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A very good volume and a green candle.
Good start.
In the USA stocks go up more faster...lol
Under the license agreement, Pharming will receive $ 5 million of Santarus if the FDA application called a Biologics License Application or BLA - is dealing with.
The FDA has 30 or 60 days if they file handle.
if fda say yes then get pharming the milestone $ 5,000,000
The share Santarus shooting in Tuesday trading on the U.S. stock market up by 20% to $ 3.80(pré market)
good news in one day!!!thats great
More 5 million...
news!!!!!!!
Pharming And Santarus Announce Submission Of Rhucin Biologics License Application To FDALeiden, The Netherlands and San Diego, US, December 28, 2010. Biotech company Pharming Group NV (NYSE Euronext: PHARM) and specialty biopharmaceutical company Santarus, Inc (NASDAQ: SNTS) today announced the submission of a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) to obtain marketing approval for Rhucin® (recombinant human C1 inhibitor) for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE).
The safety and efficacy of Rhucin for the treatment of HAE attacks were evaluated in two randomized placebo-controlled studies and are supported by four open label treatment studies. Both placebo-controlled clinical studies showed statistically significant and clinically relevant improvement in the primary endpoint of time to beginning of relief of symptoms at R hucin dosage strengths of 50 U/kg and 100 U/kg compared to placebo. In October 2010, Pharming received Marketing Authorization for Ruconest™ (Rhucin in non-European countries) for the treatment of acute HAE in the European Union. Pharming has updated the clinical dataset reviewed and approved by the European Medicines Agency with additional patient data and analyses. In total, the BLA dossier includes nine clinical studies covering 714 administrations in 190 subjects.
Santarus has licensed certain exclusive rights from Pharming to commercialize Rhucin in North America for the treatment of acute attacks of HAE and other future indications. Under the terms of the license agreement, a $5 million milestone is payable to Pharming upon FDA acceptance for review of the BLA for Rhucin.
About Rhucin (Ruconest in European countries) and Hereditary Angioedema
Rhucin (INN conestat alfa) is a recombinant version of the human protein C1 inhibitor (C1INH). Rhucin is produced through Pharming’s proprietary technology in milk of transgenic rabbits and in Europe is approved under the name Ruconest for treatment of acute angioedema attacks in patients with HAE. The FDA has granted Orphan Drug and Fast Track Status to Rhucin for the treatment of acute attacks of HAE, a genetic disorder in which the patient is deficient in or lacks a functional plasma protein C1 inhibitor, resulting in unpredictable and debilitating episodes of intense swelling of the extremities, face, trunk, genitals, abdomen and upper airway. The frequency and severity of HAE attacks vary and are most serious when they involve laryngeal edema, which can close the upper airway and cause death by asphyxiation. According to the US Hereditary Angioedema Association, epidemiological estimates for HAE range from one in 10,000 to one in 50,000 individuals. Based on prior discussions with the FDA, Pharming is planning to initiate an addition al randomized placebo-controlled, clinical study with Rhucin in approximately 50 patients to provide additional data in support of the 50 U/kg dose. Data from the placebo-controlled study will also be used to provide additional validation of the visual analog scale used in measuring the clinical effects of Rhucin
pedromm
I still believe that pharming will be taken over by another company !!!!( bv.genzym).
yes, this the begining of a new era to pharm.
Just wait for good sales during 2011 and even better in 2012.
there is news pedromm
Pharming And Swedish Orphan Biovitrum Announce First Sales Of Ruconest In Europe
Leiden, the Netherlands, and Stockholm, Sweden, December 28, 2010. Pharming Group NV (NYSE Euronext: PHARM) and Swedish Orphan Biovitrum (STO: SOBI) announce the first European sales of Ruconest™ (Conestat alfa) in Denmark and Norway.
Ruconest™ is the first recombinant C1 esterase inhibitor for acute treatment of angioedema attacks in patients with Hereditary Angioedema (HAE). Ruconest™ is developed by the Dutch Biotech company Pharming and is marketed and distributed throughout the EU by Swedish Orphan Biovitrum.
On October 28, 2010, Ruconest™ received European Marketing Authorization in the 27 EU countries plus Norway, Iceland and Liechtenstein. A number of these countries are now ready to sell Ruconest™.
