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Pharming Redeems Third Tranche Of Convertible Bond
Leiden, The Netherlands, March 12, 2012. Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today announced that it has redeemed the third tranche of its €8.4 million convertible bond. A total of 20,206,800 shares were issued to the bondholders under the terms and conditions of the bond, serving as a pre-installment for the April 15, 2012 redemption and interest payment. A further three tranches remain to be repaid.
As announced in our press release on December 23, 2011, and following the approval of increase of the Company’s authorized share capital during the extraordinary general meeting of shareholders, which was held on February 3, 2012, Pharming will redeem the bond on a month by month basis such that the bond will be redeemed in full on July 15, 2012. Pharming can decide at its discretion to redeem the bond and pay the interest due, by means of monthly equity tranches or cash payments.
The new funds from this transaction strengthen the balance sheet and enable the Company to extend its cash runway beyond the anticipated read out of Study 1310. As has been previously disclosed, the successful read out of this trial is associated with a $10 million milestone from Pharming’s US partner Santarus Inc, with an additional $5 million due upon acceptance of the Biologic License Application (BLA) by the FDA. Subject to these milestones, the Company will be financed into 2013. This guidance excludes any additional cash inflows from further partnering agreements on Rhucin® and the transgenic platform and the continuing roll-out of Ruconest® in Europe.
As of today, the number of outstanding shares has increased to 557,553,470.
Pharming To Present At Roth Growth Conference On March 12, 2012
Leiden, The Netherlands, March 8, 2012. Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today announced that Sijmen de Vries, Chief Executive Officer, will present at the following investment conference:
Roth Capital Partners 24th Annual Growth Stock Conference on Monday, March 12, 2012, at 3:00 p.m. pacific time (midnight Central European Time) in Dana Point, California, US.
A webcasts of this presentation will be available during the event at the ?Investor Relations’ section of www.pharming.com and will be archived and available on the website for 14 days.
About Roth Capital Partners Annual Growth Stock Conference
ROTH’s annual three-day conference brings together executives from over 400 growth companies and 1,000+ investors fro m the buy side. The event is designed to provide investors with a unique opportunity to gain insight into small and mid-cap growth companies across a variety of sectors, including healthcare. ROTH combines company presentations, Q&A sessions, expert panels and management one-on-one meetings to provide institutional clients with extensive interaction with senior management to gain in-depth insights into each company
Pharming Announces Preliminary Financial Results 2011
Leiden, The Netherlands, March 1, 2012. Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today published its preliminary (unaudited) financial results for the year ended December 31, 2011.
FINANCIAL HIGHLIGHTS
Revenues increased to €3.0 million (2010: €0.6 million) and include the full year effect of license fee revenues and product supplies to Sobi
Operating costs decreased to €18.2 million (2010: €25.1 million; €22.2 million excluding DNage, which was put into voluntary liquidation early 2011)
Research and development costs decreased to €13.8 million (2010: €21.2 million; €18.3 million excluding DNage) reflecting 2010 inventory impairments on R&D inventories, the prioritization of R&D expenditure and an increased focus on cost containment thr oughout the business
Net loss decreased significantly to €17.2 million. 2010 loss (€56.4 million) impacted by losses incurred with respect to financing activities and the discontinued DNage business
Cash outflows from operating activities were €16.9 million (2010: €22.9 million; excluding license payments received from Santarus and Sobi of €19.7 million in total)
At year-end 2011 cash and cash equivalents (including restricted cash) were €5.1 million* (2010: €10.5 million)
*This excludes approximately €1.1 million to be received from Sobi for Q4 2011 ? Q2 2012 supplies and the €8.0 million proceeds following the late December 2011 issuance of convertible bonds.
OPERATIONAL HIGHLIGHTS
Expansion of the geographical coverage off Ruconest® through a new agreement with Megapharm for Israel and an extension of the agreement with Sobi to include territories in the Balkans, North Africa and the Middle East
Study 1310 progresses under a Special Protocol Assessment (SPA) from the FDA
Enhancements of the intellectual property portfolio: extension of the protection of Pharmings Core Technology Platform in the US to 2027; and US patent granted on Ischemia Reperfusion, covering a method of preventing, reducing or treating an ischemia and/or reperfusion injury by administering recombinant C1 inhibitor (Ruconest®/ Rhucin®). The broad claims in the patent provide protection until 2028.
Signing of a service agreement with Renova Life which focuses on the development of transgenic rabbits to produce recombinant human Factor VIII. This represents the first step towards potentially unlocking the value inherent in Pharming’s transgenic platform.
(A conference call for analysts and press will be held at 10:00 CET, details provided below)
Chief Executive Officer of Pharming, Sijmen de Vries, commented: “During the year we have focused on improving our operational cash burn and have continued to seek new business development opportunities in new geographies and new projects. The ability to access capital is a key risk to our business and in 2011, despite difficult market conditions, we were able to identify new sources of funding, enabling us to bridge the financing gap between the Refusal To File letter that we received early in 2011 from the US FDA for Rhucin® and the anticipated read-out of our ongoing clinical trial, Study 1310, which continued with changes requested by the FDA through a SPA agreement. All in all, 2011 proved to be a challenging year, but despite that we were able to strengthen the foundations for future growth and we look forward to building on this in 2012.”
OUTLOOK
The most important activity in the near term continues to be the ongoing pivotal clinical trial (Study 13 10) which is required for US regulatory approval for Rhucin®. This study remains on track and we anticipate readout by Q3 2012. If successful we anticipate submitting a BLA approximately three months thereafter. These events are associated with large milestones payments which will have a significant impact on the company’s future growth. On successful achievement of the primary endpoint of the Phase III clinical study, the Company is eligible to receive a US$10.0 million milestone payment from Santarus and a further US$5.0 million at the acceptance of the BLA by the FDA.
We remain focused on supporting our commercialisation partners in facilitating the rollout of Ruconest® across the licensed territories and look forward to continued progress over the coming quarters. Discussions are on-going with several parties regarding the potential commercialisation of Ruconest® in other territories of the world, such as South America, other South-East Asia n countries and Japan. Such deals are important in increasing the geographical coverage of our Hereditary angioedema (HAE) franchise. In early 2012 we signed our first distribution partner in South-East Asia (Transmedic Pte) and we hope to be able to update you on additional deals over the coming quarters.
Following the validation of our transgenic platform with the EU approval of Ruconest®, we have received multiple requests regarding the potential licensing of the platform, and/ or co-development collaborations to produce complex proteins. These discussions are at an early stage and focus on significant indications which already have protein therapeutics on the market. The attractiveness of our platform appears to be its scalability, low upfront capital investments in manufacturing and its flexibility associated with manufacturing costs. We do envisage moving forward with new platform projects with partners and are currently exploring such possibilities. In 2011 w e took the important initial step of signing an agreement with Renova Life to produce rabbits for the production of recombinant Factor VIII.
In 2011 we prioritized our pipeline and decided to out-license our non-core programmes. Discussions are ongoing with potential partners for lactoferrin and fibrinogen.
FINANCIAL RESULTS
Revenues and other income from continuing operations increased to €3.2 million (2010: €1.1 million), largely reflecting a revenue increase from €0.6 million in 2010 to €3.0 million in 2011. The revenue increase includes the full year effect of license fee revenues of €1.9 million (2010: €0.5 million) and product supplies to Sobi of €1.1 million (2010: €0.1 million). In 2011 the Company incurred €1.7 million inventory impairments related to production issues related to a one-off event. The Company is investigating various possibilities to fully recover these costs.
Operating costs from continuing operations excluding cost of sales decreased to €19.9 million (2010: €22.2 million). The reduction is mainly a result of decreasing R&D costs from €18.3 million in 2010 to €13.8 million in 2011. This reflects 2010 impairment charges on R&D inventories, the continued prioritization of R&D expenditure towards Study 1310,
minimal expenditure on other projects and an increased focus on cost containment in our US business.
Net profit from financial income and expenses in 2011 was €0.7 million compared to a net loss in 2010 of €16.5 million. These items in 2010 were largely driven by the interest charges and settlement charges of various debts incurred in 2010 and earlier years.
Net loss from continuing operations decreased to €17.8 million (2010: €37.7 million). The net profit from discontinued operations in 2011 of €0.6 million compared to a net loss from dis continued operations in 2010 of €18.7 million. The effects of discontinued operations relate to the liquidation of the DNage business in early 2011, with 2010 losses largely driven by €20.7 million (non-cash) impairment charges on goodwill and intangible assets. The overall net loss significantly decreased from €56.4 million in 2010 to €17.2 million in 2011.
Throughout 2011, the company raised €3.2 million of new funds through a private placement and signed a convertible bond financing (€8.0 million gross proceeds) subject to shareholder approval in 2012 (which has been obtained through an Extraordinary General Meeting of Shareholders (EGM) held on February 3, 2012).
Year-end cash and cash equivalents (including restricted cash) amounted to €5.1 million. This amount excludes the cash proceeds from the convertible bond (€8.0 million gross) and €1.1 million outstanding as part of the Sobi extension agreement, t he former amount having been received in early 2012 and the latter partially received early 2012 and partially due by end Q2 2012.
Net cash flows used in operating activities increased from €3.2 million in 2010 to €16.9 million in 2011. However, cash inflows in 2010 were augmented by one off upfront and milestone payments paid by Santarus and Sobi of €19.7 million and in 2010 payments with respect to the discontinued DNage business of €2.9 million (2011: nil). Thus, on a comparable basis, operating cash outflows decreased by €3.1 million in 2011 compared to 2010.
