Vaccines, patents and supply

by Dr Fintan Walton, CEO, PharmaVentures.

In my experience, quick fix solutions to complex issues are usually founded on a total misunderstanding of the problem causing the issue at hand, and if implemented result in, at best, no solution at all and, at worst, result in long-term damage. Such is the case with the World Trade Organisation’s (WTO’s) proposed solution to the vaccine roll out and distribution world-wide. Their solution is a proposed temporary waiver on the holders of patent rights to COVID-19 vaccine patents on the basis that such a waiver would result in an immediate speeding up of the vaccine roll out.

There are two fundamental problems with their proposal:
First, the problem is one of global manufacturing capabilities, not patent rights. There is quite simply a shortage of biopharmaceutical manufacturing facilities and skills worldwide. We know that because, for the past 20 years, PharmaVentures has been helping companies sell and find such manufacturing facilities; there are simply very few around, largely due to the significant rise in the demand for biopharmaceutical products. So, to simply build new ones, owned and run by those lacking the skills, would take many years and therefore would not be the immediate short-term solution to vaccine production and roll out. Even if these manufacturing facilities were abundant, and there was a patent waiver, or a non-exclusive royalty-free license given to third parties, the skills and know-how to manufacture these new vaccines are simply not easily transferable in the short-term. Even those who possess all the patent rights and have all the necessary skills and know-how to manufacture are struggling to manufacture optimally against demand. The best solution, in my opinion, would be for governments of all nations, maybe through COVAX, to provide financial support to existing manufacturers to improve, optimise and expand their manufacturing facilities in return for their vaccines to be supplied at lower cost. Furthermore, those countries that have a demand for vaccine, and are seeking a higher supply of vaccine, should focus on the complex logistics of the vaccine roll out so that every village and hamlet in their country is vaccinated rapidly.

Second, waiving patent rights interferes with the most important driver for innovation in medicine. Readers of Termsheet already know that patents provide confidence for investors that their risk in investing in new technologies will be rewarded through short-term market exclusivity. To put future uncertainty on the strength of patents through future government interference would undermine that confidence and weaken our ability to find future therapies for debilitating diseases.

Another successful divestment by PharmaVentures

OXFORD, UK, May 29th, 2015.

PharmaVentures is pleased to announce that it has acted as advisor to one of the top US pharmaceutical companies in its divestment of one of its manufacturing facilities to a US contract manufacturer. The divestment, completed in mid-May, has led to the protection of hundreds of jobs.

This divestment follows PharmaVentures continued success in M&A including the executing of multiple divestments for several of the largest pharmaceutical companies in the world.

Fintan Walton, CEO, PharmaVentures, commented: “Once again we are delighted to have delivered a successful and valuable outcome for our client and in the process secured hundreds of jobs.”

Nigel Borshell, VP, PharmaVentures, who was lead advisor added: “Our network of interested players in contract manufacturing and R&D plus our rigorous sale process has yet again delivered a positive outcome for our client”.

Over the past 23 years, PharmaVentures has acted as advisor to over 700 global pharmaceutical and biotechnology clients in transactions covering licensing, merger, acquisition, divestment and joint venture activities for companies.

– ends –

About PharmaVentures, Ltd

PharmaVentures is a premier transaction advisory firm; a world leader in partnering, M&A deals and strategic alliances. For the past 23 years, PharmaVentures has acted as advisor on over 700 deal related projects covering licensing, mergers, acquisitions, divestments and joint venture activities for companies world-wide.

Their unrivalled bank of specialist experience, deal analytics and network of contacts among innovators and large pharma makes them uniquely placed to support your business in all aspects of deal making and strategic planning. PharmaVentures is well known for its deep insight into deal structures and its success for generating partnering interest.

Find out more www.pharmaventures.com

Their services include:

  • M&A (divestments, mergers, acquisitions and strategic transactions)
  • Strategy (commercialisation, deal strategy, due diligence, market entry)
  • Valuation and Positioning (licensing, M&A, fund raising & expert testimonies)
  • Licensing (in and out licensing)
  • Expert Testimony (patent infringement, deal disagreements, taxation, determining damages)

Now entering its 24th year, PharmaVentures is based in Oxford, UK, and employs 20 professionals and has associates in North America, Europe, Latin America and Asia-Pacific.

FOR FURTHER INFORMATION, CONTACT:

Dr Fintan Walton

Chief Executive

PharmaVentures Ltd

+44 1865 332700

enquiries@pharmaventures.com

PharmaVentures Advises ESTEVE in Its pharma licensing Deal for E-58425, a New Therapeutic Product for Pain

Pharma licensing agreement OXFORD, UK, January 13th, 2015

PharmaVentures is pleased to announce that it has acted as advisor to ESTEVE in their successful license agreement with MundiPharma Laboratories GmbH for E-58425, a first in class NSAID/Opioid API-API co-crystal for the treatment of pain.

ESTEVE is a privately-held pharmaceutical and chemical group that focuses on innovation and excellence in health.  In a Phase II clinical study in post-operative pain, E-58425 demonstrated significant superior efficacy and safety compared to a standard of care.

Adrian Dawkes, Vice President, PharmaVentures Ltd. who was lead advisor to ESTEVE commented: “We are delighted to have worked with ESTEVE in partnering E-58425 which represents a great step forward in the pain sector.”

Fintan Walton, Chief Executive, PharmaVentures, Ltd added: “We continue to be recognised as a strong leader in healthcare deal making and this adds to a growing list of our recent successes”.

