InVivo Therapeutics gets approval for human trials

CAMBRIDGE, Mass. -- InVivo Therapeutics Holdings Corp. said Friday that the Food and Drug Administration will allow it to start human trials of an experimental product that is intended to treat spinal cord injuries.

InVivo said it plans to start a trial of the device, called a biopolymer scaffold product, in the next few months. The company wants to study the device in five patients and said the initial study will last about 15 months.

The Cambridge, Mass., company said there are no FDA-approved treatments that intervene directly in the spinal cord following an injury.

On Thursday the FDA awarded the scaffolding a humanitarian use device exemption. Given to products intended to treat conditions that affect fewer than 4,000 people a year, the exemption could speed up approval of a product and reduce the amount of testing a company has to do. InVivo is trying to get a second exemption, a humanitarian device exemption, which would allow it to get marketing clearance if the FDA agrees the product's probable benefits outweigh its risks and that it doesn't pose a significant risk of illness or injury. InVivo would not have to prove the scaffolding is effective, although it would still have to run clinical tests.

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FDA rejects United Therapeutics' oral hypertension drug again

March 25 (Reuters) - Biotechnology company United Therapeutics Corp said its oral drug to treat hypertension was rejected for the second time by U.S. health regulators, sending its shares down 6 percent before the bell to $57.

The drugmaker did not say it would quit pursuing a marketing approval for the tablet.

"We remain confident that oral treprostinil will play an important role in treating pulmonary arterial hypertension," Chief Executive Martine Rothblatt said.

The drug, treprostinil diolamine, was first rejected by the U.S. Food and Drug Administration in October after it had failed to show statistically significant results in patients taking a six-minute walk test during clinical studies.

United Therapeutics already has a treprostinil injection named Remodulin and an orally inhaled version Tyvaso on the market to treat pulmonary arterial hypertension, a disease characterized by abnormally high blood pressure in the pulmonary artery that carries blood from the heart to the lungs.

Remodulin, the company's lead product, accounted for half of United Therapeutics's revenue last year. The company also sells Adcirca, an oral tablet to treat PAH.

Oral versions are usually preferred over other forms due to their ease of administration.

(Reporting By Vrinda Manocha in Bangalore; Editing by Sreejiraj Eluvangal)

((Vrinda.Manocha@thomsonreuters.com)(within U.S. +1 646 223 8780, outside U.S. +91 80 4135 5800)(Reuters Messaging: vrinda.manocha.thomsonreuters.com@reuters.net))

Keywords: UNITEDTHERAPEUTICS FDA/HYPERTENSIONDRUG

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UPDATE 1-FDA rejects United Therapeutics' oral hypertension drug again

* Rejects resubmission filed in February

* Co likely to conduct fresh late-stage trial - analyst

* Shares down about 6 pct in early trade

(Adds analyst comment) By Vrinda Manocha

March 25 (Reuters) - Biotechnology company United Therapeutics Corp said its oral drug to treat hypertension was rejected for the second time by U.S. health regulators, sending its shares down about 6 percent in early trade on the Nasdaq.

The drugmaker did not say it would quit pursuing a marketing approval for the tablet.

"We remain confident that oral treprostinil will play an important role in treating pulmonary arterial hypertension," Chief Executive Martine Rothblatt said.

The drug, treprostinil diolamine, was first rejected by the U.S. Food and Drug Administration (FDA) in October after it had failed to show statistically significant results in patients taking a six-minute walk test during clinical studies.

The company would probably conduct another late-stage trial for the drug as it had originally planned, Wedbush analyst Liana Moussatos told Reuters.

"After the first rejection,the company thought they'd have to do another late-stage trial and it would take four years before they could resubmit the marketing approval application," she said.

"They did some additional analysis and brought in some historical data and thought they would give it another shot."

The drug will not be approved before 2017 if the trial and the review takes four years.

