Category Archives: Acquisitions

Eli Lilly buys ARMO BioSciences for $1.6bn

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Eli Lilly has announced that it will acquire immuno-oncology company ARMO BioSciences, including the company’s lead immuno-oncology product pegilodecakin, in an all-cash transaction of $50 per share, or approximately $1.6bn.

The addition of promising cancer drug candidate pegilodecakin will bolster Lilly’s immune-oncology portfolio. The drug is currently undergoing Phase III testing in pancreatic cancer as well as earlier-Phase trials in lung and renal cell cancer, melanoma and other solid tumour types. It has demonstrated clinical benefit as a single agent and also in combination with both chemotherapy and checkpoint inhibitor therapy across several tumour types.

ARMO also has a number of other immuno-oncology product candidates in various stages of pre-clinical development.

Lilly Oncology global development and medical affairs senior vice-president Dr Levi Garraway said: “As we develop our immuno-oncology portfolio, Lilly will pursue medicines that use the body’s immune system in new ways to treat cancer. We believe that pegilodecakin has a unique immunologic mechanism of action that could eventually allow physicians to offer new hope for many cancer patients.”

ARMO BioSciences is a late-stage immuno-oncology company focused on developing product candidates that use the immune system of cancer patients to recognise and eradicate tumours. The company went public just months ago in January of this year.

ARMO BioSciences president and CEO Dr Peter Van Vlasselaer said: “ARMO is proud of the work we have done to advance the study of immunotherapies and of the development of pegilodecakin to date. Given the resources that Lilly, a leader in oncology R&D, can bring to bear to maximise the value of pegilodecakin and the rest of the ARMO pipeline, we believe it is in the best interest of ARMO, our stockholders and the patients we serve, to execute this transaction.”

With the total immuno-oncology market is expected to be worth $34 billion by 2024, pharmaceutical companies, including Lilly, are keen to invest in this cutting-edge therapeutic area that is already making a significant impact on oncology.

The announcement comes just weeks after the company recruited Dr Leena Gandhi to oversee the development of Lilly’s immuno-oncology portfolio.

The transaction is expected to close by the end of the second quarter of 2018.


Merck KGaA finds consumer health buyer in P&G for €3.4bn

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Merck KGaA has successfully found a buyer for its healthcare unit, after Proctor & Gamble announced that it was prepared to part with €3.4 billion to gain the rights to a portfolio that includes Seven Seas and Bion3 supplements.

To push the deal through, it is assumed that Merck had to climb down slightly on its valuation of the business, which it had initially pegged at around €4 billion. However, now that the deal has gone through, the company will be able to focus on its pharmaceutical business and potentially use the extra cash to grow its pipeline.

The company’s decision not to play hardball on price may well have been influenced by watching Pfizer’s failure to offload its on healthcare business.

Pfizer had a firm valuation of the business at $20 billion, a figure that all of the companies interested in taking on the business were disinclined to match.

GSK, for instance, took a look at the possibility before deciding to spend $13 billion buying Novartis out of their joint healthcare venture.

While P&G had actually previously shown interest in Pfizer’s unit, which is three times the size of Merck’s, but did not want to pay more than $15 billion for it.

All of which meant that Pfizer has been unable to find a buyer and has spent a large amount of time for no productive end – clearly Merck did not want this to be the case in its own sale.

“We like the steady, broad-based growth of the OTC Health Care market and are pleased to add the Consumer Health portfolio and people of Merck KGaA, Darmstadt, Germany, to the P&G family,” said David Taylor, Chairman of the Board, President and Chief Executive Officer.

P&G’s acquisition will see 3,300 Merck employees move over as part of the transaction, which is expected to close during the 2018/2019 financial year.

The steady growth Taylor references is the fact that Merck has achieved 6% growth for the last two years. However, Merck wants to pull away from this sector because pharmaceuticals can offer for greater return – though with an equivalent risk of any potential drug failures, as it is has found after being stung by trial failures with Bavencio.


