Pullan Consulting

Biotech Business Development Consulting

www.pullanconsulting.com and www.lindapullan.com

email:  lpullan@msn.com  805-558-0361

Issue #36, June 2009

Pullan's Pieces

Commentary on Science & Business of Drug Development

Patent Expiration in Major Pharmas

There are billions of sales in products about to have patent expirations (Burrill, State of Industry Report).   All these products need to be replaced for company growth.  So who needs the most products to replace patent losses?  Pfizer (with Wyeth) has 6 products expiring in 2009 thru 2012, and Sanofi-Aventis and GSK each have 5.  Merck (with Schering-Plough) only has 2 despite its pharmaceuticals sales in 2^nd place behind Pfizer (with Wyeth).  AstraZeneca only has 1 despite being in the top 10 for sales.   

For the smaller companies, loss of a single product can be devastating.  Reckitt-Benckiser’s Suboxone was $528 million of the companies total of $2.3B in sales in 2008.  Other companies not in the top 10 in sales facing a major patent expiration include Abbott, Amgen, Astellas, Boehringer Ingelheim, Cephalon, Eisai, Forest Labs, NovoNordisk, Nycomed, Shire, Takeda and UCB. 

Interestingly, 12 of the 33 compounds listed in the table are in CNS, with CV/Blood products second in number with 6.  Late stage CNS compounds should be in high demand. 

Sales and Patent Expiration Dates from:  Kenneth Kaitin, Burrill State of Industry Report,  Companies and indications from Evaluate Pharma. 

_____________________________________________

Johnson & Johnson Pharmaceuticals partnering profile

___________________________________________

J&J Overview

J&J is a diversified conglomerate of 119,000 employees, $63.7B in sales, and over 250 subsidiary companies, with pharmaceuticals, diagnostics, devices and consumer health products.  Its sales are in the top 10 for pharmaceuticals, with $23.5B in prescription drug sales in 2008.   Its biggest products in 2008 were Remicade (anti-TNF for RA, and currently subject of dispute as to whether the Merck Schering-Plough merger means the change of control provisions would return rights to J&J), Topamax (for epilepsy, with its patent expiring in 2009), Procrit/Eprex (for anemia licensed many years ago from Amgen), Risperdal (for schizophrenia) and Levaquin (for infection, with a patent expiry of 2011).   In 2014, Velcade (for cancer) and Xarelto (anti-clotting drug, now subject to a “complete response” letter from the FDA asking for more data) are expected to replace Topamax and Levaquin.  J&J has had 6 NMEs approved in major markets since the beginning of 2008. 

J&J R&D Structure

J&J has 6 compounds in registration or pre-registration, 12 in phase III, 18 in phase II, and 11 in phase I, and spends 21% of sales on pharmaceutical R&D (Evaluate Pharma).  It is in both small molecules and biologics. 

Within pharmaceuticals are six R&D companies with semi-independent sites and somewhat different focuses, 

1.  Johnson & Johnson Pharmaceutical Research & Development, small molecules;

2.  Centocor, biologics;  

3.  ALZA, for drug delivery technologies;

4.  Tibotec, anti-virals;

5.  3-Dimensional Pharmaceuticals, drug discovery capabilities; and  

6.  Scios, oral protein-based compounds.  

Across these companies, J&J shares preclinical development and manufacturing, and manages each of the 5 therapeutic areas “end to end”, from discovery to life cycle management.  Therapeutic areas are:

·         Neuroscience (schizophrenia, epilepsy, pain, cognition and dementia),

·         Cardiovascular and metabolism (heart disease, diabetes and obesity),

·         Infectious diseases (HIV long-acting formulations, HCV, multi-drug resistance in antibacterials and antivirals),

·         Immunology (small and large molecules, and pulmonary diseases), and

·         Oncology (tumor microenvironment).  (from J&J’s Pharma Review, available from their website)

J&J Acquisitions

In the last 12 months, J&J acquired Cougar Biotechnology (with its prostate cancer drug in two Phase III trials) for $970 million in cash, and Omrix with a thrombin topical and a fibrin sealant as approved hemostats for $438 million in cash.  J&J also acquired device companies Mentor and SurgRx. 

J&J Alliances and Licenses

J&J has a corporate BD group with contacts for each therapeutic area to direct potential partners to the right people within its complex structure.  J&J also has a Corporate Office of Science and Technology for academic collaborations.  There is a ventures arm, the J&J Development Corporation. 

Sheri McCoy, Chairman of the Pharmaceuticals Group, at the recent Pharma Review said that J&J was open to collaborations with large rivals if the commercial opportunity was big enough and a partnership would make a significant scientific difference.  She also said J&J would consider participating in a consortium of companies collaborating on pre-competitive work, such as developing biomarkers for gauging the effectiveness of new medicines.  Indeed, J&J has joined the Enlight Biosciences consortium. 

In the last 12 months, J&J announced several product related deals. 

_______________________________________

How can I help you?  

I offer help with all the aspects of partnering for therapeutics, from shaping a message or a presentation, to making contacts, to evaluation and valuation of product candidates, to negotiations.  I can help with searches of pipeline databases for competition, sizes of clinical trials, or potential partners.  I can help you find deal comparables and help estimate or model deal values.  I have a great list of business development contacts.  You do not need to pay a minimum or a retainer, just use what you need when you need it.  Let’s chat and see if there is a fit.

Pullan Consulting

Linda M. Pullan, Ph.D.

Biotech Business Development

www.pullanconsulting.com and www.lindapullan.com

e-mail: lpullan@msn.com

805-558-0361

 This newsletter is a free service of Pullan Consulting. About 2300 readers, representing VCs, BD and CEOs of biotech and pharma companies, are on the list.  Back issues are on the website www.pullanconsulting.com .  Please add the email to your safe sender list to avoid it being treated as junk.  To subscribe or unsubscribe, just send me an email.