|Theravance Plans to Separate Partnered Respiratory Assets; Derma Begins Screening Patients in Second Phase 3 Trial|
|By Staff and Wire Reports|
|Thursday, 25 April 2013 20:03|
Theravance (NASDAQ: THRX) announced its Board of Directors approved plans to separate its businesses into two independent publicly traded companies. One company, referred to as "Royalty Management Co" in this press release, will focus on managing all development and commercial responsibilities under the LABA collaboration with GlaxoSmithKline (GSK) and associated potential royalty revenues from RELVAR™ or BREO™ ELLIPTA™ (fluticasone furoate/vilanterol: FF/VI), ANORO™ ELLIPTA™ (umeclidinium bromide/vilanterol: UMEC/VI) and VI monotherapy, with the intention of providing a consistent return of capital to stockholders. The other company, referred to as "Theravance Biopharma" in this press release, will be a biopharmaceutical company focused on discovery, development and commercialization of small-molecule medicines in areas of significant unmet medical need. The result will be two independent, publicly traded companies with different business models enabling investors to align their investment philosophies with the strategic opportunities and financial objectives of the two independent companies.
"Following a review of alternatives to maximize the value of our portfolio, we have decided to separate our biopharmaceutical discovery, development and commercialization operations from our late-stage partnered respiratory assets," said Rick E Winningham, Chief Executive Officer. "We believe this separation will provide investors with the opportunity to unlock potential value from two disparate sets of assets, better align employee incentives and provide a consistent return of capital to stockholders of Royalty Management Company."
Theravance's core strategy has been to build value in the early-stage discovery and development of small-molecule product candidates and partner with pharmaceutical companies to support late-stage development and commercialization. This strategy resulted in the discovery, development and regulatory approval of VIBATIV® (telavancin) and a deep pipeline of small-molecule product candidates across several therapeutic areas, as well as major late-stage respiratory programs in partnership with GSK.
The goal of separating Theravance into two companies is to continue its businesses in a new structure designed to unlock potential value, facilitate return of capital to stockholders and further its strategy of advancing medicines that address unmet medical needs. After the separation, Theravance Biopharma will focus on Theravance's multivalent discovery capabilities and pipeline of programs, including its cardiovascular collaboration with Merck and its partnership agreements with Alfa Wassermann, Clinigen and R-Pharm. Royalty Management Co will continue to focus on managing the rights to the significant potential royalty streams from certain products developed under the LABA collaboration with GSK.
Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, announces that patient screening has begun in the second of two Phase 3 clinical trials with the investigational topical drug candidate DSC127 for the treatment of diabetic foot ulcers. This second trial will have three arms of 211 patients each, and is evaluating a 0.03% formulation of DSC127 against a topical vehicle and against a standard of care hydrogel. The first Phase 3 trial, which commenced in February with two arms of 211 patients each, is evaluating the 0.03% formulation of DSC127 against a topical vehicle.
Together these two pivotal trials are expected to enroll 1,055 patients, and are designed to assess the safety and efficacy of DSC127 in chronic, non-healing diabetic foot ulcers and to support the filing of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). In addition, approximately 200 patients will be enrolled in a chronic use safety study, which also began in February.
“The full Phase 3 pivotal program is now underway and we are committed to supporting clinical investigators at the more than 90 sites that will be participating in this program,” said Edward J. Quilty, chairman and chief executive officer of Derma Sciences. “We affirm our expectation to announce top-line Phase 3 results in the first quarter of 2015. The number of pharmaceutical treatments for diabetic foot ulcers is limited, and we believe that should DSC127 continue to show the safety and efficacy exhibited in the Phase 2 trial and should the U.S. Food and Drug Administration approve our drug candidate, DSC127 will be well received in the marketplace with potential peak global sales of $900 million.”
Mr. Quilty continued, “The addition of a pharmaceutical product is a compelling complement to the growing range of proprietary products our advanced wound care sales force is directing to the 1,200 advanced wound care clinics treating chronic, non-healing wounds, especially diabetic foot ulcers.”
3SBio Inc. (NASDAQ: SSRX) ("3SBio" or the "Company"), a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced that, at the duly convened extraordinary general meeting of shareholders ("EGM") held at 10:00am Beijing time on April 25, 2013.
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, today announced that it will present at the 12th Annual Needham Healthcare Conference on Tuesday, April 30, 2013, at 8:00 a.m. Eastern Time at The Westin New York Grand Central Hotel in New York City.
Active Biotech (NASDAQ OMX NORDIC: ACTI) and Ipsen (Euronext: IPN; ADR: IPSEY) (Paris:IPN) today announced that the companies have updated the analysis plan for the 10TASQ10 trial, a global Phase III clinical trial evaluating tasquinimod in patients with metastatic castrate-resistant prostate cancer (mCRPC) who have not yet received chemotherapy.
ADIA Nutrition, Inc. (PINKSHEETS: ADIA) is thrilled to announce that the company has retained Sellion Inc. to conduct their national sales and marketing programs.
Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, will release results for the first quarter 2013 on Monday, April 29, 2013 before the opening of the U.S. financial markets.
Cadence Pharmaceuticals, Inc. (NASDAQ: CADX), a biopharmaceutical company focused on acquiring, in-licensing, developing and commercializing proprietary products principally for use in the hospital setting, today announced that it will release its first quarter ended March 31, 2013 financial results on Thursday, May 2, 2013.
Celgene Corporation (NASDAQ: CELG) reported net product sales of $1,429 million for the first quarter of 2013, a 15 percent increase from the same period in 2012. Adjusted net income for the first quarter of 2013 increased 22 percent to $592 million compared to $484 million in the first quarter of 2012.
