Cancer Genetics Announces Partnership With AstraZeneca to Provide Biomarker & Molecular Based Testing; Merck to Acquire Idenix Print E-mail
By Mary Davila   
Monday, 09 June 2014 20:01
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 9, 2014.
Cancer Genetics, Inc. (Nasdaq:CGIX)
, an emerging leader in DNA-based cancer diagnostics, has been selected by AstraZeneca CAMCAR, S.A., a division of multinational pharmaceutical and biologics company AstraZeneca, serving Central American and Caribbean countries, to provide biomarker-based diagnostic testing for cancer. Under the terms of the agreement, CGI will perform complex testing for diagnosis and prognosis of cancer patients in Central America and the Caribbean. CGI will work in close conjunction with AZ-CAMCAR on exploring expansion opportunities into additional geographic territories, further oncology categories, and into select oncology trials.

"We chose to partner with Cancer Genetics in this endeavor because of their experience in biomarker-based diagnostic testing and their commitment to delivering timely and accurate results to healthcare professionals and patients," said Rodrigo Fernandez, Country President of AstraZeneca CAMCAR, S.A.

"Partnering with AstraZeneca further strengthens our ability to touch the lives of patients globally," said Panna Sharma, Chief Executive Officer of Cancer Genetics, Inc. "We believe our ability to provide accurate, state-of-the-art biomarker-based testing was a key factor in AstraZeneca's decision to partner with us, and serves as a testament to the growing global awareness of the value of our brand. We are committed to positively impacting cancer care globally, and this relationship serves as another major milestone in fulfilling that mission."

The relationship is expected to concentrate on multiple cancer categories, with lung cancer being an initial area of focus. According to the Pan American Health Organization ("PAHO"), lung cancer is the third most common cancer and the leading cause of cancer deaths in the Americas, with more than 300,000 new cases and nearly 250,000 deaths each year. PAHO expects the number of new cases and deaths from lung cancer to double in Latin America by 2030.



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Merck (NYSE:MRK)
, known as MSD outside the United States and Canada, and Idenix Pharmaceuticals, Inc. (NASDAQ: IDIX), today announced that the companies have entered into a definitive agreement under which Merck will acquire Idenix for $24.50 per share in cash. The transaction, which values the purchase of Idenix at approximately $3.85 billion, has been approved by the boards of directors of both companies.

“Idenix has established a promising portfolio of hepatitis C candidates based on its expertise in nucleoside/nucleotide chemistry and prodrug technologies,” said Dr. Roger Perlmutter, president, Merck Research Laboratories. “Idenix’s investigational hepatitis C candidates complement our promising therapies in development and will help advance our work to develop a highly effective, once-daily, all oral, ribavirin-free, pan-genotypic regimen that has a duration of treatment as short as possible for millions of patients in need around the world.”

Idenix is a biopharmaceutical company engaged in the discovery and development of medicines for the treatment of human viral diseases, whose primary focus is on the development of next-generation oral antiviral therapeutics to treat hepatitis C virus (HCV) infection. The company currently has three HCV drug candidates in clinical development: two nucleotide prodrugs (IDX21437 and IDX21459) and a NS5A inhibitor (samatasvir). These novel candidates are being evaluated for their potential inclusion in the development of all oral, pan-genotypic fixed-dose combination regimens.

“Merck has established a strong legacy of leadership and innovation in treating hepatitis C,” said Ron Renaud, Idenix’s President and Chief Executive Officer. “This agreement creates shareholder value by positioning Idenix’s strong portfolio of candidates for future success with a leading healthcare company with the experience and commitment to develop fixed-dosed combinations with the potential to impact the global burden of hepatitis C.”

