Dealings in Clinigen shares are expected to commence on AIM at 8.00am on Tuesday 25 September 2012, under the ticker symbol CLIN





Clinigen is a rapidly-growing specialty pharmaceutical and services company, with one clear aim: to deliver the right drug to the right patient at the right time.




To achieve our aim, we have built a group of complementary businesses which can operate efficiently in a complex global regulatory environment and which can ensure that precious medicines are delivered securely and effectively, wherever they are needed. Through three businesses, Clinigen SP, Clinigen GAP, and Clinigen CTS, we acquire, license and revitalise niche, hospital-only critical care medicines, and source and supply our own and other pharmaceutical companies’ products, whether to meet unmet medical needs or for use in clinical trials.





Clinigen Clinical Trials Supply (CTS):

We use our global expertise, systems and relationships to source and manage the supply of commercial medicines to pharmaceutical companies for use exclusively in clinical trials. This requires excellent knowledge of the global pharmaceutical market, the regulatory processes and customs authorities of countries all over the world, along with a high tech supply chain with guaranteed quality and safety standards that can deliver swiftly.

Clinigen Global Access Programs (GAP):

On behalf of pharmaceutical and biotech companies, we manage essential programs that provide access to critical medicines for physicians and their patients all over the world. But what is a Global Access Program? Known by many terms from ‘expanded access’ and ‘named patient’ to ‘compassionate use’ and ‘early access’, a global access program enables physicians to access treatments that are not available in their own country for patients with an unmet medical need. Wherever they are, we can deliver treatments quickly, efficiently and, most importantly, ethically.

Clinigen Specialty Pharmaceuticals (SP):

We acquire niche medicines that don’t fit into the portfolio of larger pharmaceutical companies. These are typically hospital-only treatments for rare or life-threatening diseases, and we specialise in revitalising them – finding new treatment areas; new markets where we can get them licensed; or, potentially, new formulations. All the while, we’re ensuring that patients already using the medicine continue to get the treatment they need, while the company whose product we have acquired can feel confident that its reputation is being well looked after.

We are currently 100+ people, headquartered in Burton-on-Trent in the UK, with facilities in Philadelphia, US, and Tokyo, Japan, and an office in London. With a customer services team who speak over 19 languages between them, our clients from all over the world find us easy to do business with, while doctors and pharmacists find us a valuable source of information about how to access the medicines they need for their patients.




http://www.clinigen.co.uk/

Blue sky coming...

Numis target price 860p

ROUNDUP – Clinigen shares jump as investors give £225mln acquisition the thumbs-up

By Ian Lyall

April 24 2015, 2:51pm
Some £2.5mln of revenue and cost synergies have been identified


---ADDS BROKER COMMENT---

Shares in the speciality pharma group Clinigen (LON:CLIN) jumped over 7% after it unveiled the £225mln acquisition of Idis Group - a deal that will create a market leader in the ethical unlicensed supply of medicines.

The purchase will be funded from Clinigen’s new debt facility and a £135mln vendor placing and is expected to be ‘significantly’ earnings enhancing in the first full year after the transaction.

Some £2.5mln of revenue and cost synergies have been identified.

But chief executive Peter George told Proactive Investors: “The real savings in this business are about driving growth through the business and changing some of the commercial terms in our business.

“So I think we will drive profit through the gross profit line much faster than we would through synergy savings because this is about a growth plan, not a cost saving plan.

“We want to hit the ground running and take the market by storm. This isn’t going to be done by making cuts in the business. That’s not what this is about.”

The companies will be filling a gap in the market by bringing potentially life-saving medicines to countries where they are not currently licensed.

A quirk of the current system is that many drugs and treatments that might have regulatory and safety clearance in the major developed or developing countries, remain unsanctioned in other territories.

“We want to become the healthcare professional solution for hospital pharmacies and clinicians to access unlicensed medicines in an ethical and completely controlled way,” George said.

Clinigen believes there is a major growth opportunity in combining the two businesses to create the biggest player in the ethical unlicensed supply market, which is estimated to be worth in excess of US$5bn a year.

“On completion, Clinigen, as the market leader, will be well placed to shape and define this fast growing and critically important market,” the company told investors.

Following the news, broker Numis repeated a 'buy' rating and upgraded its price target by 12% to 860p.

Meanwhile, broker Stifel said the acqusition would diversify Clinigen's business away from its over dependence on the antiviral drug Foscavir.

