Salix and Pharming Announce FDA Approval of RUCONEST®; Lannett Signs Agreement to Be Exclusive U.S. Distributor of ACEON® Print E-mail
By Staff and Wire Reports   
Friday, 18 July 2014 19:16
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 18, 2014. Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) and Pharming Group NV ( EURONEXT: PHARM) announced the Food and Drug Administration has approved RUCONEST® (C1 Esterase Inhibitor [Recombinant]) 50 IU/kg for the treatment of acute angioedema attacks in adult and adolescent patients with hereditary angioedema (HAE). Because of the limited number of patients with laryngeal attacks, effectiveness was not established in HAE patients with laryngeal attacks.

“We are pleased that RUCONEST® provides the HAE community with another FDA-approved option for treating painful and debilitating HAE attacks,” said Anthony Castaldo, President of the Hereditary Angioedema Association (US HAEA), a non-profit patient services and research organization with a membership of over 5,000 HAE patients in the United States.

RUCONEST® is a recombinant C1 esterase inhibitor that can be administered by the patient after receiving training by a healthcare provider. HAE attacks stem from a deficiency of the C1 inhibitor protein in the blood. HAE is a rare inherited genetic condition that is often not properly diagnosed until later in a patient’s life as the symptoms of an attack can mirror someone experiencing an allergic reaction. Severe, painful swelling can occur at any time, which means most people suffering from HAE deal with the constant fear of when their next attack might surface and how that might impair their lives and those around them.

“Results in the pivotal clinical trial demonstrate RUCONEST® is a safe and effective option for the treatment of acute hereditary angioedema attacks,” said Dr. Marc Riedl of the US HAEA Angioedema Center at the University of California – San Diego and primary investigator of the phase III study. “At the US HAEA Angioedema Center, we strive to better the lives of those suffering from hereditary angioedema and part of that is ensuring patients have access to advanced treatments that have been proven to work in clinical trials. RUCONEST is an important addition to those treatment options.”

Sijmen de Vries, CEO of Pharming, said: “The approval of RUCONEST® in the US is a very significant milestone for Pharming. For many years we have strived to make RUCONEST® - the first recombinant replacement therapy for C1Inhibitor deficiency - available to the HAE patient community in the US, because we were aware of the great value and benefit this product adds to patients’ lives. Today we are proud to have achieved this goal in the US.”

“RUCONEST® is a much needed treatment option for patients suffering from acute attacks of hereditary angioedema. Until now, there hasn’t been an FDA approved recombinant C1 esterase inhibitor option to treat symptoms of HAE,” said Carolyn J. Logan, President and Chief Executive Officer of Salix. “The unpredictability of HAE can make patients feel uncertain about when their next attack might strike, which is why it is important to have a medicine that can be administered by the patient that resolves an attack. Salix is proud to make RUCONEST® available.”

The FDA approval of the Biologics License Application (BLA) for RUCONEST® for treatment of acute angioedema attacks in patients with HAE is based on a randomized, double-blind, placebo-controlled, phase III trial (RCT) which included an open-label extension (OLE) phase and is supported by the results of two additional RCTs and two additional OLE studies. The pivotal RCT and OLE studies analyzed the results from 44 subjects who experienced 170 HAE attacks. The primary efficacy endpoint was the time to beginning of symptom relief, assessed using patient-reported responses to two questions about the change in overall severity of their HAE attack symptoms after the start of treatment. These were assessed at regular time points for each of the affected anatomical locations for up to 24 hours. To achieve the primary endpoint, a patient had to have a positive response to both questions along with persistence of improvement at the next assessment time (i.e., the same or better response).

A statistically significant difference in the time to beginning of symptom relief was observed in the intent-to-treat population (n=75) between RUCONEST and placebo (p=0.031, log-rank test); the median time to beginning of symptom relief was 90 minutes for RUCONEST patients (n=44) and 152 minutes for placebo patients (n=31).

RUCONEST® is manufactured by Pharming Group NV in the Netherlands. Salix has licensed exclusive rights from Pharming to commercialize RUCONEST® in North America and market RUCONEST® for the treatment of acute HAE attack symptoms.

Salix currently plans on making RUCONEST® accessible to patients later in 2014.



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Lannett Company, Inc. (NYSE: LCI)
announced it has signed an agreement with Symplmed, Inc. to be the exclusive distributor in the United States of an authorized generic version of ACEON® (perindopril erbumine tablets) in 2 mg, 4 mg and 8 mg dosage strengths, an angiotensin converting enzyme (ACE) inhibitor approved to treat patients with high blood pressure (hypertension) and reduce the risk of heart attack in patients with stable coronary artery disease.

According to IMS, annual total sales of Perindopril Erbumine Tablets, 2 mg, 4 mg and 8 mg, at Average Wholesale Price (AWP) were approximately $3.5 million. The company expects to commence shipping the product shortly.



Also Friday:



Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS)
, a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to endoplasmic reticulum stress, cell cycle dysregulation, neurodegeneration and apoptosis, today announced that it has updated its MANF publications list with 8 previously undisclosed independent peer-reviewed research papers.

Arno Therapeutics, Inc. (OTCQB:ARNI)
, a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, today announced that Alexander Zukiwski, M.D., has been appointed as the interim Chief Executive Officer effective immediately.

Baxano Surgical, Inc. (Nasdaq:BAXS)
, a medical device company focused on designing, developing and marketing minimally invasive products to treat degenerative conditions of the lumbar spine, today announced that the Journal of Managed Care Medicine, a peer-reviewed national publication, has accepted an economic analysis of the AxiaLIF pre-sacral interbody fusion procedure in comparison to transforaminal lumbar interbody fusion (TLIF).

Celldex Therapeutics, Inc. (Nasdaq:CLDX)
will release second quarter 2014 financial results on Wednesday, August 6, 2014 after the U.S. financial markets close. Celldex executives will host a conference call at 4:30 p.m. ET on the same day to review the second quarter 2014 financial results and to provide an update on key research and development and business objectives for the remainder of 2014.

IntelGenx Technologies Corp. (TSX-V:IGX) (OTCQX:IGXT)
today announced that its interim CEO, Dr. Horst G. Zerbe, will be hosting a conference call on July 23rd, 2014 at 10:00 AM Eastern Time.

Propanc Health Group Corporation (OTCQB:PPCH)
, an emerging healthcare company focused on the development of new and proprietary treatments for cancer patients, is pleased to announce that the Depository Trust Corporation (the "DTC") has approved its common stock for DWAC/FAST transfer through the Company's Transfer Agent, V Stock, LLC.

RadNet, Inc. (Nasdaq:RDNT)
, a national leader in providing high-quality, cost-effective, fixed-site outpatient diagnostic imaging services through a network of 250 owned and operated outpatient imaging centers, today reported that effective July 1, 2014, it has acquired certain imaging assets located at eight HealthCare Partners Medical Group facilities.

StemCells, Inc. (Nasdaq:STEM)
, today announced that it has closed its previously announced offering of common stock and short term warrants.



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