NEGATIVE EQUITY
In late 2011 the Company announced that it had entered negative equity. The negative equity position has in itself no immediate impact on the execution of the Pharming’s business plan, nor does it imply that the Company is legally required to issue new share capital. An EGM was held on February 3, 2012 and the authorise d share capital increased to 805 million shares. Pharming is continuously reviewing its financial and liquidity position and has various options to improve its equity standing under International Financial Reporting Standards (IFRS). Most notably, the Company highlights that the negative equity position was mainly caused by its inability to recognize the €19.7 million upfront payments and milestones received from Sobi and Santarus as equity and that it expects to receive two development milestones associated with the successful readout of Study 1310 (US$10.0 million) and acceptance of the BLA filing by the FDA (US$5.0 million). Under IFRS, Pharming expects to be able to recognize these milestones immediately and thus augment the equity position.
Pharming will hold its Annual General Meeting of Shareholders on May 14, 2012.
Conference Call Information
Today, Chief Executive Officer, Sijmen de Vries and Chief Financial Officer, Karl Keegan will present the preliminary full year 2011 results in a conference call for analysts at 10:00 am CET. To participate, please call one of the following numbers 10 minutes prior to the call:
Analyst call (Confirmation Code: 4520748)
Participant Telephone Numbers:
From the Netherlands: 08002658611 (toll-free) or 31 (0) 45 6316902
From the UK: 0800-358-0886 (toll-free) or 44-207-153-2027
To view the presentation live during the call, please follow the below link:
http://event.on24.com/r.htm?e=411566&s=1&k=34F366E0488A4DB5E3906183B47930C8
Following a brief presentation of the results, the lines will be opened for a question and answer session. An audio cast of the conference calls will be available on Pharming's website shortly thereafter.
Interview with CEO Sijmen de Vries (pharming)
link: http://www.pharming.com/
Pharming and Transmedic announce distribution agreement for RUCONEST
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) announced today that it has entered into an agreement with Transmedic Pte Ltd. (Transmedic), a privately owned Singapore based specialty healthcare company, for the commercialization of RUCONEST(®) (recombinant human C1 inhibitor) for the treatment of acute attacks of Hereditary Angioedema (HAE) in parts of South- East Asia. The South- East Asian territories covered under this agreement include Brunei, Indonesia, Malaysia, Philippines, Singapore, and Thailand.
Under the agreement, Transmedic will drive the respective regulatory approvals and purchase its commercial supplies of RUCONEST from Pharming at a fixed transfer price.
Sijmen de Vries, CEO of Pharming, commented: "We are pleased to have taken another step towards making RUCONEST, an innovative, highly effective and safe replacement therapy, available to HAE patients globally. In Transmedic we have found an experienced commercialization partner dedicated to bringing innovative specialty medicines to this region. Transmedic's proven ability to cater for specialty medical care in hospitals provides an excellent platform from which RUCONEST can be made available to doctors and HAE patients in these countries."
Teo Kee Meng, Managing Director of Transmedic, said: "Being able to add RUCONEST to our portfolio is another example of our continuous drive to bring the most innovative products in specialty medicine, to fulfill the unmet medical needs for patients and doctors, into our rapidly developing region; we are very excited about the potential of RUCONEST in HAE and the future indications that RUCONEST may be developed for."
About RUCONEST (RHUCIN in non-European territories) and Hereditary Angioedema RUCONEST(®) (INN conestat alfa) is a recombinant version of the human protein C1 inhibitor (C1INH). RUCONEST 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. RHUCIN(®) is an investigational drug in the U.S. and has been granted orphan drug designation 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 U.S. Hereditary Angioedema Association, epidemiological estimates for HAE range from one in 10,000 to one in 50,000 individuals.
nice move today !!!!!!!
PHGUF: The Rabbit in the Hat; Initiating Coverage with a Buy Rating
We are initiating coverage of Pharming with a Buy rating and a $0.35 price target. The key investment driver for Pharming is its innovative transgenic animal platform for production of complex recombinant proteins for therapeutic use. With an E.U.-approved product and late stage development in the U.S. and several international partners, Pharming represents a potentially significant value proposition, in our view.
Event
Pharming's key attribute, in our view, is its unique platform using the milk of transgenic animals (rabbits) for low cost production of complex human-like proteins, difficult to manufacture through other methods, to be utilized as replacement therapy in rare therapeutic indications.
Pharming's first drug, Rhucin (recombinant C1 Inhibitor) is commercialized in the E.U. in collaboration with SOBI for hereditary angioedema (HAE). Rhucin is in a Phase III study in HAE in the U.S., projected to complete in 2H12, conducted under SPA in collaboration with Santarus (SNTS - Buy - $4.87). We are optimistic about Rhucin's approval chances in the U.S. and believe that the drug is poised to take over a significant share of the HAE market, given its low COGS allowing for competitive pricing, its safety, convenience, and potentially higher efficacy.
We project peak sales of Rhucin of $150 million in the U.S. by 2019 and estimate that the future stream of cash flows from milestones and royalty payments will support Pharming's efforts to continue growing its pipeline, starting with the next product candidate, recombinant Factor VIII in hemophilia. We view Pharming as an upcoming player in the orphan disease field as it could represent an attractive supply-side partner for the increasing number of biopharma companies focused on developing biological treatments for rare diseases as well as the anticipated market for biosimilars.
Action
We assign a $0.35 price target and Buy rating for Pharming. The company's strategy to expand geographies through collaborations and to develop therapies for rare diseases will bear fruit over the long term, in our opinion. Given the pricing power of orphan drugs and the expanding markets in these indications due to better diagnoses, we believe that Pharming is well-positioned for commercial success.
Pharming Announces Initiation Of A Pediatric Phase II Clinical Study With Ruconest
Discontinues antibody-mediated rejection Phase II clinical study
Leiden, The Netherlands, February 10, 2012. Biotech company Pharming Group NV (?Pharming? or ?the Company?) (NYSE Euronext: PHARM) today announced that it has started an open-label Phase II clinical study evaluating its recombinant human C1 inhibitor (rhC1INH; RUCONEST?) for the treatment of acute attacks of angioedema in pediatric patients with Hereditary Angioedema (HAE).
The protocol for the RUCONEST pediatric study has been agreed with the Pediatric Committee of the European Medicines Agency (EMA). The study will assess the pharmacokinetic, safety and efficacy profiles of RUCONEST at a dose of 50 U/kg in pediatric HAE patients in support of a pediatric indication for treatment of HAE attacks. Pharming expects to enroll approximately 20 pe diatric patients by the end of the year, aged from 2 to 13 years. Further information on the study is available on clinicaltrials.gov.
Pharming also announced that the Company and its U.S. collaborator, Santarus, Inc., have discontinued a proof-of concept Phase II study in antibody-mediated rejection (AMR) after kidney transplantation. Recent improvements in clinical practice that significantly reduced the apparent incidence of AMR in renal transplant have decreased the need for therapeutic intervention, making patient recruitment for the clinical study difficult.
Pharming is continuing to evaluate rhC1INH for other potentially commercially attractive indications, such as ischemia reperfusion injury related indications and promising new platform derived projects like rhFVIII. Reperfusion injury is a complication arising from oxygen shortage due to an interruption of the blood supply (ischemia) resulting in tissue damage. This can occur in a transplante d organ, in the brain, in case of stroke, and in the heart, in case of myocardial infarction (heart attack).
Pharming has investigated the efficacy of rhC1INH in various pre-clinical reperfusion injury models with encouraging results and has recently (December 12, 2011) been granted a U.S. patent expiring in 2028, covering a method of preventing, reducing or treating an ischemia and/or reperfusion injury by administering certain recombinantly expressed C1 inhibitors (RUCONEST?/ RHUCIN?). This was Pharming?s first patent granted on ischemia/reperfusion injury in the U.S., and represents a significant milestone in the continuing development of the Company?s C1 inhibitor franchise in additional indications associated with the broad area of reperfusion injury.
About RUCONEST (RHUCIN in non-European territories) and Hereditary Angioedema
RUCONEST? (INN conestat alfa) is a recombinant version of the human protein C1 inhibitor (C1INH). RUCONEST 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. RHUCIN? is an investigational drug in the U.S., which has been granted orphan drug designation 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 U.S. Hereditary Angioedema Association, epidemiological estimates for HAE range from one in 10,000 to one in 50,000 individuals.
Pharming Redeems Second Tranche Of Convertible Bond
Leiden, The Netherlands, February 9, 2012. Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today announced that it has redeemed the second tranche of its €8.4 million convertible bond. A total of 8,351,146 shares were issued to the bondholders under the terms and conditions of the bond, serving as a pre-installment for the March 12, 2012 redemption and interest payment.
As announced in our press release on December 23, 2011, Pharming will redeem the bond on a month by month basis in six equal monthly tranches of €1.4 million and the interest payable, such that the bond will be redeemed in full on July 15, 2012. Pharming can decide at its discretion to redeem the bond and pay the interest due, by means of monthly equity tranches or cash payments.
As of today, the number of outstand ing shares has increased from 528,995,524 to 537,346,670.
.S. Senate Declares May 16, 2012 as Hereditary Angioedema Awareness Day Resolution recognizes need for more education, research into rare, serious genetic disorder.
By U.S. Hereditary Angioedema Association (HAEA) ary%20Angioedema%20Association%20(HAEA)&link_location=top>
U.S. Hereditary Angioedema Association (HAEA)
Last modified: 2012-02-06T17:08:10Z
Published: Monday, Feb. 6, 2012 - 9:07 am
Copyright 2012 . All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
HONOLULU, Feb. 6, 2012 -- /PRNewswire/ -- The U.S. Hereditary Angioedema Association (HAEA) announced today that the United States Senate has unanimously passed a resolution (S. Res. 286) recognizing May 16, 2012, as Hereditary Angioedema (HAE) Awareness Day . The resolution, offered by Senator Daniel Inouye (D-Hawaii) and Senator Saxby Chambliss (R-Georgia), is the result of a year-long political advocacy effort to generate recognition of the significant need for increased professional education regarding HAE, a rare and potentially fatal genetic disorder, and to highlight the need for further research aimed at improving diagnosis and treatment options for patients.
