Illumina’s Board Unanimously Rejects Roche’s Offer; Shire Announces FDA Approval of Vyvanse® Print E-mail
By Staff and Wire Reports   
Tuesday, 07 February 2012 19:55
Below is a look at some of the headlines for companies that made news in the healthcare sector on February 7, 2012.

Illumina, Inc. (NASDAQ:ILMN), a leading developer, manufacturer, and marketer of life science tools and integrated systems for the analysis of genetic variation and function, announced its Board of Directors thoroughly reviewed Roche’s unsolicited tender offer with the assistance of its financial and legal advisors and unanimously determined that the $44.50 per share cash offer is grossly inadequate in multiple respects, dramatically undervalues Illumina and is contrary to the best interests of Illumina’s stockholders. Accordingly, the Board recommends that stockholders not tender any of their shares to Roche. The Company filed today a Schedule 14D-9 with the Securities and Exchange Commission (“SEC”) detailing the reasons for its rejection. The letter sent today by Illumina to the Chairman of Roche also appears below.

“It is the Board’s unanimous belief that Roche’s offer dramatically undervalues Illumina and fails to reflect the value of the Company’s unique leadership position and future growth prospects,” said Jay Flatley, President & Chief Executive Officer. “Illumina has established itself as the innovation and market leader in tools for genetic analysis, with a proven track record of profitability and outperformance, resulting in significant value creation. Our industry is nascent, with the promise and potential to experience extraordinary growth in the years ahead as genetic information becomes broadly applied beyond molecular biology research, and into medical diagnostics, reproductive health and cancer management. As the growth of this industry accelerates, Illumina is singularly positioned to expand its market leadership, and to deliver value to our stockholders that is far superior to Roche’s offer.”


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Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that the FDA approved the prescription medication Vyvanse® (lisdexamfetamine dimesylate) Capsules, (CII) as a maintenance treatment for adults with ADHD.  The approval is based on results from a randomized withdrawal study designed to evaluate the efficacy of Vyvanse in adults (aged 18 to 55 years) who were receiving treatment with Vyvanse for a minimum of 6 months prior to enrolling in the study.  Significantly more patients treated with Vyvanse maintained ADHD symptom control compared with placebo as determined by the proportion of patients who met criteria for relapse of symptoms at end point during the six-week randomized double-blind withdrawal phase of the study (8.9% of Vyvanse-treated patients vs 75% for placebo).  This new approval adds to the indication for Vyvanse as a treatment for ADHD in patients ages 6 and above.    

Vyvanse should be used as part of a total treatment program that may include counseling or other therapies. The physician who elects to use Vyvanse for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

In a randomized withdrawal design, patients who respond to a treatment are randomized to continue receiving that treatment or placebo. Utilizing the proportion of patients experiencing symptom relapse as a primary outcome, this type of study in patients with ADHD can be used to demonstrate long-term efficacy in lieu of conducting a long-term placebo-controlled, parallel-group study. The utility of this design is that the period of placebo exposure, with the potential for worsening of ADHD symptoms, is relatively short.  "Data from this study and the resulting approval illustrate that Vyvanse can help adults with ADHD maintain symptom control. Vyvanse is the first medicine both proven to work and approved to maintain efficacy in adults with ADHD," said Jeffrey Jonas, MD, Senior Vice President of Research and Development for Shire's Specialty Pharmaceuticals and Regenerative Medicine businesses. "This underscores Shire's commitment to providing important advances in the treatment of individuals with ADHD by investing in innovative research in this area," added Dr. Jonas.

Vyvanse is a Schedule II controlled substance. Stimulants, such as amphetamines and methylphenidates, are subject to misuse, abuse, addiction, and criminal diversion. Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events.


Also Tuesday:


Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced that the Company has completed its previously announced acquisition of 100% of the capital stock of Enobia Pharma Corp., a private biopharmaceutical company focused on the development of therapies to treat patients with ultra-rare and life-threatening genetic metabolic disorders.

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced the appointment of Rajiv De Silva and Gino Santini to its board of directors, effective immediately. Mr. De Silva is currently president of Valeant Pharmaceuticals International, Inc. and chief operating officer of its Specialty Pharmaceuticals business.

Anacor Pharmaceuticals (NASDAQ:ANAC) announced today positive preliminary results from two safety studies of AN2728 - a maximal use systemic exposure (MUSE) study in psoriatic patients and a local tolerability study.

The National Association for Female Executives (NAFE) today named AstraZeneca (NYSE: AZN) one of the top 50 companies for female executives for the fourth consecutive year.

AVEO Pharmaceuticals, Inc. (Nasdaq: AVEO) today announced that financial results for the company's fourth quarter and year ended December 31, 2011 will be released before the market opens on Tuesday, February 14, 2012.

Bioanalytical Systems, Inc. (NASDAQ:BASI)
will release financial results for the fiscal 2012 first quarter ended December 31, 2011 at approximately 7:30 a.m. EST on Friday, February 10, 2012.

BioLineRx (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical development company, announced today that its Chief Executive Officer, Kinneret Savitsky, Ph.D., and its Chief Financial and Operating Officer, Philip Serlin, will be presenting at the 2012 BIO CEO & Investor Conference in New York.

