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Ciclofilin Pharmaceuticals To Present HIV/HCV Co-Infection Results At American Association for Study of Liver Diseases In Boston On November 11

November 4, 2014 – 5:00 am | Edit Post

SAN DIEGO, Nov. 4, 2014 (GLOBE NEWSWIRE) — Ciclofilin Pharmaceuticals, Inc. (“Ciclofilin” or the “Company”), a biotechnology company focused on the development of broad spectrum antivirals, today announced that its abstract (#1927) entitled “CPI-431-32, a Novel Cyclophilin A Inhibitor, Simultaneously…

Imprimis Pharmaceuticals Signs Distribution Agreement To Bring Go Dropless??? Proprietary Formulations To Ophthalmologists In Puerto Rico

November 4, 2014 – 5:00 am | Edit Post

SAN DIEGO, Nov. 4, 2014 /PRNewswire/ –Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY), a specialty pharmaceutical company focused on the development and commercialization of proprietary sterile and topical compounded drug formulations, today announced that it has entered into a distribution agreement with MD Distributor…

Thermo Fisher Scientific Targets Neurons And Primary Cells With Expansion Of Transfection Reagent Portfolio

November 4, 2014 – 5:00 am | Edit Post

CARLSBAD, Calif.–(BUSINESS WIRE)–Researchers can now more efficiently study predictive cell models and human disease with the launch of a new high-efficiency transfection reagent for mRNA delivery in neurons and primary cell types.Lipofectamine MessengerMAX offers up to a five times the efficiency of DNA reagents and enables researchers to easily transfect biologically relevant cell models…

Apricus Biosciences Announces Corporate Update And Third Quarter 2014 Financial Results Conference Call

November 4, 2014 – 5:00 am | Edit Post

SAN DIEGO, Nov. 4, 2014 (GLOBE NEWSWIRE) — Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines to meet the needs of patients, today announced that the Company’s third quarter financial results will be released on Monday, November 10, 2014. Company management…

History, Yes, But Biologist’s Imagination Is No Flight Of Fancy

November 4, 2014 – 4:30 am | Edit Post

Any book about life science innovation that starts with quotes from Frank Zappa and Albert Einstein promises to be a good read. The Biologist’s Imagination holds to that promise, as authors…
[[Click headline to continue reading.]]

Catheter Connections Fails Second Disinfection Test on Important Fungus, Announces Ivera Medical

November 4, 2014 – 3:00 am | Edit Post

SAN DIEGO, CA–(Marketwired – Nov 4, 2014) – Ivera Medical announced that an independent lab has found that the dark blue IV-Pole Strips and DualCap products for male luer connectors made by Catheter Connections failed in a second test to disinfect all critical surfaces of male luer connectors when used as directed on Candida albicans. Previously, results were published from an independent lab that found these same products failed to reach a 4-log reduction disinfection level on seven of the twelve samples inoculated with this common fungus. In this study, the Catheter Connections product failed to reach disinfection levels on all twelve of the samples tested. In order to promote transparency on this critical issue, the study report including the test protocol and related information for these tests can be found at www.curos.com.

Assessing Elderly Drivers: Doctors and Law Enforcement Receive Training

November 3, 2014 – 3:10 pm | Edit Post

Every day in America roughly 10,000 people turn age 65. To help keep roadways safe as America grays and to help preserve the freedom of mobility of older drivers, researchers at University of California, San Diego School of Medicine are training law enforcement officers to recognize warning signs of impaired driving skills and to take appropriate, compassionate action.

Halozyme to Host Third Quarter 2014 Financial Results Conference Call

November 3, 2014 – 2:15 pm | Edit Post

SAN DIEGO, Nov. 3, 2014 /PRNewswire/ — Halozyme Therapeutics, Inc. (NASDAQ: HALO) will webcast its Quarterly Update Conference Call for the third quarter 2014 on Monday, November 10, 2014 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Helen Torley, President and Chief Executive Officer, will lead the call. On the same date post-market, Halozyme will release financial results for the third quarter 2014.

The call will be webcast live through the “Investors” section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast, please log on to www.halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. For those without access to the Internet, the live call may be accessed by phone by dialing (866) 710-0179 (domestic callers) or (334) 323-7224 (international callers) using passcode 769890. A telephone replay will be available shortly after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay ID number 45298549.

About HalozymeHalozyme Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care. With a diversified portfolio of enzymes that target the extracellular matrix, the Company’s research focuses primarily on a family of human enzymes, known as hyaluronidases, which increase the dispersion and absorption of biologics, drugs and fluids. Halozyme’s pipeline addresses therapeutic areas, including oncology, diabetes and dermatology that have significant unmet medical need today. The Company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Pfizer and Baxter. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at www.halozyme.com.

Investor Contact:Schond GreenwayHalozyme Therapeutics858-704-8352ir@halozyme.com

Media Contact:Susan Neath Francis212-301-7182sfrancis@wcgworld.com

Logo - http://photos.prnewswire.com/prnh/20100302/LA63139LOGO
SOURCE Halozyme Therapeutics, Inc.

