

Inflectra specifically targets tumour necrosis factor (TNF) alpha, a protein in the body that contributes to the painful inflammation seen in rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis. The drug's safety, efficacy and tolerability have been established through a comprehensive clinical trial programme. In a phase III randomised, double-blind study, Inflectra met its primary endpoint of therapeutic equivalence to the reference product. In the study, 73.4% of patients receiving Inflectra achieved a greater than 20% improvement in RA symptoms after 30 weeks of treatment (using the ACR20 scoring system), compared with 69.7% treated with reference infliximab. The safety and tolerability of Inflectra was also demonstrated to be comparable to Remicade, supporting its approval.[4]

In 2009, Hospira entered into an agreement with South Korean-based biopharmaceutical company, Celltrion, which is developing eight monoclonal antibody biosimilars. Under the terms of the agreement, Hospira obtained the rights to Inflectra in Europe, the United States, Canada, Australia and New Zealand.

The European Commission reviews the recommendations of the CHMP. The final decision on approval, usually granted within three months of CHMP opinion, will be applicable to all European Union (EU) and European Economic Area (EEA) countries.

Hospira has many years of experience in the field of biologics and one of the largest biosimilar pipelines in the industry. It is the only U.S.-based company with biosimilars on the European market, including Retacrit™ which was launched in Europe in early 2008 and Nivestim™, which entered the European market in 2010 and Australian market in 2011.



Also Friday:



Ambit Biosciences Corporation (Nasdaq: AMBI)
announced today that the company will be added to the Russell MicroCap® Index, effective at close of business on June 28, 2013.

Arrhythmia Research Technology, Inc. (NYSE MKT: HRT)
and its subsidiaries announced today its results for the quarter ending March 31, 2013.

Creative Edge Nutrition, Inc. (OTC Pink: FITX)
, a nutritional supplement company focusing on active lifestyles, today is excited to announce the addition of Dr. Sam Alawieh, Pharm.D. to our team. Sam brings over a decade of experience in Drug research & development and drug and neutraceutical delivery mechanisms.

C. R. Bard, Inc. (NYSE: BCR)
today announced that it has entered into an agreement to sell certain assets of its Electrophysiology division to Boston Scientific Corporation (NYSE-BSX) for $275 million in cash.

Dendreon Corporation (Nasdaq: DNDN)
today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that PROVENGE® (autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or Sipuleucel-T) be granted marketing authorization in the European Union (EU), for the treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated.

First Choice Healthcare Solutions, Inc. (OTCQB: FCHS) (OTCBB: FCHS)
announced today that its subsidiary, First Choice Medical Group, ("FCMG")has secured a $1.5 million A/R line of credit from CT Capital, Ltd. d/b/a CT Capital, LP.

Hospira (NYSE: HSP)
, the world's leading provider of injectable drugs and infusion technologies, today received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending the European Commission (EC) approval of Inflectra (infliximab) for rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis.

Insmed Incorporated (NASDAQ: INSM)
, a biopharmaceutical company focused on developing and commercializing an inhaled anti-infective to treat patients battling serious lung diseases that are often life-threatening, today announced that it was included on the list of companies to join the broad-market Russell Global® and the Russell 3000® Indexes when Russell Investments reconstitutes its comprehensive set of U.S. and global equity indexes on June 28, 2013 www.russell.com/indexes.

Insmed Incorporated (NASDAQ: INSM)
, a biopharmaceutical company focused on developing and commercializing an inhaled anti-infective to treat patients battling serious lung diseases that are often life-threatening, today announced that the Company will report top-line results from its European and Canadian Phase 3 study of ARIKACE® (liposomal amikacin for inhalation) to treat cystic fibrosis patients with Pseudomonas aeruginosalung infections on Monday, July 1, 2013 at 7:00 a.m. Eastern time.

LifeVantage Corporation (Nasdaq:LFVN)
, a company dedicated to helping people achieve healthy living through a combination of a compelling business opportunity and scientifically validated products, announced that its stock has been added to the Russell Global® and Russell 2000® Indexes.

Merck (NYSE: MRK)
, known as MSD outside the United States and Canada, will hold its second-quarter 2013 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. EDT on Tuesday, July 30.

MiMedx Group, Inc.  (NASDAQ: MDXG)
, an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that the Company's wound care allograft, EpiFix®, received reimbursement coverage by Medicare Contractor Wisconsin Physician Services (WPS), effective July 1, 2013.

OvaScienceSM, (NASDAQ: OVAS)
, a life sciences company focused on the discovery, development and commercialization of new treatments for infertility, announced today announced that Michelle Dipp, M.D., Ph.D., Chief Executive Officer of OvaScience, will present at “Encuentros 2013: Inspiring Innovation” on Friday, June 28 at the MIT Media Lab in Cambridge, Mass.

Sino Bioenergy Corp. (OTC Pink:SFBE)
(Borse Berlin:3SF) today announced that it has restated its Q1, 2013 quarterly filing.

VistaGen Therapeutics, Inc. (OTCQB: VSTA)
, a biotechnology company applying pluripotent stem cell technology for drug rescue, predictive toxicology and drug metabolism assays, today announced an update on the status of its strategic financing agreement with Autilion AG.

Zoetis Inc. (NYSE: ZTS)
, formerly the animal health business of Pfizer Inc., will host a webcast and conference call at 8:30 a.m. (EDT) on Tuesday, Aug. 6, 2013. Chief Executive Officer Juan Ramón Alaix and Executive Vice President and Chief Financial Officer Rick Passov will review second-quarter 2013 financial results, discuss 2013 financial guidance, and respond to questions from financial analysts during the call.



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