Arnold & Porter has an internationally recognized life sciences transactions practice. We are distinguished by our depth and breadth of our experience that leverages the firm's U.S. and EU regulatory, intellectual property, and litigation practices. We have long experience with the full range of transactions, including M&A, licensings and collaborations, financings, and commercial arrangements. Our industry experience spans across branded pharmaceuticals, generic pharmaceuticals, eye care, medical device, diagnostics, vaccines, animal health, and also includes a wide variety of therapeutic areas within each sector.
Our life sciences transaction clients include major pharmaceutical companies, specialty pharmaceutical companies, biotechs, medical device and diagnostic companies, nonprofits and universities, and investors. We provide our clients advice on matters throughout North America, Europe, and Asia.
Our team also includes scientific advisers who hold advanced degrees in molecular biology, chemistry, biochemistry, and medicine, among other fields. They work alongside our lawyers to provide guidance and understanding of the complex technologies involved in the transaction.
Mergers and Acquisitions
We have a nationally ranked life sciences M&A practice with particular strength in cross-border transactions. We advise clients on the full spectrum of M&A deals from acquisitions of large complex companies and carve-out transactions to single-product acquisitions, including those involving contingent consideration, option structures, and product and business unit divestitures.
Recent examples of deals include the following:
- Novartis in numerous transactions, including:
- The acquisition of Admune Therapeutics, a clinical-stage biotechnology company, broadening Novartis' immuno-oncology pipeline.
- The divestiture to HLS Therapeutics of the rights to schizophrenia drug Clozaril® in the U.S. and Canada.
- The acquisition of Alcon Inc., a global leader in eye care from Nestlé S.A. for $51.6 billion, and the related divestiture of a portfolio of 20 ophthalmic products, including branded pharmaceuticals, generics, diagnostics, and over-the-counter medicines pursuant to consent orders with international competition authorities.
- The acquisition of CoStim Pharmaceuticals Inc., a Cambridge, MA-based, privately held biotechnology company focused on harnessing the immune system to eliminate immune-blocking signals from cancer.
- Pfizer in numerous transactions, including:
- The acquisition of Bamboo Therapeutics Inc., a privately held biotechnology company, for an upfront cash payment of $150 million, with up to $495 million of contingent milestone payments.
- The acquisition of InnoPharma Inc., a privately held sterile product development company focused on developing complex generic and innovative specialty pharmaceutical products in injectable and ophthalmic dosage forms, for an upfront cash payment of $225 million, with up to $135 million of contingent milestone payments.
- The acquisition of NextWave Pharmaceuticals, a specialty pharmaceutical company, for up to $700 million. NextWave is the developer of Quillivant XR™, the first once-daily liquid medication approved in the U.S. for the treatment of ADHD.
- Sandoz in:
- The acquisition of specialty dermatology generics company, Fougera Pharmaceuticals, from a consortium of private equity funds led by Nordic Capital, DLJ Merchant Banking (a Credit Suisse affiliate), and Avista Capital Partners for $1.525 billion. This move also positioned Sandoz to become the number one generic dermatology medicines company both globally and in the U.S.
- The acquisition of Oriel Therapeutics, including exclusive rights to a portfolio of generic drug candidates for asthma and COPD and related technologies.
- Lonza, a Switzerland-based pharmaceutical, biotech, and specialty ingredients supplier, in its strategic acquisition of California-based InterHealth Nutraceuticals Inc., a portfolio company of Kainos Capital, for up to $300 million.
- Alcon in the acquisition of WaveTec Vision, a privately held company that developed the ORA System, the first commercialized intra-operative guidance system for cataract surgeons implanting intraocular lenses.
- Bayer HealthCare in the sale by Bayer of its commercial rights outside of the U.S. and Canada to Kythera's ATX-101. ATX-101 is a proprietary formulation of a purified synthetic version of deoxycholic acid currently in late-stage development for the reduction of submental fat. Under the agreement, Bayer received Kythera common stock, a promissory note, and sales milestones. We also assisted Bayer in 2010 in its license to those rights from Kythera.
- Spirogen in its sale to MedImmune for $200 million, plus deferred consideration of up to $240 million in milestones. We also assisted in a simultaneous collaboration agreement between ADC Therapeutics, an affiliate of Spirogen, and MedImmune to jointly develop ADC Therapeutics' antibody-drug conjugate programs and an equity investment in ADC Therapeutics.
