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/

Broker Forecast - Peel Hunt issues a broker note on Clinigen Group
BFN
Peel Hunt today upgrades its investment rating on Clinigen Group (LON:CLIN) to buy (from add) and raised its price target to 1350p (from 1200p).

Story provided by StockMarketWire.com

Clinigen acquires IMMC in Japan
RNS
RNS Number : 2527U
Clinigen Group plc
23 October 2017
 
RNS Reach
 
23 October 2017
  
Clinigen acquires Japan's largest supplier of unlicensed medicines
 
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, has today acquired International Medical Management Corporation ('IMMC'), Japan's largest supplier of unlicensed medicines, for an undisclosed sum.
The acquisition will add to Clinigen's existing footprint in the country following the launch of its Japanese business in October 2016. The acquisition of IMMC is part of Clinigen's strategy to become the 'go to' global leader in ethical access to unlicensed medicines and will allow the Group to better address unmet patient needs.
IMMC, established in 2006, operates throughout Japan in sectors including niche vaccine, oncology and IVF. It currently has relationships with more than 850 hospitals and clinics, which will now be able to benefit from the broader access to medicines available as part of Clinigen.
Japan is the world's second largest pharmaceutical market. The unlicensed medicines market in Japan is underdeveloped, highly regulated and well controlled leading to a high unmet medical need. For instance, from the 154 new drugs launched globally between 2008 and 2012, two thirds still remained unavailable in Japan by 2013, illustrating the difficulties patients in Japan have in accessing approved medicines.
The threat of counterfeit medicines entering the supply chain in Japan, also remains an issue. Japan is the second-largest target of illegal online medicine sellers in the world behind the US.
IMMC was acquired for an upfront cash payment followed by certain potential milestone-based instalments over 12 months.
In the year ended 30 September 2017 the unaudited IMMC gross profit was ¥352m (£2.4m).
Shaun Chilton, Group Chief Executive Officer, Clinigen, said:
"This acquisition represents another strategic development, extending our geographical footprint and another step to becoming the global leader in ethical access to unlicensed medicines. The enlarged Japanese operation adds further capability in this high growth market which is crucial to our customers and a key part of Clinigen's global offering."
Yoshiyuki Kudo, President, IMMC, said:
"Clinigen's global expertise and our local knowledge will allow us to better address the unmet patient need in Japan, further benefiting our customers and increasing our offering in access to unlicensed medicines."
- Ends -

Ex-Dividend
09 Nov 17 Clinigen Group [CLIN] (3.4 p)

12:10 29/11/2017
Broker Forecast - N+1 Singer issues a broker note on Clinigen Group
N+1 Singer today reaffirms its buy investment rating on Clinigen Group (LON:CLIN) and set its price target at 1225p. Story provided by StockMarketWire.com

Wed 17th Jan - Trading statement

HY trading update
RNS
RNS Number : 0600C
Clinigen Group plc
17 January 2018

17 January 2018

HY trading update: good H1 performance with profits up over 10%

Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, today provides a trading update for the six months ended 31 December 2017.

The Group has traded well in the first half, in line with the Board's expectations.

Group revenues increased around 28%. This is higher than the growth in gross profit due primarily to an increased level of pass through costs within the early access part of Unlicensed Medicines.

Gross profit*, viewed by the Board as the best measure of top line growth, increased by around 10% compared to last year. Growth has been driven by a combination of a strong performance by Commercial Medicines and two months contribution from Quantum Pharma plc ('Quantum').

Commercial Medicines, representing around 49% of Group gross profit and including the commercial business of Quantum, delivered excellent growth, with all products across the portfolio performing strongly.

Unlicensed Medicines, representing around 41% of Group gross profit, benefited from two months contribution from the related business within Quantum and IMMC. In early access, performance was affected by a number of larger programmes coming to the end of their lifecycle. There are a significant number of new programmes now starting that are expected to drive stronger second half performance.

Clinical Trial Services, representing around 10% of Group gross profits, was below last year following two years of double digit growth. Performance is expected to step up in the second half.

The Group acquired IMMC, Japan's largest supplier of unlicensed medicines, on 23 October 2017 and Quantum on 1 November 2017. Both businesses performed well in the two months following their acquisition.

Following a period of investment last year, underlying Group overheads are expected to grow at a slower pace than gross profit.

The Group has achieved another good cash flow performance. Following the acquisitions and the payment of the final scheduled deferred consideration on the Link acquisition, net debt increased to around £142m as at 31 December 2017 (31 December 2016: £70.9m).

Shaun Chilton, Group Chief Executive Officer of Clinigen, said:

"We have delivered good growth and made strong progress against our strategic priorities, which have been enhanced by the acquisition of Quantum and IMMC.

"Our strategic priorities remain unchanged. We have and will continue to drive organic growth and search for selective acquisitions to complement our existing offering and capabilities.

