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Posts Tagged ‘biotechnology company’

Threshold Pharmaceuticals Announces Positive Phase 2b Clinical Trial Results of TH-302 in Patients With Pancreatic Cancer

Tuesday, February 21st, 2012

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Primary endpoint of Progression Free Survival was met with hazard ratio of 0.61 (p = 0.005).
The combination therapy was well tolerated with a safety profile consistent with prior studies.

SOUTH SAN FRANCISCO, CA — (CRWENEWSWIRE) -02/21/12- Threshold Pharmaceuticals, Inc. (NASDAQ:THLD) today announced that its 214 patient randomized controlled Phase 2b clinical trial evaluating the efficacy and safety of two doses of the investigational agent TH-302 in combination with gemcitabine compared to gemcitabine alone in patients with first-line advanced pancreatic cancer achieved its primary endpoint, with a 63% improvement in progression free survival and a safety profile consistent with previous studies. “With the results of this trial, we are again very encouraged that TH-302 is conferring benefit to patients with aggressive and difficult to treat cancers,” said Barry Selick, Ph.D., Chief Executive Officer of Threshold. “We look forward to its ongoing development with our partner Merck KGaA in this and other indications.”

Clinical Trial Design
Study TH-CR-404 is a multi-center, randomized, controlled, dose-ranging, Phase 2b crossover clinical trial of TH-302 in combination with gemcitabine in patients with first line advanced pancreatic cancer. The primary endpoint of the trial is progression-free survival. The secondary endpoints are overall response rate, overall survival, change in CA19-9 as well as various other efficacy and safety parameters. Tumor response was evaluated at baseline and every eight weeks using RECIST. Patients for whom monotherapy with gemcitabine is considered standard therapy were eligible for the trial. Patients were randomized equally into one of three cohorts: TH-302 at a dose of 240 mg/m2 plus gemcitabine, TH-302 at a dose of 340 mg/m2 plus gemcitabine, or gemcitabine alone. Patients who successfully completed six cycles of treatment without evidence of significant treatment-related toxicity or progressive disease could continue to receive treatment. If a patient experienced cancer progression on gemcitabine alone, the patient could cross over into one of the TH-302 plus gemcitabine cohorts. The primary efficacy analysis was performed based upon 149 investigator-assessed PFS events and, per protocol, pooled data from the two gemcitabine plus TH-302 dose groups in comparison to gemcitabine alone.

Results
The median progression-free survival (PFS) was 5.6 months for patients treated with gemcitabine in combination with TH-302 at 240 mg/m2 and 340 mg/m2 compared to 3.6 months for patients treated with gemcitabine alone. The PFS hazard ratio comparing the TH-302 combination to gemcitabine alone was 0.61 (95% confidence interval: 0.43 - 0.87) which was highly statistically significant (p = 0.005). The response rate in the combination arms was 22% compared to 12% in the gemcitabine alone group. Results also demonstrated greater efficacy in the higher TH-302 dose group compared to the lower dose group.

The combination was well tolerated with a safety profile that was consistent with our prior study of this combination regimen. As in that study, skin and mucosal toxicities related to TH-302 were dose dependent but not dose limiting. Further detailed information regarding the results of this trial will be presented at a future major medical conference.

“This study provides the proof of concept demonstration that TH-302 contributes to the efficacy of a known active agent and supports the rationale for combining TH-302, a hypoxia targeting agent, with other approved therapies,” said Stew Kroll, Senior Vice President of Biostatistics and Clinical Operations of Threshold.

About Pancreatic Cancer
Pancreatic cancer is a malignant neoplasm of the pancreas with current treatment options including surgery, radiotherapy and chemotherapy. Gemcitabine as a single agent or in combination with other treatments is the most commonly used chemotherapeutic agent in patients with advanced pancreatic cancer. It is estimated that approximately 279,000 cases of pancreatic cancer were diagnosed worldwide in 2008. Pancreatic cancer is the fourth most common cause of cancer death both in the United States and internationally. The American Cancer Society estimates that 44,030 people were diagnosed with pancreatic cancer in the United States in 2011, and approximately 37,660 people died from the disease.

About TH-302
TH-302 is a hypoxia-targeted drug that is thought to be activated under tumor hypoxic conditions, a hallmark of many cancer indications. Areas of low oxygen levels (hypoxia) within tissues are common in many solid tumors due to insufficient blood vessel growth. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be extremely hypoxic. TH-302 has been investigated in over 550 patients in Phase 1/2 clinical trials to date in a broad spectrum of tumor types, both as a monotherapy and in combination with chemotherapy treatments and other targeted cancer drugs. Threshold has several ongoing clinical trials with TH-302 including, but not limited to, a Phase 3 trial of TH-302 in patients with first-line advanced soft tissue sarcoma (STS). This randomized, multi-center Phase 3 trial will investigate the use of TH-302 plus doxorubicin compared with doxorubicin alone. The primary efficacy endpoint is overall survival. The study is conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration. It is being run in partnership with the Sarcoma Alliance for Research through Collaboration (SARC) and aims to enroll 450 patients with metastatic or locally advanced unresectable STS.

In Memorium
The results of this trial are dedicated to the memory of John G. Curd, MD, Threshold’s former Chief Medical Officer who died unexpectedly on April 20, 2011. John played a key role in the design of this trial and deserves our recognition and thanks for his efforts on behalf of all patients living with cancer.

