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larryhbern:

State of pharmaceutical development

Originally posted on New Drug Approvals:

More than 700 follow-on biologic therapies are currently in development, and they are expected to account for around a quarter of the $100 billion-worth of sales stemming from off-patent biologic drugs by the end of this decade, according to new research.

read at

http://www.pharmatimes.com/Article/14-09-30/Over_700_biosimilars_now_in_development_worldwide_report.aspx

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14:00PM – 10/1/2014: Conference Workshop “Conundrums and Conflicts in Licensing & M&A Deals” @14th Global Partnering & Biotech Investment, Congress Center Basel – SACHS Associates, London

Real Time Media Conference Coverage  –  Business and Scientific Channels: Aviva Lev-Ari, PhD, RN @ https://pharmaceuticalintelligence.com

14:00PM  “Conundrums and Conflicts in Licensing & M&A Deals” – An interactive workshop considering ethical dilemmas and challenges in biopharmaceutical deal making

Workshop facilitators: 

  • Nigel Borshell, VP,
  • Fintan Walton, Chief Executive, PharmaVentures Ltd

Four groups of three executive are participating at the Workshop on M&A, One member will act as CEO and present the Scenario and the solution

Five different M&A Scenarios will be presented

  • TRANSPARENCY – trust
  • M&A – Consultancy agreement was rejected
  • Licensing a Medical Device permanently in-dwelling – Lifetime revenue per patient $600,000 – licensor proposes cut in royalties and fees for service
  • Licensee is locked in a crippling 40% on royalties

Case #1:

TRANSPARENCY – trust

M&A – Consultancy agreement was rejected

Licensing a Medical Device permanently in-dwelling – Lifetime revenue per patient $600,000 – licensor proposes cut in royalties and fees for service – Two parties need to solve

Licensee is locked in a crippling 40% on royalties – Royalties to be renegotiated

Gross sales – not the value added TAX, TAXES ASSESSED ON INCOME DERIVED FROM SALES – AGREEMENT OVER A PERIOD OF TIME TO BE ACHIEVED

Case #2:

TRANSPARENCY – a case of financial exhaustion of funding, transparency is very important

M&A – continue negotiation to pay less

Licensing a Medical Device permanently in-dwelling – Lifetime revenue per patient $600,000 – licensor proposes cut in royalties and fees for service – who own the device? sharing is the solution

Licensee is locked in a crippling 40% on royalties – Incentive for 40% is basis to secure debt

Gross sales – not the value added TAX, TAXES ASSESSED ON INCOME DERIVED FROM SALES – TRANSPARENCY NEEDED

Case #3:

Partnership consideration

M&A – continue with 5% minority shareholder, do accept the consultancy

Licensing a Medical Device permanently in-dwelling – Lifetime revenue per patient $600,000 – licensor proposes cut in royalties and fees for service – if a contract in place on device use — is their a monopoly?

Licensee is locked in a crippling 40% on royalties – Licensee, Board and Originator – try to advance the state to Phase III

Gross sales – not the value added TAX, TAXES ASSESSED ON INCOME DERIVED FROM SALES – CONSISTENCY with business practices – change agreement

Case #4:

not an easy answer, continue with the second proposition of increasing the investment to $50Million

Licensing a Medical Device permanently in-dwelling – Lifetime revenue per patient $600,000 – licensor proposes cut in royalties and fees for service – contractual obligation, while one party request change – split the gap, giant Pharma should not change contract

Licensee is locked in a crippling 40% on royalties – negotiate with originator, fall back position to be sought – option deal

obtained

Gross sales – not the value added TAX, TAXES ASSESSED ON INCOME DERIVED FROM SALES – New agreement to increase royalties

Moderator: was it a mistake  – NOT TO TAKE VAT WHEN 99% OF CONTRACTS REQUIRES VAT, no pay of royalties of VAT

time limit beyond 2 years in royalties

#startup#biotech

#venturecapital

#mergers

#bioethics

#pharmanews

@SachsAssociates@pharma_BI

@BiotechNews


Originally posted on Orphan Druganaut Blog:

Updated07/01/14for Breakthrough Therapy #45.  07/07/14for Breakthrough Therapy #46.  07/16/14for Breakthrough Therapy #47.  07/17/14for Breakthrough Therapy #48.  07/21/14for Breakthrough Therapy #49.  09/02/14for Breakthrough Therapy #50.  09/16/14for Breakthrough Therapy #51.

