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Posts Tagged ‘Actavis’


 

Two New Drugs for Inflammatory Bowel Syndrome Are Giving Patients Hope

Reporter: Stephen J. Williams, Ph.D.

Actavis Receives FDA Approval for VIBERZI (eluxadoline) for the Treatment of Irritable Bowel Syndrome with Diarrhea (IBS-D) in Adults -First in class treatment for IBS-D treats hallmark symptoms of IBS-D; abdominal pain and diarrhea

DUBLIN, May 27, 2015 /PRNewswire/ — Actavis plc (NYSE: ACT) announced today that VIBERZI™ (eluxadoline) was approved by the Food and Drug Administration (FDA) as a twice-daily, oral treatment for adults suffering from irritable bowel syndrome with diarrhea (IBS-D). VIBERZI (eluxadoline) has mixed opioid receptor activity, it is a mu receptor agonist, a delta receptor antagonist, and a kappa receptor agonist.

Logo – http://photos.prnewswire.com/prnh/20130124/NY47381LOGO

“The FDA’s approval of VIBERZI is the first step to providing physicians with a new, evidence-based, treatment option for their adult patients with IBS-D,” said David Nicholson, Executive Vice President, Actavis Global Brands R&D. “At Actavis, we are dedicated to providing new treatment options, and the development of new agents that help address the most bothersome symptoms of IBS-D. We are very pleased to be working with the FDA to advance this IBS-D treatment and we eagerly await DEA scheduling determination later this year.”

IBS-D is a multifactorial disorder marked by recurrent abdominal pain or discomfort and altered bowel function that affects as many as 15 million adult Americans, impacting about twice as many women as men.i,ii,iii There are few treatment options available for IBS-D, particularly options that relieve both the diarrhea and abdominal pain associated with IBS-D.

“The unpredictable symptoms experienced by patients with IBS-D can have a significant impact on everyday life,” said William D. Chey, MD, Nostrant Professor of Gastroenterology at the University of Michigan Health System. “It’s exciting when physicians are able to add an additional treatment option like VIBERZI to their toolbox for patients with IBS-D.”

The FDA has recommended that VIBERZI be classified as a controlled substance. This recommendation has been submitted to the U.S. Drug Enforcement Administration (DEA).  Once VIBERZI receives final scheduling designation, the updated label will be available. Pending final scheduling designation, product launch is anticipated in Q1 2016.

About VIBERZI

VIBERZI is an orally active compound indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in men and women. VIBERZI (eluxadoline) has mixed opioid receptor activity, it is a mu receptor agonist, a delta receptor antagonist, and a kappa receptor agonist.

Efficacy was established in two Phase III clinical studies, demonstrating significant superiority over placebo on the composite endpoint of simultaneous improvement in both abdominal pain and diarrhea at both 75 mg and 100 mg twice daily doses. The primary efficacy responder endpoint was evaluated over the duration of double-blind, placebo-controlled treatment. Response rates were compared based on patients who met the daily composite response criteria (improvement in both abdominal pain and stool consistency on the same day) for at least 50% of the days from weeks 1 to 12 (FDA endpoint) and weeks 1 to 26 (European Medicines Agency endpoint).

The most common adverse events in the two Phase III clinical trials were constipation (7% and 8% for eluxadoline 75 mg and 100 mg; 2% for placebo) and nausea (8% and 7% for eluxadoline 75 mg and 100 mg; 5% for placebo). Rates of severe constipation were less than 1% in patients receiving 75 mg and 100 mg eluxadoline. Rates of discontinuation due to constipation were low for both eluxadoline and placebo (≤2%) and similar rates of constipation occurred between the active and placebo arms beyond 3 months of treatment. A total of 2,426 subjects were enrolled across the two studies.

For more information including full prescribing information about VIBERZI at http://www.actavis.com/Actavis/media/PDFDocuments/VIBERZI_PI.pdf

About IBS-D

Irritable bowel syndrome with diarrhea (IBS-D) is a functional bowel disorder characterized by chronic abdominal pain and frequent diarrhea, which affects approximately 15 million patients in the U.S.  Although the exact cause of IBS-D is not known, symptoms are thought to result from a disturbance in the way the gastrointestinal tract and nervous system interact.

IBS-D can be debilitating and there are limited therapeutic options for managing the chronic symptoms. IBS-D is associated with economic burden in direct medical costs and indirect social costs such as absenteeism and lost productivity, along with decreased quality of life.

About Actavis
Actavis plc (NYSE: ACT), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model—Growth Pharma. Actavis is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.

Actavis markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women’s health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world’s third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Actavis is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.

With commercial operations in approximately 100 countries, Actavis is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.

Actavis intends to adopt a new global name – Allergan – pending shareholder approval in 2015.

For more information, visit Actavis’ website at www.actavis.com.

