Pfizer suspending operations at U.S. injectables plant as hurricane nears

Weather is again taking a toll on the U.S. supply of injected drugs as Pfizer is suspending production at a key sterile injectables plant in Rocky Mount, North Carolina, ahead of Hurricane Florence.

The New York drugmaker says it is monitoring the situation and plans to suspend production on Thursday at two plants in North Carolina ahead of landfall by the hurricane. A spokesman said the company has taken steps to avoid interruptions in drug supplies but provided no specifics.

“Only essential emergency, utility, and monitoring personnel will be onsite during the storm. Our primary concern is the safety of our colleagues, and our ability to ensure uninterrupted supply of medicines to our patients,” an emailed statement said. “Pfizer has contingency plans in place to ensure the continuity of supply, and mitigate interruptions during natural disasters.”

The hurricane has the potential to be the worst in 60 years, with lingering rains and flooding as well as high winds. Residents around Rocky Mount have been told to be prepared to evacuate.

U.S. hospitals are already suffering shortages of many sterile injectable drugs, including pain drugs made at Pfizer’s Hospira plant in McPherson, Kansas, because of manufacturing issues laid out in a warning letter last year. Pfizer received a close-out letter for the McPherson plant in June but Pfizer has said it doesn’t expect full recovery of those supplies until 2019.

Last fall, ongoing shortages of saline were exacerbated when hurricanes ripped through Puerto Rico, tearing down power lines and interrupting production at three saline plants operated there by Baxter International.

Manufacturers upped production at other plants, and the FDA allowed some companies to import product from plants that were not approved for U.S. sales, but even those efforts could not keep the healthcare system from feeling the pinch.

https://www.fiercepharma.com/manufacturing/u-s-sterile-injectable-drug-supply-threatened-again-by-hurricane

Endo breaks from the pack with opioid litigation settlement talks

Trying to dig out from under $8 billion in debt while staring at 1,000 lawsuits tied to its opioid business, Endo is said to be trying to negotiate its own settlement deal with lawyers for states and cities.

By striking a deal on its own rather than as part of an industrywide settlement, Endo might be able to cut its exposure. Financial terms of the deal have not yet been hammered out, according to Bloomberg reports citing three unnamed sources, but the Dublin-based drugmaker reportedly has talked about changing up the way it markets drugs.

“It makes sense for a company with Endo’s financial challenges to come up with a deal and not wait for everyone else,’’ Richard Ausness, a University of Kentucky law professor, told Bloomberg. “In these situations, it’s every man for himself.’’

Hundreds of cities and counties around the U.S. are suing opioid makers and distributors to recoup costs related to the opioid addiction crisis. They allege Endo, Purdue, Johnson & Johnson, AmerisourceBergen and others “grossly misrepresented” opioid risks and that distributors failed to monitor suspicious orders. New York City itself is seeking $500 million, suggesting a mass settlement could run into the billions of dollars.

For Endo, the settlement comes after a tough multiyear stretch during which it has lost more than 90% of its market value. The company has suffered from U.S. pricing pressure, executive turnover and more.

Even as the company has been cutting jobs and operations, it has been aggressively settling overhanging litigation. In June, it struck a deal to put to rest 1,300 lawsuits tied to the marketing and risks of selling testosterone enhancing drugs. It has set aside $200 million for that. In March, it joined Teva and Japanese drugmaker Teikoku Seiyaku in a $270 million settlement of pay-to-delay allegations involving lidocaine pain patches.

https://www.fiercepharma.com/pharma/endo-breaks-from-pack-opioid-litigation-settlement-talks

Amgen’s Aimovig Starts Strong, Multiple Myeloma Drug Wows at Conference

In May the U.S. Food and Drug Administration (FDA) approved Amgen’s preventative migraine treatment Aimovig. Amgen and its developmental partner Novartis said the medication would be ready within one week for patients.

The companies made good on their promise and so far, the launch seems to be doing well. Aimovig has a list price of $6,900 per year, but an analysis of sales shows that Aimovig is elbowing its way to the front as a preferred treatment. An analysis in Seeking Alpha cites IMS data that shows new patient starts are going strong for the anti-CGRP treatment. By August, the data showed that 20,000 patients are using Aimovig, according to the Seeking Alpha analysis. An additional 11,000 patients are expected to begin taking the medication to treat their migraines within the next few months.

