|Inspire Pharmaceuticals surges on Japanese approval. Idenix reports more positive Hep C data. Oracle buys Phase Forward|
|By BioMedReports.com Staff|
|Friday, 16 April 2010 18:16|
Below is a list of the companies that made news in the healthcare sector on Friday, April 16, 2010.
Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) surged higher Friday as the company, along with Santen Pharmaceutical Co., Ltd. (TOKYO: 4536) announced today that the Japanese Ministry of Health, Labour and Welfare granted approval for the new dry eye treatment drug, DIQUAS Ophthalmic Solution 3% (generic name: diquafosol tetrasodium), on April 16, 2010.
Diquafosol was licensed for certain ophthalmic uses from Inspire and DIQUAS Ophthalmic Solution 3% was developed by Santen as a treatment for dry eye. Dry eye is a chronic disorder of the keratoconjunctival epithelium and tear film caused by various factors, and is accompanied by symptoms such as ocular discomfort and visual function disorder. In clinical studies conducted in Japan, DIQUAS Ophthalmic Solution 3% was shown to improve dry eye symptoms by promoting secretion of mucin and water, thereby bringing the tear film closer to a normal state. In addition, no serious ocular or systemic adverse drug reactions were found during the clinical trials.
Shares of Inspire shot up more than 16%, rising more than 97 cents, closing at $6.93.
Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), today reported promising in vitro data for IDX320, an HCV protease inhibitor, demonstrating potent and selective antiviral activity in multiple genotypes, or strains, of the virus. The favorable pharmacokinetic profile defined in preclinical studies was confirmed by interim Phase I clinical data in healthy volunteers. Additional data presented demonstrated that a combination of three Idenix drug candidates, including IDX320, with different mechanisms of action produced strong synergy in vitro. These data support the evaluation of direct-acting antiviral (DAA) combination regimens for the treatment of HCV.
"We are excited about the preclinical and first-in-man data presented today from the IDX320 program. With the in vitro potency and favorable pharmacokinetic profile seen to date combined with the potential for once-daily dosing and multi-genotypic coverage, we believe IDX320 could offer improvements over other protease inhibitors currently in development," said David Standring, Ph.D., Idenix's executive vice president, biology. "The Phase I single and multiple ascending dose clinical study in healthy volunteers is now complete, and we look forward to advancing IDX320 into a three-day proof-of-concept study expected to begin in the second quarter."
Yesterday, the company reported interim data from a 14-day, phase IIa clinical trial evaluating IDX184, a novel liver-targeted nucleotide prodrug of 2'-methyl guanosine monophosphate, in HCV-infected patients.
Shares moved higher by 13 cents, closing todays session at $4.54.
Phase Forward Incorporated (NASDAQ: PFWD), as reported earlier today here on BioMedReports, announced that it has agreed to be acquired by Oracle for $17.00 per share in cash, representing a valuation of approximately $685 million. The transaction is subject to stockholder and regulatory approval and other customary closing conditions and is expected to close in mid-2010.
Bob Weiler, Chairman, President & CEO of Phase Forward, said, "Deployed in over 10,000 clinical trials, Phase Forward’s software has been used successfully by hundreds of customers to accelerate innovation in drug development and patient care delivery. We look forward to combining our complementary wealth of experience with Oracle Health Sciences." Phase Forward is leading provider of data management solutions for clinical trials and drug safety.
Shares of Phase Forward rose $3.72, gaining more than 28%, closing the day at $16.80.
After the market closed Friday:
EntreMed, Inc. (Nasdaq:ENMD) today announced that it completed a registered direct offering of 5,791,505 shares of its common stock, at a purchase price of $0.518 per share, to an existing accredited institutional investor. The sale resulted in gross proceeds to the Company of approximately $3 million. The terms of the purchase were set forth in a stock purchase agreement between the parties dated April 16, 2010. The per share purchase price reflects a 20% discount to the volume weighted average price on April 15, 2010.
EntreMed plans to use the net proceeds of the offering, which are expected to be approximately $2.8 million after deducting the placement agent's fee and estimated offering expenses payable by EntreMed, to further clinical development of its Aurora A/angiogenic kinase inhibitor, ENMD-2076, and for other general corporate purposes. EntreMed recently announced the initiation of a Phase 2 study in ovarian cancer patients after encouraging Phase 1 results.
