Bayer: U.S. environment agency says glyphosate weed killer is not a carcinogen

The U.S. Environmental Protection Agency (EPA) said on Tuesday that glyphosate, a chemical in many popular weed killers, is not a carcinogen, contradicting decisions by U.S. juries that found it caused cancer in people.

The EPA’s announcement reaffirms its earlier findings about the safety of glyphosate, the key ingredient in Bayer’s Roundup. The company faces thousands of lawsuits from Roundup users who allege it caused their cancer.

“EPA continues to find that there are no risks to public health when glyphosate is used in accordance with its current label and that glyphosate is not a carcinogen,” the agency said in a statement.

Farmers spray glyphosate, the most widely used herbicide in U.S. agriculture, on fields of soybeans and other crops. Roundup is also used on lawns, golf courses and elsewhere.

The EPA did previously find ecological risks from the chemical and has proposed new measures to protect the environment from glyphosate use by farmers and to reduce the problem of weeds becoming resistant to it.

Bayer said it was pleased the EPA and other regulators who have assessed the science on glyphosate for more than 40 years continue to conclude it is not carcinogenic. “Bayer firmly believes that the science supports the safety of glyphosate-based herbicides,” it said in a statement. The company has repeatedly denied allegations that glyphosate and Roundup cause cancer.

But critics of the chemical disputed the EPA’s assurances.

“Unfortunately American consumers cannot trust the EPA assessment of glyphosate’s safety,” said Nathan Donley, a senior scientist at the environmental group Center for Biological Diversity.

Monsanto developed Roundup as the first glyphosate-based weed killer, but it is no longer patent-protected and many other versions are available. Bayer bought Monsanto last year for $63 billion.

The debate over glyphosate’s safety has put a spotlight on regulatory agencies around the world in recent years and, more recently, on U.S. courtrooms.

In 2015, the World Health Organization’s cancer arm classified glyphosate as “probably carcinogenic to humans.” But the EPA in 2017 said a decades-long assessment of glyphosate risks found the chemical was not likely carcinogenic to humans.

In February, analysts at Brazilian health agency Anvisa also determined the weed killer does not cause cancer while recommending limits on exposure.

In the first U.S. Roundup trial, a California man was awarded $289 million in August 2018 after a state court jury found the weed killer caused his cancer. That award was later reduced to $78 million and is being appealed by Bayer.

A U.S. jury in March awarded $80 million to another California man who claimed his use of Roundup caused his cancer.

https://www.marketscreener.com/BAYER-AG-436063/news/Bayer-U-S-environment-agency-says-glyphosate-weed-killer-is-not-a-carcinogen-28513904/

Wells hopes Allergan shareholder vote marks end of ‘distractive narrative’

Wells Fargo analyst David Maris says he’s hopeful that Allergan shareholders voting in favor of a combined CEO/Chairman role “marks a turn of the distractive narrative” from break-up speculation to a focus on longer-term execution and pipeline. After speaking with a number of dermatologists and cosmetic surgeons in recent weeks, Maris fells optimistic about U.S. aesthetic market growth in Q1. The analyst maintains an Outperform rating on Allergan shares into the company’s Q1 results on May 7.

https://thefly.com/landingPageNews.php?id=2901139

Nabriva’s Antibiotic Contempo Turned Down by FDA Over Manufacturing Issues

Nabriva Therapeutics, headquartered in Dublin, Ireland, announced that the Food and Drug Administration (FDA) had issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for Contepo (Fosfomycin) to treat complicated urinary tract infections (cUTI), including acute pyelonephritis.

The rejection was over manufacturing issues, rather than efficacy issues.

The company had a target action date of April 30 for Contepo for serious infections. It was upgraded from an earlier target date of June 30 after a clarification of the classification and subsequent expedited review period for the NDA submitted in October 2018. It was also granted Qualified Infectious Disease Product (QIDP) and Fast Track designations.

Contepo (Fosfomycin for injection) is a novel intravenous antibiotic with a broad spectrum of Gram-negative and Gram-positive activity, including against most multi-drug resistant (MDR) strains such as ESBL-producing Enterobacteriaceae. Intravenous Fosfomycin has been approved for over 45 years in Europe for a variety of infections. Contepo is a new dosing approach originally developed by Zavante, which Nabriva acquired.

The company expects to request a “Type A” meeting with the agency to discuss the CRL. “We will be working with the FDA in the coming weeks to gain a full understanding of the FDA’s comments, with the goal of bringing this important treatment to patients as quickly as possible,” stated Ted Schroeder, Nabriva’s chief executive officer.

About a year ago, Achaogen received an FDA approval for Zemdri (plazomicin), another antibiotic approved for multi-drug resistant (MDR) Gram-negative infections, including cUTI and pyelonephritis. The drug launched in July 2018. At the time, the company announced plans to eliminate 80 jobs, about 28% of its staff, to focus on the launch and two other research programs.

Two weeks ago, the company filed for Chapter 11 bankruptcy reorganization. It hopes to continue normal business operations and took out a $25 million loan from Silicon Valley Bank so it could. Sales of Zemdri have been disappointing, and it wasn’t approved for systemic bloodstream infections, limiting its use.

Another antibiotics company, Melinta Therapeutics, cut staff in November 2018. At the time, the company sent a statement to New Haven Biz, which said, “In the face of an extremely challenging time for the antibiotics industry, Melinta has made the difficult decision to significantly reduce our investment in discovery research and are currently looking for strategic partners to take on these activities, located at our New Haven facility.”

The company’s third-quarter 2018 statements indicate higher costs and lower-than-expected sales for its antibiotics for difficult to treat skin infections and other infectious diseases.