51 FDA Breakthrough Therapy Designations

The 51 Breakthrough Therapy Designations granted for drugs that have been identified by the sponsor companies (as of 09/16/14) are as follows:

Num Drug Name Sponsor Company Indication
1 Daratumumab Genmab/Janssen Multiple

Myeloma

(MM)

2 Ibrutinib Pharmacyclics Relapsed Or

Refractory

Mantle

Cell

Lymphoma (MCL)

3 Ibrutinib Pharmacyclics Waldenstroms

Macroglobulinemia

4 Ibrutinib Pharmacyclics Chronic or Small

Lymphocytic

Leukemia

(CLL/SLL)

5 Kalydeco Vertex                                                                                       Pharmaceuticals Cystic Fibrosis
6 Kalydeco + Lumacaftor (VX-809) Vertex    …

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12:30AM – 10/1/2014: Company Presentations @14th Global Partnering & Biotech Investment, Congress Center Basel – SACHS Associates, London

Real Time Media Conference Coverage  –  Business and Scientific Channels: Aviva Lev-Ari, PhD, RN @ https://pharmaceuticalintelligence.com

Early Stage Investment

  • Hakan Goker, Director MS Ventures

- Participation of Corporate creation: 48% of new corp creation in Europe is via VCs

- early stage investment – Entrepreneur

- Serial Investors – what is the valuation process

- large institutions – where are the good fits, challenges in early stage funding?

- early stage involve understanding very complicated Science, acquisition in Pharma – Mechanism effect on Disease in the  past

- in the present public pressure on big Pharma in a therapeutics area – leverage focused R&D via a lower cost investment is done externally

- cash is available

- Pharma Ventures invest NOT in what VCs invests

- BIOTECH is the faster and cheaper pharma

- If financial are sufficient is taking additional external financing smart to do? – Mix sources of finance — are not successful since the 2009. On the venture side it did not apply.

- In Europe companies do get valuation like in the US sometime

  • David Sabow: Head of Life Sciences, Silicon Valley Bank

- trend in Europe

- Super Angels

- Venture Debt – is never welcomed, what are the drivers a reaction to later stage pipeline, or R&D

- Capital is available – concerns: Competitive insight

- increasing value is the name of the game any method works, mix financing source is included

Panelists:

  • Bernd Goergen

- Life sciences engage Super Angels, trend declined corporate

- comparison in financing Europe vs US/UK on information asymmetry

- VCs feel better if a corporate investor is involved

- without European investor hard to get US money

  • Frank Kalkbrenner

- Boston, SF easier to get Early stage investment

- Europe, mainland – Corporate venture funds are active in Netherlands and Germany

- Venture arms of Pharma involved in early stage

- UK and Boston fund are very LOCAL in proximity, no investment is more than 100 miles away

- no shortage of opportunities in Europe, some investments overseas, In UK, In US — so missing in Germany – less experience in commercial negotiation with Universities, Scientific base, Money, People – success requires Professional management — is not abundant in Europe vs UK, US – different cunture in Europe, CEO who failed in Europe is doom, in the US is hard

- 100% of all products and Phase IIa is from internal research, Gene therapy, cant cover internally, investing in external venture gives access to innovation not to be provided inside

- access external innovation, equity investment is one tool, Early investment to become an equity relations

- Big Pharma Venture Arm is a strategic instrument rather than an ROI strategy

- two corporate ventures, two institutional ventures

- later stage development requires ofter institutional investment

- time is money, get additional financing to get to market as soon as you can, even if you are able to finance operations

-

  • Soren Moller

- difficult market for early investment

- shareholder in Scandinavia: Private investment can be a hurdle

  • Ulf Grawunder, CEO, NBE Therapeutics, GmbH

- difficult to fund Early stage concepts

- Conventional VCs: funding by VCs are worry of the long tern to ROI – ten years on average – pay to Limited Partners

- Private VCs that reinvest in ventures may consider Early Stage

-  Seeking government grants, non diluted, Patents from Universities, Team up with Academic institution to help in value creation, for proof of concept,

- compelling data, academic collaboration, IP protection

- corporate structure need to allow all types of investments: Partners requires equity for very small investment in Switzerland – non dilutive is very important

- partnering to early on requires sharing equity to early

- Option of first refusal not a strategy

- GSK – no interference with pipeline

- Entrepreneur has concern of IP in due diligence  – internal to Pharma research input on external is important