Merck’s research and development portfolio includes several HCV medicines in development, the leading of which is a combination of MK-5172, an investigational HCV NS3/4A protease inhibitor and MK-8742, an investigational HCV NS5A replication complex inhibitor. The combination of these two investigational candidates has received Breakthrough Therapy designation from the U.S. Food and Drug Administration for the treatment of HCV. In April 2014, Merck announced initiation of Phase 3 clinical trials for MK-5172/MK-8742 to evaluate the combination with and without ribavirin in various genotypes and across a broad range of patient populations with chronic HCV. Study information can be found at www.clinicaltrials.gov.

Under the terms of the agreement, Merck, through a subsidiary, will initiate a tender offer to acquire all outstanding shares of Idenix Pharmaceuticals, Inc. The closing of the tender offer will be subject to certain conditions, including the tender of shares representing at least a majority of the total number of Idenix’s outstanding shares (assuming the exercise of all options), the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. Upon the completion of the tender offer, Merck will acquire all remaining shares through a second-step merger. The companies expect the transaction to close in the third quarter of 2014.

Credit Suisse acted as financial advisor to Merck in this transaction and Hughes Hubbard & Reed LLP as its legal advisor. Centerview Partners acted as financial advisor to Idenix and Sullivan & Cromwell as its legal advisor.



Also Monday:




3D Systems (NYSE:DDD)
announced today that it has successfully completed a pilot program for its new Bespoke™ Braces, a first of its kind, personalized, 3D printed brace for children and young adults with scoliosis.

Accuray Incorporated (Nasdaq:ARAY)
, announced today that its management is now scheduled to present at the Goldman Sachs 35th Annual Healthcare Conference in Palos Verdes on Thursday, June 12, 2014 at 11:00 a.m. ET/ 8:00 a.m. PT.

Advaxis, Inc. (Nasdaq:ADXS)
, a biotechnology company developing cancer immunotherapies, announces that its management team will host a corporate business update conference call to review recent Company events, data presented at ASCO, immunotherapy industry developments and the Company's business strategy.

Alcobra Ltd. (Nasdaq:ADHD)
, an emerging biopharmaceutical company focused on the development of new medications to help patients with cognitive disorders, including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome, today announced that Dr. Jonathan Rubin, Chief Medical Officer of Alcobra, will be a featured speaker and presenter at the 2014 Annual Meeting of the American Society of Clinical Psychopharmacology (ASCP) 2014 Annual Meeting, being held June 16-19, 2014 at the Westin Diplomat Hotel in Hollywood, Florida.

The SEC determined on June 6, 2014 to impose a temporary suspension in trading of the stock of Alternative Energy Partners, Inc. (OTCBB: AEGY) (OTC Pink: AEGY) (PINKSHEETS: AEGY) that may extend through June 19, 2014.

Amgen (NASDAQ: AMGN)
today announced the appointment of David W. Meline as executive vice president and chief financial officer (CFO), effective July 21, 2014.

Cerulean Pharma Inc. (Nasdaq:CERU)
, a leader in Dynamic Tumor Targeting™, today announced that Mark E. Davis, Ph.D., Professor of Chemical Engineering at the California Institute of Technology, presented information about Cerulean's lead candidate, CRLX101, in a presentation entitled "Nanoparticle Delivery Platform for Solid Tumors" at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago on Monday, June 2nd.

Dyadic International, Inc. (OTCQX: DYAI), a global biotechnology company focused on the discovery, development, manufacture and sale of enzymes and other proteins for the bioenergy, bio-based chemicals, biopharmaceutical, food and feed industries, announced that Dyadic's Chief Operating Officer Danai Brooks will present at the 2014 Global Biotechnology Conference on Wednesday, June 18, 2014 at 4:10 p.m. ET at the John B. Hynes Memorial Convention Center in Boston, Massachusetts.

Elite Pharmaceuticals, Inc. (OTCBB:ELTP)
today announced dosing of the first subject in the treatment phase for a human abuse liability clinical study for ELI-200. ELI-200 is an abuse deterrent product for an undisclosed opioid.

Epocrates, Inc., an athenahealth, Inc. (Nasdaq:ATHN)
service, today announced that, for the fifth consecutive year, Epocrates leads the digital health market in terms of medical reference app reach on smartphones1, according to Manhattan Research's 2014 Taking the Pulse® U.S. study.