About Threshold Pharmaceuticals
Threshold
is a biotechnology company focused on the discovery and development of drugs targeting Tumor Hypoxia, the low oxygen condition found in microenvironments of most solid tumors as well as the bone marrows of some hematologic malignancies. This approach offers broad potential to treat a variety of cancers. By selectively targeting tumor cells, we are building a pipeline of drugs that hold promise to be more effective and less toxic to healthy tissues than conventional anticancer drugs. For additional information, please visit our website (www.thresholdpharm.com).

Forward-Looking Statements
Except for statements of historical fact, the statements in this press release are forward-looking statements, including statements regarding TH-302’s potential uses and benefits and current and planned clinical trials of TH-302. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, Threshold’s ability to enroll or complete its anticipated clinical trials, the time and expense required to conduct such clinical trials and analyze data, whether such trials confirm results from earlier trials and preclinical studies, potential side effects associated with TH-302, issues arising in the regulatory or manufacturing process and the results of such clinical trials (including product safety issues and efficacy results), and Threshold’s ability to raise additional capital to continue funding its operations. Further information regarding these and other risks is included under the heading “Risk Factors” in Threshold’s Quarterly Report on Form 10-Q, which has been filed with the Securities Exchange Commission on November 3, 2011 and is available from the SEC’s website (www.sec.gov) and on our website (www.thresholdpharm.com) under the heading “Investors.” We undertake no duty to update any forward-looking statement made in this news release.

Source: Threshold Pharmaceuticals, Inc.

Contact:

Joel A. Fernandes
Threshold Pharmaceuticals, Inc.
650.474.8273
IR@thresholdpharm.com

 

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Exelixis Announces Fourth Quarter and Full Year 2011 Financial Results

Thursday, February 9th, 2012

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SOUTH SAN FRANCISCO, Calif — 02/08/2012 (CRWENEWSWIRE) — Exelixis, Inc. (Nasdaq:EXEL) today reported financial results for the fourth quarter and year ended December 31, 2011.

Revenues for the fourth quarter ended December 31, 2011 were $93.3 million, compared to $40.8 million for the comparable period in 2010. The increase was primarily due to the recognition of revenue as a result of the acceleration of deferred license revenue and the receipt of a one-time termination fee in connection with the wind-down in December 2011 of our 2009 collaboration with Sanofi for the discovery of inhibitors of Phosphoinositide-3 Kinase (PI3K). This increase was partially offset by lower reimbursement revenues as a result of the transfer in 2011 of substantially all development activities pertaining to XL147 and XL765 to Sanofi under our 2009 license agreement for these compounds as well as the recognition of lower milestone revenue in 2011 compared to 2010.

Revenues for the year ended December 31, 2011 were $289.6 million compared to $185.0 million in 2010. The increase was primarily due to the revenue recognized as a result of the acceleration of deferred license revenue related to the early termination of our 2008 Agreement with Bristol Myers-Squibb for XL281 in October 2011 and the wind-down in December 2011 of our Sanofi collaboration agreement mentioned above. These increases were partially offset by lower collaboration reimbursement revenue and research funding as a result of the collaboration with Bristol Myers-Squibb coming to an end and the transfer of substantially all development activities for XL147 and XL765 to Sanofi as well as lower milestone revenue recognized in 2011 compared to the prior year.

Research and development expenses for the fourth quarter ended December 31, 2011 were $30.8 million compared to $42.3 million for the comparable period in 2010; and for the year ended December 31, 2011 were $156.8 million compared to $210.7 million for 2010. The decrease from 2011 to 2010 in both the quarter and year primarily reflected the reduction in personnel costs, laboratory costs, stock-based compensation and general corporate costs as a result of our 2010 and 2011 restructurings. In addition, clinical trial expenses continued to decrease as a result of the discontinuation of trials for compounds other than cabozantinib.

General and administrative expenses for the fourth quarter ended December 31, 2011 were $7.0 million compared to $5.7 million for the comparable period in 2010; and for the year ended December 31, 2011 were $33.1 million compared to $33.0 million for 2010. The increase in 2011 from 2010 for both the quarter and the year were primarily due to an increase in the allocation of general corporate costs to general and administrative expenses as a result of the reduction in employee headcount in research and development related to our 2010 and 2011 restructurings as well as an increase in marketing expenses relating to cabozantinib. These increases were partially offset by a decrease in facility, personnel and stock-based compensation expense as a result of the restructurings mentioned above.

Restructuring expenses for the fourth quarter ended December 31, 2011 were $3.9 million compared to $6.9 million for the comparable period in 2010; and for the year ended December 31, 2011 were $10.1 million compared to $32.7 million for 2010. The restructuring charge for the quarter and year ended December 31, 2011 primarily related to our exit of additional surplus office and lab space in South San Francisco, California partially offset by rental income from subleases entered into during 2011. The 2010 restructuring charges for the fourth quarter related primarily to employee termination benefits and for the year related to both employee termination benefits as well as the exit of surplus office and lab space in South San Francisco, California.

