< PreviousM&A ROUND-UP10 Pharma Business International www.pbiforum.netCEO Severin Schwan said the deal may offer “important new opportunities for the treatment of serious diseases”. Roche is far from alone with fortifying its presence in this field, with Thermo Fisher Scientific announcing in March its $1.7 billion acquisition of Brammer Bio, a Cambridge, Massachusetts-based CDMO which enables biopharmaceutical customers to deliver breakthrough medicines by unleashing the potential of gene therapies and gene-modified cell therapies. In the words of Thermo Fisher President and CEO Mark N. Casper, the deal brings together Brammer Bio’s viral vector capabilities together with its own Good Manufacturing Practice production expertise and propriety bioprocessing and cell culture technologies. This, he said, allows the company to partner with its customer to “drive the evolution of this incredibly fast-growing market”. Slated to close by the end of the second quarter of 2019, the deal will see Brammer Bio become part of Thermo Fisher’s pharma services business inside its Laboratory Products and Services Segment. Below the billion-dollar-deal mark there’s been a flurry of activity with Biogen swooping for London-based clinical stage gene therapy company Nightstar Therapeutics for $800 million. Biogen said the deal is motivated by the company’s desire to capitalise on its emerging growth area of ophthalmology. Nightstar has several clinical programmes, including its lead asset, aimed at treating rare retinal diseases which Biogen aims to develop when the deal closes by mid-2019. Pfizer has joined its fellow top ten pharma player Roche in boosting its presence in the gene therapy field after revealing in March that it was buying French biotech Vivet Therapeutics in deal worth up to $686.8 million. The deal better positions the $53.6 billion turnover Pfizer in the gene therapy space in a move that will see it co-develop Vivet’s propriety treatment for Wilson disease – a rare chronic liver disorder. Pfizer said the move could result in a “breakthrough 08-11.qxp_Layout 1 05/04/2019 13:24 Page 3Pharma Business International 11 www.pbiforum.netM&A ROUND-UP© Shutterstock /Phongphanmedicine”. It isn’t only major players getting in on the gene therapy action, with US medical research and drug development company Sarepta Therapeutics recently exercising its option to acquire Myonexus Therapeutics – an Ohio-based company developing first-ever corrective gene therapies for Limb-Girdle muscular dystrophies (LGMD) – for $156 million. The deal follows on from an exclusive partnership between the two companies originally announced back in May 2018. At the time, the two parties came together to develop Myonexus’ five LGMD gene therapy candidates. Three of these programmes are currently in clinical development, while the other two are in the pre-clinical stage and ready to progress to the clinic. Although gene therapy has dominated the market these last few months and, indeed, much of this issue’s column, we’d be remiss without providing an update on the biggest pharma deal of recent times. We’re talking, of course, of Bristol-Myers Squibb’s (BMS) historic $74 billion acquisition of Celgene. It hasn’t all been smooth sailing of late after Wellington Management, the largest shareholder in BMS with eight per cent stake in the company, informed the board of directors that it is “not supportive” of the proposed acquisition. Although the investment management firm agreed that BMS should be active in business development, it said that it “does not believe that the Celgene transaction is an attractive path”. This opposition was followed by activist hedge fund Starboard Value stating in late February that it intended to use its one million share stake in the company to block the acquisition. However, a month later Starboard pulled out of the fight claiming it was unlikely its opposition would have any effect on the acquisition. The deal has now secured the backing of proxy advisory firm ISS, sparking a six per cent jump in Celgene shares. At this stage, it looks as though the deal will go through after a vote to be held on April 12. In any outcome, doubtless it will feature predominantly in next issue’s round-up. 08-11.qxp_Layout 1 05/04/2019 13:24 Page 4BIRTH CONTROL EXPOSÉ12 Pharma Business International www.pbiforum.net© Shutterstock /d_odinThe new wave of male birth control 12-15.qxp_Layout 1 05/04/2019 13:25 Page 1Pharma Business International 13 www.pbiforum.netBIRTH CONTROL EXPOSÉThough there have been several promising studies into male contraceptives, most have floundered during clinical studies, been shuttered over safety concerns or exhausted their funding. Perhaps