"However, Clinigen has retained the flexibility to make further bolt-on acquisitions of specialty pharma products. The deal clearly makes financial sense since it is earnings enhancing from the start as well as making Clinigen by far the largest player in the supply of unlicensed medicines."

Headquartered in Weybridge, in Surrey, Idis has established a significant business over the past 25 years supplying drugs predominantly on an exclusive basis through managed access programmes and on-demand through its general access division.

In the year ended February its revenues were just under £197mln, while earnings before interest, tax, depreciation and amortisation were £15.6mln.

“This acquisition satisfies a number of our key strategic goals - achieving the market leader position in the $5bn-plus unlicensed medicine supply sector and strengthening our leading position in the $2bn clinical trial supply market,” George said.

"The acquisition will also accelerate our growth and gives us a much better balanced portfolio of businesses, whilst extending our unique business model.

"The enlarged entity creates an incredibly exciting business with tremendous opportunities for growth.

“I am confident that, together with Idis, we have the right people to define and shape the unlicensed medicine supply market - an increasingly important health care sector for patients with unmet needs."

The deal is a particularly good one for CBPE, the private equity owner of Idis, which invested £9.4mln buying the business in 2005.

Idis managing director Tony Dutta said: “IDIS is now the clear market leader in a market with highly attractive long term growth fundamentals.

“CBPE have been an outstanding, partner, fully supporting us as we have grown the business over the long term.

“The acquisition by Clinigen marks the beginning of a new and exciting chapter in the continued development of the business.”

Clinigen’s investors reacted positively to the acquisition, helping push the stock up 47p to 572.5p, valuing the business at £466mln.

We've not seen the 6 big figure for some time. Rapidly up to life highs now?

Stifel new buy today, tp 650p

Yehaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaaa

Nice write-up in this week's IC before Idis acquisition.

easily missed this one :-(
congrats to all those who did not

cynic, notwithstanding the current spike, the latest acquisition could be a game changer, so you may not have missed it on a correction. And then how long before big pharma sniff around...

thanks you old dog .... i'll keep a weather eye open

Good to see this one at number 16 in Investors Chronicle top AIM 100.

Clinigen Group's Idis acquisition prompts sharp rise in Peel Hunt's price target

By John Harrington

May 06 2015, 1:26pm
Idis and Clinigen are both early market entrants in outsourced management and have played a role in shaping the development of this market, but each has adopted a slightly different pricing model, with Clinigen’s resulting in a higher gross margin.
Idis and Clinigen are both early market entrants in outsourced management and have played a role in shaping the development of this market, but each has adopted a slightly different pricing model, with Clinigen’s resulting in a higher gross margin.


Peel Hunt is a fan of Clinigen (LON:CLIN), only more so after the speciality pharmaceuticals company's £225mln acquisition of Idis, a supplier of unlicensed medicines.

The broker notes that the acquisition has long been on the cards and is “one of the more strategically sensible transactions in the sector in recent years”.

Clinigen is paying around 14.4 times Idis's underlying annual earnings (EBITDA), so the deal is not cheap as chips, but Peel Hunt said the synergies available from merging the two companies made Clinigen the only company that could potentially justify paying such a price.

The deal will strengthen Clinigen's clinical trials supply (CTS) business, the global access programmes division (now named MAP) and will also increase the product acquisition radar for the speciality pharmaceuticals arm.

“The deal also added a new division in on-demand access (GAD). This is synergistic with the other three divisions and will benefit from Clinigen’s greater ambition and fire-power, bringing the vision to become the global go-to provider of ethical access to such medicines, a significant market of c$2.2bn today, with the potential to grow to c$5bn+, reflecting the shift to more specialist niche therapy, together with the increasing need for a legitimate 'ethical' and secure supply chain,” opined Dr Stefan Hamill, an analyst at Peel Hunt.

The acquisition should enhance earnings, with Peel Hunt pencilling in a 10% uplift in the year to end-June 2016 and a 33% rise in the following year, prompting Peel Hunt to crank up the price target to 1,000p from 717p previously.

“The potential for increased traction toward our blue-sky scenario, which models acceleration of on-demand, drives our scenario-based valuation to £10, making Clinigen our sector top pick,” the broker said.

Shares in Clinigen currently trade at 616p.

Peel Hunt, buy tp 1000p

Nice rise today, back up to highs...

Clinigen Group PLC (CLIN:LSE) set a new 52-week high during Friday's trading session when it reached 670.00. Over this period, the share price is up 50.22%.