Questions from the Audience

- asset financing vs VCs

- differential valuation

#biotech#startup

#investing

#venturecapital

#pharmanews

@SachsAssociates@pharma_BI

@BiotechNews


11:00AM – 10/1/2014: Scientific Collaborations  @14th Global Partnering & Biotech Investment, Congress Center Basel – SACHS Associates, London

Real Time Media Conference Coverage  –  Business and Scientific Channels: Aviva Lev-Ari, PhD, RN @ https://pharmaceuticalintelligence.com

11:00AM – 10/1/2014: Scientific Collaborations

Introductory Speech by: 

  • Ora Dar, Head of Life Sciences Sector, Office of the Chief Scientist, Ministry of Economy, Israel – $70M gov. Budget

- IT is shared and used in collaboration

- Eight companies – 2 stem cells, Virtual Biopsy, Endoscopy

- 25% is from Academia rest from Industry

- Brain stimulation and Monitoring Technologies

- Synergies: with Roche; Pontifax

- collaboration announced 2009: new companies: BioVent, Quiet Therapeutics, cCAM

- Biotechnology Incubator – Government sponsored

– Advanced applied Research: Leveraging cultures of Innovations and Entrepreneurship

- Fund announced 4/2011 OrbiMed – $222M 4.5x Leverage Gov. commitment by OrbiMed

- PPPP – Public, Private, Philanthropy

Adaption to Change is critical not the smartest will survive

  • Chaired by: 

Beth Jacobs, Managing Partner, Excellentia Global Partners

- complicated approaches of Scientific Collaborations

- Building Trust is it difficult?

- Tech transfer is having a bad rap

- Pharma tried avenues for efficiencies, Scientists in BIOTECH many are from Pharma, now their inventions go back to Pharma

Panelists: 

  • Ora Dar, Head of Life Sciences Sector, Office of the Chief Scientist, Ministry of Economy, Israel – $70M gov. Budget

- all gov. funding must by in conjunction with Private investment and commercialization ideas

- small companies needs IP to raise funding. University owns and license it to investors collaborations is in place

- Weitzman institute: antibodies platform, $17Billion sales

  • Chris Maggos, Consultant, Business Development, Alpine Institute for Drug Discovery – Not for profit

- Platform development in Academia is allowing the University to maintain equity on Projects, Oversight from Pharma is important for the know how of the industrial process

- Trust will appear quickly after relationships are established

- Tech Transfer has a role to serve the Public, Europe Universities different than US Universities

  • Edwin Constable, Head of Research, Professor of Chemistry at the University of Basel and Project leader and Member of the Management Board within the SNI, University of Basel

- Universities have different  responsibilities, public who fund Universities,juggle basic research and considering Pipeline of molecules, as a University the public good is different than a compound in a big Pharma, IP of university need be protected, identify drugs, collaborate with Hospitals for Clinical Trials

- IP need belong to the University but maintaining the IP and Protecting it may not be sensible.

- Primary PI has an idealist view of the World

- Universities need a new culture of entrepreneurship, failure in Academia is dreadful, not in Industry, risk taking need augmentations in Universities

- PPPP – three partners: Philanthropy – Gov. Axis is interesting

- disappointment – the role benefit for the Patient, drug distribution need be in place

- Translational model is the only proven others are correct and incorrect at the same time

- Monetizing IP:

- Translational Industry is in transition, where is it going?

  • Florian Schoedel, MD, PhD, Owner, PhilImmune, LLC ex-Merck

- collaborations: Gov. and Biotech – start up can reach maturity. de-bridging goals, product concept in Biotech, if Gov. funding ends, no continuation of the idea pipeline

- translation of research, big Foundations, i.e., Gates Foundation, found the right way to fund research and commercialize drugs as vaccine and deploy at needy markets in underdeveloped countries

- PI needs often a change of mind, steps they do not know, Chem Engineering vs Chemistry major, i.e,

- Research dept inside Pharma changed very much, cheaper innovations from Academia and from Biotech – efficiencies are needed

  • Maina Bhaman, Director, Healthcare Ventures, Imperial Innovations – Publicly listed

- Commercialization process and collaboration requires alignment, upfront time investment

- Transfer of IP, business that develop the molecule, then too much emphasis is placed on early IP

- Agrees, trust building is not easy

-

  • Prem Das, Chief Research Business Development Officer and heads DFCI’s Office of Research and Technology Ventures (ORTV), Dana-Farber Cancer Institute (DFCI)

- Bio marker driven, cost consideration

- Diagnostics in Cancer – DGCI – is in competition with Foundations in the DIagnostics

- Infrastructure to develop the chemistry platform

- Gov funded research IP is owned by the Institution not by the Gov.

