Showing posts with label Merck. Show all posts
Showing posts with label Merck. Show all posts

Monday, October 26, 2015

"Blowing up the current paradigm": A preview of BIO Europe


By: Leah Kinthaert

On November 2, Iain Dukes, Senior Vice President of Business Development & Licensing, at Merck will be a panelist for BIO-Europe. On that day, BIO-Europe will partner with the Alliance for Regenerative Medicine (ARM) to showcase some of the most innovative companies in the cell therapy and regenerative medicine space. For a preview, you can watch Dukes at BioPharm America 2015 on a panel with others from Boehringer Ingelheim GmbH and Theraclone here. The discussion focused on how there is still a lot of unmet medical need and how Merck and others are advancing the science of immuno oncology quickly with bold investments.

PD-L1 Positivity and Response – "An emerging controversy is the importance of PD-L1 positivity with respect to response. Mercks' view is that there is a clear relationship between PD-L1 positivity and response." Said Dukes.

Data is still emerging – "When one starts looking at combination therapies, the story gets very complicated." Dukes explained. "Going away from traditional, you develop it per tumor type. Checkpoint inhibitors, other than radiation therapy, are the only treatment paradigm that works in multiple tumor types. It really blows up the current paradigm for how one explores drugs for development in cancer."

Check in on Merck – This panel is a great chance to get a follow up from Dukes on what the last few months have had in store for Merck and how they are leveraging advances in immuno-oncology. Beatrice Gerard of Quintiles will be moderating; other panelists include: Michel Detheux of iTeos, Mohamed Ragab of Bristol-Meyers Squibb and Philippe Lopes-Fernandes of Merck-Serono. This interesting mix of individuals representing big pharma and start-ups was a great discussion generator last year and promises to be very informative for both biotech start-ups looking for guidance and R&D looking to fill gaps and bring in innovation.

About Iain Dukes – Iain has more than 20 years of experience in pharmaceutical research, drug discovery, scientific and technology licensing, start-up company leadership, consultant to numerous biotech and venture capital organizations. Before joining Merck, he served as Vice President of External Research and Development at Amgen where he led the External R&D department in identifying, assessing and transacting scientific external licensing opportunities, as well as potential opportunities for academic collaborations and platform technologies. Previously, Iain was President and CEO of Essentialis Therapeutics, a small start-up company, and before that he served as Vice President, Scientific and Technology Licensing at GlaxoSmithKline, where he built a leading licensing organization. At an earlier point, he was the Head of the Ion Channel Drug Discovery Group, and later Head of Exploratory Development in Metabolic and Urogenital Diseases at GlaxoWellcome. Iain pursued initial research training at the University of Leeds, UK, and received his D.Phil. degree from the University of Oxford where he also received a B.A. in Jurisprudence. He was a post-doctoral fellow in the Department of Physiology at the University of Pennsylvania, while simultaneously completing training at Gray’s Inn, UK in anticipation of being called to the Bar.

You can see the description of the cell therapy and regenerative medicine events on November 2 and 4 here. BIO-Europe will be held in Munich, Germany.



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Friday, September 19, 2014

Merck KGaA to Further Biosimilar Investment

Merck KGaA announced plans today keeping the group on track for its “Fit for 2018” plan for growth and transformation.  Part of those plans include an additional $165 - $190 million investment in biosimilars for 2015.  Ultimately, that exact number is dependent on the outcome of certain Phase I trials that are currently ongoing.  That, of course, is in addition the $128 million the German company has set aside for biosimilars this year.

In addition, the company plans to expand on existing partnerships with India’s Dr. Reddy’s and Brazil’s Bionovis with an in-licensing agreement for a late-stage biosimilar.  Initially, the drug will be intended for smaller, emerging markets.  Between 2015 and 2016, Merck plans to initiate anywhere from two to five Phase III clinical trials. 

The release also noted some internal shuffle within Merck.  Stefan Oschmann has been promoted to deputy CEO and Vice Chairman of the executive board while Belén Garijo will move up to the executive board and head the pharma business. 

The full press release can be found here.