Clinigen Group and Pharming Initiate GAP Program
RNS
RNS Number : 4049N
Clinigen Group plc
18 May 2015







Clinigen Group and Pharming Initiate "HAEi GAP" Global Access Program for RUCONEST®

Unique patient organization-driven program will enable patients with HAE who cannot access effective treatments to receive medication for the first time

Burton-on-Trent, UK and Leiden, Netherlands - 18 May 2015 - Clinigen Group plc ("Clinigen" or the "Group", AIM: CLIN) and Pharming Group N.V. ("Pharming or the Company", Euronext: PHARM) have entered into 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."

- Ends -






About HAE

Hereditary Angioedema (HAE) is a rare genetic disorder. It is characterized by spontaneous and recurrent episodes of swelling (edema attacks) of the skin in different parts of the body, as well as in the airways and internal organs. Edema of the skin usually affects the extremities, the face, and the genitals. Patients suffering from this kind of edema often withdraw from their social lives because of the disfiguration, discomfort and pain these symptoms may cause. Almost all HAE patients suffer from bouts of severe abdominal pain, nausea, vomiting and diarrhea caused by swelling of the intestinal wall.



Edema of the throat, nose or tongue is particularly dangerous and potentially life-threatening and can lead to obstruction of the airway passages. Although there is currently no known cure for HAE, it is possible to treat the symptoms associated with edema attacks. HAE affects about 1 in 10,000 to 1 in 50,000 people worldwide. Experts believe that a lot of patients are still seeking the right diagnosis: although HAE is (in principle) easy to diagnose, it is frequently identified very late or not discovered at all. The reason HAE is often misdiagnosed is because the symptoms are similar to those of many other common conditions such as allergies or appendicitis. By the time it is diagnosed correctly, the patient has often been through a long lasting ordeal.



About RUCONEST®
RUCONEST® (C1 Esterase Inhibitor Recombinant/ conestat alfa) 50 IU/kg is an injectable medicine that is used to treat acute angioedema attacks in adult and adolescent patients with hereditary angioedema (HAE). HAE is caused by a deficiency of the C1 esterase inhibitor protein, which is present in blood and helps control inflammation (swelling) and parts of the immune system. A shortage of C1 esterase inhibitor can lead to repeated attacks of swelling, pain in the abdomen, difficulty breathing and other symptoms. RUCONEST contains C1 esterase inhibitor at 50 IU/kg.



When administered at the onset of HAE attack symptoms at the recommended dose, RUCONEST works to return a patient's C1-INH levels to normal range and quickly begins to relieve the symptoms of an HAE attack with a low recurrence of symptoms. RUCONEST is the first and only plasma-free, recombinant C1-INH approval from the U.S. Food and Drug Administration (FDA) and was approved in July 2014 and by the European Medicines Agency (EMA) in October 2010.



About Global Access Programs

Global Access Programs provide biopharmaceutical companies with a way to allow ethical access to their pre-license/unlicensed medicines to help patients with unmet medical needs. Access is provided in response to physician requests, in a fully compliant manner, where no alternative treatment options are available.


About HAEi

HAEI - International Patient Organization for C1 inhibitor Deficiencies - is a global organization dedicated to raising awareness of C1 inhibitor deficiencies around the world. It is a non-profit international network of national HAE patient Associations. HAEI is established to promote co-operation, co-ordination and information sharing between HAE Specialists and National HAE Patient Associations in order to help facilitate the availability of effective diagnosis and management of C1 inhibitor deficiencies throughout the world. Our purpose is to join the efforts and experience of the global HAE community to achieve optimal standards of care and treatment for all those patients affected by C1 inhibitor deficiencies.



For more information, please visit: www.haei.org






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 Trials Supply, Idis Managed Access Programs (this now includes the previously branded Clinigen Global Access Programs business) and Idis General Access.



The Managed Access Programs 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



About Pharming Group NV

Pharming Group NV is developing innovative products for the treatment of unmet medical needs. RUCONEST® (conestat alfa) is a recombinant human C1 esterase inhibitor approved for the treatment of angioedema attacks in patients with HAE in the USA, Israel all 27 EU countries plus Norway, Iceland, and Liechtenstein.



