Nordion Enters into Agreement to Divest Targeted Therapies Business to BTG plc
Nordion Inc. (NDN.TO) (NDZ), a leading provider of products and services for the prevention, diagnosis and treatment of disease, announced that it has entered into an agreement to divest its Targeted Therapies business to BTG plc (BTG.L) (“BTG”), an international specialist healthcare company based in London, United Kingdom, for a cash purchase price of US$200 million. Net of cash taxes and transaction costs, Nordion expects to realize approximately US$185 million on closing. The transaction is anticipated to be completed by the end of June 2013.
Nordion manufactures and commercializes TheraSphere®, a targeted liver cancer therapy, the sole product in its Targeted Therapies business. Under the terms of the transaction agreements, BTG is expected to acquire TheraSphere and Nordion has agreed to continue manufacturing TheraSphere under a Manufacturing and Support Agreement with a contract term of three years, plus a two-year extension at BTG’s option. Approximately 40 Nordion employees are expected to join BTG following the completion of this transaction, which is subject to customary closing conditions and approval by BTG shareholders.
NPS Pharmaceuticals Prices Public Offering of Common Stock
NPS Pharmaceuticals, Inc. (NPSP) today announced the pricing of an underwritten public offering of 6,000,000 shares of its common stock at a price of $14.53 per share to the public. All of the shares are being sold by NPS. The gross proceeds to NPS from this offering are expected to be approximately $87.2 million, before deducting underwriting discounts and commissions, and other estimated offering expenses payable by NPS. The offering is expected to close on or about May 24, 2013, subject to the satisfaction of customary closing conditions.
J.P. Morgan Securities LLC and Morgan Stanley & Co. LLC are acting as joint book-running managers for the offering. Canaccord Genuity Inc. and Leerink Swann LLC are acting as lead co-managers for the offering and Oppenheimer & Co. Inc. and Wedbush PacGrow Life Sciences are acting as co-managers for the offering.
Oramed Receives FDA Clearance to Initiate Oral Insulin Trials in the U.S.
Oramed Pharmaceuticals Inc. (ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that the United States Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug application(IND) for ORMD-0801, its oral insulin capsule.
"We are very pleased to have the FDA clearance to proceed," stated Nadav Kidron, CEO of Oramed. "The upcoming trial is a major milestone for Oramed and we look forward to continuing to progress ORMD-0801's clinical development in the US."
Insmed Granted Key Composition of Matter Patent Allowance for ARIKACE in Europe
Provides Important Foundation as Company Advances European Commercial Plans for ARIKACE to Treat Lung Infections in Cystic Fibrosis Patients
Insmed Incorporated (NASDAQ: INSM), a biopharmaceutical company focused on developing and commercializing an inhaled anti-infective to treat patients battling serious lung diseases in orphan indications that are often life-threatening, today announced that the European Patent Office intends to grant E.U. Patent No. 1909759 for ARIKACE® (liposomal amikacin for inhalation). Once granted, the composition of matter patent provides exclusivity in any of the European Patent Office's member states where Insmed chooses to file at least through July 19, 2026. The Company's liposomal amikacin for inhalation is in clinical development to treat cystic fibrosis (CF) patients with Pseudomonas aeruginosa lung infections and patients with nontuberculous mycobacteria (NTM) lung infections.
Nanosphere Announces Distribution and Collaboration Agreement With Hitachi High-Technologies Corporation
Nanosphere, Inc. (NASDAQ: NSPH)Hitachi High-Technologies Corporation Provides Distribution Network to Market the Verigene System in Japan's High Growth Molecular Diagnostic Market Collaboration Leverages Each Companies' Advanced Design, Development and Manufacturing Expertise for Future Assays and Platforms
Nanosphere, Inc. (NASDAQ: NSPH), a leader in the development and commercialization of advanced molecular diagnostics systems, announced today it has signed a distribution and collaboration agreement with Hitachi High-Technologies Corporation (Hitachi High-Tech). The agreement grants Hitachi High-Tech exclusive rights to market Nanosphere products in Japan. As well, the two companies intend to collaborate on assay and platform development.
PDI Reports 2013 First Quarter Financial Results
Management to Host Conference Call Tomorrow, May 14, 2013 at 8:30AM ET
PDI, Inc. (PDII), today reported financial and operational results for the first quarter ended March 31, 2013. Summary financial and operating highlights include:First quarter 2013 revenue increase of 36% to $42.9 million compared to the same period last year. Operating income of $2.3 million for the first quarter of 2013, a $2.5 million improvement compared to a loss of $0.2 million in the first quarter of 2012. Earnings per share of $0.14 for the first quarter of 2013 compared to a loss of $0.02 per share for the same period in 2012.
