CARDIOBUZZ: MORE MONEY NEEDED FOR HEART RESEARCH

by  Todd Neale

The NIH dedicates a lot of money for research into heart disease and stroke, but it still might not be enough, a new study suggested.

In recent years, public funding for cardiovascular research has topped $2 billion annually, more than is spent on the other diseases on the nation's list of top killers, according to the NIH.

But when you weigh the disease burden against the amount of research funding received, cardiovascular disease appears to be getting short-changed.

Chris Stockmann, MSc, a PhD student in the departments of pediatrics and pharmacology/toxicology at the University of Utah Health Sciences Center, told MedPage Today that he wanted to look into the issue after reading a study published last year detailing the leading causes of death and disability in this country.

Cardiovascular disease -- including ischemic heart disease and stroke -- was at the top, both in 1990 and 2010. Rounding out the list of 10 were breast cancer, diabetes, cirrhosis, lower respiratory tract infection, colorectal cancer, Alzheimer's disease, lung cancer, and COPD.

As Stockmann and his colleagues reported in the International Journal of Cardiology, the NIH dedicated $6 billion to those conditions combined in 2010. Ischemic heart disease got the biggest chunk ($1.56 billion) and COPD got the smallest ($133 million). Considering ischemic heart disease and stroke together, cardiovascular disease received $2 billion.

Dividing those figures by the number of deaths caused by each condition, however, moved cardiovascular disease far down the ranking. Breast cancer received $19,342 in research funding per death, whereas cardiovascular disease received a comparatively meager $2,659 per death.

A similar trend was seen for hospitalizations: breast cancer received $10,653 per hospitalization, Alzheimer's disease received $4,698, and cardiovascular disease received just $878.

"Regrettably, we -- as members of the medical community -- have failed to articulate the need for public funding into the basic causes of cardiovascular disease and the clinical trials needed to understand how best to treat and prevent it," Stockmann said in an email to MedPage Today. "Although heart disease and stroke kill nearly one out of every two Americans and consume one out of every $6 spent on healthcare in this country, we have underestimated the challenge in understanding the basic pathophysiology of these diseases and in helping the public to understand how to live and enjoy the benefits of a heart-healthy lifestyle."

Joseph Hill, MD, PhD, chief of cardiology at UT Southwestern Medical Center and co-chair of the American College of Cardiology’s Academic Section Advisory Council, said in an interview that he wasn’t surprised by the findings, and pointed to a couple reasons why cardiovascular research might not get as much funding -- relative to disease burden -- as some other conditions.

First, he said, the significant reductions in heart disease mortality in recent decades might have left some people with the impression that the problem has been solved. "That, of course, is far from the truth."

And second, a perception that heart disease is a self-inflicted disorder -- caused by eating poorly, becoming obese, and smoking, for example -- might result in some people thinking that not as much funding needs to go into understanding its causes.

"There certainly is a lifestyle component that contributes importantly, but half of the problem is out of people's control," Hill said.

While admitting her bias as a cardiologist and the president of the American Heart Association, Mariell Jessup, MD, of the University of Pennsylvania also agreed that cardiovascular research is under-funded and said that it's not clear what goes into the NIH's decisions about where its money should go.

The solution to the funding problem, she told MedPage Today, is to increase the overall NIH budget rather than to advocate for money to be taken from one disease and moved to another.

"If there's a single message," she said, "it's that we as a country -- if we want to keep our place in the world as the fountain of research and as the originator of major medical strides -- have to fund to a higher level all research from the NIH – in addition to cardiovascular disease and stroke research."

Hill pointed out that the current study was a snapshot of funding from 2010 and that NIH funding has been declining for the past decade. At the same time, some other countries around the world have been increasing their investment in medical research.

"We are pulling back when many other countries are ramping up," he said. "And so the historic advantage and lead that we have had in this country is diminishing."

The study did not take into account funding from industry or foundations, and Stockmann noted that metrics other than those used in the study could be used to guide decisions about how to allocate funds for research.