Other income (expense) for the fourth quarter ended December 31, 2011 was ($4.0) million compared to ($3.8) million for the comparable period in 2010; and for the year ended December 31, 2011 were ($12.5) compared to ($1.0) million for 2010. The difference in expense for the quarter primarily related to the gain recognized in 2010 on the sale of our cell factory business. Other income (expense) for the year ended December 31, 2011 includes interest expense of approximately ($16.2) million primarily related to the note purchase agreement we entered into with Deerfield Management Company L.P. in June 2010 offset by the gain of approximately $2.3 million related to the sale of our remaining 19.9% interest in our former German subsidiary TaconicArtemis GmbH (formerly known as Artemis Pharmaceuticals GmbH). Other income (expense) for the year ended December 31, 2010 includes interest expense of approximately ($9.3) million primarily related to our 2008 Deerfield credit facility and GlaxoSmithKline loan, offset by approximately $8.2 million in gains from the sale of our plant trait and cell factory businesses.

Tax (provision) benefit for the fourth quarter ended December 31, 2011 was ($1.3) million compared to zero for the comparable period in 2010; and for the year ended December 31, 2011 was ($1.3) million compared to $0.1 million for 2010. In 2009 and 2010, we recorded an income tax benefit as a result of the enactment of the Housing and Economic Recovery Act of 2008. Approximately $0.6 million of the 2011 provision relates to a downward adjustment of the tax benefit received in 2009 and 2010 after a reevaluation of the qualified expenses in 2011. The balance of $0.7 million relates to a deferred tax revenue adjustment that resulted in a state tax liability.

Net income (loss) for the fourth quarter ended December 31, 2011 was net income of $46.3 million, or $0.35 earnings per share, basic and diluted, compared to a net loss of ($17.9) million, or a net loss per share of ($0.16), basic and diluted, for the comparable period in 2010. For the year ended December 31, 2011, net income was $75.7 million, or $0.60 earnings per share, basic and $0.58 earnings per share, diluted compared to a net loss of ($92.3) million, or a loss of ($0.85) per share, basic and diluted for 2010. The change from a loss to income in 2011 primarily related to the acceleration of deferred revenue recognized in connection with the 2011 unwinding of our 2008 collaboration agreement with Bristol Myers-Squibb and the 2011 termination of our collaboration agreement with Sanofi as described above, in addition to lower operating expenses recorded as a result of our 2010 and 2011 restructurings.

Cash and cash equivalents, marketable securities, long-term investments and restricted cash and investments totaled $283.7 million at December 31, 2011, compared to $256.4 million at December 31, 2010. The 2011 year-end cash balance excludes $27.3 million which we received in January 2012 in connection with the PI3K license agreement with Merck and the agreement to wind-down our discovery collaboration with Sanofi, both of which were signed in December 2011.

Q4 2011 Highlights and Recent Developments

* Reported top-line data for EXAM, a phase 3 pivotal trial in medullary thyroid cancer, which met its primary endpoint of progression-free survival demonstrating a 2.8-fold increase or 11.2 months vs. 4 months in progression-free survival for cabozantinib over placebo with a hazard ratio of 0.28, p<0.0001.
* Reported preliminary data for cabozantinib in patients with metastatic castration-resistant prostate cancer (CRPC) with a daily starting dose of 40 mg. Eleven patients were evaluable at Week 6, of which 10 had bone scan responses. Eight of the 10 responding patients had a confirmation of the bone scan response at week 12 and continue on treatment with a median duration of treatment of 19 weeks. There were no dose reductions or interruptions during the first 12 weeks.
* Reported preliminary data from the non-randomized extension cohort in CRPC. Median best pain reduction from baseline was 46%, and 59% of patients had at least a 30% decrease in average worst pain. Of the 27 patients with average worst pain ?4 and taking narcotics at baseline, 56% decreased their dose by at least 30%, including 26% who discontinued narcotic drugs completely, 15% had a stable dose and only 30% increased narcotic drug usage.
* Reported preliminary data for cabozantinib in women with metastatic breast cancer. In 44 evaluable patients with measurable disease and at least 12 weeks of follow up, of which 14% had a confirmed partial response (PR), 59% had stable disease (SD), and 20% had progressive disease (PD). The Week 12 disease control rate (week 12 SD or PR) was 48%. Ten patients had available bone scans at baseline and at least one post-baseline bone scan and of these, 40% achieved partial resolution of their metastatic bone lesions on bone scan by week 12.
* Initiated a phase 2 investigator-sponsored trial of cabozantinib in women with hormone receptor-positive metastatic breast cancer.
* Signed a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute’s Cancer Therapy Evaluation Program (CTEP).
* Signed an exclusive worldwide license agreement for our PI3K-delta research and development program with Merck and received a $12.0 million payment.
* Initiated the COMET-2 (previously known as the 306 trial) trial, a pivotal trial of cabozantinib vs. mitoxantrone with a pain palliation endpoint.
* Unwound the PI3K discovery collaboration with Sanofi and received a $15.25 million payment.
* Appointed J. Scott Garland as executive vice president and chief commercial officer.
* Held the annual Exelixis R&D day in New York, NY.
* Reported preliminary data for cabozantinib in 25 patients with advanced renal cell carcinoma. Seven of 25 patients (28%) showed a confirmed partial response (PR). Importantly, PRs were observed in heavily pretreated patients. The rate of disease control (PR + SD) at week 16 for all 25 patients is 72%. The Kaplan Meier estimate of median progression-free survival is 14.7 months (95% CI, lower limit 7.3 months – upper limit not reached).

