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Stephen Paul Mahinka
Partner - Washington, D.C. -
Randall B. Sunberg
Partner - Princeton
Industry Events
Honors
PLCCross-border Quarterly 2011/12 Life Sciences Legal Market Review
- Life Sciences Regulatory Super League - Ranked 10th of law firms worldwide
PLCCross-border Life Sciences Handbook 2011/12
- U.S.:
- Commercial and Partnering - Highly Recommended
- Competition/Antitrust - Highly Recommended
- Corporate - Recommended
- Government Enforcement and Investigations - Highly Recommended
- Regulatory - Recommended
- Regulatory (Medical Devices) - Recommended
- England: Regulatory - Recommended
- Japan: Corporate and Commercial - Recommended
Chambers Global 2011: Global Life Sciences - Recommended - Band 3
Chambers USA 2011: National for Life Sciences - Band 3; Washington, D.C. for healthcare/ pharmaceutical/ medical products regulatory - Band 3
UK Legal 500 2010: London: Pharmaceuticals and Biotechnology
Best Lawyers in America 2011: Biotechnology and Healthcare Law Named
BioPharm Insight 2011
(based on last 12 months)
- Ranked 1st in Legal Advisers on Asia-Pacific Licensing Agreements - Based on Volume
- Ranked 4th in Legal Advisers on European Licensing Agreements - Based on Volume
- Ranked 5th in Global League Table of Legal Advisers on Licensing Agreements - Based on Volume
- Ranked 5th in Global League Table of Legal Advisers on Licensing Agreements - Based on Value
- Ranked 4th in Global League Table of Legal Advisers on Licensing Agreements - Based on Volume
- Ranked 5th in Global League Table of Legal Advisers on Licensing Agreements - Based on Value
Clients
16 of the top 20 pharmaceutical companies
7 of the top 20 biotechnology companies
9 of the top 20 medical device companies
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Areas of Experience
Our Life Sciences Practice assists clients in structuring, negotiating and implementing merger & acquisition, joint venture, strategic alliance, corporate partnering, licensing, financing and outsourcing transactions to help them achieve their business goals. Our ability to also provide the life sciences regulatory, scientific and litigation assessment components necessary to a transaction (including intellectual property, FDA/healthcare regulatory, product liability, outsourcing, tax, antitrust, labor and employment, employee benefits and real estate), uniquely positions us to successfully complete transactions in a coordinated and efficient manner.
M&A transactions include:
- Alacer Biomedical in its sale to Allergan
- Orchid Cellmark in its sale to LabCorp for $85.4 million
- OnPoint Medical Diagnostics in its reverse merger with Vertical Health Solutions
- Galen Partners in its purchase of a controlling equity stake in Cambrooke Foods, a pharma foods company
- Embrella Cardiovascular in its $43 million sale to Edwards Life Sciences
- Axcan Pharma in its sale of the pharmaceutical products, Photofrin and Photobarr, to Pinnacle Biologics
- ARAMARK Healthcare in its acquisition of Masterplan
- Perrigo in its $540 million acquisition of Paddock Laboratories
- medSage in its sale to Respironics, a division of Philips Electronics
- Eurand in its $538 million sale to Axcan Holdings
- Sofinnova Partners in the sale of Preglem to Gedeon Richter for €337 million
- BMP Sunstone in its sale to sanof-aventis for $526 million
- Safeguard Scientifics in the sale of its partner company Clarient to GE Healthcare for $587 million
- Solstice Neurosciences in its sale to US WorldMeds for $35 million
- InfuSystem Holdings in its acquisition of First Biomedical for $17.2 million
- ViroPharma in its ₤20 million acquisition of Auralis
- Valeant Pharmaceuticals in its acquisition of Aton Pharma for $318 million
- BioClinica in its acquisition of TranSenda International
- Biovail in its acquisition of certain AMPAKINE® compounds and associated intellectual property from Cortex Pharmaceuticals
- Perrigo Company in its acquisition of PBM Products for $808 million
- The investors of Novexel including Sofinnova Partners, Atlas Venture, Novo AS, Edmond de Rotschild Investment Partners, Daiwa SMBC Capital Co, NeoMed, Abingworth and Goldman Sachs in the sale of Novexel to AstraZeneca for $505 million
- BioClinica in its acquisition of Tourtellotte Solutions and CardioNow