"Our hope in publishing this study is to spark a national dialogue on the funding of biomedical research and to provide information that may be useful as a starting point in the discussion of how to fund biomedical research in the years to come," he said.

The NIH did not respond to a request for comment.

Fuente: medpage TODAY

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PHARMA DEALS DURING APRIL 2014
(Part 3 out of 3)

This table lists all the major pharma collaborations, acquisitions and mergers agreed during March 2014

Licensor acquired / licensee acquirer	Deal type	Product / technology	Headline ($m)
GSK/ Novartis	Acquisition	Oncology portfolio including pipeline products	15,500
Biomet/ Zimmer Holdings	Acquisition	Devices - Musculoskeletal/ Orthopaedics	13,350
Novartis/ GSK	Acquisition	Vaccines portfolio, excluding influenza business	7,100
Questcor/ Mallinckrodt	Acquisition	Acthar Gel (repository corticotropin) for “difficult-to-treat” autoimmune/ inflammatory conditions	5,600
Novartis/ Eli Lilly	Acquisition	Animal Health franchise	5,400
Ranbaxy Laboratories/ Sun Pharmaceuticals	Acquisition	Generics including Lipitor, Nexium, Diovan	3,200
Furiex/ Forest Labs	Acquisition	IBS, eluxadoline, a mu opioid receptor agonist/ delta opioid receptor antagonist for treating symptoms of IBD (NDA-ready)	1,460
Insight Pharmaceuticals/ Prestige Brands	Acquisition	OTC - 30 brands Women's Health and personal care products, including pregnancy testing; MONISTAT® vaginal anti-fungal	750
iPerian/ BMS	Acquisition	CNS/ Tauopathies, mAB IPN007 to treat progressive supranuclear palsy (PSP) (preclinical)	725
Forma Therapeutics/ Celgene	R&D collaboration + options: to extend, license, acquire company	3.5-year drug discovery collaboration covering a broad range of protein target families	600
Andromeda Biotech/ Hyperion Therapeutics	Acquisition	DiaPep277 24-amino acid peptide derived from human heat shock protein 60 (hsp60) to treat T1DM (p3)	570
Oryzon/ Roche (pRED)	Early stage drug research pact	Oncology - LSD1 inhibitors, Orphan cancer blocker ORY-1001 (p1/2a for acute myeloid leukaemia)	521+
Iquum/ Roche	Acquisition	Molecular Diagnostics - Laboratory-in-a-tube (Liat™) System	450
AccessClosure/ Cardinal Health	Acquisition	Devices - Mynx vascular closure device	320
GSK/ Amgen	Termination	Prolia (denosumab) for osteoporosis in certain countries *	275
Sentinal Oncology/ Oncothyreon	Collaboration	Preclinical checkpoint kinase 1 (Chk1) programme	174
Aptiv Solutions/ ICON	Acquisition	CRO/ Adaptive Clinical Trials	143.5
California Stem Cell/ NeoStem	Acquisition	Stem cell immune-based therapy Melapuldencel-T, to treat metastatic melanoma (p2)	124+
New Wave Surgical/ Covidien	Acquisition	Device - D-HELP kit (to be re-named Clearify Visualization System)	100+
Agenus/ Merck & Co	Discovery collaboration/ licence	Immune checkpoint antibodies; 4-Antibody Retrocyte Display(R) platform	100
Silom Medical Company/ Actavis	Acquisition	Generics - 25 products in various dosage forms	100

All deals are worldwide unless otherwise noted.

* Amgen will assume full marketing duties in areas including the EU, Switzerland, Norway, Russia and Mexico.  GSK retains rights in Australia (bone) and countries such as China, Brazil, India and South Korea for other uses.

Fuente: PMLiVE

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PHARMA DEALS DURING APRIL 2014
(Part 2 out of 3)

Generics/ Specialty Pharma

Since spinning off from Covidien last year Mallinckrodt has been in fast growth and diversification mode.  Having purchased Cadence Pharmaceuticals for $1.4bn in February of this year (Ofirmev, an iv injectable acetaminophen for pain), April saw the acquisition of another California-based biotech, Questcor (formed in 1999 by the merger of RiboGene and Cypros Pharmaceutical), for $5.6bn representing a 27% premium.

