In a move that may concern those responsible for payment of healthcare costs, Pfizer and Arena Pharmaceuticals, Inc. announced that the companies have entered into a definitive agreement under which Pfizer will acquire Arena, a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases.

Under the terms of the agreement, Pfizer will acquire all the outstanding shares of Arena for $100 per share in an all-cash transaction for a total equity value of approximately $6.7 billion. The boards of directors of both companies have unanimously approved the transaction.

Pfizer expects to finance the transaction with existing cash on hand.

“The proposed acquisition of Arena complements our capabilities and expertise in Inflammation and Immunology, a Pfizer innovation engine developing potential therapies for patients with debilitating immuno-inflammatory diseases with a need for more effective treatment options,” said Mike Gladstone, Global President & General Manager, Pfizer Inflammation and Immunology. “Utilizing Pfizer’s leading research and global development capabilities, we plan to accelerate the clinical development of etrasimod for patients with immuno-inflammatory diseases.”

Arena’s portfolio includes diverse and promising development-stage therapeutic candidates in gastroenterology, dermatology, and cardiology, including etrasimod, an oral, selective sphingosine 1-phosphate (S1P) receptor modulator currently in development for a range of immuno-inflammatory diseases including gastrointestinal and dermatological diseases.

Arena has built a robust development program for etrasimod, including two Phase 3 studies in ulcerative colitis (UC), a Phase 2/3 program in Crohn’s Disease, a planned Phase 3 program in atopic dermatitis, and ongoing Phase 2 studies in eosinophilic esophagitis and alopecia areata.

In addition, Arena’s pipeline includes two development-stage cardiovascular assets, temanogrel and APD418. Temanogrel is currently in Phase 2 for the treatment of microvascular obstruction and Raynaud’s phenomenon secondary to systemic sclerosis. APD418 is currently in Phase 2 for acute heart failure.

“We’re delighted to announce Pfizer’s proposed acquisition of Arena, recognizing Arena’s potentially best in class S1P molecule and our contribution to addressing unmet needs in immune-mediated inflammatory diseases,” said Amit D. Munshi, President and Chief Executive Officer of Arena. “Pfizer’s capabilities will accelerate our mission to deliver our important medicines to patients. We believe this transaction represents the best next step for both patients and shareholders.”

Under the terms of the merger agreement, Pfizer will acquire all of the outstanding shares of Arena common stock for $100 per share in cash. The proposed transaction is subject to customary closing conditions, including receipt of regulatory approvals and approval by Arena’s stockholders.

In a case that is not quite good news for workers’ compensation claims administrators hoping to see lower generic drug prices, a federal judge on Thursday suspended California’s first-in-the-nation ban on pharmaceutical industry pay-for-delay deals, ruling the law intended to increase the flow of affordable generic drugs likely violates out-of-state commerce protections.

AB 824, was signed into law by California Governor Gavin Newsom on October 7, 2019. It creates a presumption that “reverse payment” settlement agreements regarding patent infringement claims between brand-name and generic pharmaceutical companies are anti- competitive and unlawful. A violation of the law is punishable by a civil penalty.

According to the State, AB 824 closes this loophole in the federal Hatch-Waxman Act and ensures a brand-name company cannot continue to enforce an otherwise weak patent against generic companies through these reverse payment settlement agreements.

The plaintiff in the case is a nonprofit, voluntary association comprised of the leading manufacturers and distributors of generic and biosimilar medicines, manufacturers and distributors of bulk active pharmaceutical ingredients, and suppliers of other goods and services to the generic and biosimilar pharmaceutical industry that filed suit in an attempt to invalidate AB 824.

Plaintiff argues AB 824: violates the dormant Commerce Clause by directly regulating out-of-state-conduct; is preempted by federal patent law, the delicate balance between the competing interests of patent protections and antitrust law struck by the U.S. Supreme Court in prior decisions.

The State contends that “AB 824 seeks to prevent or reduce anticompetitive pharmaceutical sales in California, and, thus, applies to agreements to engage in that conduct,” not “conduct occurring wholly outside California.”

U.S. District Judge Troy Nunley in his Opinion, agreed the law enables California to issue multimillion-dollar civil penalties against companies that have no connection to the state, and said it must be temporarily enjoined due to clear constitutional shortcomings.

“As it is written, the civil penalties provision could hypothetically reach a corporate officer of a Delaware company entering into a settlement agreement with another Delaware company regarding pharmaceutical sales in only Delaware,” Nunley wrote. “The court cannot reasonably find that Assembly Bill 824 regulates only the California market.”

“The court finds the balance of equities and the public interest element tips sharply in plaintiff’s favor such that an injunction would be proper even if there were only serious questions going to the merits,” Nunley concluded.

According to Courthouse News, the bill’s author said the judge’s decision was “beyond frustrating.”

“The association’s name and mission would imply that they are somehow on the side of patients when, in fact, they are only on the side of protecting their own profits,” said Assemblyman Jim Wood, D-Eureka.

On the other side, Jeff Francer, the association’s general counsel, celebrated the decision in an email. “AAM is encouraged that the federal court today recognized the harm caused by California in restricting litigation settlements that typically bring more affordable medicines to patients and taxpayers more quickly.”

Nearly 500 Los Angeles Unified School District employees were fired this week for refusing to comply with a mandate that they get vaccinated against COVID-19, while some 34,000 students have not yet been vaccinated as required.

KTLA News reports that the school board voted 7-0 in separate motions on Tuesday to terminate 496 employees, who make up less than 1% of the district’s approximately 73,000 workers.

