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MYGN. U.S Court of Appeals Upholds Myriad's Gene Patents
Court Finds Composition of Matter Claims for BRCA 1 and BRCA 2 Patentable
http://finance.yahoo.com/news/u-court-appeals-upholds-myriads-181942271.html
IDIX - Idenix Provides Update on IDX184 Clinical Development Program
Date : 08/16/2012 @ 8:00AM
Source : GlobeNewswire Inc.
Stock : Idenix Pharmaceuticals, Inc. (MM) (IDIX)
Quote : 8.31 0.0 (0.00%) @ 8:56AM
IDIX now trading $5.00 pre-market ... Ouch 
Idenix Provides Update on IDX184 Clinical Development Program
IDX184 has been placed on partial clinical hold by FDA
Management to host a conference call webcast today at 8:30 am ET
Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that the Company received verbal notice from the U.S. Food and Drug Administration (FDA) that a partial clinical hold has been placed on IDX184, the Company's nucleotide polymerase inhibitor under development for the treatment of hepatitis C virus (HCV).
As a result of the recent occurrence of a serious cardiac-related adverse event encountered with a competitor's nucleotide polymerase inhibitor for the treatment of HCV, the FDA has expressed an interest in further reviewing the safety of IDX184 and has placed IDX184 on partial clinical hold. In previous clinical trials as well as the ongoing phase IIb clinical trial of IDX184 in combination with pegylated interferon and ribavirin (PegIFN/RBV), there has been no evidence to date of cardiotoxicity in patients dosed with IDX184 with PegIFN/RBV beyond that seen with PegIFN/RBV alone. There are currently no patients receiving IDX184 worldwide.
The FDA has requested additional data on patients treated with IDX184. Patient safety is our main concern and Idenix will immediately begin work to comply with the FDA request and expects to submit these data to the FDA in the coming weeks. The Company intends to have an ongoing discussion with the FDA following the submission of this data.
ABOUT IDX184
IDX184 is an unpartnered, novel, liver-targeted nucleotide prodrug of 2'-methyl guanosine, which includes Idenix's proprietary liver-targeting technology. This technology enables the delivery of nucleoside monophosphate to the liver, leading to the formation of high levels of nucleoside triphosphate, potentially maximizing drug efficacy and limiting systemic side effects with low, once-daily dosing. The Company reported interim data in June 2012 for the first cohort of 31 patients from an ongoing phase IIb clinical trial of IDX184 in combination with PegIFN/RBV. Of the patients who achieved an extended rapid virologic response (undetectable levels of virus at 4 weeks and 12 weeks) and completed an additional 12 weeks of PegIFN/RBV (n=9), 100% of patients (4/4) in the 100 mg arm and 80% of patients (4/5) in the 50 mg arm achieved a sustained virologic response four weeks after the completion of treatment (SVR4).
In July 2012, an independent data safety monitoring board reviewed the safety data for this study and confirmed that the side effect profile of IDX184 combined with PegIFN/RBV is consistent with that of PegIFN/RBV alone.
ABOUT PARTIAL CLINICAL HOLD
A partial clinical hold is a delay or suspension of only part of the clinical work requested under the investigational new drug (IND) application (e.g., a specific protocol or part of a protocol is not allowed to proceed; however, other protocols or parts of the protocol are allowed to proceed under the IND). Under the partial clinical hold, Idenix cannot enroll patients into additional clinical trials until agreement is reached with the FDA on the next clinical trial design.
ABOUT IDENIX
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical Company engaged in the discovery and development of drugs for the treatment of human viral diseases. Idenix's current focus is on the treatment of patients with hepatitis C infection. For further information about Idenix, please refer to www.idenix.com.
CONFERENCE CALL AND WEBCAST INFORMATION
Idenix will hold a conference call today at 8:30 a.m. ET. To access the call, please dial (877) 640-9809 (U.S./Canada) or (914) 495-8528 (International) and enter passcode 22005490. A slide presentation will accompany the conference call and can be accessed on the Investor section of the Idenix website at www.idenix.com. Please log on approximately 10 minutes prior to the start of the call to ensure adequate time for any downloads that may be necessary.
A replay of the conference call and webcast will be available until August 27, 2012, by dialing (855) 859-2056 (U.S./Canada) or (404) 537-3406 (International) and enter the passcode 22005490.
