Pfizer Announces Ian Read’s Replacement and Succession Plan

Pfizer announced its succession plan for when Ian Read steps down as chief executive officer on January 1, 2019. The new chief executive officer will be Albert Bourla, who is currently the company’s chief operating officer. Read will stay on as executive chairman of the board of directors.

Read became Pfizer’s chief executive on December 6, 2010, and chairman on December 12, 2011. Under his leadership, the company has marked up 30 drug approvals in the U.S., a total shareholder return of 250 percent, and a direct return of capital to shareholders of more than $120 billion.

He also unsuccessfully attempted two mega-mergers. The first was a 2014 bid to buy UK-based AstraZeneca for $119 billion. This fell apart primarily due to resistance by both the U.S. and UK governments to the deal. In 2016, an attempt to acquire Dublin-based Allergan for $160 billion was dashed when the U.S. Treasury Department implemented new rules regarding tax inversions. A tax inversion is where a U.S. company buys a company based in another country with a very low corporate tax rate, then shifts their headquarters to that country to take advantage of the lower rate. It was estimated that the Allergan deal would have resulted in a $1 billion lower tax rate at the time for Pfizer.

Before taking on the role of chief operating officer on January 1, 2018, Bourla led Pfizer’s Innovative Health business. He also founded the Innovative Health Emerging Markets region, which reported revenues in 2017 of $4.4 billion. Before taking on that role, he was the group president of the Vaccines, Oncology and Consumer Healthcare business unit.

Shantanu Narayen, Lead Independent Director of Pfizer’s board of directors, stated, “Today’s leadership announcement is part of a thoughtful, multi-year success planning process. The board has been impressed with Albert’s performance, depth of experience and track record for success, and we are confident that as chief executive officer he will drive innovation and further advancements across the business.”

The news follows last week’s announcement by Merck & Co that they had rescinded the company’s mandatory retirement age of 65 for its chief executive officer, Kenneth C. Frazier, so he could stay on longer. Leslie A. Brun, lead director for Merck’s board, stated, “CEO succession has been our top priority, and removing the mandatory retirement policy enables the board to make the best decision concerning the timing of the transition.”

Depending on the source, Read is either 64 or 65. Earlier this year, Pfizer offered Read a bigger payday to keep him around until at least March 31, 2019, and also to keep him from working for a competing company through March 31, 2021. This involved a 61 percent increase in compensation to $27.9 million.

In today’s announcement, Read stated, “It’s been an honor to serve as Pfizer’s CEO for the past eight years. However, now is the right time for a leadership change, and Albert is the right person to guide Pfizer through the coming era. Albert is an energizing leader who has an unwavering commitment to serving patients. With 25 years at Pfizer, he has developed an extensive knowledge of the industry and demonstrated an ability to build and grow businesses. With Albert at the helm, our dedicated colleagues across the globe are poised to deliver the next stage of growth. I look forward to working with Albert and the board to continue serving patients and delivering value for shareholders.”

https://www.biospace.com/article/pfizer-announces-ian-read-s-replacement-and-succession-plan/

Dragonfly and Merck Strike $695 Million Deal for Solid Tumors

Waltham, Mass.-based Dragonfly Therapeutics struck a licensing agreement worth up to $695 million with Merck. Merck will license exclusive rights to Dragonfly’s TriNKET technology platform for a number of solid-tumor programs, the company announced today.

Joe Miletich, Merck’s head of discovery and preclinical development, said Dragonfly’s technology platform provides a potential for researchers to harness the power of NC cell receptors. That could lead to the development of novel therapeutics targeting solid tumor indications, Miletich said.

Bill Haney, Dragonfly’s chief executive officer, called Merck a “world leader” in solid tumor cancers. Haney said the company has a history of delivering breakthrough therapy options for patients. He pointed to the company’s TriNKET technology platform as a potential accelerator of developing new drug options.

Dragonfly’s TriNKET (Tri-specific, NK cell Engager Therapies) bind to the proteins expressed on both cancer cells and NK cells. The TriNKET system provides “an active connection between cancer cells, and cells of the immune system including NK cells themselves, T cells, B cells, and other cells that help attack and kill cancer,” according to the company. NK cells are part of the natural immune system of every human body. They also express proteins on their surface.

When the binding occurs, Dragonfly said its TriNKET system stimulates NK cells, which makes them aware of cancerous cells. That stimulation allows the NK cells to both kill the cancer cells, as well as notify other immune cells to attack the cancer. In other words, Dragonfly believes that linking to the natural killer cells and sending them to the cancer cells, it will increase the chances of eliminating the tumors.

“Overall, NK cells amplify the effectiveness of T-cells, acting as a sentinel that calls other immune system cells to attack the cancer, as well as broadening the therapeutic window by using their special characteristics of distinguishing cancer, to more specifically target tumor cells,” Dragonfly said on its website.

Under terms of the agreement, Merck will pay Dragonfly up to $695 million in upfront and milestone payments per program as well as royalties on sales of approved products.

Merck isn’t the first company that Dragonfly has collaborated with. Last year the company struck a five-year agreement with Celgene to develop immuno-oncology therapeutics for hematological cancers based on Dragonfly’s TriNKET technology platform.

