ALLSCHWIL/BASEL, Switzerland, Sept. 30, 2003 (PRIMEZONE) --
- Actelion to further develop intravenous endothelin receptor antagonist optimized for cerebral indications currently in Phase II at Axovan - Strengthening of drug discovery efforts within Actelion's core focus - All Axovan staff to receive offer to join Actelion - Initial acquisition price of CHF 60m is expected to rise in line with product advances to up to CHF 252m in the coming years
Actelion Ltd. (SWX:ATLN) (Other OTC:ALIOF) today announced that privately held Axovan AG has agreed to be acquired for an initial CHF 60 million for 100 percent of the Axovan shares. With the full due diligence completed, a binding letter of intent has been signed, with the integration process expected to start by the end of October 2003.
Jean-Paul Clozel, MD and Chief Executive Officer of Actelion, commented: "Actelion has been very successful in developing and marketing the first ever endothelin receptor antagonist (ERA), Tracleer(r) in pulmonary arterial hypertension. Having become a profitable company in less than six years of operation, our focus must now be on ensuring the continued success of Actelion. With substantial revenues foreseen in the coming years from Tracleer(r) sales in its approved indication, the acquisition of Axovan will add further growth momentum, both in the mid- and the long-term."
Jean-Paul Clozel continued: "Actelion today is the world's undisputed leader in Endothelin Science. We are now adding a promising late-stage intravenous ERA, clazosentan, optimized for cerebral diseases to our development pipeline, thereby leveraging our know-how, our experience and our global infrastructure."
Jean-Paul Clozel concluded: "In the future, Actelion aspires to be known as a company with numerous first-in-class achievements. Today, we are further broadening our research efforts within our existing area of expertise by adding numerous pre-clinical projects and compounds. More importantly, we are also adding human capital, ensuring that the more than 50 highly experienced Axovan staff will continue their existing and successful discovery and development activities."
Dr. Olivier Valdenaire, Chief Executive Officer of Axovan, will drive the integration process. He commented: "The idea to join forces has grown naturally over time, given the close professional and cultural bonds that already exist between the two companies. This will therefore be a seamless integration, ensuring that Axovan's promising pre-clinical leads, as well as Axovan's late-stage ERA, will be fully resourced to potentially become medicines one day."
Financing of the acquisition
Actelion has reported a gross cash position as of 30 June 2003 of CHF 124.7 million. The financing of the initial acquisition consideration could be made entirely from the existing cash balance; further payments are also anticipated to be assured with the expected revenue and related cash flow growth, as well as the availability of bank credit lines.
However, in order to restore the cash balance and to maintain a maximum degree of strategic flexibility, the company is currently evaluating different financing options, including, but not limited to, the issuance of equity-linked instruments such as a convertible bond. A decision could be made shortly.
Actelion's development pipeline strengthened Actelion's broad pipeline contains several projects evaluating new indications for existing drugs and several new compounds currently both in early- and late-stage development.
Tracleer(r) (bosentan), approved for the treatment of pulmonary arterial hypertension, is being evaluated in scleroderma patients suffering from digital ulcers (Phase III), idiopathic and scleroderma-related pulmonary fibrosis (Phase II/III), as well as a pilot study in metastatic melanoma (Phase II).
In addition, Actelion has initiated clinical trials with the first orally available urotensin II receptor antagonist ever to be tested in man.
In collaboration with the Celltech group, Zavesca(r) (miglustat), approved for the treatment of type 1 Gaucher disease, is currently being evaluated in other lipid-storage disorders such as type 3 Gaucher disease, Nieman-Pick and Tay-Sachs (all phase II/III).
Tezosentan (VeletriTM), an intravenous endothelin receptor antagonist optimized for cardiorenal indications, is currently in late-stage development for Acute Heart Failure (AHF). A pilot study is also evaluating tezosentan's potential as a treatment for Hepato-Renal syndrome (HRS).
By integrating Axovan, Actelion will put its substantial resources behind clazosentan, an intravenous endothelin receptor antagonist optimized for treating cerebral diseases, such as vasospasms occurring as a consequence of subarachnoid hemorrhage (SAH). In this indication, clasozentan recently finished a Phase IIa study.
The Actelion founders -- while still employed at Roche -- discovered the compound clazosentan in the early 90's. Roche then out-licensed the compound, first to Vanguard (today Vernalis), then to Axovan.
