|Horizon Pharma Announces Private Placement Financing; Abbott and Galapagos Announce Global Collaboration|
|By Staff and Wire Reports|
|Thursday, 01 March 2012 08:14|
Abbott (NYSE: ABT) and Galapagos (Euronext: GLPG) announced they have entered into a global collaboration to develop and commercialize an oral, next-generation JAK1 inhibitor in Phase II development with the potential to treat multiple autoimmune diseases.
GLPG0634 is a highly selective JAK1 inhibitor that Galapagos is developing for the treatment of rheumatoid arthritis (RA) and other autoimmune diseases. The Janus kinases (JAK) are a family of enzymes that play a key role in the signaling mechanism used by a number of cytokines that are involved in autoimmune diseases. In previously reported results from a 4-week Phase IIa study, GLPG0634 demonstrated efficacy measures among the best reported in RA. All patients completed the study, and few experienced any side effects. No anemia, change in blood pressure or lipids were observed. An additional Phase IIa dose-range finding study with GLPG0634 is expected to begin shortly.
"The addition of this novel, oral compound offers patients the potential for advanced treatment options and an improved patient experience to address RA and other autoimmune diseases," said John Leonard, M.D., senior vice president, global research and development, Abbott. "Abbott's expertise in immunology, combined with a robust portfolio of investigational treatments represents promising innovation across several areas of medical need."
"This collaboration with Abbott, the global leader in autoimmune diseases, is a great recognition of the value of GLPG0634. We view Abbott to be the best partner possible to deliver a complete clinical program and a powerful market introduction. We are excited to continue the Phase II trials and expect to deliver to Abbott a complete Phase II package in 2014," said Onno van de Stolpe, chief executive officer, Galapagos. "With GLPG0634 we have proven that we can deliver from target to clinical Proof of Concept, and we aim to do the same on many novel target programs in our pipeline. This collaboration is transformational for Galapagos, providing the means to progress these innovative products into the clinic."
Under the terms of the agreement, Abbott will make an initial upfront payment of $150 million for rights related to the global collaboration. Upon successful completion of the RA Phase II studies, Abbott will license the program for a one-time fee of $200 million if the studies meet certain pre-agreed criteria. Abbott will assume sole responsibility for Phase III clinical development and global manufacturing. Pending achievement of certain developmental, regulatory, commercial and sales-based milestones, Galapagos would be eligible to receive additional milestone payments from Abbott, potentially amounting to $1.0 billion, in addition to tiered double-digit royalties on net sales upon commercialization. Galapagos retains co-promotion rights in Belgium, the Netherlands and Luxembourg.
Horizon Pharma, Inc. (NASDAQ:HZNP) announced today the execution of a securities purchase agreement with a select group of institutional and accredited investors providing for a private placement financing. Upon the closing of the private financing, Horizon will receive gross proceeds of approximately $50.8 million resulting from the sale of 14,033,829 units at a price of $3.62125 per unit. Each unit consists of one share of Horizon's common stock and a warrant to purchase 0.25 shares of common stock at an exercise price of $4.308 per share. The financing is expected to close on March 2, 2012 subject to standard closing conditions. JMP Securities LLC, Cowen and Company, LLC and Stifel Nicolaus Weisel served as joint-lead placement agents for the financing.
Horizon expects that the net proceeds from this financing, combined with existing cash resources, will fund the company's operations into the second half of 2013 and will be used for the ongoing commercial launch of DUEXIS® in the U.S., to pursue regulatory approval for LODOTRA® in the U.S. and DUEXIS in Europe and for working capital and other general corporate purposes.
The securities to be sold in this private financing have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws, and accordingly may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Horizon has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock issued in this private financing.
Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that it will release 2011 fourth quarter and year-end results on Thursday, March 1st after the market closes.
Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) joins the European Organization for Rare Diseases (EURORDIS), the National Organization for Rare Disorders (NORD) and patient groups, families, governments, medical communities and industry in celebrating Rare Disease Day, a global effort to raise awareness of rare diseases and their profound impact on patients’ lives.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, today announced that management will present a company overview at the Cowen and Company 32nd Annual Health Care Conference on Wednesday, March 7, 2012 at 9:20 a.m. ET at the Boston Marriott Copley Place.
Antares Pharma, Inc. (NYSE Amex: AIS) today announced that Paul K. Wotton, Ph.D., President and Chief Executive Officer, will present at two upcoming investor conferences.
Arrowhead Research Corporation (NASDAQ: ARWR), a nanomedicine company with development programs in RNA therapeutics and obesity, announced today that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. US 8,114,983 B2 titled, “Compositions and use of EPAS1 inhibitors.”
AstraZeneca (NYSE: AZN) announced today that it provided $1.1 billion in savings last year to more than 569,000 patients in the United States who participate in its AZ&Me Prescription Savings Programs.
Baxter International Inc. (NYSE: BAX) announced today that it will present at Barclays Capital 2012 Global Healthcare Conference on Wednesday, March 14, 2012, at 10:15 a.m. (ET).
BioLineRx (NASDAQ:BLRX) (TASE:BLRX), a biopharmaceutical development company, announced today that a Notice of Allowance has been issued by the United States Patent and Trademark Office (USPTO) for a patent application claiming the composition of BL-1040, a novel medical device for prevention of cardiac remodeling following an acute myocardial infarction.
Cerus Corporation (NASDAQ:CERS) announced today that William “Obi” Greenman, president and chief executive officer, is scheduled to present a corporate update at the Cowen and Company 32nd Annual Healthcare Conference in Boston at 10:00 AM ET on Wednesday, March 7, 2012.