We’ll have more on the latest developments in the biosimilars market at the 15thAnnual Business of Biosimilars meeting. Join us October 20-22 in Boston, MA. Download the agenda to see what’s on tap.
                                                                                                     
SAVE $100.  Register here and use code XP1986BLOG.

Follow us on Twitter: @FutureOfBiopharma & @Biosimilars
Join us on LinkedIn





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Monday, February 17, 2014

BioProcess International: Lean Six Sigma

Our author from today's excerpt is Dr. Stephen C. Taylor, Vice President, Fujifilm Diosynth Biotechnologies 

About 10 years ago as a vice president of Avecia Biologics, I wrote an article for an early issue of BioProcess International looking ahead at likely changes in biomanufacturing (1,2,3). For the best part of the intervening period, Avecia Biologics and Diosynth slugged it out in the marketplace, each trying to grow its contract manufacturing business at the expense of the other. But in a life-altering two-year period between 2009 and 2011, both companies saw their realities and perspectives change:
• Schering Plough acquired Organon, the corporate owner of Diosynth.
• Merck/MSD acquired Avecia Biologics.
• Merck/MSD and Schering Plough merged, bringing Avecia Biologics and Diosynth under the same corporate ownership.
• Fujifilm acquired the two CMO businesses from Merck/MSD, brought them together, and challenged them to operate as a single truly global contract manufacturing organization (CMO).

Thus in April 2011 Fujifilm Diosynth Biotechnologies was born, with the Diosynth name retained to reinforce Fujifilm's long-term commitment to the CMO business. It has been an interesting experience to bring two similar competitors together and get them to operate as one effective business. Faced with the question of how to bring this about, we decided to seek some common denominators. Both businesses had already adopted the “lean six sigma” (LSS) concept as a catalyst for driving business change and improvement, so we had our first point of overlap.

You can view the full article here. BPI will be joining us February 10-12 for IBC's 2nd Annual Flexible Facilities conference taking place this February. To learn more, view our agenda. Register with code FLEX14BLOG and save 20% off of the standard rate.We hope to see you February 24-25 in Berkley, CA!


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Tuesday, October 9, 2012

Merck developing new one dose weekly diabetes drug

Merck is currently in Phase II clinical trials for their drug MK-3102.  This new diabetes fighting drug is unique because when taken once a week, it reduces HbA1c levels blood sugar levels. This was just based on trials with one drug. In Phase III, it will be tested in combination with other drugs to further reduce the blood sugar levels. There is currently only one other drug that can be taken twice a week according to Finance.com. It is not seen as a competitor as it's an injectable drug and targets a different market.

This February, Anders Boss, CSO, Mannkind Corporation will be looking more in-depth at the blood sugar drugs that are coming to the market in the presentation "Breakthroughs in Insulin Pharmacodynamics: The State of the Art and the Shape of the Future" at the first annual Innovation and Commercialization of Therapeutics for Metabolic Disorders.  For more information on this presentation and the rest of the program, download the agenda. If you'd like to join us, register today and mention code XP1803BLOG to save 15% off the standard rate.


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Thursday, October 4, 2012

BioProcess International Spotlight: The Use of Miniaturization and High Throughput Screening for Purification Process Development – A Case Study Comparison of Different Techniques and Formats

Leading up to next week's BioProcess International Conference & Exhibiton, we'll be featuring a few of the speakers who will be joining us.  John Welsh, Ph.D., Senior Research Biochemical Engineer, Merck & Co., Inc's favorite recipe to make is Crock Pot Pulled Pork.  Follow the jump to see his recipe.  At BioProcess International next week,   John will be presenting The Use of Miniaturization and High Throughput Screening for
Purification Process Development – A Case Study Comparison of Different Techniques and Formats on  Wednesday, October 10.

BioProcess International will take place October 8-12 in Providence, Rhode Island.  For more information on this program featuring over 180+ speakers, download the agenda here.  Would you like to join us?  Online registration now is closed, so call our customer service at (800) 390-4078.

