- Appoints new Chief Executive Officer to Accelerate Growth of Business
- US Commercial Operations to be Established
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Archimedes Pharma ("Archimedes"), the leading specialty pharma company,today announced that it has raised GBP65 million (approx US$100 million) innew funding. The round was led by new investor Novo Growth Equity, the growthequity fund of Novo A/S, and included participation by major currentinvestor, Warburg Pincus, a global private equity firm. Archimedes alsoannounced the appointment of a new President and Chief Executive Officer,Jeffrey H. Buchalter, formerly President and Chief Executive Officer ofUS-based Enzon.
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The funding round is the largest raised by a private European biopharmacompany in the last 15 years and is Novo Growth Equity's first investmentsince it was established at the beginning of 2009. The funds will be used toestablish Archimedes' operations in the US and support the growth of thesuccessful specialty pharma business in Europe. The funds will also be usedto support the global commercial launch of PecFent*, Archimedes' innovative,simple-to-use, fentanyl nasal spray for the treatment of breakthrough cancerpain. PecFent has been filed for approval in Europe and the US and isexpected to be approved for commercial sale in both regions during 2010.PecFent is supported by an extensive phase III clinical development programmein which the product met all primary and secondary end-points. Crucially, thephase III studies demonstrated that PecFent showed onset of pain reliefwithin five minutes of dosing, statistically significant improvements in painrelief versus immediate release morphine, together with high levels ofpatient acceptability and consistent effectiveness in use.
Jeffrey H. Buchalter has over 20 years experience in the pharmaceuticalindustry and has held senior positions at a number of multinationalpharmaceutical companies. He was most recently President and CEO of EnzonPharmaceuticals, the US biopharmaceutical company focused on the development,manufacturing and commercialisation of therapies for patients with cancer andother life-threatening conditions. Prior to this, he was CEO of ILEXOncology, where he led the transformation from a drug development company toa high quality oncology franchise with established commercial operations. Hehas also held key positions at Pharmacia, Wyeth and Schering Plough.
Simon Turton, Managing Director of Warburg Pincus, said: "We havesupported Archimedes since its foundation in 2004 and are delighted to investagain in such an exceptional company as it enters a new stage in its growth.We are particularly pleased to welcome Jeff as President and CEO and to theBoard of Archimedes. His vast experience and knowledge of the pharmaceuticalindustry, and specifically oncology, will be instrumental in accelerating theCompany's success through an international platform. This major injection offunding and the appointment of Jeff as the new President and CEO mark thebeginning of a new phase in Archimedes' growth plans."
Ulrik Spork, Managing Partner of Novo Growth Equity, said: "We have beenimpressed with the successful track record of Archimedes over the last fiveyears, and are very pleased to contribute to the further transformation ofthe Company with the launch of PecFent, Archimedes' nasal fentanyl spray, inEurope and US. Archimedes represents an ideal investment opportunity for usand supports our strategy to take major stakes in promising late stage lifesciences companies with near-term commercial potential."
Jeffrey H. Buchalter, President and Chief Executive Officer ofArchimedes, commented: "Archimedes is at a transformational stage in itsdevelopment. It has built up a successful specialty pharma business in Europeand has filed its lead product, PecFent, for product approval in both Europeand the US. I am delighted to join as President and CEO to accelerate theexpansion of Archimedes' business in Europe, support the commercialisation ofPecFent, and build the operations in the US market."
The board of Archimedes will now include Simon Turton and Piyush Shuklaof Warburg Pincus; Ulrik Spork and Goran Ando of Novo A/S; and Jeffrey H.Buchalter.
*PecFent was previously known as NasalFent.
Notes to editors:
About Archimedes Pharma
Archimedes Pharma ("Archimedes") is a specialty pharmaceutical companyalready marketing and selling an expanding portfolio of specialist productsto hospital-based prescribers in major European territories.
Focused on the oncology, pain, neurology and critical care sectors,Archimedes currently markets a range of products in the UK, France, Germanyand Ireland, and will continue to expand its commercial presence in Spain andthe US during 2010.
Products currently marketed in Europe by Archimedes include: Gliadel, abiodegradable wafer impregnated with carmustine for high-grade glioma;Zomorph, an oral sustained release morphine product for moderate to severepain, particularly cancer pain; Oramorph, a liquid immediate release morphineproduct also indicated for moderate to severe pain; Apomorphine Injection formotor fluctuations in advanced Parkinson's disease and Pabrinex, a highpotency vitamin formulation used to treat the symptoms of malnutritionespecially in patients with alcohol misuse problems.
Archimedes is also developing a robust, high value pipeline of in-houseproducts in pain, Parkinson's disease and critical care. It applies itsworld-class drug delivery technologies to proven molecules which have yet toachieve their market potential due to their current mode of delivery. Thisapproach reduces the company's development risk, while delivering significantclinical and commercial benefits.