"This first annual HAE Awareness Day will put a spotlight on HAE, its symptoms, and the impact this challenging disorder has on patients and their families," said Janet Long, Executive Vice President of the HAEA. "We hope this national recognition will broaden awareness of HAE and prompt anyone who suffers from repeated bouts of swelling to seek appropriate diagnosis and treatment."
HAE involves episodes of edema, or swelling, in the face, feet, hands, throat, and abdomen. For most patients, HAE is caused by a defect or deficiency of the blood protein C1-esterase inhibitor. HAE experts estimate that this form of HAE occurs in 1 in 10,000 to 1 in 50,000 people. Swelling symptoms identical to HAE have been identified in families that have normal C1-esterase inhibitor levels. Commonly referred to as HAE III, scientists are studying the possible causes for swelling in this patient group. HAE attacks that involve the face or throat can result in airway closure, asphyxiation and, if untreated, death. Because the disease is very rare, it is not uncommon for patients to remain undiagnosed for many years, receive inappropriate diagnoses or undergo unnecessary exploratory surgery. Medications approved by the Food and Drug Administration (FDA) for treating the symptoms of HAE are now available in the U.S.
The goals of HAE Awareness Day are to:
* Increase awareness of HAE among the general public and medical
community
* Support better care and an earlier and more accurate diagnosis for
HAE patients
* Raise funds for further national and international initiatives
* Enhance the understanding that HAE patients can lead a healthy life
The day will help launch the first biannual HAE Global Conference to be held at the Scandic Hotel Sydhavnen in Copenhagen, Denmark. Findings from the conference will be the impetus for additional HAE research.
Funding and support of the HAEA's public policy program, which encouraged the Senate to acknowledge the need for increased awareness and research, were provided by CSL Behring through the company's Local Empowerment for Advocacy Development (LEAD) ail.htm?tabSelections=1255923338644¤tPage=1> program.
For more information about HAE Awareness Day, please visit www.haeday.org .
About the U.S. Hereditary Angioedema Association (HAEA)Founded and staffed by HAE patients and HAE patient caregivers, the HAEA is a non-profit patient advocacy organization dedicated to serving persons with angioedema resulting from C1-Inhibitor deficiency. The Association provides HAE patients and their families with a support network and a wide range of services including physician referrals and individualized patient support. The HAEA's goal is to increase awareness of Hereditary Angioedema by providing patients and physicians with authoritative and readily accessible information. The HAEA is committed to advancing and conducting clinical research designed to improve the lives of HAE patients and ultimately find a cure. To learn more about the HAEA or join the Association, visit www.HAEA.org , email info@haea.org or call 866-798-5598
SOURCE U.S. Hereditary Angioedema Association (HAEA)
Pharming Reports On Extraordinary General Meeting Of Shareholders
Leiden, The Netherlands, February 3, 2012. Biotech company Pharming Group NV (?Pharming? or ?the Company?) (NYSE Euronext: PHARM) announced that at its Extraordinary General shareholders Meeting (EGM) held today, all proposals were approved, including the increase in authorised capital.
During the meeting, the Company presented alternatives to deal with the negative equity situation, including but not limited to the anticipated receipt of up to $15 million of milestone payments from successful completion of the US phase III pivotal study (Study 1310) and the subsequent acceptance of the Biologics License Application (BLA) by the US Food and Drug Administration (FDA) later this year and re-confirmed that this situation did not and does not impact upon its operational capabilities. The Company also reviewed the convertible debt financing announced on December 23, 2011 which was driven by the need to bridge the financing gap until the read out of Study 1310 and the subsequent requirement to increase the amount of authorised capital.
At the EGM, the majority of the shareholders voted in favour of the increase in the authorised share capital by 255 million shares from 550 million to 805 million shares and to amend the Articles of Association of the Company for that purpose.
Sijmen de Vries, Pharming?s CEO commented; ?During 2011, we unfortunately suffered from the combination of an unexpected regulatory set- back in the US, and the continuing global financial and European crises which affected small cap stocks in a very negative way. Despite this, we have continued to bring the company forward. Most notably for the short- term, in August 2011 we significantly de- risked the US regulatory process with an SPA agreement on Study 1310. We are, as always, very grateful to our shareholders who continue to support our stock in these difficult times. We can now look forward to upcoming milestones and associated potential value inflexion points in the near term.?
The presentation slides of today?s EGM are available on the Company?s website.
About RUCONEST (RHUCIN in non-European territories) and Hereditary Angioedema
RUCONEST? (INN conestat alfa) is a recombinant version of the human protein C1 inhibitor (C1INH). RUCONEST 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. RHUCIN? is an investigational drug in the U.S. where it has been granted orphan drug designation 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 i n 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 U.S. Hereditary Angioedema Association, epidemiological estimates for HAE range from one in 10,000 to one in 50,000 individuals.
Pharming redeems part of convertible bond
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announced that it has redeemed part of its EUR8.4 million convertible bond. A total of 38.9 million shares were issued to the bondholders under the terms and conditions of the bond, serving as a pre-installment for the February 6, 2012 redemption and interest payment, with the balance to be held for subsequent redemptions, if elected to be paid in shares. It is expected that the shares will be admitted to listing and trading on Euronext Amsterdam on January 9, 2012.
As announced in our press release on December 23, 2011, subject to the approval of the proposed increase of the Company's authorized share capital during the extraordinary general meeting to be held on February 3, 2012, Pharming will redeem the bond on a month by month basis such that the bond will be redeemed in full on July 15, 2012. Pharming can decide at its discretion to redeem the bond and pay the interest due, by means of monthly equity tranches or cash payments.
The new funds from this transaction strengthen the balance sheet and enable the Company to extend its cash runway beyond the anticipated read out of Study 1310. As has been previously disclosed, the successful read out of this trial is associated with a $10 million milestone from Pharming's US partner Santarus Inc, with an additional $5 million due upon acceptance of the Biologic License Application (BLA) by the FDA. Subject to these milestones, the Company will be financed into 2013. This guidance excludes any additional cash inflows from further partnering agreements on Rhucin® and the transgenic platform and the continuing roll-out of Ruconest® in Europe.
As of today, the number of outstanding shares has increased to 528,995,524
Merry Christmas to all! May next year find all of you happy, healthy, and prosperous!
Pharming Announces ?8.4 Million Convertible Bond Financing
Leiden, The Netherlands, December 23, 2011. Biotech company Pharming Group NV (?Pharming? or ?the Company?) (NYSE Euronext: PHARM) today announced that it has entered into a financing of approximately ?8.4 million by means of a private convertible bond with select institutional investors, which includes those shareholders that provided the Company with the recent July equity financing.
Upon closing of the transaction, Pharming will receive gross proceeds of ?8 million. The bonds have a fixed conversion price of ?0.12. The bonds may be redeemed in cash or shares at the option of the Company in six equal monthly tranches between February and July 2012 and carry a coupon of 8.5 percent per annum. In addition, 38.7 million warrants will be issued to the investors following the increase of Pharming?s authorized share capital. The warrants will be exercisable for 5 years and have an exercise price of ?0.12.
The new funds from this transaction strengthen the balance sheet and enable the Company to extend its cash runway beyond the anticipated read out of Study 1310. As has been previously disclosed, the successful read out of this trial is associated with a $10 million milestone from Pharming?s US partner Santarus Inc, with an additional $5 million due upon acceptance of the Biologic License Application (BLA) by the FDA. Subject to these milestones, the Company will be financed into 2013.
An Extraordinary General Meeting (EGM) of Shareholders will be held on 3 February 2012, at which the Company will request approval from shareholders for an increase of the Company?s authorized share capital. Such an increase is necessary to fulfill Pharming?s obligations under the financing announced today, to address the issue of negative equity that w as announced on 9 December 2011 and to maintain the flexibility required to raise additional funds for the Company if and when needed.
The current number of outstanding shares is 490 million and the current authorized share capital is 550 million. At the EGM on 3 February, 2012 the Company will request approval from its shareholders to raise the authorized share capital by 255 million shares to 805 million shares.
Details of the EGM and all related documents can be found at the Pharming website as of later today; 23 December 2012.
Roth Capital Partners acted as sole placement agent in this transaction.
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of unmet medical needs. RUCONEST? (RHUCIN? in non-European territories) is a recombinant human C1 inhibitor approved for the treatment of angioedema attacks in patients with HAE in all 27 EU countries plus Norw ay, Iceland and Liechtenstein, and is distributed in the EU by Swedish Orphan Biovitrum. Rhucin? is partnered with Santarus Inc (NASDAQ: SNTS) in North America where the drug is undergoing Phase III clinical development. The product is also being evaluated for follow-on indications in the areas of transplantation and reperfusion injury. 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. Additional 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.
Pharming announces agreement with Renova Life targeting factor VIII for the treatment of haemophilia A
Biotech company Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) today announced that it has signed a service agreement with Renova Life, Inc, (RLI) a biotech company based in Maryland, USA. The agreement covers the development and supply of founder transgenic rabbits from RLI to Pharming. The founder rabbits will enable Pharming to start the commercial production breeding process. The first protein to be expressed in the rabbits will be recombinant human Factor VIII (rhFVIII) for the treatment of haemophilia A.
RLI recently announced the birth of rhFVIII transgenic rabbits through their Chinese subsidiary, Lannuo Biotechnologies (Wuxi, China) and have previously had successful functional expression of rhFVIII in mice. Pharming will leverage its proprietary and validated rabbit platform for the production of recombinant human proteins to develop rhFVIII.
The recent European approval of Pharming's rh C1 inhibitor (Ruconest®) has demonstrated Pharming's ability to produce industrial volumes of high quality recombinant human protein through a method which requires significantly lower upfront capital investment and manufacturing costs compared to current cell based technologies.
