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Schwarzwald
0
LEIDEN, NETHERLANDS, Jun 01, 2009 (MARKETWIRE via COMTEX) -- Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) announced today that it has presented an abstract describing the interim analysis of the immunosafety of Rhucin(R) (recombinant human C1 inhibitor) in patients with Hereditary Angioedema (HAE) at the 6th C1-Inhibitor Deficiency Workshop in Budapest. Rhucin(R) immuno-safety review is an important part of both the EMEA (European Medicines Agency) and the FDA (US Food and Drug Administration) upcoming regulatory submissions. Results of the presented interim-analysis confirm the absence of immunological side-effects of Rhucin(R).
ingrid030
0
quote:
Schwarzwald schreef:

LEIDEN, NETHERLANDS, Jun 01, 2009 (MARKETWIRE via COMTEX) -- Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) announced today that it has presented an abstract describing the interim analysis of the immunosafety of Rhucin(R) (recombinant human C1 inhibitor) in patients with Hereditary Angioedema (HAE) at the 6th C1-Inhibitor Deficiency Workshop in Budapest. Rhucin(R) immuno-safety review is an important part of both the EMEA (European Medicines Agency) and the FDA (US Food and Drug Administration) upcoming regulatory submissions. Results of the presented interim-analysis confirm the absence of immunological side-effects of Rhucin(R).


er wordt niet meer in pb voor een daling getrapt, firma list en bedrog
Legrand
0
LEIDEN, NETHERLANDS, Jun 01, 2009

We leven in het jaar 2010! Oud nieuws lijkt me!?
Schwarzwald
0
Cash-Starved Pharming Spins Out DNage; But is it Enough?



By Cormac Sheridan


BioWorld International Correspondent
With its lead product Rhucin (recombinant C1 inhibitor) under regulatory review in Europe and its cash balance dwindling rapidly, Pharming Group NV is battening down the hatches by spinning out DNage BV, a firm it acquired in 2006.

DNage, of Rotterdam, the Netherlands, was spun out of the Erasmus Medical Center (EMC) at Erasmus University, in Rotterdam, in 2004 to commercialize research on aging disorders conducted by scientific founders Jan Hoeijmakers, Bert van der Horst, Wim Vermeulen and Roland Kanaar. Leiden, the Netherlands-based Pharming acquired the firm in 2006 for €e15 million in stock plus undisclosed milestone payments. (See BioWorld International, March 29, 2006.).

Its lead product, Prodarsan, is in clinical trials in Cockayne syndrome, a rare inherited disorder caused by defects in transcription-coupled DNA repair. This week, Pharming said that in lieu of earnout payments of up to €€10 million, it would grant former DNage shareholders 5 million Pharming shares plus a 49 percent stake in DNage.

However, with a quarterly cash burn of around €e6 million (US$7.4 million), Pharming is facing into stiff head winds as it seeks to raise more funding. Spinning out DNage "is not going to be enough to preserve the cash. The company's cash position is very low," Jan De Kerpel, of KBC Securities in Brussels, Belgium, told BioWorld International.

Pharming reported net cash of e€3.3 million at the end of the first quarter. It subsequently received an undisclosed up-front payment from Stockholm, Sweden-based Swedish Orphan Biovitrum AB, on the strength of a European distribution deal for Rhucin in its lead indication, treatment of acute attacks of hereditary angioedema (HAE). The deal also covers additional indications, which are at an early stage of development.

The company has more than e€15 million in convertible debt on its balance sheet, which is a major disincentive for would-be investors.

"It's a very high hurdle for new investors," De Kerpel said. For that reason, the company is not in strong negotiating position. "They have to accept anything that is being offered."

A decision on Rhucin is expected by September, and so far the indications are that the review is proceeding smoothly, he said. However, that in itself may not bring salvation. Successive delays in the program – an initial filing was rejected in December 2007, as was an appeal in March 2008 – mean that the company has lost its lead on the competition.

Two HAE products are now on the market in Europe – Firazyr (icatabant), marketed by Basingstoke, UK-based Shire plc, and Berinert (human C1-INH concentrate), marketed by Marburg, Germany-based CSL Behring GmbH. Sales of the former have been "very disappointing," De Kerpel said..

Moreover, Viropharma Inc., of Exton, Pa., has filed for approval of Cinryze (C1 esterase inhibitor) as an acute and prophylactic therapy in Europe, having successfully launched the product in the U.S.

"It's become quite crowded over here," De Kerpel said. "I'm having some concerns on the economic potential of the product."

Nevertheless, he has a "hold" rating on the stock, with a target price of €€0.50, which represents a significant uptick on its current price of €0.30. And the company does have one card up its sleeve – a €€30 million standby equity distribution agreement with Yorkville Advisors LLC, of Jersey City, N.J.

So far, it has only drawn down a fraction of the funds available under the deal.
calbo
0
quote:
Legrand schreef:

LEIDEN, NETHERLANDS, Jun 01, 2009

We leven in het jaar 2010! Oud nieuws lijkt me!?


Waarschijnlijk is de heer Schwarzwald een van de nieuwe inversteerders op 0,12 en hoopt hiermee nog even wat kopers uit te lokken om daarna keurig te dumpen etc.
Fix-it
0
quote:
Legrand schreef:

LEIDEN, NETHERLANDS, Jun 01, 2009

We leven in het jaar 2010! Oud nieuws lijkt me!?


Och...verrek...was me helemaal niet opgevallen. Shame on me!
Schwarzwald
0
AMSTERDAM, June 1 (Reuters) - Dutch biotechnology firm Pharming Group NV (PHAR.AS) said on Monday its lead product Rhucin has moved a step closer to regulatory filings for marketing approval after passing an interim analysis.

