Cardiome Provides Update on Merck's Development Plans; Watson Confirms Patent Challenge Print E-mail
By Staff and Wire Reports   
Monday, 19 March 2012 19:12
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 19, 2012.

Cardiome Pharma Corp. (Nasdaq:CRME) (TSX:COM)
announced Merck, known as MSD outside the United States and Canada, has communicated to Cardiome their decision to discontinue further development of the oral formulation of vernakalant. The decision was based on Merck's assessment of the regulatory environment and projected development timeline. Vernakalant oral was being evaluated as maintenance therapy for the long term prevention of atrial fibrillation recurrence.

"It is our understanding that vernakalant oral has continued to have a safe and effective profile as demonstrated by studies conducted since the product was licensed to Merck. We are extremely disappointed with the decision Merck has made" said Doug Janzen, President and Chief Executive Officer at Cardiome. "However, we look forward to continuing to work with Merck on the worldwide development and commercialization of vernakalant IV."

Merck will continue to support the intravenous formulation of vernakalant, which is marketed in the European Union and Latin America under the trade name BRINAVESSTM. Currently, BRINAVESSTM is approved for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults in 37 countries. Merck has plans to expand the commercialization of the product throughout this year into new markets, and anticipates launching the product in approximately 30 additional countries in 2012.

In response to the discontinuation of the vernakalant oral program, Cardiome will reduce its annual operating cash burn going forward to a target of approximately $11M before interest expense, roughly half of the current cash burn. The company ended 2011 with over $53M of cash and cash equivalents and received an additional $25M from the available line of credit from Merck in January 2012. Cardiome expects to release its 2011 year-end financial results on March 28th, 2012 which will allow time to make the necessary changes to its annual filings following this news.

Cardiome is reviewing the impact of this event on its business strategy moving forward, and will report the results of that review when it is complete.

Teleconference Details:  Cardiome will hold a teleconference call and webcast at 9:00am EST (6:00am PST) March 19th, 2012 to discuss these corporate updates.

To access the conference call, please dial 1-877-670-9780. There will be a separate dial-in line for analysts on which we will respond to questions at the end of the call. The webcast can be accessed through Cardiome's website at www.cardiome.com .

Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through April 19th, 2012. Please dial 1-855-859-2056 or 1-404-537-3406 and reference conference ID#63670695 to access the replay.

Merck Cardiome Agreement:  In April 2009, Cardiome and Merck announced a collaboration and license agreement for the development and commercialization of vernakalant. The agreement provides Merck Sharp and Dohme Corp. with exclusive global rights to vernakalant oral, and provides another Merck affiliate, Merck Sharp & Dohme (Switzerland) GmbH, with exclusive rights outside of the United States, Canada and Mexico to vernakalant IV. In 2011, Merck also acquired North American rights to vernakalant IV, becoming our global partner for the entire vernakalant franchise.


=====


Watson Pharmaceuticals, Inc. (NYSE: WPI)
confirmed its subsidiary, Watson Laboratories, Inc. – Florida, filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market Niacin Extended-release Tablets, 500 mg and 1000 mg. Watson's ANDA products are generic versions of Abbott Laboratories' NIASPAN®.

Abbott Laboratories (NYSE:ABT)
and Abbott Respiratory LLC filed suit against Watson on March 16, 2012, in the United States District Court for the District of Delaware seeking to prevent Watson from commercializing its ANDA products prior to the expiration of U.S. Patent Nos. 6,080,428 and 6,469,035. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months from the date the plaintiffs received notice of Watson's ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.



Also Monday:



Advaxis, Inc., (OTCBB: ADXS)
, a leader in developing the next generation of immunotherapies for cancer and infectious diseases, has been selected for the shortlist of the 5th Annual Vaccine Industry Excellence (ViE) Awards in the category of Best Therapeutic Vaccine (approved or in development) for its ADXS-HPV construct.

Agilent Technologies Inc. (NYSE:A)
today announced that it has entered into a Cooperative Research and Development Agreement with the U.S. Food and Drug Administration to develop new tools to detect and analyze pathogens in food.

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY)
, a leading RNAi therapeutics company, announced today that it has initiated dosing in its Phase I clinical trial with ALN-TTR02, an RNAi therapeutic targeting the transthyretin (TTR) gene for the treatment of TTR-mediated amyloidosis (ATTR).

Biomagnetics Diagnostics Corp., (PINK SHEETS:BMGP)
a developer of revolutionary diagnostic systems and technology for HIV, hepatitis, tuberculosis and malaria detection, and other innovative technologies, today announced the Company has received a commitment for financing to advance the companies growth programs.

Biostem U.S., Corporation (OTCQB: BOSM) (PINKSHEETS: BOSM)
(Biostem, the Company), a fully reporting public company in the stem cell regenerative medicine sciences sector, announced today the addition of Perinatologist Sanford M. Lederman, MD to its Scientific and Medical Board of Advisors (SAMBA).

Cannabis Science, Inc. (OTCBB:CBIS)
a pioneering U.S. biotech company developing pharmaceutical cannabis (marijuana) products, is thrilled to announce that the company has retained filmmaker Kevin Booth to collaborate on a documentary researching cannabis as a medicine and the truth behind the science of marijuana.