Lundbeck takes risk on Parkinson’s treatment, €905m on table

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CNS’ treatments are notoriously risky, especially those that are still at an early stage; however, Lundbeck has decided to take a calculated risk on Prexton Therapeutics and its sole candidate for Parkinson’s.

Lundbeck will buy out the company for €100 million up-front, with a further €805 million locked into development, regulatory and sales milestones.

The compound, foliglurax, is currently undergoing Phase 2 testing, after developing promising data in pre-clinical, animal models and a good safety profile in a Phase 1 trial. The data was enough to secure €29 million in a Series B financing round just over a year ago.

Foliglurax is being lined up as an adjunctive therapy for patients already taking levodopa, as the latter drug becomes less effective and side-effects being to take their toll on patients, such as compromised motor function. The aim for the treatment is that it is able to manage resting tremors, muscle rigidity and uncontrolled movements.

Rather than wait for the results from its Phase 2 trial, Prexton decided to take the cash whilst it was on the table – given how unpredictable CNS treatment results can be, this seems a sensible option.

As for Lundbeck, it managed to scoop the treatment before results emerge – it is playing with the exact same risk, but the upside could be a successful Phase 2, that’s already underway, and having got in early on the candidate before big players started to circle.

“By acquiring Prexton, Lundbeck will obtain global rights to foliglurax, an exciting first-in-class compound, and gain full control of the asset,” said Anders Götzsche, interim CEO and CFO at Lundbeck. “Foliglurax addresses high unmet needs with its potential indication in Parkinson’s fitting perfectly within Lundbeck’s core areas and this treatment option also appears to be highly interesting for patients, physicians and payers.”


Sanofi, Evotec in major infectious disease R&D transfer and license deal

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Big Pharma Sanofi and German CRO-biotech drug discovery hybrid Evotec are penning a deal that will see Sanofi license out a host of infectious disease assets to the biotech, with 100 staffers also moving into its R&D engine.

Sanofi is paying a one-time, upfront fee of €60 million ($74 million) to Evotec, a small sum, but one backed up with a promise to “provide significant further long-term funding to ensure support and progression of the portfolio,” although exact financial details were not shared.

The deal drills down like this: Sanofi will license most of its infectious disease (ID) research and early-stage portfolio (around 10 assets all-told) and move this unit, with around Sanofi 100 staffers alongside it, into Evotec (although this does not include the French pharma’s vaccine R&D unit).

Evotec, which does its own research and also relies heavily on external collaborations with biopharmas and academic biomedical research, will run this “open innovation platform” near Lyon, France, where Sanofi Pasteur is HQ’d.

Sanofi holds on to certain option rights on the development, manufacturing, and commercialization of anti-infective products and will “continue to be involved in infectious disease through its vaccines research and development and its global health programs,” it says in a statement.

The focus of the Evotec drug discovery will be on “new mode-of-action antimicrobials,” the pair say.

Werner Lanthaler, Ph.D., CEO of Evotec, said: “Since the acquisition of Euprotec (UK) in 2014, Evotec has had a significant strategic interest and demonstrated expertise in infectious diseases research, with an ambition to grow and become the drug discovery and development leader in this space together with its partners.

“We are pleased to be working and expanding our strategic relationship with Sanofi, which has a long history in providing novel anti-infective agents to markets globally. Finding a way to motivate more public funding and academic initiatives for the progress of novel anti-infectives on Evotec’s platform will be a key success factor for this initiative.”

The deal is still being talked over, but should be done in the coming months.

Evotec already has a series of deals with the likes of Eli Lilly, Tesaro, Oxford University, and even has its own spin-out in the form of Topas Therapeutics.

Elias Zerhouni, M.D., president of global R&D for Sanofi, adds: “Research in the field of anti-infectives is an area where building critical mass through partnering is particularly important. This new French-based open innovation center will benefit from the high-quality science ecosystem. Evotec is a trusted partner in drug discovery and has the ambition and capacity to become a real leader in the fight against infectious diseases.”

