Gilead investors see Celgene veteran Jackie Fouse as top pick for CEO spot

Biotech investors may still be getting over the shock of the departure of Gilead’s top two executives, but that hasn’t stopped analysts from speculating about who will be the troubled company’s next CEO.

Topping the list of a possible replacement for departing CEO John Milligan, Ph.D., is Jacqualyn “Jackie” Fouse, Ph.D., who had a seven-year stint as the chief financial officer and then chief operating officer at Celgene. That’s the suggestion from RBC Capital Markets analyst Brian Abrahams, who conducted an investor survey and revealed the results to investors in a note he sent out Monday.

Yes, Celgene had some troubles of its own during Fouse’s tenure, and she would have to relocate from the East Coast, but “given her track record (both vision and execution), relationship with the Street, and ability to attract talent, we believe her presence at [Gilead] would be well received,” Abrahams wrote.

The news of Milligan’s departure, which was announced along with the retirement of chairman and former CEO John C. Martin, Ph.D., came during the company’s second-quarter earnings report last week. The financial results revealed a continuing downward slide for the company, which has been suffering from the rapid drop in demand for its hepatitis C stars Sovaldi and Harvoni. During the quarter, product sales fell 21% year over year to $5.6 billion, and earnings per share plummeted 40% to $1.39.

So does Fouse have the chops to engineer the turnaround Gilead so desperately needs? The company is counting on some of its newer products to drive revenue growth going forward, including CAR-T cancer therapy Yescarta, so her oncology background would certainly come in handy. Fouse joined Celgene as CFO in 2010, moving on to take over the company’s hematology and oncology unit, before being named president and COO in 2016.

Fouse left Celgene abruptly last February, after the company named Mark Alles as its new CEO. Fouse and Alles had apparently been competing to take over the C-suite from Bob Hugin, who retired to run for a U.S. Senate seat. Still, Fouse’s departure was a surprise, and some industry watchers speculated at the time that she would soon show up as CEO of another biotech company. Fouse reportedly turned down the opportunity to take over as CEO of Teva last August and she’s now executive chairman of Dermavant, a company that’s developing a drug to treat excessive sweating and that recently bought the rights to a late-stage experimental drug to treat psoriasis and atopic dermatitis from GlaxoSmithKline.

Fouse was the winner of Abraham’s investor survey by a wide margin, though some other interesting names were proposed as good choices to lead Gilead. Some respondents suggested the company should find its next CEO via a merger, perhaps with Vertex (Jeff Leiden) or Pfizer (Ian Read). Others proposed that Gilead steal away the head of another big biotech company, such as Amgen CEO Bob Bradway or Roche Pharma CEO Daniel O’Day. Chief scientific officers might also be well-suited to take on Gilead’s challenges, some said, including Merck’s Roger Perlmutter and GlaxoSmithKline’s Hal Barron.

Gilead is expected to select a replacement for Milligan by the end of the year, when he is scheduled to step down. Martin plans to depart when the new CEO is named.

The prospect of such a radical change in the top ranks of Gilead has generated some agita on the Street. Leerink analyst Geoffrey Porges fears that “given the company’s mixed hiring record, the appointee may not necessarily be an individual with immediate industry or investor credibility,” he wrote in a note to investors last week. Jefferies analyst Michael Yee acknowledged in a note that the change “brings uncertainty” in the short term.