- Early stage IP: non-exclusive licensing

- Trust between the investigator and the commercializing entity, change attitude of PI needed, to make it work, the Scientists who is on a Journey

- gap exists in Academic mind vs industry

- R&D centers run by Scientists, Office of Innovation go to Scientists for solutions

QUESTION fro the audience

- Failure in Drug Development, why?

#startup#science#Collaboration

#biotech

#innovation

#pharmanews

@SachsAssociates@pharma_BI@BloombergTV

@BloombergNews

@BiotechNews

 

 

10:00AM – 10/1/2014: Partnering II @14th Global Partnering & Biotech Investment, Congress Center Basel – SACHS Associates, London

 

Real Time Media Conference Coverage  –  Business and Scientific Channels: Aviva Lev-Ari, PhD, RN @ https://pharmaceuticalintelligence.com

 

 

Co-Chaired by: 

  • Fintan Walton, CEO and Founder, PharmaVentures

- is it more expensive to auction?

- secrative negotiation, if successful, structure deal and terms to following – dynamics with uncertainty

  • Stephanie Leousson, Principal, Torreya Partners

Panel is asked describe investment strategies

- new strategies: geographic, going public

- past: equity in IPO, at present long tern relations to offset costs, as the price will go up

10:00AM Partnering II – Deal Making: The Evolving Landscape of Deal Terms

  • Carlos de Souza, Chief Business Officer, to-BBB

- Name chance to BBB Therapeutics, based in Netherland, BRAIN products, tumors, neural degeneration and MS.

- License or go to Public market

- partner need to bring a significant value, develop product in co-development – an alternative

- what type of deals will bering the recognition of value via selection of compaounds, win-win, cooperation and keeping the product in the pipelin

- small biotech clinical compounds and some pre-clinical: Plans to go to public market, requires years of preparation per schedule

  • Corina Savill, Head BD&L Novartis Pharma AG

- trends: 7Billion in Acquisition, deals, BIOTECH high valuation in last two years, Private market has higher pricing

- Public Market Choices: acquisition by Big Pharma via IPO and then do a deal, Avista, geographic deal, win-win, Alphatech MAD,

- Auctioneering since 2006 and continue to do such deals, Israeli Gene company – Auctioneer, proportion equiyt, company reach the level that transplant and acquision will follow. Expensive technology to develop, take Equity position in the company using auctions allowing to materialize an acquisition CONDITIONED that the technology matures per plan, maturation involve continual innovation

- Aid in Dialysis had success with IPO, no auction, An osteoporosis company – decision not to pursue OP then invest took place no further integration Plans,

- Companies running Corporate investment portfolios: allowing collaboration, numeration drives to the sky,

- licensing becomes harder than in the past, due to availability of alternative avenues for investment

- Cash value is an opportunity, acquisition need to help the company investing

- In a geographic licensing it will become an acquisition target, PERIOD needed to absorb the positioning

  • Lubor Gaal, Head of Europe Search & evaluation, Business Development BMS

- VCs some are very small following 2009, Deal to buy rather than integrate with development, staging acquision vs development of start ups — NEW landscape, late payment for VCs,

- both exist – Auctions of private companies

- first decision on Science then on Financials

- licensing and relationship:  right ot compound given, the reason to acquire a company for additional value

- companies flourish NOT in the original plan they were created

  • Luca Bolliger, VP and Group Licensing Director, RECORDATI S.A.

- In the 90s activity started, at present in 19 countries, integration PrimaryCare pursued by acquisition, move from PrimaryCare to become Global, risk profile across territories

- deals are not novelties, Upfront vs Royalties — not available to all companies, if you are not first in class less opportunity pools

  •  Philippe Lopes-Fernandes, Global Business Development, Merck Serono

- Outsourcing more that fully integration, NEW landscape smart decision are a must, sell alter is different than in the past — NO one can find the next Amgen

- Europe is the focus:

  •  Stuart Kay, Director Transactions, GlaxoSmithKline

- Access a network of connections, Source from Academia, run and manage is attractive, if not acquired, access to innovation can be yet maintained,

  •  QUESTION FROM THE AUDIENCE: Auction and Tax inversion any relations?
  • no
#startup#science#partnerships#biotech

#venturecapital

#pharmanews

 

@SachsAssociates@pharma_BI@BiotechNews

 

 


9:ooAM – 10/1/2014: Partnering I @14th Global Partnering & Biotech Investment, Congress Center Basel – SACHS Associates, London