This also comes as Sanofi continues to retool its R&D, getting back into cancer as well as blood disorders via its $11.6 billion deal for Biogen spin-out Bioverativ.


How can pharma navigate the complex marketing landscape?

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The first chapter of pharma’s commercial evolution takes us from the insatiable sales-drive of the 1980s to the present, highly complex marketing landscape.

It is easy to forget that our competitive industry still has 80-90% gross margins and, as a consequence, its traditional commercial model is driven by sales growth, rather than worrying about costs.

Under most circumstances, incremental sales drive incremental profit. Within the affiliates this is obvious, and country managers have often resisted attempts by corporate counterparts to take a centralised approach to sales and marketing, claiming their country’s commercial ecosystem is unique and not amenable to meddling.

Of course, the modern pharma company will also have to conduct market access, medical education and phase IV studies within its affiliates, but the reality is that most affiliate activity is focused on sales. For large pharma companies the sales and marketing budget usually beats R&D budgets by 1.7 times, and this is becoming increasingly difficult to justify.

Rise of primary care dominance

Throughout the 1980s and 90s the focus on sales-driven growth led to the evolution of some very different ways of working within primary care, from co-promotion and co-marketing with embedded local players, to the ‘petal’ system of multiple salesforces detailing overlapping product ranges.

The purpose of these techniques, together with employment of contract sales teams, was a sort of ‘shock and awe’ strategy which swamped the physician with frequent visits about particular products. The competitive response was usually swift and commensurate, resulting in a commercial arms race between players within a hotly contested therapeutic area.

This was known as the ‘share of voice’ model, and when applied to large primary care categories, it drove top line growth so successfully that governments and institutional payers were forced to find a response to escalating drug bills around the world.

Backlash from health technology

This response varied from country to country, but has taken two main forms; the Health Technology Assessment response and the consolidated payer response. Throughout the 1990s and 2000s, in the UK (NICE), much of Europe, Australia and parts of Asia, there has been systematic developing of a process that assesses whether a product represents value for society.

Much of the health economics work is shared among countries, and pricing comparisons made between the same product in different countries are routine. The benchmarks for the monetary value of a healthy human being are the subject of debate, but are necessary to make budgetary choices in a system without unlimited resources.

The consolidated payer model, operating in the US through pharmacy benefit managers such as Express Scripts, relies on large payers exerting pressure on manufacturers for rebates, with some undifferentiated product portfolios having to rebate as much as 50% of their gross price.

The impact of health technology assessments can be seen today, manifesting itself in pricing pressure, therapeutic substitution, a diminution of decision-making by physicians and a conscious shift towards products with a confirmed medical need. A decline in R&D productivity, however, has not made this process easy.

Dead end: Primary care hits a wall

Many commentators blame the decline in R&D productivity for the steep fall in product approvals through the 2000s but, in reality, there have been several forces at work.

The rise in genomics, together with high-speed screening techniques, led to a belief that chemical libraries could be screened against unprecedented targets and that optimised drug candidates would flood through the discovery phase into phase I trials.

The sharp product rise in the early clinical phases then came to a shuddering halt during phase II ‘proof of concept’ studies, when large numbers of clinical failures unveiled the reality – there is no short cut to understanding disease biology.

As research cul de sacs were explored, a squeeze on primary care products began in the form of price pressure from above and greater safety demands from below. As a consequence, and aided by the rise in technology, a rapid increase in the proportion of newly-approved, biological in origin drugs commenced.

Monoclonal antibodies, vaccines, enzyme replacement therapy and other therapeutic peptides, aided by insatiable demand for insulin, developed strong sales and completely changed the nature of commercial interfacing with physicians.

Biologicals change the commercial dynamic

The pressure on primary care products, together with the impact of the patent cliff in 2012/13, have combined to drive sales of primary care products into stagnation. Much of industry downsizing, particularly within commercial operations, has been in response to this.