Haemophilia A is an X chromosome linked hereditary disorder caused by defects in the Factor VIII (FVIII) gene that lead to lower levels of the functional FVIII protein. Lack of functional FVIII diminishes the body's clotting ability, which in turn can lead to damaging or fatal bleeding episodes. The global rhFVIII market was estimated to worth US$3.8 billion in 2009, with 90% of sales in the developed markets and very high unmet medical needs in the developing markets, such as China. In addition, only approximately 50% of the world-wide estimated haemophilia market can currently be supplied with appropriate FVIII therapy. Hence, there is still a high unmet medical need in this field with an estimated total market potential of US$10 billion.
Dr Fuliang Du, President of RLI, commented: "RLI is very excited to combine our recent technological successes of expressing significant quantities of active rhFVIII in mice and the subsequent birth of our first FVIII transgenic rabbits with Pharming's validated and industrialised transgenic platform."
Bruno Giannetti, COO of Pharming, stated: "Pharming is pleased to have taken this first step towards developing recombinant transgenic Factor VIII and addressing the current demands and unmet needs of the global haemophilia market. This agreement is in line with Pharming's stated strategy of leveraging the embedded value of our proprietary transgenic platform through licensing and co- development agreements, to develop protein therapeutics targeting unmet medical needs and commercially attractive markets
Santarus, Inc. (SNTS) Lazard Capital Markets 8th Annual Healthcare Conference Call November 15, 2011 1:00 PM ET
http://seekingalpha.com/article/311504-santarus-ceo-discusses-at-lazard-capital-markets-8th-annual-healthcare-conference-call-transcript
RHUCIN is our next Phase III study product. It’s currently enrolling patients in the third Phase III. Two pivotal studies have already been completed. The first was actually completed in -- I’ll show you the data, was completed in Europe, that’s in the bottom here. The second study was completed in North America. The European study was done at 100 units per kilogram dose, and then in U.S. study we use 100 kilograms, but also did a 50 kilogram dose.
What was obvious is that 50 kilogram dose was also very effective. When we met with the FDA, the FDA asked that we do an additional study of the 50 units per kilograms. So we are currently enrolling 75 patients in that particular study expect to finish it somewhere in the third quarter of 2012 and then we’ll go ahead and submit the VRA it would be for treatment of acute attacks of Hereditary Angioedema.
If you look at the marketplace there are number of products currently on the market, on the right it would be Cinryze of prophylactic treatment, this patients will be taking the product twice a week every week, typically it’s going to be patients that are getting attacks probably multiple kinds a week, the costs of treatment over a 12 months period is about $400,000 and some of those patients will still have very few attacks.
On the left side is the patients that typically have been treated with anabolic steroids and these patients have been treated for many years with anabolic steroids, many doctors are starting to reduce the dose of steroids and starting to move to these other treatments.
And then the middle what we think is going to be the biggest piece of the market are going to be acute treatment. These are patients that might be getting one attack a month. They are going to be treated either with a HC1 inhibitor, currently Berinert is on the market, it’s a plasma-derived C1 inhibitor as it Cinryze oral product like Kalbitor and Firazyr.
We will be the first combatant C1 inhibitor on the marketplace. We think it offer some safety advantages over plasma-derived products, and we also think that the doctors will see disputed onsite of process is very significant. So we are looking forward to entering this particular marketplace.
Investment Thesis
This report is intended to highlight the potential for four current products and one in development for the treatment of hereditary angioedema (HAE), a rapidly growing market. The HAE market is in an early and dynamic period of growth that should last for the next several years. I project that the US market will increase from $204 million in 2010 to $588 million in 2015. I will deal with the in-depth investment outlook for the companies involved in HAE in subsequent reports because there are other aspects of their business that have to be analyzed in order to form an investment opinion. However, I can make some general statements on the products and the companies behind them. I think that Cinryze is the dominant commercial product in the category and has excellent growth potential. Because it is the main driver of ViroPharma’s (VPHM) earnings, this gives the promise of strong growth for VPHM for the next few years.
1.Shire’s (SHPGY) Firazyr has excellent prospects for growth, but in the strong portfolio of products marketed by Shire (SHPGY), it is only modestly important to the company.
2.Dyax’s (DYAX) Kalbitor has been disappointing. It has contrary to earlier expectations not performed well in head to head competition with CSL Behring’s Berinert. The pending launch of Firazyr further weakens the potential for Kalbitor and investment outlook for Dyax for whom Kalbitor is an important contributor.
3.Berinert is marketed by the German company CSL Behring that I do not track. It is off to a strong start and has good growth prospects.
4.Santarus (SNTS) is developing Rhucin and could have it on the market in 2014. Rhucin should be a meaningful contributor to Santarus in the 2014 to 2000 period. The company believes that it can reach $200 million of peak sales, but this looks ambitious to me.
Orphan Diseases Can Be Significant Commercially Opportunities
The pharmaceutical industry for many years ignored orphan diseases because they affect few people, but the industry has come to view them as major business opportunities. Orphan diseases are classified in the US as afflicting less than 200,000 people and in the European Union as having fewer than five cases per 10,000 population. The NIH classifies 7,000 disorders as orphan diseases and estimates that 25 million patients suffer from these diseases so that in the aggregate the opportunity is huge. Drug development for orphan diseases is one of the major investment trends in the world pharmaceutical industry.
Even though patient populations addressed for individual diseases are small, much higher prices realized per patient treated can lead to meaningful commercial opportunities. For example, Genzyme’s Ceredase for Gaucher’s disease achieved peak sales of $1.2 billion in 2008 while treating only 5,700 patients, an average price realization of over $200,000 per patient. Cinryze for hereditary angioedema, which is a major focus of this report, costs around $300,000 per annum; I project its 2011 sales to be $245 million from the treatment of 825 patients.
In addition to price, there is usually more of an opportunity for longer periods of exclusivity with orphan drugs than with small molecules. Drugs designated as orphan are guaranteed seven years of marketing exclusivity in the US and ten in Europe. Moreover, in many cases the products are produced by technologies that are difficult to genericize.
Hereditary Angioedema; an Attractive Orphan Disease
Hereditary angioedema is an orphan disease that is estimated to affect between 6,000 and 30,000 individuals in the US with the most common estimate being 10,000. It is characterized by a widening of blood vessels resulting in fluid leakage and swelling in tissues (angioedema). The cause is an inherited genetic mutation that results in a deficiency of the C1 esterase inhibitor enzyme. The role of this enzyme is to inhibit a protein called kallikrein which in turn causes the release of bradykynin. Bradykynin acts on the bradykynin 2 receptor on cells in the walls of blood vessels. Excessive levels of bradykinin can cause blood vessels to widen and to open spaces between cells in the blood vessel walls.
HAE is an incurable disease in which attacks occur at unpredictable times. Swelling occurs at different locations. The mucosa of the lips, tongue and abdomen are most frequently affected. Swelling in the face can be grotesque and embarrassing.Levels of bradykinin in tissues rise rapidly during an HAE attack. If untreated, edema develops over 2 to 24 hours and it takes two to five days for the edema fluid to be resorbed. Attacks may begin at one location and move to another. An individual HAE patient may experience more than one attack a week to less than one attack per year. Attacks can be uncomfortable and disruptive at best or severely painful, disabling and potentially life-threatening at worst.
Abdominal attacks and laryngeal attacks are particularly dangerous. Abdominal attacks are often misdiagnosed as bowel obstructions or appendicitis and can result in inappropriate surgical intervention. Swelling of the mouth, tongue and pharynx can progress to laryngeal attacks which block the airways. Laryngeal attacks represent only 2% of all HAE attacks, but if they are not treated, they are estimated to be fatal in 30% of cases. About 50% of HAE patients will experience at least one laryngeal attack in their lifetime.
There are a variety of causes that trigger attacks or they may occur spontaneously. Triggers include psychological stress; localized trauma, including medical and dental and surgical procedures; fever; menses and pregnancy; as well as treatment with ACE inhibitors which block the metabolism of bradykinin and estrogens which can decrease the production of C1 inhibitor.
Because of its rarity, hereditary angioedema is often misdiagnosed by physicians who do not recognize the symptoms. This can lead to misdiagnosis as an allergic reaction or an acute abdominal event like appendicitis or bowel obstruction. This leads to prescribing drugs that are ineffective against HAE such as antihistamines, epinephrine and steroids, or unnecessary exploratory abdominal surgery. In an emergency room setting in which there is no HAE treatment specialist, effective intervention is delayed due to triage procedures, completing tests and conferring with other physicians. Even though an HAE patient may understand perfectly that they are having an attack and know the medicine necessary to treat it (they might even have the medicine with them) emergency room personnel are reluctant to treat based on input from the patient and use of a drug not prescribed by them.
HAE attacks can have a profound impact on patients’ lives. In a survey presented at an FDA advisory committee meeting, 457 HAE patients were asked to report the impact of their most recent HAE attack. About 50% of patients missed work, school, or leisure time as a result of the attack. Patients also reported missed educational and career opportunities, depression, and poor quality of life. Swelling in the face can lead to a grotesque appearance that causes people to avoid contact with other people.
Products Marketed for Hereditary Angioedema in the US
HAE can be treated prophylactically to prevent attacks or acutely to treat an attack in progress. Even with prophylaxis, acute attacks still occur and must be treated.
There are two options for prophylactically treating HAE. Androgenic (male) steroids like Danazol (danocrine) have been used for many years to treat HAE. It is estimated that 600 to 800 mg of Danazol given daily can reduce the number of HAE attacks by 90% and 100 to 400 mg can reduce attacks by 50%. Cinryze was approved in 2008 as the first alternative to androgens, which are effective, but have a broad range of troublesome side effects.