 

Real Time Media Conference Coverage  –  Business and Scientific Channels: Aviva Lev-Ari, PhD, RN @ https://pharmaceuticalintelligence.com

 

 

Co-Chaired by: 

 

  • Fintan Walton, CEO and Founder, PharmaVentures

- Strategies and Tactics

 

  • Stephanie Leouzon, Principal, Torreya Partners

 

Panelists Partnering I: 

 

  • Andrew Mackie, Global External R&D, Eli Lilly and Company

- Innovations with researches, series of molecule, prescreening, if interesting found, licensing agreement, engagement on Chemistry

- technology may be too early for the company, 20% funding from fund, advice as well as advice on coumpound of interest at the company

- pathways for selection, pipeline

- Pre clinical innovation – integration of Molecule the study is done.

- process id length, negotiation takes years

  • Jason Coloma, Global Head Venture & Innovation at Roche Partnering, F. Hoffmannn La Roche

- Oncology is Prime, structural include Genetech, contributes on Research, Access a and speed, business development in therapeutics. Venture Innovation is discovering pipeline, crossroad, partnership with VC, diversify biology, VC and non investment in area unless internal capabilities are existing,

- Which approach you are more proud of: early stage innovation, BIOTECH & VC, partnerships, value from working with Academics, Story of Scientist and building the relations takes time

  • Johan Verbeeck, Senior Director Alliance Management, J&J Innovation Center, Janssen Pharmaceutical of J&J

- Diagnostics, Pharmaceutical, growth from acquisition, 54% of pipeline are from external. Access to assets among big Pharma

- SF, Shanghai, Boston,

- presence and responsiveness and why the deal is not right

- Government and internal R&D are very important, internal R&D involves making calls on new directions

- North America is different that Europe, great good science in Europe, no risk taking. In USA, Kendall Square — risk is been taken 5 start ups over night.

- Question from the Floor: Scouts in Europe working on J&J Innovations from Spain to 8 countries in Europe,

- Satellite in Israel and in Moscow

- there are institutes for Drug Discoveries – collaboration with Pharma

- 25% from Academia, 50% partnership with industry  San Diego is a Hub

- Signing deals series of approval, university has funds and Pharma provide funds

- Some scientists can’t answer questions from Pharma

  • Frank Grams, VP, Head R&D Alliance Management & Contracting, Sanofi

- Sonafi more than 300 acquisitions, different company at present, process of integration, alliance with other industry and study from other Pharma, selling the opportunity in house, all Pharmaceutical in Sanofi: Diabetes, CVD, Opthalmonogy, OTC, Generic,

- Diabetes focus with therapeutics areas,investment in early stage all spectrum, academic alliance, pipeline, external sources, highly dependent on external world

- constant improvement

- right people to delegate, scouts, lawyer, communication – How do you create links to R&D? Structure organizational to allow for buyout.

- 80 and more collaborations, agreement with Academia in the US – outocme was almost zero, at present academic alliances must fit with strategy of Sanofi, look at it as a portfolio, getting out must be an option

  • Paola Casarosa, Corp. Vice President of Therapeutic Alliances and astrategic Partnerships, Boehringer Ingelheim

- CNS, Oncology, Immunology – How the portfolio looks and How to achieve,

- Internal vs. External — not invented here — not acceptable, integration of internal and external is in implementation, Fundamental in scouting, engagement with academia, BD acts Globally Boston, CHina, Japan, Deals – early partnering is very important to reach agreement early on

- colliding new target concepts, major effort on scouting in Academia, they are interested in external relation, No IP driven compound, but idea with innovation solution, investing in opportunities allowing foot in the door as first mover advantage

- depression, circuits of Brain — innovation

- people level very important

- Alliance reporting to R&D  – growing wiht project, supporter of this integration

- Japan support of Academia and Industry at the national level

  • Tomas Landh, Director, Strategy and Innovation Sourcing, Novo Nordisk

- new perspective on Diabetes and Obesity, Retinopathie, Hemopealia, Growth Disorder, advice on early stage research, establish repationship with PI and where PI, postdocs are moving. 60% Innovations in DIabetes from the US, face to face meeting, scientific Forums

- Integration with R&D Obesity as a complication of Diabetes, gate relations, Academia sees Pharma as friend, entrepreneurship from Academia — new direction – this is the successful adoptation

 

#startup#science#partnerships#biotech#pharmanews#venturecapital

 

@SachsAssociates@pharma_BI@BiotechNews

 

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