Forest Labs and Almirall Delays NDA Filing for Aclidinium/formoterol Combination; Ampio Announces Ampion Study Meets Primary Endpoint Print E-mail
By Staff and Wire Reports   
Wednesday, 14 August 2013 19:20

Below is a look at some of the headlines for companies that made news in the healthcare sector on August 14, 2013. Forest Laboratories, Inc. (NYSE: FRX) and Almirall, S.A. (ALM:MC) announced they will delay the planned Q4 2013 submission of a New Drug Application (NDA) for the combination of aclidinium bromide, a long acting muscarinic antagonist and formoterol fumarate, a long acting beta agonist, for the indication of Chronic Obstructive Pulmonary Disease (COPD). This decision was based on comments provided by the FDA at a recent pre-NDA meeting.

The delay is related to resolving chemistry, manufacturing and control (CMC) specifications associated with the combination formulation. Forest and Almirall are working with the FDA regarding the CMC related comments provided at the pre-NDA meeting to determine the appropriate next steps, and expects to provide an update when more information becomes available. The decision to delay the NDA filing for the combination does not affect the Tudorza® (alcidinium bromide) monotheraphy product.


Ampio Pharmaceuticals (NYSE: AMPE) announced positive results from the SPRING study ( NCT01839331) of Ampion for the treatment of osteoarthritis of the knee (OAK). In this study of 329 patients, patients treated with a single intra-articular injection of Ampion achieved a clinically meaningful reduction in pain.

The SPRING study, was a randomized (1:1:1:1), double-blind, vehicle controlled trial designed to evaluate the safety and efficacy of Ampion in OAK patients. Patients were randomized to receive one of two doses (4 mL or 10 mL) of Ampion or corresponding saline control via intra-articular injection. The primary study objective was to evaluate the relative efficacy of Ampion 4 mL versus Ampion 10 mL. The primary endpoint was mean change in pain from baseline for Ampion compared to the same volume of saline. Secondary endpoints included evaluating safety and quality of life, as well as, stiffness and function.

Ampion dose cohorts experienced statistically significant reductions in pain compared to control. There were no significant differences between the efficacy of the two Ampion doses. Selection of the optimal dose for the second Phase 3 trial will be decided in consultation with the U.S. Food and Drug Administration (FDA).

Michael Macaluso, Chairman and Chief Executive Officer, said, "We are very pleased with the results of the trial. Both doses of Ampion provided osteoarthritis patients with pain relief. The broad inclusion criteria for the trial reflected a real world application of this biologic to a diverse patient population, making these results even more impressive. This should greatly encourage the enormous population of patients afflicted with OAK and the physicians who treat them."

Also Wednesday:


Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced positive results from the SPRING study ( NCT01839331) of Ampion for the treatment of osteoarthritis of the knee (OAK).

Atossa Genetics, Inc. (NASDAQ: ATOS)
, the Breast Health Company™, today announced its second quarter 2013 financial results and corporate highlights.

Bioheart, Inc. (OTCQB: BHRT)
announced today that Mike Tomas, the company's President/CEO, has been appointed to serve on Workforce Florida's Board of Directors for a four year term by Florida Governor Rick Scott.

, the world's leading manufacturer and distributor of dental lasers, and a pioneer in laser surgery in other medical specialties, today announced that due to the unwarranted amount of confusion in the marketplace that has ensued since the filing of the registration statement on Form S-3, originally filed with the Securities and Exchange Commission (the "SEC") on July 26, 2013, BIOLASE will reduce the registration statement from $30 million to $5 million.

Bovie Medical Corporation (NYSE MKT: BVX)
, a manufacturer and marketer of electrosurgical products, today announced its financial results for the second quarter and six months ended June 30, 2013.

The Cooper Companies, Inc. (NYSE:COO)
will present at Baird's 2013 Health Care Conference in New York, New York on September 10, 2013.

CytoSorbents Corporation (OTCBB: CTSO)
, a critical care focused company commercializing its European Union approved CytoSorb® blood filter to treat life-threatening illnesses in the intensive care unit, provides a corporate update and reports its financial results for the three and six month period ending June 30, 2013.

