Merck Shares Soar After Announcing More Job Cuts; Lexicon Reports Results from Trial of LX4211 Print E-mail
By Staff and Wire Reports   
Tuesday, 01 October 2013 19:14
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 1, 2013.

Drugmaker Merck & Co. (NYSE: MRK)
saw shares rise 2.5 percent in afternoon trading as it announced 8,500 job cuts and touted savings of $2.5 billion as part of a global initiative “to sharpen its commercial and research and development focus.”

Merck CEO Kenneth C. Frazier said in a news release Tuesday that the multi-year plan would enable the company to “better target its resources.” Frazier said Merck would bolster its drug pipeline, implement a more agile operating model and reduce costs.

“These actions will make Merck a more competitive company,” Frazier said in the release. “Today’s announcement further underscores that we are committed to improving our performance in the short term while also investing for the long term to create value for patients, customers and shareholders.”

The company said the cuts were in addition to 7,500 previously announced, and it separately announced it would abandon plans to move its headquarters to a new facility in New Jersey and rather consolidate in current operations in Kenilworth, New Jersey.

The moves are expected to save $1 billion by the end of 2014 and $2.5 billion by the end of 2015. The staff cuts will result in a reduction of about 20 percent of Merck’s global workforce by the end of 2015. Merck currently employs about 81,000 workers worldwide.

The news came before the opening of trading and shareholders responded immediately, pushing the stock higher by three percent in early trading before settling at 2.5 percent gains in mid-afternoon trading.

The plan to focus on R&D comes after late-stage clinical setbacks in recent months, The New York Times reported.
It said a week ago that the Food and Drug Administration rejected its application for an anesthesia drug, citing concerns about a hypersensitivity study in patients. The FDA also rejected an application for a new sleep drug, survorexant, indicating it eventually would approve the drug in a different dosage, the Times reported.

Earlier this year Merck announced it would delay its application for an osteoporosis treatment drug, and its profits for the second quarter fell in half mainly because of competition from generic alternatives, the Times said.



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Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX)
announced LX4211, a first-in-class, dual inhibitor of sodium glucose transporters 1 and 2 (SGLT1 and SGLT2), successfully met the primary endpoint of reducing post-prandial glucose, in a study of patients with type 2 diabetes and moderate to severe renal impairment.  Reducing elevated post-prandial glucose, high blood sugar levels after meals, is a key objective of diabetes therapy.

In a placebo-controlled, proof-of-concept study, LX4211 provided clinically meaningful and statistically significant reductions (p<0.05) in post-prandial glucose in diabetes patients with moderate to severe renal impairment (Stage 3 and 4 kidney disease). Importantly, these effects were maintained in a sub-group with the most advanced renal impairment, pre-defined as those with glomerular filtration rate (GFR) less than 45 ml/min/1.73 m^2. LX4211 also produced significant elevations in GLP-1, a hormone involved in control of glucose and appetite.

Renal impairment occurs in approximately 30% of patients with type 2 diabetes and represents a major unmet medical need with limited treatment options.  LX4211's inhibition of SGLT1 in the gastrointestinal (GI) tract, reducing glucose absorption and triggering GLP-1 secretion, offers the potential for treating this medically challenging population with compromised kidney function.  In previous Phase 2 studies, LX4211 improved glycemic control in patients with type 2 diabetes with normal renal function.

"Our hypothesis was that LX4211 would improve glycemic control even in patients with the greatest degree of renal impairment due to its inhibition of SGLT1 in the GI tract," said Pablo Lapuerta, M.D., Lexicon's chief medical officer.  "The post-prandial glucose reductions and GLP-1 elevations observed in this study population support the rationale for demonstrating effective HbA1c reduction in a larger, longer-term Phase 3 trial, and provide further support for the clinical differentiation of LX4211 as a first-in-class dual SGLT1 and SGLT2 inhibitor."

In this multicenter study, 30 patients with poorly controlled type 2 diabetes and moderate to severe renal impairment were randomized to either placebo or a 400 mg dose of investigational drug LX4211 taken orally once per day before breakfast. Patients' post-prandial glucose was measured after a standardized meal both at baseline before treatment and after one week of therapy. In addition to achieving the primary efficacy objective of post-prandial glucose reduction, there were no serious adverse events observed in the study and no discontinuations of LX4211 due to adverse events. Lexicon plans to present full results of the study at scientific congresses in 2014.