Featured Session: The Use of Miniaturization and High Throughput Screening for Purification Process Development – A Case Study Comparison of Different Techniques and Formats (Features Unpublished Case Study Data)
Featured Speaker: John Welsh, Ph.D., Senior Research Biochemical Engineer, Merck & Co., Inc.
About the session: Several different microscale methods are available for high throughput protein purification applications. These methods offer the potential for decreased time and material required for process development. In this study, batch incubations, micropipette tips, and miniature columns were compared with each method evaluated in the context of both platform purification adaptability and fermentation support. Recommendations are provided for the appropriate utilization of each technique.

Follow the jump to see John's Crock Pot Pulled Pork recipe!



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Friday, June 8, 2012

Merck and Dr. Reddy's Laboratories to Develop New Biosimilars


This week, Merck announced they would be partnering up with Dr. Reddy’s Laboratories Ltd. to create new biosimilars, specifically focusing on oncology drugs. With many patents facing expiry soon, the new guidelines for biosimilars will open a brand new market for injectable medications. This will also help reduce the cost of many drugs, making them more accessible and affordable for more patients.   

Both companies will help to develop the molecules and also test the drugs, and Merck will handle most of the manufacturing. Our expertise indeveloping, manufacturing, and commercializing biopharmaceuticals gives us a clear advantage in the biosimilars field, and the partnership with Dr. Reddy's will bring their first-in-market experience in biosimilars, as well as their expertise in generics and Emerging Markets, to the table," added Stefan Oschmann, Chief Executive Officer of Merck Serono.  Dr Reddy’s currently has four biosimilar molecules, with the market for biosimilars constantly expanding, which major pharmaceutical companies will be next? How do you think these new developments will affect the pharmaceutical industry overall?

This September at the Business of Biosimilars and Generic Drugs Summit in Boston, Bassil Dahiyat, President and CEO, XENCOR will be presenting The New Paradigm in Strategic Partnerships for Follow-on Biopharmaceutical Development, where he will look at the trend of Pharma companies partnering with generic companies to produce biosimilars.  For more information on this session and the rest of the event, download the brochure.  As a reader of this blog, register to join us today and mention code XP1786BLOG and save 25% off the standard rate!


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Tuesday, July 26, 2011

PMDD Session Spotlight: Virtual and Global Team Management to Overcome the Distance Hurdle

The 8th Annual Project and Portfolio Management for the Drug and Device Industry, September 20-21st in Boston, Massachusetts, is the only event designed by manufacturers for manufacturers to deliver advanced time saving and silo busting strategies proven to bring drugs and devices to market on time and on budget. Leading up to the event, the Future of Biopharma blog will be spotlighting some of the sessions you can look forward to at the the event.  For more information on the event, download the brochure here.

Featured Session:  Virtual and Global Team Management to Overcome the Distance Hurdle
Featured Speakers:  Debbie Merrill, Senior Project Leader, Project Leadership and Management, MERCK RESEARCH LABS
Michael Stankiewicz, Project Management Director, BAUSCH + LOMB
About the session: Drug development is a global business and clinical trials are being held all over the world. The challenge of managing global clinical trials is exacerbated by time differences, cultural barriers, staffing challenges and regulatory considerations. In this session, attendees receive:
     • Proven tactics to better manage global teams
     • Strategies to overcome challenges with regional companies


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Friday, January 14, 2011

Biorepositories Asia Session Spotlight: Understand and Overcome Global Ethical Concerns to Obtain Approval from Ethics Committee

Leading up to Biorepositories Asia, we'll be highlighting a session from the upcoming conference. It will take place April 11-13, 2011, in San Francisco, California. For more information, download the brochure.

Featured Session: Understand and Overcome Global Ethical Concerns to Obtain Approval from Ethics Committee
Panelists: Rajeev Shrivastava, PhD, Senior Manager, Clinical Research, ELI LILLY AND COMPANY, INDIA

Amelia Wall Warner, PharmD, RPh, Head, Clinical Pharmacogenomics and Clinical Specimen Management Director, Experimental Medicine, MERCK RESEARCH LABORATORIES

Anita Nelsen, Manager, Genetics Sample Acquisition & R&D Human Sample BioRepository, GLAXOSMITHKLINE

Ethical issues and data privacy considerations can be a problematic barrier to global sample collection in Asia. Join this interactive discussion as industry leaders from multiple perspectives share open dialogue on some of the toughest issues surrounding sample management. Legal, regulatory, policy and ethical factors are addressed to help the industry manage patient privacy, while simultaneously pursuing the future potential of biospecimen research.