“We are very pleased to provide Ruconest™ as the first recombi nant C1 esterase inhibitor to European patients suffering from this severe, disabling, and life threatening disease”, says Anders Edvell, Vice President, Marketing and Sales at Swedish Orphan Biovitrum. “The pharmacy purchasing price, estimated from the first approved prices in Europe, will be approximately €1800 per vial, which represents a competitive price per unit C1 inhibitor.”Sijmen de Vries, CEO of Pharming: "The European launch of Ruconest™ is a very important moment for all patients suffering from acute attacks of HAE. Enzyme replacement with human C1 inhibitor, the well established gold standard for HAE treatment; will from now on become available to all patients in all countries of the EU for the treatment of the various types of acute attacks of HAE.”
About HAE and C1 esterase inhibitor
HAE is a human genetic disorder in which the patient is deficient in or lacks a functional plasma p rotein C1 inhibitor, resulting in an overreaction of the immune system. The disease is characterized by unpredictable and debilitating episodes of intense swelling of the extremities, face, trunk, genitals, abdomen and upper airway, which may last up to five days when untreated. In addition to the life-threatening nature of the disease in case of laryngeal attacks, quality of life for individuals with the disease may be seriously impaired. Approximately one in 30,000 individuals (1:10,000 ? 1:50,000) suffers from HAE with an average of approximately eight acute attacks per year.
About Ruconest
Ruconest™ (INN conestat alfa), the first recombinant C1 esterase inhibitor, is a recombinant human protein developed through Pharming’s proprietary technology in milk of transgenic rabbits. In the clinical data presented by Zuraw et al in Journal of Allergy and Clinical Immunology (October 2010), the combined results of two similar but independent , randomized, placebo-controlled studies were presented. Efficacy and safety in 70 HAE patients were evaluated in two doses of 50 and 100 U/Kg of rhC1INH for the treatment of acute angioedema attacks. Both doses of rhC1INH (50U/kg and 100U/kg) significantly reduced the time to beginning of relief of symptoms for all anatomical locations studied (abdominal, genitourinary, facial-laryngeal or peripheral) compared to placebo and resulted in a high response rate for rhC1INH (>90%). Adverse events occurred less frequently in the rhC1INH arm than in the placebo arm. No neutralizing antibodies against rhC1INH or host-related impurities were observed. The authors conclude that rhC1INH constitutes a highly effective alternative to plasma derived C1INH for the treatment of acute angioedema attacks in HAE patients.
yes i am still here pedromm
happy holidays and
2011 will be a strong year for pharming !!!!!!!!!
Are you still here plumo?
Merry Cristmas to all!!
The gap is closed today....let see if it is going up or down.
I will see the zonebourse.com.
The 0,64€ per share it is a really possibility.
The dow trend stop...and now it is time to go up.
Pedromm,
The forum on Zonebourse.com is much more active and interesting about Pharming than the one on Boursorama.com... believe me... I post there regulary, but I also keep an eye on Boursorama and I must say: it is all bs there...
Do you know the Edison report from some days ago?
Look at the valuation: 0,64 euro per share.
Source: www.edisoninvestmentresearch.co.uk
Bringing some festive cheer to Pharming’s balance sheet, Socius is providing net cash of €16.1m in a complex deal. Effectively, Socius gets €17.1m of equity with a 9.35% yield (paid in shares after four years). This resolves immediate funding issues and bridges the 2011-12 transition to a commercial company. Other (undisclosed) milestones, agreement and product supply and royalties are also expected.
Deal structure: A four-year delicate balancing act
The concept is that rather than issue equity at a discount, equity is issued at the closing price, €0.212. Socius’s upside is a nominal compound interest rate of c 10% over four years on €12m of Pharming loan notes yielding €5.5m. The interest is offset by a 0.65%, €17.1m Socius loan note: €0.4m interest. After four years, Pharming owes Socius €12.0m + €5.5m = €17.5m and Socius owes Pharming €17.1m + €0.4m = €17.5m. The net €5.1m interest is paid upfront in shares, corresponds to the warrant portion of the deal and is paid down via the P&L. Hence there is no hidden dilution.