the biggest cause is a reticence from funders to throw their weight behind research and studies assuming that there isn’t enough interest in a male contraceptive. Yet a recent YouGov poll found that thirty-three per cent of British men would take male birth control. It’s interesting to note that this is the exact same proportion of British woman who currently take a birth control pill. This figure rises to forty per cent among twenty-five to forty-nine-year olds – typically the age bracket where men have their first child. Figures from the Office for National Statistics found that, in 2015, the average age of first-time fathers in the UK rose to 33.2 years. The most interesting statistics from the YouGov poll might be that eight in ten believe that men and women should share the responsibility for contraception, a goal that some experts argue is still at least a decade away from reality. Though still very much in its testing stages, the new wave of male birth control works by decreasing sperm count in semen to the point where an individual would be considered infertile. Whether taken orally or through a topical gel, these solutions typically use a combination of testosterone and progestin. The latter is present in both sexes; in women, it plays an important role in menstruation and pregnancy, while its vital to the production of testosterone in men. This combination suppresses the follicle-stimulating and Despite a near sixty-year history, modern contraception has been aimed almost exclusively at women. At present, men are limited to condoms or a vasectomy, but a male hormone contraceptive might be closer to market than not. 14 Á12-15.qxp_Layout 1 05/04/2019 13:25 Page 2of promising contraceptives are progressing. A topical gel called NES/T containing the testosterone and progestin combo suppresses the body’s natural sperm production when rubbed regularly into the shoulder. In a recent clinical trial, four hundred couples in nine cities around the world used the gel in place of other contraceptives in their everyday lives. Researchers monitored sperm counts and any side effects that arose. Over a decade in the making, the gel was developed by researchers at Los Angeles Biomedical Research Institute and the University of Washington. Assuming it makes it to market, the gel will become the first hormonal BIRTH CONTROL EXPOSÉluteinizing hormones which, when sufficiently low, prevent sperm from forming. However, this comes with the unwanted side effect of decreasing testosterone which can lead to a lower sex drive, hair loss, fatigue, loss of muscle mass, increased body fat, decreased bone mass and more. Therefore, a testosterone replacement is critical in male contraception. Presently, none of the potential new contraceptives aimed at men have reached Phase 3 trials, where medicines and treatments are tested to see how they compare with placebos. The majority are in phase 1 or 2, which use smaller groups to access safety and its in these stages where a number 14 Pharma Business International www.pbiforum.net© Shutterstock /areeya_ann© Shutterstock /Sven Hoppe12-15.qxp_Layout 1 05/04/2019 13:25 Page 3BIRTH CONTROL EXPOSÉcontraceptive available for men. Enovid, the first oral contraception for women, was first approved by the United States Food and Drug Administration back in 1960. Since then, there hasn’t been a single male equivalent, putting much of the onus and responsibility for birth control on women, many of whom are unable to use hormonal contraceptives. But a new oral contraceptive for men might be closer to reality than not after a promising candidate recently passed safety and tolerability tests, producing hormone responses consistant with effective contraception. Called 11-beta-methyl-19-nortestosterone-dodecylcarbonate (or 11-beta-MNTDC), the potential pill is a modified testosterone that has the combined actions of the male hormone androgen and progesterone. According to the study’s co-senior investigator, Christina Wang, Associate Director at Clinical and Translational Science Institute at the Los Angeles Biomedical Research Institute, the results suggest that “this pill, which combines two hormonal activities in one, will decrease sperm production while preserving libido”. This drug had already cleared a single-dose test in a small starter trial involving a dozen healthy men. This latest clinical study tested forty healthy men aged between eighteen and fifty, all of whom were given a pill in addition to ten who received a placebo. Though the pill seriously lowered men’s testosterone levels, the research paper’s abstract claims that none of the men suffered “serious adverse events”. Despite the successes witnessed in the