Monday, August 25, 2014

PHARMA DEALS DURING JULY 2014
(Part 3 out of 3)
by Medius Asociates


This table lists all the major pharma collaborations, acquisitions and mergers agreed during July 2014
Licensor acquired / licensee acquirer
Deal type

Product / technology
Headline ($m)
Shire/  AbbVieCompany acquisition (tax inversion)Product portfolio - neuroscience, rare diseases, gastrointestinal, internal medicine54,000
Abbott/ MylanAsset acquisition (tax inversion)Ex-US developed markets specialty and branded generics business *5,300
Rottapharm/ MedaCompany acquisition    Portfolio of Rx and consumer products3,080
Cosmo Technologies/ Salix PharmaceuticalsMerger (tax inversion)    Portfolio of treatments for gastrointestinal disease and disorders2,700
Almirall/ AstraZenecaAsset acquisitionRespiratory business including various respiratory assets and device capabilities2,095
Seragon Pharmaceuticals/ Genentech Company acquisition    Selective Estrogen Receptor Degrader (SERD) platform for hormone dependent breast cancer, inc ARN-810 (p1)1,725
Baxter Bioscience/ PfizerAsset acquisitionVaccine business and production facilities635
Zealand Pharma/ Boehringer IngelheimR&D collaborationPeptide discovery collaboration with cardio-metabolic focus395
InnoPharma/ PfizerCompany acquisitionPortfolio of generic FDA approved products and injectable and ophthalmic products under development    360
Sigma-Tau/ Jazz PharmaceuticalsRegaining rights ** Defibrotide for severe hepatic veno-occlusive disease (approved EU/ NDA US)    250
ArmaGen/ Shire    Licence, collaboration    AGT-182, enzyme replacement therapy for  Hunter syndrome (preclinical)225
CureVac/ Sanofi PasteurExercise of option,  licence RNActive vaccine technology vs undisclosed pathogens (preclinical)202+
Aciex Therapeutics/ NicOxCompany acquisitionPortfolio of ophthalmic products, inc AC-170  for allergic conjunctivitis (p3)    120
Anacor Pharmaceuticals/  PharmaDerm (Sandoz)Licence†Kerydin topical for toenail onychomycosis (approved)   110
AmorChem/ RocheDiscovery collaboration, option to licenseSmall molecule therapy for myotonic muscular dystrophy 1 (discovery)107
UCB/ DermiraLicence ††Cimzia (certolizumab pegol) - drug repurposing (p2 for psoriasis)89.5 + 20 equity
Codexis/ GSKLicenceCodeEvolver protein engineering technology (platform)    63.5+
Supernus Pharmaceutical/  HealthCare Royalty PartnersRoyalty/milestone monetisationCertain royalty /milestone rights to Orenitram (treprostinil) extended-release tablets  (marketed) 30
Immunocore/ Eli LillyCo-discovery /co-development, options (cost/profit share)ImmTAC (Immune mobilising mTCR Against Cancer) technology (discovery)    25+
Noven Therapeutics/  ANI PharmaceuticalsAcquisition of NDA †Lithobid (lithium carbonate extended release  tablets) for manic-depressive illness (NDA)12
All deals are worldwide unless otherwise noted

*    Europe, Japan, Canada, Australia and New Zealand
**  US + all other countries in the Americas
†    US
††     Exclusive licence to develop for psoriasis in N. America, EU; licence to market N. America to dermatologists
Fuente: PMLiVE