In treating acute attacks, patients need rapid onset of symptom relief and quick resolution of symptoms allowing for a return to normal life. Early treatment is very important in reducing the severity of symptoms. Self-administration of drugs can reduce the time to symptom relief to an hour or so, but if the patient has to have the drug administered by a health care professional, relief can be delayed by a few hours. There have been three new products approved within the last three years to treat acute attacks: (1) Berinert like Cinryze is a C1 inhibitor replacement, (2) Kalbitor is a kallikrein antagonist and (3) Firazyr is an inhibitor of the bradykinin receptor. Rhucin is a C1 inhibitor replacement that is in development for acute attacks.
Cinryze is the only product approved for prophylaxis. It is intended to be used twice a week and this leads to much greater revenue per patient than acute therapy which typically might be used once a month. Cinryze can cost around $300,000 per year while acute therapies can cost around $80,000. Firazyr competes with Berinert and Kalbitor in the acute treatment market. I view the efficacy of these three drugs as similar. However, Firazyr is the only drug that can be administered with a single subcutaneous injection by the patient. Kalbitor has to be given by a health care professional and Berinert requires an intravenous infusion. This should afford a significant commercial advantage to Firazyr.
Projections for the HAE Market
I have tried to weigh numerous factors to come up with a model as to how the US market for HAE products may develop. Because of the fluidity of the market, I can only offer my best guesses. Here are some of the key issues and uncertainties:
1.Cinryze will remain the only branded drug in the prophylaxis segment of the market through the next four years and probably longer.
2.Throughout the initial launch of Cinryze, there has been very little switching from androgens that have long been used for prophylaxis. This could change. Just look at the NFL football players and professional wrestlers who have used androgens to enhance performance and the side effects that some have suffered. While androgens are effective and cheap, the price paid in terms of side effects may lead physicians to switch patients to Cinryze.
3.Payors have not raised any meaningful objections on the $300,000 annual price tag of Cinryze, probably because its sales have been below their radar screens. This could change as Cinryze sales are closing in on $300 million. Managed care might set up requirements for prophylaxis such as requiring a certain number of attacks per month before approving prophylactic therapy. It may use this and other tactics to try to switch patients to cheaper acute therapy.
4.Firazyr seems to have a very important and differentiated commercial advantage with its subcutaneous dosage form that can be self-administered by the patient. Cinryze, Berinert and Rhucin must be given by intravenous infusion and Kalbitor can be sub-cutaneously injected, but only by a medical professional.
5.About 60% of the usage of Cinryze is self-administered in the home even though it requires an intravenous infusion as do Berinert and Rhucin. This may partially offset the self-administration advantage of Firazyr.
6.Firazyr has an issue with pain on injection as almost all patients experience painful and injection site reactions. This could partially negate the substantial advantage afforded by subcutaneous self –injection. How these will balance out is difficult to judge.
7.I see the black box warning of anaphylaxis in Kalbitor’s label and the requirement that it be given by a health care professional as major disadvantages for the drug.
8.Santarus’ Rhucin is the fifth product to come to market and will be at a competitive disadvantage in terms of ability to spend on promotion and physician/patient education.
9.It is unclear how much importance physicians and patients will place on having an alternative with the transgenically manufactured Rhucin to blood based products like Berinert and Cinryze. Rhucin doesn’t carry the small but very troubling risk of transference of viruses and other infectious agents.
10.As a transgenic product in comparison to blood based products, Rhucin may have a cost of goods advantage that could allow it to compete on a price basis against Berinert and Cinryze.
11.Each of these drugs is also being studied in other indications such as treating acute kidney transplant rejections mediated by antibodies and angioedema resulting from the use of the anti-hypertensive ACE inhibitors. This isn’t in our projections.
A Breakdown of the US Hereditary Angioedema Market By Patients
Rhucin (recombinant C1 esterase inhibitor)
Rhucin is a C1 inhibitor that is transgenically produced in the milk of rabbits in contrast to Cinryze and Berinert that are derived from human blood. It was approved in Europe in October of 2010 and licensed to Santarus for the US market in September of 2010. Santarus and Pharming are finalizing discussions with the FDA on the Phase III protocol to support the submission of a biologic license application. The companies continue to expect that a Phase III study will be completed by the third quarter of 2012. If all goes well, Rhucin could reach the US market in early 2014.
Rhucin may be the first non-blood based C1 inhibitor on the market. Rhucin is being developed for acute use. It is infused in a vein over a five minute period. No more than two infusions can be given in a 24 hour period. Santarus points to examples in other drug categories in which a recombinant product ended up taking a majority of market share from long established blood-based products. It bypasses potential constraints of human blood supply limitations including plasma donor restrictions and avoids potential viral and other disease transmission risk.
A potential disadvantage is that the product can not be given to people with allergies to rabbits. Patients will have to be tested for this. There also might be required periodic tests to see if rabbit antibodies are raised with long term dosing
Pharming Granted U.S. Patent On C1 Inhibitor Use In Ischemia Reperfusion Injury Indications
Leiden, The Netherlands, December 12, 2011. Biotech company Pharming Group NV (?Pharming? or ?the Company?) (NYSE Euronext: PHARM) announces that the United States Patent and Trademark Office (USPTO) has granted the Company U.S. Patent 8,071,532, covering a method of preventing, reducing or treating an ischemia and/or reperfusion injury by administering recombinant C1 inhibitor (Ruconest?/ Rhucin?). The broad claims in the patent provide protection until 2028. This is Pharming?s first patent granted on ischemia/reperfusion injury in the U.S., and represents a significant milestone in the continuing development of the Company?s C1 inhibitor franchise in additional indications associated with reperfusion injury such as Delayed Graft Function (DGF) and Acute Myocardial Infarction (AMI).
The patent relates to a novel method of using recombinant C1 inhibitor (rhC1 INH), being produced either in cell cultures or in transgenic animals, wherein rhC1 INH is administered after the onset of ischemia or the start of reperfusion. Recombinant C1 inhibitor showed in contrast to plasma-derived C1 inhibitor to be still therapeutically active in a time span of 6 hours and therefore particularly useful for unforeseen occurrences of ischemic reperfusion such as stroke and myocardial infarction, whereas other claims are directed to treatment during organ transplantations.
Sijmen de Vries, Pharming?s CEO said: ?We are very pleased with this new patent which further enhances the IP portfolio surrounding our proprietary transgenic platform. In addition, it provides Pharming with an even stronger IP foundation for the potential expansion of our C1 inhibitor franchise into additional clinical indications associated with reperfusion injury, such as DG F and AMI which are significant, commercially attractive markets associated with high unmet clinical needs.?
Pharming?s intellectual property portfolio includes a number of issued patents, both in the United States and in various other countries, related to the Company?s proprietary rabbit based platform, unique to Pharming. The successful industrialization of this platform by Pharming has been validated by the EU approval of the rhC1 INH, Ruconest?, and provides unique properties enabling the development of complex proteins that to date have not been produced in an economically viable way.
Furthermore the industrial application of Pharming?s rabbit platform features certain know-how elements specific to Pharming which contribute to significantly lower capital risk and manufacturing expenditures as well as delivering a more flexible supply chain than with any other biologicals production platforms, including larger transgenic animals. It is from this rabbit based platform that Pharming plans to create new development assets to further broaden its pipeline.
This patent can be viewed by going to the U.S. Patent Office Web site, http://patents.uspto.gov, selecting the search patents screen, and typing in the patent number 8,071,532.
http://www.stock-world.de/analysen/nc3988252-First_Berlin_PHARMING_GROUP_NV_Research_Update.html
First Berlin Equity Research hat ein Research Update zu PHARMING GROUP NV (ISIN: NL0000377018) veröffentlicht. Analyst Jens Hasselmeier bestätigt seine BUY-Empfehlung und sein Kursziel von EUR 0,24. Abstract:
Pharming hat seinen 9M 2011-Bericht veröffentlicht. Zu den operativen Highlights des Q3 zählten unter anderem F&E-Fortschritte in den USA (Rhucin zur Behandlung von hereditären Angioödem (HAE)-Attacken) und die weitere Vermarktung von Ruconest (Indikation: HAE) in Europa. Unser überarbeitetes DCF-Modell ergibt unverändert ein Kursziel von EUR 0,24. Wir bekräftigen unsere Kaufempfehlung
The company's "toxic investor" is Socius Capital Group LLC. Socius is run by Michael S. Wachs of CEOcast. As revealed by Barron’s, Wachs is a “convicted financial felon” who is banned for life from the securities and banking industries. Wachs and two other “big time financial felons” run Socius.
As officially disclosed by FINRA, Wachs “misappropriated $20,800,000 in proceeds by means of false and fraudulent pretenses, representations, and promises for the sale of certain of his member firm’s assets and then diverted the proceeds to himself and others.”
Socius partner Terren S. Peizer is infamous for his role as “left hand man” to convicted felon Michael Milken in the Drexel Burnham Lambert junk bond scandal. Peizer avoided doing hard time by turning “states evidence” and testifying against his mentor.
The third member of the Socius team is convicted felon Richard Josephberg, recently paroled from prison after 21 convictions for fraud, conspiracy and tax evasion over 29 years. In between visits to his parole officer, Josephberg promotes Socius CG and Optimus Capital Partners to unsuspecting CEO’s, using aliases like Rick Berg and Rich Joseph. He is also banned for life from the securities industry. It is no wonder that Wachs, Peizer and Josephberg’s names appear nowhere on Socius’ website.
Socius has been repeatedly sued by issuers for taking their stock and then failing to fund as promised. The three felons appear to be growing increasingly desperate, as word spreads that Socius does not have anywhere near the capital they claim, that the source of their money is a criminal enterprise, and that any company doing business with them risks asset forfeiture and SEC investigation.
