Lundbeck set to acquire Chelsea Therapeutics
VALBY, Denmark and CHARLOTTE, N.C. — Lundbeck and Chelsea Therapeutics International last week announced an agreement under which Lundbeck will acquire Chelsea.
The transaction will allow Lundbeck to leverage its experience in rare neurologic disorders in the United States through the upcoming launch of Northera, which received approval from the Food and Drug Administration on Feb. 18. The drug is used for the treatment of symptomatic neurogenic orthostatic hypotension and is expected to launch in the second half of 2014. Northera will join Lundbeck’s existing line of neurology medications, which includes Onfi, Sabril and Xenazine.
"I believe this offer represents an attractive offer to the stockholders of Chelsea and is consistent with Lundbeck’s strategic and disciplined approach to acquisitions," said Ulf Wiinberg, president and CEO Lundbeck. "The proposed strategic acquisition of Chelsea — and the launch of its lead therapy, Northera — aligns with Lundbeck’s core strengths in addressing rare and challenging neurological disorders. As a company committed to people living with brain disorders, we are uniquely positioned to make Northera available to those who need it most."
Chelsea stockholders are entitled to $6.44 per share in cash and CVRs that may pay up to $1.50, for a total potential consideration of up to $ 7.94 per share, or $658 million on a fully diluted basis, the companies stated. The offer also provides Chelsea stockholders to participate in the potential commercial success of Northera.
Chelsea’s board of directors unanimously approved the transaction, which is expected to close in the third quarter of 2014.
Hillshire to acquire Pinnacle Foods
PARSIPPANY, N.J. — Pinnacle Foods on Monday announced that it has entered into an agreement to sell the company to Hillshire Brands. The transaction will include cash and Hillshire common stock.
Pinnacle Foods’ portfolio includes such branded food products as Duncan Hines, Vlasic pickles, Wish-Bone and Western salad dressings, and Mrs. Butterworth’s and Log Cabin table sryups, among other brands. The company also is home to the Birds Eye Frozen Division, which includes a variety of frozen vegetables and meals. The combined company will have annual net revenues of approximately $6.6 billion and will be led by current Hillshire President and CEO Sean Connolly.
"This transaction speaks to the value Pinnacle employees have created by executing our strategy of reinvigorating iconic brands," said Pinnacle CEO Bob Gamgort. "The combination of the brand portfolios of Pinnacle and Hillshire creates a powerful food company with broad reach across frozen, refrigerated and grocery categories."
Hillshire will acquire all outstanding shares of Pinnacle Foods; Pinnacle stockholders will receive $18.00 in cash for each share held, along with Hillshire common stock at a fixed exchange ratio of 0.50 Hillshire shares for each Pinnacle share, according to the company.
Q&A: The importance of responsible medication storage
DSN had the opportunity to sit down and talk with Doug Hebert, co-founder and VP RxArmory, and Shelly Mowrey, VP RxArmory, about the importance of substance abuse prevention.
DSN: What began your interest and passion in substance abuse prevention?
Hebert: Having worked over 26 years with the Drug Enforcement Administration; seeing firsthand the devastation and collateral damage of drug abuse, particularly when it involves children. That’s when I really took an interest in prevention and education. I often participated in presentations to community drug prevention organizations and helped organize DEA’s Red Ribbon celebration in local grade schools and middle schools. I made up my mind when I left DEA I would continue my passion in prevention and education, to educate our kids to make healthy choices in life.
Mowrey: I developed a passion for preventing youth substance abuse after experiencing firsthand hand the devastation that substance abuse has on families. Over the last decade, I have seen how prevention works and leads to lower drug use, death and addiction. My focus is reaching out to parents to arm them with the knowledge and information needed to raise drug-free children.
DSN: Compared to when you first began your careers in substance abuse prevention, are we in a better or worse situation?
Mowrey: The number of Americans using illegal drugs is now one-third the rate of what it was in the 1970’s. Where there has been an alarming trend is the abuse of pharmaceutical drugs. Every day 6,600 people in the U.S. take a prescription drug not prescribed to them by a doctor and 2,500 of those are children. Every eight minutes a child is treated in the Emergency Department for prescription drug poisonings.
Hebert: Statistically we are currently seeing a drop in the “illegal” drug use rate (except marijuana); but we always have to be cognizant of what lies in the future. Drug traffickers are always one step ahead creating new ways to target our youth with “designer” drugs like Molly, Bath Salts, and other hallucinogens putting them on a destructive path. The increased availability and use of prescription drugs only compounds what the future holds. That’s why prevention, education and decreasing the access of drugs is so important.
DSN: What is the reason for the drop of illegal drug use, but the rise in prescription drug abuse in America?
Mowrey: The perception among teens and the general public is taking prescription drugs is “safer” than abusing illegal drugs. They are prescribed by a doctor, meant for healing, and get a stamp of approval from the FDA. For many children and adults abusing pills, they believe it is a much “safer” high than abusing a street drug like heroin or cocaine. There could be nothing further from the truth. Abusing a prescription drug can be just as addictive and deadly as abusing a street drug like heroin. In addition, these prescription drugs are available and accessible in almost every household.
DSN: How important is properly storing prescription medication in the household?
Mowrey: It is estimated that 90% of children report getting the medications they abuse right from their own medicine cabinet or from a friend. If every household properly secured their prescription medications it would virtually eliminate the opportunistic theft of those medications. If someone breaks into a secure container or a lock-box to steal prescription medications; you know there’s problem. “Availably = Access = Increased Use”. It is imperative practitioners educate patients on the secure storage of prescription medications in the home.
