PHARMACEUTICAL SALES TO GROW 5.1% ON AVERAGE THROUGH 2020

by Michael Johnsen

Worldwide prescription drug sales are expected to exceed the trillion dollar mark by 2020, according to Evaluate's "World Preview 2014, Outlook to 2020" report released Wednesday. Evaluate projects the pharma industry to grow, on average, 5.1% per year from 2013 to 2020.

Biologicals will make up 52% of the top 100 prescription and OTC drug sales in 2020, Evaluate reported. Oncology will set record high growth with an 11.2% compound annual growth rate to 2020. Novartis is expected to remain the top company by global drug sales in 2020, Evaluate reported. Teva Pharmaceuticals was the leading generic drug maker in 2013. 

“This much improved growth outlook comes as welcome news after two years of actual sales stagnation,” stated Paul Hills, report author and Evaluate’s head of operations. “While the patent cliff is now but a distant memory, a new debate over drug pricing is stirring up controversy. This will only intensify as the industry continues to shift away from primary care and new technology waves offer innovative products that potentially take costs out of healthcare”.

Fuente: Drug Store News

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HILLARY CLINTON: BIOTECH FIRMS DESERVE MORE SUPPORT FROM U.S. GOVERNMENT

by Bradley J. Fikes

The biotech industry's high-cost, high-reward financial model could benefit from support from biotech-rich states like California, former secretary of state Hillary Rodham Clinton said Wednesday.

Speaking at the BIO 2014 convention in San Diego, Clinton told a luncheon audience that she understood biotech companies face extreme risks in developing new health care products. State support, along with a "national framework" including provisions to help patients who can't afford biotech therapies, are part of a rational policy, said Clinton.

A potential Democratic presidential candidate in 2016, Clinton has long worked on health care policy. She was interviewed by Jim Greenwood, president and CEO of the Biotechnology Industry Organization. BIO is holding the convention in San Diego for the first time since 2008.

Clinton also endorsed the use of genetically modified organisms, or GMOs in agriculture to improve crops, such as by engineering them for drought resistance. She suggested the biotech industry stress these characteristics instead of focusing on the term GMOs.

In addition, Clinton urged the biotech industry to give more consideration to hiring women.

Greenwood said the average cost of developing new drugs is about $1.2 billion, going through complex clinical trials for the U.S. Food and Drug Administration, with no guarantee of success.

"These people are incredible risk-takers and entrepreneurs," Greenwood said. "Most of their projects fail, and most of the drugs that get approved by the FDA never pay for themselves... You can't be engaged in the highest-risk endeavor and not have high reward. The economics don't work out."

"I recognize the dilemma," Clinton said.

State leaders such as Calif. governor Jerry Brown, who gave a brief endorsement of California biotech before Clinton spoke; Mass. Gov. Deval Patrick, and Virginia Gov. Terry McAuliffe are providing enlightened leadership for biotech, Clinton said of her fellow Democrats. But other countries are also providing subsidies, and could lure away biotech if the United States doesn't come up with a "sensible" alternative to provide incentives for risk-takers.

"California (undertook) a very important task in creating a funding stream for stem cell research," Clinton said. "Other states have followed suit, when it looked as though the federal government would not be doing that. States have a role to play, but we need a national framework."

Clinton was referring to the California Institute for Regenerative Medicine, funded with $3 billion in bond money. The program was created in 2004 by California voters in part because former president George W. Bush, the first president to fund embryonic stem cell research, limited funding to those lines of human embryonic stem cells created by August, 2001. CIRM and the federal government also fund research with many other types of non-embryonic stem cells.

On GMOs, Clinton said the biotech industry "should continue to try to make the case to those who are skeptical that they may not know what they are eating already, because the question of genetically modified foods or hybrids has gone on for many many years, and there is a big gap between what the facts are and what the perceptions are".

"If you talk about drought-resistant seeds, and I have promoted those all over Africa, by definition they have been engineered to be drought-resistant," Clinton said. "That's the beauty of them. Maybe somebody can get their harvest done and not starve, and maybe have something left over to sell".