Actavis Cautionary Statement Regarding Forward-Looking Statements

Statements contained in this communication that refer to Actavis’ estimated or anticipated future results, including estimated synergies, or other non-historical facts are forward-looking statements that reflect Actavis’ current perspective of existing trends and information as of the date of this communication. Actual results may differ materially from Actavis’ current expectations depending upon a number of factors affecting Actavis’ business. These factors include, among others, the timing and success of product launches; the difficulty of predicting the timing or outcome of product development efforts and regulatory agency approvals or actions, if any; market acceptance of and continued demand for Actavis’ products; difficulties or delays in manufacturing; and such other risks and uncertainties detailed in Actavis’ periodic public filings with the Securities and Exchange Commission, including but not limited to Actavis plc’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2015 and from time to time in Actavis’ other investor communications. Except as expressly required by law, Actavis disclaims any intent or obligation to update or revise these forward-looking statements.

i Camilleri M. Current and future pharmacological treatments for diarrhea-predominant irritable bowel syndrome. Expert Opinion on Pharmacotherapy. 2013;14:1151.

ii Grundmann O, Yoon SL. Irritable bowel syndrome: epidemiology, diagnosis, and treatment: an update for health-care practitioners. Journal of Gastroenterology and Hepatology. 2010;25:691–699.

iii Eluxadoline Xifaxin Summary Final. November 2014.

CONTACTS:
Investors:
Lisa DeFrancesco
(862) 261-7152

Media:
David Belian
(862) 261-8141

SOURCE Actavis plc

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Synergy’s Looming FDA Filing Makes It Pharma of the Month

By James Passeri Follow

| Jan 05, 2016 | 8:39 AM EST  | 0

Keep an eye on Synergy Pharmaceuticals (SGYP) this month: Analysts like it, its shares have waned since a big spike this summer, and the official filing of its star product is expected any day.

When the New York-based pharmaceutical company, which specializes in gastrointestinal therapy, announced that it passed clinical trials on its flagship drug plecanatide this summer, shares rocketed 95%.

But today analysts appear mystified at why the stock has receded 45% from its July high, especially with plecanatide’s new drug application with the Food and Drug Administration expected this month. (It’s currently trading below $6, and the consensus price target is over $13, according to data provided by Bloomberg.)

Synergy should be raking in $600 million from plecanatide, a daily tablet that treats patients with irritable bowel syndrome (IBS), within five years of obtaining FDA approval (expected in 2017, according to equity research firm BTIG. Synergy currently has a market capitalization of just $645 million.

BTIG’s $11 price target is also buoyed by roughly $142 million on the balance sheet, as well as newly appointed management including CFO Gary Sender and COO Troy Hamilton, both former executives at pharma success story Shire (SHPG). Though Shire shares are down just under 4% over the past 12 month, they have rocketed 112% over the past two years.

Synergy also stands to benefit from a growing demand for gastrointestinal treatments, feeding the appetite of Big Pharma for potential acquisitions, according to BTIG.

“With about 45 million Americans suffering from chronic constipation and IBS, and major companies like Allergan(AGN) and Valeant (VRX) focusing their marketing efforts on GI treatments, it seems logical to imagine SGYP as a takeover candidate,” BTIG analyst Timothy Chiang wrote in a November report.

Whether or not this leads to a buyout or another stock surge, Synergy certainly can be counted on for a healthy dose of small-cap volatility as its chief product takes the final steps toward reaching its customers.

 

 

Synergy Pharmaceuticals Announces Successful End-of-Phase 2 Meeting with FDA for Plecanatide in Irritable Bowel Syndrome with Constipation

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Pivotal Phase 3 IBS-C Program to be Initiated in the Fourth Quarter of 2014

NEW YORK– Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced that it has successfully completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on its lead drug plecanatide for the treatment of irritable bowel syndrome with constipation (IBS-C). Agreement was reached with the FDA for the plecanatide pivotal phase 3 IBS-C clinical development program that is scheduled to begin in the fourth quarter of this year.

“We are very pleased with the outcome of our meeting with the FDA and have a clear path forward to start the IBS-C registration program with plecanatide this year,” said Dr. Gary S. Jacob, Chairman and CEO of Synergy. “The pivotal phase 3 IBS-C trials will include both 3.0 mg and 6.0 mg plecanatide, which are consistent with the doses currently being evaluated in our phase 3 chronic idiopathic constipation (CIC) program. Plecanatide has demonstrated a clinical dose-response for efficacy with an excellent tolerability profile that is observed across trials. This is an important advantage as we look to bring two doses to market in both indications and provide physicians with options for addressing individual patient needs.”

Synergy’s pivotal phase 3 IBS-C clinical development program will consist of two registration trials, each including 1,050 patients who will receive either placebo, 3.0 mg or 6.0 mg plecanatide. IBS-C patients successfully completing either of the 12-week placebo-controlled registration trials will be offered enrollment into a long-term safety trial in order to complement and support the ongoing long-term safety database for the CIC indication.