Getting in the cash, putting out the shares
Socius’s actual cash investment is €16.1m; the extra €5.1m warrants pay the net interest. The Pharming 10% loan note of €12m to Socius covers part of this with the remaining €4.1m as a straight cash payment from Socius. Overall, once Socius has taken up its €21.2m of equity rights, it will hold 100m shares or 21.8% of the enlarged equity. The Yorkville SEDA facility remains, but management has no current intention to use it. Any additional project finance will be done using non-dilutive loans.
Runway to a 2012 commercial business
We expect the first Ruconest sales in the EU in December, although it will be a fine run thing; sobi, which recently changed its CEO, not exactly being dynamic. The BLA submission expected soon triggers a $5m Q111 milestone. Studies in transplantation (AMR) should start in Q111. Prophylactic data was very encouraging and this indication could be developed further as it is a big market.
Valuation:
Extra dilution moves indicative value to €0.64
Our risk-adjusted NPV falls to €0.64, cut by dilution but benefiting from lower cash interest charges. There should be no more major dilution events before 2012.
Update
Exhibit 1: Financials
Ruconest and Rhucin upfront payments (total €14.8m to date) are spread over 10 years, but cash was received in 2010. The sobi regulatory milestone is assumed to be fully recognised in 2010. We assume that the $5m (€3.8m) Santarus regulatory milestone in respect of BLA acceptance by the FDA will be received and fully recognised in Q111. The Socius funding (with €6m cash paid in 2010 and €10.1m due in early January) to complete early January) brings in €16.1m cash and increases creditors by €12m plus 10% interest and debtors by €17.1m plus 0.65% interest for €21.2m in equity. 2010 revenues include a €5m milestone. 2011 revenues include a $5m milestone. Upfront payments are accounted as deferred income.
Hi SpeedStone.
The value of this company is much higher than it is now.
Until the begining of the sales of ruconest really start, Pharming will stay around these levels.
In other hand, i think this will start to change when Pharm announce the 2010 results.
They have receveid a lot of cash and was able to clean there balance sheet.
Ruconest work started 10 years ago, but the result will in 2011 and 2011 to the shareholders.
Stay with us SpeedStone. There are more people interested in pharm. Go to the Boursorama forum of pharm and you will see that.
If you see the CNBC channel the quote of pharming sometimes is starting to apear.thats a good sign.
Stay focus and value of this company will be 350-500millions, what means in the share price around 0,7-1€.
Thank you for the excellent information.
It seems to me that pharm is starting a new an a important life.
Glad i have shares from this company and glad i add a few more.
Now is time to wait a litle more. The finance agreement it was excellent in deed.
Now is time sale the ruconest in Europe and prepare the lunch in USA.
6 December 2010
Bringing some festive cheer to Pharming’s balance sheet, Socius is providing net cash of €16.1m in a complex deal. Effectively, Socius gets €17.1m of equity with a 9.35% yield (paid in shares after four years). This resolves immediate funding issues and bridges the 2011-12 transition to a commercial company. Other (undisclosed) milestones, agreement and product supply and royalties are also expected.
Deal structure: A four-year delicate balancing act
The concept is that rather than issue equity at a discount, equity is issued at the closing price, €0.212. Socius’s upside is a nominal compound interest rate of c 10% over four years on €12m of Pharming loan notes yielding €5.5m. The interest is offset by a 0.65%, €17.1m Socius loan note: €0.4m interest. After four years, Pharming owes Socius €12.0m + €5.5m = €17.5m and Socius owes Pharming €17.1m + €0.4m = €17.5m. The net €5.1m interest is paid upfront in shares, corresponds to the warrant portion of the deal and is paid down via the P&L. Hence there is no hidden dilution.
Getting in the cash, putting out the shares
Socius’s actual cash investment is €16.1m; the extra €5.1m warrants pay the net interest. The Pharming 10% loan note of €12m to Socius covers part of this with the remaining €4.1m as a straight cash payment from Socius. Overall, once Socius has taken up its €21.2m of equity rights, it will hold 100m shares or 21.8% of the enlarged equity. The Yorkville SEDA facility remains, but management has no current intention to use it. Any additional project finance will be done using non-dilutive loans.
