FDA approves Korlym for Endogenous Cushing’s syndrome; Gilead Announces Data for Genotype 1 Null Responder Print E-mail
By Staff and Wire Reports   
Friday, 17 February 2012 19:21
Below is a look at some of the headlines for companies that made news in the healthcare sector on February 17, 2012.

Corcept Therapeutics (NASDAQ:CORT)
, a specialty drug company that hasn’t generated revenue since 2009, wins FDA approval for its Korlym treatment that uses the active ingredient of the abortion pill RU-486 to treat Cushing’s Syndrome. Shares +42.5% after a trading halt.

Korlym (mifepristone) was approved by the FDA to control high blood sugar levels (hyperglycemia) in adults with endogenous Cushing’s syndrome. This drug was approved for use in patients with endogenous Cushing’s syndrome who have type 2 diabetes or glucose intolerance and are not candidates for surgery or who have not responded to prior surgery. Korlym should never be used (contraindicated) by pregnant women.

Prior to FDA’s approval of Korlym, there were no approved medical therapies for the treatment of endogenous Cushing’s syndrome.

Endogenous Cushing’s syndrome is a serious, debilitating and rare multisystem disorder. It is caused by the overproduction of cortisol (a steroid hormone that increases blood sugar levels) by the adrenal glands. This syndrome most commonly affects adults between the ages of 25 and 40. About 5,000 patients will be eligible for Korlym treatment, which received an orphan drug designation by the FDA in 2007.

Korlym blocks the binding of cortisol to its receptor. It does not decrease cortisol production but reduces the effects of excess cortisol, such as high blood sugar levels.

The safety and efficacy of Korlym in patients with endogenous Cushing’s syndrome was evaluated in a clinical trial with 50 patients. A separate open-label extension of this trial is ongoing. Additional evidence supporting the agency’s approval included several safety pharmacology studies, drug-drug interaction studies and published scientific literature. Patients experienced significant improvement in blood sugar control during Korlym treatment, including some patients who had marked reductions in their insulin requirements. Improvements in clinical signs and symptoms were reported by some patients.

The most common side effects experienced by endogenous Cushing’s syndrome patients treated with Korlym in clinical trials were nausea, fatigue, headache, arthralgia, vomiting, swelling of the extremities, dizziness and decreased appetite. Other side effects of Korlym include adrenal insufficiency, low potassium levels, vaginal bleeding and a potential for heart conduction abnormalities. Certain drugs used in combination with Korlym may increase its drug level. Health care professionals must be aware of the potential for drug-drug interactions and adjust dosing or avoid using certain drugs with Korlym.

Korlym should never be used by pregnant women. Although pregnancy is an extremely rare occurrence in Cushing’s syndrome patients because of the suppressive effect of excess cortisol on female reproductive function, Korlym will carry a Boxed Warning advising health care professionals and patients that the therapy will terminate a pregnancy.


Gilead Sciences, Inc. (NASDAQ:GILD)
announced the majority of hepatitis C genotype 1 patients with a prior “null” response to an interferon (IFN)-containing regimen enrolled in the ongoing ELECTRON study experienced viral relapse within four weeks of completing 12 weeks of treatment with GS-7977 plus ribavirin (RBV). Ten patients were randomized to this arm of the ELECTRON study and data are available for eight of the 10 patients at this time. Among these eight patients, six have experienced viral relapse. Two patients have not relapsed; however, they have only reached the two week post-treatment time point.

“We will continue to explore a number of therapeutic approaches to address this significant unmet medical need, including combinations with other oral antivirals.”  “These data answer an important question about the use of GS-7977 and ribavirin for the treatment of genotype 1 null responder patients, suggesting that additional direct acting antivirals may be necessary to effectively treat this patient population,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer. “We will continue to explore a number of therapeutic approaches to address this significant unmet medical need, including combinations with other oral antivirals.”

GS-7977 is a nucleotide analog polymerase inhibitor that is currently being studied for the treatment of chronic hepatitis C. A number of ongoing Phase 2 and Phase 3 studies are evaluating the safety and efficacy of the compound with and without RBV and/or pegylated interferon (Peg-IFN) in patients with genotypes 1-6 who are treatment naïve, treatment experienced, or have had a “null” response to Peg-IFN.

Genotype 2 and 3 data from the ELECTRON study were presented at the 62nd annual meeting of the American Association for the Study of Liver Diseases (The Liver Meeting 2011). Data from the genotype 1 null responder arm of the study will be presented at an upcoming scientific conference.