This gives Mallinckrodt, Acthar Gel (repository corticotropin), which is FDA approved for 19 “difficult-to-treat” autoimmune and inflammatory associated conditions and currently primarily used to treat multiple sclerosis relapses, proteinuria associated with nephrotic syndrome, certain rheumatology-related conditions, and infantile spasms.  Whilst this is a 60-year old drug acquired by Questcor in 2001 for $100,000, generic competition is unlikely due to manufacturing challenges. Acthar sales grew by 50% in 2013 to $761.3m and is predicted to rise to $1.9bn in 2018.  Questcor also provides contract manufacturing services through its subsidiary BioVectra.

Acthar complements Mallinckrodt's portfolio of specialty pharmaceutical brands which include Exalgo, Gablofen, Pennsaid and Xartemis and reduces the company's focus on medical imaging and pain drugs. This transaction brings closer Mallinckrodt's goal to join the specialty drug big player league with a portfolio covering pain management, CNS, renal, rheumatologic and other autoimmune and inflammatory disorders.

April also saw Sun Pharmaceutical Industries relieving Daiichi Sankyo (63.9% owner) of the troubled Ranbaxy Laboratories to create India's largest pharma company, leading in 13 speciality segments, with estimated annual revenues of $4.2bn.  Sun will become the world's 5th largest specialty generic pharma company with operations in 65 countries, 47 manufacturing facilities across 5 continents, and a significant platform of specialty and generic products including 629 ANDAs.

The total cost of the all-stock acquisition is $4.0bn (an 18% premium), $3.2bn in stock and nearly $800m of Ranbaxy debt.  Daiichi Sankyo will become Sun's second largest shareholder, about a 9% ownership valued at around $2bn.  Daiichi has therefore paid a heavy price for its “generics dalliance” – this is less than half the $4.2bn it paid for its stake in Ranbaxy in 2008, not to mention the 2013 $500m payment to the US authorities to settle 7 felony charges. This move by Sun is not for the faint hearted.  Aside from the usual challenges that come with such a substantial buyout, the US regulatory cloud that has overshadowed Ranbaxy for years and the more recently announced European Medicines Agency plant inspection must be addressed.

Eclipsing all else will be restoring FDA confidence.  To this end immediate remedial action will involve management restructuring at the 4 Ranbaxy Indian plants currently subject to US shipping bans.  This may not be as simple as it seems.  Last year the FDA imposed export bans from 20 or so plants in India and warned several others, and whilst Sun Pharma has fared well in this respect, its Karkhadi plant was served with a cephalosporin antibiotics import ban for the very same issues that have dogged the Ranbaxy plants, i.e. quality control and sanitation. Once these issues have been dealt with the challenge of rebuilding prescriber confidence can commence.  Doctors have shied away from Ranbaxy brands in recent years and it is rumoured that a solution will be to replace the Ranbaxy brand with the Sun Pharma moniker at least in the US.

Sun estimates that operating synergies will save $250m in the third year, 40% coming from sales force down-sizing and 20-25% from distribution channel rationalisation.  The reward for all of this effort is Ranbaxy's new product pipeline, including generic versions of 2 blockbuster drugs: the first-to-file status for Nexium, AstraZeneca's heartburn drug, which comes off patent next month and the first to market approval for Diovan, Novartis' blood pressure drug.

A smaller generics deal was Actavis' takeover of Silom Medical Company for approximately $100m in cash.  The acquisition of this privately owned, Thailand focussed company immediately elevates Actavis into a top-five position in the growing Thai generics market, with a leading position in ophthalmics and respiratory therapeutics and a strong cardiovascular franchise. This is the latest of the Actavis buying binge frenzy adding to the acquisition of Warner Chilcott last year and Forest Laboratories last month.