"We are well positioned to deliver another good year of progress."


The Group expects to publish its interim results for the six months ended 31 December 2017 on Tuesday 27 February 2018.

*Gross profit growth rates exclude the release of the fair valuation on inventory from business acquisitions.


- Ends -

17 Jan
N+1 Singer
1,225.00
Buy
17 Jan
Peel Hunt
1,350.00
Buy
17 Jan
Numis
1,208.00
Add

15:50 18/01/2018
Broker Forecast - Berenberg issues a broker note on Clinigen Group
Berenberg today upgrades its investment rating on Clinigen Group (LON:CLIN) to buy (from hold) and raised its price target to 1220p (from 1200p). Story provided by StockMarketWire.com

AIM company Clinigen enters the 1 billion + club

1 Feb
Peel Hunt
1,350.00
Buy

Interims Tues 27 Feb 18

Interims Tues 27 Feb 18

Half year results
HIGHLIGHTS
§ Adjusted gross profit up 10% driven by strong performance by Commercial Medicines and two months contribution from Quantum Pharma plc ('Quantum')
§ Adjusted EPS up 13% to 21.2p (2016: 18.8p)
§ Strong cash flow performance with cash generated from operations of £34.3m (2016: £7.7m)
§ Interim dividend increased 10% to 1.76p (2016: 1.6p)
§ All products across Commercial Medicines portfolio performing strongly
§ Good growth in Africa and Asia Pacific region
§ Acquisition of Quantum adds complementary capability in Unlicensed Medicines and provides pipeline of products and in-house development capabilities
§ Unlicensed Medicines capability and geographical footprint further enhanced by acquisition of IMMC in Japan

28 Feb
Peel Hunt
1,350.00
Buy

Clinigen and Jazz Pharma initiate MA programme
RNS
RNS Number : 0522I
Clinigen Group plc
19 March 2018

RNS Reach
19 March 2018


Clinigen appointed by Jazz Pharmaceuticals to manage Managed Access Program for Vyxeos® (CPX-351) outside the United States
Clinigen Group plc (AIM: CLIN, 'Clinigen'), the global pharmaceutical and services company, has been appointed by Jazz Pharmaceuticals plc (NASDAQ: JAZZ, 'Jazz') to distribute Vyxeos® (daunorubicin and cytarabine) liposome for injection via a Managed Access Program ('MAP') outside the United States.
This MAP is for the treatment of adults aged 60-75 with newly-diagnosed, therapy-related, acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos® is a dual-drug liposomal encapsulation of daunorubicin and cytarabine combined in a 1:5 molar ratio respectively.
Initially, the program is being launched in the United Kingdom, Ireland, Germany, Poland, Belgium, Switzerland, Portugal, Spain and Canada.
In August 2017, the U.S. Food and Drug Administration ('FDA') approved Vyxeos® liposome for injection for the treatment of adults with newly-diagnosed t-AML or AML-MRC. Vyxeos® is not approved for use outside of the U.S.
AML is a rapidly progressing and life-threatening blood cancer that starts from young white blood cells called granulocytes or monocytes which build up in the bone marrow - the soft inner part of the bones where new blood cells are made. It is relatively rare with approximately 21,000 people in the United States and 19,000 in the European Union diagnosed each year.1 However, it is the most common type of acute (aggressive) leukemia in adults with variable treatment options and outcomes depending on the subtype of AML and the age of the patient. It has one of the lowest survival rates of all types of leukemia.
John Lagus, Head of Managed Access, Clinigen, said:
"There is a huge unmet need for adults with AML where treatment options to date have been very few. Vyxeos® provides the first FDA approved chemotherapy treatment for patients with certain types of high-risk AML in more than 40 years."

09:20 23/05/2018
Broker Forecast - Berenberg issues a broker note on Clinigen Group
Berenberg today reaffirms its buy investment rating on Clinigen Group (LON:CLIN) and cut its price target to 1160p (from 1220p). Story provided by StockMarketWire.com Broker Forecasts data provided by www.sharesmagazine.co.uk

Extended partnership agreement signed with BMS
RNS
RNS Number : 7396P
Clinigen Group plc
31 May 2018

RNS Reach
31 May 2018

Clinigen and Bristol-Myers Squibb sign extended partnership agreement in South Africa
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, has signed a commercial agreement with Bristol-Myers Squibb ('BMS') in South Africa. The agreement covers BMS' South African portfolio of products for an initial period of five years.
Clinigen's Commercial Medicines business operation will provide access for patients in South Africa for the BMS products. Clinigen will provide local regulatory expertise, supply and distribution infrastructure and experience in managing licensed medicines in the region. The agreement will lead to the transfer of Marketing Authorisations (product registration certificates) from BMS to Clinigen, which will likely be completed in the first half of 2019.
In the Africa and Asia Pacific region, Clinigen has 192 actively marketed specialist pharmaceutical and medical technology licensed products, including both branded and generic products. This agreement with Bristol-Myers Squibb will complement the Group's growing basket of essential medicine on offer to healthcare providers and their patients in the region.
Shaun Chilton, Group Chief Executive Officer, Clinigen, said:
"This agreement demonstrates the long and successful relationship we have built with BMS, which began with providing access to BMS' unlicensed products globally, and has grown with Clinigen's expansion into important future growth markets.

