LANDMARK STUDY EXPANDS KNOWLEDGE OF CANCER GENOMICS

by April Flowers

A research team led by the Broad Institute has released the findings of a landmark study across many cancer types. The findings, published in Nature, reveal that the universe of cancer mutations is much bigger than scientists previously thought.

For their study, the team analyzed the genomes of thousands of patients’ tumors, which allowed them to expand the list of known genes tied to these cancers by 25 percent. The study also demonstrated that many key cancer genes still remain to be discovered. The findings also lay a critical foundation for future cancer drug development, as well as showing that it is possible to create a comprehensive catalog of cancer genes for untold numbers of cancer types with as few as 100,000 patient samples.

“For the first time, we know what it will take to draw the complete genomic picture of human cancer,” said Broad Institute founding director Eric Lander. “That’s tremendously exciting, because the knowledge of genes and their pathways will highlight new, potential drug targets and help lead the way to effective combination therapy.”

For the last three decades, researchers have found evidence for about 135 genes that play causal roles in one or more of the 21 tumor types that were analyzed in this study. These genes are confirmed by the new results, however, the results don’t stop there. They also increased the catalog of cancer genes by one-quarter, uncovering 33 genes with biological roles in cell death, cell growth, genome stability, immune evasion, and other processes.

“One of the fundamental questions we need to ask ourselves is: Do we have a complete picture yet? Looking at cancer genomes tells us that the answer is no: there are more cancer genes out there to be discovered,” said Mike Lawrence, a computational biologist at the Broad Institute.

“We could tell that our current knowledge was incomplete because we discovered many new cancer genes,” said Gad Getz director of the Broad Institute’s Cancer Genome Computational Analysis group and a Broad associate member. Getz is also the director of the Bioinformatics Program at Massachusetts General Hospital Cancer Center and the department of pathology. “Moreover, we could tell that there are many genes still to be discovered by measuring how the number of gene discoveries grows as we increase the number of samples in our analysis. The curve is still going up!”

To catalog the vast majority of these mutations, the researchers estimate they will need to analyze roughly 2,000 samples of each cancer type. This averages out to about 10,000 samples across approximately 50 tumor types. “Given that there are around 32 million people living with cancer worldwide, this is a very reasonable number to study,” said Getz.

The team analyzed tumor types in which lots of mutations occur (such as melanoma and forms of lung cancer) and those that have a much lower frequency of mutations (such as rhabdoid and medulloblastoma, both childhood cancers) for the current study.

Nearly 5,000 cancer sample genomes were analyzed, in total. The team compared them with matched samples from normal tissue. To validate their approach, the team used methods pioneered by the group over the last few years to rediscover nearly all previously known cancer driver genes for these types of cancer.

Follow up will be needed to determine which, if any, of the altered genes pinpointed by the team could be important targets for drug development. The Broad Institute has initiatives such as the Cancer Program’s Target Accelerator aimed at doing just that. Until then, the new findings offer a wider view of the cancer genomics universe, and tantalizing clues about what remains to be discovered if more samples are analyzed.

Fuente: redOrbit

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DEAL-MAKING SEEN FOR DRUGMAKERS IN 2014

by Deena Beasley and Ransdell Pierson

The torrid pace of deals in the pharmaceutical and biotechnology sectors through 2013 is not expected to let up this year, thanks to new technologies to address unmet medical needs.

Between 2011 and 2016, patents in developed markets will expire on brand-name drugs that would otherwise have generated sales of $127 billion, according to data firm IMS Health. To replace some of the lost revenue, larger drugmakers are looking to bring in new products, often in areas of significant scientific advancement such as treatments for cancer, rare diseases and drugs designed to turn off the activity of rogue genes. Much of the breakthrough science is coming from biotechnology, meaning drugs derived from living cells.

There were 10 major M&A deals involving publicly traded biotech companies last year, led by Amgen Inc's $10 billion buyout of Onyx Pharmaceuticals. That was up from nine the previous year and six in 2011, according to JP Morgan.

"I think deal making this year will be even better because there was a lot of validation last year," said Joseph Gulfo, chief executive officer at Breakthrough Medical Innovations LLC, a consulting company to drug and medical device companies. "The new discoveries and data have sparked a tremendous amount of interest from the bigger companies."

Rather than the mega-mergers typically done to achieve big cost savings through layoffs and factory closings, most drugmakers are aiming for deals that increase sales. Many of them detailed their strategies this month at the annual JP Morgan Healthcare Conferenceare.

Those strategies included acquisitions of smaller companies as well as risk-sharing through product licensing and drug development partnerships.

AbbVie Inc, maker of top-selling arthritis drug Humira, is interested in a "gradual buildup" of its pipeline of experimental drugs, having forged a dozen collaborations with other drugmakers in the past three years, most involving drugs in mid-stage trials, said Chief Financial Officer Bill Chase.

"We don't have the need to go out and do a big deal. Large synergy deals are not overly attractive," he said.