Devices on the move

Zimmer Holdings, a maker of reconstructive, spinal and trauma devices such as artificial hips and knees which was spun out of Bristol-Myers Squibb in 2001, has agreed to acquire rival Biomet for $13.35bn, $10.35n in cash and shares of stock valued at $3.0bn.  Zimmer will now be second only to J&J in the fast growing $45bn muscle and orthopaedic injury market, which finds itself increasing serving sports musculoskeletal injury needs.  Zimmer and Biomet had combined revenues of $7.8bn in 2013 and are expected to generate cost savings of $135m in the first year and $270m by the third year.  This is the fifth-largest medical device deal in past decade, the biggest since J&J's Synthes purchase for $19.7bn in 2012.

April also saw Cardinal Health acquire the privately held device maker AccessClosure for $320m in cash.  This will give Cardinal access to the Mynx vascular closure device that seals the femoral artery using a secure, dissolving sealant resulting in a healed artery after 30 days.  The company generates about $80m in sales annually.

Finally New Wave Surgical was acquired by Covidien for $100+m.  The reward the D_HELP kit (to be re-named Clearify Visualization System) currently used in 1,200 US hospitals to keep laparoscopic and robotic lenses heated, defogged and clean during procedures.  Who would have thought that such inspiration would have generated a 30-40X return on investment in such a short period?  The founder/ inventor R. Alexander Gomez raised about $3m and created a company with 145 employees and $21m in revenue in just 10 years.

Pharma mainstays not forgotten – pills, orphans, diagnostics, and even stem cells

Interest in good old fashioned drug development was demonstrated by the Forest Laboratories acquisition of Furiex Pharmaceuticals for $1.1bn in cash and potentially $360m in contingent value rights should the main focus of the deal, the drug eluxadoline, receive FDA approval and is not scheduled as a controlled drug.  Eluxadoline is a first-in-class, locally-acting mu opioid receptor agonist/ delta opioid receptor antagonist for treating symptoms of diarrhoea-predominant irritable bowel syndrome (IBS-d).  NDA submission is planned by third quarter of 2014.  Forest plans to sell Furiex's royalty rights to alogliptin and Priligy on to Royalty Pharma for about $415m.

Forest is building a leading position in the $38bn gastroenterology (GI) market adding eluxadoline to its broader GI portfolio including Linzess.  Actavis has consented to Forest's acquisition of Furiex.  The timing of Actavis' previously announced acquisition of Forest remains unaffected.

The second highest value acquisition primarily involving a drug was Hyperion Therapeutics' purchase of Andromeda Biotech, the developer of DiaPep277, in a deal that could be worth close to $570m.  DiaPep277 is a first-in-class, 24-amino acid peptide derived from human heat shock protein 60 (hsp60) that has demonstrated a beneficial effect on the autoimmune attack of pancreatic beta cells in patients with Type 1 diabetes thereby preserving endogenous insulin secretion.  For sole rights to DiaPep277 Hyperion will pay $12.5m in cash and about $7.9m in stock up front, with $120m tied to regulatory milestones and $430 million for commercial success.

In recent years Roche has signed a string of deals (Constitution Medical Investors, Pacific Biosciences, Bayer) underpinning its commitment to diagnostics.  In April it added the acquisition of IQuum giving access to the CE marked and FDA cleared Laboratory-in-a-tube (Liat™) System.  This enables healthcare workers to perform rapid molecular diagnostic testing in a point of care setting, with minimal training.  The Liat™ Influenza A/B Assay, the first test available for use on the system, discriminates between influenza A and B.  IQuum is also developing a workstation that can perform up to 8 nucleic acid tests simultaneously as well as assays for HIV, cytomegalovirus, influenza subtypes and dengue fever.  For this Roche will pay $275m upfront and up to $175m in milestones.

Last but not least in significance was the cell based therapy company Neostem's $124m stock-and-cash acquisition of California Stem Cell.  This was largely driven by the phase 2 autologous melanoma stem cell immune-based therapy, Melapuldencel-T.  However the platform technology also has potential utility in hepatocellular carcinoma and other immune-responsive tumour types and may herald the much awaited fruition of this long promised modality.

