Impax Pharmaceuticals, Inc.

Earlier this week, the U.S. FDA approved Amneal Pharmaceuticals' novel oral formulation of carbidopa/levodopa, branded Crexont, for the treatment of Parkinson's disease. Crexont, which combines both immediate-release granules and extended-release pellets,provides a longer duration of 'good on' time with less frequent dosing compared to existing immediate-release treatments. Additionally, according to Amneal, existing oral treatments are short-acting, and patients can experience more motor fluctuations. This was NJ-based Amneal's second attempt to win FDA approval for Crexont, with the agency handing the drugmaker a CRL last July . The letter indicated that while the safety of levodopa was established, it was not adequately established for the other ingredient, carbidopa. The FDA had requested additional information. Back in 2015 , Impax Pharmaceuticals won approval for its carbidopa and levodopa combo extended release capsules for Parkinson's motor symptoms, branded Rytary. Crexont relies on a different formulation and dosage strength. Amneal expects to make Crexont available to patients in the U.S. this September.

After having already received FDA approval for a carbidopa/levodopa combination in 2015, Amneal Pharmaceuticals is again at the regulator’s doorstep with another new combination of the decades-old Parkinson’s treatment. The biopharma’s papers for IPX203 are now at the FDA, the company said earlier this week. The New Jersey biopharma already has an approved Parkinson’s drug known as Rytary, an extended-release formulation of the medicine combo originally known as Sinemet. Impax Pharmaceuticals snagged that approval in 2015 and Amneal subsequently acquired the generics maker in 2018. In August 2021, Amneal said its latest extended-release oral capsules were better than an immediate-release version of the common Parkinson’s combo of carbidopa/levodopa. IPX203 met the primary endpoint in the Phase III clinical trial of 506 patients with the CNS disorder that has for decades befuddled drug developers. Patients in the RISE-PD trial — which took place in the US and Europe — experienced more “Good On” time and less “Off” time when taking Amneal’s extended-release version, the company said. Other companies have also won FDA nods for combinations of carbidopa/levodopa, including Riverside Pharmaceuticals’ Dhivy in November 2021. The original approval of the pairing of levodopa and carbidopa was in 1975, when the FDA gave the green light to Merck’s Sinemet. Generics have followed suit from the likes of Alembic Pharmaceuticals, Mylan and others.

June 7, 2017 By Alex Keown , BioSpace.com Breaking News Staff LONDON – AstraZeneca continues to divest itself of some older drugs. Today the company announced it was selling the global rights (excluding Japan) to its migraine treatment Zomig to Germany-based Grünenthal for $302 million. In its announcement, AstraZeneca said treatments for migraines and cluster headaches are not areas in which AstraZeneca is strategically focused. Grünenthal, AstraZeneca said, is the right choice to acquire the drug because of its focus on developing pain treatment therapies. “Grünenthal is an established partner with expertise in the treatment of pain. It is well placed to ensure patients continue to benefit from Zomig, and to extend the commercial potential of the medicine through its dedicated salesforce,” Mark Mallon , AstraZeneca’s head of global product and portfolio strategy, said in a statement. AstraZeneca has been on a quest to meet a revenue goal of $45 billion in sales by 2023. The company has been eying its respiratory and oncology pipelines as potential financial tent-poles. Along the way to that goal though, AstraZeneca has been in the process of selling off several drugs, particularly as many of them face revenue challenges from the loss of patents or rival generic drugs. In May, AstraZeneca sold the European commercial rights to its beta-blocker heart drug Seloken and the associated fixed-dose combination Logimax to Italy-based Recordati S.p.A. for $300 million. Earlier this year, AstraZeneca laid out how many of its drugs are losing revenue due to competition. For example, AstraZeneca said sales of schizophrenia drug Seroquel XR were down 83 percent in the United States and 37 percent in Europe. COPD drug Symbicort saw a decline of 21 percent in the United States, which AstraZeneca said was in line with predictions for 2017. For Grünenthal, the acquisition of Zomig fits nicely with its pipeline, which includes its lead candidate neridronic acid, an investigational aminobisphosphonate currently in Phase III development for treatment of complex regional pain syndrome, formerly known as Reflex Sympathetic Dystrophy. Grünenthal is active in about 30 different pain segments. The company is developing treatments for pain associated with Parkinson’s disease and arthritis. Grünenthal also has a therapy for treatment of bladder pain syndrome. In an interview with BioSpace earlier this year, Baertschi said the company is looking to build beyond pain and enter into other related areas, such as developing therapies for inflammation and rheumatoid arthritis. Gabriel Baertschi , chief executive officer of Grünenthal, said in a statement that migraine treatments are one of the areas the company has not delved into. “Migraine is a very debilitating disease with more than 75 million people worldwide suffering from attacks that can lead to sensitivity to light or sound, to nausea or even vomiting,” Baertschi said in a statement. “This is an important step to reach our ambition to become a €2 billion company by 2022. It will also support our efforts to bring four to five innovative products to market in the same timeframe.” Under terms of the deal, AstraZeneca will continue to manufacture Zomig during a transition period. While Grünenthal will have rights to Zomig in the United States, Impax Pharmaceuticals will continue to license the product for sale in America. Zomig generated $96 million in 2016 outside of Japan. Those sales figures were not disclosed. The deal is expected to complete in the second quarter of 2017.