Fuente: U-T SAN DIEGO

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PHARMA DEALS DURING AUGUST 2014

(Part 3 out of 3)

by Medius Associates

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

Licensor acquired / licensee acquirer	Deal type	Product / technology	Headline ($m)
InterMune/ Roche	Company acquisition	Pirfenidone for idiopathic pulmonary fibrosis (IPF) (approved EU, Canada)	8,300
MannKind/ Sanofi	Licence	Afrezza (human insulin) Rapid-Acting Inhaled Insulin (approved US)	925
Charleston Laboratories/ Daiichi Sankyo*	Collaboration (co-promotion rights)	Hydrocodone combination products, inc CL-108, for acute pain and reduction of Opioid-Induced Nausea and Vomiting (OINV) (phase III)	650
Gamida Cell/ Novartis	Investment, option to acquire	Stem cell therapies including NiCord (phase I/II)	635
Beijing Jialin Pharma/ Luye Pharma	Company acquisition (58%)	CV and cancer drug portfolio	600
TARIS Biomedical/ Allergan	Company acquisition	LiRIS for interstitial cystitis / bladder pain syndrome (IC/BPS) (phase II)	587.5
Santaris/ Roche (pRED)	Company acquisition	Locked Nucleic Acid (LNA) platform for RNA-targeting therapeutics	450
Sapiens Steering Brain Stimulation/ Medtronic	Company acquisition	Deep brain stimulation technologies for neurodegenerative diseases e.g. PD and essential tremor	200
Dream Pharma/ Alvogen	Company acquisition	Generics	187
Emergent BioSolutions/ Morphosys**	Licence, joint development & commercialisation	MOR209/ES414, anti-PSMA/anti-CD3 bi-specific antibody targeting prostate cancer (preclinical)	183
Immune Design/ Sanofi	Licence	GLAAS discovery platform to develop therapeutics for a selected food allergy	168
Guizhou Taibang Biological Products/ China Biologic	Company acquisition (19.84% stake)	Plasma-based products	87.1+
Ziopharm Oncology/ Solasia Pharma	Amendment of 2011 licence/ collaboration	Darinaparsin (Zinapar or ZIO-101) and  related organoarsenic molecules	72.2
Millennium (Takeda)/ Infinity Pharma	Option to buy out future potential royalties	IPI-145 for treatment of blood cancers (phase III)	57.5
Rush University Medical Center/  DRI Capital	Acquisition of royalty rights	Ampyra (dalfampridine) extended release tablets (marketed)	42
Alpine Biosciences/ Oncothyreon	Company acquisition	Protocells, nanoparticle technology for targeted delivery of nucleic acids, proteins, peptides, small molecules (platform)	27
Valeo Pharma/ Valeant	Product portfolio acquisition	Dermatology brands and specialty products	25.3
ViaCyte/ Janssen R&D	Rights agreement	VC-01 based on pancreatic progenitor cells to treat type 1 diabetes (preclinical)	20
Hanmi Pharm/ Luye Pharma†	Licence	Poziotinib, a pan-HER inhibitor for the treatment of cancer (phase II)	20
Abbott/ US Department of Defense	Collaboration	To develop portable blood tests to evaluate potential concussions or mild traumatic brain injuries (TBIs)	19.5

All deals are worldwide unless otherwise noted.

*    US

**  ww excluding US and Canada

†    China

Fuente: PMLiVE

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PHARMA DEALS DURING AUGUST 2014

(Part 2 out of 3)

by Margaret Beer

August brought a mixed bag of deals covering several therapeutic areas (oncology, CNS, diabetes, respiratory, allergies, dermatology), modalities (small molecules, biologics, RNA, stem cells), technologies (platform and therapeutic), drug delivery, formulations, diagnostics, generics and many deal types (acquisitions of companies, products and royalties, options, licences and even a termination)

… with CNS in hot pursuit

Five of the announced deals involved CNS targets with again both conventional and alternative approaches in the mix.