“The data for cabozantinib continues to mature and highlight the broad potential in prostate cancer as well as other significant indications. Prostate cancer, in particular, provides an ideal opportunity to convert the unique clinical profile of cabozantinib into a commercially differentiated product addressing length and quality of patients’ lives,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “Over the last few months we have reported data in four non-CRPC tumor types. Most recently, we reported data in patients with renal cell carcinoma showing a 14.7 month median PFS and a 28 percent response rate in a heavily pre-treated population. We plan to expand the development program for cabozantinib to pursue RCC and other indications in a cost-efficient manner by leveraging our development agreement with the National Cancer Institute and a robust investigator-sponsored trial program.”

Financial Outlook

For the full year 2012, we expect revenues in the range of $40 million to $60 million and operating expenses in the range of $190 million to $220 million. Our cash and cash equivalents, marketable securities, restricted cash and investments and long-term investment balance at the end of 2012 is expected to be at least $200 million which is based on certain assumptions about cash inflows from new business development activities, milestone payments from existing collaborations, and/or potential financing activities, including accessing the capital markets.

Conference Call and Webcast

Exelixis’ management will discuss the company’s financial results for the quarter and year ended December 31, 2011, financial guidance for 2012, and development program and plans for cabozantinib, and also provide a general business update, during a conference call beginning at 2:00 p.m. PST/ 5:00 p.m. EST today, Wednesday, February 8, 2012. To listen to a live webcast of the discussion, visit the Event Calendar page under Investors at www.exelixis.com.

An archived replay of the webcast will be available on the Event Calendar page under Investors at http://www.exelixis.com and via phone until 11:59 p.m. EST on March 8, 2012. Access numbers for the phone replay are: (888) 286-8010 (domestic) and (617) 801-6888 (international); the passcode is 46993799.

About Exelixis

Exelixis, Inc. is a biotechnology company committed to developing small molecule therapies for the treatment of cancer. Exelixis is focusing its proprietary resources and development efforts exclusively on cabozantinib (XL184), its most advanced product candidate, in order to maximize the therapeutic and commercial potential of this compound. Exelixis believes cabozantinib has the potential to be a high-quality, broadly-active, differentiated pharmaceutical product that can make a meaningful difference in the lives of patients. Exelixis has also established a portfolio of other novel compounds that it believes have the potential to address serious unmet medical needs, many of which are being advanced by partners as part of collaborations. For more information, please visit the company’s web site at www.exelixis.com.

Basis of Presentation

Exelixis has adopted a 52- or 53-week fiscal year that ends on the Friday closest to December 31st. For convenience, references in this press release as of and for the fiscal year ended December 30, 2011 are indicated on a calendar year basis, ended December 31, 2011 and references as of and for the fiscal quarters ended December 31, 2010 and December 30, 2011 are indicated as ended December 31, 2010 and 2011, respectively.

Forward-Looking Statements

This press release contains forward-looking statements, including, without limitation, statements related to the continued development and clinical, therapeutic and commercial potential of cabozantinib; Exelixis’ financial outlook for 2012, including expected revenues and operating expenses and 2012 year-end cash and cash equivalents, marketable securities, restricted cash and investments and long-term investments balance; and upcoming data presentations. Words such as “expect,” “plan,” “will,” “believe,” “outlook,” “guidance,” “potential,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Exelixis’ current plans, assumptions, beliefs and expectations. Forward-looking statements involve risks and uncertainties. Exelixis’ actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: risks related to the potential failure of cabozantinib to demonstrate safety and efficacy in clinical testing; Exelixis’ ability to conduct clinical trials of cabozantinib sufficient to achieve a positive completion; the availability of data at the referenced times; the sufficiency of Exelixis’ capital and other resources; the uncertain timing and level of expenses associated with the development of cabozantinib; the uncertainty of the FDA approval process; timely receipt of potential reimbursements, milestones, royalties and profits under Exelixis’ collaborative agreements; Exelixis’ ability to enter into new collaborations; market competition; and changes in economic and business conditions. These and other risk factors are discussed under “Risk Factors” and elsewhere in Exelixis’ quarterly report on Form 10-Q for the quarter ended September 30, 2011 and Exelixis’ other filings with the Securities and Exchange Commission. Exelixis expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Exelixis’ expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Exelixis and the Exelixis logo are registered U.S. trademarks.

Source: Exelixis, Inc.

Contact:
Exelixis, Inc.
Frank Karbe
Chief Financial Officer
650-837-7565
fkarbe@exelixis.com
Charles Butler
Vice President
Corporate Communications
& Investor Relations
650-837-7277
cbutler@exelixis.com

 

 

EXELIXIS, INC.

CONSOLIDATED STATEMENT OF OPERATIONS DATA

(in thousands, except per share data)

(unaudited)

Three Months Ended December 31,

Year Ended

December 31,

2011 2010 2011 2010
Revenues:
Contract $ 15,549 $ 17,358 $ 41,309 $ 61,271
License 77,565 22,715 245,549 96,363
Collaboration reimbursement 195 704 2,778 27,411
Total revenues 93,309 40,777 289,636 185,045
Operating expenses:
Research and development 30,778 42,304 156,836 210,678
General and administrative 7,009 5,662 33,129 33,020
Restructuring charge 3,948 6,920 10,136 32,744
Total operating expenses 41,735 54,886 200,101 276,442
Income (loss) from operations 51,574 (14,109 ) 89,535 (91,397 )
Other income (expense):
Interest income and other, net (16 ) (195 ) 1,462 138
Interest expense (4,010 ) (3,961 ) (16,259 ) (9,340 )
Gain on sale of businesses
44 400 2,254 8,197
Total other income (expense) (3,982 ) (3,756 ) (12,543 ) (1,005 )
Consolidated income (loss) before taxes 47,592 (17,865 ) 76,992 (92,402 )
Income tax benefit (provision) (1,295 ) (1,295 ) 72
Net income (loss) $ 46,297 $ (17,865 ) $ 75,697 $ (92,330 )
Shares used in computing basic income (loss) per share amounts
133,795
108,962
126,018
108,522
Shares used in computing diluted income (loss) per share amounts
133,936
108,962
130,479
108,522
Net income (loss) per share, basic $ 0.35 $ (0.16 ) $
0.60
$ (0.85 )
Net income (loss) per share, diluted $ 0.35 $ (0.16 ) $
0.58
$ (0.85 )

EXELIXIS, INC.