The company said the latest analysis showed that patients treated with Rhucin had not experienced a triggered immunological side-effect, such as the production of antibodies.

The EMEA has twice rejected Pharming's application to market Rhucin, which treats hereditary angioedema, characterised by acute attacks of painful swelling of the skin, intestine, mouth and throat.

Pharming has said it intends to refile an application for approval of Rhucin with the European Medicines Agency (EMEA) in September, while a filing with the U.S. Food and Drug Administration (FDA) would follow.

"Results of the presented interim analysis confirm the absence of immunological side-effects," Pharming said in a statement, adding it had presented the analysis at a workshop in Budapest.

Shares in Pharming rose in morning trade and at 0923 GMT were up 13.4 percent at 0.69 euros, to be the second-largest gainer in a positive Amsterdam market, outperforming a 2.7 percent rise in the Amsterdam AEX index .AEX.

"This gives more confidence to the story and confidence about the filings for Rhucin at the EMEA and FDA," AEK analyst Bernd Hilhorst said, adding that although it confirms earlier data it is still a minor step for the company.

"The major problem in Pharming are the financials," he said.

Hilhorst anticipates Pharming will gain marketing approval for Rhucin late in the second quarter of 2010, at about the same time he expects the company's current cash position to have dried up.

Pharming had a cash position at the end of the first quarter of 16 million euros ($22.4 million). It said in April attracting new financing remains a top priority after previously announcing a restructuring of its convertible bonds and a 20 million euros stand-by equity line with Yorkville Advisors.

But Hilhorst said Pharming should also increase its focus on making product deals.

"They have to be very active in the deal making. They have a good product line and are a good solid company, but they have to create deals to get value extracted from the products," he said.

Pharming Chief Operations Officer Bruno Giannetti said to comply with a request from the EMEA, a full immunosafety analysis of the effects of Rhucin will form an important element of the company's submission to the EMEA. It will also be part of FDA submission.

Pharming also said clinical trials of Rhucin are continuing and reiterated it is also preparing filings for Rhucin in territories outside the United States and the European Union. ($1=.7146 euros) (Editing by Mike Nesbit)
calbo
0
quote:
Schwarzwald schreef:

Cash-Starved Pharming Spins Out DNage; But is it Enough?



By Cormac Sheridan


BioWorld International Correspondent
With its lead product Rhucin (recombinant C1 inhibitor) under regulatory review in Europe and its cash balance dwindling rapidly, Pharming Group NV is battening down the hatches by spinning out DNage BV, a firm it acquired in 2006.

DNage, of Rotterdam, the Netherlands, was spun out of the Erasmus Medical Center (EMC) at Erasmus University, in Rotterdam, in 2004 to commercialize research on aging disorders conducted by scientific founders Jan Hoeijmakers, Bert van der Horst, Wim Vermeulen and Roland Kanaar. Leiden, the Netherlands-based Pharming acquired the firm in 2006 for €e15 million in stock plus undisclosed milestone payments. (See BioWorld International, March 29, 2006.).

Its lead product, Prodarsan, is in clinical trials in Cockayne syndrome, a rare inherited disorder caused by defects in transcription-coupled DNA repair. This week, Pharming said that in lieu of earnout payments of up to €€10 million, it would grant former DNage shareholders 5 million Pharming shares plus a 49 percent stake in DNage.

However, with a quarterly cash burn of around €e6 million (US$7.4 million), Pharming is facing into stiff head winds as it seeks to raise more funding. Spinning out DNage "is not going to be enough to preserve the cash. The company's cash position is very low," Jan De Kerpel, of KBC Securities in Brussels, Belgium, told BioWorld International.

Pharming reported net cash of e€3.3 million at the end of the first quarter. It subsequently received an undisclosed up-front payment from Stockholm, Sweden-based Swedish Orphan Biovitrum AB, on the strength of a European distribution deal for Rhucin in its lead indication, treatment of acute attacks of hereditary angioedema (HAE). The deal also covers additional indications, which are at an early stage of development.

The company has more than e€15 million in convertible debt on its balance sheet, which is a major disincentive for would-be investors.

"It's a very high hurdle for new investors," De Kerpel said. For that reason, the company is not in strong negotiating position. "They have to accept anything that is being offered."

A decision on Rhucin is expected by September, and so far the indications are that the review is proceeding smoothly, he said. However, that in itself may not bring salvation. Successive delays in the program – an initial filing was rejected in December 2007, as was an appeal in March 2008 – mean that the company has lost its lead on the competition.

Two HAE products are now on the market in Europe – Firazyr (icatabant), marketed by Basingstoke, UK-based Shire plc, and Berinert (human C1-INH concentrate), marketed by Marburg, Germany-based CSL Behring GmbH. Sales of the former have been "very disappointing," De Kerpel said..

Moreover, Viropharma Inc., of Exton, Pa., has filed for approval of Cinryze (C1 esterase inhibitor) as an acute and prophylactic therapy in Europe, having successfully launched the product in the U.S.

"It's become quite crowded over here," De Kerpel said. "I'm having some concerns on the economic potential of the product."

Nevertheless, he has a "hold" rating on the stock, with a target price of €€0.50, which represents a significant uptick on its current price of €0.30. And the company does have one card up its sleeve – a €€30 million standby equity distribution agreement with Yorkville Advisors LLC, of Jersey City, N.J.

So far, it has only drawn down a fraction of the funds available under the deal.




Ook al oud nieuws heer Schwarzwald, is al geplaatst.
En de schrijver van dit stukje, zoals ik reeds in een eerdere posting heb aangegeven, mister Sheridan heeft zijn kantoor in dezelfde stad als de hierboven genoemde Engelse concurrent nl. Basingstoke.
Dus.............
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