tag:blogger.com,1999:blog-5208562407788722307.post6848925662615156455..comments2021-02-05T09:12:24.123+00:00Comments on Pompe disease - the real story: Pharming Press release of 3 May 1999Kevin O'Donnellhttp://www.blogger.com/profile/00826027508838686684noreply@blogger.comBlogger2125tag:blogger.com,1999:blog-5208562407788722307.post-71001288940262397622009-12-22T14:29:59.215+00:002009-12-22T14:29:59.215+00:00Patents
Pharming received its first patent for tr...Patents<br /><br />Pharming received its first patent for transgenic animal technology in Japan<br />from the Japanese patent office, covering the use of casein promoters for the<br />production of biopharmaceuticals in the milk of transgenic animals. In addition, Pharming’s received its 10th US patent, covering the purification of human Lactoferrin from milk. The total number of patents increased to 22, while at year-end 1998 the number was 19.<br /><br />Corporate Affairs<br /><br />Pharming N.V., the Belgium subsidiary of Pharming, received a grant of EUR 2.7 million from the Flanders Government to expand facilities and product development programs in Geel, Belgium, particularly the<br />construction of a state-of-the-art plant for the purification of biopharmaceuticals from the milk of transgenic rabbits. <br /><br />AEX Listing<br /><br />In view of unfavourable stock market conditions for biotechnology companies<br />world-wide, Pharming postponed its co-listing on the Amsterdam Exchanges until further notice. Pharming has been quoted on the pan-European exchange EASDAQ since July 2, 1998.<br /><br />"Pharming has had a strong start to the year, and our lead programme, the Phase II clinical trial with human alpha-Glucosidase for Pompe’s disease, is progressing well," said George J. M. Hersbach, President and Chief<br />Executive Officer of Pharming Group N.V. "We also received our second Orphan Drug Designation for human C1 Esterase inhibitor, which is very good news for our product development portfolio and testimony to the<br />excellent performance of our Orphan Products business unit. Pharming has a very strong cash position that will allow us to support the market launch of human alpha-Glucosidase, and to further develop our product portfolio."<br /><br />Pharming focuses on the development, production and world-wide commercialisation of human therapeutic proteins, produced at high levels in the milk of transgenic animals that have been generated using the Pharming’s proprietary technology. <br /><br />Statements included in this press release which are not historical in nature are intended to be, and are hereby identified as, "forward-looking statements" for purposes of the safe harbour provided by Section 21E of the Securities Exchange Act of 1934, as amended by the Private Securities<br />Litigation Reform Act of 1995. Forward-looking statements may be identified<br />by words including "anticipates", "believes", "intends", "estimates",<br />"expects" and similar expressions. The company cautions readers that<br />forward-looking statements, including without limitation those relating to the<br />company's future operations and business prospects, are subject to certain<br />risks and uncertainties that could cause actual results to differ materially<br />from those indicated in the forward-looking statements. Factors that could<br />cause actual results and future operations and business prospects to<br />materially differ from those anticipated in these forward looking statements<br />include, but are not limited to, clinical and scientific results and<br />developments concerning corporate collaborations and the company's<br />proprietary rights and other known and unknown risks including risk factors<br />described in the prospectus relating to the company's recent initial public<br />offering. Pharming Group N.V. cautions readers not to place undue reliance<br />upon any such forward-looking statements, which speak only as of the date<br />made. Pharming expressly disclaims any obligation or undertaking to<br />release publicly any updates or revisions of such statements to reflect any<br />changes in Pharming’s expectations or any change in events, conditions or<br />circumstances on which any risk statement is based.Kevin O'Donnellhttps://www.blogger.com/profile/00826027508838686684noreply@blogger.comtag:blogger.com,1999:blog-5208562407788722307.post-378551260463297112009-12-22T14:28:17.891+00:002009-12-22T14:28:17.891+00:00Pharming Group N.V. Reports Q1 Earnings 1999