United Therapeutics already has a treprostinil injection named Remodulin and an orally inhaled version Tyvaso on the market to treat pulmonary arterial hypertension, a disease characterized by abnormally high blood pressure in the pulmonary artery that carries blood from the heart to the lungs.

Moussatos said United Therapeutics did not need oral treprostinil to maintain its growth. She had earlier projected $399 million in peak annual sales for the drug, but had not included the oral variant in her model.

Remodulin, the company's lead product, accounted for $458 million in revenue last year, about half of United Therapeutics's net revenue. The company also sells Adcirca, an oral tablet to treat PAH.

Oral versions of drugs are usually preferred over other forms due to their ease of administration.

(Reporting By Vrinda Manocha in Bangalore; Editing by Sreejiraj Eluvangal)

((Vrinda.Manocha@thomsonreuters.com)(within U.S. +1 646 223 8780, outside U.S. +91 80 4135 5800)(Reuters Messaging: vrinda.manocha.thomsonreuters.com@reuters.net))

Keywords: UNITEDTHERAPEUTICS FDA/HYPERTENSIONDRUG

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UPDATE 2-FDA rejects United Therapeutics' oral hypertension drug again

* Rejects resubmission filed in February

* Co likely to conduct fresh late-stage trial - analyst

* Shares down 2 pct

(Adds company comment, details)

By Vrinda Manocha

March 25 (Reuters) - Biotechnology company United Therapeutics Corp said the oral version of its drug to treat hypertension was rejected for the second time by U.S. health regulators, sending its shares down as much as 7 percent in morning trade on the Nasdaq.

The drugmaker had resubmitted its marketing approval application last month, and an analyst said the fresh rejection was likely to necessitate new trials and a delay of about four years before the company tried again.

The drug, treprostinil diolamine, was first rejected by the U.S. Food and Drug Administration (FDA) in October after it had failed to show statistically significant results in patients taking a six-minute walk test during clinical studies.

The company would now probably conduct another late-stage trial for the drug as it had originally planned, Wedbush analyst Liana Moussatos told Reuters. After the first rejection, the company had said that it could take four years to conduct a new trial and make a new application, she said.

However, "they did some additional analysis and brought in some historical data and thought they would give it another shot," she added.

United Therapeutics already has a treprostinil injection named Remodulin and an orally inhaled version Tyvaso on the market to treat pulmonary arterial hypertension (PAH), a disease characterized by abnormally high blood pressure in the pulmonary artery that carries blood from the heart to the lungs.

The FDA's latest rejection letter did not contain any new issues, the company's vice president for business development, Martin Auster, told Reuters.

"Our infused and inhaled versions have only penetrated a fraction of the market," Auster said. "We believe an orally delivered offering would be preferred by patients and physicians."

Wedbush's Moussatos said United Therapeutics did not need oral treprostinil to maintain its growth. She had earlier projected $399 million in peak annual sales for the drug, but had not included the oral variant in her model.

Remodulin, the company's lead product, accounted for $458 million in revenue last year, about half of United Therapeutics's net revenue. The company also sells Adcirca, an oral tablet to treat PAH.

United Therapeutics' PAH drugs compete with Gilead Sciences Inc's Letairis, Pfizer's Revatio and Swiss biotechnology company Actelion Ltd's Tracleer and Veletri.

United Therapeutics shares, which have risen about 14 percent since the drug was first rejected last year, were down about 2 percent at $59.73 on the Nasdaq.

(Reporting By Vrinda Manocha in Bangalore; Editing by Sreejiraj Eluvangal)

((Vrinda.Manocha@thomsonreuters.com)(within U.S. +1 646 223 8780, outside U.S. +91 80 4135 5800)(Reuters Messaging: vrinda.manocha.thomsonreuters.com@reuters.net))

Keywords: UNITEDTHERAPEUTICS FDA/HYPERTENSIONDRUG

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Medical device maker Cytori Therapeutics loses approval fight

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