FutureWorld (OTCQB: FWDG)
announces today that it has signed a preliminary agreement with American Green in the distribution of its ZaZZZ robotic dispensaries nationwide under the brand name CaNNaBoX™.

Galmed Pharmaceuticals Ltd. (Nasdaq:GLMD)
, a clinical-stage biopharmaceutical company focused on the development and commercialization of a once-daily, oral therapy for the treatment of liver diseases and cholesterol gallstones, announced today that it filed a provisional patent application in the United States for the use of its drug, aramchol, for the treatment of lipodystrophy.

iKang Healthcare Group, Inc. (Nasdaq:KANG)
, the largest provider in China's fast growing private preventive healthcare services market in terms of revenue in 2013, today announced its unaudited financial results for the fourth quarter and the fiscal year ended March 31, 2014 (the "fiscal year 2013",from April 1, 2013 to March 31, 2014).

Immunomedics, Inc., (Nasdaq:IMMU)
today announced that IMMU-132, the Company's antibody-drug conjugate (ADC) for solid cancer therapy, has received orphan drug status from the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer.

Intuitive Surgical (Nasdaq:ISRG)
announced today it will join a group of industry supporters of a new clinical outcomes registry.

K2M Group Holdings, Inc. (Nasdaq:KTWO),
a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies, techniques and minimally invasive procedures, today announced that the underwriters for the Company's initial public offering exercised their option to purchase 1,000,000 shares of common stock from the selling stockholders at a price of $15.00 per share before underwriting discounts.

Karyopharm Therapeutics Inc. (Nasdaq:KPTI)
, a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases, today announced the initiation of a Phase 2 trial of its novel, oral Selective Inhibitor of Nuclear Export (SINE) compound Selinexor (KPT-330) in patients with metastatic hormone-refractory prostate cancer (HRPC).

Myriad Genetics, Inc. (Nasdaq:MYGN)
announced today that James Evans, chief financial officer of Myriad, has notified the Company of his intent to retire in order to attend to family health issues.

Receptos, Inc. (Nasdaq:RCPT)
today announced that the Phase 2 portion of the RADIANCE trial of its selective S1P1 receptor modulator, RPC1063, in relapsing multiple sclerosis (RMS) met the primary endpoint, reduction in MRI brain lesion activity.

Rockwell Medical, Inc. (Nasdaq:RMTI)
, a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, today announced that it has won its appeal for size determination as a small business and is now working with the U.S. Food & Drug Administration (FDA) to have its $2.2 million PDUFA User Fee for filing its New Drug Application (NDA) for Triferic refunded. Rockwell expects to receive a check for $2.2 million from the Department of Treasury.

Sagent Pharmaceuticals, Inc. (Nasdaq:SGNT)
, a leading specialty pharmaceutical company with an emphasis on the injectable market, has been ranked seventh on Crain's 2014 Fast Fifty list, published by Crain's Chicago Business.

Synergetics USA, Inc. (NASDAQ: SURG),
a medical device company that designs, manufactures, and markets innovative surgical devices for ophthalmic and neurosurgical applications, today reported sales, gross profit, operating margin and net income for the third quarter ended April 30, 2014.

TetraLogic Pharmaceuticals Corporation (Nasdaq:TLOG)
today announced results from its collaboration with the Walter and Eliza Hall Institute of Medical Research, Melbourne, Australia, indicating that SMAC mimetics, including TetraLogic's lead compound birinapant, may have broad applicability in the treatment of infectious disease.

Versartis, Inc. (Nasdaq:VSAR)
, an endocrine-focused biopharmaceutical company that is developing a novel, long-acting form of recombinant human growth hormone (rhGH) for the treatment of growth hormone deficiency (GHD), today announced it will hold a conference call and webcast on Monday, June 23, 2014 at 5:00 p.m. EDT (4:00 p.m. CDT).



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