About Plecanatide

Plecanatide is Synergy’s lead uroguanylin analog in late-stage clinical development to treat patients with CIC and IBS-C. Uroguanylin is a natural gastrointestinal (GI) hormone produced by humans in the small intestine and plays a key role in regulating the normal functioning of the digestive tract through its activity on the guanylate cyclase-C (GC-C) receptor. The GC-C receptor is known to be a primary source for stimulating a variety of beneficial physiological responses. Orally administered plecanatide mimics uroguanylin’s functions by binding to and activating the GC-C receptor to stimulate fluid and ion transit required for normal bowel function. Synergy has successfully completed a phase 2b trial of plecanatide in 951 patients with CIC and is currently enrolling patients in two pivotal phase 3 CIC trials. The company also recently announced positive top-line data results from a phase 2b dose-ranging study with plecanatide in patients with IBS-C.

About Synergy Pharmaceuticals

Synergy Pharmaceuticals (NASDAQ:SGYP) is a biopharmaceutical company focused on the development of novel therapies based on the natural human hormone, uroguanylin, to treat GI diseases and disorders. Synergy has created two unique analogs of uroguanylin – plecanatide and SP-333 – designed to mimic the natural hormone’s activity on the GC-C receptor and target a variety of GI conditions. SP-333 is currently in phase 2 development for opioid-induced constipation and is also being explored for ulcerative colitis. For more information, please visit www.synergypharma.com.

 

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Reporter: Aviva Lev-Ari, PhD, RN

The court upheld its original opinion that Actavis had not infringed on the patent, but it held this time that Actavis had not carried out the experimentation to the extent laid out by the patent.

Cephalon, Inc. v. Watson Pharm., Inc.

Justia.com Opinion Summary: The patents relate to a method of drug delivery via the mucous membrane lining or mucosa in the oral cavity. The oral mucosal route provides direct access to the bloodstream without having to travel through the gastrointestinal tract, which allows the drug to avoid the “first pass effect,” the percentage of drug lost to metabolization in the liver. Drug delivery across the oral mucosa potentially provides patients with rapid onset of action at a lower dosage. The patents disclose use of effervescent agents used as penetration enhancers, which influence drug absorption across the buccal, sublingual and gingival mucosae and use of an additional pH adjusting substance in combination with an effervescent agent for promoting the absorption. Watson filed an Abbreviated New Drug Application for a generic version of FENTORA®. In response, Cephalon instituted a patent infringement suit. The district court found that Watson’s ANDA products did not infringe and held the asserted patents invalid for lack of enablement. The Federal Circuit reversed on the issue of enablement, holding that Watson failed as a matter of law to show with clear and convincing evidence that Cephalon’s patents require undue experimentation to practice the invention. The court upheld the noninfringement finding.
SOURCE:

Before REYNA, BRYSON,∗ and WALLACH, Circuit Judges.

WALLACH, Circuit Judge.

This action arises out of the filing of an Abbreviated New Drug Application (“ANDA”) by Watson Pharmaceuticals, Inc., Watson Laboratories, Inc., and Watson Pharma, Inc. (collectively, “Watson”) for a generic version of FENTORA®. In response to Watson’s ANDA filing,

Cephalon, Inc. and CIMA Labs, Inc. (collectively, “Cephalon”) instituted this patent infringement suit at the United States District Court for the District of Delaware asserting U.S. Patent Nos. 6,200,604 (“the ’604 patent”) and 6,974,590 (“the ’590 patent”). After a bench trial, the district court found that Watson’s ANDA products did not infringe and held the asserted patents invalid for lack of enablement. Cephalon, Inc. v. Watson Pharms., Inc., 769 F. Supp. 2d 729, 761 (D. Del. 2011). We reverse on the issue of enablement because Watson failed as a matter of law to show with clear and convincing evidence that Cephalon’s patents require undue experimentation to practice the invention. As to the noninfringement finding, the district court did not clearly err. Thus, we reverse– in–part and affirm–in–part.

Courts: Teva’s Cephalon fells Actavis in oral painkiller delivery appeal

February 20, 2013 | By 

A federal appeals court reversed its decision in favor of Cephalon in a dispute with Actavis ($ACT) over an oral mucosal painkiller delivery patent.

Cephalon, a subsidiary of Teva Pharmaceuticals ($TEVA), patented the delivery platform Fentora, an approach to the oral absorption of the painkiller fentanyl for cancer patients that uses penetration enhancers and pH-controlling materials to ease the passage of the drugs through the mouth.

The decision is a reversal of a lower court’s decision to side with Actavis–at that time Watson Pharmaceuticals ($WPI)–in 2011 when the company’s generic version of Cephalon’s Fentora came under question as a possible infringement against the patented technique.