Pharming Reports Financial Results Third Quarter 2011
Leiden, The Netherlands, November 17, 2011. Biotech company Pharming Group N.V. (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today published its financial report for the third quarter ended September 30, 2011.
FINANCIAL HIGHLIGHTS
Revenues and other income from continuing operations increased to €2.3 million (9M 2010: €0.2 million) due to recognition of license fee income and product sales to Swedish Orphan Biovitrum (SOBI) following launch of Ruconest® in December 2010.
Operating costs of €15.1 million (9M 2010: €14.5 million). The small increase versus 2010 is mainly caused by the capitalization of (€0.4 million) R&D costs during 2010. Cost containment continues to be effective and G&A costs were held stable.
The total net loss in the nine months end ed September 30, 2011 significantly decreased to €13.3 million (9M 2010: €34.6 million). This was primarily due to differences in the financial expenses (related to financing transactions in the corresponding period last year) and the positive impact of discontinuing the DNage operations (9M 2011 €0.6 million profit compared to a €4.0 million loss in 9M 2010).
The net cash flows used in operating activities amounted to €13.0 million (9M 2010: €3.4 million) but the corresponding period in 2010 included one-off licensing receipts of €14.7 million. Excluding these upfront licensing fees the net cash outflows would have shown a €5.1 million decrease of which €2.1 million is associated with the DNage operations and €3.0 million with the continuing business.
In the nine months to September 30, 2011, net cash and cash equivalents, including restricted cash, were €9.8 million (December 31, 2010: €10.5 mil lion). The €0.7 million decrease reflects the net cash outflows from investing activities as net operating cash outflows of €13.0 million (€3.4 million 9M 2010) were offset with net cash inflows from financing activities of €13.0 million. Pharming completed a private placement raising €3.2 million with new US based specialist investors early in Q3, 2011.
OPERATIONAL HIGHLIGHTS
Agreement was reached with the U.S. Food and Drug Administration (FDA) on the design of a Phase III clinical study for Rhucin® (study 1310) under the Special Protocol Assessment (SPA) process to support the submission of a Biologics License Application (BLA). The study design includes a modification to the way the primary endpoint will be assessed and an increase in the number of study patients from 50 to approximately 75. We continue to expect that the Phase III study will be completed by the third quarter of 2012. If approved, Rhu cin® will be the first recombinant C1 inhibitor on the US market, and could offer an attractive therapeutic option for patients with HAE.
Continued expansion of C1 Inhibitor franchise through an extension of the existing 2010 agreement with SOBI. This includes new territories in the Balkans, North Africa and the Middle East in addition to a significant additional order of €1.5 million over a one year period ending in the second quarter of 2012. Following a mutual agreement with Esteve to return the rights to market Ruconest® in Spain, Portugal, Andorra and Greece, these territories were taken up by SOBI and it now has exclusive distribution rights in all European Union countries, Iceland, Norway and Switzerland.
Continuing roll-out of Ruconest® in Europe with product now available in Sweden, Norway, Finland, Denmark, UK, Germany, Austria, France, Lithuania, Romania and the Netherlands.
Chief Executive Officer, Sijmen de Vries, comme nted: “We continue to make progress in rolling out Ruconest across Europe and are pleased to have extended our distribution agreement with SOBI as well as securing minimal order sizes over the coming three quarters. These cash inflows help augment our cash runway as we approach a potentially very significant next step for Pharming: the read out of study 1310. We are delighted that the US development path has been clarified following the agreement of the SPA with the FDA. This presents us with the opportunity for a potentially transformative shift towards becoming a more commercially driven company.”
OUTLOOK
Following the validation of our proprietary transgenic platform through the EU approval of Ruconest, we have received multiple requests regarding the potential licensing of the platform, and/ or co- development collaborations to produce complex proteins. These discussions are at an early stage and focus on significant in dications which already have protein therapeutics on the market. The attraction of our platform appears to be the quality of the proteins, its scalability, low upfront capital investments in manufacturing and its flexibility associated with manufacturing costs. The platform is appropriate for the production of a wide range of proteins but our initial discussions are focused on plasma proteins and metabolic factors. These therapeutic targets are associated with orphan diseases with high unmet need and are also commercially very attractive. Whilst an exciting new development, at this time, we do not envisage moving forward with new projects without partners and we are evaluating key opportunities throughout Asia and South America.
We remain focused on supporting our partner SOBI in facilitating the rollout of Ruconest across the licensed EU territories and look forward to continued progress over the coming quarters. Discussions are on-going with several parties regard ing the potential commercialization of Ruconest in South America, South- East Asia, Japan and Australia/New Zealand and we hope to be able to provide updates on these over the coming quarters.
Study 1310 remains on track and is the pivotal study which supports our US development plan. We anticipate read-out by Q3, 2012 and if successful, anticipate submitting a BLA shortly thereafter. These events are associated with significant milestones of US$10.0 million for the positive study read-out and US$5.0 million for acceptance of the BLA for review by the FDA.
FINANCIAL RESULTS
Financial results for the first nine months of this year showed significant increase in revenues compared with the equivalent period last year.
In the nine months to September 30, 2011 the Company generated revenue and other income from continuing operations of €2.3 million (9M 2010: €0.2 million). This increase reflects the recogn ition of license fee income and product sales following launch of Ruconest® in December 2010. Costs associated with the revenues and other income amounted to €1.4 million.
Total operating costs from continuing operations rose slightly to €15.1 million (9M 2010: €14.5 million). Whilst G&A costs were held stable, the comparator period benefited from capitalisation of R&D costs (€0.4 million).
Financial income and expenses from continuing operations resulted in a €0.2 million profit (9M 2010: €16.3 million loss). Except for the derivative financial liability (this refers to the outstanding warrants associated with the issue of bonds in early 2010), which yielded a €0.4 million profit in the first nine months of 2011, the anti-dilution provisions, convertible bonds and earn-out obligations were all settled in 2010 so that no further expenses in relation to these items were incurred in 2011.
Following liquid ation of DNage in early 2011, the Company deconsolidated the DNage entity from its statement of financial position, resulting in a one-time profit from discontinued operations of €0.6 million (9M 2010: €4.0 million losses).
Overall, the total net loss including the contribution of minority shareholders decreased to €13.3 million (9M 2010: €34.6 million). The net loss per share for the first nine months of the year decreased to €0.03 (9M 2010: €0.15).
FINANCIAL POSITION
In the nine months to September 30, 2011, net cash and cash equivalents, including restricted cash, ended at €9.8 million (December 31, 2010: €10.5 million). The €0.7 million decrease reflects the net cash outflows from investing activities as net operating cash outflows of €13.0 million were offset with net cash inflows from financing activities of €13.0 million. The financing cash flows include receipt o f €9.0 million following our year end 2010 financial transaction with Socius and €1.0 million following the exercise of warrants by Socius, both in the first quarter, and the €3.2 million gross proceeds from a private placement completed in July.
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. RHUCIN has been granted orphan drug designation in the U.S. 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, fa ce, 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 U.S. Hereditary Angioedema Association, epidemiological estimates for HAE range from one in 10,000 to one in 50,000 individuals.
Pharming And Santarus Announce Presentation Of Retrospective Analysis Of Data From Clinical Studies Of Rhucin
Findings to be presented at the annual meeting of The American College of Allergy, Asthma & Immunology
Leiden, The Netherlands, November 4, 2011 Biotech company Pharming Group NV (NYSE Euronext: PHARM) and specialty biopharmaceutical company Santarus, Inc. (NASDAQ: SNTS) today announced that a retrospective analysis of integrated efficacy data from patients with Hereditary Angioedema (HAE) undergoing treatment with the investigational drug RHUCIN® (recombinant human C1 inhibitor, or C1INH) for acute attacks of HAE will be presented in an oral presentation at the 2011 Annual Meeting of the American College of Allergy, Asthma & Immunology (ACAAI) in Boston, MA on November 6, 2011. The findings of a separate retrospective analysis of immuno-safety data will be presented in the poster sessions at the ACAAI meeting. The data analyzed were derived from placebo-controlled and open-label clinical studies conducted with RHUCIN in patients with HAE.
“We were pleased to have the integrated efficacy data accepted for oral presentation and to have the opportunity to present the poster on immuno-safety of RHUCIN at this major U.S. medical meeting of physicians who treat patients with HAE,” said Rienk Pijpstra, MD, MBA, Chief Medical Officer at Pharming.
The abstract Clinical Efficacy of Recombinant Human C1 Inhibitor in North American Patients with Acute Hereditary Angioedema Attacks (R. Levy, et al) is scheduled for an oral presentation at the ACAAI meeting. This integrated efficacy dataset included 70 HAE patients treated for 179 angioedema attacks with 50 U/kg RHUCIN, including patients treated for repeated attacks. Median time to the primary endpoint of onset of symptom relief was 60 minutes and median time to minimal symptoms was 240 minutes. Abdominal attacks had the fastest onset of relief (36 min), followed by urogenital (56 min), oro-facial-pharyngeal-laryngeal (65 min), and peripheral attacks (84 min). In addition, 96% of attacks (172/179) had a clinical response within 4 hours.
A second abstract Immuno-safety of Recombinant Human C1 Inhibitor in Patients with Hereditary Angioedema: An Integrated Analysis (C. Hack, et al) will be discussed in a poster presentation. Data from 155 patients in the RHUCIN acute treatment studies with 424 administrations of RHUCIN were analyzed. The frequency of anti-C1INH antibodies was low and similar in pre- and post-exposure samples (1.7% and 1.8%, respectively). Occurrence of anti-C1INH antibodies did not correlate with repeated treatment or time since last treatment. No neutralizing antibodies were detected. A total of 5/155 (3%) RHUCIN-treated patients had confirmed anti-host-related impurities (HRI) antibodies, which included one patient with anti-HRI antibodies prior to exposure to RHUCIN. The presence of anti-C1INH and anti-HRI antibodies was not associated with clinical symptoms.