- Medical Imaging Holdings in its acquisitions of Sonora Medical Systems, Barrington Medical Imaging, and Echoserve
- Abingworth, Crédit Agicole Private Equity, Fobion, Gimv, Sofinnova, Veslius, and Wellcome Trust, as investors of Fovea Pharmaceuticals, in its $562 million sale to Sanofi-Aventis
- Leo Pharma in its re-acquisition of U.S. rights to its topical psoriasis treatments from Warner Chilcott for approximately $1 billion
- PeriGen in is acquisition of LMS Medical Systems
- Pierrel Research in its acquisition of Encorium Group
- Chiesi Farmaceutici in its $70 million strategic transaction with Cornerstone Therapeutics
- Biovail Laboratories International SRL in its $510 million acquisition from GlaxoSmithKline of U.S. rights for Wellbutrin XL, approved for major depressive disorder and seasonal affective disorder and originally developed by Biovail
- Sekisui America Corporation in its $25.5 million acquisition of American Diagnostica
- CardioNet in its $14 million acquisition of Biotel
- Bio-Imaging Technologies in the sale of its CapMed Division to Metavante Technologies
- GPC Biotech in its merger Agennix to form a new publicly listed company
- Lundbeck in its acquisition of Ovation Pharmaceuticals for $600 million and up to $300 million in contingent payments
- NexMed in its sale of the U.S. rights for its topical alprostadil erectile dysfunction treatment (Alprox) to partner, Warner Chilcott
- PharmaNet Development Group in its sale to JLL Partners for $250 million
- Meridian Healthcare Group in its sale to Lincare for $44 million
- United Drug plc in the acquisition of The Specials Laboratory for $38 million
- Valeant Pharmaceuticals in the acquisition of Dow Pharmaceutical Sciences for $285 million
- RecoverCare in its acquisition of T.H.E. Medical
- Biovail in its acquisition of Prestwick Pharmaceuticals for $100 million
- Neose Technologies in its $43 million sale to Novo Nordisk and BioGenix
- Nanogen in its acquisition by Elitech Group
- Health Care Service Corporation in the acquisition of MEDecision
- Eli Lilly in the sale for $50 million of a drug development unit to and long-term strategic $1.6 billion services agreement with Covance
- PhotoMedex in its $13 million acquisition of Photo Therapeutics
- Sekisui Chemical Co. in its acquisition of XenoTech valued at $50 million
- Sharp Corporation in its $99 million sale to United Drug plc
- Barrier Therapeutics in its $148 million sale to Stiefel Laboratories
- Catalent Pharma Solutions in the sale of its New Mexico pharmaceutical laboratory to Oso Biopharmaceuticals Manufacturing
- EP MedSystems in its acquisition by St. Jude Medical for $92.1 million
- Bio-Imaging Technology in its acquisition of Phoenix Data Systems for $22 million
- Cytogen in its acquisition by EUSA Pharma for $22.6 million
- AmerisourceBergen in its acquisition of Bellco Drug Corp for $190 million
- Oncology Therapeutics Network (OTN), a portfolio company of One Equity Partners, in its sale to McKesson for $575 million
- New Brunswick Scientific in its sale to the Eppendorf Group for $110 million
- Perrigo Company in its acquisition of Glades Pharmaceuticals
- Wockhardt Limited in its acquisition of Radiant Research
- VIASYS Healthcare in its sale to Cardinal Health for $1.5 billion
- Merck in its divestiture of several marketed products to Iroko Pharmaceuticals
- Sierra Health Services in its sale to UnitedHealth Group for $2.6 billion
- Bio Imaging Technology in its acquisition of Theralys SA
- BioRexis Pharmaceutical in its acquisition by Pfizer
- Cytogen in the sale of its 50% joint venture interest in PSMA Development Company LLC to Progenics
- CMS Private Equity Fund in its acquisition of Med-Dispense
- Provid Pharmaceuticals in its acquisition of Tripos Discovery Research
- Lundbeck in its acquisition of Saegis Pharmaceuticals
- Sun Capital Partners in its $17 million acquisition of Respiratory Distributors
- HAPC in its acquisition of InfuSystem for $140 million
- GNI Ltd. in its acquisition of a controlling interest in Shanghai Genomics in part through the required auction process to purchase the shares of state-owned entities
- United Drug plc in its combined $50 million acquisition of Endoscopy Limited
- OTN in its acquisition of the oncology distribution unit of Cardinal Health
- Nanogen its acquisition of Amplimedical S.p.A.