CONSOLIDATED BALANCE SHEET DATA

(in thousands)

December 31, December 31,
2011
2010 (1)
(unaudited)
Cash and cash equivalents, marketable securities and long-term investments (2) $ 283,720 $ 256,377
Working capital $ 136,499 $ (16,455 )
Total assets $ 393,262 $ 360,790
Total stockholders’ equity (deficit) $ 90,632 $ (228,325 )
(1) Derived from the audited consolidated financial statements.
(2) These amounts include restricted cash and investments of $4.2 million and $6.4 million as of December 31, 2011 and 2010, respectively.

 

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THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY!

Disclaimer: Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. CRWENewswire.com publisher and its affiliates and contractors are not registered investment advisers or broker/dealers. Our disclaimer is to be read and fully understood before using our site, reading our newsletter or joining our email list. Release of Liability: Through use of this website viewing or using, you agree to hold CRWENewswire.com report and Crown Equity Holdings Inc. CRWE, its operators, shareholders, employees and/or contractors harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damages (monetary or otherwise) that you may occur. (Read more at http://crwenewswire.com/disclaimer). Rule 17B requires disclosure of payment for investor relations. Crown Equity Holdings Inc. (CRWE.OB) is a media-advertisement and newswire company. Crown Equity Holdings Inc. (CRWE.OB), in some cases, provides media advertising and public awareness for both public and private companies, as well as disseminating news. As such, in some cases, when Crown Equity Holdings Inc. (CRWE.OB) advertises for a particular client, Crown Equity Holdings Inc. (CRWE.OB) charges an advertising fee which it must disclose under 17B. The fee may be in cash, in free trading stock or in restricted stock. Crown Equity Holdings Inc. (CRWE.OB), if paid in stock, can and may sell those securities during the advertising period.

 
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Astrogenetix and NASA Sign Agreement to Continue Developing Medicines in Space to Save Lives on Earth

Wednesday, February 8th, 2012

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AUSTIN, Texas, Feb. 8, 2012 (CRWENEWSWIRE) — Astrogenetix Corporation, a subsidiary of Astrotech Corporation (Nasdaq:ASTC), has entered into a Space Act Agreement (SAA) with NASA, (National Aeronautics and Space Administration). This SAA commits to providing the critical resources needed to continue utilizing the International Space Station (ISS) and to further the development of important on-orbit microgravity vaccines and therapeutic drug experiments.

Astrogenetix entered into a similar SAA in 2009 resulting in 12 successful missions on the Space Shuttle that led to the discovery of potential vaccine targets for both salmonella and MRSA. This experience clearly identified that the most important part of the discovery process is the repeated frequency of access to microgravity. The new SAA reflects this important priority and NASA has committed to provide a minimum of 28 missions between 2013 and 2016.

Astrogenetix has been working with NASA for over three years to put the necessary agreements in place that would pave the way for the continued commercial utilization of the ISS. It is very clear that NASA shares in our commitment to utilize this most unique of all laboratories and continue with the very promising progress that we have already shown to be possible,” explained Astrogenetix Chairman, Thomas B. Pickens, III.

“As of December 2011, NASA has completed the construction of the International Space Station and with signing of this landmark SAA, the ISS is now realizing its vision of becoming a fully operational National Laboratory. The Agency is very committed to the commercial success of companies like Astrogenetix and we look forward to supporting this very important work,” said Mark Urhan, Director ISS, NASA.

About Astrogenetix, Incorporated

A subsidiary of Astrotech Corporation, Astrogenetix is a biotechnology company formed to commercialize biotechnology products processed in the unique environment of microgravity. The Company offers a turn-key platform for pre-flight sample preparation, flight hardware, mission planning and operations, crew training and certification processes needed within the highly regulated and complex environment of manned space flight.

The statements in this document may contain forward-looking statements that are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks, trends, and uncertainties that could cause actual results to be materially different from the forward-looking statement. These factors include, but are not limited to, continued government support and funding for key space programs, product performance and market acceptance of products and services, as well as other risk factors and business considerations described in the company’s Securities & Exchange Commission filings including the annual report on Form 10-K. Any forward-looking statements in this document should be evaluated in light of these important risk factors. The Company assumes no obligation to update these forward-looking statements.

Source: Astrogenetix, Incorporated

Contact:

John Porter
Chief Executive Officer Astrogenetix, Inc.
512.485.9530
info@astrogenetix.com

 

 

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THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY!