- AstraZeneca on the contingent value rights (CVRs) used to acquire Omthera Pharmaceuticals, a specialty pharmaceutical company based in Princeton, New Jersey. Omthera was focused on the development and commercialization of new therapies for abnormal levels of lipids in the blood, referred to as dyslipidemia.
- Asahi Kasei in its acquisition of all of the shares of Artisan Pharma, a U.S. biotech focused on treating blood clotting disorders. The transaction involved a restructuring of Artisan, which was jointly owned by several investors and Asahi Kasei, and Artisan's primary asset was licensed from Asahi Kasei.
- Recordati, an Italian stock exchange-listed, Madrid-based international pharmaceutical group with operations in the U.S., the main European jurisdictions, Russia, CEE, and Turkey, on both a major investment in North Africa, and on an acquisition in Spain. Recordati acquired a majority ownership in Opalia Pharma S.A., a Tunisian pharmaceutical company which is the third largest in the local market, and pharmaceutical company Laboratorios Casen Fleet S.L.U., which allowed the client to reinforce its presence in Spain, the fifth largest market for pharmaceuticals in Europe, and also to acquire a portfolio of products.
- SpePharm AG, an affiliate of independent European specialty pharmaceutical company Norgine B.V., on its sale of SAVENE® — a drug used for the treatment of extravasation in anthracycline chemotherapy in adults — to LSE and AIM-listed global pharmaceutical company Clinigen Group plc.
- Aduro Biotech in its cross-border acquisition of the share capital of BioNovion, a privately held monoclonal antibody discovery and development company based in The Netherlands, for cash and stock of Aduro.
Licensing and Collaborations
We assist clients in a wide range of complex licensing, collaboration and other partnering arrangements throughout all stages of a product's life cycle. Our experience covers the following types of transactions:
- Patent licensing
- Early-stage discovery and research collaboration/funding agreements
- MTAs, CDAs, and other enabling agreements
- CRADAs and other government funding and research matters
Our clients regularly entrust us with high-priority, high-value deals, including in-licenses of blockbuster drugs, collaborative agreements for the development of novel therapies, contentious negotiation or renegotiation of major commercial contracts relating to key products, and settlement of major intellectual property and contract litigation, including Hatch-Waxman settlements. Our clients also look to us to guide them through transactions that are unusually complex, including difficult multi-party arrangements, or in connection with matters in rapidly evolving or emerging areas, such as immunotherapy and personalized medicine.
Our licensing and partnering practice is diverse. For example, our attorneys have represented:
- Insmed Incorporated in the negotiation of a license and collaboration agreement with AstraZeneca regarding an early-stage respiratory drug. The transaction reflected a deal value of $150 million in achievable milestones and double-digit royalties.
- Temptime Corporation in the negotiation of a complex, multimillion dollar patent license, pertaining to time/temperature indicators for use in the monitoring of human vaccines.
- Idera Pharmaceuticals in the negotiation of a license and collaboration agreement with GSK regarding the modulation of gene targets. The transaction reflected a deal value of $100 million.
- Alcon in the formation of a strategic alliance with U.S.-based PowerVision to develop fluid-based accommodating intraocular lenses (AIOL) for cataract patients. Alcon's investment in PowerVision will fund further development and clinical trials, and provide Alcon the option to acquire the company.
- Novartis in numerous matters, including:
- Long-term agreement with California-based Thermo Fisher Scientific to develop and commercialize a multi-marker, universal next-generation sequencing (NGS) oncology test to serve as a companion diagnostic for non-small cell lung cancer across multiple drug development programs.
- Significant multi-year alliance with Aduro Biotech to develop next generation cancer immunotherapies targeting the Stimulator of Interferon Genes (STING) pathway, for an upfront payment of $200 million to Aduro and an equity investment of $50 million.
- Master collaboration agreement with QIAGEN N.V. to enable the development and commercialization of companion diagnostics to be paired with existing Novartis products, as well as compounds in its development pipeline.
- Collaboration agreement with MolecularMD Corporation to develop a companion diagnostic test to aid in the identification of Ph+ chronic myelogenous leukemia (CML) patients who have achieved durable minimal residual disease with nilotinib (Tasigna®), and to provide molecular monitoring for patients during treatment-free remission.
