Global Corporate development

More information

Global Corporate development

More information

News Release

Merz Therapeutics Closes $185M Asset Purchase Agreement with Acorda Therapeutics

Upper Polygon
Lower Polygone
  • Acquisition of INBRIJA (levodopa inhalation powder) and (F)AMPYRA (fampridine) expands specialty neurology portfolio
  • Lays groundwork for Parkinson’s disease franchise and anchor in multiple sclerosis therapy
  • Plans include growth of U.S. workforce by more than 50%

 

RALEIGH, N.C. – July 10, 2024 – Merz Therapeutics announces today the successful acquisition of INBRIJA® (levodopa inhalation powder) and (F)AMPYRA® (fampridine), and related assets from Acorda Therapeutics, Inc. AMPYRA® (dalfampridine) is Food and Drug Administration (FDA) approved in the U.S. and commercialized as FAMPYRA in the European Union and other territories throughout the world. This transaction was conducted through a court-structured 363 sale under the U.S. Bankruptcy Code. The completion of this deal, valued at USD 185 million in cash, bolsters Merz Therapeutics’ market position by enhancing offerings for people living with Parkinson’s disease and expanding into the multiple sclerosis (MS) space.

“The addition of INBRIJA and (F)AMPYRA to the treatment portfolio underlines Merz Therapeutics’ global Pivot for Growth strategy to both evolve the current portfolio and achieve critical scale and global reach,” said Stefan König, CEO of Merz Therapeutics. “Merz Therapeutics is well poised to build on what we have accomplished in the specialty neurology space, strengthening our market position in Parkinson’s disease and expanding into the MS segment. This deal demonstrates Merz Therapeutics’ interest and ability to acquire assets that will deliver greater, sustainable outcomes for more people living with neurological disorders.”

INBRIJA and (F)AMPYRA are projected to immediately add topline revenue which will enhance Merz Therapeutics’ ability to accelerate clinical development of its existing and new assets. Its U.S. business is forecasted to contribute more than 75% of INBRIJA’s and (F)AMPYRA’s total global revenues over the next 10 years. Additionally, the company expects the U.S. workforce to increase by more than 50%.

INBRIJA is a significant advancement for people living with Parkinson’s disease as it provides an on- demand, inhalable form of levodopa, offering an effective way to manage “OFF” episodes. This method of delivery, achievable through the innovative and proprietary technology platform, ARCUS®, is especially valuable for people who need rapid relief from their symptoms, which cannot be achieved reliably through oral intake.

(F)AMPYRA is the first medication approved for improving walking in patients with MS, demonstrated by improved walking speed.

“Expanding the portfolio with INBRIJA, including plans for worldwide product roll-out, and (F)AMPYRA allows Merz Therapeutics the opportunity to leverage its experience in the specialty neurology space to serve even more patients living with neurological disorders and support the physicians who treat them,” said Stefan Albrecht, Chief Scientific and Medical Officer. “Because these treatments complement the company’s product portfolio and distribution system, we are well positioned to support patients who depend on these products seamlessly.”

INDICATION & IMPORTANT SAFETY INFORMATION FOR INBRIJA® (levodopa inhalation powder) 

Indication

INBRIJA is a prescription medicine used when needed for OFF episodes in adults with Parkinson’s treated with regular carbidopa/levodopa medicine. INBRIJA does not replace regular carbidopa/levodopa medicine.

 

Important Safety Information

Do not use INBRIJA if you take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last 2 weeks.

Before using INBRIJA, tell your healthcare provider about your medical conditions, including:

  • asthma, chronic obstructive pulmonary disease (COPD), or any chronic lung disease
  • daytime sleepiness, sleep disorders, sleepiness/drowsiness without warning, or use of medicine that increases sleepiness, including antidepressants or antipsychotics
  • dizziness, nausea, sweating, or fainting when standing up
  • abnormal movement (dyskinesia)
  • mental health problems such as hallucinations or psychosis
  • uncontrollable urges like gambling, sexual urges, spending money, or binge eating
  • glaucoma
  • pregnancy or plans to become pregnant. It is unknown if INBRIJA will harm an unborn baby.
  • breastfeeding or plans to breastfeed. Levodopa can pass into breastmilk and it is unknown if it can harm the baby.

 

Tell your healthcare provider if you take:

  • MAO-B inhibitors
  • dopamine (D2) antagonists (including phenothiazines, butyrophenones, risperidone, metoclopramide)
  • isoniazid
  • iron salts or multivitamins that contain iron salts

 

Do not drive, operate machinery, or do other activities until you know how INBRIJA affects you. Sleepiness and falling asleep suddenly can happen as late as a year after treatment is started.

Tell your healthcare provider if you experience the following side effects:

  • falling asleep during normal daily activities with or without warning. If you become drowsy, do not drive or do activities where you need to be alert. Chances of falling asleep during normal activities increases if you take medicine that cause sleepiness.
  • withdrawal-emergent hyperpyrexia and confusion (fever, stiff muscles, or changes in breathing and heartbeat) if you suddenly stop using INBRIJA or carbidopa/levodopa, or suddenly lower your dose of carbidopa/levodopa.
  • low blood pressure when standing up (that may be with dizziness, fainting, nausea, and sweating). Get up slowly after sitting/lying down.
  • hallucinations and other psychosis – INBRIJA may cause or worsen seeing/hearing/believing things that are not real; confusion, disorientation, or disorganized thinking; trouble sleeping; dreaming a lot; being overly suspicious or feeling people want to harm you; acting aggressive; and feeling agitated/restless.
  • unusual uncontrollable urges such as gambling, binge eating, shopping, and sexual urges has occurred in some people using medicine like INBRIJA.
  • uncontrolled, sudden body movements (dyskinesia) may be caused or worsened by INBRIJA. INBRIJA may need to be stopped or other Parkinson’s medicines may need to be changed.
  • bronchospasm – people with asthma, COPD, or other lung diseases may wheeze or have difficulty breathing after inhaling INBRIJA. If this occurs, stop taking INBRIJA and seek immediate medical attention.
  • increased eye pressure in patients with glaucoma. Your healthcare provider should monitor this.
  • changes in certain lab values including liver tests

 

The most common side effects of INBRIJA are cough, upper respiratory tract infection, nausea, and change in the color of saliva or spit.