Discussion addresses how to:
• Manage variation with global ethics committees
• Understand protected health information and data confi dentiality laws and regulations
• Address concerns around collection for unspecific use
• Effectively communicate with global investigators and sites participating in clinical trials



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Wednesday, May 12, 2010

Merck shares what it has in store for this year

Merck recently shared what it is working on for the 2010 year and beyond in terms of the drugs they are developing.

They're looking at five new drugs to enter the market this year:

1. Boceprevir,for hepatitis C
2. Janumet XR (sitagliptin/metformin) and NOMAC/E2 (all USA), which is
a new diabetes combo
3. MK-0431D, for sitagliptin and simvastatin
4. Ridaforolimus, a
sarcoma drug (worldwide)
5. Daptomycin,
injectable antibiotic

Noting the new possible pathway for biologics that healthcare reform has provided, Merck currently has five biosimilars in late stage development.

Read the full story here.




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Wednesday, January 20, 2010

2010 DDP Awards Nominee: Technology Innovation Nominee: Elan Drug Technologies

Elan Drug Technologies’ NanoCrystal® technology is truly one of the most successful drug delivery technology innovations in the past ten years. Designed to overcome issues associated with poor water solubility, ten years since its first filing with the FDA, it has gone on to achieve product in-market sales for clients in excess of $7.8B.

Five products are now launched in over 100 territories worldwide incorporating this technology. Rapamune® (Wyeth) immunosuppressant, which was launched in 2001, eliminated need for refrigeration of tablet product and provided a 23% improvement in bioavailability. Emend® (Merck) was launched in 2003 for the treatment of nausea and vomiting with a 600% improvement in bioavailability, the product was successfully launched in Japan at end of 2009. TriCor® 145, which provided improved bioavailability and minimal food effect, was launched by Abbott in 2004. Megace ES®,, for cachexia in AIDS patients, was launched in 2005 with a 28% improvement in bioavailability, with a free from food effect. In August 2009, the first once- monthly schizophrenic injectable depot formulation, INVEGA® Sustenna™, was launched by Janssen using this technology.

Since 2001, 11 products using our technologies have been launched for our clients in over 100 countries worldwide, making us the most successful drug delivery company in the past decade. We believe more than any other drug delivery company we have developed superior, commercially successful technologies for our clients.

The winners will be announced at an awards ceremony on Tuesday, January 26 at the Drug Delivery Partnerships International Conference.


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Friday, January 8, 2010

Would you like to guest blog from Drug Delivery Partnerships?

That’s right, we’re offering a few exclusive all-access complimentary passes to Drug Delivery Partnerships – January 25-27, 2010 in Orlando, and you could attend the conference – on us ($3,000+ value). We’re looking for experienced bloggers who are well-versed in drug delivery innovation to begin blogging now and also at this year’s event. In return for your posts, you’ll be able to attend educational sessions and training seminars delivered by industry thought-leaders and Pharma professionals through in-depth case studies featuring the industry experts from leading pharmaceutical companies Sanofi Aventis, GlaxoSmithKline, Merck and Company, CIGNA and more.

To apply to be a guest blogger, simply send your name, title, company and a few writing samples (a link to your blog is recommended) to Jennifer Pereira at jpereira@iirusa.com no later than Wednesday, January 13, 2010. We will review the submissions and contact all winners directly with more details. This opportunity doesn’t come often and we encourage you to apply and join us January in Orlando.

For more information about the event, please follow the links below:

For more on the Drug Delivery Partnerships event, visit the website:
http://bit.ly/6chdrj

Download the 2010 Drug Delivery Partnerships Brochure:


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Tuesday, December 8, 2009

Would you like to guest blog from Drug Delivery Partnerships?