Illumina, Inc. (NASDAQ:ILMN) today announced that it has sequenced the DNA of John, Judy, Anne and Paul West, the first publicly named family to have their DNA sequenced to full coverage by the company. The service was completed in Illumina's CLIA certified and CAP accredited laboratory utilizing Illumina's Genome Analyzer technology. "Sequencing individuals provides fantastic visibility into our genetic makeup," said Mr. West, who is currently CEO of Novocell, Inc., a stem cell engineering company. "By sequencing a family of at least four we can go a step further to interpret compound heterozygote variations in genes – those cases where multiple variations in a single gene, but on opposing chromosome copies, combine as a virtual homozygote. I expect that these are much more prevalent, and the source of much more phenotypic variability, than previously understood. Working with medical geneticists, we look forward to exploring this new visibility into factors influencing our future health."
Micromet, Inc. (Nasdaq:MITI), a biopharmaceutical company focused on the development and commercialization of next-generation antibodies for the treatment of cancer, announced today that Otello Stampacchia, Ph.D., an advisor to Omega Funds, has decided not to stand for re-election at the upcoming annual meeting of stockholders, and has resigned from its board of directors effective immediately due to an increase in his duties at Omega Funds.
News from earlier in the day Friday:
ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced that it has resolved the stockholders' equity continued listing deficiencies originally identified by the NYSE Amex in a June 2009 letter to the Company. In part to address the NYSE Amex's requirement that the Company address its low stock price, ADVENTRX also announced that its Board of Directors has approved a 1-for-25 reverse split of its common stock, which was authorized by its stockholders at a special meeting held in August 2009. The Company's common stock will begin trading on a split adjusted basis on the NYSE Amex when the market opens on Monday, April 26, 2010.
Æterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) fell today as the late-stage drug development company specialized in oncology and endocrinology, announced today that it has received commitments from institutional investors to purchase US$15 million of securities in a registered direct offering. Under the terms of a Securities Purchase Agreement, the Company will sell to such institutional investors an aggregate of approximately 11.1 million common shares of its capital at a price of US$1.35 per share and issue warrants to acquire an aggregate of approximately 4.4 million common shares at an exercise price of US$1.50 per share. Shares dropped more than 24%, closing down 39 cents to $1.25.
Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) and Alexion Pharma International Sàrl today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved the Company’s New Drug Application (NDA) for the use of Soliris® (eculizumab) as a treatment for patients in Japan with paroxysmal nocturnal hemoglobinuria (PNH). PNH is an ultra-rare, debilitating and life-threatening blood disorder defined by chronic red blood cell destruction, or hemolysis. Soliris, a first-in-class terminal complement inhibitor, is the first therapy approved in Japan for the treatment of patients with PNH. Soliris received orphan drug designation from the MHLW in 2009 and was approved under the Ministry’s priority review process.
Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spine disorders, with a focus on treating conditions related to the aging spine, announced that is has priced an underwritten public offering of 16,000,000 shares of common stock, consisting of 8,000,000 shares to be sold by the Company and 8,000,000 shares to be sold by a selling shareholder, HealthpointCapital Partners, L.P., at a price to the public of $5.00 per share.
ArQule, Inc. (NASDAQ: ARQL) today announced that the Company is presenting several pre-clinical and early clinical-stage studies at the American Association for Cancer Research (AACR) 101st Annual Meeting, April 17-21, 2010 in Washington, D.C. that relate to the ongoing development of: ARQ 621, a novel inhibitor of the Eg5 kinesin motor protein in Phase 1 clinical testing; ARQ 736, a novel inhibitor of BRAF in pre-clinical development; and ARQ 501, an activator of the DNA damage response mechanism mediated by the E2F-1 transcription factor that has completed initial clinical testing.
Bristol-Myers Squibb Company (NYSE: BMY) will begin posting updates about select Phase 1 and 2 investigational compounds on the company website. The updates will communicate an overview of new data presented at medical meetings or data published in scientific journals. The first update will be posted on Saturday, April 17, 2010.
