Alembic Pharmaceuticals Ltd.

A federal judge in Delaware has overturned a $107.5 million award for Pfizer, ruling in favor of AstraZeneca in a patent infringement case. Less than three months after a Delaware federal jury ordered AstraZeneca to pay $107.5 million to Pfizer in a patent infringement case, a Delaware judge has nullified the award and invalidated the patents behind the lawsuit.While denying AZ’s claims that it didn’t commit infringement and that Pfizer did not suffer damages, Judge Matthew Kennelly voided the Pfizer patents because it lacked clear written descriptions of its inventions and would not allow “persons of ordinary skill in the art” to duplicate them, according to court documents.Pfizer did not respond to a request for comment.The lawsuit surrounded AstraZeneca’s blockbuster lung cancer treatment Tagrisso, which was approved in 2015 and generated $5.8 billion in sales last year. Pfizer claimed that AZ used intellectual property that was patented two decades ago by Pfizer subsidiary Wyeth for a HER2-positive breast cancer drug that was licensed to Puma Biotechnology in 2011. Pfizer picked up Wyeth in a $68 billion buyout in 2009.In 2021, Pfizer and Puma filed the lawsuit against AZ claiming that Tagrisso’s label “encourages acts” of direct infringement. The companies also contended that AZ was aware of the patent protections.Last year, Los Angeles-based Puma recorded sales of $203 million of the breast cancer drug, which is marketed as Nerlynx and was approved in 2017. It is the lone product in the company’s portfolio, and Puma has sole rights to its development and commercialization. Earlier this year, the court removed Puma as a plaintiff from the case, even though it “maintains contractual rights to recover monetary damages in the AstraZeneca litigation,” according to a Securities and Exchange Commission filing in May, days before the jury sided with Pfizer.Meanwhile, AZ has successfully fended off Tagrisso generics with three of its own patent infringement suits. The latest settlement was in 2022, blocking Alembic Pharmaceuticals from making a Tagrisso copycat until the branded med’s intellectual property protection expires in the next decade, except if authorized.

To date, Glenmark says it hasn’t received any reports of elevated potassium levels or serious side effect reports linked to the recall. While patients with low potassium often need medication to boost levels of the electrolyte in the body, too much of a good thing can cause serious health concerns. Glenmark Pharmaceuticals on Tuesday said it’s recalling 114 batches of 750mg potassium chloride extended-release capsules thanks to failed dissolution of the product. Failed dissolution of the capsules could cause patients to develop heightened potassium levels, also known as hyperkalemia, which can result in irregular heartbeat. That side effect can potentially in turn lead to cardiac arrest. Glenmark’s potassium chloride capsules are used to treat patients with low potassium, or hypokalemia. For patients who consistently use the drug—and especially in those with other underlying health conditions like hypertension, heart failure or kidney dysfunction—there is a “reasonable probably of developing hyperkalemia that may lead to a range of severity of adverse events,” including those that are potentially life-threatening, Glenmark said in a release. To date, Glenmark says it hasn’t received any reports of elevated potassium levels or serious side effect reports linked to the recall. The company is performing the product pull voluntarily in conjunction with the FDA. The suspect batches of potassium chloride capsules were shipped out across the U.S. to wholesalers, distributors and retailers, Glenmark said. The lots in question were set to expire between June 2024 and September 2025. The recall comes a little less than a year after Glenmark extricated itself from a sticky debt situation. Last September, the Mumbai, India-based company revealed plans to extinguish its debt by pawning off 75% of its active pharmaceutical ingredient (API) business to Nirma Limited for Rs 5,651 crore ($681 million). At the time, Glenmark’s chairman and managing director Glenn Saldanha said the company was facing a gross debt of approximately Rs 4,600 crore ($555 million). Elsewhere, the threat of hyperkalemia has forced other recalls in the past. Back in March of 2021, generic drugmaker Alembic Pharmaceuticals yanked one lot of 20mg telmisartan tablets for hypertension in the U.S. due to a complaint that a single 30-count bottle with a 20mg label instead contained 40mg tablets. Patients who received a double dose of the hypertension med over a prolonged period of time could suffer low blood pressure, worsening kidney function or a potentially life-threatening elevation of potassium levels, Alembic warned at the time.

Takeda's Exkivity market withdrawal, Kyowa Kirin's acquisition of Orchard Therapeutics and Biogen's Actemra biosimilar approval made our news this week. Takeda will withdraw lung cancer drug Exkivity after a confirmatory trial failure. Kyowa Kirin is buying gene therapy biotech Orchard Therapeutics. Biogen's biosimilar version of Roche's Actemra, bought from Bio-Thera Solutions, won an FDA nod. And more. 1. Takeda to pull lung cancer med Exkivity around the world after confirmatory trial flop Takeda will pull Exkivity from the market in the U.S. and beyond. The drug won an accelerated approval in 2021 for previously treated non-small cell lung cancer with EGFR exon 20 insertion mutations. But the phase 3 EXCLAIM-2 confirmatory trial in the first-line setting was a blunder. Exkivity failed as a monotherapy, just as Johnson & Johnson’s rival therapy Rybrevant succeeded in a combination with chemotherapy. 2. Orchard lands $387M Kyowa buyout, reaping harvest of US gene therapy progress Kyowa Kirin is paying $387.4 million upfront to purchase Orchard Therapeutics, which has a gene therapy for early-onset metachromatic leukodystrophy approved in Europe and under review at the FDA. Orchard investors will get an additional $1 per share if the FDA approves the med. After some clinical setbacks, Kyowa CEO Masashi Miyamoto recently said the company was working on acquisitions. 3. Biogen nabs FDA nod for biosimilar version of Roche's blockbuster Actemra The FDA has approved the first biosimilar to Roche’s blockbuster autoimmune drug Actemra. The copycat, now branded as Tofidence, will be marketed by Biogen. The company got the drug in 2021 from Chinese company Bio-Thera Solutions by paying $30 million upfront. The approval comes as Biogen conducts a strategic review of its biosimilar franchise. 4. Adlai, building on the ashes of Novartis' failure, raises $57.5M IPO to run phase 3 cancer trial Chinese-American biotech Adlai Nortye has raised $97.5 million through a Nasdaq IPO and private placement, and traded down 33% on its first day. The company has a Novartis castoff, a PI3K inhibitor called buparlisib, serving as its lead candidate. The drug is in pivotal testing in head and neck cancer. Novartis sold the drug for just $9.5 million upfront after seeing safety issues in a phase 3 breast cancer study. 5. In selling 3 businesses, Viatris bids adieu to 10 manufacturing plants, 6,000 employees Viatris is shedding some over-the-counter, women’s health and active pharmaceutical ingredient assets for more than $3 billion. In one deal, Viatris has agreed to sell its API business in India to IQuest Enterprises. The deal features six manufacturing sites and an R&D lab. Other News of Note 6. Flooding halts manufacturing at Alembic Pharmaceuticals plant in India 7. Lokavant snares $8M investment to expand its presence in Asia-Pacific region