RxNews Recap for Thursday 04-01-10. Investors applaud MDRNA's aquisition of Cequent. Amag in licensing deal with Takeda. After the bell RegeneRx receives going concern notification. Print E-mail
By BioMedReports.com Staff   
Thursday, 01 April 2010 19:51


Below is a list of the companies that made news in the healthcare sector on Thursday, April 01, 2010.

MDRNA, Inc. (NASDAQ:MRNA), a leading RNAi-based drug discovery and development company, announced today that they will acquire privately held Cequent in an all stock transaction valued at approximately $46 million. The combined company will have multiple proprietary RNAi drug discovery platforms with the capability to deliver RNAi-based therapeutics via systemic, local and oral administration. In addition, the acquisition expands MDRNA's oncology pipeline with a product for Familial Adenomatous Polyposis (FAP) -- a genetic disorder that is a precursor to colon cancer -- that will soon begin Phase 1 clinical testing under an Investigational New Drug application (IND) filed with the U.S. Food and Drug Administration. The transaction will also include certain loan provisions that will fund MDRNA operations through the anticipated closing of the merger in early July 2010.

"We anticipate that this transaction will accelerate the development of the most promising products of both companies," commented Mr. Bruce Thaw, Esq., Chairman of the Board of MDRNA. "We believe that the combined company will be in a strong position to advance multiple RNAi drug discovery platforms, establish premier R&D partnerships with large pharmaceutical and biotechnology companies and accelerate RNAi-based therapeutics to patients in need."

Shares rose 9 cents or 8.18% to close at $1.19. The stock at one point hit a high of $1.33. Volume was heavy as more than 4 million shares traded hands.

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) and Takeda Pharmaceutical Company Limited (TSE: 4502) today jointly announced that the companies have entered into a license, development and commercialization agreement related to Feraheme® (ferumoxytol) Injection for intravenous (IV) use in all therapeutic indications. Japanese drugmaker Takeda bought the rights to market Feraheme in Europe, the Commonwealth of Independent States, Canada, Turkey, and the Asia-Pacific region excluding China, Japan, and Taiwan.

AMAG will receive $60 million upfront for Takeda, and as much as $220 million if Feraheme advances through clinical development and regulatory review. AMAG will also get royalties of more than 10 percent on sales if the drug is approved. "One of our primary goals is to expand the reach of Feraheme to patients around the world with iron deficiency anemia," said Brian J.G. Pereira, MD, President and Chief Executive Officer of AMAG Pharmaceuticals, Inc. "Takeda’s global presence, their pipeline that includes complementary products to Feraheme and their strength in the marketing and commercialization of therapeutics across many specialties where iron deficiency anemia is present makes them the ideal partner for Feraheme."

Shares initially shot up on the news, hitting a high of $37.58 but later pulled back due to profit taking. The stock finished the day at $35.02, up 11 cents.

After the market closed Thursday:

RegeneRx Biopharmaceuticals, Inc. (NYSE Alternext US:RGN) shares fell in the after hours session as the company announced that its audited financial statements for the fiscal year ended December 31, 2009, included in its Annual Report on Form 10-K filed on March 31, 2010, contained a going concern qualification from its independent registered accounting firm.

This announcement is required by NYSE Amex Company Guide Section 610(b), which requires separate disclosure of receipt of an audit opinion containing a going concern qualification. This announcement does not represent any change or amendment to the company's financial statements or to its Annual Report on Form 10-K for the fiscal year ended December 31, 2009.

Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) moved lower after the bell as the company reported that it received a letter, dated March 31, 2010, from the Listing Qualifications Staff of The NASDAQ Stock Market notifying Sunesis that it does not comply with the minimum $1.00 per share requirement for continued listing on The NASDAQ Capital Market set forth in NASDAQ Listing Rule 5550(a)(2).

News from earlier in the day Thursday:

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that the underwriters of its recently completed initial public offering of common stock have exercised their option to purchase an additional 968,539 shares of common stock to cover over-allotments. The sale of the additional shares is anticipated to close on April 6, 2010. Including proceeds from the sale of the additional shares, the aggregate net proceeds to AVEO from the initial public offering, after deducting underwriting discounts and commissions and estimated offering expenses, are approximately $80.7 million.