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Tuesday, August 19, 2014

PHARMA DEALS DURING JULY 2014
(Part 2 out of 3)
by Jill Ogden


July proved to be another busy month of deal activity with around half of the top twenty deals with financial terms disclosed being acquisitions of whole companies, business units, products or royalties. In the last four days of this July, $6.3bn worth of commitments were made in acquisitions, licences and collaborations across five deals.
Continuing, but by no means exhausting, the seemingly cyclical theme of expanding and contracting pharma companies, Reckitt Benckiserannounced this month that it intends to spin-off its pharmaceuticals unit into a separate company with a UK listing. Deutsche Bank analysts have estimated that Reckitt Benckiser Pharmaceuticals could have a potential value of around £2.9 bn ($4.89 bn), approximately 3.7 x net revenues for 2013.  Other analysts have estimated the separate pharma unit could be worth anywhere between £2 bn to £5.5 bn. However, with revenues falling by 8 per cent in H1 2014 as a result of US generic competition for Suboxone (the pharma unit's top selling drug), it remains to be seen what level of valuation will be achieved. 
Elsewhere, London's Financial Times reported that GSK's CEO Andrew Witty had suggested in an interview that the new consumer healthcare business being set up as a JV with Novartis might also one day become a standalone company. A day or so later, a company spokesperson made a statement that there were no plans to spin off the consumer healthcare business in the near term.
Some licensing activity...

An initial glance at this month's table of top deals shows that "acquisition" is the key word, whether this is of companies, business units or product assets. However there are still some licensing/ partnering deals in evidence. It is good to see long-term, collaborative relationships progressing as exemplified by the deals between Zealand and Boehringer Ingelheim, and CureVacwith Sanofi Pasteur.

In Zealand's second collaboration with Boehringer Ingelheim, the companies will collaborate during a 4.5-year programme on the development of a novel therapeutic peptide in the cardio-metabolic area.  Zealand could receive up to $395 m for the first compound to reach the market plus R&D funding and tiered royalties on product sales. In 2014, under this new agreement, Zealand expects to receive payments from its partner of around $7.5 m. As we often see with these early stage collaborative deals, Zealand also retains co-commercialisation rights in its home territory, i.e. Scandinavia.
CureVac's relationship with Sanofi Pasteur dates back to 2011 when the companies entered into a collaboration and option agreement covering mRNA-based vaccines generated using CureVac's RNActive technology platform against five pre-defined pathogens. Sanofi Pasteur has now exercised its option to take an exclusive licence to the first RNActive vaccine. It will pay CureVac an undisclosed option exercise fee, as well as a fee to extend its exclusive and non-exclusive options on all five pathogens, and will fund all further R&D and commercialisation costs for the licensed vaccine.  CureVac is also eligible to receive clinical, regulatory and commercial milestones of up to $202 m, as well as royalty payments associated with products sales of RNActive vaccines.
Acknowledging the importance of therapeutic area expertise and in an innovative deal to expand the application of Cimzia outside its current indications, UCB has granted an exclusive licence to US-based dermatology specialist Dermira to develop Cimzia for psoriasis in the US, Canada and the EU. Cimzia, a pegylated antibody fragment that blocks tumour necrosis factor alpha, is currently indicated for several disorders including Crohn's disease, rheumatoid arthritis and psoriatic arthritis.  Based on promising phase 2 data in psoriasis, Dermira will be responsible for phase III costs and will receive up to $49.5 m from UCB in development and regulatory milestones. If Cimzia gains approval in psoriasis, UCB will grant Dermira an exclusive commercial licence to market the product to dermatologists in North America; UCB will record the sales and pay Dermira tiered royalties based on sales to dermatologists in North America, and up to $40 m in commercial milestones.  In addition to the cash payments, UCB has made an initial $5 m equity investment in Dermira and will invest up to a further $15 m in its partner's future equity financings.
Collaborative spirit

The willingness of large and sometimes competing companies to collaborate and pool their assets and strengths appears to be increasingly a good sign.  This month we saw another batch of clinical collaborations, mostly in the field of immuno-oncology and focusing on immune checkpoint inhibitors to continue on from previous months.  These deals rarely have financials attached.  Amongst the collaborations announced during July was that between AZ and Kyowa Hakko Kirin (KHK) for a co-funded phase 1/1b immuno-oncology study to evaluate two separate combinations of three immunotherapeutic antibodies in multiple solid tumours.  The focus of the study will be KHK's anti-CCR4 antibody, mogamulizumab, in combination with either AZ's anti-PD-L1 antibody, MEDI4736, or AZ's anti-CTLA-4 antibody tremelimumab.

