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/

25 Jul Numis 430.00 Buy

Clinigen Group PLC (CLIN:LSE) set a new high during today's trading session when it reached 355.00. Since the IPO on Sep 25, 2012, the share price is up 93.18%.

Clinigen Group marching at the double - worth watching


http://www.proactiveinvestors.co.uk/companies/news/59434/clinigen-group-marching-at-the-double-59434.html

Investment summary: Impressive update

http://www.edisoninvestmentresearch.com/researchreports/ClinigenQV2607013.pdf

Yesterday’s pre-close trading update from Clinigen (LON:CLIN) had brokers queuing up to praise the fast-growing speciality pharmaceuticals firm.

Management indicated revenue and gross profits for the year just finished should show significant organic growth year-on-year, coming in slightly ahead of market expectations. Administrative costs have been lower than expected which has led to a further positive impact on underlying earnings (EBITDA).

That prompted City broker Investec to admit its earnings forecast for this year might be a bit below par.

“It appears Clinigen has delivered organic growth slightly ahead of our estimates and with lower operating costs, we expect profits will be some 10% ahead of our FY13E forecasts,” Investec said in a ‘buy’ note.

At the time of its interim results the company said the division's margins were down to 13% from 17% the year before, but management is confident of reaching a gross profit margin of 15%, according to Investec, while house broker Numis expects margins to have recovered by the end of the current financial year.

Numis has bumped up its full-year revenue estimates for 2013 and 2014 for the Clinical Trials Supply business by 3%.

The performance of the Global Access Programs (GAP) division seems to have caught Investec on the hop, with growth well ahead of the broker’s forecasts. It is not expecting a six-fold increase in GAP’s revenue every year, however.

“We understand that one or two of the division’s high profile contracts have reached peak potential ahead of our expectations, hence we do not see all the outperformance flowing into FY14E,” the broker said.




http://www.proactiveinvestors.co.uk/columns/broker-spotlight/13673/broker-round-up-ii-noricum-gold-clinigen-green-dragon-gas-13673.html

Clinigen to Manage Third Access program for BTG

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Clinigen Group plc

31 July 2013










Clinigen Group to Manage Third Access Program for BTG

Supplying Potentially Life-Saving Oncology Antidote in 37 European Countries

Burton-on-Trent, UK - 31 July 2013 - Clinigen Group plc ('Clinigen' or the 'Group') (AIM: CLIN) today announced that Clinigen Global Access Programs ('Clinigen GAP') has extended its existing distribution agreement with Protherics Medicines Development Ltd, a BTG International group company ('BTG'), to exclusively manage a named patient program in 37 European Countries for uridine triacetate for use as an antidote to overexposure to the chemotherapy drug 5-fluorouracil ('5-FU'). Wellstat Therapeutics Corporation ('Wellstat') is seeking approval in the US and Europe for its investigational drug, uridine triacetate, and granted named patient supply rights to BTG in the 37 European Countries in 2012. Uridine triacetate is the third product that BTG has placed under Clinigen GAP's management.

Under the named patient program, uridine triacetate will be available for healthcare professionals to treat patients who are overexposed to the widely-used cancer chemotherapy 5-FU due to dosing errors, an inability to breakdown 5-FU normally, and other forms of impaired clearance. According to data from the European Medicines Agency ('EMEA') the number of patients in the European Union affected by a 5-FU overdose each year is over 10,0001. Uridine triacetate has orphan drug designation from the EMEA and the US Food and Drug Administration ('FDA').

Although uridine triacetate is not yet approved in Europe, this program operates within regulatory compliant mechanisms to allow healthcare professionals to prescribe uridine triacetate to individual named patients. Clinigen will provide access to uridine triacetate 24 hours a day, 7 days a week.

Mark Corbett, Senior Vice President, Clinigen GAP said, "We are pleased to be extending our current agreement with BTG to add a third program to the portfolio already handled by Clinigen. We are committed to ensuring that our bespoke access program delivers uridine triacetate to health care professionals for their patients within a critical time period. 5-FU overexposure is an important unmet medical need and making available the supply of uridine triacetate on a named patient basis will provide healthcare professionals access to this investigational antidote to treat patients."


1European Medicines Agency (2009). Public summary of positive opinion for orphan designation of 2', 3', 5'-tri-O-acetyluridine for the treatment of 5-fluorouracil overdose. EMEA/COMP/231352/2009

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1 Aug Investec 313.00 Hold

A buy in this weeks IC - Burton-on-Trent based specialist medicines supplier Clinigen (CLIN) looks to be performing well after the company reported that it looks on course to beat forecasts for earnings this year. Clinigen reports its full year results on Wednesday 25 Sept 2013. The run should continue with the first substantial contributions from acquired products.

