Thursday, September 20, 2018
PDL BioPharma shareholder SevenSaoi issues letter to board
PDL BioPharma shareholder Capital, with 2,590,198 shares of common stock, has delivered a letter to the Board of Directors of PDL. The letter addresses SevenSaoi’s “serious concerns with the company’s failed acquisition strategy” and calls upon the Board to authorize a large share repurchase. The letter states, among other things: “PDL is grossly overcapitalized – the company currently has $375M in cash, an additional $400M+ in expected royalty cash flow through 2022, and low working capital requirements. As a percent of market capitalization, PDL’s cash balance is currently 7.6x that of its median peer and 2.2x that of the most overcapitalized peer (…) : PDL’s share price discount persists in large part due to investor concern that PDL’s massive cash balance will be deployed in expensive acquisitions that destroy shareholder value (…) management’s, and especially Mr. McLaughlin’s, poorly-devised compensation scheme includes massive incentives for them to make acquisitions, to the exclusion of other productive and value enhancing uses of capital, such as share repurchases.”
https://thefly.com/landingPageNews.php?id=2793119
Top 22 Canadian cannabis stocks up 127% since Constellation pact, says Stifel
Yesterday’s significant outperformance for Canadian cannabis stocks, led by Tilray (TLRY), at one point pushed the total market capitalization for Canadian Licensed Producers above $C80B, before they closed with a combined market cap of C$73B, calculates Stifel analyst Christopher Growe. Since August 15, when Constellation Brands (STZ) announced a pact to invest C$5B into Canopy Growth (CGC), the top 22 Canadian cannabis stocks are up 127% in stock price, noted Growe. A $C73B market cap in relation to what he estimates to be an addressable Canadian market of C$10B is “difficult to fathom,” so valuations require global opportunities to be realized, added Growe, who said he questions the pace of development and degree of advantage for these companies. Companies in the cannabis space that can be traded in the U.S. include Aurora Cannabis (ACBFF), CV Sciences (CVSI), Canopy Growth, Cronos Group (CRON) and Tilray.
https://thefly.com/landingPageNews.php?id=2793123
Cigna price target raised to $250 from $235 at Leerink
Leerink analyst Ana Gupte raised her price target on Outperform-rated Cigna (CI) to $250 from $235 following meetings with a panel of PBM and Specialty Rx specialists, which increased her bullishness on Cigna and Market Perform-rated Express Scripts (ESRX). In a research note to investors, Gupte says she also came away with raised confidence on the achiveability of the $4B annual drug cost savings from the Express Scripts switch by Anthem (ANTM) to IngenioRx in partnership with CVS (CVS). She adds that smaller independent PBMs still have niche opportunities with smaller regional third-party health plans, noting that Magellan Health (MGLN) is well positioned in this market, though loss of substantial business in Florida Seriously Mentally Ill is a headwind in Rx as well.
https://thefly.com/landingPageNews.php?id=2793131
Pfizer New Phase 3 Cardiomyopathy Study Presented at Meeting
Pfizer Inc. (NYSE:PFE) announced today that additional sensitivity and post-hoc analyses from the Tafamidis Phase 3 Transthyretin Amyloid Cardiomyopathy (ATTR-ACT) study provide further detail on the effect of tafamidis across wild-type, hereditary, and New York Heart Association (NYHA) class sub-groups of patients with transthyretin amyloid cardiomyopathy (ATTR-CM).1 Tafamidis is the only investigational treatment that has completed a Phase 3 trial evaluating its safety and efficacy for the treatment of ATTR-CM.1 ATTR-CM is a rare, fatal, and underdiagnosed condition associated with progressive heart failure for which there are currently no approved pharmacologic treatments.2
The findings were presented today during the Late Breaking Clinical Trials session at the Heart Failure Society of America 22nd Annual Scientific Meeting in Nashville, TN.The primary results were presented at the ESC Congress 2018 in Munich, Germany on August 27, 2018 and simultaneously published online in the New England Journal of Medicine (NEJM).
The broader primary results showed tafamidis significantly reduced the hierarchical combination of both all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo over a 30-month period (P=0.0006) in patients with wild-type and hereditary ATTR-CM.1 A new sensitivity analysis presented today also demonstrated a significant reduction in the combination of all-cause mortality and frequency of all-cause hospitalization compared to placebo over a 30-month period (P=0.0088).1
In addition, tafamidis reduced the risk of all-cause mortality across all sub-groups (wild-type, hereditary and NYHA I, II and III functional class) versus placebo. This included a 29% and 31% reduction in the risk of death observed in wild-type (HR 0.71; 95% CI [0.474, 1.052]) and hereditary (HR 0.69; 95% CI [0.408,1.167]) sub-groups, respectively.1 Across wild-type and hereditary sub-groups, tafamidis consistently reduced the decline in the six minute walk test distance, a measure of functional capacity, and aspects of quality of life measured by the Kansas City Cardiomyopathy Questionnaire – Overall Score, compared with placebo at Month 30. Tafamidis was also well tolerated, with an observed safety profile comparable to placebo.1
“These additional insights further support tafamidis as a potential treatment option for people with wild-type or hereditary ATTR-CM,” said Brenda Cooperstone MD, Senior Vice President and Chief Development Officer, Rare Disease, Pfizer Global Product Development. “We look forward to learning more through further analyses of this study and continue to work with global regulatory authorities to bring this medicine to patients.”