Emdeon Inc. (NYSE:EM), a leading provider of healthcare revenue and payment cycle management solutions, today announced it has achieved compliance with the CAQH® Committee on Operating Rules for Information Exchange (CORE) Phase II rules. CAQH, a nonprofit alliance of health plans and trade associations, is a catalyst for industry collaboration on initiatives that simplify healthcare administration for health plans and providers, resulting in a better care experience for patients and caregivers. Emdeon achieved CORE Phase I compliance in March 2007. CORE Phase II sets industry-wide standards that improve electronic administrative information exchange between health plans and providers.
Hansen Medical, Inc. (NASDAQ:HNSN) today announced that it has priced its public offering of 14,000,000 shares of its common stock at a price to the public of $2.00 per share. Hansen Medical has granted the underwriter a 30-day over-allotment option to purchase on the same terms and conditions up to an additional 2,100,000 shares of common stock. The gross proceeds to Hansen Medical, before expenses, from the sale of shares, are expected to be $28,000,000 assuming the 30-day over-allotment option is not exercised. The closing of the offering is expected to take place on April 21, 2010. Piper Jaffray & Co. will be the sole underwriter for the offering.
MedQuist Inc. (Nasdaq:MEDQ) and its majority shareholder CBay Inc., leading providers of technology-enabled clinical documentation services and Spheris, a leading global provider of clinical documentation technology and services, announced Thursday after the market close that the United States Bankruptcy Court for the District of Delaware has approved the sale of substantially all of Spheris' assets to MedQuist Inc. and CBay Inc. Under the terms of the sale, MedQuist will acquire Spheris' U.S. assets and CBay will acquire the stock of Spheris India Private Limited, a subsidiary of Spheris. The purchase price is $98,833,900 in cash and an unsecured subordinated promissory note issued by MedQuist Transcriptions, Ltd. in an aggregate principal amount of $17,500,000. The Companies expect the transaction to close in April.
Merge Healthcare Incorporated (NASDAQ: MRGE) and AMICAS, Inc. (NASDAQ: AMCS) announced today that the tender offer by Project Ready Corp., a wholly-owned subsidiary of Merge Healthcare, for all of the outstanding shares of AMICAS common stock has been extended to 5:00 p.m., New York City, New York time, on Friday, April 23, 2010, unless further extended.
Molecular Insight Pharmaceuticals, Inc. (NASDAQ:MIPI), fell today as the biopharmaceutical company discovering and developing targeted therapeutic and imaging radiopharmaceuticals for use in oncology, today announced that the Company has received a 30-day extension of its waiver agreement with its Bond holders, allowing restructuring discussions to continue.
On March 15, 2010, Molecular Insight executed a waiver agreement with holders of the Company's outstanding Senior Secured Bonds and the Bond Indenture trustee and announced ongoing discussions with the holders of its Bonds concerning a restructuring of its outstanding debt. Under the terms of the waiver agreement, the Bond holders and Bond Indenture trustee agreed to waive a default arising from the inclusion of a going concern paragraph in the independent auditor's report on the Company's financial statements for the year ended December 31, 2009 and other technical defaults under the Bond Indenture until 12:01 AM Eastern Standard Time on April 16, 2010. The term of the waiver is now extended until 12:01 AM Eastern Standard Time on May 18, 2010. Shares were off 17%, dropping 47 cents to $2.26.
NanoLogix, Inc. (Pinksheets:NNLX) announced that today its board of directors adopted a stockholder rights plan. The rights plan is similar to plans adopted by many other companies.
NPS Pharmaceuticals, Inc. (Nasdaq: NPSP) announced that it has priced an underwritten public offering of 9,000,000 shares of its common stock at a price to the public of $5.50 per share. Net proceeds, after estimated underwriting discounts and commissions and estimated expenses, will be approximately $46.2 million.
Par Pharmaceutical Companies, Inc,(NYSE:PRX) moved higher after the company, through its wholly-owned subsidiary, Strativa Pharmaceuticals, today announced that the U.S. Food and Drug Administration (FDA) has approved Oravig (miconazole) buccal tablets for the treatment of oropharyngeal candidiasis (OPC), more commonly known as thrush, in adults and children age 16 and older. Oravig is the first and only local, oral prescription formulation of miconazole – an antifungal medication – approved for this use in the U.S.