Theravance and Elan Enter Into a $1.0 Billion Royalty Participation Agreement
Theravance to receive $1.0 billion upfront payment upon closing; Elan to receive a 21% participation interest in potential future royalty payments associated with four respiratory programs
Theravance, Inc. (NASDAQ: THRX) and Elan Corporation, plc (NYSE: ELN) today announced that they have entered into a royalty participation agreement wherein Elan will purchase a participation interest in potential future royalty payments related to four respiratory programs partnered with GlaxoSmithKline plc (GSK): RELVAR™ ELLIPTA™/BREO™ ELLIPTA™, ANORO™ ELLIPTA™, MABA (Bifunctional Muscarinic Antagonist-Beta2 Agonist) monotherapy (GSK961081, or MABA '081), and vilanterol (VI) monotherapy. Under the terms of the agreement, Elan will make a one-time cash payment of $1.0 billion to Theravance in exchange for a 21% participation interest in the potential future royalty payments from the four programs when, as and if received by Theravance.
Unilife Corporation Announces Financial Results For Fiscal Year 2013 Third Quarter
Unilife Corporation ("Unilife" or "Company") (NASDAQ: UNIS; ASX: UNS), a developer and supplier of injectable drug delivery systems, today announced its financial results for the quarter ended March 31, 2013, (the third quarter of Fiscal Year 2013).
Recent HighlightsIn April, Unilife signed a 15-year customization and commercial supply contract with a U.S. pharmaceutical company for the EZMix™ dual-chamber syringe. This contract is expected to generate up to $110 million in cumulative revenue from customization programs, production scale-up, device sales and a royalty from net drug sales.
CardioComm Solutions Files New Patents for Automated Enabling of Over-The-Counter, Consumer, Bio-Monitoring Devices for Home Monitoring and Remote Diagnostic Interpretation
The HeartCheck PEN ECG device is the first to utilize the patent pending SMART Monitoring technologies to enable/unlock a consumer medical devices to record, display, transmit and receive bio-signals and images.
CardioComm Solutions, Inc. (TSX VENTURE:EKG) ("CardioComm Solutions" or the "Company"), a global medical provider of electrocardiogram ("ECG") acquisition and management software solutions, today confirmed it has filed for U.S. and Canadian patents for use of their proprietary technologies in the automated, software enabled and server based unlocking of over-the-counter ("OTC"), consumer based, bio-monitoring devices. Under the U.S and Canadian patents, filed on May 6, 2013 and May 8, 2013 respectively, the Company will be permitted to apply the statement "Patent Pending SMART Monitoring Technologies" in its corporate materials until the application process has been completed.
Medicago successfully produces VLP vaccine candidate for H7N9 virus responsible for recent influenza outbreak in China
-Medicago Ready to Collaborate with Authorities to Further Study the Potential of this Vaccine to Protect Against H7N9-
Medicago Inc. (TSX: MDG; OTCQX: MDCGF), a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today announced that it has successfully produced a new VLP vaccine candidate for the H7N9 virus that is responsible for the current influenza outbreak in China.
Genomic Health Announces Availability of Oncotype DX® Prostate Cancer Test with Potential to Triple the Number of Patients Who Can Confidently Choose Active Surveillance and Avoid Side Effects of Invasive Treatments
Groundbreaking Results from University of California, San Francisco (UCSF) Clinical Validation Study Presented at American Urological Association (AUA) Annual Meeting First-of-its-Kind, Biopsy-Based Test Developed and Validated in Seven Studies Including More Than 1,100 Patients
Genomic Health, Inc. (GHDX) is making its Oncotype DX® prostate cancer test available to physicians and their patients today following the presentation by the University of California, San Francisco (UCSF) of a positive clinical validation study at the 2013 American Urological Association (AUA) Annual Meeting in San Diego.
Teva and Alexza Announce Teva’s License to Market ADASUVE® in the U.S.
Adasuve® (loxapine) inhalation powder is approved in the U.S. for the acute treatment of agitation associated with schizophrenia and bipolar disorder
Teva Pharmaceuticals USA, Inc., a subsidiary of Teva Pharmaceutical Industries Ltd (TEVA), and Alexza Pharmaceuticals, Inc. (ALXA) announced today that the companies have entered into an exclusive U.S. license and supply agreement for ADASUVE (loxapine) inhalation powder 10 mg for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults. Teva will be responsible for all U.S. commercial and clinical activities for ADASUVE, including U.S. post-approval clinical studies, and has gained rights to conduct additional clinical trials of ADASUVE for potential new indications in neurological disorders. Alexza will be responsible for manufacturing and supplying ADASUVE to Teva for commercial sales and clinical trials.
Santarus Reports First Quarter 2013 Financial Results
Total revenues increase 73% with significant increase in net income over prior year period Raises 2013 financial outlook to include total revenues of $330 million to $340 million, net income of $57 million to $64 million and non-GAAP adjusted earnings of $81 million to $91 million
Santarus, Inc. (SNTS), a specialty biopharmaceutical company, today reported financial and operating results for the quarter ended March 31, 2013.
Key financial results for the 2013 first quarter include:Total revenues of $79.4 million grew 73% compared with total revenues of $45.9 million in the first quarter of 2012
Genetic Technologies Executes Agreement With Nationwide Provider Network
Genetic Technologies Limited (ASX: GTG) (NASDAQ: GENE), is pleased to advise that it has executed an agreement with Three Rivers Provider Network, Inc. of Chula Vista, California, USA.