Janssen Submits Application to FDA for Urothelial Cancer Treatment
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of erdafitinib for the treatment of patients with locally advanced or metastatic urothelial cancer (UC) and certain fibroblast growth factor receptor (FGFR) genetic alterations whose tumors have progressed after prior chemotherapy. Erdafitinib is an investigational, once-daily, oral pan-FGFR inhibitor that received Breakthrough Therapy Designation from the FDA in March 2018.
‘Erdafitinib has demonstrated promising results in the treatment of metastatic urothelial cancer, a disease where patients unfortunately have limited treatment options today,’ said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. ‘We look forward to working with the FDA in the agency’s review of the application as we believe erdafitinib will provide patients with an important therapeutic option.’
The NDA submission is based on data from the BLC2001 (NCT02365597) Phase 2 clinical trial, which evaluated the efficacy and safety of erdafitinib in the treatment of adult patients with locally advanced or metastatic UC, whose tumors have certain FGFR alterations. The primary endpoint of this study was the percentage of participants with objective response, defined as Complete Response or Partial Response based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1* criteria. The study results were recently presented at the American Society of Clinical Oncology (ASCO) 2018 Annual Meeting in Chicago (Abstract #4503) and were recognized as a ‘Best of ASCO’ selection.
‘The erdafitinib FDA submission is an important milestone as we work to bring a new treatment option to patients diagnosed with metastatic urothelial cancer,’ said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. ‘Our organizational focus on areas of high unmet medical need underscores our commitment to advancing transformational science and developing solutions that may prolong and improve patient lives.’
Astellas Launches Clostridium difficile Treatment in Japan
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., ‘Astellas’) today announced that it has launched Dafclir Tablets 200 mg (generic name: fidaxomicin, ‘Dafclir’) for the treatment of infectious enteritis (including pseudomembranous colitis1) (susceptible strains: fidaxomicin susceptible Clostridium difficile (CD)2) in Japan.
Dafclir is an oral macrocyclic antimicrobial agent3 with a new mechanism of action and a selective antibacterial spectrum licensed from Merck & Co., Inc.Kenilworth, N.J., U.S.A., known as MSD outside the U.S. and Canada (‘Merck’). Astellas has developed the product in Japan based on an exclusive development and marketing agreement with Merck. In addition, our subsidiary Astellas Pharma Europe Ltd. has acquired exclusive license for the development and commercialization in Europe, where it is already being marketed as a CD infection treatment, and additional countries in the Middle East, Africaand the Commonwealth of Independent States (CIS)4.
CD, a bacterium that infects large intestine and produces toxins, causes nosocomial infections and antibacterial agent-associated colitis worldwide. Infection and proliferation result in colitis and severe diarrhea and in the most serious cases death. As difficulty in treatment of infectious enteritis caused by CD with the currently available pharmaceutical products, mainly due to the recurrence, has been reported in Japan, new treatment options have been needed. Besides its potent antibacterial activity against CD, due to its narrow antibacterial spectrum, Dafclirminimally disrupts the balance of intestinal flora, and it inhibits spore formation5.
Astellas will further contribute to patients who are suffering from infectious enteritis caused by CD in Japan by launching Dafclir as a new therapeutic option.
Astellas reflected the impact from this launch in its financial forecasts of the current fiscal year ending March 31, 2019.
Pfizer, Glaxo, Novo, Novartis plants unfazed by storm; Merck not as lucky
Drug manufacturers were shaking off the remnants of Hurricane Florence on Monday after the dangers from the monstrous storm morphed into hazardous flooding.
GlaxoSmithKline, Pfizer and Novartis and Novo Nordisk all confirmed their manufacturing operations were back online.
GSK said it has reopened and resumed production at its inhaler plant. Our manufacturing plant in Zebulon, North Carolina, reopened Sunday and our commercial campus in Research Triangle Park reopens today, Mary Anne Rhyne, director of corporate communications at GSK, said in an email today.
Neither facility endured any serious damage, but the drugmaker was still hearing from employees who were affected directly, she said. Before the storm, we shared a list of resources with all employees and asked them to stay in touch with their managers so that we could offer support as appropriate.
In a two-sentence statement, Pfizer said today it restarted operations at its sterile injectables plants in North Carolina. Both facilities are operational, and had minimal impact.
Given existing shortages of sterile injectable drugs in the U.S., there was concern about how the supplies might be affected when the New York drugmaker announced plans to suspend production ahead of the storm.
But the company kept essential emergency, utility and monitoring personnel onsite during the storm, allowing it to restart production quickly. Pfizer, ahead of the storm, also had taken steps to avoid interruptions in drug supplies.
Like Pfizer, Novo said its plant was relatively unscathed and was making diabetes medicines. Novo spokeswoman Marisa Sharkey said the company was urging employees to use caution when getting around, because the effects of the storm are still lingering in North Carolina.
Merck & Co., was in a more perilous situation. Spokeswoman Pamela Eisele said Merck facilities in “Wilson, North Carolina and Durham, North Carolina are in areas which are currently affected by flash flooding; however, at this time, no damage is expected to the facilities”
Neither facility is yet operational but cleanup at both had started. Eisele said a facility in Elkton, Virginia, was still operational but the company was keeping watch for flash floods in the area.
While NOAA`s Weather Prediction Center said the storm is now tagged a tropical depression, the death toll climbed to 18. Flooding is now considered the gravest danger, as rivers in the state have turned into dangerous torrents, making travel dangerous in many places.
It is the second time in a year pharma production has been affected by hurricanes after storms wreaked havoc in Puerto Rico last fall. It took months to repair power infrastructure, and keeping fuel flowing to power generators also became an issue.
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