Up 10.36% - Clinigen Group PLC (CLIN:LSE) set a new high during today's trading session when it reached 396.75. Since the IPO on Sep 25, 2012, the share price is up 125.43%.

A buy in this weeks shares mag - House broker Numis reckons Clinigen can spend £40m on acquisitions over the next year. The shares deserve their high rating - trading on 19.4 times forecast earnings for 2013 - because of growth momentum, management expertise and market opportunities.

Notice of Results

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Clinigen Group plc

06 September 2013






Clinigen Group plc

Notification of Full Year Results Date

Burton-on-Trent, UK - 6 September 2013 - Clinigen Group plc (AIM: CLIN), the global specialty pharmaceuticals and services company, will announce its full year results for the period ended 30 June 2013 on Wednesday, 25 September 2013.

A group analyst briefing will be held at 09:30am GMT on Wednesday, 25 September 2013 at the Group's London offices at 1 King Street, London EC2V 8AU. Analysts who wish to participate should either contact Claire Dickinson on +44 (0)20 7457 2020 or email Clinigen@CollegeHill.com to register.

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Clinigen Group PLC




Clinigen Group plc is a fast-growing specialty global pharmaceuticals and services business, dedicated to serving patients, the medical community and the healthcare industry to supply critical life saving treatment. With offices in the UK, US and Japan, Clinigen is focused on delivering the right drug to the right patient at the right...



Clinigen seals epilepsy drug deal with Eisai
By Jamie Nimmo September 09 2013, 7:38am Epilepsy is a common neurological condition that causes seizuresEpilepsy is a common neurological condition that causes seizures

AIM-listed pharma company Clinigen (LON:CLIN) has unveiled a deal with Eisai that will see it manage an access programme for its anti-epilepsy drug Fycompa in Germany.

The agreement will mean an uninterrupted supply of the drug at no cost to the German healthcare system following the temporary suspension of commercial distribution in the country.

The programme will be managed by Clinigen GAP (Clinigen Global Access Programs) and will begin when stocks of the drug run out in Germany, which is not expected to happen until the end of this calendar year.

Fycompa is the only drug approved in Europe for countering the effects of epilepsy, a common neurological condition that causes seizures.

Chief executive Peter George said: “We look forward to assisting in the provision of continued access to Fycompa in Germany and are pleased with the confidence entrusted in us by Eisai.

“As a specialist provider of global access programmes we have the experience and expertise to deliver this bespoke access programme within Germany.”

He added: “This programme represents the addition of another major pharmaceutical company to our expanding client base.”

In Shares this week - Clinigen is in good health, better than expected results on the way a year after aim listing.

On the year to the day it joined Aim (25 Sept) the group will report sales and growth profits that could well exceed expectations, owing to robust organic growth and lower than expected costs. The market is looking for sales of £120.6 m and £20.8m pre-tax profit, double that achieved last year. It will also declare its maiden dividend of 1.8p per share, equivalent to a 0.5% yield.

European Marketing Authorisation transfer on track
RNS
RNS Number : 0396O
Clinigen Group plc
16 September 2013





Clinigen Group on Track with European Marketing Authorization Transfers for Cardioxane® and VIBATIV®

Burton-on-Trent, UK - 16 September 2013 - Following the acquisition of Cardioxane® from Novartis and the in-licensing of VIBATIV® from Theravance, Inc. in March 2013, Clinigen Group plc ('Clinigen' or the 'Group') (AIM: CLIN) today reported significant progress in the handover of these products with the transfer of key Marketing Authorizations in Europe to Clinigen. The transfers have progressed according to internally agreed timelines and both projects are continuing on schedule.

For oncology support therapy Cardioxane® (dexrazoxane), Marketing Authorizations in France, the UK, the Netherlands, and Poland have been transferred from Novartis to Clinigen. As Marketing Authorization holder Clinigen has assumed responsibility for manufacturing, registration, distribution, and commercialization of Cardioxane® in these countries, ensuring a smooth transition and an uninterrupted supply of the drug to patients. Clinigen plans to transfer all Marketing Authorizations from Novartis and fully manage supply globally by the end of 2014, which is a similar timeline to Foscavir® when it transferred from AstraZeneca to Clinigen.

Furthermore, the European Commission has approved the transfer of Marketing Authorization for the anti-bacterial VIBATIV® (telavancin) from Theravance, Inc. to Clinigen. VIBATIV® has been suspended for use in the European Union since 2012 following a suspension of operations at the contract manufacturer. Having completed the technical transfer to a new contract manufacturer, Clinigen is working closely with the European Medicines Agency to remove the marketing suspension and expects to have European product available, as planned, in the first quarter of 2014.

