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TearLab Corporation To Participate In November Investor Conferences -

November 11, 2014 – 5:00 am | Edit Post

SAN DIEGO, Nov. 10, 2014 (GLOBE NEWSWIRE) — TearLab Corporation (Nasdaq:TEAR) (TSX:TLB) (“TearLab” or the “Company”) announced today that it will participate in two investor conferences in November. On November 12th, TearLab will participate in the 2014 Stephens Fall Investment…

Multiple Models Reveal New Genetic Links in Autism

November 11, 2014 – 2:00 am | Edit Post

With the help of mouse models, induced pluripotent stem cells (iPSCs) and the “tooth fairy,” researchers at the University of California, San Diego School of Medicine have implicated a new gene in idiopathic or non-syndromic autism.

Lowering the Cost of Failure in Biopharmaceuticals

November 11, 2014 – 1:00 am | Edit Post

In any business, projects fail, but in biopharmaceuticals, the consequences of failure are especially damaging. Projects in the industry tend to be long and expensive—from clinical trials to…
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Getting over the overhead

November 10, 2014 – 6:47 pm | Edit Post

UCSD researchers have found how to coax more charitable contributions out of donors.

Daiichi Sankyo and Ambit Announce Results of Tender Offer

November 10, 2014 – 5:37 pm | Edit Post

TOKYO and SAN DIEGO, Nov. 10, 2014 /PRNewswire/ — Daiichi Sankyo Company, Limited (hereinafter, Daiichi Sankyo) (TSE: 4568) and Ambit Biosciences Corporation (hereinafter, Ambit Biosciences) (NASDAQ: AMBI) today announced the results of Daiichi Sankyo’s tender offer to purchase all of the outstanding shares of Ambit Biosciences’ common stock for $15.00 per share plus one non-transferable contingent value right per share, which will entitle the holder thereof to a maximum payment of $4.50 upon the achievement of certain commercialization related milestones relating to quizartinib. The tender offer is being effected by Daiichi Sankyo’s subsidiary, Charge Acquisition Corp.  

The depositary for the tender offer has advised Daiichi Sankyo and Ambit Biosciences that, as of the expiration of the tender offer at 5:00 p.m. Eastern Time on November 10, 2014, a total of 15,674,238 shares of Ambit Biosciences common stock had been validly tendered and not withdrawn, representing approximately 85 percent of Ambit Biosciences’ outstanding shares. All shares that were validly tendered and not withdrawn during the initial offering period have been accepted for payment.

“We are very pleased to complete the acquisition of Ambit Biosciences and look forward to continuing to advance quizartinib in light of its potential to significantly improve outcomes for patients with very few options,” said Daiichi Sankyo Co., Ltd. President and CEO, Joji Nakayama.

The condition to the tender offer that a majority of Ambit Biosciences’ outstanding shares be validly tendered has been satisfied, and Daiichi Sankyo’s acquisition of Ambit Biosciences is expected to be completed later today through a merger under Section 251(h) of the General Corporation Law of the State of Delaware.  As a result of the merger, each share of common stock of Ambit Biosciences not tendered in the tender offer (other than shares held by Ambit Biosciences, Daiichi Sankyo or their wholly owned subsidiaries, and other than shares held by a holder who has properly demanded and perfected appraisal rights under Delaware law) will be converted into the right to receive $15.00 per share in cash, plus one non-transferable contingent value right per share. This is the same price per share paid in the tender offer.

Following completion of the merger, Ambit Biosciences shares will cease to be traded on the NASDAQ Global Market.

About Daiichi Sankyo

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets. While maintaining its portfolio of marketed pharmaceuticals for hypertension, dyslipidemia and bacterial infections used by patients around the world, the Group has also launched treatments for thrombotic disorders and is building new product franchises. Furthermore, Daiichi Sankyo research and development is focused on bringing forth novel therapies in oncology and cardiovascular-metabolic diseases, including biologics. The Daiichi Sankyo Group has created a “Hybrid Business Model,” to respond to market and customer diversity and optimize growth opportunities across the value chain. For more information, please visit: www.daiichisankyo.com. 

The Daiichi Sankyo oncology portfolio continues to grow and currently includes both small molecules and monoclonal antibodies with novel targets in both solid and hematologic cancers.