Also Tuesday:


Alphatec Holdings, Inc. (Nasdaq:ATEC)
, the parent company of Alphatec Spine, Inc., a medical device company that provides physician-inspired solutions for patients with spinal disorders, announced today that it will showcase several new products at the upcoming North American Spine Society (NASS) meeting in New Orleans, LA, which will be held from October 9th – 12th, 2013.

Diversicare Healthcare Services Inc. (Nasdaq:DVCR)
, a premier provider of long-term care services primarily in the Southeast and Southwest, announced today that effective October 1, 2013, the Company has assumed operations of the previously announced properties in Ohio and Indiana from Catholic Health Partners.

Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK)
announced today that the last patient has been enrolled in the second cohort of a two-cohort randomized Phase 2 clinical trial of MM-121 in combination with paclitaxel in the neoadjuvant setting of HER2-negative breast cancer. MM-121, also known as SAR256212, is a fully human monoclonal antibody that targets ErbB3, a cell surface receptor implicated in tumor growth and survival, being developed in collaboration with Sanofi.

Myriad Genetics, Inc. (Nasdaq:MYGN)
today announced that BioMarin Pharmaceutical Inc. will use Myriad's BRACAnalysis® test in connection with its pivotal Phase 3 clinical studies for BMN 673.

NanoString Technologies, Inc. (Nasdaq:NSTG)
and Fluidigm Corporation (Nasdaq:FLDM) have agreed to settle lawsuits filed by Fluidigm in the United States and Singapore. In the U.S. case, Fluidigm charged NanoString with false advertising, unfair competition, and unlawful trade practices based on a comparison study of NanoString's Single Cell Gene Expression Assay on the nCounter® Analysis System with the Single Cell Gene Expression capabilities of Fluidigm's BioMark™ HD system.

Oncolytics Biotech Inc. (TSX:ONC) (NASDAQ: ONCY)
today announced that abstracts detailing results from two Phase II studies examining the use of REOLYSIN® in combination with carboplatin and paclitaxel in patients with non-small cell lung cancer (NSCLC) with Kras or EGFR-activated tumors (REO 016) and in patients with squamous cell carcinoma of the lung (REO 021), are now available on the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer website at http://wclc.iaslc.org.

Premier, Inc. (Nasdaq:PINC)
today announced the closing of its initial public offering of 32,374,751 shares of Class A common stock, including 4,222,793 shares issued upon the exercise in full by the underwriters of their option to purchase additional shares to cover over-allotments.

Precision Optics Corporation, Inc. (OTCQB: PEYE)
today announced operating results on an unaudited basis for the fourth quarter and year ended June 30, 2013.

Quture International, Inc. (OTCQB: QUTR)
today announced the formation of the new subsidiary QualVal Solutions (QualVal).

RadNet, Inc. (Nasdaq:RDNT)
, a national leader in providing high-quality, cost-effective diagnostic imaging services through a network of fully-owned and operated outpatient imaging centers, today announced that Mark Stolper, Executive Vice President and Chief Financial Officer, will be presenting at the Deutsche Bank 21st Annual Leveraged Finance Conference in Scottsdale, AZ on Wednesday, October 2, 2013 at 8:05 a.m. Mountain Standard Time.

RadTek, Inc. (OTCQB: RDTK)
, a leader in engineering of X-ray imaging, has secured a contract with uNeed Partners to provide the engineering advisory work in construction of their new Particle Therapy Cancer Center. RadTek Co., Ltd. in Korea, a majority shareholder of RadTek, Inc., has an ever evolving relationship with uNeed Partners and this affiliation has allowed RadTek, Inc. to secure a contract for these advisory services.

Sigma-Aldrich Corporation (NASDAQ:SIAL)
will hold its quarterly conference call to discuss third quarter 2013 financial results on Tuesday, October 22, 2013, at 11:00 AM EDT.

StemCells, Inc. (Nasdaq:STEM)
today announced that it intends to offer and sell common stock and warrants, subject to market and other conditions, in an underwritten public offering.

Synergetics USA (NASDAQ: SURG)
, announced today that it plans to close its King of Prussia, Pennsylvania facility and consolidate the manufacturing operations into its existing facility in O'Fallon, Missouri.



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