BioElectronics Corp. (PINKSHEETS: BIEL), the maker of inexpensive, disposable drug-free anti-inflammatory devices, today announced the completion of its full year audit and the filing of Form 10K with the Securities and Exchange Commission. BioElectronics is now a fully reporting company. "We have now completed our audits through full year 2009. The process of providing full transparency is very important to us and we expect to remain fully compliant and reporting moving forward," commented Andrew Whelan, CEO of BioElectronics Corp. "The recent developments at the Company are very exciting as our international distribution continues to grow and as we continue to work through the clearance process with the U.S. FDA. We are especially excited about the strength of our balance sheet, which shows strong financial ratios and a significant level of debt repayment throughout 2009. We believe BioElectronics is now very well positioned to move into the revenue growth phase we envision for the rest of this year and into next." Biel was up more than 10% on the news.

Bioheart, Inc., (OTC Bulletin Board: BHRT) announced today that Howard Leonhardt, Bioheart's Chief Scientific and Technology Officer, converted a loan he had made to Bioheart and the loan's related interest, constituting together over $2 million, into restricted common shares and warrants through Bioheart's PIPE ("Private Investment in Public Equity"). Mr. Leonhardt is also Bioheart's founder and former chairman.$2 million due to my great confidence in the future of the company. I feel that Bioheart's current stock price does not reflect its potential.

Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) moved higher today after the company announced that six abstracts highlighting translational and preclinical data for Cyclacel's cell cycle inhibitor drugs have been selected for presentation at the American Association of Cancer Research (AACR) Annual Meeting, being held from April 17-21, 2010, in Washington, DC.

Eli Lilly and Company (NYSE:LLY) announced today that its chemotherapy ALIMTA® (pemetrexed for injection) received a positive "Final Appraisal Determination" from the United Kingdom's National Institute for Health and Clinical Excellence (NICE). Specifically, NICE's Final Appraisal Determination recommends ALIMTA as an option for the maintenance treatment of people with locally advanced or metastatic non-small cell lung cancer with other than predominantly squamous cell (nonsquamous) histology if disease has not progressed immediately following platinum-based chemotherapy first-line chemotherapy.(1) This recommendation is the second step in a three-step approval process; NICE expects to issue its final guidance this summer.

Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ:APCVZ), the parent company of APP Pharmaceuticals, Inc., announced today that APP and other Fresenius Kabi companies have entered into license and settlement agreements with sanofi-aventis covering patents that apply to Eloxatin® (oxaliplatin injection and oxaliplatin for injection). The agreements with sanofi-aventis resolve a patent infringement lawsuit, which was pending in the United States District Court for the District of New Jersey. Shares rose more than 13% on heavy volume.

Hemispherx Biopharma, Inc. (NYSE Amex: HEB) jointly announced today a collaborative clinical research effort with Max Neeman International for one of Hemispherx' flagship products, Alferon N Injection® (interferon Alfa-n3).

Hospira, Inc. (NYSE:HSP), the world leader in generic injectable pharmaceuticals, today announced it has reached a legal settlement with Sanofi-Aventis to resolve patent litigation concerning Hospira's U.S. sales of its oxaliplatin injection, a generic version of Sanofi-Aventis' oncolytic agent, Eloxatin®. Under the settlement terms, Hospira will stop selling oxaliplatin injection in the United States by June 30, 2010, and can relaunch the product in the United States on Aug. 9, 2012. The settlement will not affect Hospira's financial guidance for 2010. .

LifePoint Hospitals, Inc. (NASDAQ: LPNT) today announced that it had entered into an agreement with the Board of Directors of Clark Regional Medical Center (CRMC) whereby 100-bed Clark Regional Medical Center, located in Winchester, Kentucky, would become part of LifePoint Hospitals. The hospital is fully accredited by the Healthcare Facilities Accreditation Program. The transaction is expected to close April 30, 2010.

MedQuist Inc. (Nasdaq:MEDQ), a leading provider of technology-enabled clinical documentation services, has announced an agreement with healthcare informatics software developer Artificial Medical Intelligence Inc. (AMI) to provide computer-assisted coding (CAC) within MedQuist's CodeRunner™ coding workflow platform..

NeoStem, Inc. (NYSE:NBS), today provided an update of its 2010 business outlook. "With the acquisition of a 51% interest in Suzhou Erye Pharmaceutical Co. Ltd., development of our adult stem cell collection network and advances in the development and commercialization of stem cell therapies, 2009 was a transformational year for the Company," said Robin Smith, MD, Chairman and CEO of NeoStem. Since the acquisition, I am pleased to report that both our aggregate shareholder value and liquidity have increased substantially. In 2010, we are focused on growing our pharmaceutical platform, expanding our US stem cell collection network, and implementing and advancing our adult stem cell initiatives in China."

Neogen Corporation (Nasdaq:NEOG) announced today that it had purchased all the outstanding shares of GeneSeek, Inc., of Lincoln, Neb. GeneSeek is considered the leading commercial agricultural genetics laboratory in the United States.