Disclaimer: Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. CRWENewswire.com publisher and its affiliates and contractors are not registered investment advisers or broker/dealers. Our disclaimer is to be read and fully understood before using our site, reading our newsletter or joining our email list. Release of Liability: Through use of this website viewing or using, you agree to hold CRWENewswire.com report and Crown Equity Holdings Inc. CRWE, its operators, shareholders, employees and/or contractors harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damages (monetary or otherwise) that you may occur. (Read more at http://crwenewswire.com/disclaimer). Rule 17B requires disclosure of payment for investor relations. Crown Equity Holdings Inc. (CRWE.OB) is a media-advertisement and newswire company. Crown Equity Holdings Inc. (CRWE.OB), in some cases, provides media advertising and public awareness for both public and private companies, as well as disseminating news. As such, in some cases, when Crown Equity Holdings Inc. (CRWE.OB) advertises for a particular client, Crown Equity Holdings Inc. (CRWE.OB) charges an advertising fee which it must disclose under 17B. The fee may be in cash, in free trading stock or in restricted stock. Crown Equity Holdings Inc. (CRWE.OB), if paid in stock, can and may sell those securities during the advertising period.

 
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Threshold Pharmaceuticals and Merck KGaA Announce Global Agreement to Co-Develop and Commercialize Phase 3 Hypoxia-Targeted Drug TH-302

Friday, February 3rd, 2012

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SOUTH SAN FRANCISCO, CA–(CRWENEWSWIRE) -02/03/12 - Threshold Pharmaceuticals, Inc (NASDAQ:THLD)

* Threshold to receive $25 million upfront, plus further potential milestones and royalties
* Deal provides Threshold option to co-commercialize in the United States
* Phase 3 trial in soft tissue sarcoma on-going and randomized Phase II trial in patients with pancreatic cancer expected to report in February 2012

Threshold Pharmaceuticals, Inc. today announced that a global agreement was signed with Merck KGaA, Darmstadt, Germany, to co-develop and commercialize TH-302, Threshold’s small molecule hypoxia-targeted drug. TH-302 is currently being investigated in a global Phase 3 clinical trial in patients with soft tissue sarcoma, a randomized Phase 2 trial in patients with advanced pancreatic cancer from which top-line results are expected in February, as well as additional clinical studies in other solid tumors and hematological malignancies.

Under the terms of the agreement, Merck will receive co-development rights, exclusive global commercialization rights and will provide Threshold an option to co-commercialize the therapeutic in the United States. In exchange, Threshold will receive an upfront payment of $25 million and could receive up to $35 million in additional development milestones during 2012. Threshold is also eligible to receive a $20 million milestone payment based on positive results from its randomized Phase 2 trial in pancreatic cancer. Total potential milestone payments are $525 million, comprised of $280 million in regulatory and development milestones and $245 million in sales-based milestones.

In the United States, Threshold will have primary responsibility for development of TH-302 in the soft tissue sarcoma indication. Threshold and Merck KGaA will jointly develop TH-302 in all other cancer indications being pursued. Merck KGaA will pay 70% of worldwide development costs for TH-302.

Subject to FDA approval in the United States, Merck KGaA will initially be responsible for commercialization of TH-302 with Threshold receiving a tiered, double-digit royalty on sales. Under the royalty-bearing portion of the agreement, Threshold retains the option to co-promote TH-302 in the United States. Additionally, Threshold retains the option to co-commercialize TH-302 allowing the company to participate in up to 50% of the profits in the United States based on certain revenue tiers. Outside of the United States, Merck KGaA will be solely responsible for the commercialization of TH-302 with Threshold receiving a tiered, double-digit royalty on sales in these territories.

“The addition of TH-302 to our pipeline provides an important opportunity in several different tumor types to expand our oncology development program,” said Susan Jane Herbert, Head of Global Business Development and Strategy, Merck Serono. “Given the fact that pancreatic cancer is a very difficult to treat indication, successful Phase II results could represent an important upside for our company.”

“We are excited by the new resources that our partnership is going to bring to the development of TH-302 and the expertise in clinical development and commercialization that Merck will contribute to this program,” said Barry Selick, President and CEO of Threshold. “This collaboration provides Threshold a strong and committed partner with a shared vision for TH-302.”

Morrison & Foerster LLP acted as legal counsel for Threshold in this transaction.

About TH-302
TH-302 is a hypoxia-targeted drug that is thought to be activated under tumor hypoxic conditions, a hallmark for many cancer indications. Areas of low oxygen levels (hypoxia) within tissues are common in many solid tumors due to insufficient blood vessel growth. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be extremely hypoxic.

TH-302 has been investigated in over 550 patients in Phase I/II clinical trials to date in a broad spectrum of tumor types, both as a monotherapy and in combination with chemotherapy treatments and other targeted cancer drugs.

Threshold has several ongoing clinical trials including, but not limited to, a controlled Phase 2 trial of TH-302 in combination with gemcitabine versus gemcitabine alone in patients with advanced pancreatic cancer and a Phase 3 study evaluating TH-302 in combination with doxorubicin versus doxorubicin alone in patients with soft tissue sarcoma.

TH-302 development in soft tissue sarcoma

A Phase 3 trial of TH-302 in patients with first-line advanced soft tissue sarcoma (STS) was initiated in September 2011, based on results from a Phase 1/2 trial investigating its use in combination with the chemotherapeutic doxorubicin. This randomized, multi-center Phase 3 trial will investigate the use of TH-302 plus doxorubicin compared with doxorubicin alone. The primary efficacy endpoint is overall survival. The study is conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration. It is being run in partnership with the Sarcoma Alliance for Research through Collaboration (SARC) and aims to enroll 450 patients with metastatic or locally advanced unresectable STS.