NuVasive to Host Investor Morning on November 13, 2014

November 3, 2014 – 2:05 pm | Edit Post

SAN DIEGO, CA–(Marketwired – Nov 3, 2014) – NuVasive, Inc. ( NASDAQ : NUVA ) (“NuVasive” or the “Company”), a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today that it will host a meeting for investors and analysts on Thursday, November 13, 2014 from 8:00 a.m. to 10:00 a.m. PT at the W Hotel in San Francisco, California.

Neurocrine Biosciences Reports Third Quarter 2014 Results

November 3, 2014 – 2:01 pm | Edit Post

SAN DIEGO, Nov. 3, 2014 /PRNewswire/ — Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced its financial results for the quarter ended September 30, 2014.  For the third quarter of 2014, the Company reported a net loss of $15.9 million, or $0.21 loss per share, compared to a net loss of $11.1 million, or $0.17 loss per share, for the same period in 2013.  For the nine months ended September 30, 2014, the Company reported a net loss of $41.1 million, or $0.56 loss per share, as compared to net loss of $35.4 million, or $0.53 loss per share, for the first three quarters of last year.

The Company’s balance sheet at September 30, 2014 reflected total assets of $257.8 million, including cash, cash equivalents, investments and receivables of $248.3 million. 

“We have made significant progress over the past quarter with our VMAT2 program, including the initiation of the Kinect 3 Phase III study, receiving Breakthrough Therapy Designation from the FDA for tardive dyskinesia, and starting the first clinical assessment of NBI-98854 in children with Tourette syndrome,” said Kevin Gorman, Ph.D., President and Chief Executive Officer of Neurocrine Biosciences. “We look forward to multiple clinical trial readouts in 2015 including Phase III topline efficacy data for elagolix in endometriosis and Phase IIb efficacy data for elagolix in uterine fibroids reported by our partner AbbVie, as well as Kinect 3 Phase III topline efficacy data and Phase Ib data in Tourette from our VMAT2 inhibitor.”

Research and development expenses were $12.2 million during the third quarter of 2014, compared to $9.5 million for the same period in 2013. General and administrative expenses increased from $3.2 million for the third quarter of 2013 to $4.7 million for the third quarter of 2014. For the nine months ended September 30, 2014, research and development expenses were $30.9 million, compared to $30.3 million for the same period last year, while general and administrative expenses were $13.0 million, compared to $10.0 million. This increase in year-to-date expenses is primarily due to higher personnel costs, with share-based compensation expense representing $2.8 million of the year-to-date increase in expenses.

Pipeline Highlights

VMAT2 Update

The Company recently initiated a Phase III study of NBI-98854, the Kinect 3 study. The Kinect 3 study, along with the previous efficacy studies of NBI-98854, is designed to complete the placebo-controlled clinical efficacy evaluation of NBI-98854 in tardive dyskinesia. The primary endpoint in the Kinect 3 study is the mean change from baseline in the Abnormal Involuntary Movement Scale (AIMS) as assessed by blinded central raters. The Kinect 3 study will include approximately 240 subjects randomized to either placebo, once daily 40mg of NBI-98854 or once daily 80mg of NBI-98854 for six weeks of placebo-controlled dosing followed by an extension of active dosing through Week 48. The Company also intends to conduct a separate one-year open-label safety study of NBI-98854 to support the anticipated 2016 filing of a New Drug Application in tardive dyskinesia.

Top-line efficacy data from the initial six weeks of placebo-controlled dosing is expected in the second half of 2015.

The Company also recently received Breakthrough Therapy Designation from the FDA for NBI-98854 in the treatment of tardive dyskinesia.

The Company is also exploring NBI-98854 in an initial Tourette syndrome clinical trial, the T-Force study.  This study is an open-label, multi-dose, two-week evaluation of 36 subjects with Tourette syndrome. Children and adolescents enrolled in the trial will receive once-daily dosing of NBI-98854 during a two-week treatment period to assess both the safety and tolerability of NBI-98854 in Tourette patients. Additionally, the Yale Global Tic Severity Scale and the Premonitory Urge for Tics Scale will be employed during the study to assess the impact of NBI-98854 on the patients’ Tourette symptoms. Data readout from this study is expected in 2015.

Elagolix Update

AbbVie is currently conducting the Violet Petal Study, a Phase III study of elagolix for endometriosis.  The study is a 24-week, multinational, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of elagolix in 875 women, age 18 to 49, with moderate to severe endometriosis-associated pain.  Approximately 160 sites in the United States, Puerto Rico and Canada are conducting this study which completed patient recruitment and randomization during the second quarter. Topline efficacy data from this study is anticipated to be available in January 2015.

AbbVie is also conducting the second Phase III study of elagolix for endometriosis, the Solstice Study.  This study is similar in design to the Violet Petal Study and will assess 788 women, age 18 to 49, with moderate to severe endometriosis-associated pain at more than 200 sites globally.

Elagolix is also being evaluated in women with uterine fibroids.  AbbVie is conducting a Phase IIb clinical trial evaluating the change in menstrual blood loss of 520 women, age 18-51, with heavy menstrual bleeding associated with uterine fibroids.