RUCONEST is commercialized by Pharming in Austria, Germany and The Netherlands. RUCONEST is distributed by Swedish Orphan Biovitrum AB (publ) (SS: SOBI) in the other EU countries, and in Azerbaijan, Belarus, Georgia, Iceland, Kazakhstan, Liechtenstein, Norway, Russia, Serbia, and Ukraine.



RUCONEST is partnered with Salix Pharmaceuticals, Ltd. ("Salix") in North America. Valeant Pharmaceuticals International, Inc. (NYSE: VRX/TSX: VRX) completed its acquisition of Salix Pharmaceuticals, Ltd. on April 1, 2015.



RUCONEST is also being investigated in a randomized Phase II clinical trial for prophylaxis of HAE, in a phase II clinical trial for the treatment of HAE in young children (2-13 years of age) and evaluated for various additional follow-on indications.



Pharming has a unique GMP compliant, validated platform for the production of recombinant human proteins that has proven capable of producing industrial volumes of high quality recombinant human protein in a more economical way compared to current cell-based technologies. Leads for Enzyme Replacement Therapy (ERT) in Pompe, Fabry's and Gaucher's diseases are under early evaluation. The platform is partnered with Shanghai Institute of Pharmaceutical Industry (SIPI), a Sinopharm Company, for joint global development of new products. Pre-clinical development and manufacturing will take place at SIPI and are funded by SIPI. Pharming and SIPI initially plan to utilize this platform for the development of recombinant human Factor VIII for the treatment of Haemophilia A.



For more information, please visit http://www.pharming.com

Clinigen Group and Clovis Initiate GAP Program
RNS
RNS Number : 4247O
Clinigen Group plc
28 May 2015

Clinigen Group Appointed as Specialist Partner to Manage Global Access
Program for Clovis Oncology's Rociletinib for the Treatment of
EGFR Mutant Non-Small Cell Lung Cancer

Burton-on-Trent, UK - 28 May 2015 - Clinigen Group plc ('Clinigen', AIM: CLIN) today announce the initiation of a global access program in Europe for rociletinib (CO-1686) which is being developed for the treatment of advanced non-small cell lung cancer (NSCLC).

This program is intended to allow access to rociletinib for individual named patients with advanced or metastatic epidermal growth factor receptor (EGFR)-mutant T790M-positive NSCLC who have previously been treated with an EGFR-targeted therapy and for whom their physician determines that there is no satisfactory alternative therapy or rociletinib clinical trial available.

Lung cancer is the most common cancer worldwide with 1.35 million new cases annually. Of these, approximately 85% of cases are NSCLC. This is a rapidly progressing cancer with a five-year survival rate of less than 5% in advanced patients.

Patients with an EGFR activating mutation often respond well to marketed EGFR inhibitor therapies, including Tarceva® (erlotinib), Iressa® (gefitinib) and Gilotrif® (afatinib). However, most will ultimately see their cancer progress, with approximately 60% developing acquired resistance from a second "gatekeeper" mutation, T790M. Currently, there are no therapies approved for the treatment of this mutation. Clinigen's Managed Access Programs division will provide rociletinib to individual patients in selected countries in Europe initially, until the approval and launch of the drug.

Rociletinib is an oral, potent, mutant selective inhibitor of EGFR, which is currently in Phase II/III development for the treatment of NSCLC. In 2014, rociletinib was granted Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA).

Simon Estcourt, Managing Director, Managed Access Programs, Clinigen Group said: "Non-small cell lung cancer is a devastating disease affecting a huge number of people worldwide. Our experience in managing access programs on a global scale will enable us to provide critically ill patients with rapid access to rociletinib before it is commercially available. We look forward to working with Clovis to address this area of unmet medical need."

"At Clovis, we are preparing our near-term regulatory submissions seeking approval in the U.S. and E.U. for rociletinib for patients with advanced EGFR-mutant lung cancer," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We are very pleased to be working with Clinigen to make rociletinib available for patients until this therapy is commercially available in Europe."

- Ends -

About Rociletinib

Rociletinib is an oral, potent, mutant-selective inhibitor of epidermal growth factor receptor (EGFR) under investigation for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC). Rociletinib targets the activating mutations of EGFR (L858R and Del19), while also inhibiting the dominant acquired resistance mutation, T790M, which develops in approximately 60 percent of patients treated with first- and second-generation EGFR inhibitors, while sparing wild-type, or "normal" EGFR at anticipated therapeutic doses. Rociletinib was granted Breakthrough Therapy designation by the U.S. FDA in May 2014.