Cempra, Inc. (Nasdaq: CEMP) today announced that Prabhavathi Fernandes, Ph.D., president and chief executive officer of Cempra, will present at the 12th Annual Needham Healthcare Conference at 1:40 p.m. EDT, Wednesday, May 1, at the Westin New York Grand Central Hotel in New York.
CONMED Corporation (NASDAQ: CNMD) today announced financial results for the first quarter ended March 31, 2013.
Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) announced today that it will release its first quarter 2013 results after the market closes on Thursday, May 2, 2013.
eHealth, Inc. (NASDAQ: EHTH), America's first and largest private health insurance exchange, announced today its financial results for the first quarter ended March 31, 2013.
Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today positive top-line results from the TOPIC trial for AUBAGIO (teriflunomide).
ICON plc, (NASDAQ:ICLR), a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today reported its financial results for the first quarter ended March 31, 2013.
KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO) today announced that the company has been selected to present at the 12th Annual Needham Healthcare Conference, to be held in New York City on April 30-May 1, 2013.
McKesson Corporation (NYSE: MCK) announced that is has renewed its current distribution agreement with CVS Caremark.
NeuroMetrix, Inc. (Nasdaq: NURO), a medical device company focused on the treatment of diabetic peripheral neuropathy (DPN), today reported business and financial highlights for the first quarter ended March 31, 2013.
NewLink Genetics Corporation (NASDAQ: NLNK), a biopharmaceutical company primarily focused on discovering, developing and commercializing immunotherapeutic products in oncology, announced today that Nicholas N. Vahanian, M.D., NewLink's Chief Medical Officer, is scheduled to present at the Needham and Company 12th Annual Healthcare Conference in New York on Tuesday, April 30, 2013 at 12:50 p.m. ET.
Nuvilex, Inc. (OTCQB: NVLX) is an international biotechnology firm quietly going about its business in Silver Spring, Maryland.
Regarding the report "The Long Term Returns of Obesity Prevention Policies" unveiled this week by the Campaign to End Obesity (CEO), Orexigen Therapeutics, Inc. (Nasdaq: OREX) issued the following statement: Orexigen commends CEO as well as the author of the report, Alex Brill, and the Robert Wood Johnson Foundation (RWJF) who funded the report, for this new research illustrating the importance of long-term budget impact analyses on preventive health policies, specifically those aimed at obesity.
OvaScienceSM, (OTC: OVSC), a life sciences company focused on the discovery, development and commercialization of new treatments for infertility, announced that Michelle Dipp, M.D., Ph.D., Chief Executive Officer of OvaScience, will be a featured speaker at the Greater Boston Chamber of Commerce Women’s Network Breakfast being held today at the Ritz-Carlton in Boston.
OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that the Company's first quarter 2013 financial results will be released on Thursday, May 2, 2013, and that the Company will host a conference call and live webcast at 4:30 p.m. ET that afternoon.
OvaScienceSM, (OTC: OVSC), a life sciences company focused on the discovery, development and commercialization of new treatments for infertility, today announced that the Company’s common stock that currently trades on the Over-the-Counter Bulletin Board has been approved for listing on the NASDAQ Global Market (NASDAQ) and is expected to begin trading on NASDAQ under the ticker symbol “OVAS” on April 30, 2013.
Pfizer Inc. (NYSE: PFE) today announced top-line results for a Phase 4 clinical trial in which the primary objective was to measure blood pressure (hypertension) among pediatric patients with Juvenile Idiopathic Arthritis (JIA; also known as Juvenile Rheumatoid Arthritis or JRA) taking celecoxib (Celebrex) capsules or naproxen.
During the first quarter ended March 31, 2013, Safeguard Scientifics, Inc. (NYSE:SFE), a holding company that builds value in growth-stage healthcare and technology companies, deployed capital into two new partner companies—Pneuron Corporation and Sotera Wireless—bringing Safeguard’s partner company roster to 20.
Sangamo BioSciences, Inc. (Nasdaq: SGMO) announced today that Edward Lanphier, Sangamo's president and CEO, will provide an update on the progress of Sangamo's ZFP Therapeutic®development programs and an overview of the company's business strategy at 12:50 pm ET on Wednesday, May 1, 2013, at the 12th Annual Needham Healthcare Conference which will be held in New York.
Senomyx, Inc. (NASDAQ: SNMX), a company using proprietary taste science technologies to discover, develop, and commercialize novel flavor ingredients for the food, beverage, and ingredient supply industries, today reported financial results for the first quarter 2013.
Shire plc (LSE: SHP, NASDAQ: SHPG), announces that its subsidiary, Shire LLC, has settled all pending litigation with Actavis, Inc., Actavis LLC, and Actavis Elizabeth LLC (collectively "Actavis") and Watson Laboratories, Inc.-Florida, Watson Pharma, Inc. and ANDA, Inc. (collectively "Watson") in connection with Actavis' and Watson's Abbreviated New Drug Applications ("ANDAs") for generic versions of Shire's INTUNIV® ( guanfacine hydrochloride) for the treatment of Attention Deficit Hyperactivity Disorder.
VentriPoint Diagnostics (TSX VENTURE:VPT) (OTCQX:VPTDF) has received from the U.S. Food and Drug Administration (US-FDA) a short list of suggestions, clarifications and requests for additional information that they require to complete the review of the Pulmonary Arterial Hypertension (PAH) 510(k) submission.
Vycor Medical, Inc. (OTCBB: VYCO) announced today it has secured two new patents (2008-518369 and 11/993280) covering its Spinal ViewSite™ Cervical Access System (VCAS).