Conference Call and Webcast Today at 5:00PM Eastern TimeNeurocrine will hold a live conference call and webcast today at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).  Participants can access the live conference call by dialing 877-888-4314 (US) or 785-424-1875 (International) using the conference ID: NBIX.  The call can also be accessed via the webcast through the Company’s website at http://www.neurocrine.com.

If you are unable to attend the webcast and would like further information on this announcement please contact the Investor Relations Department at Neurocrine Biosciences at ir@neurocrine.com.  A replay of the conference call will be available approximately one hour after the conclusion of the call by dialing 800-723-0528 (US) or 402-220-2654 (International) using the conference ID: NBIX.  The call will be archived for one month.

Neurocrine Biosciences, Inc. discovers and develops innovative and life-changing pharmaceuticals, in diseases with high unmet medical needs, through its novel R&D platform, focused on neurological and endocrine based diseases and disorders.  The Company’s two lead late-stage clinical programs are elagolix, a gonadotropin-releasing hormone antagonist for women’s health that is partnered with AbbVie Inc., and a wholly owned vesicular monoamine transporter 2 inhibitor for the treatment of movement disorders.  Neurocrine intends to maintain certain commercial rights to its VMAT2 inhibitor for evolution into a fully-integrated pharmaceutical company.

Neurocrine Biosciences, Inc. news releases are available through the Company’s website via the internet at http://www.neurocrine.com.

In addition to historical facts, this press release may contain forward-looking statements that involve a number of risks and uncertainties.  Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with Neurocrine’s R&D pipeline as well as its business overall.  Specifically, the risks and uncertainties the Company faces with respect to elagolix, include the risk that the elagolix endometriosis Phase III clinical trials will fail to demonstrate that elagolix is safe and effective; the risk that elagolix Phase III clinical trials will be delayed for regulatory or other reasons; the risk that the elagolix uterine fibroids clinical program will not proceed to later stage clinical trials; and the risks associated with the Company’s dependence on AbbVie for elagolix Phase III development, commercial manufacturing and marketing and sales activities.  In addition, the Company faces risks and uncertainties with respect to the rest of the Company’s R & D pipeline including; risk that the Company’s VMAT2 Phase III clinical program will fail to demonstrate that NBI-98854 is safe and effective; risk that the VMAT2 Phase III program will be delayed for regulatory or other reasons; risk that the Breakthrough Therapy designation may not result in an expedited development and review process for NBI-98854 and may not lead to regulatory approval; risk that the Company will be unable to complete the Tourette syndrome Phase I clinical trial for regulatory or other reasons; risk that the Company’s research programs will not identify pre-clinical candidates for further development; and  risk that the Company’s other product candidates will not be found to be safe and effective.  With respect to its business overall, the Company faces risk that it will be unable to raise additional funding required to complete development of all of its product candidates; risk relating to the Company’s dependence on contractors for clinical drug supply, commercial manufacturing and marketing and sales activities; uncertainties relating to patent protection and intellectual property rights of third parties; risks and uncertainties relating to competitive products and technological changes that may limit demand for the Company’s products if approved.  The Company also faces the other risks described in the Company’s annual report on Form 10-K for the year ended December 31, 2013 and quarterly reports on Form 10-Q for the quarters ended March 31, 2014 and June 30, 2014.  Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.

 

NEUROCRINE BIOSCIENCES, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

(unaudited)

Three Months EndedSeptember 30,

Nine Months EndedSeptember 30,

2014

2013

2014

2013

Revenues:            

License fees              

$            -

$      729

$            -

$   2,189

Total revenues               

-

729

-

2,189

Operating expenses:           

Research and development   

12,194

9,490

30,927

30,330

General and administrative   

4,663

3,245

13,016

10,007

Total operating expenses             

16,857

12,735

43,943

40,337

Loss from operations         

(16,857)

(12,006)

(43,943)

(38,148)

Other income:     

Gain (loss) on sale/disposal of assets   

1

6

(4)

38

Deferred gain on real estate   

805

781

2,414

2,344

Investment income, net          

176

93

432

317

Other income (loss), net          

-

(5)

3

1

Total other income       

982

875

2,845

2,700

Net loss

$ (15,875)

$ (11,131)

$ (41,098)

$ (35,448)

Net loss per common share:

Basic and diluted     

$   (0.21)

$   (0.17)

$   (0.56)

$   (0.53)

Shares used in the calculation of net loss per common share:

Basic and diluted     

75,948

67,199

74,050

66,868

 

NEUROCRINE BIOSCIENCES, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

(unaudited)

September 30,

2014

December 31,2013

Cash, cash equivalents and short-term investments, available for sale

$          179,674

$          145,739

Other current assets

4,194

2,723

Total current assets

183,868

148,462

Property and equipment, net

2,292

1,771

Long-term investments, available for sale

67,148

-

Restricted cash

4,443

4,443

Total assets

$          257,751

$          154,676

Current liabilities

$            14,045

$            11,699

Long-term liabilities

19,669

22,567

Stockholders’ equity

224,037

120,410

Total liabilities and stockholders’ equity

$          257,751

$          154,676

 
SOURCE Neurocrine Biosciences, Inc.