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Tuesday, September 25, 2018

Concerns About Debt and Value Continue to Be Raised Over Takeda-Shire Merger


As the acquisition of Dublin-based Shire by Japan-based ​Takeda Pharmaceutical edges forward, yet another major Takeda shareholder has spoken out in opposition to the deal.
The $62.2 billion deal was originally announced in May. And immediately, numerous analysts and shareholders expressed skepticism and concern over the deal. Most were worried that Takeda was taking on too much of Shire’s debt, part of the deal that would push the price closer to $80 billion. CNN wrote at that time, “The price tag has alarmed investors in Takeda: Its shares are down 18 percent since it first revealed it was considering an approach for Shire in late March. The Japanese company has a market value of just $33 billion, stoking fears about how much debt it will have to take on to fund the acquisition.”
Then a shareholder group strongly opposed the deal. During a June annual meeting, the group of 130 Takeda shareholders expressed their opposition and took action, advancing a proposal that would require advance shareholder approval be required for large acquisitions. The proposal received about 10 percent of votes in favor, essentially failing to pick up wider opposition to the merger.
Earlier this month, a member of the Takeda family, Kazu Takeda, aligned himself with the oppositional group, telling The Times, “Hasty decisions on big deals should be avoided. It will lead to disaster if there are large-scale mergers and acquisitions without careful consideration.”
He also said part of his opposition was the feeling the deal would undermine one of the primary principles of “Takeda-ism,” which is that the company makes money by making people happy. He told The Times, “We understand that scaling up is necessary, but Takeda management has to think about the traditional corporate culture and the health of the company.”
And now, a third voice has been added into the mix, although none of the opposition appears to be making headway in scuttling the deal. The Sunday Times reported this weekend that an unidentified investor, one of the top 10 shareholders in Takeda, expressed skepticism that value will be created from the takeover. The shareholder said, “There will be some value distraction from the deal. That’s why we are skeptical.”
The investor also said he believes that the combined value of the two companies is less than their individual value.
Takeda and its chief executive officer, Christophe Weber, are reported to have a plan to deal with the debt. There are possible plans to sell Shire’s Xiidra eye treatment once the deal is completed, and possibly sell its Natpara, a drug used to control blood calcium levels.
Bloomberg indicates Takeda is currently finishing the country regulatory approvals necessary for the deal, “most recently getting passage for the takeover in China. Further regulatory approvals remain before the companies’ shareholders will get a vote.”
Bloomberg News surveyed 25 “M&A and event-driven desks, equity analysts and fund managers,” to get their views on the deal. They expect the acquisition to be finished in March, in keeping with the company’s original guidance.
The combined companies will have headquarters in Japan. Takeda shareholders will own approximately 50 percent of the merged companies. They will have a combined workforce of about 52,000 people worldwide. The merged companies have projected job cuts of 6 to 7 percent, or low to mid 3,000s. Takeda is also considering consolidating Shire’s operations into its own in Boston, Switzerland and Singapore.
Takeda would gain more access to the U.S. market. Shire would gain more exposure in Japan and emerging markets.
The deal will require a positive vote of 75 percent of Shire’s voting shareholders. At this point, the original opposition group represents about 1 percent of voting shareholders. It remains to be seen whether continued criticism by major shareholders will gain any steam.

Medtronic Device Helps Paralyzed Patients Walk Again in Clinical Studies


A commercially-available medical device developed by Medtronic is helping paralyzed patients walk again.
The device, which stimulates the spinal cord through electrical pulses, has been successful in helping some individuals who lost the ability to walk through injuries to their spine, regain the ability to walk in a limited fashion. Three of four patients treated at the Kentucky Spinal Cord Injury Research Center with the device have regained some mobility. They are able to walk again with the assistance of the implanted device and a walker. An additional study conducted by the Mayo Institute documented the results of a single individual who had the device implanted. He was able to stand independently and walk 102 meters with a walker, Forbes reported this morning.
Following the patient’s positive experiences, the studies were published in the New England Journal of Medicine and in Nature Medicine.
Kendall Lee, the co-principal investigator from the Mayo Clinic, said the study has shown that the “networks of neurons below a spinal cord injury still can function after paralysis.” Kristin Zhao, also a co-principal investigator, said the next challenge is fully understanding how this happened, why it happened and which patients will best respond to the device.
As Forbes touts the patient successes in the spinal implant trial. Medtronic this morning announced the commercial launch of a new spinal cord treatment. The company launched the Infinity Occipitocervical-Upper Thoracic (OCT) System that is designed to simplify posterior cervical spine surgery. The Infinity OCT System is a “complete procedural solution that integrates navigation and biologics with Medtronic’s comprehensive devices and instrumentation to create efficiency in fusion procedure workflows for the upper back and neck,” the company said.
The new system is used to immobilize and stabilize the spine while it fuses. Medtronic said. There are innovative components including a multi-axial screw with 60 degrees of angulation in any direction, a set screw (locking cap) with a quick-start thread to minimize cross threading, and 3.0mm and 5.5mm diameter screws for expanded patient demographics and clinical applications, according to company data.
When paired with other Medtronic devices, the O-arm Imaging System and StealthStation Navigation System, Medtronic said the Infinity OCT System “provides a fully-enabled procedural solution designed to bring efficiency and simplicity to even the most complex posterior cervical procedures.”
Doug King, the president of Medtronic’s spine division, said the company has spent the past 35 years advancing new technologies aimed at improving spinal patient outcomes.
“We engineered every component of the Infinity OCT System to perform efficiently during the most complex spine procedures, as well as to integrate seamlessly with our market-leading imaging and navigation technologies,” King said in a statement.
The Infinity OCT System is indicated for certain conditions including degenerative disc disease, instability or deformity, tumors, and traumatic spinal fractures or traumatic dislocations. Spine trauma can sometimes result in a spinal cord injury.
Medtronic anticipates the global commercial availability of the new system in the later part of 2018 and in 2019.