For those out there still wanting to share don't despair - and note that on closer inspection early stage collaborations continue to endure as exemplified by BMS (preclinical tauopathies deal with iPerian), Roche (LSD1 inhibitors with Oryzon) and Merck & Co (Immune checkpoint antibody deal with Agenus).  There is hope yet for us all!

Fuente: PMLiVE

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PHARMA DEALS DURING APRIL 2014
(Part 1 out of 3)

As is customary, April's Deal Watch is restricted to deals with disclosed financial terms but what a month it has been!  Not surprisingly the Novartis/ GSK/ Lilly tripartite deal has dominated, however having said that, there has been no let up in the “acquisition feeding frenzy” seen across the industry throughout the month.

Novartis, GSK and Lilly drill down and focus

Just like Alice in her Wonderland relying on transformative potions and cakes we have over recent decades watched large companies in their “Pharmaland” expand and contract as they re-invent their modus operandi.  Most notable has been the wholesale closure of R&D facilities, but did anyone anticipate the game of musical chairs that came to light with the April GSK-Novartis-Lilly deal?

This series of asset-swapping deals, with a total combined value of some $28.5bn, will realign the corporate and marketing landscape for each of these big pharma players. In one fell swoop three new giant specialists will emerge: Novartis claims the cancer crown; GSK vaccines; Lilly Animal Health. In addition, it will see the birth of a new consumer health giant, a joint venture between GSK and Novartis.

So the bottom line is:

• Novartis acquires GSK's oncology products for $14.5bn plus $1.5bn contingent on development milestones in the melanoma space.  Novartis also gains option rights to GSK's current and future oncology R&D pipeline becoming its preferred commercialisation partner.
• GSK acquires Novartis' vaccine business for $7.1bn ($5.25bn upfront; up to $1.8bn in milestones) plus on-going royalties, excluding its influenza business.
• Lilly acquires Novartis' Animal Health franchise for $5.4bn cash.
• Novartis OTC and GSK Consumer Healthcare to form a joint venture, a world leading healthcare business of which Novartis will have a 36.5% share; 4/11 seats on the Board.

It changes here, it changes there, the landscape changes everywhere

Oncology: 

This is the “hot field” in the industry and of course Novartis, a cancer heavyweight is ideally placed to maximise the potential of GSK's, by Andrew Witty's own admission, “nascent oncology business”. Novartis' pipeline includes more than 25 new molecular entities targeting key oncogenic pathways including: Gleevec and its follow-up Tasigna (blood-cancer); Afinitor (kidney cancer and recently approved for breast cancer); Jakavi (rare bone marrow disorder); Signifor (Cushing's disease) plus 16 products in 24 pivotal trials.

GSK's recently approved MEK inhibitor Mekinist and BRAF inhibitor Tafinlar will position Novartis to become a leader in the potential blockbuster market for metastatic melanoma, neglected by their current portfolio. Additional revenues for these two drugs are also promised in other cancer types not to mention their “combo” potential. Indeed a whopping $1.5bn payment depends on the results of the on-going combination trial against Roche's Zelboraf.

Additional GSK products include the VEGFR inhibitor, Votrient (renal cell carcinoma), Tykerb (HER2+metastatic breast cancer), Arzerra (chronic lymphocytic leukaemia) and Promacta (thrombocytopenia).  GSK will continue with its immunotherapy and epigenetics research programmes so in effect will provide a further pipeline source for Novartis which will have co-marketing opt-in rights for any future products.

Vaccines:

Along with Merck & Co and Sanofi, GSK enjoys big player status in the vaccine space and as such can “return the honours” in transforming the commercial prospects of Novartis' vaccine franchise. The icing on the cake is Bexsero for the prevention of meningitis B, which has EU approval and orphan drug designation in the US.  Also included in the meningitis “goodie bag” is the late-stage combo candidate MenABCWY. The new GSK vaccine business will have more than 20 different vaccines in development, including assets to prevent hospital and maternal infections and diseases prevalent in developing countries such as malaria and tuberculosis.  GSK will also acquire additional manufacturing capability in India and China.  Upon closure of the deal GSK will have 29% of the global vaccine market and vaccines will account for 14% of Glaxo's top-line revenues.