Do not orally inhale more than 1 dose (2 capsules) for any OFF period. Do not take more than 5 doses (10 capsules) in a day.

Please see the accompanying full Prescribing Information for INBRIJA.

 

INDICATION & IMPORTANT SAFETY INFORMATION FOR AMPYRA® (dalfampridine)

INDICATION

AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg, is the first and only brand prescription medicine indicated to help improve walking in adults with multiple sclerosis (MS). This was demonstrated by an increase in walking speed.

 

IMPORTANT SAFETY INFORMATION 

Do not take AMPYRA if you:

  • have ever had a seizure,
  • have certain types of kidney problems, or
  • are allergic to dalfampridine (4-aminopyridine), the active ingredient in AMPYRA.

 

Take AMPYRA exactly as prescribed by your doctor.

Before taking AMPYRA, tell your doctor if you:

  • have any other medical conditions
  • are taking compounded 4-aminopyridine
  • are taking any other prescription or OTC medicines, such as cimetidine
  • are pregnant or plan to become pregnant. It is not known if AMPYRA will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if AMPYRA passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you take AMPYRA.

 

Stop taking AMPYRA and call your doctor right away if you have a seizure while taking AMPYRA. You could have a seizure even if you never had a seizure before. Your chance of having a seizure is higher if you take too much AMPYRA or if your kidneys have a mild decrease of function, which is common after age 50. Your doctor may do a blood test to check how well your kidneys are working before you start AMPYRA.

AMPYRA should not be taken with other forms of 4-aminopyridine (4-AP, fampridine), since the active ingredient is the same.

AMPYRA may cause dizziness or vertigo. If you have these symptoms do not drive, operate machinery or do other dangerous activities.

AMPYRA may cause serious side effects, including severe allergic reactions. Stop taking AMPYRA and call your doctor right away or get emergency medical help if you have shortness of breath or trouble breathing, swelling of your throat or tongue, or hives.

The most common side effects for AMPYRA in MS patients were urinary tract infection; trouble sleeping; dizziness; headache; nausea; weakness; back pain; problems with balance; multiple sclerosis relapse; burning, tingling, or itching of your skin; irritation in your nose and throat; constipation; indigestion; and pain in your throat.

Please see the accompanying full Prescribing Information for AMPYRA.

About INBRIJA

INBRIJA® is an inhaled prescription levodopa medicine used to treat the return of Parkinson’s symptoms (known as “OFF” episodes) in people with Parkinson’s disease who are treated with carbidopa/levodopa medicines. It does not replace the regular carbidopa/levodopa medicines. INBRIJA is not to be used by people with Parkinson’s disease who take or have taken a nonselective monoamine oxidase inhibitor, such as phenelzine or tranylcypromine, within the last 2 weeks. The most common side effects of INBRIJA are cough, upper respiratory tract infection, nausea and change in the color of saliva or spit.

About FAMPYRA

FAMPYRA® is a prolonged-release (sustained release) tablet formulation of the drug fampridine (4-aminopyridine, 4-AP or dalfampridine). FAMPYRA is indicated in the European Union for the improvement of walking in adult patients with multiple sclerosis (MS) with walking disability (EDSS 4-7). In clinical trials, the highest incidence of adverse reactions identified with FAMPYRA given at the recommended dose was urinary tract infection. Other adverse drug reactions identified were mainly divided between neurological disorders such as insomnia, balance disorder, dizziness, paraesthesia and headache, and gastrointestinal disorders including nausea, dyspepsia and constipation. In post-marketing experience, there have been reports of seizure. Please see FAMPYRA EPAR for more information.

About AMPYRA

AMPYRA® is an extended-release tablet formulation of dalfampridine (4-aminopyridine, 4-AP or fampridine). AMPYRA is a potassium channel blocker approved as a treatment to help improve walking in adults with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. Please see the AMPYRA Patient Medication Guide for more information.

About Merz Therapeutics

Merz Therapeutics is dedicated to improving the lives of patients around the world. With its relentless research, development and culture of innovation, Merz Therapeutics strives to serve unmet patient needs and realize better outcomes. Merz Therapeutics seeks to address the unique needs of people who suffer from movement disorders, neurological conditions, liver disease and other health conditions that severely impact patients’ quality of life.

Merz Therapeutics is headquartered in Frankfurt am Main, Germany and is represented in more than 90 countries, with a North America affiliate based in Raleigh, North Carolina. Merz Therapeutics GmbH is part of the Merz Group, a privately held, family-owned company that has dedicated 115 years to developing innovations that serve unmet patient and customer needs.

Please visit www.merztherapeutics.com

 

Press Contact for North America Inquiries:

Merz Therapeutics

Nicole Lovern

Corporate Communications

6601 Six Forks Road, Suite 430, Raleigh, NC 27615

(571) 442-9665

Nicole.Lovern@merz.com

 

###