August 17, 2011 12:58 PM Eastern Daylight Time 

MAPLE GROVE, Minn.–(EON: Enhanced Online News)–Entellus Medical inc., a medical device company that markets minimally invasive solutions for treatment of patients with chronic sinusitis, today announced the completion of a $35 million round of fund raising. the new financing was led by Covidien Ventures, who joined existing investors SV Life Sciences, Essex Woodlands, Split Rock Partners, and Greenspring Associates. Proceeds from the financing will be used to fund the company’s ongoing operations and commercialization of Entellus’ multiple product lines, which are used by Ear, Nose, & Throat (ENT) physicians to dilate narrowed or obstructed sinus drainage pathways.

“the recent financing led by Covidien Ventures, along with the strong support of our existing investors, provides Entellus the capital necessary to substantially grow our business while providing significant savings to the healthcare system and numerous benefits to the patients who suffer from chronic or recurring sinusitis.”

Chronic sinusitis impacts approximately 37 million Americans and leads to surgical intervention in approximately 525,000 U.S. patients per year. Entellus Medical products employ balloon technology to open sinus drainage paths and have been demonstrated in clinical studies to safely reduce the symptoms of chronic and recurrent sinusitis sufferers. Entellus products have also been proven to reduce absenteeism of these patients while also improving work productivity.

the company’s product lines include the XprESS multi-sinus dilation tool, which offers ENT physicians an easy-to-use, cost-effective tool to trans-nasally treat the frontal, sphenoid or maxillary sinuses in either a doctor’s office or operating room. the company’s FinESS product line is uniquely designed for use in a doctor’s office and enables ENT physicians to directly visualize and dilate the drainage path from the maxillary sinus. the maxillary sinus is the most common sinus that undergoes surgical intervention. a study published in 2011 showed that the FinESS procedure performed in a doctor’s office was safe, well-tolerated by patients and provided long-term relief of sinus-related symptoms.

the procedures in which Entellus products are exclusively used are covered by many health insurance plans which together constitute approximately 150 million covered lives in the U.S. When performed in the doctor’s office, these procedures are less costly to the healthcare system than traditional endoscopic sinus surgery performed in hospital or surgicenter operating rooms.

According to Brian Farley, President and CEO of Entellus Medical, “The recent financing led by Covidien Ventures, along with the strong support of our existing investors, provides Entellus the capital necessary to substantially grow our business while providing significant savings to the healthcare system and numerous benefits to the patients who suffer from chronic or recurring sinusitis.”

About Entellus MedicalEntellus Medical (entellusmedical.com) provides complete solutions for the minimally invasive treatment of chronic and recurrent sinusitis patients and is leading the way with easy-to-use, cost-effective products designed for office-based balloon dilation of narrowed sinus pathways. With this approach, Entellus sinus dilation products also provide significant efficiency and cost-effectiveness for sinus dilation procedures performed in operating rooms.

SOURCE: Corcept Therapeutics

  Mar 31, 2011 16:25 ET

MENLO PARK, CA–(Marketwire – March 31, 2011) – Corcept Therapeutics Incorporated (NASDAQ: CORT), a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic and psychiatric disorders, today announced that it will submit its New Drug Application (NDA) for the use of CORLUX in Cushing’s Syndrome to the FDA the week of April 11, 2011.

“We are in the final stages of preparing our NDA submission and are on track to submit our application to the FDA within the next two weeks,” said Joseph Belanoff, M.D., Chief Executive Officer of Corcept. ”We look forward to submitting our NDA for CORLUX to the FDA, and, if approved by the FDA, providing an important treatment option to patients suffering from Cushing’s Syndrome.” 

CORLUX in Cushing’s Syndrome Regulatory and Commercialization Update

The completion of the NDA submission is a critical milestone for Corcept on our path to making CORLUX available to Cushing’s Syndrome patients. Additional initiatives in support of this objective include the following:

• We plan to submit a request to the FDA for Priority Review along with our NDA submission. according to the FDA, “Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists.” the FDA’s goal for completing a Priority Review is six months. the FDA will notify us within 45 days of our request whether our NDA has been assigned a Priority Review or a Standard Review (for which the FDA’s goal is a ten month review time).

• We expect that the FDA will notify us whether our NDA submission has been accepted for filing within 74 days of submission, which the FDA bases on their initial 60-day review of the completeness of our application.

• We expect to make detailed data from our Phase 3 trial of CORLUX in Cushing’s Syndrome available to the endocrinologists who treat the disorder at the Endocrine Society Annual Meeting (ENDO), June 4-7 in Boston.

• We are developing plans and engaging third-party vendors to support a commercial launch of CORLUX in the United States, if approved by the FDA.

About Cushing’s Syndrome

Endogenous Cushing’s Syndrome is caused by prolonged exposure of the body’s tissues to high levels of the hormone cortisol and is generated by tumors that produce cortisol or ACTH. Cushing’s Syndrome is an orphan indication which most commonly affects adults aged 20 to 50. An estimated 10 to 15 of every one million people are newly diagnosed with this syndrome each year, resulting in over 3,000 new patients in the United States. An estimated 20,000 patients in the United States have Cushing’s Syndrome. Symptoms vary, but most people have one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Cushing’s Syndrome can affect every organ system in the body and can be lethal if not treated effectively.

About CORLUX

Corcept’s first-generation compound, CORLUX, also known as mifepristone, directly blocks the cortisol (GR-II) receptor and the progesterone (PR) receptor. Intellectual property protection is in place to protect important methods of use for CORLUX. Corcept retains worldwide rights to its intellectual property related to CORLUX.

About Corcept Therapeutics Incorporated

Corcept is a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic and psychiatric disorders. the company has completed its Phase 3 study of CORLUX for the treatment of Cushing’s Syndrome, and has an ongoing Phase 3 study of CORLUX for the treatment of the psychotic features of psychotic depression. Corcept also has a Phase 2 program for CORT 108297 and an IND-enabling program for CORT 113083. both of these novel compounds are selective GR-II antagonists – compounds which block the effects of cortisol but not progesterone. Corcept has developed an extensive intellectual property portfolio that covers the use of GR-II antagonists in the treatment of a wide variety of psychiatric and metabolic disorders, including the prevention of weight gain caused by the use of antipsychotic medication, as well as composition of matter patents for our selective GR-II antagonists.

Statements made in this news release, other than statements of historical fact, are forward-looking statements, including, for example, statements relating to Corcept’s clinical development and research programs, the timing of the NDA submission and introduction of CORLUX and future product candidates, including CORT 108297 and CORT 113083, estimates of the timing of enrollment or completion of our clinical trials and the anticipated results of those trials, the ability to create value from CORLUX or other future product candidates and our estimates regarding our capital requirements, spending plans and needs for additional financing. Forward-looking statements are subject to a number of known and unknown risks and uncertainties that might cause actual results to differ materially from those expressed or implied by such statements. for example, there can be no assurances with respect to the cost, rate of spending, completion or success of clinical trials; financial projections may not be accurate; there can be no assurances that Corcept will pursue further activities with respect to the development of CORLUX, CORT 108297, CORT 113083 or any of its other selective GR-II antagonists. these and other risk factors are set forth in the Company’s SEC filings, all of which are available from our website (corcept.com) or from the SEC’s website (sec.gov). We disclaim any intention or duty to update any forward-looking statement made in this news release.