Still, wrote Yee, the prospect of a “new” future for Gilead also offers hope for “more pipeline, more bold steps, more aggressive BD, and a chance for PE expansion and stock appreciation.” Gilead’s decision to clean house may be nerve-racking, he wrote, but it could very well transform the company “from pharma-like, to more biotech-like.”

https://bit.ly/2AAcBpo

Molina 2Q Results; Increases Fiscal Year 2018 Guidance

• Net income of $3.02 per diluted share on a GAAP basis in the second quarter of 2018, compared with $1.64 per diluted share in the first quarter of 2018
• Second quarter 2018 results include a net benefit of $0.83 per diluted share for non-run rate items, primarily relating to the 2017 Marketplace risk adjustment
• Premium revenue increases $191 million, or 4.4%, in the second quarter of 2018 compared with the first quarter of 2018
• Medical care ratio of 85.3% in the quarter
• General and administrative expense ratio of 6.9% in the quarter
• Net profit margin of 4.1% in the quarter and 3.2% year to date
• 2018 guidance increases by $3.00 per diluted share at the midpoint to a range of $7.15 – $7.35 net income per diluted share on a GAAP basis
• 2018 guidance includes the net benefit of $0.96 per diluted share for the non-run rate items recorded in the first half of the year

https://bit.ly/2v7EmQG

FDA’s Gottlieb on antimicrobial stewardship in veterinary settings

Antimicrobial resistance is a global public health challenge. Antimicrobial drugs have been widely used in human and veterinary medicine for more than 60 years. When used judiciously, antimicrobials can effectively fight bacterial infections. However, we know that overuse or misuse of these drugs promotes the development of antimicrobial-resistant bacteria.

For all of these reasons, it’s critical that we implement good antimicrobial stewardship practices in human healthcare and veterinary settings. We must continue to take new steps to slow the development of resistance and extend the usefulness of these lifesaving drugs.

Combating antimicrobial resistance continues to be a top priority for the U.S. Food and Drug Administration (FDA).

To further these efforts, the FDA will soon implement a new, five-year blueprint for how the FDA plans to build on its current programs to advance antimicrobial stewardship in veterinary settings. We’ll expand on the FDA’s existing actions, and launch some new programs. Our aim is to reduce overuse of antimicrobial drugs and combat the rising threat of resistance.

As part of the FDA’s regulatory mission, our Center for Veterinary Medicine (CVM) is responsible for ensuring the safety and effectiveness of animal drugs, including antimicrobials. CVM has already taken important steps to update the approved conditions of use for medically important antimicrobials (i.e., antimicrobials important for treating human disease) to support judicious use in food-producing animals. While important progress has been made, we know that additional work is needed to address the complex challenge of antimicrobial resistance.

At FDA, we believe that the concept of antimicrobial stewardship encompasses several important principles of judicious use. These are critical to slowing the rate at which bacteria develop resistance to antimicrobial drugs. In simple terms, we believe medically important antimicrobial drugs should only be used when necessary to treat, control or prevent disease. In addition, when such use is necessary, these antimicrobials should be used in an optimal manner. They should only be used under the oversight of a licensed veterinarian.

Among the steps that CVM has already taken, perhaps the most significant action was implementation of Guidance for Industry #213. On Jan. 3, 2017, the FDA announced that it had completed implementation of GFI #213. This was the culmination of a process launched in 2013. The goal was to transition medically important antimicrobials that are used in the feed or drinking water of food-producing animals to veterinary oversight, and to eliminate the use of these products in animals for production purposes, such as for growth promotion.

Of the 292 new animal drug applications initially affected by GFI #213, 84 were completely withdrawn. Of the remaining 208 applications, 93 applications for oral dosage form products intended for use in water were converted from over-the-counter to prescription status; while another 115 applications for products intended for use in feed were converted from over-the-counter to veterinary feed directive status. Moreover, production indications (e.g., growth promotion) were withdrawn from all 31 applications that included such indications for use.

Last year, we also published a paper proposing the use of a biomass denominator to adjust annual data on the amount of antimicrobials sold or distributed for use in food-producing animals in the U.S. This adjusted estimate is intended to provide more insight into broad shifts in the amount of antimicrobials sold for use in food-producing animals and give the FDA a more nuanced view of why sales increase or decrease over time in a manner that is specific to U.S. animal production. The agency also recently launched the Resistome Tracker. This is an interactive research and data visualization tool for antibiotic resistance genes.

