|Amarin's Vascepa Given Marketing Exclusivity, Shares Up After Hours; Teva Receives CHMP Positive Opinion for DuoResp® Spiromax®|
|By Staff and Wire Reports|
|Friday, 21 February 2014 19:55|
The FDA has given Amarin (NASDAQ: AMRN) three years of marketing exclusivity for its Vascepa triglyceride-reduction drug.
Though exclusivity officially only extends through July 25, 2015, Amarin expects it to be "supplemented by a 30-month stay under the Hatch-Waxman Amendments that would be triggered after patent infringement litigation initiated by Amarin" in response to the approval of a generic version of Vascepa.
Amarin says it's "evaluating whether to challenge" the FDA's decision to give only three years of exclusivity, rather than five, and insists its efforts to bolster Vascepa's patent position have lowered the relative value of marketing exclusivity. Shares up +4.8% after hours.
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for DuoResp® Spiromax® (budesonide & formoterol fumarate dihydrate) inhalation powder for the treatment of patients with asthma and chronic obstructive pulmonary disease (COPD) when a combination inhaled corticosteroid and long-acting beta2-adrenoceptor agonist is appropriate. This CHMP decision creates a path forward for a final approval decision from the European Commission that is expected in the next few months.
DuoResp® Spiromax® is a new multi-dose dry-powder inhaler with a combination of budesonide, an inhaled corticosteroid to treat the underlying inflammation in asthma and COPD, and formoterol fumarate dihydrate, a rapid-acting and long-lasting beta2 agonist for the relief of bronchoconstriction in asthma and COPD. The Spiromax® inhaler uses unique breath-actuated technology to deliver a consistent dose of the medicines from the first dose to the last.
DuoResp® Spiromax® was developed to improve ease of use and provide consistent delivery of medicine to patients. Many patients with asthma and COPD are under-treated as a consequence of poor inhaler technique. This leads to unnecessary burden in the form of additional clinic visits and need for emergency care. DuoResp® Spiromax® will enter the ICS/LABA fixed combination inhaled market segment that has total product sales of $13.9B USD worldwide, and $4.4B USD within Europe.
“We have planned for strong growth in Respiratory,” said Michael Hayden, President, Global R&D and Chief Scientific Officer, “The Spiromax® inhaler is an important addition to our Respiratory portfolio and supports our strategy to become a leading presence in Respiratory with a robust and differentiated pipeline, projected to be a multi-billion dollar franchise by the end of the decade.”
In addition to the European application, applications will be made in a number of major countries worldwide.
“The Committee’s favorable view of the registration dossier for DuoResp® Spiromax® marks an important step in Teva’s journey to deliver a valuable new treatment option for the treatment of patients with asthma and COPD,” said Rob Koremans, M.D., President and CEO, Teva Global Specialty Medicines. “We look forward to receiving the final decision from the European Commission.”
Two late stage trials in patients with persistent asthma are currently ongoing to compare the benefits of DuoResp® Spiromax® vs Budesonide/Formoterol Multi-dose Dry Powder Inhaler. Both studies are expected to report in 2014 but are not required to be completed to gain final approval from the European Commission.
Air Methods Corporation (Nasdaq:AIRM) will report financial results for the fourth quarter ended December 31, 2013 after the close of the market on Thursday, February 27, 2014.
Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that the U.S. Food and Drug Administration (FDA) has awarded three years of marketing exclusivity to Vascepa® (icosapent ethyl) capsules in connection with the July 26, 2012 approval of Vascepa pursuant to the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act.
Visitors will have a chance to connect with Cerner Corp. (Nasdaq:CERN) clients from around the globe at the Healthcare Information and Management Systems Society annual conference in Orlando, Fla.
Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced two oral presentations related to its broad-spectrum investigational antiviral, brincidofovir (CMX001), at the BMT Tandem Meetings being held February 26 – March 2, 2014 in Grapevine, Texas.
Dehaier Medical Systems Ltd. (Nasdaq:DHRM), an emerging leader in the development, assembly, marketing and sale of medical devices and homecare medical products in China, today announced that it entered into a securities purchase agreement (the "Securities Purchase Agreement") with certain institutional investors for the sale of 737,700 common shares in a registered offering at the price of $9.12 per common share.
FutureWorld (OTCQB:FWDG), a U.S. Diversified Holding Company formed to capitalize on the burgeoning technology markets globally, announces today that it is in discussions with the "Hemp" industry on deploying wireless agricultural sensor networks for precision agriculture, irrigation systems, and greenhouses, etc.
Innovus Pharmaceuticals, Inc., (OTCBB:INNV) today announced the availability of its over the counter ("OTC") benzocaine-based topical premature ejaculation treatment EjectDelay™ in the United States ("U.S.").
Masimo (NASDAQ: MASI) today announced that its management is scheduled to present at the Raymond James 35th Annual Institutional Investors Conference at the JW Marriott Grande Lakes Orlando on Tuesday, March 4, 2014, at 7:30 a.m. Eastern Time.
Merge Healthcare Incorporated (Nasdaq:MRGE), a leading provider of innovative enterprise imaging, interoperability and clinical systems that seek to advance healthcare, today announced that its Board of Directors has appointed William J. Devers Jr., president of Devers Group Inc, as a director, effective immediately.
Teleflex Incorporated (NYSE: TFX) today announced financial results for the fourth quarter and full year ended December 31, 2013.