According to the analysis, which cites anecdotal evidence, Aimovig is being used by patients who are “both episodic and chronic migraine patients” and is also being taken by patients who “are on another suboptimal preventive drug.”

Aimovig was approved by the FDA after Phase III results showed the medication reduced monthly migraine attacks in half. The medication developed by the two powerhouse companies is the only FDA-approved treatment specifically developed to prevent migraine by blocking the calcitonin gene-related peptide receptor (CGRP-R).

The Seeking Alpha analysis offers a caveat though. Some of the early use of Aimovig “has gone to free product trials.” And, the analysis notes, there are other anti-CGRP medications pending regulatory approval. Other companies with significant investments in migraine headache research like Allergan (ubrogepant), Teva (fremanezumab) and Eli Lilly (galcanezumab) and Alder BioPharmaceuticals (Eptinezumab) are also focused on the pathway as a treatment for the devastating headaches.

While Amgen enjoys paving the way in migraine research, the company could also surge forward in the multiple myeloma market. Over the weekend Amgen released data from its pipeline drug AMG-420, bispecific T cell engager, it acquired two years ago from Boehringer Ingelheim. Data, as reported on Seeking Alpha, showed five patients treated with AMG-420 showed “stringent complete responses” in relapsed/refractory multiple myeloma. What’s more impressive, and will likely put multiple myeloma-leading companies like Celgene and bluebird bio on notice, is that following treatment with AMG-420, four of the five patients “were MRD-negative, meaning they had no detectable form of disease after treatment,” Seeking Alphareported.

Amgen unveiled the data at a multiple myeloma conference over the weekend. AMG-420 targets B-cell maturation antigen (BCMA), a target in multiple myeloma due to its restricted normal tissue expression and uniform expression on multiple myeloma cells.  When Amgen acquired the treatment from BI two years ago, it noted that the modified antibodies from the therapeutics “are designed to engage two different targets simultaneously, thereby juxtaposing T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells.”

The drug still has a way to go before it could potentially see regulatory approval, but if it keeps up, it could become a leading treatment in the multiple myeloma space. Shares of Amgen are up slightly in early trading to $202.50.

https://www.biospace.com/article/-fd1a-amgen-s-aimovig-starts-strong-multiple-myeloma-drug-wows-at-conference/

Vivek Ramaswamy’s Urovant Files for IPO to Raise $150 Million

Urovant Sciences, a Vivek Ramaswamy company under the Roivant umbrella, has filed for an initial public offering (IPO) to raise $150 million. It will list on Nasdaq under the UROV symbol.

Urovant is a clinical-stage biopharma company focused on developing and commercializing drugs for urologic conditions. Its lead product candidate is vibegron, an oral, once-daily, small molecule beta-3 agonist. Urovant, in keeping with Ramaswamy’s business model, licensed the drug from Merck Sharp & Dohme Corporation. It is being developed to treat overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Urovant has been studying vibegron in its Phase III EMPOWUR clinical trial in 1,400 patients for overactive bladder (OAB). In the filing, Urovant states, “We expect to report top-line results from this clinical trial in the first or second quarter of 2019, and if these results are positive, we plan to submit a new drug application to the U.S. Food and Drug Administration, or FDA, by early 2020. OAB is a highly prevalent condition, with more than 30 million Americans over the age of 40 suffering from bothersome symptoms.”

The drug was investigated in Phase IIb and a Japanese Phase III clinical trial in more than 2,600 OAB patients, meeting all primary and secondary efficacy endpoints compared to placebo. The filing indicates that the preliminary analysis of the ongoing Phase III trial is showing similar results.

“We believe vibegron, if successful in meeting the efficacy endpoints in our pivotal Phase III EMPOWUR trial, and if approved by the FDA, may offer a differentiated profile compared to current OAB therapies, including the potential for broader efficacy claims if the FDA approves the including of urgency data, rapid onset of action data, and a single convenient once-daily dose in the label,” the company states.