Isaac Kobrin, MD and Head of Development at Actelion, commented: "Actelion has, in record time, successfully developed and registered the first ERA ever. We plan to use our profound knowledge to address all pending issues with regulatory authorities to resolve all obstacles in order to rapidly move the compound forward in its clinical development program."
Upon achieving important milestones in successfully developing clazosentan, as well as registering and marketing the drug on a global basis, Actelion will make further payments to Axovan shareholders, potentially raising the total acquisition price -- including minor milestones for potentially advancing discovery projects -- to up to CHF 252m in the coming years. In 2004, payments could reach between CHF 35m and 50m.
Drug Discovery pipeline broadened Several of Actelion's drug discovery projects are in an advanced stage and have the potential to satisfy important unmet medical needs in cardiovascular, central nervous system and oncology indications. Following the urotensin II receptor antagonist (cardio-renal indications) that recently started human testing, Actelion has so far disclosed that its pre-clinical pipeline contains three advanced projects in the areas of orexin antagonism (obesity/sleep), beta-secretase (BACE) inhibition (Alzheimer) and renin inhibition (systemic hypertension).
By fully integrating Axovan's promising and highly productive pre-clinical efforts in the area of G-protein-coupled receptors (GPCR), Actelion expects to further increase the output of its drug discovery efforts. Advanced projects to be integrated into Actelion pre-clinical efforts include programs in areas such as thrombosis and inflammation.
Background on Axovan's history
Axovan was founded in 2000 as a research company focusing on G-protein coupled receptors. Actelion participated in the first Venture Capital (VC) round to seed another company with similar culture and focus such as Actelion to complement its own research efforts, focusing on G-coupled protein receptors, as well as aspartyl proteases. At the time of foundation, Actelion actually held more than 20 percent of the company.
In 2002, Axovan raised further VC funds, bringing raised funds to a total of CHF 38 million. After this financing round, Actelion's stake in Axovan dropped to its current leval of about 6 percent. Other major Axovan shareholders include Atlas Venture, BCV, Genevest, HBM Partners, Heidelberg Innovation, Neomed, Varuma AG and Venture Partners.
As a result of Actelion being a shareholder in Axovan as well as several Actelion board members representing investors in Axovan, the investment bank Morgan Stanley Dean Witter has been commissioned to prepare a fair value opinion to confirm the adequacy of the acquisition consideration. In addition, all Actelion board members with a potential conflict of interest did abstain from the decision-making and voting process at Actelion in relation to the contemplated acquisition of Axovan.
Actelion Ltd
Actelion Ltd is a biopharmaceutical company with its corporate headquarter in Allschwil/Basel, Switzerland. Actelion's first drug Tracleer(r), an orally available dual endothelin receptor antagonist, has been approved as a therapy for pulmonary arterial hypertension. Actelion markets Tracleer(r) through its own subsidiaries in key markets worldwide, including the United States (based in South San Francisco), the European Union as well as Canada and Switzerland. Actelion, founded in late 1997, is a leading player in innovative science related to the endothelium -- the single layer of cells separating every blood vessel from the blood stream. Actelion focuses on the discovery, development and marketing of innovative drugs for significant unmet medical needs. Actelion shares are traded on the SWX Swiss Exchange (ticker symbol: ATLN).
NOTES TO THE EDITOR:
A local media update will be held today at 14.00hrs CET at Gewerbestrasse 24, 4123 Allschwil.
Actelion will also host an Investor Conference Call and discussion (Q&A) today, Tuesday, 30 September 2003, 15.30hrs CET, 09.30hrs am EST.
Actelion will report its Q3 results on 28 October 2003, 07.00hrs CET, 01.00hrs am EST.
Actelion will provide a detailed update on its Research and Development pipeline at the upcoming R&D day in London (29 October 2003) and New York (30 October 2003).
Local Media Update Actelion will host a Media Update and iscussion/Q&A on 30 September 2003 in Allschwil at Gewerbestrasse 24, 14.00 CET / 08.00 a.m. EST / 13.00 GMT.
Conference Call
Actelion will host an Investor Conference Call and discussion/Q&A on
Tuesday, 30 September 2003,
15.30 CET / 09.30 a.m. EST / 14.30 GMT
Dial: +41 (0) 91 610 56 00 (Europe)
+1 (1) 866 291 41 66 (U.S.)
+44 (0) 207 107 06 11 (U.K.)
Webcast -- Live and replay on demand Actelion webcasts its Investor Conference Call. On the Web, you may either follow the call live or have the call replayed later on demand. To access the webcast, simply visit the link on our homepage http://www.actelion.com/ for further information.