Archimedes submitted a centralised Marketing Authorisation Applicationwith the European Medicines Agency (EMA) for PecFent in April 2009 andsubmitted a New Drug Application (NDA) with the US Food and DrugAdministration (FDA) in August 2009. The product is expected to be approvedfor commercial sale during 2010 in both territories.
PecFent
Archimedes' transformational product is PecFent, an innovative and highlydifferentiated fentanyl citrate nasal spray, for the rapid relief ofbreakthrough cancer pain, based on Archimedes' PecSys(TM) technology. PhaseIII data illustrates that PecFent has a potential best-in-class profile amongfentanyl products for breakthrough cancer pain and is the first product todemonstrate onset of pain relief within five minutes of dosing.
PecFent is an aqueous fentanyl citrate solution utilising Archimedes'proprietary PecSys(TM) technology. The PecFent solution has a low viscosityand is easily delivered in a low volume of 100mcl using a nasal spray pump.The pump produces a fine mist of similarly sized spray droplets which aredeposited into the front of the nostril. The calcium ions present on thenasal mucosa cause the pectin to form a thin gel layer, which allows fentanylto be retained on the nasal mucosa, allowing a rapid but controlledabsorption into the systemic circulation. The PecSys(TM) technology avoidsproblems associated with simple solutions used in nasal sprays, such asexcessive levels of drug and dripping or swallowing of the drug solution.
Archimedes' technologies - ChiSys(R), PecSys(TM) and TARGIT(R) - are alsoused in a number of partnered products in late-stage clinical development.ChiSys, an innovative drug delivery technology which enhances the residencetime of molecules on mucosal membranes, has proven potential for vaccinedelivery. Pre-clinical and clinical studies of nasally administered vaccineshave demonstrated enhanced immune response. PecSys(TM) is Archimedes'patented drug delivery system built around its novel pectin technology,designed to maximise the potential of systemically absorbed drugs byenhancing drug performance and improving patient acceptance.
For more information, please visit: http://www.archimedespharma.com.
Jeffrey H. Buchalter
Jeffrey H. Buchalter has over 20 years experience in the pharmaceuticalindustry. He was previously President and CEO of Enzon Pharmaceutical Inc.since 2004 and also served as Chairman of the Board of Directors until May2009. Prior to this, Jeffrey was President and CEO of ILEX Oncology, Inc.where he led the company's transformation from a drug development contractresearch organization to a product-driven pharmaceutical company. Beforejoining ILEX Oncology Inc., Jeffrey held key roles at Pharmacia, Wyeth(formerly American Home Products) and Schering-Plough Corporation.
Jeffrey received the American Cancer Society's Joseph F. Buckley MemorialAward and an invitation from former President George Bush to serve as acollaborating partner in the National Dialogue on Cancer. Jeffrey wasrecently appointed Chairman to the Board of Trustees of The NationalChildren's' Cancer Foundation (NCCF); he is also a member of the Board ofDirectors of TopoTarget A/S, a publicly held Danish biopharmaceutical company.
Jeffrey has a B.S. in finance from Seton Hall University, and an M.B.A.in marketing from Temple University.
About Warburg Pincus
Warburg Pincus is a leading global private equity firm. The firm has morethan $30 billion in assets under management. Its active portfolio of morethan 100 companies is highly diversified by stage, sector and geography.Warburg Pincus is a growth investor and an experienced partner to managementteams seeking to build durable companies with sustainable value. Founded in1966, Warburg Pincus has raised 12 private equity funds which have investedmore than $35 billion in approximately 600 companies in more than 30countries. Since the firm's first European transaction in 1983, WarburgPincus has invested more than $6 billion in European companies, includinginvestments in Archimedes, Eurand and ProStrakan. Additional life scienceinvestments include Allos Therapeutics, Ganic Pharmaceuticals, InterMune,Rib-X Pharmaceuticals and ZymoGenetics. The firm has offices in Beijing,Frankfurt, Hong Kong, London, Mumbai, New York, San Francisco, Shanghai andTokyo. For more information, please visit http://www.warburgpincus.com.
About Novo A/S and Novo Growth Equity
Novo A/S is the holding and investment company of the Novo Group, and iswholly owned by the Novo Nordisk Foundation. Novo A/S was formed in 1999 toactively manage the assets of the foundation. It employs about 30 people andhas approximately USD 15 billion of assets under management. These includessignificant shareholdings in the publicly listed Novo Nordisk A/S (NYSE: NVO)and Novozymes A/S (NVZMF.PK), Novo A/S provides seed, venture and growthcapital to development stage companies within life science and biotechnology,as well as manages a broad portfolio of financial assets. Novo A/S iscommitting up to USD 300 million annually to its investments in seed, ventureand growth equity life science companies. Of this, nearly two-thirds aredirected to the Novo Growth Equity activities focusing on investment inpromising late stage companies with near term commercial potential. Forfurther information please visit http://www.novo.dk.
For further information, please contact:
Capital MS&L:
Mary Clark, Supriya Mathur, Tel: +44(0)20-7307-5347
SOURCE Archimedes Pharma