Runway to a 2012 commercial business
We expect the first Ruconest sales in the EU in December, although it will be a fine run thing; sobi, which recently changed its CEO, not exactly being dynamic. The BLA submission expected soon triggers a $5m Q111 milestone. Studies in transplantation (AMR) should start in Q111. Prophylactic data was very encouraging and this indication could be developed further as it is a big market.
Valuation:
Extra dilution moves indicative value to €0.64
Our risk-adjusted NPV falls to €0.64, cut by dilution but benefiting from lower cash interest charges. There should be no more major dilution events before 2012.
Update
Exhibit 1: Financials
Ruconest and Rhucin upfront payments (total €14.8m to date) are spread over 10 years, but cash was received in 2010. The sobi regulatory milestone is assumed to be fully recognised in 2010. We assume that the $5m (€3.8m) Santarus regulatory milestone in respect of BLA acceptance by the FDA will be received and fully recognised in Q111. The Socius funding (with €6m cash paid in 2010 and €10.1m due in early January) to complete early January) brings in €16.1m cash and increases creditors by €12m plus 10% interest and debtors by €17.1m plus 0.65% interest for €21.2m in equity. 2010 revenues include a €5m milestone. 2011 revenues include a $5m milestone. Upfront payments are accounted as deferred income.
www.edisoninvestmentresearch.co.uk/re...
Socius Exercises Investment Rights Leiden, The Netherlands, December 6, 2010. Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today announced that Socius CG II, Ltd, a subsidiary of Socius Capital Group, LLC (“Socius”), based in New York and Los Angeles, following Pharming’s call for the €12 million loan notes, as announced last Friday, exercised their investment rights under the € 16.1 million investment agreement with Pharming .
As announced last Friday, under these investment rights, Pharming will issue 75,849,057 shares to Socius, In addition to these shares, Socius is entitled to 24,339,623 warrants with an exercise price of €0.212 (21.2 cents). The shares will be delivered and admitted to listing and trading on Euronext Amsterdam following the publication of a prospectus (expected within the next two weeks),
Socius c an either place the shares acquired by it in the market or accumulate them up to a maximum holding in Pharming of 21.8% of the number of outstanding shares. Socius is committed not to short sell or enter into any hedging transactions related to Pharming shares.
Good news. They invest in pharm because they know the huge potencial of this one.
Only 3 followers on this forum?
A beautiful value for the speculation in the past... now becoming a strong value with very high growth potential for the next months.
My personnl target is 0,7 by the end of the year.
With all the good news accumulating, it is still possible.
What do you think?
news !!!!!!!!!!!!!
i like that
Pharming Announces Euro 16.1 Million Investment From Socius Capital Group
Leiden, The Netherlands, December 3, 2010. Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today announced the Company has entered into a definitive agreement with Socius CG II, Ltd, a subsidiary of Socius Capital Group, LLC (“Socius”), a Delaware limited liability company. Socius, based in New York and Los Angeles, has completed financings with numerous life sciences and other emerging growth companies in the United States and Europe. Pharming will receive €16.1 million gross proceeds in cash in return for non-convertible debt notes and equity if Socius exercises its investment rights.
The €16.1 million investment in Pharming comes from the issuance of ten year debt notes to Socius for the amount of €12 million (the “Pharming Notes”) and €4 million in cash as partial consideration for the issuance of equity to Socius if Socius exercises its €21.2 million investment rights in full. Socius will pay the remaining €17.2 million of its investment rights to Pharming with four year secured loan notes (the “Socius Notes”) with an annually accruing interest rate of 0.65% payable to the Company.
The Socius investments rights totalling a maximum value of €21.2 million are divided between:
# the right to make an equity investment up to €16.1 million in shares, priced at €21.2 cents, which represents yesterday’s closing bid price, and
# the right to acquire warrants up to €5.1 million with a strike price equal to yesterday’s closing bid price of €21.2 cents.
The shares will be delivered to Socius once Pharming has published a prospectus and placed this on its website. Publication of the prospectus is expected in the coming two weeks. T he warrants are exercisable after ten trading days following the delivery of the shares.
The Pharming Notes will accrue interest at an annual rate of 10%, which will be deferred. After four years, both sets of notes will be equal in value. At that stage, Socius and Pharming will both have the right to redeem their notes for no additional cash consideration.