That’s right, we’re offering a few exclusive all-access complimentary passes to Drug Delivery Partnerships – January 25-27, 2010 in Orlando, and you could attend the conference – on us ($3,000+ value). We’re looking for experienced bloggers who are well-versed in drug delivery innovation to begin blogging now and also at this year’s event. In return for your posts, you’ll be able to attend educational sessions and training seminars delivered by industry thought-leaders and Pharma professionals through in-depth case studies featuring the industry experts from leading pharmaceutical companies Sanofi Aventis, GlaxoSmithKline, Merck and Company, CIGNA and more.

To apply to be a guest blogger, simply send your name, title, company and a few writing samples (a link to your blog is recommended) to Jennifer Pereira at jpereira@iirusa.com no later than Wednesday, January 13, 2010. We will review the submissions and contact all winners directly with more details. This opportunity doesn’t come often and we encourage you to apply and join us January in Orlando.

For more information about the event, please follow the links below:

For more on the Drug Delivery Partnerships event, visit the website:
http://bit.ly/6chdrj

Download the 2010 Drug Delivery Partnerships Brochure:


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Thursday, October 15, 2009

Merck Extends Galapagos Discovery Deal

According to this article in Fierce Biotech Merck has decided to extend its research collaboration with Galapagos. The agreement earlier this year called for Galapagos to be responsible for the discovery and development of small molecule candidate drugs for atherosclerosis therapies. This extension shows Merck's commitment to fighting both cardiovascular and metabolic diseases. Read the full article here.


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Tuesday, October 13, 2009

Mark McClellan, Carolyn Clancy, and Jim Greenwood to Keynote

Impending legislation coupled with new FDA initiatives, leave many companies wondering what to expect as we head into 2010. Join the Biopharm Regulatory Reform Summit as Steven Kozlowski, MD, Director, Office of Biotechnology Products, FDA discusses the challenges in establishing a regulatory pathway for biosimilars. Quality, patient safety, and efficacy are all primary issues the FDA must focus upon in the review and approvals for these complex biologics. Dr. Kozlowski addresses these issues in addition to comparative effectiveness and factors to consider for drug development plans for products in the pipeline. Bring home regulatory insights to challenges with defining “biosimilars” and their scope, biosimilars’ regulatory pathway, and the latest on comparative effectiveness.

Don’t miss the keynote presentations from Mark McClellan, Senior Fellow, Director of the Engleberg Center for Healthcare Reform, Carolyn Clancy, MD, Director, AHRQ, and Jim Greenwood, CEO, BIO.

Join the Meet and Greet session with Jacquelyn White, Director, Office of Strategic Operations and Regulatory Affairs, CMS

In an era of personalized medicine, IIR’s Biopharm Regulatory Reform Summit provides a unique opportunity to interact with industry thought leaders focusing exclusively on the true downstream effects of reform on how biopharm does business. Join senior leadership for two days to create actionable strategies to respond to reform, protect profitability, and deliver patient driven care for pharmaceutical, biotech and medical device executives.

2009 Faculty Highlights
• Dr. Mark B. McClellan, Senior Fellow, Director of the ENGELBERG CENTER FOR HEALTHCARE REFORM
• Carolyn Clancy, MD, Director, AGENCY FOR HEALTHCARE RESEARCH AND QUALITY (AHRQ)
• Jim Greenwood, CEO, BIOTECHNOLOGY INDUSTRY ORGANIZATION (BIO)
• Joseph Antos, Health Adviser to the Congressional Budget Office, AMERICAN ENTERPRISE INSTITUTE FOR PUBLIC POLICY RESEARCH
• D. Bruce Burlington, MD, Pharmaceutical Product Development and Regulatory Affairs, Independent Consultant, former Executive Vice President Business Practices and Compliance, WYETH
• Jane Galvin, Managing Director, Regulatory Affairs, BLUE CROSS BLUE SHIELD (BCBS)
• Julie K. Letwat, JD, MPH, Government and External Affairs, TAKEDA PHARMACEUTICALS AMERICA
• Amy Miller, PhD, Director, Public Policy, PERSONALIZED MEDICINE COALITION
• Les Paul, MD, Vice President, Clinical and Scientific Affairs, NATIONAL PHARMACEUTICAL COUNCIL (NPC)
• Ian D. Spatz, Principal, ROCK CREEK POLICY GROUP and Senior Advisor, MANNATT HEALTH SOLUTIONS, formerly, Vice President, Global Health Policy, MERCK
• Dan Todd, Executive Director, Health Policy, EMD SERONO
• Myrl Weinberg, President, NATIONAL HEALTH COUNCIL
• Jacquelyn White, Director, OFFICE OF STRATEGIC OPERATIONS AND REGULATORY AFFAIRS, CMS