Founded in 1998, GeneSeek employs 36 and has grown rapidly in recent years, recording 2009 revenues of approximately $12.5 million. GeneSeek's customers include an impressive list of the world's largest animal and plant breeders and animal health companies.

"Neogen has added to its genomic capability during the past year to speed the development of food and animal safety diagnostic tests, as well as develop novel intervention tools to solve food and animal safety problems," said James Herbert, Neogen's chief executive officer and chairman. "The addition of GeneSeek provides a significant, immediate advancement in this capability."

PROLOR Biotech, Inc. (NYSE Amex: PBTH), a company developing next generation biobetter therapeutic proteins, today announced that the Israeli Office of the Chief Scientist has approved a 2010 continuation of its grant to PROLOR's Israeli-based R&D subsidiary for the company's development program for interferon-beta-1a-CTP (IFN-Beta-CTP), its longer-acting version of interferon-beta-1a (IFN-Beta). IFN-Beta, which is indicated for the treatment of multiple sclerosis (MS), is currently marketed by Merck Serono as Rebif® and by Biogen Idec as Avonex®, with combined 2009 annual sales estimated at more than $4.4 billion worldwide.

Santarus, Inc. (NASDAQ:SNTS), a specialty biopharmaceutical company, today announced that Schering-Plough HealthCare Products, Inc., the consumer healthcare subsidiary of Merck & Co., Inc., has commenced promotion of ZEGERID OTC™ (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules) under its licensing agreement with Santarus for the over-the-counter (OTC) market in North America. The OTC heartburn market in the U.S. is estimated at approximately $1.8 billion based on data from market research firm Information Resources, Inc. and Santarus estimates..

Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI), announced that it missed the deadline of March 31, 2010, for the filing of its 2009 Annual Report on Form 10-K with the U.S. Securities & Exchange Commission as additional time is necessary to finalize its financial statements for the year ended December 31, 2009. Spectrum Pharmaceuticals expects to file the Annual Report on Form 10-K shortly.

Synergetics USA, Inc. (NASDAQ: SURG), a medical device company that designs, manufactures, and markets innovative microsurgical instruments for ophthalmic and neurosurgical applications, today announced the closing of a strategic agreement with Stryker Corporation. The agreement includes the sale of Synergetics’ accounts receivable, open sales orders, inventory and certain intellectual property related to the Omni® product line. In addition, the agreement provides for Synergetics to supply disposable ultrasonic instrument tips and certain other consumable products used in conjunction with the Sonopet/Omni® ultrasonic aspirator console and handpieces; and pursue certain development projects for new products associated with Stryker’s intraoperative ultrasound products.

Synergetics will receive between $2.5 million and $3.0 million in proceeds from the transactions once all inventory transfers are completed.

Also Thursday:

Allergan, Inc. (NYSE: AGN) and Serenity Pharmaceuticals, LLC today announced a global agreement for the development and commercialization of Ser-120, a Phase III investigational drug currently in clinical development for the treatment of nocturia, a common yet often under-diagnosed urological disorder in adults characterized by frequent urination at night time.

Caleco Pharma Corp. (OTCBB:CAEH) a biopharmaceutical and consumer health products company that identifies and develops biotech products, today provided an update that details recent corporate events in the later half of the first calendar quarter of 2010.  

CPEX Pharmaceuticals Inc. (NASDAQ: CPEX) today announced that its partner, Serenity Pharmaceuticals, has entered into a global agreement with Allergan, Inc. (NYSE: AGN) for the development and commercialization of Ser-120, a product candidate currently in Phase III clinical trials for the treatment of nocturia that utilizes CPEX’s patented intranasal drug delivery technology.

CVS Caremark (NYSE:CVS) announced today that it has been awarded Mail Service Pharmacy accreditation from URAC, a Washington, DC-based health care accrediting organization that establishes quality standards for the health care industry.

Forest Laboratories, Inc. (NYSE: FRX), an international manufacturer and marketer of pharmaceutical products, will release its Fiscal 2010 Fourth Quarter financial results before the U.S. stock market opens on Tuesday, April 20, 2010.

iBio, Inc. (OTCBB: IBPM) announced today the appointment of Dr. Pamela Bassett to its Board of Directors. Dr. Bassett is Managing Director of Life Sciences Research at Cantor Fitzgerald & Company, a leading global financial services provider to the institutional equity and fixed-income markets.

Imagenetix, Inc. (OTC Bulletin Board: IAGX) announced today Lowell W. Giffhorn, CFO will be presenting at the 6th Annual Spring Growth Stock Conference hosted by Security Research Associates, Inc. The conference will be held on Tuesday, April 6th at the Omni Hotel in San Francisco.