Existing partners Bristol-Myers Squibb (BMS) and Ono Pharmaceuticalalso announced that they will jointly develop and commercialise multiple immunotherapies as single and combination treatments.  In this collaboration the focus is Opdivo (nivolumab), an anti-PD-1 antibody that is approved in Japan for unresectable melanoma, and Yervoy (ipilimumab), an anti-CTLA-4 antibody that is FDA approved for late-stage melanoma.
As part of the collaborative spirit, the UK's Medical Research Council(MRC) announced this month that it has entered into an arrangement under which seven leading pharma companies (AZ, GSK, J&J, Lilly, Pfizer, Takeda and UCB) have agreed to make available deprioritised development compounds for British academic researchers to work on.  Based on a similar concept to the AZ-MRC initiative reported in Issue 45, this open innovation programme will publish a list of available compounds and UK scientists will be able to apply for MRC funding to use them in academic research.  According to the MRC press release, the provisions covering any arising IP rights generated using the compounds will vary from project to project and will be similar to those currently used in academically-led research.

Fuente: PMLive

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Wednesday, August 13, 2014

PHARMA DEALS DURING JULY 2014
(Part 1 out of 3)
by Jill Ogden


July proved to be another busy month of deal activity with around half of the top twenty deals with financial terms disclosed being acquisitions of whole companies, business units, products or royalties. In the last four days of this July, $6.3bn worth of commitments were made in acquisitions, licences and collaborations across five deals.
It is interesting to look back to see what was happening this time last year. In the last three days of July 2013, nine deals were announced with a total value of just over $12 bn, of which Irish-based Elan's $8.6 bn acquisition by Perrigo was a major point of discussion. Twelve months on and we are again mulling over tax inversions and the benefits of having an HQ outside the US with a lower rate of corporation tax rate. This time it is AbbVie's acquisition of Shire, albeit for a much bigger price tag than Elan, that was bubbling throughout June and tops this month's Deal Watch table at just over $54bn. Shire accepted AbbVie's fourth offer of £52.48 per share, comprising £24.44 in cash and 0.8960 of new AbbVie shares.
Tax inversions certainly continue to be in vogue amongst US companies. In addition to the AbbVie-Shire transaction, this month saw Mylan buying Abbott's non-US developed markets specialty and branded generics business in a $5.7 bn all stock deal (3 x the additional annual revenues forecast from the acquired assets). As part of this transaction Mylan will form a new company to be incorporated in the Netherlands, thereby reducing its tax rate. The deal brings to Mylan a portfolio of over 100 specialty and branded generic products in five major therapeutic areas (cardio-metabolic, gastrointestinal, anti-infective/respiratory, CNS/pain and women's and men's health).  This acquisition not only extends Mylan's geographical reach but also strengthens its presence in non-US markets bringing a large sales force in more than 40 ex-US countries. 
This month's merger between Cosmo Technologies and Salix Pharmaceuticals valued at $2.7 bn is another tax inversion. Cosmo Technologies is an Irish-domiciled subsidiary of Italian-based Cosmo Pharmaceuticals, which has a focus in gastrointestinal disease and dermatology. The plan is for Salix to become a wholly-owned subsidiary of Cosmo Technologies, which will then change its name to Salix Pharmaceuticals plc and be listed on NASDAQ. With an already established sales force in the US for its gastrointestinal product range, the merger brings Salix additional complementary products.   The new company will own Cosmo Pharmaceuticals' US and certain other patents outside Europe for several gastrointestinal products. The new Salix will also have rights of first negotiation for all future gastrointestinal products Cosmo Pharmaceuticals and its affiliates seek to market in the US and non-compete provisions that prohibit Cosmo from competing directly with the new company in the gastrointestinal area in the US.