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Thursday, October 1, 2009

What Criteria are Payers Using to Determine Drug Value? Value Driven Pharma Conference Highlights

Treading on unprecedented ground, this past April, CIGNA and Merck announced that they will provide performance-based pricing for two diabetes drugs. This performance-based contract was an industry “first” – linking discounts with improved medication adherence and health outcomes. This major effort by both companies, making the much imagined manufacturer-payer relationship model a reality, is being applauded by payers, associations and consumer groups alike as a model for the industry. With payers seeking innovation that supports the ultimate goal of cost-reduction and better patient health, the time is now for the manufacturer/payer relationship to move together toward aligning all incentives value-driven initiatives.

Which explains why we have received unprecedented response to the upcoming Value-Driven Pharma event scheduled for October 15-16, 2009 at the Capital Hilton in Washington, DC.

Conference Highlights include:
• Keynote Address by Former Senator Tom Daschle with a “View From the Beltway: How Stakeholders Can Work Together to Demonstrate Value in The Best Interests of Patients, Policy & The US Healthcare System

• Keynote Address by Allan Korn, MD, FACP, Chief Medical Officer & Senior Vice President for Clinical Affairs at the BLUE CROSS BLUE SHIELD ASSOCIATION, addressing avoiding the egregious excesses of the past. Is the best science and most compelling data of little interest if, at the end of the day, products derived from them are utterly unaffordable?

• Presentation by Cyndy Pigg, Executive Director & CEO, FOUNDATION FOR MANAGED CARE PHARMACY on measuring & defining value and how to effectively adopt a more comprehensive value based metric system

• Luis Gutierrez, Jr., President of Commercialization Services at COVANCE will speak to designing clinical studies to produce credible value date for third-party payers

• Three unique and valuable points of view on Tailored Therapeutics and Personalized Medicine by Led Paul, Vice President, Clinical & Scientific Affairs, NATIONAL PHARMACEUTICAL COUNCIL (NPC), Randy Vogenberg, Executive Director, Biologic Finance & Access Council Program at the JEFFERSON SCHOOL OF HEALTH , and Surya Singh, MD, Chief Medical Officer & Vice President, PROVENTYS

Visit www.valuedrivenpharma.com and take a moment to review the agenda.

With a comprehensive program, featuring an expert speaking faculty, including those listed above, representing the industry, payers, government and other healthcare insiders, register today to reconnect or meet with the industry pricing decision makers and both reassess and acquire the tools to remain profitable and competitive in this new “value-driven” world.

Send your entire Pharma team! For information on group discounts, please contact Aloycia Bellillie at abellillie@iirusa.com Note: No two discounts can be combined.

Interested in sponsorship opportunities? Gain the exposure you need for your business. Contact Susan Feigenbaum at 646-895-7478 or sfeigenbaum@iirusa.com for sponsorship inquiries


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Thursday, April 30, 2009

Merck and Schering-Plough mega-merger to create a company greater than the sum of its parts

As a standalone company, Merck & Co. faces a tough future of declining sales. Datamonitor forecasts that the merger with Schering-Plough will succeed in returning Merck to positive sales growth and provide a raft of new pipeline and marketed products. However, before this can be achieved, outstanding issues surrounding Schering-Plough's partnership with Johnson & Johnson must be resolved.

Datamonitor forecasts that Merck & Co.'s prescription pharmaceutical portfolio will see sales decline at a 2008-13 compound annual growth rate (CAGR) of -0.3%. The key factor driving this decline is generic competition against patent expired major products out to 2013, including Singulair, Cozaar/Hyzaar, Fosamax and Zocor. Although Merck's new launch products (including Isentress and Janumet) will boost annual sales by $3.5 billion and core marketed products will generate a further $2.2 billion annual increase, a multitude of expiring products will wipe $6.1 billion from annual sales. Ultimately, Merck's 2013 annual sales would stand $435m below 2008 levels.