Socius can either place the shares acquired by it in the market or accumulate them up to a maximum holding in Pharming of 21.8% of the number of outstanding shares. Socius is committed not to short sell or enter into any hedging transactions related to Pharming shares.
Sijmen de Vries, CEO, commented: "This transaction provides Pharming with a financial bridge between the development-focused organisation of today and the commercial-focused entity that we are evolving into. The capital will be deployed into executing our growth strategy, in particular the development of our recombinant C1 inhibitor franchise beyond the current scope of acute hereditary angioedema. This investment represents the majority of our capital needs to continue to execute on our plans for the foreseeable future. For our remaining smaller financing needs several non-dilutive (debt) financing instruments are under consideration."
Conference call information
In a live audio webcast today at 11:30 am Central European Time (CET), Pharming's CEO Sijmen de Vries and CFO Karl Keegan will present more details on this financing agreement. Following the presentation, the lines will be opened for a question and answer session.
To participate in the conference call, please call one of the following telephone numbers:
- From the Netherlands: 0800 265 8543 (toll-free) or +31 (0)45 631 6902
- From the UK: 0800 358 0886 (toll-free) or +44 207 153 2027
nice news for pharming
Pharming Awarded ?Best Biotechnology Company’ By The World Technology Network
Leiden, The Netherlands, December 2, 2010. Pharming Group NV (“Pharming”) (NYSE Euronext: PHARM) today announced that last night it received the Award for Best Biotechnology Company for 2010 by the World Technology Network (WTN) at the World Technology Summit (November 30-December 1, 2010) in New York City. Pharming has been awarded for “its innovative work on production of life enhancing drugs derived from its transgenic platform, an achievement viewed by the voting committee as one of the greatest likely long-term significant achievements within the science and technology arena.”
The World Technology Awards are presented annually by the WTN at a dinner of its World Technology Summit to individuals and corporations achieving significant, lasting progress in categories pertaining to science, technology, finan ce, IT, design, and many more. The first World Technology Summit and Awards took place on November 12, 1999 in London. Last night’s Awards dinner was held at the Time Life Building in Manhattan and the awards are presented in association with Time, NASDAQ, Fortune, AAAS, Science, NYAS, and The Technology Review.
Sijmen de Vries, Pharming’s CEO, said, “This has been a highly significant year for Pharming with the European approval of our lead product Ruconest for treatment of acute attacks of Hereditary Angioedema. This highly innovative product is produced through Pharming’s proprietary transgenic technology and will be launched this year. Ruconest has been in clinical development with the needs of patients at the forefront of our drive to get this to market. We are delighted to accept this award on behalf of the entire Pharming team as recognition for their commitment and hard work.”
Previous winners have included Alnylam , Advanced Cell Technology, Amyris Biotechnologies, Genencor International, Genentech, International Rice Genome Sequencing Project
Next week i will buy more...wait a litle and will go up again.
news today pedromm
Pharming Announces Topline Study Results On Prophylactic Use Of Ruconest In Hereditary Angioedema
Leiden, The Netherlands, November 29, 2010. Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today announced the results of its exploratory Phase II study on the safety and prophylactic effect of recombinant human C1 inhibitor (“rhC1INH”) in patients with Hereditary Angioedema (HAE).
The study is an open-label exploratory phase II study of the safety and prophylactic effect of a weekly 50 U/kg rhC1INH treatment in asymptomatic patients with hereditary C1INH deficiency (the “OPERA study”). In the study, 25 asymptomatic HAE patients with a history of frequent attacks received once weekly administrations of 50 U/kg of Ruconest for 8 weeks. Patients reported a median of 60 HAE attacks (range 39 to 467) over the past two years, corresponding to an averag e of 0.6 attacks per week (range 0.4 to 4.5). The breakthrough attack rate observed during the study was much lower with a median of 2 attacks over the 8 week period, corresponding to an average of 0.25 attacks per week (range 0 to 1.5). Weekly administrations of 50 U/kg rhC1INH was generally safe and well tolerated.
Dr. Rienk Pijpstra, Chief Medical Officer of Pharming: “The results of this exploratory study suggest that Ruconest, in addition to the approved indication in Europe for the acute treatment of angioedema attacks, could also offer significant value for long term prophylaxis in patients with frequent attacks. We plan further pharmacological investigations to optimize Ruconest dose and dosing interval for this indication.”