The highest value CNS deal was the exclusive licence agreement collaboration between Daiichi Sankyo and Charleston Laboratories, a company that specialises in drugs that reduce side effects associated with opioid analgesics and other products. The companies will co-develop and commercialise novel, fixed-dose hydrocodone combinations for pain relief and opioid-induced nausea and vomiting (OINV) in the US. Among the drugs is CL-108 a fixed-dose, bi-layered tablet combining immediate-release promethazine with a modified release hydrocodone and acetaminophen. CL-108 has recently successfully completed a phase 3 study in the treatment of moderate to severe acute pain and the reduction of OINV.

Under the terms of the agreement Charleston will receive an upfront payment of $100 m plus $100 m tied to an undisclosed near-term milestone and $450 m to future approved novel fixed-dose hydrocodone products. Charleston will receive escalating, tiered, double-digit royalties.

An appetite for less conventional approaches to the treatment of CNS disorders is exemplified by the acquisition of the neuromodulation company Sapiens by Medtronic for $200 m. Sapiens is developing a Deep Brain Stimulation (DBS) system that features 40 individual stimulation points designed to allow more precise targeting. This should reduce procedure time and stimulation-induced side effects and has utility in conditions such as Parkinson's disease and essential tremor. This acquisition will compliment and strengthen Medtronic's neuromodulation leadership position in the areas of chronic pain management, common movement disorders, spasticity and urologic and GI disorders. 

The growing interest in neuromodulation is also highlighted by St Jude Medical's acquisition of NeuroTherm earlier this month giving access to its radiofrequency ablation technology allowing minimally invasive procedures to reduce chronic pain in the neck and back.

Will the fools or angels win out?

The prospect of lost revenues resulting from Lantus' tumble off the patent cliff next year seems to be sufficient motivation for Sanofi, one of the leading pack diabetes drug companies, to ignore any lurking concerns caused by Pfizer's woeful experience with inhaled insulin (Exubera) and jump into this precarious game with MannKind. 

Having said that nerves must still be twitching given the relatively modest $150 m upfront payment and MannKind's 10-year struggle to get Afrezza to this point. The long process involved three FDA approval attempts and MannKind will need to exercise patience with the promised profit share down the line.

The deal, a global licence to develop and market Afrezza, comes less than seven weeks after FDA approval was finally achieved, albeit with regulatory restrictions. The drug-device combination consists of a dry formulation of fast-acting human insulin delivered through a small, discreet inhaler for use at meal times to improve glycaemic control in adult patients with type 1 and type 2 diabetes.

As well as the $150 m upfront MannKind will receive up to $775 m in milestones and a 35% profit share on sales. Peak sales predictions range from $600 m to $1 bn. Perhaps it will take Sanofi's marketing might to overcome the boxed warnings, risk of acute bronchospasm and the memories of prescribing physicians to realise the higher end.  MannKind can only hope. The planned launch is the first quarter of next year. 

The second diabetes deal this month is ViaCyte's rights agreement with Janssen. 

This is also the second deal involving stem cells to be announced this month. Janssen is a long-standing investor in ViaCyte and this additional $20m ensures a future stake in the company and the right to acquire VC-01, a stem cell derived islet replacement therapy for insulin-dependent diabetes. VC-01 is a combination product consisting of pancreatic progenitor cells derived from proprietary human embryonic pluripotent stem cells which are encapsulated in ViaCyte's proprietary Encaptra device.  The product has recently secured IND status. When implanted under the skin, the cells mature and further differentiate into insulin-producing beta and other endocrine cells that regulate blood glucose in a manner similar to normal islet cells. 

The e-world invasion

Finally, although not areas normally covered in Deal Watch, both the number and value of several deals outside pharma are worthy of mention. These include Cerner's $1.3 bn acquisition of Siemens' Health Information Technology unit and Venn Life Sciences' majority acquisition of Cardinal Systems and its Data Management and Randomisation Systems for $900 m. As in all other spheres of life we predict the electronic age and all that is associated with it will increasingly creep into pharma deal making activity going forward.

Fuente: PMLiVE

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