The court upheld its original opinion that Actavis had not infringed on the patent, but it held this time that Actavis had not carried out the experimentation to the extent laid out by the patent.

Back in 2011, when the courts first overturned Cephalon’s patents, the decision threatened the financial viability of Fentora, which brought the company $181.6 million globally in 2010–about 6% of its revenue. But the reversal of that decision comparatively represents a clear blow to generic drugmakers, particularly to the feasibility of their latching onto the market.

SOURCE:

Teva jacks up prices on Cephalon legacy brands

December 7, 2011 | By 

Here’s one way to increase your drug sales overnight: First, buy a company. Then, raise its product prices up to 25%. That, apparently, is Teva Pharmaceutical Industries’ ($TEVA) strategy for Cephalon ($CEPH), the U.S.-based drugmaker it acquired just a couple of months ago. Almost as soon as the deal closed, Teva “implemented a series of unusually robust price increases” for several of Cephalon’s branded meds, Deutsche Bank says.

Citing a wholesale pricing report from Medi-Span, Deutsche Bank analysts say Teva hiked the prices on Cephalon painkiller Fentora and wakefulness drug Provigil 15%–and raised the price on Provigil follow-up Nuvigil 25%. The latter increase came on top of an 8% price rise just 6 months before.

The analysts approved of the increases, Globes news service reports. “Taken together, these recent increases could likely bolster the outlook for Teva’s North American pharmaceutical sales in the fourth quarter, and, more importantly, in 2012,” they wrote (as quoted by Globes). Together with Teva’s profit-sharing deal with Ranbaxy on copycat Lipitor, its recent launch of a Zyprexa copy, and the planned debut of generic Lexapro, Deutsche Bank figures Teva’s new target price at $46, compared with yesterday’s $40 close.

 http://www.fiercepharma.com/story/teva-jacks-prices-cephalon-legacy-brands/2011-12-07

Teva jacks up prices on Cephalon legacy brands – FiercePharma http://www.fiercepharma.com/story/teva-jacks-prices-cephalon-legacy-brands/2011-12-07#ixzz2LSwmSlMG

Cephalon sues to block generic Fentora sales, citing dangers

March 16, 2011 | By 

Fentora maker Cephalon is fighting back against potential generic competition. It has asked a federal judge to block the sale of Watson Pharmaceuticals’ generic version of the drug, alleging it is potentially dangerous because it contains “a novel salt form” never approved by the FDA.

In its suit brought against the government in the U.S. District Court for the District of Columbia, Cephalon maintains that “[b]arring an injunction,” the FDA’s approval of Watson’s product “will usher into the marketplace a generic drug of untested safety and efficacy.”

Cephalon filed its suit four days after a federal judge in Delaware ruled the generic made by Watson didn’t infringe two patents exclusively licensed to Cephalon. The company said at the time it is reviewing the decision and is weighing its options. Patents on Fentora are due to expire in 2019, according to the FDA’s Orange Book.

http://www.fiercepharma.com/story/cephalon-sues-block-generic-fentora-sales-citing-dangers/2011-03-16

Cephalon sues to block generic Fentora sales, citing dangers – FiercePharma http://www.fiercepharma.com/story/cephalon-sues-block-generic-fentora-sales-citing-dangers/2011-03-16#ixzz2LSxRdxQx

Court overturns two patents for Cephalon painkiller

March 14, 2011 | By 

Cephalon ($CEPH) is weighing its options after a federal court overturned two patents related to the painkiller Fentora.

The U.S. District Court for the District of Delaware ruled on two of three patents in the case involving Frazer, PA-based Cephalon and Watson Pharmaceuticals, according to the companies. Cephalon said Friday it is reviewing the decision and is weighing its options, including an appeal. Patents on Fentora are due to expire in 2019, according to the FDA’s Orange Book.

The decision might open the door to Watson and other generic drug makers to start marketing copycat versions of Fentora. Watson obtained FDA approval of a generic version of the painkiller in January. Cephalon previously made an agreement with Teva Pharmaceutical Industries through which the generics giant would hold off from marketing its version of the treatment until 2018. But that deal gives Teva the green light to start sales if another competitor begins selling a generic version.

Louise Chen, an analyst for Collins Stewart, tells the AP that Cephalon might decide to increase the price of Fentora and then start sales of its own generic version of the drug. Cephalon would be protecting a product that brought $181.6 million in worldwide sales in 2010, or about 6 percent of the company’s total annual revenue.

 http://www.fiercepharma.com/story/court-overturns-two-patents-cephalon-painkiller/2011-03-14

Court overturns two patents for Cephalon painkiller – FiercePharma http://www.fiercepharma.com/story/court-overturns-two-patents-cephalon-painkiller/2011-03-14#ixzz2LSzBfsSb

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