In terms of resuscitating its sales growth prospects, Merck has selected an attractive merger target in Schering-Plough. Indeed, boasting a 2008-13 sales CAGR of 4.5%, Schering-Plough is the fastest growing Big Pharma player in the US. The addition of Schering-Plough is expected to lift Merck's 2008-13 compound annual sales growth rate from -0.3% to +1.7%.

The merger also presents the combined unit with an opportunity to achieve further operating cost cuts and accelerate profit growth. Like the majority of their Big Pharma peers, Merck and Schering-Plough already had cost-minimizing plans in place, focused primarily on reducing sales force head count. Taken together, these plans were expected to deliver combined cost savings of nearly $2.5 billion. However, following the announcement of the merger, the companies' management teams have proclaimed that they will achieve annual cost savings of $3.5 billion beyond 2011 through reductions in spend on marketing and administration, manufacturing and R&D.

From a sales and operating profit perspective, then, Merck's merger with Schering-Plough appears highly rational. However, beyond the numbers, the deal also offers an opportunity for Merck to diversify its portfolio across key strategic dimensions, most notably molecule type and therapy area.

Merck is primarily a small molecule company, generating over 80% of 2008 sales from this traditional molecule type. The remainder of Merck's pharmaceutical sales is generated from its vaccine operations. Merging with Schering-Plough will bring a portfolio that includes both monoclonal antibodies (mAbs; Remicade and its follow-on, Simponi) and therapeutic proteins (Puregon, Peg Intron etc).

That said, the degree of molecule type diversification offered by this merger should not be overstated. The new company will remain entrenched in the small molecule market, with this molecule type accounting for 79.7% of combined 2008 sales.

More significantly, perhaps, is Schering-Plough's influence on Merck's traditional therapy area focus. In terms of generated revenues for 2008, Merck's three main areas of focus are cardiovascular, respiratory and infectious diseases. However, of the $12 billion portfolio that will be exposed to generic competition by 2015, 29% comes from cardiovascular, 36% from respiratory, and 7% from infectious diseases. Taking this into account, the need for a drastic deal that will reshape Merck's future and therapeutic focus becomes apparent.

Schering-Plough possesses three franchise focuses which complement Merck's strengths, and the resultant infrastructure overlaps would enhance synergy opportunities. These opportunities, however, are not without their own issues and hindrances.

First and most obviously, the deal would allow Merck to consolidate 100% of the companies' cholesterol joint venture sales. Through working closely together on the development and marketing of Zetia (ezetimibe) and Vytorin (ezetimibe and simvastatin), the two companies would undoubtedly have had a chance to assess their compatibility in terms of practices and corporate cultures. Management claims that 100% ownership of the cholesterol franchise will make for a streamlined decision-making ability and facilitate the creation of future combinations for Zetia.

However, despite the franchise's considerable worth (generating sales of $4.6 billion in 2008), it has recently suffered from major setbacks such as the widespread controversies surrounding the ENHANCE and SEAS studies. With the medical community focusing on intensive statin therapy for the treatment of dyslipidemia, the possibility that prescriptions for Zetia and Vytorin in the US will fall to the equivalent levels noted in Europe looms large.

The second significant synergy created through the deal is the integration of Schering-Plough's respiratory franchise with Merck's business in this category. This would be especially timely given Singulair's 2012 patent expiration, and would add pipeline (Asmanex/Foradil and the QAB/Asmanex collaboration with Novartis) as well as marketed products (Nasonex, Asmanex).

Thirdly, Schering Plough's protease inhibitors for hepatitis C (boceprevir in Phase III and SCH-900518 in Phase II) are in an area where Merck has also been active and will allow the new company to advance the most promising single and combination agents out of the two pipelines. The hepatitis C compounds also complement Merck's strengths in other infectious diseases, such as antibiotics and HIV.