Oasmia Gets Positive Opinion for Apealea(R) (paclitaxel micellar) in EU


Apealea receives positive CHMP opinion in the European Union for treatment of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer in combination with carboplatin in first relapse
Uppsala, Sweden, September 21, 2018 – Oasmia Pharmaceutical ABOASM, +22.98% today announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Apealea in combination with carboplatin for treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. The CHMP considers that the product Apealea in combination with carboplatin has a positive benefit-risk balance and is considered approvable for the above-mentioned indication.
The CHMP’s positive opinion will now be considered by the European Commission. If the CHMP opinion is affirmed, the European Commission will grant a centralized marketing authorization with unified labelling that is valid in 28 countries of the European Union (EU), as well as the European Economic Area members, Iceland, Lichtenstein and Norway.

Wells Fargo Bullish On Applied Genetic Technologies Ahead Of Program Update

The bullish case for Applied Genetic Technologies Corp AGTC 19.34%, a nano-cap biotech conducting human clinical trials of adeno-associated virus-based gene therapies, can be made on the basis of an encouraging pipeline and valuation reasons, according to Wells Fargo.

The Analyst

Wells Fargo's Jim Birchenough upgraded Applied Genetic Technologies from Market Perform to Outperform with a price target lifted from $6 to $20.

The Thesis

Applied Genetic's peer Nightstar Therapeutics PLC NITE 2.49% released initial data from a Phase 1/2 study of its product candidate NSR-RPGR that showed multiple patients achieved an improvement in microperimetry, Birchenough said in the upgrade note. (See his track record here.)
This is notable, as Nightstar's efficacy in visual fields validates Applied Genetic's ongoing Phase 1/2 trial with its partner Biogen Inc BIIB 0.24%, the analyst said. There's evidence of higher gene expression with Applied Genetic's vector than with Nightstar's AAV8 vector, he said.
Nightstar's data release should be well-received by investors ahead of Applied Genetic's data flow and program updates in its X-linked retinitis pigmentosa trials, Birchenough said.
With the stock is trading below its cash on hand and at a discount to Nightstar, Applied Genetic has favorable risk-reward profile, according to Wells Fargo.
https://www.benzinga.com/analyst-ratings/analyst-color/18/09/12394892/wells-fargo-bullish-on-applied-genetic-technologies-ahe

Baird: Not surprised by upside pre-announcement from Tandem Diabetes


After Tandem Diabetes pre-announced better than expected Q3 revenue and an updated full-year view that implies Q4 revenue largely in line with consensus estimates, Baird analyst Jeff Johnson said he was not surprised by the upside and expects the company’s solid fundamentals to persist as U.S. growth remains strong and international revenue starts to contribute. However, he thinks the current valuation reflects this strength and maintains a Neutral rating and $47 price target on Tandem Diabetes shares.
https://thefly.com/landingPageNews.php?id=2795255

Cambrex to expand, invest at High Point, North Carolina site

Cambrex Corporation announced that it is to establish a center of excellence for API clinical supply and process development at its site in High Point, North Carolina. Cambrex will acquire its currently leased 35,000 sq. ft. facility, as well as an adjacent 45,000 sq. ft. building which will be fitted out with kilo-scale and pilot-scale vessels, continuous reaction production, and chemistry, engineering and analytical development laboratories. The purchase of the current and adjacent facility is in response to growing customer requirements for clinical supply manufacturing, analytical and chemical development. The center will also focus on the development of new technologies, innovative chemistry and engineering solutions as well as expertise in technology transfer to commercial scale. At its High Point facility, Cambrex produces complex APIs and intermediates requiring multi-step synthetic processes in batch sizes from milligrams to 100 kg in support of clinical trials from Phase I through to Phase III. The site is licensed with the US Drug Enforcement Administration to manufacture Schedule II to Schedule V controlled substances. The acquisition enhanced Cambrex’s portfolio of small molecule API services and complements its large scale, multi-purpose manufacturing facilities in the US and Europe.
https://thefly.com/landingPageNews.php?id=2795249

Humana, University of Houston announce long-term strategic partnership


Humana and the University of Houston announced a long-term strategic partnership to train the health care leaders of tomorrow with a focus on advancing population health, improving health outcomes and expanding the use of value-based payment models. Together, the two organizations will create the Humana Integrated Health System Sciences Institute at the University of Houston, which will unite the university’s new College of Medicine, as well as the existing colleges of Nursing, Pharmacy, Social Work and Optometry. A $15M gift over 10 years from Humana will help defray start-up and operational costs for the College of Medicine, as well as fund endowed chairs for each of the five colleges. The strategic collaboration is designed to graduate physicians, nurses, pharmacists and other health care professionals who are trained in population health and have a propensity for primary care and for working with the underserved. With its emphasis on underserved communities, the University of Houston and Humana partnership aligns with Humana’s Bold Goal of improving the health of the communities it serves 20 percent by 2020 by making it easier for people to achieve their best health. Humana is taking a population health approach to pursue this goal, while working to address social determinants of health such as food insecurity, social isolation and inadequate transportation.
https://thefly.com/landingPageNews.php?id=2795139