Even if Nabriva eventually gets Contepo approved, it faces a tough market. As a recent Wiredarticle, “The Antibiotics Business Is Broken—But There’s a Fix,” notes, drug development is generally built on the idea that if you spend 10 to 15 years developing a drug and spend at least $1 billion to do so, you can then charge a high enough price or sell enough of the drug to earn back the R&D expenses, reward investors and be profitable.

“That math works for most of the products of the pharmaceutical industry, from old drugs that people take every day—antidepressants, beta-blockers, statins—to the newest cancer therapies known as CAR-T, which can cost almost $500,000 per dose. But antibiotics don’t fit that equation. Unlike cancer drugs, most antibiotics are inexpensive; the few with high price tags are reserved for rare hospital use. And unlike drugs to treat chronic diseases, people take antibiotics for only short periods of time,” Wired wrote.

As a result, big pharma has largely gotten out of the antibiotics business, while about 90% of research on new antibiotics is being conducted by small biotech with market caps of less than $100 million, more than half pre-revenue. And they desperately need funds and revenue to recoup costs and build marketing infrastructure, something that can be difficult to get in the antibiotics business.

https://www.biospace.com/article/fda-rejects-nabriva-s-contepo-antibiotic-broader-implications-for-the-antibiotics-market/

Charles River Labs Hit by Hackers, Some Client Data Compromised

Charles River Laboratories is the latest company to be hit by hackers.

The company disclosed the data breach in a filing with the U.S. Securities and Exchange Commission on Tuesday. The hacking occurred in March and the company said the data of about 1 percent of its total number of clients was compromised.

“While the investigation is ongoing, the Company has recently determined that some client data was copied by a highly sophisticated, well-resourced intruder,” the company said in its filing.

In its filing, Charles River said the percentage of clients who were affected by the data breach “does not necessarily equate to the potential revenue or financial impact related to this incident, which the company has yet to determine.” Charles River said as of this time, there is no indication that any of the client data that was determined to have been accessed was deleted, corrupted or altered. Charles River said it has notified all clients whose data was known to have been copied and compromised.

The hacking was first discovered in mid-March, Charles River disclosed. Upon discovery, the company coordinated an investigation with U.S. authorities and cybersecurity experts. Charles River Labs notified clients on April 30, the company said in its filing.

Charles River said it will aggressively move to further secure its information systems. The company will add enhanced security features and monitoring procedures to further protect its client data.

While Charles River has taken substantial steps to minimize unauthorized access into its information systems, the company said that until the ongoing remediation process is complete, it will be unable to determine whether or not the hacking incident has been entirely remediated.

“However, Charles River believes it has closed the point of entry employed by the intruder in connection with this incident. The company has not observed any further indications of continued unauthorized activity in its information systems,” Charles River said in its filing.

Last year, the federal National Counterintelligence and Security Center (NCSC) pegged biotechnology as a rich target for foreign hackers. According to the report, “biomaterials, biopharmaceuticals and new vaccines and drugs as of particular interest” to foreign hackers. Additionally, the government report said hackers are interested in garnering information on advanced medical devices, infectious disease treatment and genetically modified organisms.

“The United States remains a global center for research, development, and innovation across multiple high-technology sectors. Federal research institutions, universities, and corporations are regularly targeted by online actors seeking all manner of proprietary information and the overall long-term trend remains worrisome,” the NCSC report said.

In 2017, pharma giant Merck was the target of an attack. Merck & Co., among other companies, was targeted by a malware attack that was believed to have originated in Ukraine. The malware strain, known as NotPetya, is a type of ransomware, and it shut down computer systems and sought to extort funds from companies in order to release those compromised systems. When Merck was hit by the malware, the company said the event forced it to halt production, which hurt profits. It was enough to prompt federal lawmakers to take action after they feared drug shortages.

https://www.biospace.com/article/charles-river-labs-hit-by-hackers/

Pacira jumps 14% after Heron receives Complete Response Letter from FDA

Shares of Pacira (PCRX) after jumping after Heron Therapeutics (HRTX) received a Complete Response Letter from the FDA regarding its new drug application for HTX-011 for the management of postoperative pain. HTX-011 is a potential competitor to Pacira’s pain treatment Exparel. The CRL to Heron stated that the FDA is unable to approve the new drug application in its present form based on the need for additional manufacturing and non-clinical information, Heron said this morning in statement. “Based on the complete review of the NDA, the FDA did not identify any clinical safety or efficacy issues, and there is no requirement for further clinical studies or data analyses,” the company added. In premarket trading, Pacira shares are up 14% to $45.39 while Heron shares are down 24% to $16.55.

https://thefly.com/landingPageNews.php?id=2901015

Exact Sciences price target raised to $115 from $95 at Craig-Hallum

Craig-Hallum analyst Per Ostlund raised his price target for Exact Sciences to $115 from $95 saying that while Q1 is typically thought of as a seasonally challenged quarter sequentially, the company blew past Cologuard volume guidance and raised its 2019 outlook. The analyst reiterates a Buy rating on the shares.

https://thefly.com/landingPageNews.php?id=2901023

Teladoc price target lowered to $70 from $80 at Craig-Hallum

Craig-Hallum analyst Matt Hewitt lowered his price target for Teladoc to $70 from $80, while reiterating a Buy rating on the shares. The analyst views Q1 as a “solid” quarter that highlights the diversification of Teladoc’s revenue model, noting that despite flu volumes being down 32% year over year revenue grew by 23% organically, which enabled essentially in-line results.

https://thefly.com/landingPageNews.php?id=2901025