Most of those fired had likely been on leave since mid-October when LAUSD staffers were to have received at least their first vaccine dose, the Los Angeles Daily News reported. Employees were required to receive their second dose by Nov. 15.

Of the 496 employee dismissals, 418 were classified employees who are non-credentialed but critical staff that can include positions such as instructional aides, custodians, cafeteria workers and others.

The district initially set an Oct. 15 deadline for its employees to be fully vaccinated against COVID-19 but extended the deadline to Nov. 15.  “The effective date of separation for employees without record of any vaccine by October 15, 2021, will not be prior to November 1, 2021,” according to the district. “Employees will remain in paid status through October 31, 2021.”

The mandate applies to all district students, along with charter school students on co-located district school facilities. Students “with qualified and approved exemptions under LAUSD’s existing immunization policies” are exempt.

LAUSD is one of several large districts in California to adopt their own rules requiring students to get the COVID-19 vaccination, ahead of a statewide policy that will take effect after federal officials fully approve the immunizations by age group. The state policy, announced by Gov. Gavin Newsom in October, is not expected to go into place before July, but the precise date is still unknown.

Districts including San Diego Unified, Sacramento City Unified, Oakland and West Contra Costa are among those that have deadlines for student vaccine policies scheduled to take effect in early 2022. The policies vary according to district, with some allowing students to opt for weekly testing and others making the shot a requirement for in-person classes.

In Los Angeles, students who are not fully vaccinated – or exempt – will be forced into the district’s independent study program or will have to leave the Los Angeles public school system.

Shifting 34,000 students into independent study would be challenging because the program faces staffing shortages, according to the Times.

Ray Meister, MD, MPH, Executive Medical Director Division of Workers’ Compensation Department of Industrial Relations, has just announced a new educational offering for Qualified Medical Evaluators.

The Division of Workers’ Compensation launched an update to the online physician education course, Evaluating California’s Injured Workers: Qualified Medical Evaluators (QMEs).

The Center for Occupational and Environmental Health designates this enduring material for a maximum of 2 AMA PRA category 1 Credit(s) and the course is approved for 2 hours of QME continuing education credit. Those who took the previous course are eligible to retake the updated course for the additional credit.

This course will cover the following topics:

1) How to prepare for an evaluation and outline the components of a quality report
2) The concept of apportionment and how to apportion to causation of disability
3) What constitutes substantial medical evidence and how it applies to apportionment
4) Potential bias and how to avoid it in your medical-legal reports
5) Administrative regulations to stay in compliance as a QME

The DWC also offers a CME course on the Medical Treatment Utilization Schedule (MTUS). All providers involved in the care of California’s injured workers have no-cost access to the MTUS-ACOEM treatment guidelines.

– – Learn how to use the MTUS, the MTUS-ACOEM treatment guidelines and formulary to increase UR approvals
– – Learn how to use evidence-based treatment guidelines and medical recommendations in caring for your patients.
– – Learn which medications are consistent with the MTUS-ACOEM treatment guidelines and exempt from Prospective Review authorization.

Both courses are offered free of charge.

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the California Medical Association (CMA) through the joint providership of The Center for Occupational and Environmental Health (COEH) and State of California Department of Industrial Relations Division of Workers’ Compensation. The Center for Occupational and Environmental Health is accredited by the CMA to provide continuing medical education for physicians.

The Center for Occupational and Environmental Health (COEH) designates this enduring material for a maximum of 2.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Mercury News reports that More than 100 Los Angeles city firefighters have been placed off duty without pay for failing to comply with the city’s vaccine mandate.

The City, in August, directed its employees to get vaccinated unless they request a medical or religious exemption. Those who haven’t done either by Dec. 18, including firefighters, eventually will be subject to termination, a LAFD spokeswoman said.

In November, the Los Angeles Fire Department sent out notices to 222 firefighters informing them they would be sent home without pay unless they got the vaccine or requested an exemption, an LAFD spokeswoman said.

As of Monday, 113 firefighters had failed to respond to those notices, she said. They were placed off duty without pay, but will be allowed to use vacation hours or banked overtime to offset their lost wages.

“The number of firefighters placed off duty changes daily due to members updating their (vaccine status),” LAFD officials said in a statement. “That number will fluctuate.”

The union representing firefighters, the United Firefighters of Los Angeles City Local 112, requested a preliminary injunction through the court to prevent enforcement of the mandate, saying that it could lead to hundreds of firefighters being put on leave.

But last week that request was denied by a Los Angeles Superior Court judge.

The judge said that even if all of the unvaccinated LAFD employees decided to leave because of the vaccine mandate, the department has sufficient contingency plans. Further, she noted, COVID-19 has disrupted the agency and led to two firefighter deaths.

There are more than 3,340 sworn LAFD firefighters and paramedics. The department recently welcomed 54 new recruits, and another class that began in November should be on duty by March, LAFD officials said.

The union, which did not return several messages for comment, also has an unfair labor practices charge pending before the Los Angeles City Employee Relations Board, according to a union bulletin sent out to members. “While we are disappointed with the outcome, we will continue to fight to protect the rights of all UFLAC members,” the bulletin says. The union has not challenged in court the constitutionality of the mandate, but says the city has failed to follow bargaining procedures.

A total of 321 unvaccinated sworn and civilian staff had applied for medical or religious exemptions as of Monday, the LAFD’s spokeswoman said. So far, none have been granted or rejected. Officials were unable to estimate how long it might take to examine the cases, but the process may drag past the Dec. 18 deadline.