In October, the European Commission granted Pharming Marketing Authorization for its lead product Ruconest for the treatment of acute attacks of Hereditary Angioedema. Pharming’s marketing and distribution partner Swedish Orphan Biovitrum is preparing this year’s launch of Ruconest initially in Germany, the UK, Sweden, Finland and Denmark, followed by a rolling launch in each of the other European Area countries covered by the agreement.
About HAE and Ruconest™ (Rhucin® in non-European countries)
HAE is a human genetic disorder in which the patient is deficient in or lacks a functional plasma protein C1 inhibitor, resulting in an overreaction of the immune system. The disease is characterized by unpredictable and debilitating episodes of intense swelling of the extremities, face, trunk, genitals, abdomen and upper airway, which may last up to five days when untreated. In addition to the life-threatening nature of the disease in case of laryngeal attacks, quality of life for individuals with the disease may be seriously impaired. Approximately one in 30,000 individuals (1:10,000 ? 1:50,000) suffers from HAE with an average of ap proximately eight acute attacks per year.
Ruconest is a recombinant version of the human C1 inhibitor (C1INH) protein approved for the treatment of angioedema attacks in patients with HAE in all 27 EU countries plus Norway, Iceland and Liechtenstein. The product is produced through Pharming’s proprietary technology in milk of transgenic rabbits.
Plumo a new trend is about to happened. It will be up or down?
Lets wait and see...
very, very quiet....lol
Have you see the bid and the ask.
They have big orders in there.
Very quiet for now. Some consolidation also.
My French is very bad
I just don´t understand how to subscribe to call people to ihub.
what do you mean?
But more people are starting to talk in a buyout!
If you want you could also follow in this forum:
http://www.boursorama.com/forum-pharminggroup-1rAPHARM-1
I just don´t understand how to subscribe to call people to ihub.
Can you help me?
no i haven't listened
the future of pharming is started.income and sales
now waiting bla
and last a buyout for 10€
lol
Have you listened the CC?
Peolple made some interesting questions:
They will start sales imediatelly,
They don´t need no major stock issue
And they rebemenber they have in the Q1 2011 another milestone to receive from Santaurus. After the begining of the review BLA they will receive 5 million dollars.
good post pedromm !!!!!!
Now we have a support at 0,25...lets go up...
This payment it will be very important...
Today we have a lot volume and i saw a lot of selling going on also.
That important to clear all the persons who bought around 0,15-0,20.
Now new buyers are coming at 0,25 0,26, and they will drive this stock up.
Price targets will now start to climb. It is real what is going on.
And they also receive a % of sales.
They will encrease the market value and they are not issuing a lot of shares, they now have around 358Million.
If this go around 0,5€ the value of Pharming will 179Million euros what isn´t to much!
A good future. Step by Step...And some corrections on the way.
up and down with the shareprice
let's go up up to the sky
A lot of volume....It is interesting.
Also important!
Lets see till the end of the year how much Pharm will sell.
tomorrow cc
let see the 0.30 and more !!!!!!!!
YES Finally...glad bought a litle more
Pharmings Ruconest For HAE Granted European Marketing Authorization
Leiden, The Netherlands, and Stockholm, Sweden October 28, 2010. Biotech company Pharming Group NV (Pharming or ?the Company?) (NYSE Euronext: PHARM) and Swedish Orphan Biovitrum (Sobi) (STO: SOBI) today announced that the European Commission has granted Pharming Marketing Authorization for its lead product Ruconest? for the treatment of acute attacks of Hereditary Angioedema (HAE). Pharming will now receive a ?5 million milestone payment from marketing and distribution partner Sobi.
Following the unanimous positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP), Ruconest?s Marketing Authorization has now been ratified by the European Committee.
Patients suffering from HAE experience unpredictable, painful and debilitating attacks, due to reduced levels of C1 inhi bitor, resulting in intense swelling of parts of the body (for example, face, throat, abdomen) which can last up to five days if left untreated. Ruconest is a recombinant version of the human C1 inhibitor protein, produced by Pharming?s proprietary transgenic technology. As published in last October?s issue of the Journal of Allergy and Clinical Immunology, Ruconest has been shown to have excellent efficacy and safety. Pharming has withdrawn the orphan status application in order to avoid delays in commercializing the product.
