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Effective URL: https://endpts.com/astrazeneca-prepares-to-live-with-the-ira-shifting-focus-of-arguments-to-orphan-drug-changes/
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* Channels * All News * In Focus * Special * AI * Bioregnum * Biotech Voices * Cell/Gene Tx * China * Coronavirus * Deals * Diagnostics * Discovery * FDA+ * Financing * Health Tech * Law * Letters to the Editor * Manufacturing * Marketing * Opinion * Outsourcing * Peer Review * People * Pharma * R&D * Startups * Weekly * Webinars * Biopharma Jobs * More * Work at Endpoints * Letter to Editors * IPO Tracker * Webinars * Events * Sponsored Posts * Advertise * Privacy Policy * Endpoints Merch * About Us * Help * SIGN UP * LOG IN Pascal Soriot, AstraZeneca CEO (Cole Burston/Bloomberg via Getty Images) November 10, 2023 03:55 PM EST Pharma Law ASTRAZENECA PREPARES TO LIVE WITH THE IRA, SHIFTING FOCUS OF ARGUMENTS TO ORPHAN DRUG CHANGES MAX GELMAN SENIOR EDITOR NEW YORK — AstraZeneca may be getting ready to live with the Inflation Reduction Act. On Friday morning, CEO Pascal Soriot told reporters that the drugmaker is most focused on getting the 2022 law adjusted, not invalidated. His comments are the most direct yet from a major pharma CEO about a future in which the IRA is not fully overturned by the courts, as several drugmakers have sued to try and do. “We saw a better approach is actually not to go against the law itself — because the law has been passed by Congress, it’s a law — but to challenge the implementation,” Soriot told reporters in New York. advertisement advertisement Aradhana Sarin Soriot and CFO Aradhana Sarin were discussing an IRA provision that exempts orphan drugs from price negotiations under the law only if they receive the orphan designation — which comes with seven years of market exclusivity — for a single disease. Most orphan drugs, however, receive designations for multiple diseases. Under the IRA, they’d lose their exclusive market rights and be eligible for price negotiation if they got more than one orphan designation. “Our argument is, we accept it, we accept that governments need to manage costs,” Soriot said. “But for rare diseases, we need to make sure there’s enough incentive for companies to continue to invest.” Soriot gave the example of Lynparza, the company’s ovarian, breast and prostate cancer drug. The drug was first approved for third-line ovarian cancer in 2014 and gained an orphan designation and the corresponding market exclusivity. It sold relatively little in its first three years on the market and then became a multibillion-dollar drug after clinching more approvals. US government spending on the drug was only about $45.9 million in 2021 — far lower than drugs at the top of the list. It’s not currently on the list of drugs up first for negotiation. ‘WE HAVE TO GET A RETURN’ Despite that, Soriot said AstraZeneca wouldn’t have pursued the same strategy for the treatment and would have foregone the late-line ovarian cancer FDA submission. “It’s not that we want to be difficult, but at the end of the day, we have to get a return on investment so we can reinvest in our pipeline,” Soriot said. “So for two or three years, essentially, we will launch the product everywhere in the world. And we will not file in the US because you lose three years selling very little.” Such threats have become common among drugmakers, who routinely tell regulators in the US and in Europe that policies will push them out of the market. Only on rare occasions has that proven to be the case, and it’s not clear how many companies might actually follow through once the IRA is in full force. But Friday’s comments are notably different from other pharma CEOs who have cast the IRA in far more dire terms. Eli Lilly CEO David Ricks said the gag order built into the negotiation process is “feeling a little Orwellian”; Biogen CEO Chris Viehbacher called the entire law “draconian.” DRUGMAKER LAWSUITS Like Merck, Bristol Myers Squibb and J&J, AstraZeneca has sued over the law. AstraZeneca’s lawsuit argues that the IRA gave too much authority to the Centers for Medicare & Medicaid Services, and as a result CMS violated the law’s provisions. The suit also claims that the law itself is unconstitutional by infringing on the “Due Process Clause” in the Fifth Amendment, depriving AstraZeneca’s ability to sell its drugs without sufficient procedural protection. Other drugmakers have also sued on Fifth Amendment grounds, citing the “Takings Clause.” The clauses and their constitutional implications are distinct, but both deal with private property. “The IRA deprives AstraZeneca of two constitutionally protected property interests: its investment-backed patent rights and common-law right to sell its products at market prices free from arbitrary and inadequately disclosed governmental constraints. And the statute works this deprivation upon AstraZeneca involuntarily,” AstraZeneca said in the complaint. At the meeting with reporters on Friday, Soriot was asked if his comments about the IRA being law meant the company would withdraw its suit. He and Sarin didn’t directly answer, and said the focus of their suit was on how the law was implemented, not the validity of the law itself. A spokesperson for the company said after the interview that AstraZeneca has no plans to withdraw its suit. ARGUMENTS OVER THE ORPHAN CLOCK The orphan drug issue Soriot gave as an example is compounded by another clause in the law. Under the IRA, small-molecule drugs are given nine years before they’re subject to negotiation. Large molecule biologics get 13 years. In Soriot’s view, he believes the law should be adjusted to start the market exclusivity clock not after an orphan drug’s first approval, but only after it receives its first approval in a non-orphan indication. Using the Lynparza example, Soriot said the clock should start not when it received the third-line ovarian cancer approval in December 2014, but at its first approval in a non-orphan indication — its January 2018 approval for BRCA-mutated breast cancer. “CMS was much too liberal, too expansive in its interpretation of the law,” Soriot said. “That’s really what we focused on,” he continued, while noting that other drugmakers’ suits may succeed. But, he said, “our most important goal is to get this fix around starting the clock.” AUTHOR MAX GELMAN SENIOR EDITOR max@endpointsnews.com @MaxGelman Max Gelman on LinkedIn TRENDING NOW VERVE SHARES FIRST BASE EDITING RESULTS IN HUMANS, SUGGESTING THERAPY CAN LOWER CHOLESTEROL IN PATIENTS WITH GENETIC ... AFTER SHOWING WEGOVY CUT CARDIOVASCULAR RISK BY 20%, RESULTS DETAIL IMPACT ON DEATH AND HEART FAILURE FIRST DATA FOR LILLY'S RNA TREATMENT FOR HEART DISEASE POINT TO LONG-TERM DURABILITY IN TINY GROUP OF PATIENTS ALNYLAM’S LONGER-TERM RNAI TREATMENT LOWERS BLOOD PRESSURE IN MID-STAGE STUDY ANTHOS' BLOOD THINNER CUTS THE RISK OF BLEEDING AMID RACE TO DEVELOP SAFER ANTICOAGULANTS sponsored CLINICAL STUDIES IN JAPAN TODAY: ANOTHER LOOK AT THE WORLD’S SECOND-LARGEST PRESCRIPTION DRUG MARKET IN A ... 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