Inhibitex, Inc. (Nasdaq: INHX) today announced that John J. Alam, M.D. has joined Inhibitex as its Senior Medical Advisor.

International Isotopes Inc. (OTC Bulletin Board: INIS) announces the financial results for fiscal year ended December 31, 2009.

Medtronic, Inc. (NYSE: MDT) commended the U.S. Congress and President for signing H.R. 3590, the Patient Protection and Affordable Care Act legislation that includes provisions of the National Pain Care Policy Act of 2009.

Neoprobe Corporation (OTCBB: NEOP), a diversified developer of innovative oncology and surgical diagnostic and treatment products, today announced that its President and CEO, David Bupp, will present at the upcoming Future Leaders in the Biotech Industry conference on April 8, 2010, at 4:30 p.m. The conference is being held at the Millennium Broadway Hotel in New York City.

NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced today that Anthony DiTonno, President and Chief Executive Officer, is scheduled to present at the BioCentury Future Leaders in the Biotech Industry Conference 2010, to be held Thursday, April 8, 2010 at the Millennium Broadway Hotel & Conference Center in New York, New York.

Opexa Therapeutics, Inc. (NASDAQ: OPXA), a company developing a novel T-cell therapy for multiple sclerosis (MS), announced today that the company will participate in a panel discussion on Personalized Medicine for the Treatment of Multiple Sclerosis on April 7, 2010.

OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced today that its 2% Convertible Senior Notes due 2025 (the "notes") are now convertible at the option of the holders and will remain convertible through June 30, 2010, the last trading day of the current fiscal quarter, as provided for in the Indenture governing the notes.

Phase Forward (NASDAQ: PFWD), a leading provider of data management solutions for clinical trials and drug safety, will participate in four industry events in April including CDISC Interchange Europe 2010, April 26-30 at the Lancaster London Hotel in London.

Renhuang Pharmaceuticals, Inc. (Pink Sheets: RHGP) a developer, manufacturer and distributor of botanical products, bio-pharmaceuticals and traditional Chinese medicines ("TCM"), today announced that on March 28, 2010, the Company's patent application for its proprietary Siberian Ginseng (Acanthopanax) Total Glucosides Total Flavonoids Soft Capsules and related formulation method passed a preliminary review conducted by the State Intellectual Property Office of the People's Republic of China ("SIPO").

Rodman & Renshaw Capital Group, Inc. (NASDAQ: RODM), today announced that on April 7, 2010, Rodman will host a panel discussion in its media center with the following panelists: Robert B. Darnell, M.D., Ph.D., Investigator, Howard Hughes Medical Institute Heilbrunn Cancer Professor and Senior Physician, The Rockefeller University Dawn McGuire, M.D., Chair Clinical Advisory Board, Opexa Therapeutics Neil Warma, President and CEO of Opexa Therapeutics

RXi Pharmaceuticals Corporation (Nasdaq: RXII), a biopharmaceutical company pursuing the development and commercialization of proprietary therapeutics based on RNA interference (RNAi), today announced that the Company's President and Chief Executive Officer, Noah D. Beerman, will present a corporate overview at the 17th annual Future Leaders in the Biotech Industry investment conference, on Thursday, April 8, 2010 at 3:30 pm ET.

Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI), a commercial-stage biotechnology company with a primary focus in oncology, today announced that it missed the deadline of March 31, 2010, for the filing of its 2009 Annual Report on Form 10-K with the U.S. Securities & Exchange Commission as additional time is necessary to finalize its financial statements for the year ended December 31, 2009.

Spherix Incorporated (Nasdaq: SPEX), an innovator in biotechnology for diabetes therapy, and a provider of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today reported results for the year ended December 31, 2009.

Walgreens (NYSE, NASDAQ: WAG), the nation’s largest drugstore chain with more than 70,000 health care providers, today unveiled data as well as highlights from consumer surveys examining the most significant trends emerging from the 2009-2010 flu season.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. District Court for the Southern District of Indiana issued a decision yesterday on two patents for Gemzar® (gemcitabine); the compound patent expiring on November 15, 2010, and a method of use patent expiring on May 7, 2013 and that the U.S. District Court for the District of Nevada has granted Teva's Motion for Summary Judgment with respect to the validity of U.S. Patent No. 7,320,969.

XenaCare Holdings, Inc. (OTCBB:XCHO), a company specializing in the branding, marketing and retail distribution of consumer healthcare products including its over-the-counter (OTC) pain reliever, Cobroxin, has generated sales of $ 895,487 for the 1st Quarter of 2010. That is an $837,263 increase over First Quarter 2009.

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