"Clinigen is increasingly becoming the partner of choice for pharmaceutical companies to license and distribute their products. This agreement shows that our strategy for Commercial Medicines of adding regional commercial agreements to our existing portfolio of global products, a key strategic priority for the Group, is working."

- Ends -

10:20 31/05/2018
Broker Forecast - Numis issues a broker note on Clinigen Group
Numis today upgrades its investment rating on Clinigen Group (LON:CLIN) to buy (from add). Story provided by StockMarketWire.com Broker Forecasts data provided by www.sharesmagazine.co.uk

Year end trading update
RNS
RNS Number : 7933U
Clinigen Group plc
17 July 2018

17 July 2018

Year end trading update

Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, today provides an unaudited trading update for the year ended 30 June 2018.

The Group has had a strong year, combining a good financial performance with excellent progress on delivering the Group's strategy. The Board expects results to be in line with current market expectations and the Group is well positioned to drive further growth across all parts of the business in the year ahead.

Revenues increased by around 26% on a reported basis and by around 27% on a constant currency basis* compared to last year. This is higher than the growth in gross profit due primarily to an increased level of pass through costs within the early access part of Unlicensed Medicines. Gross profit** increased by around 14% on a reported basis and by around 16% on a constant currency basis*. Following tight cost control and benefits obtained from the integration of the acquisitions, EBITDA growth is expected to increase at a higher rate than gross profit.

Commercial Medicines continued to deliver excellent growth with the Group continuing to realise the benefits of its expanding geographical presence. The performance in Clinical Trial Services ('CTS') and Unlicensed Medicines strengthened in the second half with the latter benefiting from a number of new early access programs starting. Integration of Quantum is going to plan with the unlicensed to licensed portfolio performing well.

In addition, today the Group announced it has acquired from Novartis the global rights outside the United States to Proleukin®. Proleukin® is indicated for use in metastatic renal cell carcinoma, as well as for metastatic melanoma in certain markets and is a good fit with the Group's current Commercial Medicines portfolio of products in the oncology and infectious disease therapy areas - see separate press release.

Shaun Chilton, Group Chief Executive Officer of Clinigen, said:

"This year has demonstrated the strength and diversity of the Group's portfolio. Our largest business operation, Commercial Medicines, has had an excellent year more than offsetting weakness in CTS.

"I am particularly pleased with the performance from our acquisitions in the year, Quantum and IMMC, and the performance in the Africa and Asia Pacific region.

"With a strong balance sheet and cash generative business model, our strategy remains to drive growth across our portfolio organically, by making acquisitions and through geographic expansion."

* Constant currency is growth applying prior period's actual exchange rate to this period's result.
** Gross profit growth rates exclude the release of the fair valuation on inventory from business acquisitions.


- Ends -

Clinigen acquires global rights to Imukin
RNS
RNS Number : 6382V
Clinigen Group plc
25 July 2018

RNS Reach
25 July 2018

Clinigen acquires global rights to Imukin®
from Horizon Pharma
Clinigen Group plc (AIM: CLIN, 'Clinigen' or the 'Group'), the global pharmaceutical and services company, has acquired the global rights to Imukin® (recombinant human interferon gamma-1b) from Horizon Pharma plc ('Horizon'). Horizon will retain the rights to Actimmune® (recombinant human interferon gamma-1b) in the US, Canada and Japan.
Imukin® is licensed in 19 countries globally to reduce the frequency of serious infections in patients with Chronic Granulomatous Disease (CGD) and for the treatment of Severe Malignant Osteopetrosis (SMO), both considered rare conditions.
Clinigen will revitalise Imukin® by working with healthcare professionals to ensure its benefits to patients are well understood. The Group will also make the medicine available to those who need it through the Group's global distribution network for both licensed and unlicensed supply.
Imukin® is the second global acquisition of a biologic by Clinigen following the acquisition of the global rights (outside the US) of Proleukin® from Novartis on 17 July 2018.
Shaun Chilton, Group Chief Executive Officer, Clinigen, said:
"Imukin® strengthens our commercial offering and represents a good strategic fit with our medicines portfolio growth strategy focused on products in oncology and rare diseases."
David Bryant, Chief Business Officer, Clinigen, said:
"Our second acquisition in recent weeks delivers on our long term strategy of acquiring global rights to assets with the aim of revitalising and returning them back to the broadest possible access."