FORWARD-LOOKING STATEMENTS
This press release contains "forward-looking statements" for purposes of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995, including but not limited to the statements regarding the Company's future business and financial performance. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words "expect," "plans," "anticipates," "intends," "will," and similar expressions are also intended to identify forward-looking statements, as are expressed or implied statements with respect to the Company's potential pipeline candidates, including any expressed or implied statements regarding the efficacy and safety of IDX184 or any other drug candidate; the successful development of novel combinations of direct-acting antivirals for the treatment of HCV; and the likelihood and success of any future clinical trials involving IDX184 or our other drug candidates. Actual results may differ materially from those indicated by such forward-looking statements as a result of risks and uncertainties, including but not limited to the following: there can be no guarantees that the Company will advance any clinical product candidate or other component of its potential pipeline to the clinic, to the regulatory process or to commercialization; management's expectations could be affected by unexpected regulatory actions or delays; uncertainties relating to, or unsuccessful results of, clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; changes in the Company's business plan or objectives; competition in general; and the Company's ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. These and other risks which may impact management's expectations are described in greater detail under the heading "Risk Factors" in the Company's annual report on Form 10-K for the year ended December 31, 2011 and the quarterly report on Form 10-Q for the quarter ended June 30, 2012, each as filed with the Securities and Exchange Commission (SEC) and in any subsequent periodic or current report that the Company files with the SEC.
All forward-looking statements reflect the Company's estimates only as of the date of this release (unless another date is indicated) and should not be relied upon as reflecting the Company's views, expectations or beliefs at any date subsequent to the date of this release. While Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, even if the Company's estimates change.
CONTACT: Idenix Pharmaceuticals Contacts:
Kelly Barry (617) 995-9033 (media)
Daniella Beckman (617) 224-4471 (investors)
CAT. Caterpillar, Striking Workers in Joliet, Ill., Reach Tentative Deal
http://www.newsdaily.com/stories/bre87e0xb-us-caterpillar-joliet/
NAVB chart.
Good post PS !
Tomorrow should be an interesting day 
MYGN. results for its fourth quarter and fiscal year ending June 30, 2012. Revenue for the fourth fiscal quarter increased 24 percent over the same period in the prior year to $133.0 million and resulted in fiscal year 2012 revenue of $496.0 million, an increase of 23 percent over fiscal 2011. Fourth fiscal quarter diluted earnings per share were $0.34, an increase of 14 percent over the same period of the prior year. Fiscal 2012 diluted earnings per share equaled $1.30, an increase of 18 percent year-over-year.
http://finance.yahoo.com/news/myriad-genetics-reports-fourth-quarter-200500412.html
"Myriad achieved record revenue and operating profits last year," said Peter D. Meldrum, President and Chief Executive Officer of Myriad Genetics, Inc. "We are committed to building on this strong performance in fiscal 2013 as we continue to execute on our strategic directives: to grow existing tests and markets, to expand internationally and to launch new tests, including companion diagnostics, across a diverse set of major disease indications."
Fourth Fiscal Quarter 2012 Results
Molecular diagnostic testing revenue in the fourth fiscal quarter equaled $127.5 million, an increase of 21 percent compared to the prior year period. Revenue from the Oncology segment equaled $87.0 million, an increase of 16 percent over the fourth fiscal quarter of 2011. Women's Health revenue totaled $40.5 million, an increase of 32 percent over the same period in the prior year.
Revenue from the BRACAnalysis(R) test, which represented 81.7 percent of total revenue in the fourth quarter, was $108.7 million, a 17 percent increase over the same period of the prior year.
Revenue from the COLARIS(R) and COLARIS AP(R) tests, which represented 8.7 percent of total revenue during the quarter, was $11.5 million, an increase of 51 percent compared to the same fiscal quarter of the prior year.
Myriad's other molecular diagnostic tests contributed $7.3 million to fourth quarter revenue, or 5.5 percent of total revenue, an increase of 47 percent over the same period in the prior year.
Companion diagnostic service revenue in the fourth fiscal quarter equaled $5.5 million and represented 4.1 percent of total company revenue. Revenue in the fourth fiscal quarter of 2011 equaled $2.0 million as the Company acquired this business in May 2011.
Operating income was $47.3 million, an increase of 13 percent from the prior year period. This level of operating income included the impact of increased investment in research and development to support existing molecular diagnostic tests and future products, as well as investments for international expansion and Myriad RBM.
Net income for the fourth fiscal quarter was $29.1 million, an increase of 12 percent over the $26.0 million reported in same period of the prior year.