Perhaps most merger and acquisition activity within pharma also has its origins in this relentless pressure on primary care sales and the need to reload the pipeline quickly with biologicals and specialties.

The success of biologicals and other specialties, such as oral cancer drugs, in terms of both approval and sales, has required the industry to change its commercial emphasis. The huge traditional focus on primary care or family doctors has changed to specialists, and their support workers within a secondary care or hospital environment.

The increased complexity of the specialty sell, sometimes involving multiple decision-makers, formulary approval, health economic arguments, companion diagnostics and performance-related reimbursement, has required a much smaller, but more skilled group of people to interface with the healthcare network.

Many companies have yet to find the necessary mix of skills within their workforce and are still working under the old assumptions that spending on promotional activities can remain as high as it used to be under traditional models. They do so at their peril. Check out Part 2in the next issue, as promotional resources and modern data come under intense scrutiny.


Big pharma could turn to viruses to boost cancer immunotherapies

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Merck & Co’s $394 million acquisition of Viralytics has stoked interest in oncolytic viruses, a class of drugs that have been in the shadow of the checkpoint inhibitors and CAR-T therapies that are helping to set the standard of care in cancer.

But Merck’s deal to acquire Viralytics suggests this could be about to change, according to one of the Australian company’s close competitors, Norway’s Targovax.

Representatives of Targovax interviewed by pharmaphorum said the marketplace is set to get increasingly crowded in the future as pharma tries to use the approach to improve efficacy of checkpoint inhibitors.

There is only one FDA-approved oncolytic virus, Amgen’s Imlygic (talimogene laherparepvec) in 2015, but sales have been disappointing.

But with another 10 oncolytic viruses in clinical development, and another 40 in labs, the hope is that oncolytic viruses could be used to ‘prime’ tumours before treatment with checkpoint inhibitor immunotherapy, which has a response rate as low as 20% in some cancers.

Oncolytic viruses work by injecting genetic material into cancer cells, which modify them and make them visible to the immune system, which moves in to destroy the.

The issue with Imlygic is that it is approved as a monotherapy – and the thinking is that oncolytic viruses are likely to be more effective when used in combination with other drugs, notably immunotherapy drugs such as checkpoint inhibitors.

This is the approach taken by Viralytics, and by Targovax, which is looking to find partners as it progresses its two oncolytic viruses through the clinical trial process.

Now that Viralytics is effectively part of Merck & Co, this leaves Targovax as one of the most advanced independent biotechs working with oncolytic viruses.

Bristol-Myers Squibb has also done a big oncolytic virus deal, acquiring rights late last year to an “armed virus” targeting cancer from the UK biotech, PsiOxus Therapeutics, worth almost $900 million if the project is successful.

Merck deal ‘no suprise’

Targovax’s chief medical officer, Magnus Jaderberg, told pharmaphorum in an interview that the Viralytics deal came as no surprise following strong phase 2 results from its Cavatak, based on the Coxsackievirus, back in 2015.

Jaderberg said: “As soon as they released the data we felt that somebody would go after them and we were right. We were not surprised about the deal and we think it is very positive for us.”

He expects more interest in oncolytic viruses from Roche and Genentech, which so far have not done a big oncolytic virus deal, perhaps to boost their immunotherapy Tecentriq, which has produced some mixed results in trials.

Already partnered with Medimmune on one deal, Targovax is planning a phase 2 trial of its adenovirus-based drug TG01, targeting resected pancreatic cancer in combination with Merck’s Keytruda (pembrolizumab).

This could be extended to a phase 3 trial leading to registration in this disease, where there has been no significant progress for the best part of two decades CHECK.

Targeting RAS mutations, the drug could be used in 30% of all cancers that express this biomarker, suggesting a sales potential well in excess of the $400 million a year the company forecasts if approved in early pancreatic cancer.

Also in the Targovax pipeline is ONCOS-102, an oncolytic virus, which is in phase 1b/2 trials for mesothelioma and could produce an early readout in the coming weeks.