About Ambit Biosciences

Ambit Biosciences is a biopharmaceutical company focused on the discovery, development and commercialization of drugs to treat unmet medical needs in oncology, autoimmune and inflammatory diseases by inhibiting kinases that are important drivers for those diseases. Ambit’s lead drug candidate, quizartinib (AC220), is a once-daily, orally-administered potent and selective, inhibitor of FMS-like tyrosine kinase-3 (FLT3) and is currently in a registrational phase 3 clinical trial, referred to as QUANTUM-R, in patients with relapsed/refractory FLT3-ITD positive, acute myeloid leukemia (AML). Quizartinib is also being studied in newly diagnosed patients in combination with chemotherapy as well as maintenance following a hematopoietic stem cell transplantation (HSCT). In addition to quizartinib, Ambit’s clinical pipeline includes AC410, an oral JAK2 inhibitor, and CEP-32496, a BRAF inhibitor licensed to Teva Pharmaceutical Industries Ltd. Ambit’s preclinical portfolio includes a proprietary CSF1R inhibitor program.

Forward Looking Statements

This press release contains forward-looking statements. Any statements contained herein which do not describe historical facts, including but not limited to, statements regarding: the proposed transaction between Daiichi Sankyo and Ambit Biosciences; the expected timetable for completing the transaction; and Ambit Biosciences’ product candidates, including regarding the therapeutic and commercial potential of quizartinib, are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include: the ability to timely consummate the transaction and the possibility that the transaction will not be completed; the ability of Daiichi Sankyo to successfully integrate Ambit Biosciences operations and employees; the anticipated benefits of the transaction may not be realized; risks related to drug development and commercialization; and those additional factors discussed in Ambit Biosciences’ most recent Quarterly and Annual Reports on Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission (hereinafter, the SEC). Daiichi Sankyo and Ambit Biosciences caution investors not to place considerable reliance on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this document, and Daiichi Sankyo and Ambit Biosciences undertake no obligation to update or revise any of these statements.
SOURCE Daiichi Sankyo Company, Limited

Isis debt offering to help drug commercialization

November 10, 2014 – 4:56 pm | Edit Post

Debt offering of $425 million will also Carlsbad biotech replace higher-interest bonds.

The Brain’s “Inner GPS” Gets Dismantled

November 10, 2014 – 3:06 pm | Edit Post

Imagine being able to recognize your car as your own but never being able to remember where you parked it. Researchers at University of California, San Diego School of Medicine have induced this all-too-common human experience permanently in rats and from what is observed perhaps derive clues about why strokes and Alzheimer’s disease can destroy a person’s sense of direction.

Halozyme Reports Third Quarter 2014 Financial Results

November 10, 2014 – 2:05 pm | Edit Post

SAN DIEGO, Nov. 10, 2014 /PRNewswire/ – Halozyme Therapeutics, Inc. (NASDAQ: HALO) today reported financial results for the third quarter ended September 30, 2014. Financial highlights for the third quarter include revenues of $14.6 million and a net loss of $20.3 million, or $0.16 per share. This compares to revenues of $16.0 million and a net loss of $19.3 million, or $0.17 per share, for the third quarter of 2013.

“The third quarter was notable for completion of a review and update to our corporate strategy based on a portfolio assessment. The recent Fast Track and Orphan Drug designations for PEGPH20, new pre-clinical data further supporting the pan-tumor potential for PEGPH20 and strong investigator interest in both pancreatic and lung cancer trials have confirmed this as our priority proprietary product for investment. The growth in the number of approvals for ENHANZE™ – based products and the launch success of Roche’s Herceptin SC affirms our confidence in the growth potential of the ENHANZE platform,” stated Dr. Helen Torley, President and Chief Executive Officer. “Our pursuit of Hylenex® in Type 1 diabetes is a potential opportunity to expand the indication and increase sales of Hylenex.  While discussions with the FDA are ongoing, we have learned that the FDA will likely request additional clinical data for a label update translating to potentially higher projected costs and longer time to market than had originally been anticipated.  In the ongoing weeks, we intend to continue to seek clarity with FDA on what data will be required, if any.  Once we have gained clarity as to the regulatory requirements for a label update, we intend to enter into collaborations with third parties or explore other strategic alternatives in order to exploit this opportunity.  I am excited by the opportunity to focus our resources on advancing PEGPH20 and to expand utilization of our ENHANZE platform.”