DARA BioSciences, Inc. (NASDAQ: DARA)
, a specialty pharmaceutical company focused on the commercialization of its complementary product portfolio of oncology and oncology supportive care products, announced today its financial results for the second quarter ended June 30, 2013.

eHealth, Inc. (NASDAQ: EHTH)
, the nation's first and largest private online health insurance exchange, released answers to frequently asked questions for Aetna policy holders in California who may be confused about their coverage options.

Galectin Therapeutics Inc. (Nasdaq:GALT)
, the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today reported its financial results for the second quarter and first six months ended June 30, 2013.

Hyperion Therapeutics, Inc. (Nasdaq:HPTX)
today reported net revenue of $7.3 million following the first full quarter of sales of its newly approved compound, RAVICTI® (glycerol phenylbutyrate) Oral Liquid and one month of sales of BUPHENYL® (sodium phenylbutyrate) Tablets and Powder following the company's acquisition of that product.

LeMaitre Vascular, Inc. (Nasdaq:LMAT)
is presenting at the Three Part Advisors Midwest IDEAS Investor Conference at the University of Chicago, Gleacher Center in Chicago, IL. JJ Pellegrino, Chief Financial Officer, will provide an update on the Company on Tuesday, August 27, 2013 at 3:15 pm CDT.

MusclePharm Corporation (OTCQB: MSLP)
, a fast growing company that develops and markets sports nutritional supplements which address active lifestyles, announced today its financial results for the second quarter ended June 30, 2013 ("Q2 2013").

Organovo Holdings, Inc. (NYSE MKT: ONVO), a biotechnology company focused on delivering breakthrough three-dimensional (3D) bioprinting technology, today issued a caution to investors regarding content on certain internet sites targeting existing and potential investors in its common stock.

Pacific Health Care Organization, Inc., (OTCQB: PFHO) today announced its financial results for the second quarter ended June 30, 2013.

Pluristem Therapeutics Inc. (NASDAQCM: PSTI) (TASE: PLTR)
, a leading developer of placenta-based cell therapies, announced today the results of a pre-clinical trial using the Company’s PLacental eXpanded (PLX) cells in tendon injury.

RXi Pharmaceuticals Corporation (OTCQX: RXIID), a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using RNA-targeted technologies, today reported its financial results for quarter ended June 30, 2013, and provided a business update.

SANUWAVE Health, Inc. (OTCBB:SNWV) today reported financial results for the three and six months ended June 30, 2013 and provided a business update.

Speaking from Buenos Aires, SmartMetric™ Inc. (OTCQB: SMME) President & CEO Chaya Hendrick said the company's MedicalKeyring™ is able to store a person's complete medical files including a person's complete mammogram images.

Symmetry Technologies Inc. (OTC:SMMR) is pleased to announce the acquisition  from a Houston, PhD led Biomedical research firm, all work product, rights, and interest in the  "Inducible Expression System for Biosynthetic Production of Testosterone in Men"  being developed by them.

TelVue® Corporation (PINKSHEETS: TEVE), the innovation leader in Television and Internet Broadcasting for media companies, cable operators and communities, reported second quarter net income to Common Stockholders (through June 30) of $34,177 which was a turnaround from the 2012 second quarter loss of $1.0 million.

Urologix®, Inc. (OTC:ULGX) will host a conference call to present fourth quarter and full fiscal year 2013 results on Tuesday, August 20, 2013 at 4:00 p.m. CT, following the Company's post-market press release on the same day.

Verisante Technology, Inc. (TSX VENTURE:VRS) (OTCQX:VRSEF), a leader in cancer detection technology, announced today that SeeThruEquity, an investment research firm, has initiated coverage on the Company with a fair value of $1.05 per share.

ZELTIQ®, (Nasdaq:ZLTQ) a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology platform, today announced that Mark Foley, President and Chief Executive Officer and Patrick F. Williams, Senior Vice President and Chief Financial Officer, are scheduled to present at the Canaccord Genuity 33rd Annual Growth Conference at the InterContinental Boston Hotel in Boston, Massachusetts.

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