Three NASDAQ Stocks on the Move in the News: INHX, IDIX, and TNGN – Beacon Equity Research
Inhibitex, Inc. (NASDAQ:INHX) has traded as high as $24.08 during today’s trading session and last traded at $23.87 for a gain of 141.84% from Friday’s close!! I hope you were paying attention to my last alert on Inhibitex when it was still trading at $8.85! INHX shares have traded as high as $16.49 over the last 52 weeks and the stock is currently 44.75% over that high. Get my next ALERT 100% FREE
Bristol-Myers Squibb Company (NYSE:BMY) and Inhibitex, Inc. announced Saturday that the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire Inhibitex for $26.00 per share in cash pursuant to a cash tender offer and second step merger. The transaction, with an aggregate purchase price of approximately $2.5 billion, has been approved by the boards of directors of both companies. The board of directors of Inhibitex has agreed to recommend that Inhibitex’s shareholders tender their shares in the tender offer. In addition, shareholders with beneficial ownership of approximately 17% of Inhibitex’s common stock have entered into agreements with Bristol-Myers Squibb to support the transaction and to tender their shares in the tender offer.
Inhibitex is a clinical-stage biopharmaceutical company dedicated to the development of innovative products that can treat or prevent serious infections, whose primary focus is on the development of nucleotide/nucleoside analogs for the treatment of hepatitis C virus (HCV). Its lead HCV asset is INX-189, an oral nucleotide polymerase (NS5B) inhibitor in Phase II development that has exhibited potent antiviral activity, a high barrier to resistance and pan-genotypic coverage. Nucleotides/nucleosides are emerging as an important class of antivirals that may play a critical role as the backbone of future direct-acting antiviral-only combination approaches to HCV treatment.“The acquisition of Inhibitex builds on Bristol-Myers Squibb’s long history of discovering, developing and delivering innovative new medicines in virology and enriches our portfolio of investigational medicines for hepatitis C,” said Lamberto Andreotti, chief executive officer, Bristol-Myers Squibb. “There is significant unmet medical need in hepatitis C. This acquisition represents an important investment in the long-term growth of the company.”
“This transaction puts INX-189 and the Company’s other infectious disease assets in the hands of an organization that can more optimally develop them and which believes as strongly as we do in INX-189’s potential in the treatment of chronic HCV,” said Russell Plumb, President and Chief Executive Officer of Inhibitex. “Bristol-Myers Squibb’s expertise in antiviral drug development, and its existing complementary portfolio, will assure that the potential of INX-189 is realized as part of future oral combination therapies for millions of patients in need around the world.”
“Bristol-Myers Squibb continues to drive advances in the field of hepatitis C research and development through internal development and selective partnerships,” said Elliott Sigal, M.D., Ph.D., executive vice president, chief scientific officer and president, R&D, Bristol-Myers Squibb. “The addition of Inhibitex’s nucleotide polymerase inhibitor to our own promising portfolio, which includes other direct-acting antivirals, brings additional options to develop all-oral regimens with better cure rates, shorter duration of therapy and lower toxicity than the current standard of care.”
The transaction is expected to be dilutive to earnings for Bristol-Myers Squibb through 2016, with an expected impact on earnings per share of approximately $0.04 in 2012 and approximately $0.05 in 2013.
Under the terms of the definitive agreement, Bristol-Myers Squibb will commence a cash tender offer to purchase all of the outstanding shares of Inhibitex’s common stock for $26.00 per share. The closing of the tender offer is subject to customary terms and conditions, including the tender of a number of shares that constitutes at least a majority of Inhibitex’s outstanding shares of common stock (on a fully diluted basis) and expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. The agreement also provides for the parties to effect, subject to customary conditions, a merger to be completed following the completion of the tender offer which would result in all shares not tendered in the tender offer being converted into the right to receive $26.00 per share in cash. The merger agreement contains a provision under which Inhibitex has agreed not to solicit any competing offers for the company. Bristol-Myers Squibb will finance the acquisition from its existing cash resources. The companies expect the tender offer to close approximately thirty days after commencement of the tender offer.
Citi is serving as financial advisor to Bristol-Myers Squibb in connection with the acquisition and Kirkland & Ellis LLP is its legal advisor. Credit Suisse Securities (USA) LLC is serving as financial advisor to Inhibitex in connection with the acquisition and Dechert LLP is its legal advisor.
Idenix Pharmaceuticals, Inc. (NASDAQ:IDIX) has traded as high as $10.39 during today’s trading session and last traded at $9.33 for a gain of 32.34% from Friday’s close. IDIX shares have traded as high as $8.51 over the last 52 weeks and the stock is currently 9.63% over that high. Get my next ALERT 100% FREE
Idenix, a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced interim data from a 12-week phase IIb clinical trial of IDX184, the Company's lead product candidate for the treatment of hepatitis C virus (HCV) infection. IDX184, a pan-genotypic oral nucleotide polymerase inhibitor, has demonstrated a high barrier to resistance in vitro and potent antiviral activity in both preclinical and clinical studies.