Charles River Laboratories International, Inc. (NYSE: CRL)
announced today that it will present at the UBS 22nd Annual Global Healthcare Services Conference in New York on Wednesday, February 8th, at 1:30 p.m. EST, and the Leerink Swann 2012 Global Healthcare Conference in New York on Wednesday, February 15th, at 10:30 a.m. EST.

Compugen Ltd. (NASDAQ: CGEN) today reported financial results for the fourth quarter and year ended December 31, 2011.

CONMED Corporation (NASDAQ: CNMD) today announced that its CONMED Linvatec business unit will formally launch multiple new medical devices in its Sports Medicine and Powered Instrument product lines at the Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS) in San Francisco, CA on February 8 - 11, 2012.

CytoSorbents Corporation (OTCBB: CTSO), a critical care focused company using blood purification to treat life-threatening illnesses, announced that it will exhibit at the 2012 Symposium of Intensive Medicine and Intensive Care from February 22-24, 2012 in Bremen, Germany.

Kedem Pharmaceuticals Inc.(OTCBB: KDMP), a specialty pharmaceutical company with focus on sublingual drug delivery is pleased to participate February 9 -12 at the World Money Show in Orlando, Fl., Booth #609, The company CEO Dr. Hasssan Salari will be on hand to discuss with the attendees the company's progress on X-Excite, the Company's lead therapeutic drug for erectile dysfunction.

Illumina, Inc. (NASDAQ:ILMN), a leading developer, manufacturer, and marketer of life science tools and integrated systems for the analysis of genetic variation and function, today announced that its Board of Directors thoroughly reviewed Roche’s unsolicited tender offer with the assistance of its financial and legal advisors and unanimously determined that the $44.50 per share cash offer is grossly inadequate in multiple respects, dramatically undervalues Illumina and is contrary to the best interests of Illumina’s stockholders.

IsoRay Inc. (AMEX: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, said today that the findings of a Cleveland Clinic study adds to the continuing evidence supporting the efficacy of brachytherapy.

Lannett Company, Inc. (NYSE AMEX:LCI) today reported financial results for the fiscal 2012 second quarter and six months ended December 31, 2011.

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces the appointment of Nishan de Silva, M.D., as Vice President of Corporate Development.

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND)
today reported financial results for the three and 12 months ended December 31, 2011, and reviewed business highlights of the fourth quarter of 2011 and early 2012.
Merck (NYSE:MRK), known outside the United States and Canada as MSD, today announced the top-line results of the TRA-2P (Thrombin Receptor Antagonist in Secondary Prevention of atherothrombotic ischemic events) study of vorapaxar.

Metabolix, Inc. (NASDAQ: MBLX), a bioscience company focused on bringing clean, sustainable solutions to the plastics, chemicals and energy industries, announced today that it will be presenting at the 12th Jefferies Global Clean Technology Conference at 4:00 p.m. ET on Wednesday, February 22, 2012 in New York City.

Navidea Biopharmaceuticals, Inc. (NYSE Amex: NAVB) today announced that Dr. Mark Pykett, President and Chief Executive Officer, will participate at the 14th Annual BIO CEO & Investor Conference, hosted by the Biotechnology Industry Organization (BIO), on February 13-14 at the Waldorf Astoria in New York City.

Obagi Medical Products, Inc. (Nasdaq:OMPI)
, a leader in topical aesthetic and therapeutic skin health systems, today announced it will report financial results for its fourth quarter and year ended December 31, 2011 after market close on Thursday, March 8, followed by an investor conference call at 4:30 p.m. Eastern time (1:30 p.m. Pacific time).

Repligen Corporation (NASDAQ: RGEN) announced today that Walter C. Herlihy, Ph.D., President and Chief Executive Officer, will present a corporate update at the 14th Annual BIO CEO & Investor Conference on Monday, February 13, 2012 at 2 p.m. EST at the Waldorf Astoria in New York City.

Safeguard Scientifics, Inc. (NYSE: SFE), a holding company that builds value in growth-stage life sciences and technology companies, today announced it led a Series B financing for Spongecell, Inc., a New York City-based advertising technology company that turns standard banner ads into dynamic ads with rich media features.

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the Company’s New Drug Application (NDA) for crofelemer 125 mg tablets for the proposed indication for the control and symptomatic relief of diarrhea in patients with human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) on anti-retroviral therapy (ART).

Spectrum Pharmaceuticals (NasdaqGS:SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, announced today that an overview of the Company’s business strategy will be given at the BIO CEO Investor Conference, being held at the Waldorf=Astoria Hotel in New York City.

Targacept Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing novel NNR TherapeuticsTM, today announced that it will report financial results for the fourth quarter and year ended December 31, 2011 on Tuesday, February 21, 2012, after the U.S. financial markets close.

Tonix Pharmaceuticals Holding Corp. (OTCBB:TNXP) (“TONIX” or the “Company”), a specialty pharmaceutical company developing therapies for challenging disorders of the central nervous system (“CNS”), including fibromyalgia syndrome (“FM”) and post-traumatic stress disorder (“PTSD”), will be presenting at the 14th Annual Bio CEO & Investor Conference on February 14, 2012, at 8:30 a.m. EST at the Waldorf=Astoria Hotel in New York City.



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