Animal health:

The Novartis Animal Health franchise transaction is the 8th and largest acquisition for Elanco, Lilly's Animal Health arm, since 2007 and catapults it to the global number 2 spot in terms of sales, second only to Zoetis. The acquired business includes a portfolio of some 600 products including vaccines and anti-parasite medicines that will provide access to the fish farming market, more than 40 development projects, 9 manufacturing sites, 6 dedicated R&D facilities, and a commercial infrastructure in 40 countries.

Consumer healthcare:

The joint GSK/ Novartis Consumer Healthcare business inherits a leading position in four key OTC categories - Wellness, Oral Health, Nutrition and Skin Health. According to GSK it will generate approximately $10.9bn in annual sales, second only to Johnson & Johnson (J&J). Well-known brands include:

• Pain: Excedrin (Novartis), Beecham's headache powder and Panadol (GSK)  
• Smoking cessation: Nicorette and Nicoderm (GSK), Nicotinell (Novartis) 
• Cold-and-flu: Theraflu and Triaminic (Novartis), Coldrex (GSK)
• Oral care products: toothpastes (Sensodyne), denture adhesive etc (GSK)
• Nutritional supplements: Horlicks (GSK) a big seller in emerging markets, Benefiber (Novartis) fibre supplement.

GSK will be responsible for the OTC manufacturing network, a bonus for Novartis that no doubt will be relieved to be off-loading its troubled Lincoln, NE plant. GSK believes that sales, administrative and overlapping infrastructure synergies for this and the vaccines operations with amount to £1bn savings, 40% of which will be attributed to the consumer business.

Will all this impact on Merck & Co's rumoured sale of its consumer healthcare arm?  Interested parties are thought to include Bayer, Sanofi and Reckitt Benckiser.

And in the end

GSK's transformation will result in a shift away from prescription drugs, restricting its activities to respiratory and HIV, and towards consumer products and vaccines which are less vulnerable to the patent life cycle. All told 24% of its revenues will come from in consumer health, 62% pharmaceuticals and 14% vaccines.

At $16bn Novartis on the surface is paying way over the odds for oncology products that currently bring in $1.6bn, however, replacing low-margin vaccines with high-margin oncology medicines may be well worth the price. Since sinking $7.5bn in the 2006 Chiron buyout, vaccines have been an unhappy place for Novartis eventually making a $165m operating loss in 2013. This deal places Novartis 2nd only to Roche in oncology, an area in which it has a proven track record and which will now generate 20% of total sales. Remaining revenues will come from pharmaceuticals, eye care (Alcon) and generics (Sandoz) and of course its stake in GSK Consumer Health.

Lilly will continue to focus on prescription drugs (diabetes, oncology, neuroscience, cardiovascular, urology etc) but will now also have a world leading position in Animal Health. The Novartis/ Lilly transaction is expected to close by the end of the first quarter 2015 and the Novartis/ GSK transaction during the first half of 2015.

And now for something completely different..

Takeover fever goes wild with April seeing virtually all sectors of the industry affected.  Of the remaining 18 top 21 deals this month, 12 involved wholesale takeovers with deals in Devices (Biomet/ Zimmer Holdings, AccessClosure/ Cardinal Health; New Wave Surgical/ Covidien), Generics/ Speciality Pharma (Questcor/ Mallinckrodt, Ranbaxy Laboratories/ Sun Pharmaceuticals; Silom Medical Company/ Actavis), Pharmaceuticals/Biologics (Furiex/ Forest Laboratories, Andromeda Biotech/ Hyperion Therapeutics), OTC (Insight Pharmaceuticals/ Prestige Brands), Diagnostics (Iquum/ Roche), CRO (Aptiv Solutions/ ICON) and even Stem Cells (California Stem Cell/ NeoStem). Four of these takeovers were in the multi-billion dollar league.

Fuente: PMLiVE

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