It is also developing ONCOS-102 in partnership with AstraZeneca’s MedImmune unit and the Cancer Research Institute for ovarian and colorectal cancer.

Jaderberg has been busy tapping up his contacts in big pharma having previously worked as chief medical officer for Bristol Myers Squibb in Europe.

He has already been in talks with manufacturers of checkpoint inhibitors to try and get licensing deals in place to fund further development.

Wiklund said: “It is tough as a small biotech to lift a phase 3 programme – it is obvious we are interested in licensing out one or both of our programmes.”

But Targovax’s CFO Erik Digman Wiklund was cagey about the prospects of a big buyout as seen in the case of Viralytics. “It is incredibly unpredictable, it is difficult to make any comment,” he said.


Pfizer might buy BMS for $130bn – but should it?

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Pfizer could soon launch a multi-billion dollar bid for immunotherapy rivals Bristol-Myers Squibb.

But moves into new fields of innovation and digital tech – such as Roche’s buyout of Flatiron – are likely to be more popular with investors.

Pfizer, the pharma company that become the world’s biggest through a series of mega-mergers, may be about to pull the trigger again.

This time, Pfizer could be sizing up Bristol-Myers Squibb, and would have to pay $125-130 billion to persuade BMS shareholders to agree any such deal, based on the company’s current $109 bn market value.

While there is always excitable chatter online about possible buy-outs, this prediction has come from a reputable source – Citi analyst Andrew Baum, one of the most high profile pharma analysts.

Last week Baum raised his price target for Bristol-Myers Squibb to $78 from $72, and he believes the probability of a Pfizer takeover has now risen from a 50/50 to a 65% chance of a bid.

At the core of BMS’ appeal to Pfizer is the huge success of its cancer immunotherapy Opdivo, which remains the leading checkpoint inhibitor, despite stiff competition from Merck’s Keytruda and others.

Baum gave three reasons why he believed Pfizer was now more likely to make a move. First is the good news BMS received from its Checkmate-227 trial in early February. This could put it back in contention in first line lung cancer treatment, where it has lost out to Keytruda and Roche’s Tecentriq.

Secondly, BMS sealed a major deal with Nektar last week on a next generation immunotherapy NKTR-214, a move which Baum believes could materially increase Opdivo’s market share.

Finally, Baum says Pfizer’s own immuno-oncology strategy is “looking increasingly suspect,” as it is failing to keep pace with the immunotherapy frontrunners. That means that a BMS buy out might be Pfizer’s last chance to have a stake in the $50bn annual immuno-oncology market.

And of course, anyone familiar with Pfizer and its current CEO Ian Read knows that big M&A deals are a Pfizer tradition. Plans for two earlier mega-mergers in recent years had to be aborted – a $118bn bid for AstraZeneca was defeated in 2014, and a $160 billion ‘reverse merger’ with Allergan had to be scrapped in 2016 because of US tax obstacles.

Now the US has passed tax reform, Pfizer has billions more to play with, and will undoubtedly be considering its options.

However times have changed, and it’s far from clear whether investors would be impressed with a mega-merger, a strategy which has fallen out of favour.

Nooman Haque is managing director of Life Sciences and Healthcare at Silicon Valley Bank’s UK division. He says ‘horizontal mergers’ which combine two broadly similar companies are less appealing in 2018.

“Pfizer are always touted as a likely acquirer, because that has been their modus operandi. But I get the sense that investors are a little bit sceptical of horizontal mergers.

“That’s because the equity story at the moment in life sciences is all about innovation – it’s not about driving out cost efficiencies and headcount reduction. That’s not the story that investors are buying into.”

Nooman says mergers based largely on cost savings and efficiency could even be viewed as a negative, because they don’t address the innovation gap.

Roche and Flatiron – the shape of things to come

Much more exciting are the companies opening up new fields such as cell and gene therapy, and digital health.
The most eyecatching deal in this latter category was Roche’s $1.9 billion outlay on Flatiron just last week.