Vivek Ramaswamy is a former hedge-fund manager who originally founded Axovant Sciences, then spun Roivant Sciences out of it in May 2014. Since then, Roivant has spun out numerous so-called “vant” companies, typically built on a drug acquired from a larger pharma company for a relatively low price. In some cases, the drugs were abandoned by the selling company because they were deemed failures, and Ramaswamy feels they can be evaluated for narrower or different indications. The most notorious and spectacular failure of this approach was with Axovant, which acquired intepirdine from GlaxoSmithKline for $5 million to be developed for Alzheimer’s disease. In September 2017, the drug crashed and burned in a Phase III clinical trial.

Ramaswamy came into the business with $400 million and has shown a talent for convincing investors to pony up funds for his company and recruiting talent to work for them.

Urovant licensed vibegron from Merck Sharp & Dohme, a subsidiary of Merck & Co., in June 2017 for an unspecified amount. But the company isn’t a one-trick pony. On August 28, it licensed another product, hMaxi-K, a gene therapy for patients with overactive bladder (OAB) who have failed oral pharmacologic therapy from Ion Channel Innovations. The therapy had already been evaluated in two Phase I studies, which showed the therapy to be safe and well tolerated and showed dose-dependent improvements in urinary urgency and frequency. Urovant hopes to launch a Phase II trial of hMaxi-K in 2019.

In a statement at the time, Keith A. Katkin, president and chief executive officer of Urovant, said, “We are pleased to add the gene therapy hMaxi-K to our clinical development portfolio. We are eager to study the potential of hMaxi-K as an alternative therapy for OAB patients who are not getting adequate relief from other therapies. Urovant also has access to gene therapy expertise through the Roivant family of companies.”

https://www.biospace.com/article/ip3o-vivek-ramaswamy-s-urovant-files-for-ipo-to-raise-150-million/

Pfizer, Merck Combo Therapy Shows Significant Improvement in Phase 3

Late-stage trial results show that a combination of Bavencio (avelumab) and Inlyta (axitinib) significantly improved progression-free survival in previously untreated patients with advanced renal cell carcinoma.

The Phase III JAVELIN Renal 101 study is being conducted by Merck KGaA and Pfizer. The progression-free survival news was announced following an interim analysis by an independent Data Monitoring Committee. The data showed the statistically significant response in patients whose tumors had programmed death ligand-1‒positive (PD-L1+) expression greater than 1 percent, as well as study patients regardless of PD-L1 tumor expression.

Bavencio is a human anti-programmed death ligand-1 (PD-L1) antibody. In preclinical models, Bavencio has been shown to release the suppression of the T cell-mediated antitumor immune. The drug has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro, according to data provided by the companies. Pfizer’s Inlyta has been approved in the United States as a second-line monotherapy for the treatment of advanced RCC.

This morning the two companies said if PFS was statistically significant in the PD-L1+ subgroup, then “PFS in the entire study population was to be analyzed for statistical significance.” The study is expected to continue as planned until the final analysis can reveal the other primary endpoint of overall survival, the companies said this morning. Following the interim results, Merck KGaA and Pfizer said they intend to pursue a regulatory submission in the United States based on the results they have seen so far. The companies added that a detailed analysis of the interim results will be submitted for presentation at an upcoming medical conference.

Chris Boshoff, head of immuno-oncology, early development and translational oncology at Pfizer, said the JAVELIN Renal 101 trial is the “first positive Phase III study” that combines an immune checkpoint blocker with a tyrosine kinase Inhibitor. That data supports the potential combination of Bavencio and Inlyta as a “new cancer treatment approach for patients with advanced RCC,” Boshoff said.

“These positive results reinforce Pfizer’s long-standing heritage in advancing standards of care for people with RCC, and we look forward to discussing these data in greater detail with health authorities,” Boshoff said in a statement.

RCC is the most common form of kidney cancer, with the most common form of RCC being clear cell carcinoma. That type of RCC accounts for about 70 percent of all renal cell carcinoma cases, the two companies said. Between 20 and 30 percent of patients are diagnosed at the metastatic stage, which means first-year survival rates for those patients is about 12 percent, the companies said. Both Merck KGaA and Pfizer said the outlook for these patients is poor.

The combination treatment received the U.S. Food and Drug Administration’s Breakthrough Therapy Designation in December 2017.

