Cubist Announces FDA Acceptance of Tedizolid New Drug Application; Genzyme Receives CRL from FDA on Lemtrada Application Print E-mail
By Staff and Wire Reports   
Monday, 30 December 2013 19:36
Below is a look at some of the headlines for companies that made news in the healthcare sector on December 30, 2013.

Cubist Pharmaceuticals (NASDAQ: CBST)
announced the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for its investigational antibiotic tedizolid phosphate (TR-701) with Priority Review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of June 20, 2014. Cubist is seeking FDA approval of tedizolid for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

Tedizolid phosphate is an oxazolidinone being developed for both intravenous (I.V.) and oral administration for the treatment of serious Gram-positive infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). The NDA submission is based on positive data from two global Phase 3 clinical studies of tedizolid in ABSSSI, which met the primary and secondary endpoints defined by the FDA and the European Medicines Agency (EMA).

Earlier in 2013, the FDA designated tedizolid as a Qualified Infectious Disease Product (QIDP), according to the Generating Antibiotic Incentives Now (GAIN) Act, for its potential indication in ABSSSI. The QIDP designation for tedizolid phosphate has allowed for certain incentives related to the development of new antibiotics, including eligibility for Priority Review and, if tedizolid phosphate is ultimately approved by the FDA, a five year extension of Hatch-Waxman exclusivity.

“We are pleased to receive NDA acceptance for tedizolid, and look forward to working closely with the Agency on this Priority Review,” said Steven Gilman, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Cubist Pharmaceuticals. “If approved, we expect tedizolid will address the serious public health threat of MRSA and offer a new treatment option for patients with serious skin infections.”

During the first half of 2014 Cubist expects to submit a Marketing Authorization Application (MAA) for tedizolid to the EMA in the ABSSSI indication. Cubist is also expecting to submit a New Drug Submission (NDS) to Health Canada in the same timeframe.


Genzyme, a Sanofi company (EURONEXT:SAN and NYSE:SNY), announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental Biologics License Application seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis.

A Complete Response Letter informs companies that an application is not ready for approval. FDA has taken the position that Genzyme has not submitted evidence from adequate and well-controlled studies that demonstrate the benefits of Lemtrada outweigh its serious adverse effects. Genzyme understands that the conclusion is related to the design of the completed Phase 3 active comparator studies of Lemtrada in relapsing-remitting MS patients. FDA has also taken the position that one or more additional active comparator clinical trials of different design and execution are needed prior to the approval of Lemtrada.

Genzyme strongly disagrees with the FDA's conclusions and plans to appeal the agency's decision.

“We are extremely disappointed with the outcome of the review and the implications for patients in the U.S. suffering with multiple sclerosis who remain in need of alternative therapies to manage a devastating disease,” said Genzyme President and CEO, David Meeker, M.D. “We strongly believe that the clinical development program, which was designed to demonstrate how Lemtrada compares against an active comparator as opposed to placebo, provides robust evidence of efficacy and a favorable benefit-risk profile. This evidence was also the basis for the approvals of Lemtrada by other regulatory agencies around the world.”

Lemtrada is approved in the European Union, Canada, and Australia, and additional marketing applications for Lemtrada are under review by regulatory agencies around the world.

Sanofi does not anticipate that the CVR milestone of U.S. approval of Lemtrada by March 31, 2014 will be met.

Also Monday:

Amicus Therapeutics (Nasdaq:FOLD)
, a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, has completed a $25 million long-term debt financing with a lending syndicate consisting of MidCap Financial, LLC, Oxford Finance LLC, and Silicon Valley Bank.

GeneNews Limited (TSX:GEN)
announces, further to its press releases of November 13, December 5, December 12, December 16 and December 19, 2013 the extension of the term of certain related warrants (the "Related Warrants") in connection with a conversion of certain outstanding convertible debentures of the Company (the "Convertible Debentures").

Ingen Technologies Inc. (PINKSHEETS: IGNT), the holding company of two subsidiaries; a medical device manufacturing company selling its patented medical products worldwide, and a newly acquired growing wireless telecom business providing services to major telecom companies worldwide, announced the results of the shareholder conference held on December 16th, 2013.