So while several US companies have already completed or have tax inversions pending, or are even waiting in the wings, politicians in Capitol Hill have called for legislation to prevent businesses from relocating to avoid paying the higher US corporate tax rate of 35 per cent.  Moreover, it has been proposed that a legislation to limit corporate tax inversions should be implemented retroactively from May 2014. In order to guard against any unfavourable new tax laws that may be introduced (although it appears unlikely that such legislation could be passed this year), companies with pending deals are including contingency arrangements to allow them to back out of the transaction.  Both Medtronic's $42.9 bn takeover of Irish-based Covidien and Salix's merger with Cosmo have contingencies to allow the US companies to back out of their respective deals if unfavourable changes in tax legislation are enacted.  In contrast Shire has negotiated a break-up fee of at least $500m should AbbVie walk away from the acquisition. 
Big Pharma continue to expand and contract
Pfizer's quest to bolster its pipeline continues with this month's acquisitions of InnoPharma, a company with a portfolio of generic FDA-approved products, for $360m ($225 m cash and $135 m in contingent milestones) and Baxter BioScience's vaccine business for $635 m. 
InnoPharma has a focus in the development of novel formulations of existing but complex generic drugs. In addition to 10 FDA-approved generic drugs, InnoPharma has a portfolio of more than 30 injectable and ophthalmic products in development. The business will be absorbed into Pfizer's sterile injectables portfolio, which is part of the Global Established Pharma (GEP) unit. The expanded Pfizer portfolio will cover 73 currently marketed products, as well as products filed with the FDA.
The divestiture of its commercial vaccine business to Pfizer is part of Baxter BioScience's ongoing activities to focus on the core disease areas of haematology and immunology prior to being spun off from Baxter International as a separate company. The transaction includes two vaccines currently marketed outside the US and primarily in Europe: NeisVac-C, a vaccine against group C meningococcal meningitis (MenC), and FSME-IMMUN against tick-borne encephalitis (TBE).  The deal includes the associated production facilities for these two marketed vaccines but apparently does not include a number of R&D stage vaccine programmes for influenza and Lyme disease, for which Baxter continues to explore its options. Baxter forecasts that its revenues from vaccines will be  approximately $300 m for 2014.
Underscoring its strategy in focusing the business in the core areas, in July Baxter also announced the acquisition of AesRx, a private US company developing a phase II stage prophylactic treatment for sickle cell disease (SCD), called Aes-103. The financial details were not disclosed.  Aes-103 is a first-in-class, oral, small molecule with Orphan status. AesRx is also developing a novel formulation of clotrimazole (Aes-210), which is a viscous, muco-adhesive gel delivered to distal regions of the bowel by retention enema. This novel formulation is currently undergoing phase 2 studies in the initial indication of pouchitis, with the potential to expand the label to ulcerative colitis/distal ulcerative colitis.
Among the other large pharma on the acquisition trail this month were AstraZeneca (AZ) and Genentech/ Roche, both in billion dollar deals. The acquisition of Almirall's respiratory business enhances AZ's respiratory franchise bringing a portfolio of marketed and developmental single and combination products for the treatment of asthma and COPD. AZ will also acquire Almirall Sofotec, Almirall's inhalation device business which includes Genuair, its novel multi-dose dry powder inhalation (DPI) device. Almirall will receive $875 m upfront and up to $1.22 bn in development, launch, and sales-related milestones.  Further sales-related payments may also be payable by AZ.
At the very start of the month, Genentech announced its intention to buy Seragon Pharmaceuticals for $725 m cash upfront with $1 bn-worth of contingent development milestones downstream.  Only founded in August 2013, Seragon is a venture-backed company that was spun-out of Aragon Pharmaceuticals after Aragon's acquisition by J&J, so this may well be a pleasing exit for the investors. Seragon's focus is in hormone dependent cancers and specifically the development of its Selective Estrogen Receptor Degrader (SERD) platform of oral, small molecule therapeutics for breast and other cancers. The lead SERD compound, ARN-810, is currently undergoing phase I studies in post-menopausal women with locally advanced or metastatic oestrogen receptor positive breast cancer who have failed first generation anti-hormonal therapies, such as tamoxifen and aromatase inhibitors.
Fuente: PMLiVE