Dr Marco Cicardi, MD, Professor of Internal Medicine at the University of Milan, Italy, said: ?Patients with HAE experience an average of eight attacks a year. This distressing and potentially life-threatening condition requires new approaches for acute treatment and Ruconest offers this. This recombinant product is the only HAE treatment achieving circa 90% of success in treating attacks.?
Ruconest is now approved for use in the 27 EU countries plus Norway, Iceland and Liechtenstein. Sobi will launch Ruconest initially in Germany, the UK, Sweden, Finland and Denmark, followed by a rolling launch in each of the other European Area countries.
Sijmen de Vries, CEO of Pharming: "The granting of marketing authorization for Ruconest? is a very important step in Pharming?s evolution from a drug development company to a commercial specialty pharmaceutical business. Together with our marketing partners, we look forward to the launch of Ruconest this year and making this novel new treatment available to the European HAE population. I would also like to thank the many European physicians and patients who participated in our clinical trial program with Ruconest.?
?Ruconest has the potential to offer patients with significant medical needs a safe and valuable alternative treatment. Moreover, it is a good fit with Sobi?s commercial port folio of rare disease products. We are very much looking forward to exciting fruitful partnership with Pharming and the opportunity to provide this new exciting product to patients who need it in Europe,? said Martin Nicklasson, CEO of Sobi.
Conference call information
Pharming?s management team will be available for questions on today?s marketing approval of Ruconest in a conference call tomorrow, October 29, at 8:30 am CET. To participate in the call, please call one of the following numbers:
- From the Netherlands: 0800 265 8543 (toll-free) or +31 (0)45 631 6901
- From the UK: 0800 358 0886 (toll-free) or +44 207 153 2027
An audio cast of the conference calls will be available on Pharming's website shortly thereafter.
About Ruconest (Rhucin in non-European countries)
Ruconest (INN conestat alfa) is a recombinant version of the human C1 inhibitor (C1INH) protein. T he product is produced through Pharming?s proprietary technology in milk of transgenic rabbits. Ruconest has identical amino acid sequence as endogenous human C1INH. The safety and efficacy of Ruconest has been demonstrated in two placebo controlled and four open-label studies. Both randomized placebo-controlled clinical trials showed statistically significant and clinically relevant improvement in time to relief of symptoms and time to minimal symptoms compared to placebo.
The European public assessment report (EPAR) for Ruconest will be published on the EMA website. It explains how the CHMP assessed Ruconest and its recommendations on the conditions for use of Ruconest.
About Hereditary Angioedema
HAE is a human genetic disorder in which the patient is deficient in or lacks a functional plasma protein C1 inhibitor, resulting in an overreaction of the immune system. The disease is characterized by unpredictable and debilitating e pisodes of intense swelling of the extremities, face, trunk, genitals, abdomen and upper airway, which may last up to five days when untreated. In addition to the life-threatening nature of the disease in case of laryngeal attacks, quality of life for individuals with the disease may be seriously impaired. Approximately one in 30,000 individuals (1:10,000 1:50,000) suffers from HAE with an average of approximately eight acute attacks per year.
About Swedish Orphan Biovitrum
Swedish Orphan Biovitrum is a Swedish based niche specialty pharmaceutical company with an international market presence. The company is focused on providing and developing specialist pharmaceuticals for rare disease patients with high medical needs. The portfolio consists of about 60 marketed products and an emerging late stage clinical development pipe-line. Our focus areas are: hemophilia, inflammation/autoimmune diseases, fat malabsorption, cancer and inherited meta bolic disorders. Swedish Orphan Biovitrum had pro-forma revenues 2009e of about 2 BSEK and approximately 500 employees. The head office is located in Sweden and the share (STO: SOBI) is listed on NASDAQ OMX Stockholm. For more information please visit www.sobi.com.
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of genetic disorders, specialty products for surgical indications, and nutritional products. Pharming?s lead product Ruconest? (Rhucin in non-EU territories) has Market Authorization in the European Economic Area. The product is also under development for follow-on indications, i.e. antibody-mediated rejection (AMR) and delayed graft function (DGF) following kidney transplantation. The technologies of the Company include innovative platforms for the production of protein therapeutics, including technology and processes for the purification and formulation of these products. Add itional information is available on the Pharming website www.pharming.com.