Dragonfly was launched in 2015. The company was founded by Tyler Jacks, director of MIT’s Koch Institute, along with Haney, and Natural Killer cell expert, David Raulet. Dragonfly’s own research is still in the preclinical phase. On its website, the company lists a number of assets but does not provide information about the different indications the company is targeting.

https://www.biospace.com/article/dragonfly-and-merck-strike-695-million-deal-for-solid-tumors/

Piper keeps Overweight on Regeneron after Libtayo approval

Piper Jaffray analyst Christopher Raymond keeps an Overweight rating on Regeneron Pharmaceuticals (REGN) after Friday’s FDA approval of Libtayo in cutaneous squamous cell carcinoma. Timing is about a month ahead of the late-October FDA action date for Regeneron/Sanofi’s (SNY) PD-1 inhibitor, but a positive decision was expected given the drug’s “compelling data” in advanced CSCC, Raymond tells investors in a research note. While Libtayo will enter the market as the sixth approved PD-(L)1 inhibitor and third approved PD-1 agent, Raymond thinks readouts from the ongoing development program in other indications such as first-line non-small-cell lung carcinoma may make the case for moderate Libtayo uptake.
https://thefly.com/landingPageNews.php?id=2797409

Alnylam initiated at Cantor Fitzgerald

Alnylam initiated with an Overweight at Cantor Fitzgerald. Cantor Fitzgerald analyst Alethia Young started Alnylam Pharmaceuticals with an Overweight rating and $135 price target.

https://thefly.com/landingPageNews.php?id=2797413

Vertex initiated at Cantor Fitzgerald

Vertex initiated with an Overweight at Cantor Fitzgerald. Cantor Fitzgerald analyst Alethia Young started Vertex Pharmaceuticals with an Overweight rating and $217 price target.

https://thefly.com/landingPageNews.php?id=2797419

Insys Therapeutics in definitive license agreement with Lunatus for Subsys

Insys Therapeutics announced that it has signed a definitive license agreement with Lunatus for commercialization of Subsys in eight countries in the Middle East. In May, the two companies announced their intent to form an exclusive partnership. This announcement confirms that the definitive agreement has been executed, making Dubai-based Lunatus the exclusive licensee and authorized agent for Subsys in the territory, which comprises Bahrain, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia and the United Arab Emirates.

https://thefly.com/landingPageNews.php?id=2797453

Viking Therapeutics says Phase 2 study of VK5211 achieves primary endpoint

Viking Therapeutics announced positive new findings from the company’s 12-week, Phase 2 clinical trial of VK5211 in patients who recently suffered a hip fracture. As previously reported, the trial achieved its primary endpoint, demonstrating statistically significant, dose-dependent increases in lean body mass, less head, following treatment with VK5211 as compared to placebo. Additionally, newly presented data demonstrated dose-dependent decreases in mean fat mass, coupled with dose-dependent increases in mean body weight following VK5211 treatment. Findings also demonstrated dose-dependent increases in 6-minute walk distance following VK5211 treatment, reaching a greater than 20-meter improvement over placebo at the study’s highest dose. VK5211, Viking’s lead program for musculoskeletal disorders, is an orally available, non-steroidal selective androgen receptor modulator designed to selectively stimulate muscle and bone formation with reduced activity in peripheral tissues such as skin and prostate. The Phase 2 clinical trial was a randomized, double-blind, placebo-controlled, parallel group, international study designed to evaluate the efficacy, safety and tolerability of VK5211 in patients recovering from hip fracture surgery. A total of 108 patients were randomized to receive once-daily VK5211 doses of 0.5 mg, 1.0 mg, 2.0 mg, or placebo for 12 weeks. Key results presented at ASBMR included: All doses of VK5211 demonstrated statistically significant increases in total lean body mass, less head, following 12 weeks of treatment, the study’s primary endpoint. Placebo-adjusted increases in lean body mass were 4.8% at 0.5 mg, 7.2% at 1.0 mg, and 9.1% at 2.0 mg. Patients receiving VK5211 experienced dose-dependent decreases in mean fat mass following 12 weeks of treatment, which reached statistical significance at the study’s highest dose of 2.0 mg. Placebo-adjusted reductions in mean fat mass were approximately 2.2% at 0.5 mg, 5.4% at 1.0 mg, and 6.2% at 2.0 mg. The observed reductions in mean fat mass were coupled with dose-dependent increases in mean body weight following 12 weeks of treatment, demonstrating beneficial changes in overall body composition among VK5211-treated subjects. The increases in mean body weight were 2.54 kg at 0.5 mg, 2.95 kg at 1.0 mg, and 3.09 kg at 2.0 mg. Patients receiving VK5211 demonstrated dose-dependent improvements in the 6-minute walk distance as compared to placebo, though this exploratory endpoint was not powered for significance. For patients in the 2.0 mg VK5211 treatment arm, the mean distance increased by approximately 22 meters compared to placebo. VK5211 treatment resulted in statistically significant improvements compared to placebo in serum procollagen type 1 propeptide, a marker of anabolic bone turnover, at 12 weeks. Patients were also assessed 12 weeks after completion of the study to evaluate safety and efficacy at 24 weeks. At this 24-week timepoint, the increases in total lean body mass, less head, for all VK5211 treatment arms remained above placebo, though the increases were no longer statistically significant. The durable increases in muscle mass that were maintained three months following the last dose of VK5211 highlight the potent treatment effect VK5211 demonstrated in these patients. No drug-related SAEs were observed in patients receiving VK5211. There were no significant differences in the rates of adverse events reported among patients receiving VK5211 compared with placebo. There were no dose-related differences in reported adverse events among various VK5211 treatment groups.

https://thefly.com/landingPageNews.php?id=2797513