Partnering with Pharming

Pharming supports its partners to get products approved for commercialisation by the various regulatory authorities, and subsequently allow patients to benefit from access to these products. As our first product we believe that Ruconest® is a valuable addition to the therapeutic options available to HAE patients.

Ruconest®’s intrinsic activity and safety profile gives it a significant competitive advantage over competing treatments and, over time, could result in the product achieving significant market penetration in major global markets. We continue to partner with commercially oriented companies that are committed to making Ruconest® a commercial success.

To date, Ruconest® commercialisation rights remain available for Japan, India and certain territories in Latin America, Africa and Asia.

For more information please contact us at: partners@pharming.com

Map of Ruconest Distribution

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About Clinigen Group

The Clinigen Group is a specialty global pharmaceutical company headquartered in the UK, with offices in the US and Japan. The Group is dedicated to delivering ‘the right drug, to the right patient at the right time’. In April 2015, Clinigen acquired Idis, the market leader in the global supply of unlicensed medicines. The Group now operates as four synergistic businesses; Clinigen Specialty Pharmaceuticals, Clinigen Clinical Trial Supply, Idis Managed Access (this now includes the previously branded Clinigen Global Access Programs business) and Idis General Access.

The Managed Access business develops and implements exclusive access programs for biotechnology and pharmaceutical companies and has provided physicians with an ethical solution to access unlicensed medicines for thousands of patients with an unmet medical need.

For more information, please visit www.clinigengroup.com

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About the Global Access Programs

The Global Access Programs (GAP) is an international global access collaboration for HAEi, the International Patient Organization for C1- Inhibitor Deficiencies. The “HAEi GAP” will provide access to RUCONEST® (conestat alfa) to eligible patients with hereditary angioedema (HAE), who currently do not have access to effective medication to treat acute attacks of the disease.

HAEi GAP is the first global access program for HAE and the first to be driven by a patient organization. The program enables patients in countries where RUCONEST is not commercially available to gain access to the drug through an ethical and regulatory compliant “Named Patient Program” mechanism.

“HAEi is committed to securing access to HAE medications for patients across the globe,” said Anthony J. Castaldo, President of HAEi. “We are extremely proud to have established HAEi GAP with our current partners and will continue to work with other manufacturers with the hope of expanding the program in the future.”

Simon Estcourt, Managing Director, Managed Access Programs, Clinigen Group said: “HAEi’s ground-breaking program will ensure that HAE sufferers worldwide can gain access to effective and potentially life-saving treatment. Our secure supply chain and regulatory expertise will enable us to work closely with Pharming to supply patients with RUCONEST ethically and legitimately, removing the need and the risk for patients to resort to other less reliable or even illegal sources of the drug. We look forward to working with both HAEi and Pharming on this unique project.”

Sijmen de Vries, CEO, Pharming said: “We are delighted to be the first partners of HAEi and to initiate this program by providing access to RUCONEST, a recombinant human C1- inhibitor, approved by EMA and FDA for the treatment of acute attacks of HAE in patients. In this way we can help to improve the lives of those HAE patients that otherwise would continue suffering from this debilitating and unpredictable disease.”

For more information, please click here. 

Cytobiotek logoAbout Cytobioteck S.A.S.

Cytobioteck is a company focused on delivering new therapies to patients struggling with rare and orphan diseases of a low prevalence but of a high impact in those who suffer from them. Our mission is to benefit these patients so their future is ensured to improve and their life quality. As a result, our vision is to grow as the leader in the region delivering orphan drugs.

As of 2015, Cytobioteck has expanded his operations and is currently delivering drugs to México, Colombia, Venezuela, Perú, Argentina, Brazil and Central America (Panamá, Costa Rica, República Dominicana), being able to introduce orphan drugs in the market and obtaining full reimbursement from the authorities for the most expensive products in the globe.
For more information, please click here.

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Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products and medical devices for the prevention and treatment of gastrointestinal diseases. Salix’s strategy is to in-license late-stage or marketed proprietary therapeutic products, complete any required development and regulatory submission of these products, and commercialize them through the Company’s 500-member specialty sales force.

Ruconest in the United States

As of the 17th of July 2014, Ruconest has been granted Orphan Drug designation by the FDA for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE). With Ruconest now approved by the FDA, Salix believes this designation should provide seven years of marketing exclusivity in the United States.

RUCONEST® is manufactured by Pharming Group NV in the Netherlands. Salix has licensed exclusive rights from Pharming to commercialize RUCONEST® in North America and market RUCONEST® for the treatment of acute HAE attack symptoms.Salix currently plans on making RUCONEST® accessible to patients later in 2014.

For more Information on clinical studies in the U.S with Ruconest for acute attacks of HAE is available at clinicaltrials.gov by clicking here.

FDA Approval

The FDA approval of the Biologics License Agreements (BLA) for RUCONEST® for treatment of acute angioedema attacks in patients with HAE is based on a randomized, double-blind, placebo-controlled, phase III trial (RCT) which included an open-label extension (OLE) phase and is supported by the results of two additional RCTs and two additional OLE studies. The pivotal RCT and OLE studies analyzed the results from 44 subjects who experienced 170 HAE attacks. The primary efficacy endpoint was the time to beginning of symptom relief, assessed using patient-reported responses to two questions about the change in overall severity of their HAE attack symptoms after the start of treatment. These were assessed at regular time points for each of the affected anatomical locations for up to 24 hours. To achieve the primary endpoint, a patient had to have a positive response to both questions along with persistence of improvement at the next assessment time (i.e., the same or better response).