trial, Wang admits that we are likely at least ten years away from a male contraceptive hitting the market. By then, over seventy years after Enovid was approved, there might just be true equality in birth control. Pharma Business International 15www.pbiforum.net12-15.qxp_Layout 1 05/04/2019 13:25 Page 4PROCESSING16 Pharma Business International www.pbiforum.net© Shutterstock /Fisherman64Automating excellence Automating excellence 16-19.qxp_Layout 1 05/04/2019 13:26 Page 1Pharma Business International 17 www.pbiforum.netPROCESSINGThe pharmaceutical supply chain has always been one of the most complex and forward thinking, given the nature of the products that move through it. Although many of the same machines used in the processing and production of pharmaceuticals can also be found in food factories, medicines present a unique quandary. With complex, sensitive and sometimes volatile ingredients being handled and processed, a similar level of intuitive and multifaceted machines are needed. A human workforce invites accident and error, and with the best will in the world, a flesh and blood worker is fallible and prone to physical fatigue and a whole spectrum of emotional and psychological issues. A robot worker shares none of these concerns and, maintenance, cleaning and servicing aside, can run indefinitely. Though automation is a familiar sight in a typical pharmaceutical processing plant, human workers, for now, are still necessary. The times, though, are a changing. A number of reports have indicated that tens of thousands (in some cases hundreds of thousands) of workers will lose their jobs to robots and automation in the coming decades. The lack of a With access to medicines continuing to advance, and patient care improving all round, new revenue streams are being made available to the market year on year. As with almost every other industry reliant on complex manufacturing, automated technology is having a transformative effect. 18 Á16-19.qxp_Layout 1 05/04/2019 13:26 Page 2PROCESSING18 Pharma Business International www.pbiforum.netdefinitive answer shows that nothing is sacrosanct and we’re still running on assumption, yet the fact of the matter is that the robots are coming. Far from what the doom-mongering tabloids would have us believe, the influx of automation is the great next great industrial leap forward. Leveraging this shift could usher in greater benefits for workers, as well as opening an entirely new sector in the design, manufacture and maintenance of these automated systems. Although Governments in the UK, US and elsewhere are pondering the ethical dilemma posed by robot workers, whether they should be taxed or are entitled to the same rights as their human counterparts, there’s still decades to adjust the industrial status quo. With its acceptance of new technologies, the pharmaceutical industry is considered a leader. Alongside the influx of new markets and greater numbers of previously untapped consumers, the global pharma market is being driven by its willingness to investigate new technologies. Key to this growth is companies putting their money where their proverbial mouth is and invest in new technologies. Some of the most recent developments are taking place in packaging machinery, where © Shutterstock /Gorodnkoff16-19.qxp_Layout 1 05/04/2019 13:26 Page 3PROCESSINGPharma Business International 19 www.pbiforum.netmachines without electrical cabinets – or entirely cabinet-less – are becoming a more common fixture on the production line. The servo modules within the control architecture for robots, significantly reduces the number of electronic parts, eliminating the need for some cabinets. Benefits of this include lower maintenance costs (due to reduced electronics), greater efficiency and the availability and use of identical system parts. With the industry’s position as a leader, if these technologies and more demonstrated adequate aptitude in the pharmaceutical sector, other markets that are typically slower to adopt new tech may embrace it also. Though political posturing, price hikes and corporate greed might suggest otherwise, pharma’s first port of call is to its patients. By the sector’s very nature, patients are (by and large) at the heart of everything it does. It makes sense that it is also benefiting society by diving technological growth in other areas, be it food or other consumer products. Automation is here to stay and for the pharmaceutical industry, that’s a welcomed state of affairs.© Shutterstock /Dmitry KalinovskyFar from what the doom-mongering tabloids would have us believe, the influx of automation is the great next great industrial leap forward.16-19.qxp_Layout 1 05/04/2019 13:26 Page 4Next >