Columbia Laboratories Inc. (Nasdaq: CBRX) announced today that Frank Condella, president and chief executive officer, will present at the Cowen and Company 32nd Annual Health Care Conference.
Deltagen, Inc. (Pink Sheets: DGEN), a leading provider of drug discovery tools and services to the biopharmaceutical industry, today reported unaudited consolidated financial results for the three months and year ended December 31, 2011.
Exact Sciences Corp. (Nasdaq: EXAS) today announced that it will present at two investor conferences during March.
Fluidigm Corporation (NASDAQ:FLDM) today announced that President and Chief Executive Officer Gajus Worthington will present at the Cowen and Company 32nd Annual Healthcare Conference on Monday, March 5, 2012 at the Boston Marriott Copley Place, Boston, Mass., beginning at 3:30 p.m. Eastern Time.
Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), today announced its support of International Rare Disease Day with a series of events to celebrate and recognize the global rare disease community.
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that its corporate presentation will be webcast from the Cowen and Company 32nd Annual Health Care Conference in Boston.
Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK), a specialty pharmaceuticals company, announced today that the US Food and Drug Administration, (FDA) granted final approval for the Company's Abbreviated New Drug Application, (ANDA) for Levetiracetam oral solution 100mg/mL, the generic for UCB Pharma’s Keppra ® oral solution which had combined brand and generic sales of $62 million for the 12 months ended December 2011 according to IMS sales data.
Hubei Minkang Pharmaceutical Ltd. (OTCBB:HBMK) ("Hubei Minkang" or the "Company") is pleased to announce that its Chinese subsidiary, Hubei Minkang Pharmaceutical Co., Ltd. ("Hubei PRC") has recently signed a Memorandum of Understanding with Henan Wanlong Pharmaceutical Co., Ltd. ("Henan Wanlong") of Zhengzhou, Henan, China with respect to a proposal for Hubei PRC to acquire 51% of Henan Wanlong to expand distribution and increase sales growth.
MannKind Corporation (Nasdaq: MNKD), focused on discovering, developing and commercializing treatments for diabetes and cancer, announced today that it will present at the Cowen and Company 32nd Annual Health Care Conference on March 7, 2012 at 10:40am Eastern at the Boston Marriott Copley Place in Boston, Massachusetts.
In the next step toward the development of an artificial pancreas, Medtronic, Inc. (NYSE:MDT) today announced that the results of the in-clinic ASPIRE (Automation to Simulate Pancreatic Insulin REsponse) study have been published online and in the March edition of Diabetes Technology & Therapeutics.
Navidea Biopharmaceuticals, Inc. (NYSE Amex: NAVB), a specialty biopharmaceutical developer of innovative precision diagnostics products, today announced consolidated results for the fourth quarter of 2011 and for the year ended December 31, 2011.
NPS Pharmaceuticals, Inc. (NASDAQ: NPSP), a biopharmaceutical company developing orphan therapeutics for rare gastrointestinal and endocrine disorders, today announced the appointment of Georges Gemayel, Ph.D., to its board of directors.
Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, announced today Goldman Small Cap Research has reissued its buy recommendation on Nuvilex with a short term price target of $0.50 per share.
Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biotechnology company developing Tovaxin®, a novel T-cell therapy for multiple sclerosis (MS), announced today that the Company has executed an agreement with Pharmaceutical Research Associates, Inc. (PRA) to provide contract research organization (CRO) services to support Opexa’s upcoming Phase IIb clinical trial for Tovaxin in patients with Secondary Progressive multiple sclerosis (SPMS).
Plandaí Biotechnology, Inc. (OTCBB: PLPL) Chief Executive Officer, Roger Duffield, announced today that Dr. Ming Hu, Professor of Pharmaceutics at the University of Houston, has accepted a position on the company's scientific board.
AMI Research (http://www.amistockreports.com), a leading provider of equity research reports and a subsidiary of IR Firm, Hawk Associates Inc., announced today that it has initiated equity research coverage on Pressure BioSciences, Inc. (NASDAQ: PBIO).
Repligen Corporation (NASDAQ:RGEN) announced today that Walter C. Herlihy, Ph.D., President and Chief Executive Officer, will present a corporate update at the Cowen and Company 32nd Annual Health Care Conference to be held at the Boston Marriott Copley Place, Boston, from March 5-7, 2012.
Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced that a review of ganetespib results in non-small cell lung cancer (NSCLC) was presented by Dr. Suresh Ramalingam, Associate Professor, Chief of Thoracic Oncology and Director of Medical Oncology, Emory University, at the International Association for the Study of Lung Cancer (IASLC) 12th Annual Targeted Therapies for the Treatment of Lung Cancer Meeting.
Synergetics USA, Inc. (NASDAQ: SURG) announced today that it will host a conference call the morning of Tuesday, March 13, 2012, at 10:30 a.m. Eastern time to review the Company's results for the fiscal second quarter ended January 31, 2012.
Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced that the Company will be presenting at the Cowen and Company 32nd Annual Health Care Conference on Wednesday, March 7 at 8:00 a.m. (ET) in Boston.
Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced that its board of directors has approved the initiation of a quarterly cash dividend to its shareholders – the first in the company’s history.
Zalicus Inc. (NASDAQ: ZLCS) a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain and immuno-inflammatory diseases today announced that Mark H.N. Corrigan, MD, President and CEO is scheduled to present at the Cowen and Company 32nd Annual Health Care Conference at 11:20 a.m. ET on Wednesday, March 7, 2012, at the Boston Marriott Copley Place.