HIGH VALUATIONS

With the 65 percent run-up in the Nasdaq Biotechnology Index last year, valuations of companies have gotten so high that licensing and partnership deals are becoming a more popular way to share financial risk.

"Biotech companies realize that developing a drug these days is economically and mathematically different than 20 years ago," said James Sabry, global head of partnering at Roche unit Genentech. "Most don't have that level of sophistication. Partnering with a pharma company is the only way to create long-term value."

Companies like Amgen and Roche performed well last year and don't really need to acquire new assets, beyond companion diagnostics to complement their products, said Anne O'Riordan, global managing director of Accenture Life Sciences.

According to Accenture's analysis, drugmakers that rank in the mid-tier in terms of growth prospects from new drugs and geographic expansion would include GlaxoSmithKline, Novartis and Sanofi.

A third clump of companies have relatively weak late-stage drug development pipelines and are still in the midst of dealing with expiring patents on top-selling drugs.

But most still have high profit margins and generate robust cash flows. "A lot of them can afford to buy something," O'Riordan said.

AstraZeneca, which recently paid $4 billion to buy Bristol-Myers Squibb's share of the two companies' diabetes joint venture, probably falls into that third camp, O'Riordan said.

Israel-based drugmaker Teva Pharmaceutical Industries, recently named turnaround specialist Erez Vigodman as its CEO and agreed to buy NuPathe Inc to expand its portfolio of medicines to treat conditions affecting the central nervous system.

Israel Makov, chairman of Biolight Israeli Life Sciences Investments Ltd, and a former CEO of Teva, said he believes deal flow among healthcare companies will be just as robust in 2014 as last year: "Why? Because there is a lot of money in the system and few places to invest it."

He predicted "more and more Big Pharma buying biotech because the problem with Big Pharma is the pipeline, and biotech can provide them the pipeline. Its even more expensive to develop a drug on your own and fail."

Companies like Teva, Merck & Co, Eli Lilly and Pfizer are avidly on the lookout for deals to supplement the flow of drugs from their own laboratories.

Eli Lilly CEO John Lechleiter said his company is "very active in the animal health space; we're gonna be buyers not sellers there."

He also said Lilly will look for ways to bolster its existing strengths in therapeutic areas such as neuroscience, diabetes, oncology, autoimmune diseases, or to widen its geographic presence.

"Growth is a challenge ... we have to take risk," Merck CEO Kenneth Frazier said in comments at the conference, while noting that the company still needs to build shareholder value and protect its capital.

Roger Perlmutter, head of research at Merck, said there are no longer many undervalued late-stage pharmaceutical product candidates. "There are earlier-stage products and we intend to exploit that opportunity," he said.

Fuente: REUTERS

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PHARMA DEALS DURING JUNE 2014 

(Part 3 out of 3)
by Medius Associates

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

Licensor acquired / licensee acquirer	Deal type	Product / technology	Headline ($m)
Covidien/ Medtronic	Company acquisition	Medical device company adding US critical mass	42,900
Idenix Pharmaceuticals/ Merck & Co	Company acquisition	Hepatitis C assets include IDX21437 (p1/2 nucleotide inhibitor) to combine with Merck HCV drugs	3,850
Labrys Biologics/ Teva	Company acquisition	Includes Labrys' p2b anti-CGRP mAb for treatment of episodic migraine	825
Chelsea Therapeutics/ Lundbeck	Company acquisition	Includes Northera (droxidopa) for neurogenic orthostatic hypotension (approved)	658
OAO Veropharm/ Abbott Laboratories	Company acquisition	Russian based manufacturing company	630
DAVA Pharmaceuticals/ Endo International	Company acquisition	Generics business including generic Doxycycline and Cefdinir	575
Bionomics/ Merck & Co	Exclusive research and licence agreement	BNC 375 in Alzheimer's disease (preclinical)	526
Adaptimmune/ GSK	Co-development and  option	TCR engineered T-cells which target NY-ESO-1 and other targets in oncology (p1/2)	350
Genia Technologies/ Roche	Company acquisition	Single molecule, semiconductor, DNA sequencing using nanopore technology	350
Medreich/ Meiji Seika	Company acquisition	India-based manufacturing company	290
Cellectis/ Pfizer	Collaboration	Chimeric Antigen Receptor T-cell (CAR-T) immunotherapies directed at multiple selected oncology targets (platform)	265* +  $28m equity
Dimension Therapeutics/ Bayer	Licence	Gene  therapy for the treatment of haemophilia A (preclinical)	252
Synairgen/ AstraZeneca	Exclusive global licence	SNG 001 inhaled beta interferon (p2)	232
Ligand Pharmaceuticals/ TG Therapeutics	Exclusive global licence	Development, commercialisation of Interleukin-1 Receptor Associated Kinase-4 (IRAK-4) inhibitors (preclinical)	208
Pregenen/ bluebird bio	Company acquisition	Gene editing technology platform	156
OraSure Technologies/ AbbVie	Co-promotion**	ODM-201, an investigational novel oral androgen receptor inhibitor (p2)	75
Orion/ Bayer	Co-development, option to co-promote in Europe	OraQuick HCV rapid test in US	68
Sorrento Therapeutics / Morphotek	Research and option agreement	To generate chemotherapeutic antibody drug conjugates (ADCs) (platform)	50
NanoString Technologies/ Celgene	Development	Development of a companion diagnostic assay	45
ECR Pharmaceuticals / Valeant	Company acquisition	Akorn subsidiary with branded generics business	41

All deals are worldwide unless otherwise noted.