- Pfizer in numerous matters, including:
- An exclusive license to commercialize Basilea Pharmaceutica's CRESEMBA® (isavuconazole), an anti-fungal treatment for invasive aspergillosis and mucormycosis, in Europe (ex-Nordics).
- A worldwide licensing agreement with OPKO Health Inc., granting Pfizer exclusive rights to develop and commercialize OPKO's long-acting human growth hormone (hGH-CTP) for the treatment of growth hormone deficiency (GHD) in adults and children, for an upfront payment of $295 million with up to $275 million of contingent milestone payments plus undisclosed royalties.
- A licensing agreement with Gliknik Inc., a privately held biopharmaceutical company, for GL-2045, Gliknik's recombinant stradomer™, a drug candidate that is designed to replace and improve on pooled human intravenous immunoglobulin.
- Sandoz, the generic pharmaceuticals division of Novartis, in a collaboration agreement with biotechnology company MedinCell to develop and commercialize long-acting injectable drug products based on MedinCell's proprietary technology platform for controlled and sustained drug delivery, with a primary focus on oncology.
- Norgine B.V., a European specialty pharmaceutical company, on a collaboration and exclusive licensing agreement with Austria-based biotech company Innovacell. The agreement covered Europe, the Middle East, and Africa. The agreement was for Innovacell's personalized cell-based therapy ICEF15. Through the collaboration, Norgine will co-develop ICEF15 with Innovacell and Norgine will commercialize the product.
- GE Healthcare in connection with the negotiation of a worldwide brachytherapy seed loading services agreement in Theragenics Corporation. Under the agreement, Theragenics is to load and package brachytherapy seeds in prescription loaded needle and other configurations, primarily for use in the treatment of early-stage prostate cancer.
- Sequella, a Maryland biotech, in an agreement with Maxwell Biotech Venture Fund to complete the clinical development and commercialization of Sequella's lead compound for treatment of tuberculosis in the Russian Federation and neighboring Commonwealth of Independent States. The structure of the deal included an equity investment, clinical trial supply purchase, milestones, and royalty payments.
- The American National Red Cross in a collaboration agreement for the development of a diagnostic test to detect and quantify the risk of fetal-maternal hemorrhage.
We have broad experience in representing life science companies in:
- Private venture capital equity and debt transactions
- Initial public offerings
- Follow-on public offerings
- PIPE transactions
- Rule 144A transactions
- Bank lending and other debt financings
For example, we assisted MacroGenics and Trivascular Technologies in their initial public offerings, and Bayer Healthcare in the sale of product rights for a combination of stock and debt.
Universities and Nonprofits
We regularly assist our for-profit clients in their transactions with universities and other nonprofits. In life sciences, we work closely with members of our patent, tax, and government contracts practice groups. Our experience covers licensing, commercial agreements, government contracts, and tax issues. Examples of our experience include representing:
- Novartis in an exclusive global collaboration agreement with the University of Pennsylvania to research, develop, and commercialize targeted chimeric antigen receptor (CAR) immunotherapies for the treatment of cancers, as well as jointly establish a new research and development facility on the Penn campus called the Center for Advanced Cellular Therapies.
- eLife Sciences, a collaboration of The Wellcome Trust, Howard Hughes Medical Institute, and Max Planck Society, in connection with its formation and initial operation of a top-tier, open access online scientific journal for biomedical and life sciences research.
- The founders of The Lieber Institute for Brain Development in its formation and establishment at Johns Hopkins University and in subsequent collaborations. The Lieber Institute is a neuroscience research institution focused on basic research about the causes of schizophrenia and related developmental behavioral disorders, including the development of new diagnostics and treatments.
- AstraZeneca in a drug discovery and development collaboration with the University of Pennsylvania. The deal was recognized by the Licensing Executives Society as a "Deal of Distinction" and was cited as being an innovative and "excellent illustration of the interface between industry and academia."
- JDRF on its development of an intellectual property policy applicable to university and academic medical center grant recipients involved in the Artificial Pancreas Project.
- The Sean N. Parker Foundation in its $24 million gift to Stanford University and the related establishment of the Sean N. Parker Center for Allergy and Asthma Research at Stanford.