Bio Roundup: Amarin’s Stunner, Lung Cancer News, Data Dumps & More

Xconomy National — 

Six years ago, a biotech called Amarin won FDA approval of a prescription fish-oil pill, Vascepa, because it could lower triglycerides, a type of fat in the blood. But Amarin didn’t have the evidence that lowering triglycerides with fish oil would really help people. Sales lagged. Amarin’s shares sank. While other groups tested other fish oils and found no evidence of concrete cardiovascular benefits, Amarin pressed on with a massive study, bleeding cash for years.

The strategy seems to have paid off. Amarin said this week that the REDUCE-IT study showed Vascepa lowered the risk of heart disease, marking a huge surprise victory for the company and a new turn in a long-running scientific debate.

Elsewhere, there was plenty of news out of a big lung cancer meeting in Toronto, a bushel of biotechs went public, and the second-ever RNA interference drug could soon be headed for an FDA review. Let’s get the roundup rolling.


—For the first time, a pill containing fish oil showed in a clinical trial that it might help reduce the chance of heart disease in people already taking statins to control high cholesterol. The pill is Vascepa, from Amarin (NASDAQ: AMRN), and the 8,379-patient trial called REDUCE-IT concluded that patients were 25 percent less likely, relative to those on statins and a placebo, to suffer a cardiovascular event. Crucial full details will be released in November, but investors aren’t waiting. Amarin’s shares have skyrocketed more than 360 percent this week.

—Gilead Sciences (NASDAQ: GILD) announced it would begin making generic versions of its own hepatitis C drugs that cost up to 75 percent less. The branded versions have years of patent life remaining but are facing legal and financial challenges.


—AstraZeneca (NYSE: AZN) released positive Phase 3 lung cancer data for its drug durvalumab (Infimzi), which when combined with chemotherapy bested chemo alone in patients with advanced cancer.

—Roche detailed the results of a study, IMpower132, that tested a combination of its immunotherapy atezolizumab (Tecentriq) and chemotherapy in newly diagnosed advanced non-small cell lung cancer patients. Though cross-trial comparisons come with caveats, the overall results didn’t appear to match an immunotherapy-chemo combo from Merck (NYSE: MRK). Still, Roche’s regimen notably showed promise in peoples whose tumors don’t express the protein PDL1, EP Vantage reports.

—Roche is trailing rivals in non-small cell lung cancer, but in the less common, more aggressive form—small-cell lung cancer—its drug combination is ahead. Roche detailed the results of IMpower133, through which an atezolizumab-chemo regimen extended the lives of people with SCLC by two months, compared to chemo alone. Roche’s rivals aren’t far behind with their own combos, however, as Reuters reports here. (And Bristol-Myers Squibb’s nivolumab (Opdivo) was cleared for SCLC patients last month.)

—Roche also said it will file for approval of entrectinib for patients whose non-small cell lung cancer has a specific genetic alteration, a ROS1 fusion. Roche is also testing entrectinib in a variety of tumors with so-called NTRK fusions and is aiming for a tissue-agnostic drug approval—that is, clearance to treat tumors with NTRK fusions regardless of where in the body they form.

—A combination of the Blueprint Medicines (NASDAQ: BPMC) targeted cancer drug BLU-667 and osimertinib (Tagrisso), from AstraZeneca, showed promise in two patients with lung cancer and an EGFR mutation whose tumors resisted prior treatment.


—Six life science companies closed out the final week of the third quarter with IPOs, raising a total of $586 million in new capital. Among the newcomers to Wall Street: Gritstone Oncology (NASDAQ: GRTS), a developer of personalized cancer vaccines; Arvinas (NASDAQ: ARVN), which is advancing protein degradation drugs; and Sutro Biopharma (NASDAQ: STRO, a developer of protein-based drugs with a long-running alliance with Celgene (NASDAQ: CELG).

—Equillium of La Jolla, CA, filed for an IPO to finance clinical testing of a drug to treat graft-versus-host disease.

—LogicBio Therapeutics, a gene therapy developer, filed for an IPO to fund clinical tests of its experimental treatment for a rare inherited liver disease.


—KSQ Therapeutics, a Cambridge, MA, startup using the CRISPR gene editing system as a drug discovery tool, raised another $80 million and revealed a pipeline of 13 experimental cancer drugs.

—Morphic Therapeutic, a startup from Boston-area scientific entrepreneur Tim Springer, raised an $80 million Series B to bring its first oral, integrin-blocking drugs to human tests.

—Novartis (NYSE: NVS) is laying off 2,550 people in Switzerland and the U.K., part of a shift among big drug makers from high-volume pills to more expensive “specialty” drugs, like biologics. Swiss unions are pushing back. Reuters has more.

—The FDA approved the latest in a new crop of drugs meant to reduce the frequency of migraines, galcanezumab (Emgality) from Eli Lilly (NYSE: LLY). The drug has a list price of $575 per month, or $6,900 per patient, per year.

—The FDA cleared Sarepta Therapeutics (NASDAQ: SRPT) to resume testing … Next Page »

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