Luciano Rosetti, global head of research and development at Merck KGaA, said the data released today illustrates the impact the combination therapy can have as a potential first-line treatment for people with advanced renal cell carcinoma.

https://www.biospace.com/article/-cp8r-pfizer-merck-combination-therapy-shows-significant-improvement-in-phase-iii/

Sensus Healthcare Presents at National Cancer Care Alliance Confab

Sensus Healthcare, Inc. (SRTS), a medical device company specializing in the non-invasive treatment of non-melanoma skin cancers and keloids with superficial radiation therapy (SRT), today announced that Joe Sardano, President and Chief Executive Officer, participated at the National Cancer Care Alliance (NCCA) Leadership Board and Practice Quarterly Meeting, which took place Thursday, August 30 through Friday, August 31, 2018, in Chicago.

“At this pivotal point in Sensus’ acceleration as an international provider of solutions for non-invasive skin cancer treatment, it is an honor to address the NCCA at the invitation of founder and current chair of the board Dr. Barbara McAneny,” Sardano said. “We share the organization’s mission to use innovation to improve the treatment of cancer, and we continue to receive encouraging interest from the oncology community in our recent innovations in the treatment of non-melanoma skin cancer and keloids, particularly with the launch of the SRT-100+.”

The details of Mr. Sardano’s presentation are as follows:

Date: Friday, August 31, 2018
Time: 10:15 a.m. CT
Venue: Chicago Marriott Downtown Magnificent Mile
Presentation topic: Treatment of Skin Cancer

About Sensus HealthcareSensus Healthcare, Inc. is a medical device company that is committed to providing non-invasive and cost-effective treatment for non-melanoma skin cancers and keloids. Sensus uses a proprietary low-energy X-ray technology known as superficial radiation therapy (SRT), which is a result of over a decade of dedicated research and development. Sensus has successfully incorporated SRT into its portfolio of treatment devices, the SRT-100™, SRT-100+ and SRT-100 Vision™. To date, SRT technology has been used to effectively and safely treat oncological and non-oncological skin conditions in thousands of patients. Sensus also offers Sensus Laser Systems, three next-generation devices that showcase the latest in technology and function for the aesthetic dermatology market.
For more information, visit https://www.sensushealthcare.com.

https://finance.yahoo.com/news/sensus-healthcare-presents-national-cancer-120400031.html

Alliance One unit gets Health Canada license to sell cannabis oils

FIGR, Inc. is pleased to announce its subsidiary, Canada’s Island Garden (CIG), has received approval from Health Canada for its most recent license amendment request, allowing for the sale of medicinal cannabis oils. The license is issued through Health Canada, pursuant to the Access to Cannabis for Medical Purposes Regulations. The sales license authorizes CIG to sell medicinal cannabis oil products. The company previously received its sales license for dried cannabis (flower) on February 7, 2017 .

“Securing our license to sell cannabis oils marks a significant milestone for our company. As the only licensed producer in Prince Edward Island , we can now participate in the derivative cannabis market by further expanding our product line for patients and offering an alternative to inhaled products,” said Edwin Jewell , president of CIG.

“Our team has been working diligently to meet Health Canada’s requirements. We are very excited to move into the next phase of our growth. Obtaining this license means we can now sell both medicinal dried cannabis and medicinal cannabis oil products.”

CIG previously announced a supply agreement with the province of Prince Edward Island for 1,000 kilograms/kilogram equivalent of cannabis products, which will now include cannabis oils.

More information about our products can be found at www.canadasislandgarden.com

About FIGR, Inc.

FIGR is a holding company that owns majority stakes in two Canadian cannabis producers, Canada’s Island Garden, a licensed producer in Charlottetown, Prince Edward Island , and Goldleaf Pharm, a late-stage licensed producer applicant in Simcoe, Ontario . FIGR is a wholly owned indirect subsidiary of Alliance One International (AOI). The FIGR brand combines generations of farm wisdom with modern scientific rigor to challenge convention and imagine new possibilities. For more information, visit www.figrcannabis.com.

About Alliance One International, Inc.

Alliance One International (AOI) is an agricultural company that delivers value-added products and services to businesses and customers, and is a trusted provider of responsibly sourced, independently verified, sustainable and traceable products and ingredients.

https://finance.yahoo.com/news/figr-inc-subsidiary-receives-health-110000077.html