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Monday, August 11, 2014

DISRUPTIVE CHANGES ARE COMING TO THE DELIVERY OF MEDICAL CARE


We have grown accustomed to scientific research producing major medical advances such as those I wrote about in The Future of Medicine — Megatrends in Healthcare. But there are now some very disruptive changes coming in how medical care will be delivered by your doctor or hospital.
Some examples:
Team-based care for chronic illness. The combination of an aging population and adverse behaviors such as obesity and smoking will create epidemics of diabetes, heart failure, and other diseases that last a lifetime and are difficult to treat. They require team-based, multi-disciplinary care. Team-based care is not the norm today, and the lack of it substantially increases the costs and diminishes the quality of care. The primary care physician must become the team coordinator, be more an orchestrator and less an intervener.
Echelons of care for acute illness. Advances in the care of as heart attacks and strokes also demand a different model of care. The role model is trauma — people with minor injuries are sent to a local ER, more severely injured to a regional trauma center, and the most severe to a Level 1 dedicated trauma center. This approach is accepted for trauma but not yet for heart attacks and stroke. Today the standard of care for a heart attack is immediate angioplasty with stent placement to stop the heart attack in progress and reduce heart muscle damage. The patient brought to a small community hospital should be referred on to a larger center equipped with trained interventional cardiologists, an expert staff, and the needed equipment — all available 24/7. This will result in higher-quality care but will disrupt the economics of many doctors and hospitals.
More high-tech hospitals. More serious illnesses means there will be a need for more hospitals, more beds (especially ICU beds), and more operating rooms with highly sophisticated technologies. This marks a departure from recent decades, when the mantra has been “too many hospitals and too many beds.” Since smaller hospitals will have difficulty accessing the credit markets to finance expensive technology and facilities, we can expect to see a wave of hospital mergers and fewer stand-alone hospitals.
Patient-centric medicine. There is an emergence of consumerism in health care. (“The patient will no longer be patient.”) So, our current provider-oriented culture will have to change to a patient-oriented culture. Patients will insist on prompt service, improved safety and quality, greater respect, much more convenience, and a closure of the current information gap between doctor and patient. Absent satisfaction, patients will go elsewhere. These are very disruptive changes indeed from the present provider-centric approach to care delivery.
Delegation of care. Shortages of physicians will mean more reliance on others to deliver care — e.g., nurse practioneers and physician’s assistants for primary care, social workers and psychologists for mental health care, and optometrists for vision care. Physicians will need to change their attitudes toward these providers by involving them and embracing their value.
A new value proposition for technology. We think of new technologies as being of value if they improve diagnosis, treatment, or prevention while providing a decent return on investment. (See my earlier post on this topic.) But in the future, we will also expect a new technology to help health care professionals compensate for shortages of certain kinds of care providers, enhance their responsiveness to more demanding patients, control rather than exacerbate costs, and enhance safety and quality — very different from today’s value proposition.
Employee physicians. Professionals’ expectations are changing as much as those of patients. While most physicians in the U.S. today are in private practice, a growing number — especially younger ones — want to be employed. They want to spend less time on administrative tasks and want more time for family activities. Women are now 50% of graduates from medical school; many will want time off for child-rearing, further exacerbating the shortage of doctors..
E-health. The internet and digital medical information will have a major disruptive effect on the practice of medicine. Many physicians eschew these technologies today — often because insurers don’t reimburse them for the time involved. But they will be expected by their patients to use e-mails, telemedicine and telediagnosis, ePrescriptions, and an electronic medical record. If doctors want to keep their patients, they’ll have to change.
These are some of the major changes I see coming down the pike. Do you agree that they will transform the delivery of care? Are there others you would add to the list?
What are the challenges that health care organizations and professionals must overcome to make the transition to this new age? Will there be strong resistance or will change come about smoothly?

Fuente: Harvard Business Review

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