* Deal terms included up to $185m milestones per product; estimated headline could be approximately $2.8bn if all products are successful.

**US only

Fuente: PMLiVE

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PHARMA DEALS DURING JUNE 2014 

(Part 2 out of 3)

by Sharon Finch

Hot gossip

Rumours were posted by the Financial Times that Shire was about to make a $5 bn bid for NPS Pharmaceuticals. So strong were the rumours that this led to NPS issuing an official denial. Next up was the comment that Allergan was on the cusp of making a bid for Shire, but of course it was pipped at the post by AbbVie confirming that a $46 bn bid ($78.89 per share) had been made (the 28 day offer period closes on July 18).  This offer has been rejected but any move on NPS cannot now go forward as the UK Takeover Code restricts companies from acquiring assets that could be deemed to deter the acquisition during the offer period.

So on a lower scale, Shire remains busy focusing on the day to day business with a move into specialised patient populations targeting the pre-school market via a new clinical study with Vyvanse. Success in this endeavour could secure a six-month data exclusivity. Also building on its R&D collaboration with arGEN-X, Shire entered into a long term alliance paying an upfront of $20.4m (cash and equity) for access to therapeutic antibodies in cancer and autoimmune diseases.

Streamlining is evident at Teva with the company undertaking a major cost cutting exercise.

But it is also looking to build on its pain franchise as noted with its purchase of Labrys Biologics for up to $825 m. This brings access to Labrys' monoclonal antibody drug LBR-101, which is under development for the prevention of chronic and episodic migraine and will clearly complement Copaxone.

Oncology focus and immuno-oncology is still growing

Still keeping its place in the headlines and following its recent licence with Nogra Pharma with the notable $710 m upfront payment, Celgene closed a deal with NanoString Technologies for the development of a companion diagnostic assay to support the development of Revlimid for treatment of Diffuse Large B-Cell Lymphoma at a more modest headline of $45 m.

Of course the growth area within oncology is the immunological approach and GSK closed a $350 m co-development and option deal with Adaptimmune. Adaptimmune develops TCR engineered T-cells and the agreement focuses on co-development around the cancer testis antigen NY-ESO-1, to which GSK has an option on the programme though to clinical proof of concept.

Similarly, Pfizer signed up with the French company Cellectis for its CAR-T platform which uses chimeric antigen receptors to reprogramme T-cells to target cancers.  Under the terms of the agreement, Pfizer secured exclusive development and marketing rights for 15 targets selected by Pfizer.

Cellectis has reserved 12 other targets and Pfizer will provide preclinical development assistance for four of these. Deal terms include an $80 m upfront payment, R&D funding and up to $185 m in milestones for each candidate, giving an estimated headline value of $2.8 bn.  In addition, Pfizer has agreed to make a 10 per cent equity investment stake purchasing new shares at €9.25 ($12.63) each, representing an estimated $28 m. Instead of arriving at a personalised solution by harvesting individual patient's T-cells, Cellectis is using allogenic CAR-Ts to provide a treatment which should be manufactured and standardised more easily.  Cellectis plans to open a research site in the US to work more closely with Pfizer.

Joining the checkpoint modulator fray, Merck Serono formed a partnership  with Morphosys to discover and develop antibodies against certain immune checkpoints using the Morphosys Ylanthia platform. Financial terms were not disclosed but include milestone and royalties.

Staying with the mid-caps and turning to prostate cancer, Bayer and Orion entered into a joint development deal for ODM-201. This phase III-ready, androgen receptor inhibitor therapy will supplement Bayer's oncology pipeline. The phase II results showed a decline in PSA levels of more than 50% in the study of 124 patients. Bayer paid €50 m ($68 m) upfront payment with further milestones in return for global rights which should complement Xofigo (from the acquisition of Algeta).  The companies will jointly fund the phase III trials.  Orion will retain co-promotion rights in Europe.

Facing the music

Not all of the deals announced this month are related to innovations and acquisitions. Reflecting some of the news flow, we saw Pfizer make a settlement of $325 m for the alleged improper marketing of Neurontin. Pfizer is not the only major pharma in this position; also this month GSK settled US claims of irregular marketing activities in asthma and antidepressants at a reported $105 m.

So the deals keep flowing as we move into the summertime. It will be interesting to see how the major acquisitions play out, following the closure of the Pfizer-AZ saga. Could this be the summer of unrequited proposals?

Fuente: PMLiVE

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