For the past 23 years, PharmaVentures has acted as advisor to over 600 global pharmaceutical and biotechnology clients in transactions; covering licensing, mergers, acquisitions, divestments and joint venture activities for companies.

PharmaVentures becomes latest Partner of One Nucleus

Oxford, UK, January 12th 2015

PharmaVentures has become the latest Partner to join forces with One Nucleus. Both PharmaVentures and One Nucleus are committed to playing an active and supportive role in assisting in the success of the life sciences sector nationally and internationally. 

The One Nucleus mission is to help enable its member companies to be globally competitive. A key element of supporting their members in achieving such competitiveness is enabling access to first class commercial intelligence and corporate advisory services. Such support provides businesses with the best possible opportunity to develop timely and effective strategies for success. PharmaVentures, together with their PharmaTelevision business, will make their services at specially reduced rates to One Nucleus members.

Fintan Walton, CEO of PharmaVentures explained, “We are delighted to be working with One Nucleus in support of their membership. The support we can make available through our corporate advisory services and PharmaTelevision will make the difference to their partnering and development strategies”.

Harriet Fear, CEO of One Nucleus said, “Our Partner Programme is a bespoke package of support and collaboration between One Nucleus and larger organisations who are central to the success of the sector. We are very excited that PharmaVentures has become a One Nucleus Partner and is involved in a range of our activities including ON Helix – our major Cambridge based translational research conference we host annually, our Life Science Leadership Series and the Ask One Nucleus online Dashboard”.

About One Nucleus

One Nucleus is an international membership organisation for life science and healthcare companies. We are based in Cambridge with the majority of our members across the Cambridge/London corridor – at the heart of Europe’s largest life science and healthcare cluster.

Organisation History

Established in 1997, One Nucleus is a not-for-profit membership organisation located in Cambridge. We have over 470 organisations as members, including pharmaceutical, biotech, medical device and diagnostic companies and associated technical and commercial service providers.

One Nucleus’ mission is to maximise the global competitiveness of our members.  For our science and technology-based members, that means them being global leaders in the research, development and commercialisation of healthcare innovations that radically improve the quality of people’s lives around the world. For our business and professional services members, it means them delivering exceptional services that significantly enhance the business performance of their clients.

For further information, contact:

Tony Jones, Director of Business Development

Email: tony@onenucleus.com

Tel: +44 (0)1223 896450

Web:  www.onenucleus.com

Pfizer/AZ: The bigger issue is not M&A but how in the future we find effective medicines

The debate and discussions in the media on the attempted bid by Pfizer for AstraZeneca (AZ) have largely revolved around the short term impact on jobs in the UK as well as the rights of shareholders and how corporations exploit tax loop holes.

The real question is how we as a society can actually find the drugs that are desperately needed for many incurable diseases? The Pfizer bid for AZ is only a symptom [no pun intended] of the continuous reconfiguring and restructuring of how pharmaceutical R&D can be performed so that we can efficiently find these cures.

How drugs are selected and finally make it to market is determined, quite correctly, through the scrutiny of the regulatory authorities such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). There is an inherent risk in taking a drug through clinical trials and less that 10% of drugs entering human clinical trials will make it to the patient. So how can companies reduce this risk and increase the chances of success?

Pharmaceutical companies have been grappling with the ‘how’ for the past two decades. Further more in recent years the landscape has been changing, for example, the regulatory hurdles, quite correctly, have been raised so the chances of finding the ‘right’ drug are lower and so more difficult. Both the pricing and reimbursement (P&R) of drugs place additional hurdles and additional risk on whether drug actually gets to the patient. In the UK P&R is regulated through the UK’s Department of Health via the Pharmaceutical Price Regulation Scheme (PPRS) and the National Institutes of Care Excellence (NICE) respectively. This changed landscape has meant that pharmaceutical companies have had to rethink how they do research. The concept of large companies doing all their own drug research has been on the wane for years. Great ideas cannot emerge in one place they happen everywhere and there is evidence that smaller R&D groups are more productive than large ones. As such pharmaceutical companies have become more dependent on external R&D provided by universities, charities and venture capital backed biotechnology (biotech) companies. Moreover, pharma companies have been refocusing their efforts to a smaller group of therapeutic areas with the greatest unmet clinical need. For the past five years all major pharmaceutical companies have been reducing their internal R&D efforts and this, by the way, independent of the world economy.

Furthermore pharmaceutical companies have been moving their R&D activities to locations with the highest research skills, these include Cambridge, Mass, and Cambridge, England. This has meant moving away from ‘remote’ R&D sites which originated as manufacturing sites, such as AstraZeneca closing its Cheshire, Alderley Park site and moving to Cambridge and Pfizer moving away from Sandwich in Kent. Most of the large pharmaceutical companies have done similar moves.

This changed landscape means that pharmaceutical companies have had to raise the scrutiny of their existing drug candidates and abandon more of them. To replace them they need to either find more candidates from biotechs or acquire them through acquisitions like Pfizer’s bid for AZ or through deals such as Novartis acquiring GSK’s oncology franchise.

In the end a key driver is a focus on building the strongest product pipeline. Simply put companies can strengthen their pipeline through acquisition by keeping the best of the combined businesses and spinning out or axing the weaker candidates.  Regardless of whether Pfizer acquires AZ or not, the change in ‘how’ R&D is done will lead to further rationalisation of R&D and a greater role for biotech to be the key innovators and, as such, we should see a further rise in M&A as well as licensing and partnerships.