Three Rivers Provider Network ("TRPN") claims to be the largest supplemental PPO Network Foundation in the US, providing healthcare benefits to more than 10 million members, at more than 1 million locations nationwide.
The agreement with TRPN is the fifth such credentialing agreement executed between the Company and similar U.S. Preferred Provider Organisations ("PPOs") and increases the total number of covered lives, for which its BREVAGen™ test could be adjudicated as "in-network," to more than 23 million.
STAAR Surgical Reports Strong First Quarter 2013 Financial Results
~Total Sales of $18 Million Increased 16% from Q1 2012 / 21% Increase on Constant Currency Basis ~~Visian® ICL™ Sales Grew 24% to Record $10.6 Million ~~nanoFLEX™ Toric IOL Launched for Europe ~~GAAP Net Income of $0.01 per share, Non GAAP Adjusted Net Income of $0.08 company Continues to Invest to Drive Top and Bottom Line Growth
STAAR Surgical Company (STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today reported record revenue for the first quarter ended March 29, 2013 of $18.0 million compared to $15.5 million reported for the first quarter of 2012.
Transition Therapeutics Announces Results of Clinical Study of Type 2 Diabetes Drug Candidate TT-401
Transition Therapeutics Inc. ("Transition" or the "Company") (NASDAQ: TTHI, TSX: TTH) announced the results of a five-week proof of concept clinical study of TT-401 in type 2 diabetic and obese non-diabetic subjects. In the study, TT-401 a once-weekly administered peptide, demonstrated significant improvements in glycemic control and reductions in body weight.
The study enrolled diabetic patients at five dosing levels and non-diabetic obese patients at one dose level. All dosing cohorts received five doses over a five week period. Diabetic patients were on stable doses of metformin. At the end of the treatment period, TT-401-treated patients in the three highest dose groups experienced statistically significant reductions in mean fasting plasma glucose relative to placebo.
Oramed Pharmaceuticals to Present Results of its Key Clinical Studies of Oral Insulin in Type 1 Diabetes Patients at the GTC Diabetes Summit, Boston, MA; April 29-30, 2013
Oramed Pharmaceuticals Inc. (ORMP) (http://www.oramed.com), a developer of oral delivery systems of drugs currently administered by injection, announced today that its abstract, entitled "Oral insulin capsules toward management of Type 1 diabetes mellitus," will be presented at the Global Technology Community Diabetes Summit 2013. The poster will be presented today, April 29th, by Dr. Miriam Kidron, Oramed's Chief Scientific Officer, between 5:00pm-7:00pm EDT during the poster session and evening reception in the Ballroom Foyer of the Hyatt Regency Hotel.
Bayer HealthCare to Acquire Conceptus(R)
Conceptus, Inc. (Nasdaq:CPTS), developer of the Essure® procedure, the leading surgery-free permanent birth control method, announced today that Conceptus has signed a definitive merger agreement with Bayer HealthCare LLC, Leverkusen, Germany.
With this acquisition, Bayer will be able to offer a complete range of short-term, long-term and permanent contraceptive choices for women. Within the next ten business days, Bayer will launch a public tender offer to acquire all shares of common stock of Conceptus, Inc. The transaction values Conceptus, Inc. at approx. US$1.1 billion (approx. €852 million) representing US$31.00 per share in cash. Closing is subject to customary conditions, in particular anti-trust approval in the U.S., and is expected by mid-year 2013.
OPKO Health To Acquire PROLOR Biotech
—Acquisition Adds Promising Late Stage Product hGH-CTP Targeting Growth Hormone Deficiency and Preclinical Products Targeting Hemophilia, Obesity & Diabetes— —Complementary Drug Development Technologies Strengthen OPKO's Innovation Leadership— —PROLOR to Host Conference Call at 8:30 A.M. EDT Thursday, April 25 to Discuss Transaction—
OPKO Health, Inc. (OPK) and PROLOR Biotech, Inc. (NYSE MKT: PBTH) today announced that the companies have signed a definitive merger agreement under which OPKO will acquire PROLOR, a biopharmaceutical company focused on developing and commercializing longer-acting proprietary versions of already approved therapeutic proteins, in an all-stock transaction.
InspireMD Receives Approval From US Food and Drug Administration to Begin US Regulatory Trial
InspireMD, Inc. (NYSE MKT: NSPR) ("Inspire" or the "Company"), the developer of the MGuard™ Embolic Protection Stent (EPS), announced today that on April 19, 2013, the Company received an approval with conditions for its Investigational Device Exemption (IDE) application with the U.S. Food and Drug Administration (FDA). An approval with conditions indicates that the FDA concurs with the overall trial design and while minor details are being finalized, allows the company to initiate enrollment in the MASTER II IDE trial.
The multi-center, randomized trial will consist of 1,114 patients suffering from ST Elevation Myocardial Infarction (STEMI), throughout 35 sites in the U.S. and an additional 35 sites in Europe, and will support the Company's application to market its MGuard™ Prime MicroNet™ covered coronary stent system in the US.