| | | |   | Happy new year! Meghana and Damian here, taking a look at biotech in Q1, contemplating march-in rights, and seeing where Ovid Therapeutics is headed. | | | Keeping score in 2022 There's lots to watch in biotech in the new year, so STAT’s Adam Feuerstein has assembled another handy scorecard for the first quarter. Among the highlights, a readout from Gilead Sciences. It paid $21 billion to buy Immunomedics and its antibody drug Trodelvy, which is approved for triple negative breast cancer and bladder cancer. A new study testing the drug in patients with hormone receptor-positive, metastatic breast cancer will read out soon — and it’s pivotal for the success of Gilead’s cancer business. Another big one: AbbVie’s drug cocktail for cystic fibrosis is vying for FDA approval. If green-lighted, it will be major competition for Vertex Pharma’s $7 billion-plus cystic fibrosis enterprise.
Other companies we’re keeping a close eye on: Nektar Therapeutics, Intellia Therapeutics, Mirati Therapeutics, and so many more…. Read more. | March-in rights for prostate cancer patients? Xtandi, a blockbuster prostate cancer drug made by Astellas Pharma, costs $156,000 in the U.S. — which is three to five times the price paid in other wealthy countries. The drug was developed at a publicly funded institution, however, with the help of government grants. So should Americans have to pay such high prices for drugs created with their tax dollars? This case is a litmus test of whether the Biden administration will use its march-in rights to curb the drug’s cost, opine Peter Arno, Robert Sachs, and Kathryn Ardizzone. Doing so, they say, would send a strong message that price-gouging is no longer acceptable. Read more. | Navigating the impact of Covid-19 on oncology clinical trials In the midst of pandemic lockdown restrictions, patients faced severely limited access to timely medical care, resulting in a drastic reduction in cancer diagnoses. As resources were reallocated, clinical trials studying cancer treatments declined by 60% globally compared to pre-pandemic numbers, while nearly 80% of non-Covid trials were delayed or suspended altogether. Learn how a pharmaceutical company ensured the continuation of its clinical trials, none of which were suspended or delayed due to Covid-19. | Ovid’s next act: treatments for epilepsy Last we heard from Ovid Therapeutics, the company had sold off its most advanced investigational drug in the wake of a clinical failure that wrecked its stock price. Now Ovid is spending some of the proceeds, licensing some early-stage drugs from AstraZeneca in hopes of developing new treatments for epilepsy.
Under the deal, disclosed today, Ovid is paying $12.5 million in cash and stock for a library of small molecules targeting a transporter called KCC2, which ferries potassium chloride to neurons. The drugs, developed by AstraZeneca and Tufts University, are meant to stabilize excitable neurons, thereby addressing the underlying cause of epileptic disorders.
It’s a small amount of money for some preclinical drugs, but Ovid is calling the deal the first in a series of transactions through which the company plans to rebuild its pipeline after a major setback. In late 2020, Ovid’s experimental drug for a devastating rare disease called Angelman syndrome proved no better than placebo in a pivotal clinical trial, cutting the company’s market value in half. | Prenatal testing isn’t as accurate as it seems More than a third of pregnant women in America undergo some sort of prenatal testing. Prenatal testing companies tend to advertise their findings as “reliable” and “highly accurate,” offering “peace of mind” and even “total confidence.” But the results are inaccurate very frequently, the New York Times writes — a fact that’s often misunderstood by the public. Some studies indicate that prenatal tests have false positives for rare genetic conditions more than 90 percent of the time. It’s important to note, however, that these noninvasive prenatal tests are actually screens — casting a net for embryos that are more likely to have chromosomal abnormalities. They should be looked at as a first step before confirmation with amniocentesis or chorionic villus sampling, but are often misinterpreted by patients and even clinicians. | More reads - Xeris Biopharma scores FDA approval for endogenous Cushing’s syndrome drug Recorlev. (FiercePharma)
- Bharat Biotech starts picking up unused Covaxin stock, re-labelling them after shelf life extended. (India Today)
- Bristol Myers Squibb, Amgen and Pfizer approach steepest patent cliffs among large drugmakers. (FiercePharma)
- New York jury holds Teva Pharmaceuticals liable in opioid crisis. (STAT)
| Thanks for reading! Until tomorrow,  | | | |
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