CorMedix Inc.  (NYSE Amex: CRMD)
, is a development stage pharmaceutical and medical device company that seeks to in-license, develop and commercialize therapeutic products for the treatment of cardiac and renal dysfunction, specifically in the dialysis and non-dialysis areas, today announced its financial results for the year ended December 31, 2011.

Covidien (NYSE: COV)
, a leading global provider of healthcare products, today announced the appointment of Richard DeRisio as Vice President, Global Quality Assurance and Regulatory Affairs, effective immediately.

Cytori Therapeutics (NASDAQ: CYTX)
announced today the publication of RESTORE-2 trial results in the peer-reviewed European Journal of Surgical Oncology.

ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC)
, a biotechnology company focused on the development of novel immune-based cancer therapies, announced today that Peter Ho Ph.D., Director of Business Development and Licensing, will be presenting at the Annual Partnering Conference at the Amsterdam RAI Convention Center in Amsterdam on Tuesday, March 20, 2012 at 10:45am CET.

Lucid, Inc. (OTC/BB: LCDX.OB, LCDXW.OB)
today announces the publication of the Association of Scientific Medical Societies (AWMF) S1 guideline on the use of confocal laser scanning microscopy (CLSM) for dermatological applications.

Medidata Solutions (NASDAQ: MDSO)
has further expanded its Partner Program by naming EXTEDO, provider of regulatory information management software and service solutions, a Medidata Technology Partner.

MMRGlobal, Inc. (OTCBB: MMRF)
("MMR"), a leading provider of Personal Health Records (PHRs), MyEsafeDepositBox storage solutions and electronic document management and imaging systems for healthcare professionals, today announced that the Company plans on reporting increased revenues, reduced costs, reduced operating expenses, increased gross profits, decreased losses and a solid pipeline of domestic and international contracts in its 2011 Annual Report on Form 10-K at the close of market on March 30th.

Nuvilex, Inc. (OTCQB:NVLX)
, an emerging biotechnology provider of cell and gene therapy solutions through its ongoing acquisition of the assets of SG Austria, today discussed the proprietary Cell-in-a-Box® technology, providing additional information about the science and technology behind the product.

OPKO Health, Inc. (NYSE:OPK)
today announced an expansion of the previously announced exclusive licensing deal with Arctic Partners Ab Oy (Turku, Finland) for two biomarkers in the kallikrein family which used together with prostate specific antigen, PSA, can reduce the need for prostate biopsies by over 50%.

Plandaí Biotechnology, Inc. (OTCBB: PLPL)
, a producer of highly bioavailable plant extracts, today announced the launch of a new, investor friendly website designed to educate the public about the company's proprietary CRS processing system and the importance of bioavailability in nutrition.

Proteonomix, Inc. (OTCBB: PROT)
, a biotechnology company focused on developing therapeutics based upon the use of human cells and their derivatives, announces the completion of a previously announced $3.8 million private placement.

Provectus Pharmaceuticals, Inc. (OTCBB:PVCT)
, a development-stage oncology and dermatology biopharmaceutical company, announced top-line data for the company's randomized controlled trial (RCT) of PH-10 for mild-to-moderate plaque psoriasis.

As global demand for innovative new stem-cell therapies grows by the day, Rainbow BioSciences’ (OTCBB:RBCC) new agreement with n3D Biosciences could help to bring these therapies to market faster than ever before.

Rosetta Genomics (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostic tests, today announced that data from several studies demonstrating the clinical utility of the Company's miRview® products to identify and classify a variety of cancers will be presented by Mats Sanden, M.D., D.D.S., FCAP, Medical & Laboratory Director of Rosetta Genomics, at the 101st Annual Meeting of the United States and Canadian Academy of Pathology taking place from March 17-23, 2012 in Vancouver, British Columbia.

SDIX (Nasdaq: SDIX) - a leading provider of biotechnology-based products and services for a broad range of life science, biotechnology, diagnostic, and food safety applications, expects to release its fourth quarter and full year 2011 results at approximately 4 p.m. ET on Thursday, March 22, 2012.

Stellar Pharmaceuticals Inc. (OTCQB:SLXCF) (OTCBB:SLXCF) (PINKSHEETS:SLXCF), a Canadian public company, announced today that the Company intends host a conference call at 4:00 p.m. Eastern Time on Monday, March 19, 2012 to discuss the details of the approval of CAMBIA®, (diclofenac potassium for oral solution) for the treatment of migraine attacks with or without aura in adults, by Health Canada as noted in the press release dated Friday, March 16, 2012.

Taro Pharmaceutical Industries Ltd. (Pink Sheets: TAROF)
today announced that it has been authorized for listing on the New York Stock Exchange (“NYSE”).

TheDirectory.com, Inc. (PINKSHEETS: SEEK)
today announced that it will launch its much anticipated Local Business Dashboard on April 12th, 2012.

Transgenomic, Inc. (OTCBB: TBIO)
today announced that Craig Tuttle, Chief Executive Officer of Transgenomic, will be presenting at the 2012 Maxim Group Growth Conference on Monday, March 26, 2012 at 3:00 PM Eastern Time in New York City.



"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'.

Add this page to your favorite Social Bookmarking websites
Digg! Reddit! Del.icio.us! Mixx! Google! Live! Facebook! Technorati! StumbleUpon! MySpace! Yahoo!

blog comments powered by Disqus
 

Newsletter