To build on the progress already made, we’re announcing that the FDA will shortly publish a blueprint on how we’ll press forward and implement additional steps to address antimicrobial resistance in veterinary settings. This blueprint will serve as the FDA’s new, five-year plan. We’ll include key goals, objectives and actions that CVM will focus on during fiscal years 2019 – 2023.

Our new activities will be aimed at addressing three key goals:

Aligning antimicrobial drug product use with the principles of antimicrobial stewardship; supporting efforts to foster better stewardship of antimicrobials in veterinary settings; and enhancing the monitoring of antimicrobial resistance and antimicrobial drug use in animals.

The specific objectives and actions will be outlined in our forthcoming plan.

Some of the important issues to be addressed in this new plan include establishing appropriate durations of use of medically important antimicrobials, and bringing all dosage forms of medically important antimicrobials under veterinary oversight. We are also developing and advancing new strategies for promoting antimicrobial stewardship in companion animals.

We’ll advance these goals in new guidance that the FDA will develop with broad stakeholder input. And we’ll enhance transparency and keep the public apprised of progress being made.

For example, we’ll shortly publish a list of all medically important antimicrobials labeled for use in animals that lack a defined duration of use on their labels. We’ll keep this list updated as we work to implement a science-based approach for addressing this important issue.

We’re also advancing new strategies to improve the collection and sharing of data on antimicrobial drug use and resistance. To advance evidence-based practices, we need to make sure that the entire community has access to good information. And we need to develop a long-term strategy for implementing a practical, efficient antimicrobial use monitoring and reporting system for veterinary settings. Our plan will address new ways to advance these goals.

Many stakeholders helped make our previous efforts a success. These include the animal pharmaceutical and feed industry; veterinary organizations; animal producer organizations; consumer organizations; various local, state and federal agencies; legislators; and other key stakeholders.

I look forward to releasing this plan shortly, and continuing to work collaboratively to promote stewardship and preserve the effectiveness of antimicrobials for human and animal health.

For more information:
Antimicrobial Resistance 
Judicious Use of Antimicrobials

https://bit.ly/2KdtPbD

Curcumin Extract Targets Fatty Liver Disease

New study investigating BCM-95® turmeric extract for potential as a preventive and treatment agent for Non-Alcoholic Fatty Liver (NAFLD) disease demonstrated exciting results. BCM-95 offers a potentiated delivery form of curcumin, a naturally occurring plant polyphenol. BCM-95 is a leading brand in the US curcumin supplement space, marketed by DolCas Biotech.

Inherent to the unique composition of BCM-95 is a full complement of pure curcuminoids and essential oils from turmeric, with a specific content of turmerones, ensuring high free-curcumin bioavailability.

The latest study was conducted at the Harry S. Truman Memorial Veterans Hospital in Columbia, Mo., and published on July 16, 2018, in the journal Physiological Reports. The robust 4-arm parallel-run murine study was led by Rory P. Cunningham, et al, at the University of Missouri Department of Nutrition and Exercise Physiology and examined BCM-95 across various parameters of liver function.

Specifically, the study focused on comprehensive changes occurring in NAFLD. Results demonstrated that supplemental dietary curcumin attenuated the development of NAFLD, as well as diminished its progression to the more severe Non Alcoholic steatohepatitis (NASH) in female Wistar rats, via its ability to reduce inflammation, oxidative stress, and hepatic steatosis. All three factors coexist in the pathology of Fatty Liver Disease.

The researchers suggested that curcumin’s role in reducing hepatic steatosis, as evidenced by increased protein markers of key lipogenesis enzymes (pACC/ACC) and lipid transporter ApoB100, acted to mitigate progression to NASH.

BCM-95 treatment was shown to decrease molecular markers of hepatic fibrosis and significantly reduce hepatocellular inflammation in both the treatment and prevention models, with significantly lowered serum markers of liver injury (AST and ALP).