During the quarter the Company repurchased 2.6 million shares or $61.0 million of its common stock, resulting in an average price of $23.70, under its previously announced stock repurchase program. Fourth fiscal quarter diluted weighted average shares outstanding were 86.3 million as compared to 88.1 million in the same period of the prior year.
Days sales outstanding for Myriad's accounts receivable improved to 41 days, compared with 43 days in the same period of the prior year and bad debt expense was 5.5 percent of total revenue.
Fiscal Year 2012 Results
Fiscal 2012 molecular diagnostic testing revenue equaled $472.4 million, an increase of 18 percent compared to the prior year. Revenue from the Oncology segment equaled $327.6 million, an increase of 16 percent over fiscal 2011. Women's Health revenue totaled $144.8 million, an increase of 24 percent over the prior year.
Revenue from the BRACAnalysis test was $405.5 million, an increase of 15 percent over the prior year.
Revenue from the COLARIS and COLARIS AP tests was $43.3 million, an increase of 48 percent compared to the prior year.
Myriad's other molecular diagnostic tests contributed $23.6 million to fiscal 2012 revenue, an increase of 32 percent over the prior year.
Companion diagnostic service revenue in the fiscal 2012 equaled $23.6 million. Revenue in fiscal 2011 equaled $2.0 million as the Company acquired this business in May 2011.
Operating income was $180.3 million, an increase of 14 percent from the prior year. Investment in research and development increased 54 percent versus the prior year and investments in the Company's international expansion and Myriad RBM lead to a 23 percent increase in sales, general and administrative expense.
Net income for the fiscal year was $112.2 million, an increase of 11 percent over the $100.7 million reported in the prior year.
During the fiscal year the Company repurchased 5.7 million shares or $128.5 million of its common stock, resulting in an average price of $22.59, under its previously announced stock repurchase program. Diluted weighted average shares outstanding were 86.5 million as compared to 91.7 million in the prior year.
The Company ended the fiscal year with $454.2 million in cash, cash equivalents and marketable investment securities. The Company has no debt or other restrictions on its cash.
Business Highlights of Fiscal Year 2012
Entered into a loan and acquisition option agreement with Crescendo Bioscience, under which Myriad made a $25 million strategic debt investment in Crescendo to secure an exclusive, three-year option to acquire the company. The potential acquisition of Crescendo Bioscience, if completed, would expand the Company's portfolio of molecular diagnostic products to include products for autoimmune disorders, such as rheumatoid arthritis.
Established subsidiaries and sales offices in Germany, France, Spain, Italy and Switzerland, as well as laboratory operations in Germany.
Published a study in the British Journal of Cancer which highlighted the ability of the Company's Prolaris(R) test to significantly predict prostate cancer aggressiveness and consequent death from the disease.
Presented a study at the 27th Annual EAU Congress, and the 2012 Genitourinary Cancers Symposium, which concluded that the Company's Prolaris test demonstrated significant and unique prognostic ability in men who had undergone radical prostatectomy and accurately predicted their elevated risk for prostate cancer recurrence.
Presented a study at the 2012 ASCO Annual Meeting that demonstrated that the Company's lung cancer prognostic test significantly predicted cancer-specific death in early stage adenocarcinoma lung cancer patients.
Acquired an exclusive license to intellectual property covering the analysis of the RAD51C gene for risk of hereditary breast and ovarian cancer.
Entered into companion diagnostic agreements with Cephalon Inc., a subsidiary of Teva Pharmaceutical Industries Ltd., and Pharma Mar to conduct companion diagnostic testing for their clinical trials.
Presented a study at the San Antonio Breast Cancer Symposium which demonstrated that the BRACAnalysis test is a cost-effective intervention for a much larger group of unaffected women than current guidelines would suggest.
Fiscal Year 2013 Outlook
The Company expects fiscal year 2013 total revenue of $550 million to $565 million and diluted earnings per share of $1.44 to $1.48. These projections are forward looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The Company will provide further detail on its business outlook during the conference call it is holding today to discuss its fiscal results for the fourth fiscal quarter and fiscal year 2012 financial results.
Resting side-long. COBR. (no mod). 
per 10-Q: 8/13/12
Net earnings for the current quarter improved $385,000, or $.06 per share, from 2011’s second quarter. For the three months ending June 30, 2012 the Company reported net earnings of $902,000, or $.14 per share, compared to earnings of $517,000, or $.08 per share, for the comparable prior year period.
Investor Relations.
http://phx.corporate-ir.net/phoenix.zhtml?c=87273&p=irol-IRHome
NFLX ended up to be a sweet play & still is (imo)
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