Pharma - Health Care Chief

Roche's Genentech filed a lawsuit against Biogen in federal court, alleging that Biogen owes extra patent royalties on sales of its wildly successful Tysabri treatment for multiple sclerosis and Crohn's disease. When Genentech created a method for producing antibodies forty years ago, several biopharma companies waited in line to license the technology. The invention, known as the "Cabilly patents" is named after scientist Shmuel Cabilly, and enabled Genentech and its parent firm Roche to construct a quasi-toll booth that produced approximately $1 billion in royalty payments per year. The validity of these patents expired in 2018, but Roche is still attempting to recover the remaining royalties it believes are still pending. According to Genentech's lawsuit, even though Tysabri was sold years after it was manufactured using Genentech's patents, Biogen is still obligated to pay royalties. Roche said that Biogen had not paid royalties on its Tysabri since the end of 2018 in a breach of contract lawsuit filed in federal court in the Northern District of California and wanted a jury trial. When Tysabri was introduced in 2004, Biogen began to pay fees. According to court records, the agreement called for Biogen to pay a mid- to low-single-digit percentage on Tysabri sales in the United States and a "reduced royalty" on sales of the medication elsewhere in the globe. Payments were made every three months. Yet according to Roche, Biogen produced Tysabri and kept stockpiles of it, according to the standard practice taking place in the industry. Notwithstanding the fact that Tysabri sales occurred after 2018, according to Roche, it is still owed royalties on the drug that was accumulated before Cabilly's expiration. Roche stated in their complaint: “Because the process for manufacturing antibodies is complex, and the consequences of a stockout potentially catastrophic, it is customary for biopharmaceutical firms that make and sell therapeutic antibodies to stockpile at least several calendar quarters worth of product, and often more than that.” Tysabri, which produced more than $2 billion in revenue each of the previous two years, is one of Biogen's most successful medications. During the four-year period from 2019 to 2022, the sales of the medication were $7.9 billion. The case raises concerns about other businesses that were in a similar licensing agreement with Roche and may have ceased paying royalties after completing sales in 2018. Genentech issued a statement in which it claimed that the company is not commenting on the case as they are confident in the enforcement of the Cabilly patents, even though the litigation is still in process. Biogen did not comment on the case. Business between Roche and Biogen has not been affected by the dispute. A late-stage bispecific antibody called glofitamab is being researched for use against blood malignancies such as B-cell non-lymphoma, and Hodgkin's. Almost three months ago, Roche and Biogen reached an agreement for royalties on its possible commercialization. Also read, The recommended price range for Eisai’s Leqembi increased by ICER

Genentech sues Biogen for royalties on blockbuster MS drug

Editorial Team

March 7, 2023
3 min read

The ICER (Institute for Clinical Economic Review) is an influential drug pricing group in the United States, and it has updated its evaluation of Leqembi, an Alzheimer’s drug by Eisai. The agency has suggested a comparatively higher price point that was agreed upon beforehand for the medication in light of a rival drug’s failure. ICER said that for the drug to be cost-effective it should be priced between $8,900 and $21,500. The new price suggested by ICER means that Eisai should potentially decrease the current price of $26,500 by as low as 19% and as high as 66%. However, the upper bracket of the price range given by ICER is a $900 increase from the original report from back in December. A virtual public meeting will be held by ICER in mid-March before anything is finalized. The new recommended prices are the net prices of the drug after rebates and discounts. The net prices are generally not released to the public and are decided behind closed doors. This updated report has come after the approval of a rival drug, Eli Lilly’s deonanemab was rejected by the FDA in January. Along with Biogen’s already approved Aduhelm, both these drugs cause a reduction in the beta-amyloid plaques found in the brain. According to an ICER spokesperson, the agency changed the analysis of Alzheimer’s patient characteristics a little bit following the rejection of Eli Lilly’s drug, which is why the new prices were recommended for Leqembi. ICER’s CMO (Chief Medical Officer) gave credit to Eisai for presenting evidence that suggests the slowing down of cognition decline by the use of the anti-amyloid antibody in early Alzheimer’s patients. The CMO also said that the first medication that is effective in stopping or reversing dementia will have a very high price in the United States market. The wide range in the recommended price also shows that reaching a consensus was troublesome for the appraisal committee. ICER’s opinions are of use to insurance companies, payers, and at times lawmakers for the purpose of decision-making, despite the agency not being a government body that can directly affect the drug’s pricing. ICER’s analysis could be of use when the Eisai talks to the U.S. government regarding coverage of Lecembi on Medicare. Not long ago, the CMS (Centers for Medicare and Medicaid Services) rejected an appeal to reconsider a reimbursement policy for the drug and other medicines in the same class. The drug is being considered for full approval and has been approved by the FDA under the accelerated approval path. Side effects/ risks associated with the drug: Patients who take Leqembu can, at times, develop a possibly fatal side effect called ARIA (amyloid-related imaging abnormalities). It is suspected that the death cases are connected to Leqembi, and it was reported in the clinical trials of the drug. The patients in the trial were carefully managed and strictly monitored. The CMO voiced concern about the impact of the side effect. Talking about the risks involved with ARIA, the CMO stated, “we have some uncertainties as to whether the average benefits of lecanemab exceed its risks.” You can also read: BMS Settles Lawsuit with Fired Employees Who Declined COVID Vaccination

The recommended price range for Eisai’s Leqembi increased by ICER

Editorial Team

March 3, 2023
3 min read

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