In addition to these and other marked decreases in biochemical markers of the disease, reductions of fibroblast growth factors connected with resistance to blood glucose control by the liver in obese and overweight persons also occurred.

“A nearly two-point reduction in the NAFLD Activity Score (NAS) is quite significant for a plant-based ingredient, like BCM-95,” notes Shavon Jackson-Michel, ND, Director of Medical & Scientific Affairs at DolCas Biotech. “This is especially significant since there are few conventional treatments for NAFLD, a dysfunction believed to affect some 30% percent of the population.”

BCM-95’s uniquely bioavailable and bio-efficacy enhanced curcumin product is favored by many formulators. The 15-year-old brand is now supported by 50 studies. BCM-95 holds GRAS status and is kosher and halal certified.

DolCas Biotech, LLC, owns the worldwide brand rights of BCM-95 in a joint venture with India-based manufacturer, Arjuna Naturals Extracts, Ltd. With full oversight of BCM-95’s entire supply chain, a 15-year history of safe use, and GRAS status (as affirmed by a panel of experts and uncontested by the FDA) DolCas and Arjuna offer the industry a pure, clean, and safe raw material.

https://bit.ly/2v7AH5q

For Pfizer 1st FDA OKd Erythropoietin Stimulating Agent, No Rapid Uptake Seen

Plagued by regulatory delays, the FDA finally granted approval for Retacrit in May 2018, making it the first biosimilar erythropoietin-stimulating agent (ESA) to become available in the US market. Vifor Pharma, which also holds exclusive US commercialization rights to Roche’s Mircera, a long-acting ESA, will be responsible for Retacrit commercialization in the US dialysis setting. A survey of 202 nephrologists in June 2018 indicates a lukewarm audience with respect to Retacrit.

In general, about 45% of nephrologists are accepting that Retacrit will be equivalent to Amgen’s Epogen and Janssen’s Procrit in terms of efficacy and safety, and about 60% report being comfortable with the risk-benefit profile of biosimilar ESAs in both the dialysis and chronic kidney disease (CKD) setting. However, a growing preference for long-acting ESAs, Amgen’s Aranesp and Mircera, may present an uphill battle. Indeed, the most significant shift observed this quarter in the dialysis setting is the expansion of Mircera into small/medium dialysis organizations. Securing preferred status for Retacrit at one of the Large Dialysis Organizations, either DaVita or Fresenius Kidney Care, could catapult the brand, as was observed when Fresenius converted to Mircera in 2015. Only 15% of the surveyed nephrologists indicated they would be displeased if their primary dialysis unit converted, however, they are largely opposed to mandates requiring the switch of patients who are stable on their current ESA.

In the CKD non-dialysis (CKD-ND) setting, where ESA treatment rates are significantly lower, the dynamics are slightly different. About half of the office-based nephrologists stock ESAs in their practices, operating a “buy and bill” practice. Although Procrit has a higher share, a greater percentage of nephrologists prefer long-acting Aranesp in the CKD-ND setting, and 21% report that this preference will be a barrier to the use of Retacrit in this setting. Close to 40% of the nephrologists practicing in offices that do stock ESAs state that they will only be inclined to stock Retacrit if use is mandated by insurance companies.

The anemia market is much more tumultuous in the CKD-ND setting, where Keryx is actively promoting the new indication for Auryxia to treat iron-deficiency in non-dialysis patients. While iron utilization trends in the dialysis setting are essentially flatlined (Venofer continues to dominate, Triferic continues to languish) in the non-dialysis setting, Keryx is challenging the status quo and appears to be winning. More than half of the nephrologists report use of Auryxia for the IDA indication with robust future projections across all stages of CKD-ND. Two-thirds report that the new indication has led to increased use of the brand overall, and 46% state that they are likely to use Auryxia prior to IV iron. The availability of samples appears to be a key driver of new patient starts, and in a setting where promotion of IV and oral iron products is almost non-existent, Keryx’s active presence is strongly correlated to Auryxia uptake. Since the approval of Auryxia, a growing percentage of nephrologists are reporting a decrease in the use of IV iron.