RHUCIN Phase III Study
Pharming is conducting a Phase III clinical study with RHUCIN under a Special Protocol Assessment (SPA) that is intended to support the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). RHUCIN is being evaluated for the treatment of acute attacks of angioedema in patients with HAE in an international, multicenter, randomized, placebo-controlled Phase III study at a dosage strength of 50 U/kg with a primary endpoint of time to beginning of relief of symptoms. 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 $10 million milestone is payable to Pharming upon successful achievement of the primary endpoint of the Phase III clinical study. The study is expected to be completed by the third quarter of 2012.
nice move today !!! +30% up
Pharming grants SOBI additional territories for the commercialisation of Ruconest(R)
Biotech company Pharming Group NV ("Pharming") (NYSE Euronext: PHARM) today announces that it has reached mutual agreement with Esteve to return the rights to market Ruconest® in Spain, Portugal, Andorra and Greece. SOBI will now take up the exclusive distribution rights in these countries, extending its territories for Ruconest® to all European Union countries, Iceland, Norway and Switzerland.
Sijmen de Vries, CEO of Pharming, said "In addition to the new territories in the Balkans, North Africa and the Middle East announced earlier this month, SOBI now has exclusive rights for the commercialization of Ruconest® (recombinant human C1 inhibitor) for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE) in all European markets where the product has received market authorization through central European approval. We are confident that this agreement will optimize the commercial roll- out of Ruconest®."
Pharming announces extension of their license agreement for the commercialization of Ruconest(R)
Pharming Group (EU:PHARM)
Intraday Stock Chart
Today : Monday 15 August 2011
Biotech company Pharming Group NV ("Pharming") (NYSE Euronext: PHARM) today announced that they have agreed an extension of their existing agreement with Swedish Orphan Biovitrum (STO: SOBI) to include new territories in the Balkans, North Africa and the Middle East for the commercialization of Ruconest® (recombinant human C1 inhibitor) for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE).
In addition, SOBI has placed a significant additional order for vials of Ruconest®. The shipment forms part of SOBI's preparation for the continued roll-out and intensified marketing of Ruconest® across Europe. SOBI will over a period of 1 year pay EUR1.5 million to Pharming for these additional shipments under this order. Under the terms of the distribution partnership, SOBI buys finished product from Pharming for a transfer price that includes a sales related tiered royalty component.
Sijmen de Vries, CEO of Pharming, said "We are delighted to expand our current commercialization deal with SOBI. This is another significant step towards making Ruconest more widely available. With this extension, patients in all EC territories, the Balkans, North Africa and the Middle East will soon be able to benefit from the efficacy and safety that Ruconest offers as the only recombinant enzyme replacement therapy for HAE".
About Ruconest (Rhucin) and Hereditary Angioedema
Ruconest® / 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. Rhucin has been granted orphan drug designation in the U.S. 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 U.S. Hereditary Angioedema Association, epidemiological estimates for HAE range from one in 10,000 to one in 50,000 individuals.
Pharming Signs Commercialization Agreement With Megapharm For Ruconest? In Israel
Leiden, The Netherlands, June 7, 2011. Biotech company Pharming Group NV (?Pharming?) (NYSE Euronext: PHARM) today announced that it has entered into an agreement with MegaPharm Ltd. (MegaPharm), a privately owned Israeli pharmaceutical company, for the commercialization of Ruconest? (recombinant human C1 inhibitor) in Israel for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE).
Under the agreement, MegaPharm will pay Pharming for completion of certain commercial, regulatory and clinical milestones. MegaPharm will purchase its commercial supply of Ruconest from Pharming at a supply price, based on a percentage of net sales of Ruconest. The number of HAE patients in Israel is estimated at approximately 250. MegaPharm anticipate to launch Ruconest in 2012.
Sijmen de Vr ies, CEO of Pharming, commented: "We are pleased to have taken a another step towards making Ruconest, an innovative, highly effective and safe replacement therapy, available to HAE patients globally. In MegaPharm we have a strong commercialization partner with a proven track record in this region and strong presence in the immunology therapeutic area.?
Miron Drucker, CEO of MegaPharm, said: ?We are delighted to have concluded an agreement with Pharming to market Ruconest in Israel. We have been active in the Allergy and Immunology fields for many years and this is an important step in the company?s strategy to strengthen our presence and expand our portfolio in this therapeutic area.?
Ruconest? is a human protein developed through Pharming?s proprietary technology where the human protein is expressed in milk of transgenic rabbits. Pharming is developing Rhucin/Ruconest for treatment of patients with acute attacks of H ereditary 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 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 Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of unmet medical needs. Ruconest? (Rhucin? in non-European territories) is a recombinant human C1 inhibitor approved for the treatment of angioedem a attacks in patients with HAE in all 27 EU countries plus Norway, Iceland and Liechtenstein, and is distributed in the EU by Swedish Orphan Biovitrum (STO: SOBI). 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 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. Additional information is available on the Pharming website, www.pharming.com.
About MegaPharm
MegaPharm Ltd. is one of the leading private biotech, pharmaceutical and medical nutrition marketing companies in Israel with a strong biotech orientation, exclusively representing a number of major American and European pharmaceutical companies. MegaPharm has demonstrated dynamic sales growth by developing a strong company pres ence and expertise in select therapeutic areas, and diversified segments of the healthcare business. For more information see www.megapharm.co.il.
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.
Contact:
Pharming
Sijmen de Vries, CEO, T: +31 (0)71 52 47 400
MegaPharm
Issy Peimer, V.P. Business Development, T: +972.528.690.616
New data support efficacy of Ruconest across all HAE attack locations
Pharming Group NV ("Pharming" or "the Company") (NYSE Euronext: PHARM) announced today that new clinical data from open-label studies on their recombinant human C1 inhibitor (rhC1INH; conestat alfa; Ruconest™ in Europe, Rhucin® in other countries) was presented during the 7(th) C1INH deficiency workshop in Budapest, Hungary, 20-22 May 2011.
New data was presented on 194 treatments with Ruconest / Rhucin using a fixed dose of one vial (2100 U) or more at the investigator's discretion, in 57 patients with acute Hereditary Angioedema (HAE) attacks. This open-label study was an extension of one of the two pivotal randomized controlled studies which formed the basis for approval in Europe. The majority of acute Angioedema attacks (63%) were treated with a single dose of Ruconest (2100 U). Use of more than one dose was more common during attacks at oro-facial-pharyngeal- laryngeal locations (57%) than during abdominal (26%) and peripheral (37%) attacks. The median time to the beginning of relief of symptoms across treatments, was approximately 60 minutes with an overall response rate of 87% and no relapses. No product related adverse reactions were observed during this study.
Results were also presented for 53 potentially life threatening acute angioedema attacks involving the upper airways. The median time to the beginning of relief of symptoms for these upper airway attacks was 76 minutes (95% confidence interval, 62; 120 min) and the median time to the beginning of relief of symptoms was 265 minutes (95% confidence interval, 240; 720 min). These results are consistent with previously reported results for other anatomical locations. The overall response rate in treating these severe attacks was 100%. There were no treatment failures, nor relapses reported, and Ruconest was generally safe and well tolerated. The safety dataset of Ruconest / Rhucin now includes a total of 714 administrations in 190 subjects.
Dr. Pijpstra, Chief Medical Officer at Pharming commented: "These new data support that Ruconest is an effective novel therapy for the treatment of acute HAE attacks, including those potentially life-threatening attacks involving the upper airways. In addition, the European open label efficacy data suggest that although a 50 U/kg dose is recommended to achieve optimal efficacy, many attacks respond well to a single vial dose of 2100 U."
Pharming Announces First Quarter Financial Report 2011
Leiden, The Netherlands, May 12, 2011. Biotech company Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today published its financial report for the three month period ended March 31, 2011.
Financial Highlights first three months
Revenues of €0.6 million for the three month period (Ruconest™ first sales recorded in December 2010)
Significant reduction in operating cash outflows to €4.5 million (Q1 2010: €6.3 million)
Decrease in operating loss from continuing operations to €4.3 million (Q1 2010: €5.0 million)
Significant decrease in net loss to €3.6 million (Q1 2010: €7.7 million)
Cash at March 31, 2011 of €15.6 million compared to €10.5 million at year end 2010
Operational Highligh ts in first quarter
Rollout of Ruconest in Europe progressing
Clarity from the FDA on requirements for the US development of Rhucin®
Protocol for Phase III study 1310 amended in accordance with FDA requests and submitted
Continuing focus on limiting cash burn
Lease financing of production equipment completed, internal cost saving exercise ongoing
Business development process initiated to leverage Pharming’s technology platform
Sijmen de Vries, CEO, commented: "The first three months of 2011 have been an intense period for Pharming, as we focused on addressing the FDA’s refusal to file letter for Rhucin. Pharming is now implementing the agreed changes in the Protocol for Study 1310. We are also continuing to seek and evaluate new sources of value creation and financing for the Company, including additional partnerships for our C1 inhibitor franchise and potential de als which utilise our validated proprietary, low cost production platform. We look forward to updating on further progress throughout the year."
Financial Highlights
Pharming’s revenues from license fees and product sales were €0.6 million in the three months to March 31, 2011, compared to nil in the same period of 2010, resulting in the operating loss from continuing operations decreasing to €4.3 million (Q1 2010: €5.0 million). General and administrative costs and research and development expenses remained broadly constant during the three month period, compared to the corresponding period in 2010.
In the three months to March 31, 2011, the shareholders of DNage, in which Pharming had 51% ownership, decided to voluntary liquidate DNage and accordingly the DNage entity has been deconsolidated. This has resulted in a one-time net profit of €0.6 million compared to losses from the DNage operations of &euro ;1.0 million incurred during the corresponding period in 2010. Both results have been presented as discontinued operations in the statement of income.