Flatiron is a pioneer in digital health record analytics, particularly focused around cancer. By compiling and analysing real world health data digitally, Flatiron could help create a personalised medicine model which would revolutionise medicine.

Building robust digital records also opens up the possibility of AI and genomics being adopted faster into every day healthcare – something that big pharma will not want to be excluded from.

Daniel O’Day, head of Roche’s pharma division said the deal was an important step in its personalised healthcare strategy.

“We believe that regulatory-grade real-world evidence is a key ingredient to accelerate the development of, and access to, new cancer treatments. As a leading technology company in oncology, Flatiron Health is best positioned to provide the technology and data analytics infrastructure needed not only for Roche, but for oncology research and development efforts across the entire industry.”

One key point that O’Day stressed was that Flatiron’s autonomy would be preserved, as would its ability to providing its services to all, not just Roche.

While this raises questions about just how Roche will leverage its advantage, there is no doubt that this ‘open innovation’ model is the norm, and the only way to achieve penetration into a burgeoning digital health field.

Nooman comments: “It’s the sort of deal that could set off an M&A spree as Roche’s rivals look to make similar acquisitions. Novartis’s new CEO Vas Narasimhan is talking a lot about technology and AI in drug discovery, and there may be pressure on all these big players to find the ‘right’ digital deal that has the potential to transform their business.”

He adds: “Whether it’s AI drug discovery or acquiring large datasets, I don’t know, but in other industries similar follower behaviours are observed.”

Nevertheless, he agrees that finding synergies won’t be easy for Roche.

“Flatiron has a good, turbocharged Electronic Medical Record (EMR), and relationships with oncology clinics and (presumably) a great dataset. How that will be used depends on how open Roche are to change.

“The conservative vision would be to leverage those oncology clinic relationships to, for example, make recruitment and trial management easier – that’s not insignificant, but it’s also not ground-breaking.”

He says a more adventurous approach would be to deliver what Flatiron was created to do: a “data+ insights+relationships” combination which would allow Roche to develop therapies and treatment pathways that result in better patient outcomes.

“Delivering that will be a challenge, because Roche is still a large pharma company – and the fact that the deal is structured with the Flatiron team in place makes it look more like a division of Roche, feeding its oncology programme, and not a meshing of cultures.

He concludes: “Perhaps in the short term that’s the right way. But my feeling is the bigger prize is the potential for Roche to become a different type of pharma company.”

Given the huge excitement around such developments, Pfizer CEO Ian Read may think twice before pulling the trigger on a mega-merger, which would take years to deliver and would almost certainly see thousands of job losses in US-based R&D.

Pfizer does have plenty of other options, and already has partnerships with some of the most exciting biotech pioneers, including three companies working in different gene-editing technologies: Sangamo, Spark and CRISPR Therapeutics – all potential buy-out options if their platform proves its clinical value.

It is also investing in numerous small scale digital projects, including its Pfizer HealthcareHub in London. Given these options, Ian Read may well decide that 2018 is the year to move away from the tried-and-tested mega merger, and aim instead for that ‘different type of pharma company’ model now emerging.


Gilead signs $3bn-plus gene-editing deal with Sangamo

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Gilead Sciences has claimed another stake in the emerging cell therapy sector with a $3bn agreement to use Sangamo Biosciences gene-editing platform for new cell-based cancer therapies.

The company seems determined to stay in the forefront of the pharma industry’s push into cell therapies, with the latest deal coming shortly after it acquired CAR-T specialist Kite Pharma for $12bn and almost immediately bolted on another CAR-T tech through the takeover of Cell Design a few weeks later.

Sangamo is getting $150m upfront from Gilead in the deal, which will see Kite claim an exclusive license to use the biotech’s zinc finger nuclease (ZFN) technology to develop up to ten off-the-shelf (allogeneic) as well as autologous CAR-T therapies. It also stands to receive up to $3bn in milestones – $300m per product – as well as tiered royalties on sales.