In addition to the synergy opportunities that will arise from the deal, Merck will also have the opportunity to either acquire new portfolios in areas where it has not traditionally been active or bolster failing or vulnerable franchises. For example, Merck stands to benefit significantly by acquiring the substantial women's health and urology portfolio that Schering-Plough built following the purchase of Organon. The most prominent acquisition, however, will be within the immunology & inflammation portfolio, where Remicade (infliximab) is expected to add annual sales in excess of $2 billion.

Indeed, the immunology & inflammation arena is particularly significant to the deal, as the acquisition of Schering-Plough's products will bolster a failing portfolio and signify a sharp change in therapy area focus for Merck. However, Johnson & Johnson's involvement may cause problems for the combined entity going forward.

Schering-Plough has exclusive worldwide marketing rights to anti-TNF Remicade in all markets outside of the US, Japan and portions of the Far East. J&J's subsidiary Centocor brokered this deal in 1998 and, as of a renegotiation in December 2007, the agreement now extends beyond 2014. Schering-Plough reported 2008 Remicade sales of $2,118m, so this is a substantial deal taken on its own. However, the original 1998 deal also included Remicade 'follow-on' molecule Simponi (golimumab). In 2005, Schering-Plough exercised its rights to develop and market Simponi, which is expected to launch during 2009 and to reach blockbuster status, creating a vital future source of revenue for Merck.

However, four change-of-control provisions are built into the licensing deal with (J&J) which could potentially prevent Merck from gaining the overseas rights to both anti-TNF brands. The 'reverse takeover' strategy used in this deal, which essentially means that the smaller Schering-Plough will technically acquire Merck, aims to prevent these clauses from being triggered. Nonetheless, Datamonitor believes that at least one of these clauses will be breached, giving J&J the right to terminate the agreement without compensation.

The prospect of a battle is certainly a dampener on the deal, but the question needs to be asked: why would J&J object? Maintaining Schering-Plough's expertise and experience in marketing an anti-TNF in the EU must be a consideration for J&J. If the company objects to the deal and retains Remicade and Simponi, it will be forced to find new marketing partners in the EU, something that will surely damage the franchise.

There is always the possibility that J&J could move to outbid Merck. This would be out of character for J&J, but the possibility cannot be discounted outright. In the past J&J has avoided entering public bidding wars with its pharmaceutical or biotech peers. However, the healthcare giant currently faces numerous company-specific challenges. As such, it may break from its traditional ways and actively pursue an attractive target among its Big Pharma peers.


Related research
Pharmaceutical Company Outlook to 2013

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Monday, April 27, 2009

Drug Pricing Based on Patient Outcomes

According to this post in FierceHealthcare pharma companies have started adjusting pricing on their drugs to reflect its performance on improving patient outcomes. Merck has agreed to adjust pricing on Januvia and Janumet, which are diabetes drugs, based on how well they treat type 2 diabetes.

Performance-based pricing for meds is extremely rare, but with increased pressure coming from insurance companies it is only a matter of time before we will see more and more pharma companies following this pattern.

Read more about this piece on the NY Times

Related Conference:
Value Driven Pharma Conference

With healthcare costs soaring in the US, payers are tightening their belts and increasingly making coverage decisions based on value. The risk-benefit ratio for all new drugs is under scrutiny as never before and the high cost of healthcare has placed a tremendous amount of pressure on manufacturers to demonstrate the value of products. IIR’s Value-Driven Pharma event brings together stakeholders across the healthcare value chain to exchange best practices


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Thursday, March 26, 2009

Merck’s Merger with Schering-Plough Takes Everyone by Surprise

Many people were caught off-guard by Merck’s announcement that it would merge with Schering-Plough in a $41.1 billion dollar deal. According to this post on PharmExec.com this deal will take form of a “reverse merger,” which means that technically speaking Schering-Plough will inherit Merck even though they will operate under the Merck name.

Many believe that this reverse merger occurred because an existing international marketing agreement between Johnson & Johnson and Schering which allows Johnson to take all rights to sell Remicade and golimumab if Schering-Plough is acquired by another company. Still unknown is what part Johnson & Johnson will play in this huge merger. This will be something to we will look out for in the upcoming months.


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