- Meridian Health Care Group and subsidiary Primedica in the acquisition of Symphony Respiratory Care
- Schering-Plough in its acquisition of Bayer AG’s primary care pharmaceutical product business in the United States and related strategic alliances on oncology products and on Zetia® in Japan
- Med-Design in its sale to Specialized Health Products International
- Nanogen in its acquisition of Spectral Diagnostics-Rapid
- Laureate Pharma in its acquisition by Discovery Pharmaceuticals
- Biophan Technologies in its acquisition of interest in Myotech
- Duramed Pharmaceuticals in its $156 million acquisition of Mircette desogestrel tablets from Organon International
- Cerenis Therapeutics in its $30 million sale to Sifinnova, Healthcap, Alta Partner, EDF, and NIF, a consortium of French and U.S. venture capital firms
- excelleRX in its acquisition by Omnicare
- InKine Pharmaceutical in its sale to Salix Pharmaceuticals
- United Drug plc in its acquisitions of In2Focus Development Services, TD Packaging, and Presearch Limited
- Femme Pharma Global Healthcare in its divestiture of its Danazol® product to KV Pharmaceuticals
- One Equity Partners in its acquisition from Bristol-Myers Squibb of Oncology Therapeutics Network
- Biovail in its more than $100 million divestiture of its Teveten® and Teveten HCT® products and sale of the marketing rights of its Cardizem®LA product to Kos Pharmaceuticals
- Viscogliosi Brothers in its acquisition of Fixano France
- Smiths Group plc in its $925 million acquisition of Medex
- Perrigo Company in its $818 million cash and stock acquisition of Agis Industries Ltd.
- Closure Medical in its $421 million acquisition by Johnson & Johnson
- Viasys Holdings in its acquisition of the medical division of Oxford Instruments plc for $24 million
- Barrier Therapeutics in its acquisition of the rights to Solage topical solution from Moreland Enterprises
- Sanofi-Aventis in the divestiture of Campto® to Pfizer
- Nanogen in its acquisition of SynX
- Esperion in its acquisition by Pfizer for $1.3 billion
- United Drug plc in its $11 million acquisition of Mantis Surgical Limited
- Cell Pathways in its stock-for-stock acquisition by OSI Pharmaceuticals
- 3-Dimensional Pharmaceuticals in its acquisition by Johnson & Johnson
- Enzon in its acquisition of Abelcet® product rights and related manufacturing facility and other assets from Elan for $370 million
- Pharmacia in the divestiture of its late stage compound to Nastech in connection with its then proposed merger with Pfizer
- Principia in its stock-for-stock acquisition by Human Genome Sciences
- Cephalon in its $444 million stock-for-stock acquisition of Anesta
Collaborations, joint ventures, and alliances transactions include:
- Merck in its joint venture with Sun Pharmaceutical Industries for innovative formulations
- Lundbeck in its donation together with Novartis of their rights to compound Lu AE58479 for SSADH deficiency to the National Institutes of Health
- Auxilium Pharmaceuticals in its up to $262 million development, commercialization and supply collaboration with Asahi Kasei for Xiaflex® in Japan
- Takeda in its up to $750 million development and commercialization collaboration with Intra-Cellular Therapies on selective phosphodiesterase type 1 (PDE1) inhibitors for cognitive impairment associated with schizophrenia
- Lundbeck in its commercial rights agreement with Cephalon to register and commercialize several Cephalon products including Fentora, Provigil, Treanada, Trisenox, Myocet and Nuvigil in Canada and Latin America
- Lundbeck in its drug discovery collaborations with Zenobia Therapeutics and Vernalis plc for inhibitors for LRRK2
- Invida Group in its exclusive licensing and distribution collaboration with Orexo AB covering the Pacific region for Abstral™
- Lundbeck in its distribution agreement with Merck to acquire the rights outside the U.S., China and Japan to Asenapine (Sycrest), a drug approved for bipolar disorder
- Lundbeck in its development and commercialization collaboration agreement with Kyowa Hakko Kirin relating to adenosine A2A antagonist products outside of Japan and the Asia region for all fields, including Parkinson's disease
- Onyx Pharmaceuticals in its more than $300 million development and commercialization collaboration with Ono Pharmaceutical for Carfilzomib and ONX-0912 in oncology indications in Japan
- Concordia Pharmaceuticals in its licensing agreement with Ono Pharmaceutical to develop and commercialize salirasib, an agent for the treatment of pancreatic, non-small cell lung and colorectal cancers, in Japan
- Diamyd Medical AB in its up to $625 million license, development and commercialization agreement with Ortho-Mcneil-Janssen Pharmaceuticals focused on GAD65 antigen-based therapy for the treatment and prevention of type 1 diabetes and associated conditions