Kite will be responsible for all development, manufacturing and commercialisation of products under the collaboration, and will be responsible for agreed upon expenses incurred by Sangamo.

Gene-editing techniques are used to modify the cells – either harvested from patients or taken from donor stocks – that are infused into cancer patients in order to mount an immunotherapeutic assault on cancers. The deal with Sangamo means rivals in the CAR-T category such as Novartis, Celgene/Juno and off-the-shelf specialist Cellectis won’t be able to use the ZFN technology in their own gene-editing toolboxes.

ZFN is a gene-editing approach that uses a DNA-cutting nuclease enzyme attached to zinc finger -binding proteins to recognize and edit specific sequences of DNA. Other techniques include CRISPR/Cas9 – used by Novartis and Juno – and Cellectis’ favoured TALENS.

However, according to CEO Sandy Macrae, Sangamo has made significant strides in improving the precision, efficiency and specificity of ZFN, which means the technique now “sets the standard on what therapeutic genome editing should be”.

He said that Kite’s “financial strength and clear determination” to bring new cellular therapies products forward makes it an ideal partner for ZFN in this setting.

Kite highlighted the potential of the technology for developing allogeneic CAR-Ts, which have been put forward as potentially a major advance over autologous therapies, as they should be much quicker and cheaper to deliver – an important consideration given the current debate over the escalating costs of cancer treatment.

“The emergence of gene editing as a tool to edit immune cells holds promise in the development of therapies with potentially improved safety, efficacy and efficiency,” commented Gilead’s CEO John Milligan.


Lupin scoops up women’s health specialist Symbiomix for $150 million

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The US arm of Mumbai’s Lupin Pharmaceuticals has announced that it is has acquired US-based gynaecologic treatment specialist Symbiomix Therapeutics for $150 million in a move to double down on its offerings in the women’s health market.

The deal comprises an upfront payment of $50 million in addition to a number of time-based and performance-based milestone payments, all funded from internal funds. “The acquisition of Symbiomix and Solosec franchise significantly expands Lupin’s branded women’s health specialty business, which is presently anchored by Methergine tablets,” the company said of the deal.

Solosec, Symbiomix’s key offering, is an oral granule treatment of bacterial vaginosis, approved by the FDA in September his year and expected to hit the market by mid-2018, with at least ten years of exclusivity in the US thanks to its designation as a Qualified Infectious Disease Product (QIDP).

“This transaction is an important milestone in the evolution of our specialty business and gives Lupin a new therapeutic to bring to obstetricians and gynaecologists to treat a serious health condition they see frequently in their practices,” commented Vinita Gupta, Chief Executive Officer of Lupin.

The move from Lupin represents a step forward in its drive to pursue expansion of its speciality drugs portfolio in the US, a strategy which has seen the company recently shift focus onto the areas of women’s health, paediatrics and neurology.


Merck buys into KalVista and its DME candidate

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Shares in KalVista Pharmaceuticals have surged on news of a deal with Merck & Co potentially worth more than $750 million.

Under the deal, Merck, which is known as MSD outside of the US and Canada, is paying KalVista $37 million upfront and taking a 9.9 percent stake in the firm in return for access to its experimental diabetic macular oedema drug KVD001.

KalVista has granted to Merck certain rights including an option to acquire KVD001 through a period following completion of the Phase II proof-of-concept trial that KalVista intends to commence later this year.

Merck also has a similar option to acquire investigational orally delivered molecules for DME that KalVista will continue to develop as part of its ongoing research and development activities.

KalVista also stands to bank further payments associated with the exercise of the options by Merck and the achievement of milestones for each programme potentially totalling up to $715 million.

“The KalVista team has already made important progress in advancing this candidate into the clinic. At Merck, we look forward to the opportunity to apply our expertise and resources upon the achievement of proof of concept for KVD001,” said Ben Thorner, senior vice president and Head of Business Development & Licensing Merck Research Laboratories, explaining the firm’s interest in the deal.