Third Quarter 2014 Highlights

Royalty revenues of $2.9 million represent over 70% growth from second quarter:  Royalty revenues represent April to June sales as a result of the one quarter lag in royalty reports.  The Herceptin SC launch is progressing well with approximately 20% market share in the markets launched through October.  A notable recent milestone for Herceptin SC is the recent reimbursement approval and launch in France, traditionally one of the largest EU oncology markets.
HYQVIA® approved by the FDA and launched in the U.S.: In September, the U.S. Food and Drug Administration (FDA) approved HYQVIA for the treatment of primary immunodeficiency (PI) in adults and Baxter began commercial introduction of the product on October 20th. HYQVIA is the first subcutaneous immune globulin (IG) treatment approved for PI patients with a dosing regimen requiring only one infusion up to once per month (every three to four weeks) and one injection site per infusion to deliver a full therapeutic dose of IG.
PEGPH20 (PEGylated recombinant human hyaluronidase) received Fast Track and Orphan Drug designation for pancreatic cancer: The FDA has granted Fast Track designation for Halozyme’s program investigating PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of patients with metastatic pancreatic cancer.  The FDA Office of Orphan Products Development also granted Orphan Drug status for PEGylated recombinant human hyaluronidase for the treatment of pancreatic cancer which grants this designation to medical products that demonstrate promise for the treatment of rare diseases or conditions.
PEGPH20 (PEGylated recombinant human hyaluronidase) enrollment progressing: 42 of 44 sites have received IRB approval for the Study 202 protocol amendment. A total of 25 of the target of approximately 100 new patients have been enrolled to date.
SWOG resumes clinical trial of PEGPH20 in combination with modified FOLFIRINOX for advanced pancreatic cancer: SWOG Cancer Research has resumed patient enrollment and dosing of PEGPH20 in its ongoing Phase 1b/2 clinical trial (S1313). The trial is designed to evaluate PEGPH20 in combination with modified FOLFIRINOX chemotherapy (mFOLFIRINOX) in patients with metastatic pancreatic adenocarcinoma. The study has resumed under a revised protocol approved by the Independent Review Boards at the participating clinical trial sites.
CONSISTENT 1 trial of Hylenex in patients with Type1 diabetes to be ended after first year: While discussions with FDA are ongoing, we have determined that with all patients having completed 12 months on the trial at this time, we do not need additional data contribution from the second year of CONSISTENT 1 and we will be stopping the study.
Second disclosed program under the Halozyme-Pfizer collaboration: Pfizer intends to investigate a subcutaneous formulation using Halozyme’s Enhanze technology with rivipansel. Rivipansel is an investigational compound under evaluation for the treatment of vaso-occlusive crisis in individuals with sickle cell disease.
Reduction in force of approximately 13% completed in November 2014 to align with strategic priorities:  We completed a corporate reorganization to align with strategic priorities. This reorganization resulted in a workforce reduction of 22 employees.  We will incur a one-time charge in the fourth quarter of 2014 that will be largely offset by reduced compensation expenses during the quarter.Third Quarter and Nine Months 2014 Financial Highlights

Revenues for the third quarter of 2014 were $14.6 million, compared to $16.0 million for the third quarter of 2013. Revenues in the third quarter included $5.8 million in product sales of bulk rHuPH20 for use in manufacturing Roche’s collaboration products, $3.6 million in Hylenex product sales, $2.9 million in royalty revenue from sales of products under our collaborations and $2.1 million in collaboration revenues.  Revenues for the nine months were $45.0 million compared to $42.3 million for the same period in the previous year. 
Research and development expenses for the third quarter of 2014 were $19.9 million, compared to $25.7 million for the third quarter of 2013. The decrease was primarily due to the inclusion in this quarter of manufacturing expenses in cost of product sales instead of research and development expenses as in the prior period last year.
Selling, general and administrative expenses for the third quarter of 2014 were $8.6 million, compared to $8.1 million for the third quarter of 2013. The increase was mainly due to an increase in patent expenses.
The net loss for the third quarter of 2014 was $20.3 million, or $0.16 per share, compared to a net loss for the third quarter of 2013 of $19.3 million, or $0.17 per share. The net loss for the nine months to date totaled $63.1 million, or $0.52 per share, compared to a net loss of $61.5 million, or $0.55 per share, for the first nine months of 2013.
Cash, cash equivalents and marketable securities were $134.5 million at September 30, 2014, compared to $147.6 million at June 30, 2014. Net cash used in the third quarter of 2014 was approximately $13.1 million.Webcast and Conference Call

Halozyme will webcast its quarterly update conference call today, November 10, 2014 at 4:30 p.m. EDT/1:30 p.m. PDT. During the call, management will discuss the financial results for the third quarter of 2014 and provide a business update. To listen to the live webcast please visit the “Investors” section of Halozyme’s corporate website at www.halozyme.com. A webcast replay will be available shortly after the call at the same address. To participate by phone, please dial (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 Halozyme