In the three months to March 31, 2011, Pharming recorded a net loss of €3.6 million (Q1 2010: €7.7 million). The net loss per share was €0.01 (Q1 2010: €0.05). At the end of the period, the number of shares outstanding was 461,116,470 compared to 154,501,037 at the end of the corresponding period in 2010 and 436,261,010 shares at December 31, 2010.
In Q1 2011 the Company received an aggregate amount of €10.0 million from Socius in relation to a year end 2010 receivable of €9.0 million plus €1.0 million following the exercise of all 24,339,623 warrants. Mainly due to these receipts and net operating cash outflows of €4.5 million, the total cash position increased from €10.5 million at December 31, 2010 to €15.6 million at the end of Q1 2011 (Q1 2011: &euro ;3.3 million).
Operational Highlights
The rollout of Ruconest in Europe continues and both we and our partner, SOBI, remain confident that the launch is on track. Progress on reimbursement has been made across Europe both at national and regional levels.
We have received clarity from the FDA on the US development requirements for Rhucin. The issues raised by the FDA have been discussed and we have submitted the amended protocol for Study 1310 to the FDA.
We continue to focus on limiting our cash burn and to date a number of cost saving initiatives have been implemented. In Q3 2010 Pharming signed a manufacturing agreement with Sanofi Chimie to increase the production capacity of the drug substance of Ruconest. This will improve the cost of goods and competitiveness of Ruconest. We recently completed the lease financing of production equipment for this process. In order to leverage our proprietary technology platform, a business development process on potential new platform collaborations has been initiated.
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of unmet medical needs. Ruconest™ (Rhucin® in non-European territories) is a recombinant human C1 inhibitor approved for the treatment of angioedema attacks in patients with HAE in all 27 EU countries plus Norway, Iceland and Liechtenstein. 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 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. Additional 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.
Contact:
Karl Keegan, CFO, T: +31 (0)71 52 47 181
Pharming Annual Shareholders Meeting
Leiden, The Netherlands, 11 May, 2011. Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) provided an update on its product, financial and corporate developments during the Annual Meeting of Shareholders (AGM) today.
During the meeting, the Company confirmed its strategy to become an international specialty pharmaceutical company. This includes the development of therapeutic products for significant medical needs, such as Ruconest/ Rhucin. With its production platform validated by the recent EU approval of Ruconest, Pharming also now intends to leverage its low cost and scalable manufacturing platform to produce other proteins.
At the AGM, the majority of the Shareholders voted in favour of the re- appointments of Dr. J.B. Ward and Mr. J. Blaak as members of the Board of Supervisory Directors of Pharming (BOSD), the re- appo intment of Dr. B. Giannetti as member of the Board of Management of Pharming (BOM), the option arrangements for the BOM, the remuneration of the BOSD, the increase in the authorised share capital by 50,000,000 shares and the re-appointment of PricewaterhouseCoopers as Auditors.
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of unmet medical needs. Ruconest™ (Rhucin® in non-European territories) is a recombinant human C1 inhibitor approved for the treatment of angioedema attacks in patients with HAE in all 27 EU countries plus Norway, Iceland and Liechtenstein. 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 advanced technologies of the Company include innovative platforms for the production of protein therapeutics, technology and processes for the purification a nd formulation of these products. Additional 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.
Contact:
Karl Keegan, CFO, T: +31 (0)71 52 47 181 or +31 (0)6 3168 0465
Pharming Amends Phase III Clinical Study With Rhucin In Acute Hereditary Angioedema Leiden, The Netherlands, May 5th, 2011. Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) today announced that following discussions with the U.S. Food and Drug Administration (FDA), Pharming and its U.S. commercialization partner, Santarus, Inc. have submitted an amendment to the protocol for the RHUCIN® (recombinant human C1 inhibitor) Phase III clinical study into which the first patient was enrolled in February 2011.? The Phase III clinical study is evaluating the investigational drug RHUCIN for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE). Pharming still anticipates that the Phase III study will be completed within 12 to 18 months from its original initiation.
On March 31st , Pharming and Santarus met with the FDA to discuss the FDA refusal to file letter received in February 2011 and to gain further clarification on the protocol for the ongoing study to support the RHUCIN Biologics License Application (BLA).? Based on input from the FDA and from the FDA meeting minutes, Pharming and Santarus have now submitted an amendment to the protocol, including an increase of the number of patients from 50 to approximately 75 and a modification to the manner in which the primary endpoint will be assessed. This modification eliminates the need for further validation of the visual analog scale.?
“We are pleased to be working closely with the FDA to amend the protocol for the Phase III study, which we believe addresses the issues raised by the agency, and upon successful completion of the study, will provide the additional clinical support requested for our future BLA submission” said Rienk Pijpstra, MD, MBA, Chief Medical Officer at Pharming.
hey pedromm
just home form work.
nice day .no news today?
what´s going on...crazy today
Hello Plumo
How are you?
The last week was terrible to share price of Pharm.
Finally today stop the losses, however the current share price is 0,099.
Today i read from the CEO that there is no more plans to issue shares, what it is good and at 21 of March Pharm will trade in a new index.
Hold your shares if you still have( i have)...is this a good time to buy more...time will tell...but i think so
best regards
Socius Exercises Warrants
Leiden, The Netherlands, March 7, 2011. 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, exercised all 24,339,623 warrants under the €16.1 million investment agreement entered into with Pharming in December 2010.
Under the terms of the agreement, Socius received 24,339,623 warrants with an exercise price of €0.212 (21.2 cents), which have now been exercised. Payment of the exercise takes place through a cash consideration of €0.04 per share (€973,584.92) and issuance of a Promissory Note for the remaining consideration of €4,186,415.08.
As of December 31, 2010, Pharming had 436,261,010 shares outstanding. The new number of outstanding shares is 461,116,470 comprising th e previous balance and including the exercise of the warrants by Socius (24,339,623) and shares (515,837) issued as part consideration of bonus payments to Pharming staff.
Pharming And Santarus Announce Initiation Of Phase IIIB Clinical Study With Rhucin In Acute Hereditary Angioedema
Leiden, The Netherlands, February 22, 2011. Pharming Group NV (“Pharming” or “the Company”) (NYSE Euronext: PHARM) and San Diego based specialty biopharmaceutical company Santarus, Inc. (NASDAQ: SNTS) today announced that Pharming has begun an international, multicenter, randomized, placebo-controlled Phase IIIb clinical study evaluating the investigational drug RHUCIN® (recombinant human C1 inhibitor) for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE). Pharming expects to enroll approximately 50 patients in the study which may provide additional data, if required by the U.S. Food and Drug Administration (FDA), in support of an approval for RHUCIN at the 50 U/kg dose. Data from the study will also be used to provide additional validation of the visual analog scale used in measuring the clinical effects of RHUCIN. The study is expected to be completed in 12 to 18 months.[/b]
The safety and efficacy of RHUCIN for the treatment of HAE attacks were previously evaluated in two randomized placebo-controlled studies and 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 RHUCIN dosage strengths of 50 U/kg and 100 U/kg compared to placebo. In October 2010, Pharming received Marketing Authorization in the European Union for RUCONEST™ (RHUCIN in non-European territories) for the treatment of acute angioedema attacks in patients with HAE. Pharming submitted a Biologics License Application (BLA) for RHUCIN to the FDA in late December 2010. In total, the BLA dossier included 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, Pharming is responsible for conducting and paying for the current clinical study with RHUCIN in the treatment of acute attacks of angioedema in patients with HAE.
Thank you.
At the end thats good, because they won´t spend any more money there.
Pharming Discontinues Funding Of DNage
Leiden, The Netherlands, 01 February, 2011. Biotech company Pharming Group NV (“Pharming”) (NYSE Euronext: PHARM) today announces that it has discontinued the funding of DNage.
In July 2010, Pharming announced the completion of the spin-off of its subsidiary DNage. As part of the spin- off agreement, Pharming agreed to provide DNage with an undisclosed,limited bridge funding for a specified term, to allow DNage time to seek new investors. DNage has been unable to secure new investors and its shareholders have now decided to put DNage into voluntary liquidation.
About Pharming Group NV
Pharming Group NV is developing innovative products for the treatment of unmet medical needs. Ruconest™ (Rhucin® in non-European territories) is a recombinant human C1 inhibitor approved for the treatment of angioedema attacks in patients with HAE in all 27 EU countries plus Norway, Iceland and Liechtenstein. 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 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. Additional 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.
Contact:
Karl Keegan, Chief Financial Officer Pharming Group NV., T: +31 (0)71 52 47 400 or E: k.keegan@pharming.com
I think FDA has 30 ou 60 days to answer to bla procedeure.
30 days has already gone. Lets wait for good news and new buyers coming in.
I also would like to know how was the first month of sales....
still 4 weeks to go before the FDA decides
And if today this close green, we will have a sign on macd
SpeedStone strong buys again....seems that a new coud now appear.
holding around the 100 day average... The next movement will define the next trend.
My understanding is this:
Plumo there a lot of shares that pharm have sold this year,that are know in the market.
Those big organizations still have a lot shares in their hands and once we are reaching the end of the year they sold to close positions.
And of course all the people who bought at 0,15-0,18 are just for taking profit.
Pharm and the share price need news like a fuel to live. And we don´t expect any special news until the FDA give some news about the BLA submission. This will occur one or two months from now.
I give one more help, more techinical.
The first important supporte for Pharm is the 100 days average on the dayly chart.Four times touch and go up, including today. And the second the price at 0,20€.
And in the one hour chart once macd give signal is a good time to buy.
I have 250000 shares of pharm know.
One part of them i hold and rest i try to trade.
I hope to see pharm at 0,5€ - 1€ within two years.
not so a good day today pedromm .
why?
A very good volume and a green candle.
Good start.
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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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