TH-302 development in pancreatic cancer

Results from a randomized, controlled, multi-center Phase 2 trial of TH-302 in patients with first-line pancreatic cancer are expected to be announced in February 2012. This trial of 214 previously untreated patients with locally advanced unresectable or metastatic pancreatic adenocarcinoma started in June 2010, and completed enrollment in June 2011. Two different doses of TH-302 in combination with the chemotherapeutic gemcitabine were compared to gemcitabine alone, with progression free survival (PFS) as the primary endpoint.

Soft tissue sarcoma

Sarcomas are a group of aggressive cancers of connective tissue of the body for which there are currently limited treatment options. Soft tissue sarcomas are treated with surgery, chemotherapy and radiation. Doxorubicin as a single agent or in combination with ifosfamide are the most commonly used chemotherapeutic regimens in patients with advanced soft tissue sarcoma, but response rates are generally low and toxicity can be significant. The American Cancer Society estimates that 10,980 people were diagnosed with a soft tissue sarcoma in the United States in 2011, and approximately 3,920 people died from the disease. In Europe, it is estimated that more than 32,000 people were diagnosed with soft tissue sarcoma in 2010.

Pancreatic cancer

Pancreatic cancer is a malignant neoplasm of the pancreas with current treatment options including surgery, radiotherapy and chemotherapy. Gemcitabine as a single agent or in combination with other treatments is the most commonly used chemotherapeutic agent in patients with advanced pancreatic cancer. It is estimated that approximately 279,000 cases of pancreatic cancer were diagnosed worldwide in 2008. Pancreatic cancer is the fourth most common cause of cancer death both in the United States and internationally. The American Cancer Society estimates that 44,030 people were diagnosed with pancreatic cancer in the United States in 2011, and approximately 37,660 people died from the disease.

About Merck Serono

Merck Serono is the biopharmaceutical division of Merck KGaA, Darmstadt, Germany, a global pharmaceutical and chemical company. Headquartered in Geneva, Switzerland, Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. In the United States and Canada, EMD Serono operates as a separately incorporated affiliate of Merck Serono.

Merck Serono has leading brands serving patients with cancer (Erbitux®, cetuximab), multiple sclerosis (Rebif®, interferon beta-1a), infertility (Gonal-f®, follitropin alfa), endocrine and metabolic disorders (Saizen® and Serostim®, somatropin), (Kuvan®, sapropterin dihydrochloride), (Egrifta®, tesamorelin), as well as cardiometabolic diseases (Glucophage®, metformin), (Concor®, bisoprolol), (Euthyrox®, levothyroxine). Not all products are available in all markets.

With an annual R&D expenditure of over EUR 1bn, Merck Serono is committed to growing its business in specialist-focused therapeutic areas including neurodegenerative diseases, oncology, fertility and endocrinology, as well as new areas potentially arising out of research and development in rheumatology.

About Merck

Merck is a global pharmaceutical and chemical company with total revenues of EUR 9.3 billion in 2010, a history that began in 1668, and a future shaped by more than 40,000 employees in 67 countries. Its success is characterized by innovations from entrepreneurial employees. Merck’s operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

For more information, please visit www.merckserono.com or www.merckgroup.com

About Threshold Pharmaceuticals

Threshold is a biotechnology company focused on the discovery and development of drugs targeting tumor hypoxia, the low oxygen condition found in microenvironments of most solid tumors as well as the bone marrows of patients with some hematologic malignancies. For additional information, please visit the company’s website: www.thresholdpharm.com.

Forward-Looking Statements
Except for statements of historical fact, the statements in this press release are forward-looking statements, including statements regarding potential payments from Merck to Threshold, development and commercialization plans for TH-302, TH-302’s potential ability to treat soft tissue sarcoma and pancreatic cancer, planned clinical trials and anticipated results, and potential therapeutic uses and benefits of TH-302. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, Threshold’s ability to accomplish milestones that will trigger payments, Threshold’s and Merck’s ability to enroll or complete its anticipated clinical trials, the time and expense required to conduct such clinical trials and analyze data, whether such trials confirm results from earlier trials and preclinical studies, potential side effects associated with TH-302, issues arising in the regulatory or manufacturing process and the results of such clinical trials (including product safety issues and efficacy results), and Threshold’s and Merck’s ability to obtain regulatory approval for the marketing of TH-302. Further information regarding these and other risks is included under the heading “Risk Factors” in Threshold’s Quarterly Report on Form 10-Q, which has been filed with the Securities Exchange Commission on November 3, 2011 and is available from the SEC’s website (www.sec.gov) and on our website (www.thresholdpharm.com) under the heading “Investors.” We undertake no duty to update any forward-looking statement made in this news release.

Source: Threshold Pharmaceuticals, Inc.

Contact:

Joel A. Fernandes
Threshold Pharmaceuticals, Inc.
650.474.8273
IR@thresholdpharm.com

 

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Disclaimer: Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. CRWENewswire.com publisher and its affiliates and contractors are not registered investment advisers or broker/dealers. Our disclaimer is to be read and fully understood before using our site, reading our newsletter or joining our email list. Release of Liability: Through use of this website viewing or using, you agree to hold CRWENewswire.com report and Crown Equity Holdings Inc. CRWE, its operators, shareholders, employees and/or contractors harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damages (monetary or otherwise) that you may occur. (Read more at http://crwenewswire.com/disclaimer). Rule 17B requires disclosure of payment for investor relations. Crown Equity Holdings Inc. (CRWE.OB) is a media-advertisement and newswire company. Crown Equity Holdings Inc. (CRWE.OB), in some cases, provides media advertising and public awareness for both public and private companies, as well as disseminating news. As such, in some cases, when Crown Equity Holdings Inc. (CRWE.OB) advertises for a particular client, Crown Equity Holdings Inc. (CRWE.OB) charges an advertising fee which it must disclose under 17B. The fee may be in cash, in free trading stock or in restricted stock. Crown Equity Holdings Inc. (CRWE.OB), if paid in stock, can and may sell those securities during the advertising period.