For countries where Cardioxane® and VIBATIV® do not have Marketing Authorization, Clinigen will leverage the capabilities of its Global Access Programs business (Clinigen GAP) to supply the medicines on a named patient basis.

"The transfer of the European Marketing Authorizations to Clinigen marks an important step in the integration of both Cardioxane® and VIBATIV® into our Specialty Pharmaceuticals business," said Peter George, Chief Executive Officer, Clinigen Group. "Clinigen has now assumed full control of all key commercialization activities and will provide further updates as we begin to realize the benefit of supplying Cardioxane® directly. In addition, our priority for the remainder of the year is to work towards lifting the current suspension of the Marketing Authorization for VIBATIV®."



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Sun, 22 September 2013


Since floating on AIM almost a year ago, Clinigen has done just what it said it would, Matthew Goodman wrote in the Sunday Times. The pharmaceutical company has produced new drugs, such as a breast cancer treatment, and has boosted its income. The shares have been rewarded by more than doubling in price since being traded. Management’s lock-up period ends soon but if they decide to cash in this may be offset by pent-up demand, Goodman said.


http://sharecast.com/news/share-tips-foxtons-unite-ag-barr/21172803.html

Nice write up in The Sunday Times.

Final Result
25 Sep 13 Clinigen Group [CLIN]

Preliminary Results

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Clinigen Group plc

25 September 2013












Clinigen Group plc

Preliminary Results for the year ended 30 June 2013

Burton-on-Trent, UK - 25 September 2013 - Clinigen Group plc ('Clinigen' or the 'Group') (AIM: CLIN), the global specialty pharmaceuticals business, has today published its preliminary results for the 12 months ended 30 June 2013.

Financial highlights

- Group revenue up by 49% to £122.6m (FY12: £82.1m) driven by strong organic growth across all three operational businesses

o Clinigen CTS full year sales up 49% to £87.8m and full year gross profit up 13% to £11.4m

o Clinigen GAP revenue grew more than six-fold to £10.5m; full year gross profit was up more than five-fold to £3.9m

o Clinigen SP full year sales of £24.3m (+12%) and full year gross profit of £19.8m (+8%)

- Underlying EBITDA increased by 30% to £22.4m (FY12: £17.3m)

- Underlying pre-tax profit increased by 29% to £20.4m (FY12: £15.8m) and reported pre-tax profits increased by 42% to £14.5m (FY12: £10.3m)

- Underlying earnings per share up 38% to 18.5 pence (FY12: 13.4 pence) and reported earnings per share 15.1 pence (FY12: 13.2 pence)

- Cash generation continues to be strong; cash and cash equivalents at 30 June 2013 were £11.3m, up from £5.2m at 30 June 2012

- Final dividend of 2.0 pence per share proposed, bringing the total dividend to 2.6 pence per share



Business highlights

- Clinical Trial Supply ("CTS")

o Sales performance driven by sizable anti-viral studies and increased activity in the US

o In June, extension of exclusive EU supply agreement with Accord Healthcare

- Global Access Programs ("GAP")

o Awarded Sanofi's Campath and Astellas' MDV3100 early access programs

o In July, BTG awarded a third access program to Clinigen and, in September, Eisai selected Clinigen to manage an access program in Germany

- Specialty Pharmaceuticals ("SP")

o Foscavir® sales volume continued to grow, with further expansion into the US and new indications in Europe

o Exclusive commercialization agreement in EU for Antibacterial, VIBATIV®

o Acquisition of oncology support therapy, Cardioxane® for US$33m





Peter George, Chief Executive Officer, said:



"We have over-delivered on our commitments made at the time of the IPO last September. In turn, the listing on AIM has lived up to our expectations. It has provided a stronger platform from which to drive our organic growth, both in the UK and internationally, as well as giving us additional financial flexibility to support our acquisition plans and the acceleration of our international growth strategy. The IPO has also enabled greater investment in the infrastructure and recruitment of additional high quality people to the business.



"Our ambition for the next financial year is to maintain this momentum across all three operating businesses; principally organic growth for CTS and GAP, and through further acquisition of products for SP. Geographically, we are focusing our attention on the US, Latin America and Asia.



"With a sound financial base, an increasing international footprint, as well as the recent organizational changes, we have the right foundations to continue the scale-up of the business and maintain our growth."



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Clinigen: Investec places both its target price (prev.: 313p) and its hold recommendation unchanged


25 Sep Numis 485.00 Buy