Looking to the future, nephrologists largely agree that there is an opportunity to improve renal anemia outcomes in both the dialysis and CKD-ND settings. However, the comparative level of unmet need for new renal anemia therapies pales in comparison to the level of unmet need for agents such as Proteon Therapeutics’ vonapanitase for improved vascular access outcomes in dialysis and the need for new treatments for diabetic nephropathy in CKD-ND. Although familiarity has been steadily rising for the HIF-PH inhibitors (AZ/Astellas/Fibrogen’s roxadustat, Akebia/Otsuka’s vadadustat, and GSK’s daprodustat), only 12% selected one of these agents as the most desired pipeline agent. Early expectations suggest that many nephrologists expect the HIFs to have a safety advantage over ESAs, to be priced at a premium to ESAs, and to largely be used in populations not eligible for ESA treatment. A stronger market access position, in terms of formulary status at dialysis units, insurance coverage, and out-of-pocket costs, may be the deciding factor as to which HIF dominates, as presently the agents are viewed as largely interchangeable. The recently announced merger between Keryx and Akebia creates a potential competitive commercial advantage for vadadustat. In leveraging the growing momentum and existing commercial structure for Auryxia, the combined force has the unique opportunity to position iron therapy alongside HIF-PH therapy, and companies with “renal know-how” tend to fare well in this highly promotion-sensitive specialty.

RealTime Dynamix™: Renal Anemia (US) is an independent report series published on a quarterly basis. The series provides a close-quarters analysis of key performance metrics, focusing on brand gains and losses, industry contact rates, familiarity and adoption rates of recently launched products and awareness of products in development. The next quarterly update will be released in September.

https://bit.ly/2M75RA

Shire’s Sales Up Ahead of Takeda Acquisition

As its acquisition by Takeda Pharmaceutical edges closer and closer, Shire reported a solid second-quarter.

Shire reported $3.809 billion in product sales, an increase of six percent, and total revenues for the quarter of $3.920 billion, an increase of five percent. Operating income from continuing operations was $830 million, an increase of 108 percent, while non-GAAP operating income was flat at $1.492 billion. Net income was up 156 percent to $616 million.

“Shire continued to deliver on its key priorities of commercial execution, pipeline advancement, debt pay-down, and portfolio optimization during the second quarter,” said Flemming Ornskov, Shire’s chief executive officer, in a statement. “We drove product sales growth of six percent over the prior year period led by the strong performance of our Immunology franchise, continued uptake of our recently launched products, and expansion in international markets.”

Reuters notes, “Earlier on Tuesday, Takeda said its first-quarter operating profit had halved from a year ago, when it had booked gains from asset sales. It is buying Shire to broaden its drugs portfolio and plug a gap in its late-stage pipeline.”

The acquisition deal was officially made on May 8, with Takeda buying Shire for $62.2 billion. Earlier in the deal process, Shire sold its oncology business to France’s Servier for $2.4 billion. Oncology was a small part of Shire’s portfolio, bringing in about $262 million in 2017. The sale of the oncology business was unrelated to the Takeda acquisition bid.

The combined companies will have headquarters in Japan. Takeda shareholders will own about 50 percent of the merged companies. The two companies will have a combined workforce of about 52,000 people worldwide. The merged companies have projected job cuts of six to seven percent, which means cuts in the low to mid-3,000s. In addition, Takeda is considering consolidating Shire’s operations into its own in Boston, Switzerland and Singapore.

A small group of Takeda shareholders was attempting to halt the acquisition, but their bid didn’t gain traction. A group of 130 Takeda shareholders felt Takeda was taking on too much debt to pull off the deal, and it wasn’t worth it. At the annual general meeting in June, the group put their proposal to a vote, asking that advance shareholder approval be required for large acquisitions. Their proposal received about 10 percent of votes in favor, which was unlikely to lead to stopping the Shire acquisition.

