Cortendo plans tax-fuelled shift to Dublin

Posted on August 6, 2015 by MaryO

Cortendo, a Swedish-American biopharmaceutical company that has invested millions developing treatments for rare conditions such as Cushing’s syndrome, is the latest global drug company to propose a move to Ireland for tax reasons.

The company operates from Pennsylvania, is listed in Norway but is incorporated in Sweden.

In recent days it told its investors it had submitted a prospectus to the Central Bank relating to the establishment of a Dublin-based public limited company.

Cortendo is proposing that the new Dublin company would become the parent of the group, replacing its current Swedish domicile. The Irish company would buy all of the outstanding stock in the current Cortendo parent, paying investors with an issuance of depositary receipts.

Depositary receipts have become popular financial instruments in the biopharma industry, and are typically used by non-US drug companies that want to trade in over-the-counter and traditional US markets.

Cortendo told its shareholders the move to Ireland “will have the effect of facilitating tax-efficient allocations of capital [and] tax-efficient returns of capital to shareholders”.

“Furthermore, the board expects that certain features of Irish company law will enable the Cortendo group to operate more flexibly and efficiently,” the company said.

Cortendo had not yet responded to a request prior to publication for details on what, if any, staff or operations would be shifted to Dublin as part of the move.

The company last month indicated it may seek to list its shares in the United States, although it did not discuss a valuation. It set up its Irish unit in May, according to company filings.

The company focuses on developing drugs to treat rare endocrine diseases, including the potentially fatal Cushing’s and acromegaly, inflammation of the hands and feet that can lead to diabetes.

Its main drugs have not yet been commercialised but it has high hopes for its treatment for Cushing’s , which is at a late stage of development. The company’s latest annual report shows an operating loss of about €8 million.

From http://www.irishtimes.com/business/health-pharma/swedish-drug-firm-plans-tax-fuelled-shift-to-dublin-1.2307007

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Clinical Trial for Cortendo

Posted on March 13, 2015 by MaryO

Cortendo Clinical Trial

 

About the Study

OBJECTIVE:

The purpose of this study is to test the effects of different doses of COR-003 on people with endogenous Cushing’s syndrome, primarily by measuring the cortisol levels in urine and secondarily by measuring other health parameters such as blood pressure, weight, liver function, etc. This study is also being conducted to find out if COR-003 is safe to use. This study is open-label, which means both the health providers and the participants in the study are aware of the drug or treatment being given.

STUDY DESIGN:

  • The study will begin with a screening period to make sure subjects are eligible to participate in the study.
  • After the screening period, subjects who are eligible for participation will each be given several different doses of COR-003, to be taken by mouth in tablet form.
  • After an individualized dose has been selected, participants will take COR-003 for 6 months.
  • Finally, participants will continue in the study for an additional 6 months at doses to be determined by the study doctor.
  • Throughout the study, participants will meet regularly with a study doctor and will take part in a variety of medical tests to make sure they are doing well and to see if COR-003 is working.
  • Participants in the study should be sure they have the time to participate. Participants will generally be followed for over a year.

See if you may be eligible for this clinical study. By providing your contact information, you will receive more information about the study and your eligibility.

About Cortendo

Cortendo is the sponsor of this study. This means Cortendo planned and organized this study. Cortendo will also collect and analyze the data from the study.

Cortendo is a global pharmaceutical company primarily focused on researching and providing treatments for rare diseases in endocrinology, such as Cushing’s syndrome. The company was founded in Sweden and its worldwide headquarters is located just outside of Philadelphia.

Fill out this form for more information: https://www.cushingssyndromestudy.com/registration.aspx

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Research Study: An Open Label Study to Assess the Safety and Efficacy of COR-003 (2S, 4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome

Posted on November 14, 2014 by MaryO

Objectives:         

The purpose of this study is to test the effects of different doses of COR-003 on people with Cushing’s syndrome (CS) primarily by measuring the cortisol levels in urine and secondarily by measuring other health parameters such as blood pressure, weight, and liver function. This study is also being conducted to see if there is any harm caused when using COR-003.