DSN: What impact does drug enforcement have on preventing drug abuse?
Hebert: I spent most of my DEA career targeting international and domestic drug trafficking organizations responsible for manufacturing, transportation and distribution of “illegal” drugs. I’ve witnessed tons of illegal drugs seized year after year knowing it had little impact on the supply. You come to the realization we cannot arrest ourselves out of the drug situation.
Don’t get me wrong, drug enforcement is an extremely important element. There are a lot of dangerous criminals, gangs, and terrorist organizations using drug trafficking to finance other criminal activity; and they need to be removed from society. Enforcement is one part of the equation with emphasis in education/prevention, and treatment.
DSN: You mentioned DEA’s role in targeting “illegal” drug trafficking. What about DEA’s role in targeting pharmaceutical drug trafficking.
Hebert: Ten years ago, DEA observed an alarming trend in drug use statistics. What caught DEA’s attention was the steady decline of “illegal” drug use in the U.S., while the opposite was occurring with pharmaceutical drugs, particularly opioids. A few years later, DEA declared international drug cartels were no longer the biggest drug threat to the U.S., but rather our own domestic pharmaceutical drug industry. Pharmaceutical drug abuse is still the biggest drug threat in the U.S. today.
DSN: What is DEA doing to specifically to address the biggest drug threat in the U.S.?
Hebert: In 2009, DEA combined a section of the enforcement side of the agency with regulatory side to create Tactical Diversion Task Forces throughout the U.S. Most doctors are responsibly prescribing controlled substances for legitimate medical reasons. There are a few doctors abusing that privilege; prescribing controlled substances for no medical reason. These DEA Diversion Task Forces specifically target those doctors, pharmacists and pharmacies that are egregiously abusing their DEA Registration.
DSN: What steps can healthcare providers take to fight prescription drug misuse, abuse and diversion?
Mowrey: Prescription drug abuse is a public health crisis. Never think it can’t be your patient misusing a medication. Unfortunately moms, dads, friends and neighbors are building a tolerance to these medications and becoming dependent on them. Doctors can take steps to curb the prescription drug epidemic by incorporating pain contracts, having a treatment plan for their patient, providing substance abuse treatment options to those who have a high tolerance and dependence for the medication and need help.
Doctors should sign up and utilize the Prescription Drug Monitoring Program (PDMP) in their state. This program allows a doctor to see the pharmacies and doctors that have prescribed or dispensed medication to the patient. This cuts down on doctor shopping; protecting the doctor and patient. Doctors must also initiate a dialogue with patients about safely storing prescription medications in a locked container.
DSN: What types of activities or initiatives have you seen healthcare providers (or communities) take that has made a significant impact in decreasing drug abuse?
Mowrey: Most successful initiatives are those involving substance abuse prevention professionals, law enforcement, substance abuse treatment providers, and the health care community working together. For example, the “Prescription Drug Reduction Initiative” in Arizona is a multi-systemic approach showing results. As part of the initiative, permanent prescription drug drop boxes were placed in the communities and collected nearly 6,000 pounds of unused or expired medication in one year. Parents were educated in securing their prescription medications; thus reducing the access. Parents were better prepared to talk with their children about the dangerous consequences of misusing medication. Best practice guidelines were established for prescribers and pharmacists as well as patient education.
Results show, it increased the number of practitioners using the PDMP, reduced the number of pills prescribed and reduced the number of prescriptions in the targeted communities.
DSN: How urgent is this problem?
Mowrey: Forty lives are lost every day to a prescription pain reliever overdose. If we had 40 dolphins washing up on the shores of California, people would be outraged working night and day to figure out why so many dolphins are dying. We have to be salient when addressing this public health crisis. Too many children are dying and their deaths are 100% preventable.
Hebert: DEA has already established pharmaceutical drug abuse is the biggest drug threat in our Nation. The practitioner is the first-line of defense; treating patients, educating them on the safe use of pain medications, and emphasizing the importance of safely securing prescription medications in the home.
Doug Hebert is the Co-Founder and Vice President of RxArmory, a company that provides a safe, convenient and affordable method of securing prescription drugs into existing medicine cabinets, reducing the risk of diversion and preventing accidental or intentional misuse. Doug is a former supervisory Special Agent of the United States Department of Justice, Drug Enforcement Administration (DEA). Doug supervised DEA enforcement groups, state & local task forces, money laundering operations, training, and pharmaceutical diversion. As part of a DEA nationwide initiative, Doug established two DEA Tactical Diversion Task Forces in Arizona addressing the diversion of pharmaceutical controlled substances throughout the State.
Shelly Mowrey is the Vice President of RxArmory. She is an expert in substance abuse prevention and education. Before joining RxArmory, Shelly created Drug Free Arizona, the state’s leading substance abuse prevention provider. While there for 12 years, she developed prevention programs, media campaigns and professional development trainings for communities that have been instrumental in reducing youth drug use in the state of Arizona. She created specialized programs for parents, youth, corrections, faith-based organizations, teachers, nurses and healthcare providers. Shelly has received extensive training provided by the Drug Enforcement Administration, the Community Anti-Drug Coalitions of America, the Arizona Department of Health Services, The Partnership at DrugFree.org and the Arizona Narcotics Officers Association.