About Global Access Programs

Global Access Programs, also known as Managed Access Programs, provide biopharmaceutical companies with a way to allow ethical access to their pre-license/unlicensed medicines to help patients with unmet medical needs. Access is provided in response to physician requests, in a fully compliant manner, where no alternative treatment options are available.



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 Trials Supply, Idis Managed Access Programs (this now includes the previously branded Clinigen Global Access Programs business) and Idis General Access.

The Managed Access Programs 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

29 May Numis 840.00 Buy
29 May N+1 Singer 714.00 Buy
29 May Numis 840.00 Buy

Company site -

Thursday, May 28, 2015 - 10:45




Burton-on-Trent, UK – 28 May 2015 – Clinigen Group plc (‘Clinigen’ or the ‘Group’, AIM: CLIN), the specialty global pharmaceutical company, has been named the winner of the Business of the Year Award with Turnover of €26-150m at Tuesday’s 2014/15 European Business Awards Gala Ceremony in London.

Peter George, Chief Executive Officer, Clinigen Group said: “I am immensely proud that Clinigen has been recognized as Business of the Year across all of Europe. This is a huge achievement and testament to how far the Group has come over the last year as we continue in our mission to deliver the right drug to the right patient at the right time.”

Clinigen was one of only 10 companies in Europe to be shortlisted for the Business of the Year with Turnover of €26-150m category and one of 11 overall category winners out of over 20,000 applicants from 33 countries.

The Group has been previously been named as one of over 700 European ‘National Champions’ by a judging panel consisting of European business and political leaders, academics and entrepreneurs. It was also recognized by the European Business Awards as one of only 110 Ruban d’Honneur finalists in February.

Adrian Tripp, CEO of the European Business Awards said: “Our winners are shaping the face of European business and helping keep Europe’s position as a leading player on the global business stage. Huge congratulations to Clinigen Group for their success. ”

The Business of the Year Award recognizes companies that successfully demonstrate financial returns, strong growth, innovation and market leadership in their sectors. In 2011 Clinigen was named the fastest growing company in the UK by the Sunday Times Virgin Fast Track 100. The Group joined the London Stock Exchange’s AIM in September 2012, the first UK healthcare company to list in London in five years, and won Best Newcomer at the AIM Awards in 2013. In April 2015 Clinigen acquired Idis, creating the market leader in the ethical unlicensed supply of medicines.

Clinigen has seen six-fold revenue growth over the past four years and has increased profit margins from 8% to 20%. The Group is committed to best practice and operating as an award-winning company.

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HAEi Global Access Program for RUCONEST� Now Live
RNS
RNS Number : 5738T
Clinigen Group plc
21 July 2015

HAEi Global Access Program for RUCONEST® Now Live

Unique patient organization-driven program is enabling people with HAE who cannot access effective treatments to receive medication for the first time

Clinigen Group plc ("Clinigen" or the "Group", AIM: CLIN) and Pharming Group N.V. ("Pharming" or the "Company"), Euronext: PHARM) today announce that their global collaboration to provide access to Pharming's RUCONEST® (conestat alfa) is now live. The unique access program was initiated by HAEi, the International Patient Organization for C1- Inhibitor Deficiencies.

RUCONEST is a recombinant human C1- inhibitor, approved by the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for the treatment of acute attacks of hereditary angioedema (HAE). The "HAEi GAP" program enables patients in all countries where RUCONEST is not commercially available to gain access to the drug through an ethical and regulatory compliant "Named Patient Program" mechanism.

Physicians wishing to request RUCONEST through the HAEi GAP program should contact the Clinigen customer services team at customer.services@clinigengroup.com or on 0044 1283 494340.

"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 to be able to announce that, from today, physicians are able to request RUCONEST to meet the needs of their patients."

Simon Estcourt, Managing Director, Managed Access, Clinigen Group said: "We are very pleased to work with Pharming to help HAEi realize their mission to ensure that sufferers of hereditary angioedema worldwide can access this effective and potentially life-saving treatment. The ground-breaking program provides RUCONEST to patients in an ethical and compliant way, removing the need and the risk for patients to resort to other less reliable or even illegal sources of the drug."

Sijmen de Vries, CEO, Pharming said: "As the first pharmaceutical company to partner with HAEi and provide access to RUCONEST through HAEi GAP, we are leading the charge to improve the lives of those HAE patients that otherwise would continue suffering from this debilitating and unpredictable disease."

- Ends -