Phase...Pharming Group N.V. Reports Q1 Earnings 1999<br />Phase II Clinical Trial for Pompe’s Disease on Track<br /><br />Leiden, The Netherlands, May 3, 1999 – Pharming Group N.V. (Easdaq:<br />PHAR) today announced financial results for its first quarter ended March<br />31, 1999.<br /><br />Pharming reported that revenues for its first quarter of 1999 increased to<br />EUR 1.9 million, from EUR 0.1 million in the first quarter 1998. The revenues<br />comprised payments from corporate partners. Expenses increased in Q1<br />1999 to EUR 5.6 from EUR 3.7 million in Q1 1998 reflecting, amongst other<br />factors, the continued development of human alpha-Glucosidase for the<br />treatment of Pompe’s disease. Net loss for the first quarter amounts to EUR<br />3.1 million, compared to EUR 3.6 million in the same period in 1998<br />(excluding exceptional charges in Q1 1998 of EUR 7.1 million for acquired<br />technologies).<br /><br />As of March 31, 1999, Pharming had cash and cash equivalents of EUR<br />67.4 million, primarily invested in term deposits. Pharming believes that its<br />current cash position will allow it to reach its next phase of development,<br />namely the market launch of its lead biopharmaceutical product human<br />alpha-Glucosidase for Pompe’s disease, as well as further developing its<br />product portfolio.<br /><br />Highlights Q1<br /><br /> Phase II clinical trial for Pompe’s disease on track <br /> Second US Orphan Drug Designation for human C1 Esterase inhibitor<br /> Cattle transfer from The Netherlands to Finland completed <br /> First patent for transgenic animal technology in Japan <br /> EUR 2.7 million grant from Flanders Government to support<br /> expansion of Pharming’s facilities in Geel, Belgium <br /><br /> <br /><br />Product Development<br /><br />In the first quarter of 1999, patients were enrolled in the first-ever<br />clinical<br />study of human alpha-Glucosidase to treat Pompe’s disease at the Sophia<br />Children’s Hospital in Rotterdam, the Netherlands. The pilot Phase II trial<br />includes juvenile and infantile patients. Each patient in the trial will be<br />treated for six months. The infantile segment of this study is fully underway.<br />On basis of observations from the current Phase II Clinical Study, we expect<br />to expand the current trial also at other centers in the second quarter. An<br />interim update with respect to this study can be expected later in the<br />second quarter of 1999. This study will be followed by pivotal trials expected<br />to begin in mid 1999 in Europe and the US. This program is the focus of a<br />joint venture between Pharming and Genzyme General to develop and<br />commercialize world-wide the enzyme human alpha-Glucosidase as a<br />treatment for Pompe’s disease, a lethal hereditary muscle disease. Human<br />alpha-Glucosidase has been designated an Orphan Drug by the US Food<br />and Drug Administration (FDA). Upon successful completion of the<br />development program, the Pharming/Genzyme joint-venture will obtain 7<br />years of market exclusivity in the US once its product receives marketing<br />approval from the US FDA.<br /><br />In the first quarter of 1999, Pharming obtained its second Orphan Drug<br />Designation from the US FDA for recombinant human C1 Esterase inhibitor,<br />in both prophylaxis and acute treatment of hereditary and acquired<br />angioedema. Hereditary angioedema (HAE) is an autosomal dominant<br />disorder that results in a deficiency of functional human C1 Esterase<br />inhibitor. The deficiency causes a runaway reaction of the immune system<br />and clinical symptoms include swelling of the skin, abdominal organs, and<br />upper airway tract. Hereditary angioedema seriously affects quality of life<br />and can lead to life-threatening complications. The number of patients in the<br />western world suffering from HAE is estimated to be between 10,000 and<br />50,000.Kevin O'Donnellhttps://www.blogger.com/profile/00826027508838686684noreply@blogger.com