Replies to post #9360 on GTC Biotherapeutics (fka GTCB)

[DewDiligence]

Pharming Provides Update on Business Strategy at Shareholders Meeting

[Nothing earthshaking here. The CEO, who is 65, will retire by year end, and the company will consider out-licensing some programs.]

http://biz.yahoo.com/iw/080416/0387318.html

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Wednesday April 16, 8:00 am ET

Leiden, The Netherlands, April 16, 2008. Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) announces that it will provide an update of its business strategy during the Annual Meeting of Shareholders later today. It also announced organisational changes in its Board of Management and Board of Supervisory Directors.

During the meeting the Company will confirm its strategy to focus its business on the further development of Rhucin® and to aim for registration of the product as a treatment for acute attacks of Hereditary Angioedema as soon as possible. It expects to receive the data from a placebo-controlled clinical trial in the USA in the near future. In addition, over one hundred additional treatments of attacks in an open label protocol have now been performed, the results of which will become available around the same time as those of the placebo-controlled trial. Several patients have been treated multiple times in this study. After analysis of all these data the filing strategy in the USA and EU will be determined.

Pharming expects that it will have an opportunity to meet with the regulatory authorities in the USA and EU before it submits its filings. It is likely that in the EU Pharming will ask for scientific advice from the authorities, to facilitate the development of a database that will give sufficient assurance that the product is also safe and efficacious after repeat use.

While the financial position of the Company remains strong, Pharming will consider alternative financing possibilities for other key programs to maintain a strong cash position over the next few years. Such possibilities could include outlicensing of programs as well as financing linked to one or more specific products or programs.

In the planned evolution of the Pharming organisation certain changes in the Board of Management and the Board of Supervisory Directors will be implemented. Having reached the age of 65, Dr. Francis Pinto will announce today that he is planning to resign from his current position as CEO later this year. The Board of Supervisory Directors has initiated a process for his succession assuring a smooth transition over the next few months. The Company will further announce that Mr. Jaap Blaak (currently member of the Board of Supervisory Directors) will take over the chairmanship of this Board from Mr. Veltman, who will stay on as a member.

About Pharming Group NV

Pharming Group NV is developing innovative products for the treatment of genetic disorders, ageing diseases, specialty products for surgical indications, intermediates for various applications and nutritional products. Pharming has two products in late stage development - Rhucin® for HAE and human lactoferrin for use in food products. The advanced technologies of the Company include innovative platforms for the production of protein therapeutics, technology and processes for the purification and formulation of these products, as well as technology in the field of DNA repair (via DNage). Additional information is available on the Pharming website, http://www.pharming.com and on http://www.dnage.nl.
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[DewDiligence]

Pharming Starts Clinical Program in Ageing Diseases

[Is it just a coincidence that this PR comes out one day after SIRT is acquired by GSK?]

http://biz.yahoo.com/iw/080423/0389641.html

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Wednesday April 23, 5:59 am ET

LEIDEN, NETHERLANDS--(MARKET WIRE)--Apr 23, 2008 -- Pharming Group NV ("Pharming") (NYSE Euronext: PHARM) announced today that its wholly owned subsidiary DNage has started a Phase I clinical study to evaluate the pharmacokinetics and tolerability of Prodarsan® in humans.

Premature ageing, the primary target of Prodarsan®, is a group of rare genetic diseases which manifests itself in several forms that are genetically and clinically similar although not identical. Dependent on the specific form of the disease, patients have a strongly reduced life expectancy and exhibit many ageing-related diseases early on in their lives. There is currently no effective therapy available for these patients.

Pharming has demonstrated that Prodarsan® as an oral, liquid formulation has significant effects in animal models for Cockayne Syndrome ("CS"). CS is one of the more common forms of premature ageing and is characterized, amongst others, by growth failure, mental retardation, eye abnormalities and a reduced life expectancy. The positive effects of Prodarsan® in preclinical testing on life expectancy in general and more specifically on the eye abnormalities are promising for further development of the product and its testing in humans.

The Phase I trial that is now being conducted consists of a combined single and multiple dose escalating clinical study in healthy volunteers. By studying the pharmacokinetics and tolerability of Prodarsan® and the effects of food intake on the absorption and elimination of the product, an oral dosing scheme will be determined that targets the pharmacological effective concentration range effectively. It is expected that following a successful completion of this trial the first clinical studies in patients will start later in 2008.

Prodarsan® is a defined combination of small molecules [?] which is being developed to delay the progression of age-related diseases. Prodarsan® is thought to act by reducing DNA-damage accumulation, which has recently been established as an important element in ageing and the development of ageing related pathology. For instance, patients that suffer from premature ageing usually have a genetic defect that results in insufficient DNA-repair. DNage had previously also shown that defected DNA-repair in animals leads to the development of ageing related diseases such as Osteoporosis and Neurodegeneration.
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[DewDiligence]

Notes on Pharming Group, NV

[Updated for 1Q08 results
and new program on aging.]

#msg-27808107 EMEA rejects Rhucin appeal
#msg-26347101 Pharming appeals Rhucin rejection, reiterates US plans
#msg-22208171 Phase-3 Rhucin data
#msg-22482530 Pharming seeks US Rhucin partner

#msg-28598316 1Q08 financial results
#msg-28546713 Update from 2008 annual meeting
#msg-28738755 New program in “aging”

#msg-18949245 IP cross-license with GTC
#msg-27220955 Pharming licenses cattle IP from ACTC