- Biovail in its license agreement with Kyowa Hakko Kirin to acquire the U.S. and Canadian rights to commercialize products containing istradefylline
- GlaxoSmithKline in its up to $1.58 billion antisense drug collaboration with Isis Pharmaceuticals for the development and commercialization of therapeutics for rare and infectious diseases
- Smiths Detection in its collaboration with Novartis Diagnostics relating to Smiths' Bio-Seeq platform and LATE-PCR technology for use in a range of point-of-care diagnostic tests
- Biovail in its development and commercialization agreement with Alexza Pharmaceuticals
- NovaDel in its license and distribution agreement with ECR Pharmaceuticals Company to commercialize and manufacture NovaDel’s ZolpiMist
- NovaDel Pharma in negotiating its license agreement with Mist Acquisition to manufacture and commercialize NitroMist
- Biovail in its acquisition of the U.S. and Canadian rights to develop and commercialize Santhera Pharmaceuticals' treatment of Dyskinesia in Parkinson's Disease
- Shire in its multimillion dollar transformative manufacturing arrangement, whereby it transitioned the manufacture of several specialty pharmaceutical products to DSM Pharmaceuticals
- Biovail in its up to $395 million collaboration with Acadia Pharmaceuticals to develop and commercialize Pimavanserin for neurological and psychiatric indications
- Shire in its co-promotion agreement with GlaxoSmithKline for Shire’s product Vyvanse™
- Morphotek, and parent company Eisai, in a discovery, development and commercialization collaboration between Morphotek and Human Genome Sciences for therapeutic monoclonal antibodies for oncology and immunology
- Biovail in its supply agreement with sanofi-aventis U.S. for the marketing and distribution of the drug Aplenzin in the United States and Puerto Rico
- Lonza Group in its joint venture with Teva Pharmaceutical Industries to develop, manufacture, and market a portfolio of biosimilars
- Abeille Pharmaceuticals in its license agreement with Strakan International Limited relating to Abeille’s AB-1001 product
- Eurand in its license and supply agreement with Daewoong Pharmaceuticals relating to Eurand's novel extended-release (ER) formulation of the muscle relaxant Cyclobenzaprine HCl
- Auxilium Pharmaceuticals in its up to $485 million development, commercialization and supply collaboration with Pfizer for Xiaflex™ in Europe and Eurasia
- Profectus BioSciences in the worldwide acquisition and license of Wyeth's therapeutic and prophylactic DNA and vectored vaccine programs for HIV, HCV, HPV, HSV and Malaria
- Merck in its commercialization agreement with Gilead Sciences relating to Atripla
- Aprecia Pharmaceuticals in its development and exclusive distributorship agreement with Hampton-Laine related to three products for the treatment of epilepsy
- Immunomedics in its up to $620 million development and commercialization collaboration with Nycomed for the subcutaneous formulation of its humanized anti-CD20 antibody in non-cancer indications
- Lundbeck in its $100 million upfront and up to $250 million in connection with regulatory approvals, development, and commercialization collaboration with Myriad for the Alzheimer's disease drug Flurizan
- Takeda Pharmaceutical in its $100 million upfront and up to $1 billion development and commercialization collaboration and technology transfer transaction with Alnylam relating to RNAi therapeutics
- Shire in its up to $325 million development and commercialization collaboration with Alba Therapeutics for gastrointestinal permeability inhibitor AT-1001
- Adolor in its up to $265 million development and commercialization collaboration with Pfizer for delta opioid agonists
- Acura Pharmaceuticals in its development and commercialization collaboration with King Pharmaceuticals for opioid analgesic products
- Shire in its up to $440 million genetic disorders development and commercialization collaboration with Amicus Therapeutics
- NPS Pharmaceuticals in the restructuring of its mGluRs collaboration with AstraZeneca
- Keryx Biopharmaceuticals in its phosphate binder collaboration with Japan Tobacco
- NPS Pharmaceuticals in its license and distribution agreement with Nycomed relating to GATTEX™
- Cardiokine in its up to $220 million development and commercialization collaboration with Biogen Idec for lixivaptan, a selective V2 vasopressin receptor antagonist
- Shire in its up to $825 million development and commercialization collaboration with Renovo for Juvista (human TGFβ3)
- Beijing Med-Pharma in its pending agreement with Alliance Boots plc to form a joint venture entity Alliance BMP Limited to acquire 50% interest in Guangzhou Pharma
- Ambrilia Biopharma in its up to $232 million worldwide licensing agreement with Merck relating to its HIV/AIDS protease inhibitor program
