MAP Pharmaceuticals Provides Update on LEVADEX; Impax Confirms Patent Challenge Generic GRALISE®

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By Staff and Wire Reports   
Thursday, 12 April 2012 19:34
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 12, 2012.

MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) submitted a request to the U.S. FDA for a meeting to discuss the Complete Response letter received on March 26, 2012. The Company announced that the FDA has scheduled a meeting with the Company, to occur in the second quarter.

On April 3, 2012, the United States Patent and Trademark Office (USPTO) issued to the Company U.S. Patent No. 8,148,377, titled "Method of Therapeutic Administration of DHE to Enable Rapid Relief of Migraine While Minimizing Side Effect Profile." This new patent, which expires in 2028, is the third in a series of patents issued to the Company relating to the pharmacokinetics of LEVADEX. The new patent results from the Company's discovery that dihydroergotamine can be administered to achieve pharmacokinetic profiles of DHE that result in rapid efficacy while minimizing side effects that are typically seen with other migraine drugs.



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Impax Laboratories, Inc. (NASDAQ: IPXL)
confirms it has initiated a challenge of the patents listed in the Orange Book in connection with Gralise® (gabapentin tablets, 300 mg and 600 mg).

Impax filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of Gralise® with the U.S. Food & Drug Administration (FDA). Following receipt of the notice from FDA that Impax's ANDA had been accepted for filing, Impax notified the New Drug Application holder and patent owner of its paragraph IV certification.

On April 10, 2012, Depomed, Inc. filed suit for patent infringement against Impax Laboratories, Inc. in the United States District Court for the District of New Jersey. This action formally initiates the patent challenge process under the Hatch-Waxman Act.



Also Thursday:




Abiomed, Inc. (NASDAQ: ABMD)
, a leading provider of break-through heart support technologies, today announced it has received CE Marking approval in the European Union to market the Impella cVAD device, a new percutaneous Impella® heart pump that provides peak flow of approximately 4 liters of blood per minute.

Acorda Therapeutics, Inc. (Nasdaq: ACOR)
today announced it has been named to the Forbes 2012 100 Most Trustworthy Companies.

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

AstraZeneca (NYSE: AZN)
today announced the availability of DUTOPROL™ (metoprolol succinate extended release/hydrochlorothiazide) Tablets, the first and only once-daily antihypertensive agent that contains the active ingredient of TOPROL-XL® (metoprolol succinate) plus a low-dose diuretic (also known as a water pill) that provides proven blood pressure lowering at 24 hours.1,2

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO)
today announced that previously reported results from a successful Phase 2 clinical trial evaluating the efficacy and safety of tivozanib in 272 patients with advanced renal cell carcinoma (RCC) were published in the Journal of Clinical Oncology.

BioTime, Inc. (NYSE Amex:BTX)
today announced that its Board of Directors has recently formed a Science and Technology Committee to oversee the development and commercialization of BioTime’s technology and products in regenerative medicine and oncology.

Cerus Corporation (NASDAQ:CERS)
announced today that its first quarter results will be released on Tuesday, May 1, 2012, after the close of the stock market.

CytRx Corporation (Nasdaq: CYTR)
, a biopharmaceutical company specializing in oncology, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a key patent covering the tumor-targeting conjugate INNO-206 linker platform technology and INNO-206 pharmaceutical compositions.

Deaf-Talk, Inc. (PINKSHEETS: MGQG), dba DT Interpreting (DTI), the industry leader in on-demand video sign language interpreting, announced today that the firm recently contracted with BR Fisher (www.brfisher.com) and Vance Wright Adams and Associates (www.vwadesign.com) to completely upgrade both the content and design of its web portal, www.dtinterpreting.com.

Elan Corporation, plc (NYSE: ELN)
announced today that it will host a conference call on Thursday, April 26, 2012 at 8:30 a.m. Eastern Time (ET), 1:30 p.m. British Summer Time (BST) with the investment community to discuss Elan’s first quarter 2012 financial results, which will be released before the European and U.S. financial markets open.

Emergent BioSolutions Inc. (NYSE: EBS)
announced today that it will report financial results for the first quarter 2012 on Thursday, May 3, 2012, after market close.

Humana Inc. (NYSE: HUM)
announced today that its pharmacy benefits management subsidiary Humana Pharmacy Solutions, Inc. (HPS), is offering employers a new Rx4Value formulary and Walmart Rx Network that together guarantee up to 20 percent savings on employers’ average prescription price1.

Impax Laboratories, Inc. (NASDAQ: IPXL)
today confirms that it has initiated a challenge of the patents listed in the Orange Book in connection with Gralise® (gabapentin tablets, 300 mg and 600 mg).

Meridian Bioscience, Inc. (NASDAQ: VIVO)
today announced it has signed a new group purchasing agreement with the Premier healthcare alliance to offer illumigene® C. difficile and illumigene Group B Streptococcus to its members at specially negotiated pricing. Premier serves more than 2,500 U.S. hospitals and 81,000-plus other healthcare sites.

Pacira Pharmaceuticals, Inc. (Nasdaq: PCRX)
today announced the pricing of an underwritten public offering of 6,000,000 shares of its common stock at a price of $9.75 per share to the public. All of the shares are being sold by Pacira.

PerkinElmer, Inc., (NYSE:PKI)
a global leader focused on improving the health and safety of people and the environment, today announced that on Thursday, April 26, 2012, after market close, the Company will release first quarter 2012 results.

Roche (SIX: RO, ROG; OTCQX: RHHBY)
released the following statement regarding its pending offer for Illumina, Inc. (NASDAQ: ILMN):  “We continue to believe that on the basis of the public information that has been available to us, our offer price of $51 per share is full, fair and extremely attractive by every conceivable financial metric.

Safeguard Scientifics, Inc. (NYSE: SFE)
, a holding company that builds value in growth-stage life sciences and technology companies, today announced that it will release its financial results for the first quarter ended March 31, 2012 prior to market open on Thursday, April 26, 2012.

Seattle Genetics, Inc. (Nasdaq:SGEN)
and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), today announced that they have formed a collaboration with Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group.

Skinvisible Pharmaceuticals, Inc. (OTCQB: SKVI) (OTCBB: SKVI)
is pleased to announce that its licensee, Women's Choice Pharmaceuticals LLC, a specialty pharmaceutical company based in Gilbert, Arizona, has partnered with Advanced Medical Enterprises, LLC (AME Inc.) to market ProCort® in Puerto Rico.

TheDirectory.com, Inc. (PINKSHEETS: SEEK)
today announced that it has rescheduled its investor conference call for Tuesday, April 24th after the market closes.

Verastem, Inc., (NASDAQ: VSTM) a biopharmaceutical company focused on discovering and developing drugs to treat breast and other cancers by targeting cancer stem cells, announced that the Company will present at the BioCentury Future Leaders in the Biotech Industry conference on April 20, 2012, in New York City.



BiomedReports is not paid or compensated to report news and developments about publicly traded companies. Full disclosure can be read in the About Us Section

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