Integra LifeSciences Holdings Corporation (Nasdaq:IART)
announced today that Mr. Peter Arduini, Integra's President and Chief Executive Officer, will present at the 32nd Annual J.P. Morgan Healthcare Conference in San Francisco, CA.

Intelligent Living Inc. (OTCQB: ILIV)
today publicly disclosed its strategy and roadmap to capture market share in the growing healthcare IT, wellness products and gaming industries., Inc. (SCV) announced today that a new audio interview with Medbox, Inc. (OTC Markets:MDBX), a leader in providing consulting services and patented systems to the medical and retail industries, is now available.

Northwest Biotherapeutics, Inc. (NASDAQ: NWBO)
, a biotechnology company developing non-toxic DCVax® personalized immune therapies for solid tumor cancers, announced today that the British Broadcasting Company (BBC) TV network has broadcast a report profiling the first European patient in the Company's Phase III clinical trial of DCVax-L for Glioblastoma multiforme brain cancer (GBM), the most common and aggressive form of brain cancer.  

NuVasive, Inc. (NASDAQ: NUVA)
, a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today that Alex Lukianov, Chairman of the Board and Chief Executive Officer, is scheduled to present at the J.P. Morgan Healthcare Conference at the Westin St. Francis Hotel located at 335 Powell Street in San Francisco, CA, on Wednesday, January 15, 2014, at 9:00 a.m. PST.

Nuvilex, Inc. (OTCQB:NVLX)
, an international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that Dr. Mark L. Rabe, Chairman of the Scientific Advisory Board (SAB) of its wholly-owned subsidiary Medical Marijuana Sciences, Inc., has developed a Charter and Goals and Objectives for that Board.

NuVasive, Inc. (NASDAQ: NUVA)
, a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today that Alex Lukianov, Chairman of the Board and Chief Executive Officer, is scheduled to present at the J.P. Morgan Healthcare Conference at the Westin St. Francis Hotel located at 335 Powell Street in San Francisco, CA, on Wednesday, January 15, 2014, at 9:00 a.m. PST.

Oculus Innovative Sciences (Nasdaq:OCLS)
today announced it received a determination letter from the listing qualifications department of the NASDAQ Stock Market LLC ("NASDAQ") notifying the company that it is now compliant with the stockholders' equity requirement for continued listing on the Nasdaq Capital Market and is no longer subject to delisting at this time.

OmniComm Systems, Inc. (OTC:OMCM)
, today announced the production availability of Version 4.2 of TrialMaster, its flagship product for Electronic Data Capture (EDC). This new release includes hundreds of innovative productivity and functionality enhancements, including additional features for auto-redaction for faster and more efficient centralized and risked-based monitoring, and major new features for exporting data utilizing OmniComm's award winning Export Utility.

Prothena Corporation plc (Nasdaq:PRTA)
, a clinical stage biotechnology company focused on the discovery, development and commercialization of novel antibodies for the potential treatment of a broad range of diseases, today announced that it was selected for addition to the NASDAQ Biotechnology Index (Nasdaq:NBI), which became effective before market open on December 23, 2013.

Quidel Corporation (NASDAQ: QDEL)
, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of its AmpliVue Group B Strep Assay.

RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL)
, an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary formulations and combinations of existing drugs, today announced that it has entered into a definitive agreement with leading healthcare investor OrbiMed Israel Partners Limited Partnership, an affiliate of OrbiMed Advisors LLC, for the sale of RedHill's American Depository Shares ("ADSs") and warrants in a private placement transaction (the "Private Placement") for a total sum of $6.0 million.

ScripsAmerica, Inc. (OTCBB:SCRC)
today announced the addition of a new section to the Company's website,, that will serve as a thorough source of shareholder information and be continuously updated by management.

Tornier N.V. (Nasdaq:TRNX)
, a global medical device company focused on providing surgical solutions to orthopaedic extremity specialists, announced today that David Mowry, the Company's President and Chief Executive Officer, and Shawn McCormick, the Company's Chief Financial Officer, will present at the 32nd Annual J.P. Morgan Healthcare Conference.

"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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