This study is an open label study. That means both the health providers and the participants in the study are aware of the drug or treatment being given.

Eligibility:

Adult Subjects (18 years or older) with elevated levels of cortisol due to endogenous CS.

Confirmed diagnosis of persistent or recurrent CS (with or without therapy) or newly diagnosed disease, if subjects are not candidates for surgery. CS will be defined according to the criteria in the guidelines for diagnosis of CS (Nieman 2008).

Women who are pregnant or lactating are not eligible for this study.

Individuals with other health conditions or diagnoses may not be eligible for this study.

These and other eligibility criteria are best reviewed with a doctor who is participating in the study. You can also get more detailed eligibility information about the study by clicking here to visit http://www.clinicaltrials.gov.

Study Design:

  • The study will begin with a screening period to make sure subjects are eligible to participate in the study.
  • After the screening period, subjects who are eligible for participation will each be given several different doses of COR-003, to be taken orally in tablet form.
  • After an individualized dose has been selected, participants will take COR-003 for six months.
  • Finally, participants will continue in the study for an additional six months at doses to be determined by the study doctor.

 

Throughout the study, participants will meet regularly with a study doctor and will take part in a variety of medical tests to make sure they are doing well and to see if COR-003 is working.

Participants in the study should be sure they have the time to participate. Participants will generally be followed for over a year:

Study Locations

The study is currently taking place in several places around the world (United States, Belgium, France, Israel, Netherlands, Spain, and Sweden).
Additional information on the study can be found at clinicaltrials.gov through this link.

Study sponsor: Cortendo AB

For more information, please contact:

Jim Ellis at Cortendo AB tel: +1 (610) 254-9245 or jellis@cortendo.com

 

Filed under: adrenal, Clinical trials, Cushing's, pituitary, Treatments | Tagged: , , , , , , , , , , , , , | Leave a comment »

Cortendo gains $11M for late-stage Cushing’s study

Posted on October 31, 2014 by MaryO

Cortendo is coming to America. Founded in Sweden, the little biotech has a new CEO who’s building the executive team in the Philadelphia area. And he’s dropping plans for a listing on the Oslo exchange in favor of a U.S. IPO after raising $11 million in bridge financing.

Cortendo CEO Matthew Pauls

The big idea at Cortendo is to take an existing drug–ketoconazole, which is used off-label for Cushing’s disease–and tinker with it to make it safer and more effective. HealthCap, the Third Swedish National Pension Fund (“AP3”), Storebrand and Arctic Fund Management are putting up the venture round. And their money is funding an on-going Phase III study designed to make their case with the FDA.

“It is a nice bridge to the U.S. which also allows us from funding perspective to drive that critically important Phase III to closure,” says CEO Matthew Pauls, an ex-Shire ($SHPG) and Insmed exec from the commercial side of the industry who joined the company a couple of months ago.

Cushing’s is characterized by elevated levels of cortisol, which trigger a host of serious and potentially lethal side effects. The new drug–dubbed COR-003–is designed to hit key enzymes in the cortisol synthesis pathway, using a more targeted segment of ketoconazole.

“We took basically the better half of the molecule and are using it explicitly for Cushing’s syndrome,” says the CEO. Now Cortendo–which is run by a core team of 6, which Pauls plans to expand–will drive for final late-stage data in 2017, setting up a prospective application with the FDA that could allow the company to proceed with plans to create its own commercial operations.

There are about 20,000 to 25,000 Cushing’s patients in the U.S., adds Pauls, with maybe 30,000 to 40,000 in Europe. About half of those patients can expect surgery to address the disease, with the rest candidates for medicinal therapies.

The U.S. represents the company’s largest market opportunity, says Pauls. So it makes sense to drop the Oslo listing in favor of a U.S. exchange. Exactly when that filing could come and where, he adds, hasn’t been determined yet.

– here’s the release

From http://www.fiercebiotech.com/story/little-cortendo-gains-11m-late-stage-cushings-study-hatches-us-ipo-plans/2014-10-30

Filed under: Clinical trials, Cushing's, Rare Diseases | Tagged: , , , , , , | Leave a comment »

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