- Schering-Plough in its global collaboration with Novartis Pharma AG to develop and commercialize a once-daily inhaled fixed-dose combination therapy for asthma and COPD
- Enzon in its LNA oncology development and commercialization alliance with Santaris
- Aprecia Pharmaceuticals in a collaboration agreement for the development of its platform drug delivery technology for certain ophthalmic applications to Bausch & Lomb
- Genizon Biosciences in its licensing agreement with Genentech for its Crohn’s disease GeneMap product
- Daiichi Pharmaceuticals in its licensing agreement with YM BioSciences for its anti-EGFR humanized antibody nimotuzumab
- CytoKine Pharmasciences in out-licensing its antibody platform technology to GenMab
- Tengion in its research collaboration agreement with the Wake Forest Institute for Regenerative Medicine for the development of organs and tissues for the treatment of human diseases and disabilities
- Cerenis Pharmaceuticals in its research collaboration agreement with BioNeer
- Daiichi-Sankyo in its $340 million global development and collaboration deal with KAI Pharmaceuticals
- NexMed in its licensing, development and commercialization collaboration with Novartis for its fungal product
- Pharmasset in its development and commercialization collaboration with Bukwang Pharmaceuticals of Korea for the treatment of chronic hepatitis B virus
- Sanofi-Aventis in its authorized generic arrangements with Prasco Laboratories for Allegra®
- Cytogen in the conjugated antibody development and commercialization collaboration between PSMA Development Company LLC, Cytogen’s joint venture with Progenics, and Seattle Genetics
- Biovail in its strategic collaboration and research and development alliance with Kos Pharmaceuticals in the area of cardiovascular disease
- Amersham in the merger of its brachytherapy business with Galil Medical’s urology business to create Oncura
- Shire in its up to $500 million collaboration with New River Pharmaceuticals for the development and commercialization of a late-stage ADHD compound
- Cancervax in its $290 million collaboration with Serono for the development and commercialization of its cancer therapy, Canvaxin®
- Adolor in its co-promotion agreement with GlaxoSmithKline for Arixtra®
- Takeda in its $210 million collaboration with Sucampo for the development and commercialization of lubiprostone for the treatment of IBS
- Pharmasset in its $300 million collaboration with Roche to develop and commercialize nucleoside polymerase inhibitors for the treatment of chronic hepatitis C virus infections
- Sanofi-Aventis in the restructuring of its Actonel® collaboration with Procter & Gamble
- NexMed in its license of European marketing rights to Schering AG
- Sanofi-Aventis in its up to $485 million collaboration with Regeneron to develop and commercialize VEGF-Trap products, and related equity investment
- Adolor in its late-stage licensing transaction with EpiCept for the development and commercialization of LidoPain® SP and related products
- Sanofi-Aventis in its collaboration with ImmunoGen to discover, develop and commercialize novel antibody-based anti-cancer products
- Adolor in its worldwide late stage compound development and commercialization agreement with GlaxoSmithKline
- Arena Pharmaceuticals in its drug discovery collaboration with Merck
- Sanofi-Aventis in its up to $480 million collaboration with Genta for the co-development and co-commercialization of Genasense®
- Johnson & Johnson Merck Consumer Pharmaceuticals Co. (a joint venture of J&J and Merck) in renegotiating its Scandinavian distributorship rights for all of its over the counter products with Pharmacia AB Consumer Healthcare
- Quintiles in its co-development and co-promotion collaboration with Eli Lilly for Cymbalta®
- Pharmacia in the restructuring of its Lorex joint venture with Sanofi-Aventis for the marketing of Ambien®
- Eos Biotechnology in its collaboration agreements with ICOS, Seattle Genetics, and Avanir
- Sanofi-Aventis in its $450 million alliance with Millennium Pharmaceuticals for target-based drug discovery and commercialization, bioinformatics technology transfer and related equity investment
- 3-Dimensional Pharmaceuticals in drug discovery alliances with Centocor and Bristol-Myers Squibb
- Genaera in its collaboration and licensing transaction with MedImmune, including the related equity investment and restructuring of the company’s previous collaboration with Genentech
- Sanofi-Aventis in its inhalative insulin strategic alliance with Pfizer, including a worldwide development and commercialization collaboration, and formation of a Frankfurt-based manufacturing joint venture, as well as license agreements with Nektar Therapeutics





