Boosters For All Adults as Early as This Week
(Editor’s note: The FDA this week sent a notice indicating it could approve Moderna’s humanized monoclonal antibodies as soon as this week, perhaps as early as Monday.)
Mylan NV (MYL), one of the world’s largest biotech drug makers, raised the red flag over Moderna Therapeutics’ strategy.
The FDA-approved firm may seek approval of a monoclonal antibody to treat cancer in all adults, a steep step up from its initial treatment for premature ejaculation. Companies aren’t allowed to market new products for new indications without proof of safety and effectiveness for those conditions first.
Mylan has a decades-long experience in serving the cancer market in a number of forms, including Claritin, which it bought from Abbott Laboratories (ABT) back in 1997.
Mylan is not alone. Many public and private drug makers are extremely wary of injections of Moderna’s technology as it creates the first new method of creating human monoclonal antibodies. Even more so, they are extremely upset by what they claim is an underhanded strategy to get the nod.
For instance, New York-based GlaxoSmithKline Plc (GSK) has some well-known stars in its corner when it comes to Moderna technology, including Dr. Steven Rosenberg, the former president of its protein science operations. Previously, he was CEO of the company’s platform protein-focused group.
Another prominent name is Millennium Pharmaceuticals, a spin-off from Novartis AG (NVS) , which may have an uncanny vision for the gene therapy, the one component of Moderna’s platform which has attracted the most attention.
After a large data presentation at the recent American Society of Clinical Oncology (ASCO) meeting, according to a report by a Roche subsidiary, Roche said the first human models of a variety of deadly lung cancers will be obtained with animal testing this year.
Millennium has also touted Moderna as part of its latest high-profile campaign, one that’s targeted at driving adoption of the gene therapy platform (Tekritumomab Tau, its name for the host-targeting part of the Moderna platform, is in a dozen or so clinical trials.)
The Moderna approach uses a class of molecules called messenger RNA (mRNA) which was originally produced by biologists for scientists like Rosenberg. Moderna actually helped validate the use of mRNA by publishing a paper on the science back in 2000.
Specifically, Moderna CEO Stephane Bancel has published two widely read essays (published on his own website) that point to the fact this technology could one day get approved for adults. He’s offering prospects for over four dozen uses of Moderna technology.
The AIADC, the industry group that represents New York-based GlaxoSmithKline and New Jersey-based Mylan, has clearly been monitoring Moderna’s efforts.
In a meeting with the FDA last month, AIADC President Joe Knott expressed concern about the implications Moderna’s approach would have on patients and said the biotech firm could be misleading them.
According to Reuters, Bancel said Moderna is offering dozens of different medicines but he has maintained it doesn’t intend to market them for a wider patient population without proof that they have been tested in the same manner as a standard medication.
In response, Knott called Moderna’s approach misleading and threatened to withhold funds from the firm if it didn’t back down.
Shares of Moderna have dropped by 10% since May 2 when Mylan raised the alarm.
Meanwhile, Glaxo, which has run into big problems on clinical trial issues at Mapp Biopharmaceuticals, appears to be moving with cautiousness.
Mark Vernon of the Quartz news site points out that the FDA and Moderna are both operating on the periphery of the earliest accepted Guidelines of Gene Therapy for Life-threatening Disorders, the ARO-Akt-Plus Model.
Contrary to news reports, Moderna’s CAR-T technology does not exist yet; it is not being considered for clinical studies.
Yet, the lab where the experimental cell therapy was discovered is located just down the road from Glaxo headquarters.
Indeed, Moderna bought the full license to this technology from the New York-based company and has kept its doors open for all of Glaxo’s research staff.
For the time being, it appears Glaxo is waiting