More Information on clinical studies in the U.S with RUCONEST is available at clinicaltrials.gov by clicking here.

Sipi

Shanghai Institute of Pharmaceutical Industry, a research institute, engages in the research of organic synthesized pharmaceuticals, microbiological and biochemical pharmaceuticals, biotechnological drugs, traditional Chinese medicines and novel preparations, pharmaceutical preparations, and new drug delivery systems. The company was founded in 1957 and is based in Shanghai, China. As of December 11, 2012, Shanghai Institute of Pharmaceutical Industry operates as a subsidiary of China State Institute of Pharmaceutical Industry.

The China State Institute of Pharmaceutical Industry and the China National Pharmaceutical Group Corporation, (Sinopharm) comprises the largest medical and healthcare group in China which is directly managed by State-owned Assets Supervision and Administration Commission of the State Council (SASAC). Their core business is the distribution, logistics, retail, scientific research and manufacture of healthcare related products.

Sinopharm is aiming to be an international pharmaceutical and healthcare group which will cover the whole industrial chain and give strong impetus to the industry.

Ruconest® in China

Ruconest® in China

Pharming’s technology and manufacturing know- how, will be transferred to SIPI, such that joint global development for new products can take place at SIPI’s facilities in Shanghai, benefiting from both the cost advantages of the Pharming’s platform and the competitive development and manufacturing costs structures at SIPI.

SIPI will retain an exclusive licence to commercialize, develop and manufacture Ruconest in China; it will also take part in the continuing development of rhFVIII and other therapeutic biological of mutual interest.

The strategic collaboration with Shanghai Institute of Pharmaceutical Industry (SIPI), effectuated in 2013, represented an important step forward towards building a pipeline of new products using our technology platform. Under the collaboration our entire technology platform, quality assurance and quality control (QA/QC) processes, and production system are being transferred to the SIPI Shanghai facilities. Pharming and SIPI intend to develop new compounds from this facility. SIPI will have commercialisation rights for China and its territories. Pharming will have commercialisation rights ex-China. SIPI will supply Pharming at a “cost–plus” basis.

The first new compound to be jointly developed is recombinant human Factor VIII for the treatment of Haemophilia A. Haemophilia A is an X chromosome linked hereditary disorder caused by defects in the Factor VIII gene that leads to lower levels of the functional Factor VIII protein. Lack of functional Factor VIII diminishes the body’s clotting ability, which in turn can lead to damaging or fatal bleeding episodes.

SIPI also obtained development and commercialisation rights for China and its territories for Ruconest. The manufacturing process for Ruconest is also being duplicated at SIPI, under all of the Pharming QA/QC and manufacturing standards, such that SIPI could manufacture rhC1 inhibitor for China and its territories, but could also supply Pharming in the future.

For more information about SIPI and its partnership with Pharming please click here.

Swedish Orphan Biovitrum is a Swedish based niche speciality pharmaceutical company with an international market presence. The company is focused on providing and developing specialist pharmaceuticals for rare disease patients with high medical needs. The portfolio consists of about 60 marketed products and an emerging late stage clinical development pipe-line. Sobi’s focus areas are: hemophilia, inflammation/autoimmune diseases, fat malabsorption, cancer and inherited metabolic disorders.

Ruconest® in Europe

Sobi has continued its roll-out of Ruconest® and the drug is now available in the majority of the European territories. Increasingly HAE patients in EU countries benefit from treatments with Ruconest and with the progression of reimbursement of Ruconest, we expect a continuous increase in patients using Ruconest® in the future. In October 2014 Sobi and Pharming agreed to extend the Sobi territories by adding a number of countries representing the former CIS, and Sobi returned commercialisation rights for Austria, Germany and the Netherlands to Pharming.

For more information about Sobi and its partnership with Pharming please click here.

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Eczacıbaşı

Eczacibasi’s Pharmaceuticals Division was established with production of the vitamin D-Vital, in Dr. Nejat F. Eczacıbaşı’s laboratories.  Turkey’s first modern pharmaceutical plant was established in 1952 by Eczacıbaşı. Today, Eczacıbaşı’s Pharmaceuticals Division produces pharmaceuticals, veterinary products and personal care products in addition to imported pharmaceuticals through international licence agreements.

For more information please click here.

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Megapharm Ltd

Megapharm Ltd. is one of the leading private biotech marketing companies in Israel engaged in both the pharmaceutical and healthcare business. Megapharm has formed a dedicated Clinical Research Department offering the possibility of early phase clinical research studies. Ruconest is approved for use in Israel, and studies in Israel are fully recognized by all international health and licensing authorities, including the FDA. Clinical studies are conducted on behalf of our business partners for the products to be marketed by Megapharm.

For more information please click here.

 

transmedic

Transmedic

Transmedic started in 1980 as an equipment distributor to cater to the medical needs of an increasingly affluent Asia.  Today, it is a leading specialty partner of healthcare institutions and professionals.  Manufacturers trust us to promote and implement their latest technologies and remedies. Customers see us as a facilitator of medical advances.  Transmedic aspires to play a key role in bringing first world healthcare benefits to this region.

For more information please click here.

 

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The Hyupjin Corporation

The Hyupjin Corporation is an importer and distributer of healthcare products in the Republic of Korea. The Hyupjin Corporation develops and imports essential products from prominent companies in the US and Europe since its establishment under its former name, The Dai Ho Corporation, in 1975. For about 30 years, its devotion in the medical market and medical communities has flourished in concrete relationships with MD’s in hospitals, clinics and other healthcare professionals. They work to build upon their own knowledge and know-how’s in medical community.

To read more please click here.