In today’s announcement, Ornskov also stated, “During the quarter, our Board reached an agreement with the Takeda Board on the terms of a recommended offer for Takeda to acquire Shire. The acquisition is expected to close in H1 2019, subject to shareholder approval of both companies and additional regulatory approvals. In the meantime, we remain resolutely focused on execution as these results demonstrate.”

Shire also gave a pipeline update, noting that the U.S. Food and Drug Administration (FDA)approved Cinryze for pediatric use and the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended marketing authorization for Veyvondi in Europe. Ornskov added, “In addition, we gained U.S. FDA approval for our state-of-the-art plasma manufacturing facility near Covington, Georgia supporting the continued growth of our immunoglobulin portfolio.”

https://bit.ly/2LICQPg

Sanofi Q2 Sales Down, but Plans to Fix Diabetes Division

For its second-quarter financial report, Paris-based Sanofi reported a decrease in net sales for the quarter of 5.7 percent, down to 8.176 billion euros. Sanofi Genzyme sales grew 14.1 percent, driven by Dupixent and consolidation of Bioverativ, which it acquired earlier this year. Bioverativ was a spinoff from Biogen. Bioverativ spun off from Biogen’s hemophilia unit in January 2017. Sanofi bought it for $11.6 billion in January 2018.

The company’s second-quarter earnings per share (EPS) rose 1.5 percent to 1.25 euros. Its Emerging Market sales grew 5.2 percent, with double-digit growth in China.

“In the second quarter, we achieved significant milestones in building our new rare Blood Disorder franchise and the successful continued execution of the global roll-out of Dupixent,” said Olivier Brandicourt, Sanofi’s chief executive officer, in a statement. “As the impact from the U.S. losses of exclusivity peaked in the second quarter, the growth of our diversified businesses largely compensated for these headwinds. We look forward to entering a new growth phase led by our increasing focus on Specialty Care and our leadership positions in Emerging Markets and Vaccines.”

Sanofi’s diabetes and cardiovascular franchises, however, which have struggled in the U.S. after it lost exclusivity for insulin drug Lantus, had a 9.4 percent on-year decline. Earlier this month, Sanofi told Dow Jones Newswires that it is attempting to convince intermediaries, particularly in the U.S., to approach its insulin products in a different way, in order to increase sales. It’s not clear if that will help since most companies in the diabetes market are struggling with U.S. pricing for insulin-related products.

MarketWatch writes, “On Tuesday the company again declined to specify which intermediaries it has been in talks with, as formulary decisions haven’t yet been announced. But a company spokesman confirmed that Medicare bids for 2019 have been submitted, with decisions expected in October. The company also confirmed that data from the Bright study, which has informed Sanofi’s new insulin unbundling strategy, will be presented to Medicare, but declined to comment on whether Medicare bundles its insulins.”

Overall, Sanofi Genzyme (Specialty Care) reported 14.1 percent growth, Sanofi Pasteur (Vaccines) reported a decrease of 15.7 percent, Diabetes & Cardiovascular reported a drop of 15.6 percent, Consumer Healthcare grew by 4.1 percent, and General Medicines & Emerging Markets dropped 3.7 percent.

In the quarterly conference call, Brandicourt indicated Sanofi is positioning itself for a new phase of growth. And with both its acquisition of Bioverativ and Ablynx, both in January, the company shows a heavy push into blood disorders. Ablynx’s most advanced pipeline product is caplacizumab for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP).

PMLive notes, “A bright point was the rare blood disorder business bolted on with the $11.6 billion acquisition of Bioverativ, up 15.5 percent on a pro forma basis to 257 million euros, and Sanofi is hoping that the 3.9 billion euro takeover of antibody specialist Ablynx and lead rare disease drug caplacizumab will also pay off in the years to come.”

https://bit.ly/2O0Tlmu