Halozyme 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. For more information on how we are innovating, please visit our corporate website at www.halozyme.com.
Safe Harbor Statement

In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the Company’s future expectations and plans for enrollment of patients in Study 202 for PEGPH20, the development and commercialization of product candidates including planned clinical trials, the potential benefits and attributes of such product candidates, gaining clarity as to the regulatory pathway for updating the Hylenex®  label for use in Type 1 diabetes, entering into new collaborations and potential royalty revenue from products from collaborations) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words “believe,” “enable,” “may,” “will,” “could,” “intends,” “estimate,” “anticipate,” “plan,” “predict,” “probable,” “potential,” “possible,” “should,” “continue,” and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected expenditures and costs, unexpected fluctuations or changes in revenues from collaborators, unexpected results or delays in development and regulatory review, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 10, 2014.

 

Halozyme Therapeutics, Inc

 Condensed Consolidated Statements of Operations

(Unaudited)

(in thousands, except per share data)

Three Months Ended September 30,

Nine Months Ended September 30,

2014

2013

2014

2013

Revenues:

Product sales, net

$    9,617

$           10,025

$  27,679

$  14,634

Royalties

2,895

-

5,382

-

Revenues under collaborative agreements

2,094

5,988

11,896

27,667

Total revenues

14,606

16,013

44,957

42,301

Operating Expenses:

Cost of product sales

5,141

683

16,585

2,706

Research and development

19,904

25,689

59,968

75,714

Selling, general and administrative

8,587

8,135

27,589

22,991

Total operating expenses

33,632

34,507

104,142

101,411

Operating loss

(19,026)

(18,494)

(59,185)

(59,110)

Investment and other income, net

122

52

287

165

Interest expense

(1,376)

(850)

(4,203)

(2,547)

Net Loss

$ (20,280)

$         (19,292)

$ (63,101)

$ (61,492)

Basic and diluted net loss per share

$     (0.16)

$             (0.17)

$     (0.52)

$     (0.55)

Shares used in computing basic and diluted net loss per share

124,041

112,765

122,157

112,554

 

Halozyme Therapeutics, Inc

Condensed Consolidated Balance Sheets

(Unaudited)

(in thousands)

September 30,

December 31,

2014

2013

ASSETS

Current assets:

Cash and cash equivalents

$             46,375

$            27,357

Marketable securities, available-for-sale

88,089

44,146

Accounts receivable, net

8,275

9,097

Inventories

6,916

6,170

Prepaid expenses and other assets

8,945

8,425

Total current assets

158,600

95,195

Property and equipment, net

3,249

3,422

Prepaid expenses and other assets

2,277

2,676

Restricted cash

500

500

Total Assets

$           164,626

$          101,793

LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)

Current liabilities:

Accounts payable

$               4,342

$              3,135

Accrued expenses

15,023

14,369

Deferred revenue, current portion

5,153

7,398

Current portion of long-term debt, net

10,075

-

Total current liabilities

34,593

24,902

Deferred revenue, net of current portion

47,572

45,745

Long-term debt, net

39,762

49,772

Other long-term liabilities

2,759

1,364

Stockholders’ equity (deficit):

Common stock

125

115

Additional paid-in capital

485,014

361,930

Accumulated other comprehensive (loss) income

(46)

17

Accumulated deficit

(445,153)

(382,052)

Total stockholders’ equity (deficit)

39,940

(19,990)

Total Liabilities and Stockholders’ Equity (Deficit)

$           164,626

$          101,793

 

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

Media Contact:Susan Neath Francis212-301-7182sfrancis@w2ogroup.com

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

NuVasive(R) Focused on Surgeon Support and Showcasing Industry-Leading Products at North American Spine Society 29th Annual Meeting

November 10, 2014 – 2:05 pm | Edit Post

SAN DIEGO, CA–(Marketwired – Nov 10, 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, today announced that it will attend the 29th North American Spine Society (“NASS”) Annual Meeting, held November 12-15, 2014, at the Moscone Center in San Francisco, CA. The Company’s attendance underscores NuVasive’s ongoing commitment to surgeon support through numerous educational workshops and the exhibition of several of the Company’s products and procedures that have revolutionized the spine industry.

Carlsbad Biotech Gets FDA Clearance For Stem Cell Line

November 10, 2014 – 12:44 pm | Edit Post

International Stem Cell Corp., a Carlsbad-based biotech company developing stem cell therapies and biomedical products, announced that the U. S. Food and Drug Administration has cleared the company’s human parthenogenetic stem cells line for investigational clinical use.