Oravig, which adheres to the gum, utilizes innovative buccal tablet technology enabling once-daily dosing that delivers miconazole directly at the local site of infection throughout the day with minimal systemic absorption. Oravig is easy-to-use and provides patients with a flavorless, odorless and convenient treatment option that does not interfere with daily activities such as eating and drinking.
Radient Pharmaceuticals Corporation (AMEX:RPC) announced today the third and final closing of its 12% Convertible Promissory Note and Warrant financing. In the third closing, RPC sold an additional $3,957,030 in aggregate principal amount of Notes. When combined with the first and second closings, that total aggregate principal amount of Notes was in excess of $10,400,000. The net proceeds for the third closing were approximately $2,310,000. Warrants to purchase 4,705,657 shares of RPC common stock were also issued as a part of the third closing. The terms of the Notes and the Warrants are substantially similar to the terms of the Notes and Warrants issued in the first and second closings, with the exception the exercise price of the warrants issued in the third closing was $.69 per share.
RadNet, Inc. (Nasdaq:RDNT), a national leader in providing high-quality, cost-effective, fixed-site outpatient diagnostic imaging services through a network of 185 fully-owned and operated outpatient imaging centers, today reported it has completed the previously announced acquisition of Truxtun Medical Group.
Repligen Corporation (Nasdaq:RGEN) today announced preliminary financial results for fiscal year 2010 which ended March 31, 2010. Total revenue for the year is expected to be $21.0 million, including $10.3 million of bioprocessing product revenue and $10.7 million of royalty and other revenue. Research and development expenses are expected to be between $13.8-$14.2 million and selling, general and administrative expenses between $6.8-$7.2 million. The net loss for the year is expected to be between $3.6-$4.0 million and cash and investments as of March 31, 2010 are expected to be $59.1 million. "While, as always, there are a number of external factors that could influence our actual results for this next year, I am optimistic that we are beginning to see a return to growth for our bioprocessing business," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. "Our revenues support development of our existing pipeline with minimal cash burn and also allow us to actively seek acquisition opportunities to build our therapeutic and bioprocessing businesses."
AdvanSource Biomaterials Corporation (NYSE Amex: ASB), a leading developer of advanced polymer materials for a broad range of medical devices, today announced it will be exhibiting at the BIOMEDevice Boston 2010 Exposition and Executive Forum being held at the Boston Convention and Exposition Center in Boston, Massachusetts from April 21-22, 2010.
Millipore Corporation (NYSE:MIL), a leading provider of technologies, tools and services for the global life science industry, today announced that it will disclose its financial results for the first quarter on Thursday, May 6, 2010, after the close of the stock market.
Orthovita, Inc. (NASDAQ: VITA), an orthobiologics and biosurgery company, will hold a conference call on Tuesday, May 4, 2010, at 8:30 a.m. Eastern Time, to review and discuss its financial results for the first quarter 2010.
PPJ Enterprise (PPJ) (PINKSHEETS: PPJE), a leader in proprietary automated health care reimbursement cycle (all specialties), online health information digital systems and practice information management digital system software for health care and general businesses worldwide, has announced that its subsidiary, Professional Billing Service (PBS), has received commitments of additional $2.5 Mil worth of collection work from and existing Southern California Surgery Center this week that may bring additional $150,000 in the next 12months.
Rite Aid Corporation (NYSE: RAD) announced today that John Standley, president and chief operating officer, Frank Vitrano, chief financial and chief administrative officer, and Matt Schroeder, group vice president, strategy, investor relations and treasurer, will address the Barclays Capital Retail and Restaurants Conference on April 29, 2010 in New York City. Rite Aid’s presentation is scheduled for approximately 2:30 p.m. EDT.
Tikcro Technologies Ltd. (OTC BB: TIKRF) today reported results for the fourth quarter and year ended December 31, 2009.
ZymoGenetics, Inc. (NASDAQ: ZGEN) announced today that it will report first quarter financial results on Tuesday, May 4, 2010 after market close. Following the announcement, members of the company’s senior management will discuss the results and provide a corporate update.
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.