 
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1st Detect Announces the Delivery of Pre-Production Mini-Mass Spectrometers to Select Customers

Friday, January 27th, 2012

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AUSTIN, Texas, Jan. 26, 2012 (CRWENEWSWIRE) — 1st Detect Corporation, a subsidiary of Astrotech Corporation (Nasdaq:ASTC), is pleased to announce the delivery of pre-production mini-mass spectrometers to select customers for evaluation.

“After years of development, we are very proud to have leading analytical equipment vendors evaluating our mini-mass spectrometer,” said Thomas B. Pickens III, Chairman of 1st Detect. “We believe 1st Detect’s mini-mass spectrometer technology represents a breakthrough by delivering performance comparable to large laboratory mass spectrometers in a small and affordable instrument that can reach many applications that were never before possible. This is a major development milestone as 1st Detect is now transforming from its R&D phase to a market driven, commercially focused business enterprise.”

The 1st Detect mini-mass spectrometer technology is capable of detecting trace levels of volatile compounds and has been developed for the security, industrial and research laboratory markets. We believe the technology platform is ideally suited for these applications, having been designed to provide highly accurate and rapid analysis and detection of very low concentrations of chemical compounds.

“I am extremely excited about the technology breakthroughs the 1st Detect team has innovated,” added Mr. Pickens. “Our talented R&D team has spent years developing what we consider to be the best performing miniature mass spectrometer available. This product fulfills an unmet need in the chemical detection market by providing a true mini-mass spectrometer that is superior to the widely adopted ion mobility spectrometry (IMS) products.”

The 1st Detect proprietary mini-mass spectrometry technology provides a broad and versatile platform that we plan to integrate with follow-on products optimized for the security and industrial markets including airports, border crossings, law enforcement, military uses, agricultural processing, refineries, chemical plants, pharmaceutical manufacturing, process control, water and wastewater treatment facilities.

About 1st Detect Corporation

1st Detect Corporation was formed by Astrotech Corporation (Nasdaq:ASTC - News) to develop and commercialize miniature-mass spectrometer technology first developed under an agreement with NASA for use on the International Space Station (ISS). 1st Detect offers what we believe is a breakthrough mini-mass spectrometry technology that fills an unmet need by being highly accurate, rapid, lightweight, durable and cost-effective. For more information on 1st Detect Corporation, please visit www.1stDetect.com.

About Astrotech Corporation

Astrotech is one of the first space commerce companies and remains a strong entrepreneurial force in the aerospace industry. We are leaders in identifying, developing and marketing space technology for commercial use. Our ASO business unit serves our government and commercial satellite and spacecraft customers with pre-launch services on the eastern and western range. 1st Detect Corporation is developing what we believe is a breakthrough mini-mass spectrometer, while Astrogenetix, Inc. is a biotechnology company utilizing microgravity as a research platform for drug discovery and development.

This press release contains forward-looking statements that are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks, trends, and uncertainties that could cause actual results to be materially different from the forward-looking statement. These factors include, but are not limited to, continued government support and funding for key space programs, the ability to expand ASO, the availability of capital for reinvestment in growth initiatives, the continued development of technology solutions, product performance and market acceptance of products and services, as well as other risk factors and business considerations described in the Company’s Securities and Exchange Commission filings including the annual report on Form 10-K. Any forward-looking statements in this document should be evaluated in light of these important risk factors. The Company assumes no obligation to update these forward-looking statements.

Source: Astrotech Corporation

Contact:

FOR MORE INFORMATION:
James Wylde
Vice President, Business Development
1st Detect Corporation
972-617-9939
jwylde@1stDetect.com

 

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THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY!

Disclaimer: Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. CRWENewswire.com publisher and its affiliates and contractors are not registered investment advisers or broker/dealers. Our disclaimer is to be read and fully understood before using our site, reading our newsletter or joining our email list. Release of Liability: Through use of this website viewing or using, you agree to hold CRWENewswire.com report and Crown Equity Holdings Inc. CRWE, its operators, shareholders, employees and/or contractors harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damages (monetary or otherwise) that you may occur. (Read more at http://crwenewswire.com/disclaimer). Rule 17B requires disclosure of payment for investor relations. Crown Equity Holdings Inc. (CRWE.OB) is a media-advertisement and newswire company. Crown Equity Holdings Inc. (CRWE.OB), in some cases, provides media advertising and public awareness for both public and private companies, as well as disseminating news. As such, in some cases, when Crown Equity Holdings Inc. (CRWE.OB) advertises for a particular client, Crown Equity Holdings Inc. (CRWE.OB) charges an advertising fee which it must disclose under 17B. The fee may be in cash, in free trading stock or in restricted stock. Crown Equity Holdings Inc. (CRWE.OB), if paid in stock, can and may sell those securities during the advertising period.

 
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