This press release contains forward looking statements that involve known and unknown risks, uncertainties and other factors, which may cause the actual results, performance or achievements of the Company to be materially different from the results, performance or achievements expressed or implied by these forward looking statements.
Swedish Orphan Biovitrum may be required to disclose the information provided herein pursuant to the Swedish Securities Markets Act. The information was provided for public release on October 28, 2010 at 16:30 a.m. CET.
For more information please contact:
Pharming Group NV
Marjolein van Helmond, T: +31 (0)71 52 47 431 or +31 (0)6 109 299 54 or E: m.helmond@pharming.com
Swedish Orphan Biovitrum
Erik Kinnman, VP Investor Relations, T: +46 73 422 15 40 or E: erik.kinnman@sobi.com
Ma rtin Nicklasson, CEO, T: +46 8 697 20 00
EUR5 mln SOBI
There are some sell pressure, but i am glad to see that it is with low volume.
waiting in the sidelines....I will try to add a litle more to get ready to the big move.
nobody home the last days.
and we waiting and waiting and,....
holding strong
holding well around 0,25€
No, i think it is 5million euros.
yes, very important
how much will it be?
10 milj € of more ?
very important
"the main focus in Q4 2010 will continue to be on the market launch of Ruconest, which is on track. This pivotal event in Pharming’s evolution will be marked by an associated milestone payment from SOBI upon European Market Authorization. "
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Immunology 2011 Annual Meeting
- Specialty biopharmaceutical company Santarus, Inc. (NASDAQ: SNTS) and biotech company Pharming Group NV (NYSE Euronext: PHARM) today announced new data on 62 patients with Hereditary Angioedema (HAE) who received repeat treatment with the investigational drug RHUCIN® (recombinant human C1 inhibitor) for 168 acute angioedema attacks. The median time to beginning of relief of symptoms across treatments for repeat attacks was approximately 60 minutes with response rates that were consistently 90% or greater. This open-label study was an extension of the randomized, double-blind, placebo-controlled study conducted by Pharming in North America. The findings were presented Sunday, March 20, 2011 in a poster session at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2011 Annual Meeting in San Francisco.
Specialty biopharmaceutical company Santarus, Inc. (NASDAQ: SNTS) and biotech company Pharming Group NV (NYSE Euronext: PHARM) today announced the receipt of a "refusal to file" letter from the U.S. Food and Drug Administration (FDA) for the RHUCIN® (recombinant human C1 inhibitor) Biologics License Application (BLA) submitted by Pharming. In the letter the FDA indicated that the BLA was not sufficiently complete to enable a critical medical review.
September 13, 2010
Pharming Signs Commercialization Agreement With Santarus For Rhucin® In North America
Biotech company Pharming Group NV ("Pharming") (NYSE Euronext: PHARM) today announced that it has entered into an agreement with specialty biopharmaceutical company Santarus, Inc ("Santarus") (NASDAQ: SNTS) for the commercialization of Rhucin® (recombinant human C1 inhibitor; Ruconest™ in Europe) in North America (the United States, Canada and Mexico) for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE) and other future indications
August 25, 2010
Pharming Plans Submission Rhucin BLA To Us FDA End 2010
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announced that it intends to submit the Biologic License Application (BLA) to the US Food and Drug Administration (FDA) to obtain marketing approval for Rhucin® for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE). Following pre-BLA discussions with the FDA, Pharming is preparing the BLA dossier for submission towards the end of this year but no later than January 2011.
in http://www.pharming.com/index.php?act=inv
Ruconest is a novel biotech alternative to plasma derived C1inh for the
treatment of HAE attacks
- Identical amino acid sequence
- Differences in glycosylation profile
- Highly purified
• Approved at a higher dose (50U/kg) achieving optimal efficacy
- Similar affinity to target proteases
- Functional units are directly comparable (1vial of Ruconest> 4 vials of plasma product)
- Dose is more important driver of efficacy than half-life
- No relapse
• Reassuring safety profile
- No pharmacological AEs
- No induction of allergies observed
- No induction of neutralizing antibodies
- Contraindicated in pts with rabbit allergy
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