Results from ongoing studies in genotype 1 treatment-naïve patients will be available in the coming months. The first data evaluating GS-7977 plus RBV for 12 weeks in genotype 1 naïve patients will come from an arm of the QUANTUM study with 25 patients at the end of the first quarter of 2012. This will be followed in the second quarter by data from the ELECTRON study involving 25 patients and, early in the third quarter, data on GS-7977 and RBV treatment for 24 weeks from an arm of the QUANTUM study will become available.

Also Friday:

Applied DNA Sciences (OTCBB: APDN)
, based in Long Island, New York, is pleased to announce that its smartDNA anti-intruder mist system is available as a tool to help counter the string of deadly pharmacy robberies which have plagued Long Island in recent months.

Bruker Corporation (NASDAQ: BRKR)
announced today that it plans to release its fourth quarter and full year 2011 financial results on Wednesday, February 22nd, 2012 before the market opens.

Catalyst Health Solutions, Inc., (NASDAQ: CHSI)
today announced that Michigan’s Office of Retirement Services has extended the pharmacy benefits management contract between the Michigan Public School Employees Retirement System (MPSERS) and Catalyst Rx through 2013.

CytRx Corporation (NASDAQ: CYTR)
, a biopharmaceutical company specializing in oncology, today announced that, as anticipated, on February 15, 2012, the Company was notified by The NASDAQ Stock Market that because the Company has not regained compliance with the $1.00 minimum bid price requirement under NASDAQ Listing Rule 5550(a)(2), the Company’s common stock would be subject to delisting from The NASDAQ Capital Market unless the Company requests a hearing before a NASDAQ Hearings Panel (the “Panel”).

Digirad Corporation (NASDAQ: DRAD)
today reported 2011 fourth quarter revenue of $11.9 million, 2011 full-year revenue of $53.7 million and an ending cash and available-for-sale securities balance of $30.5 million at December 31, 2011.

Gilead Sciences, Inc. (NASDAQ:GILD)
announced today that the majority of hepatitis C genotype 1 patients with a prior “null” response to an interferon (IFN)-containing regimen enrolled in the ongoing ELECTRON study experienced viral relapse within four weeks of completing 12 weeks of treatment with GS-7977 plus ribavirin (RBV).

HealthMed Services, Ltd. (PINKSHEETS: HEME)
President, Dr. Henry J. Smith, today revealed that the Company has further development on an improved Donor Organ Transport System that will maintain and preserve isolated donor organs in good condition for remarkable and prolonged periods of time, allowing timely and better donor and patient matching.

Idera Pharmaceuticals, Inc. (Nasdaq: IDRA)
today announced that Dr. James B. Wyngaarden has chosen to retire from the Company’s Board of Directors after 21 years of dedicated service.

ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC)
, a biotechnology company focused on the development of novel immune-based cancer therapies, today announced that John Yu, MD, Chairman and Chief Scientific Officer of ImmunoCellular Therapeutics, will deliver a presentation at the Cambridge Healthtech Institute’s inaugural Targeting Stem Cells Symposium as a part of the 19th Annual Molecular Medicine Tri-Conference from February 19-23, 2012.

Medtronic, Inc. (NYSE: MDT)
today announced U.S. Food and Drug Administration (FDA) approval of the Resolute Integrity™ Drug-Eluting Stent (DES) for the treatment of coronary artery disease (CAD).

MMRGlobal, Inc. (OTCBB: MMRF)
("MMR"), a leading provider of Personal Health Records ("PHR"), MyEsafeDepositBox storage solutions and electronic document management and imaging systems for healthcare professionals, today announced that the Company and VisiInc PLC in Australia signed an agreement to license MMR's Australian patents for "Method and System for Providing Online Medical Records" for use in MMR and Visi™ consumer and professional health IT products and services, including the MyMedicalRecords Personal Health Record.

Pfizer Inc. (NYSE: PFE)
and Zhejiang Hisun Pharmaceutical (SSE Code: 600267), a leading pharmaceutical company in China, today signed a framework agreement, advancing their previously announced memorandum of understanding (MOU) to establish a joint venture to develop, manufacture and commercialize off-patent pharmaceutical products in China and global markets.

Plandaí Biotechnology, Inc. (OTCBB: PLPL)
today commented on the Murphy Analytics, LLC research report issued February 8, 2012 that initiated a buy recommendation with a twelve-month price potential of $2.20 per share.

PURE Bioscience, Inc. (NASDAQ: PURE)
, creator of the patented silver dihydrogen citrate (SDC) antimicrobial and SDC-based products, today announced that it will hold its 2012 annual meeting of stockholders on July 25, 2012.

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