IDX184 Phase IIb Study Design
In July 2011, the Company initiated enrollment of treatment-naive genotype 1 HCV-infected patients into a randomized, double-blind, parallel group phase IIb clinical trial of IDX184. The study features two treatment arms, either 50 mg or 100 mg of IDX184 administered once-daily for 12 weeks, each arm in combination with pegylated interferon and ribavirin (PegIFN/RBV). Study objectives include safety and tolerability, and antiviral activity endpoints.
IDX184 Phase IIb Interim Study ResultsThe first 31 patients have completed 28 days of treatment, and the interim data have shown that IDX184 was well-tolerated and that there were no serious adverse events associated with therapy. The side effect profile was consistent with that seen with PegIFN/RBV. The independent DSMB has reviewed the data for the first 31 patients and has recommended continuing enrollment of the study. The Company has submitted the interim data, along with the DSMB's recommendations, to the U.S. Food and Drug Administration (FDA) and is requesting the continuation of this study and removal of the partial clinical hold for IDX184.
RVR findings demonstrated that 73% of patients in the 100 mg IDX184 arm (n=15) and 63% in the 50 mg arm (n=16) had undetectable virus (LLOQ < 25 IU/ml) at 28 days. Currently 87% of patients in the 100 mg arm and 94% in the 50 mg arm had undetectable virus at a median of 8 weeks of treatment. There have been no virologic breakthroughs observed in the study to date.
"These interim results are encouraging as they confirm the antiviral activity and safety of IDX184 in combination with pegylated interferon and ribavirin," Eric Lawitz, M.D., of Alamo Medical Research, Camden Medical Center, stated. "Nucleotide drugs such as IDX184 are becoming an important component in the rapidly evolving treatment regimens for HCV. Eventually, the goal for treatment will be to reduce or eliminate reliance on interferon and to shift to all oral combinations of direct-acting antiviral agents that can reduce potential side effects and decrease the amount of time on therapy."
Ron Renaud, President and Chief Executive Officer of Idenix, commented, "We are very pleased with the interim results for IDX184 and with the progress we made in 2011 across our programs. In 2012, we will build on this progress and believe we are well positioned to play a major role in treating HCV patients for the foreseeable future."
Tengion, Inc. (NASDAQ:TNGN) has traded as high as $.84 during today’s trading session and last traded at the high of the day for a gain of 23.51% from Friday’s close. TNGN shares have traded as high as $6.24 over the last 52 weeks, which is over 86.5% off that high at last traded stock price. Get my next ALERT 100% FREE
Tengion, a leader in regenerative medicine, announced it has completed the relocation of its corporate headquarters from East Norriton, Pennsylvania to the Company's existing facility in Winston-Salem, North Carolina. The relocation is part of the Company's previously announced restructuring, which was designed to fund the Company's lead development programs through key milestones in 2012 while reducing anticipated cash utilization. The Company will continue to maintain its Pennsylvania facility while it explores options to significantly reduce the net rental obligation for the facility.
"We are excited to move our corporate headquarters to Winston-Salem after having much of our research and development operations located here since 2004," said John L. Miclot, President and Chief Executive Officer. "This relocation allows us to focus our resources more efficiently on advancing our Neo-Urinary Conduit™ and Neo-Kidney Augment™ programs. The presence of a well-educated, high-quality workforce was also a factor in the decision to move our headquarters to Winston-Salem."
"We are delighted to welcome Tengion to our North Carolina family of life sciences companies," said Norris Tolson, President and CEO of the North Carolina Biotechnology Center. "We are really pleased to hear that this leader in regenerative medicine is making North Carolina its home."
Tengion is continuing to advance its ongoing Phase 1 clinical trial of the Neo-Urinary Conduit, which is being evaluated in bladder cancer patients requiring a urinary diversion following bladder removal (cystectomy). This trial is designed to assess the safety and preliminary efficacy of the Neo-Urinary Conduit in up to 10 patients, as well as to allow the clinical investigators to optimize the surgical procedure and post-surgical care by incorporating the outcomes observed in each patient into the surgical approach for subsequent patients, as necessary. Three patients have been enrolled and implanted to date at the University of Chicago and The Johns Hopkins Hospital. The Company anticipates implanting a fourth patient during the first quarter of this year, and, assuming appropriate safety data, up to 10 patients by the end of 2012.
Tengion is also continuing its preclinical development of the Neo-Kidney Augment™ program toward the submission of a Pre-IND filing to the U.S. Food and Drug Administration (FDA) during the first half of this year.
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