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Gentium : Action-Reaction

Gentium : Action-Reaction

Italian drugmaker Gentium S.p.A. (GENT: Quote) was trading around $9 when we alerted readers to the stock in June of this year. The shares touched a new 52-week high of $11.25 yesterday (Sep.12) before closing the day's trading at $10.84. As the company's investigational drug - Defibrotide, for the treatment of severe Veno Occlusive Disease, inches closer to EU approval, it might be worth keeping an eye on this stock.

Veno Occlusive Disease, or VOD, a condition in which some of the veins in the liver are blocked, is a complication of cancer treatment given prior to stem cell transplantation. Severe VOD is associated with multiple-organ failure and high rates of morbidity and mortality. Currently, there are no approved treatments for VOD by either the FDA or the European Medicines Agency.

Gentium's Marketing Authorization Application for Defibrotide was submitted to the European Medicines Agency, or EMA, last May, and is under review. The EMA's Committee for Medicinal Products for Human Use, or CHMP, which reviewed the Defibrotide application, issued the LoQs (List of Questions) last September, seeking some clarifications from the company regarding the drug candidate.

In February of this year, Gentium responded to the EMA's List of Questions for Defibrotide application. However, as further clarification was required, the CHMP issued a LoOI, or List of Outstanding Issues, for the Defibrotide application in May of 2012. In line with the regulatory timetable, in June of this year, the company submitted its response to the List of Outstanding Issues received from the CHMP.

As part of the review process, the company has been asked to present Oral Explanations on September 19, 2012 to the EMA's CHMP regarding the Defibrotide application. Following the meeting, the company expects a final opinion on Defibrotide next quarter. (Q4, 2012).

Defibrotide is not approved anywhere in the world. Last August, Gentium voluntarily withdrew the Defibrotide NDA submitted to the FDA seeking approval in the indication of hepatic veno-occlusive disease in adults and children undergoing hematopoietic stem cell transplantation as concerns were raised regarding the completeness of the datasets for both the treatment and prevention studies.

The company has been working closely with the FDA in connection with the resubmission of the Defibrotide NDA, which is expected to be filed in the first half of 2013.

Even though Defibrotide is not approved anywhere in the world, it continues to be distributed through the company's cost recovery and named-patient programs. The volume of Defibrotide distributed has been on the rise over the years, thanks to increased awareness of Defibrotide and the distribution partnerships established by Gentium. In the second quarter ended June 30, 2012, Defibrotide usage was up 47% over the comparable year-ago quarter.

Apart from the revenue generated through distribution of Defibrotide, Gentium also recognizes revenue from the sale of APIs, or Active Pharmaceutical Ingredients, including urokinase and sulglicotide, produced at the company's manufacturing plant in Italy. Urokinase, an API made from human urine, is used to dissolve fibrin clots while sulglicotide, developed from swine duodenum, is used for ulcer healing and gastrointestinal protection.

A quick look at the company's balance sheet...

In the second quarter ended June 30, 2012, Gentium's net income was EUR 0.82 million or EUR 0.05 per share compared to EUR 0.97 million or EUR 0.06 per share in the second quarter of 2011. Total quarterly revenues were EUR 8.51 million, up from EUR 6.72 million in the comparable quarter last year. The company ended Q2, 2012 with cash and cash equivalents of EUR 10.32 million.

With pending regulatory catalysts, it remains to be seen how the stock price plays out in the coming months.

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by RTT Staff Writer

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