Protocols

Positive ocular implant data bring Allergan one step closer to NDA; Vivek Ramaswamy spawns another ‘Vant’

→  In 2016, Brent Saunder’s Allergan $AGN orchestrated a string of deals after its $160 billion merger with Pfizer fell through thanks to Obama-era tax rules, including ForSight VISION5 and its glaucoma technology for $95 million upfront. But Allergan also has its own internally developed ophthalmology program, its ocular implant bimatoprost SR is designed to help lower intraocular pressure for at least 4 months in patients struggle with eye drops. On Monday, Allergan said a second Phase III study demonstrated positive data adding to the results of a late-stage study reported in June 2018. An NDA is slated to be submitted in the second half of 2019.

→ Vivek Ramaswamy has announced the launch of yet another “Vant.” This one is called Alyvant, and its tech is designed to help pharmaceutical companies integrate market research, sales force optimization, and digital engagement into a single platform to connect patients and physicians with relevant medicines cost-effectively. The company, led by industry veteran Gillian Cannon, already has an agreement with an unnamed pharmaceutical partner to co-promote three approved branded drugs. “This technology platform allows us to engage new market segments that are underserved by traditional pharma commercial models, while also reducing the need for expensive and wasteful mass-market DTC campaigns that inflate the cost of delivering new medicines to patients,” said Benjamin Zimmer, president of parent company Roivant Health, in a statement.

→ You may remember Myriad Genetics from its legal fight with Tesaro over the necessity of its diagnostic as a companion to the biotech’s PARP inhibitor. But as investigative journalist Roddy Boyd (of Valeant fame) writes in his latest exposé for Southern Investigative Reporting Foundation, it was not the company’s only genetic test that proved futile.

Boyd’s seven-month investigation centered around GeneSight, a diagnostic that promises to guide a psychiatrist in selecting an antidepressant by analyzing a patient’s genetic profile. Put simply: It didn’t work — failed the primary endpoint and 23 out of 25 secondary ones — but the execs spinned it as if it did, kicking stock prices up. It was, in Boyd’s words, a demonstration of the “company’s ability to spin ever more fantastical nonsense — and to brilliantly navigate the opaque line between required disclosure and misdirection.”

But that’s not all. In a separate story, Boyd reports that in 2013, Myriad Genetics avoided a cut to the reimbursement level by the Centers for Medicare and Medicaid Services thanks to an aggressive lobbying campaign by a staffer working for Sen. Orrin Hatch. The Salt Lake City-based company’s close relationship with the long-serving Utah senator, he wrote, helped Myriad win in six months a regulatory break that could have taken years. Add that to an apparent billing loophole that Myriad had seized for its breast cancer-related gene test, and you get millions in added revenue at a time increased competition is driving prices down for genetic testing, according to Boyd.

(Editor’s note: After this item appeared Monday, a spokesperson for Myriad Genetics contacted Endpoints News and offered this in response: “Myriad disputes (the) accuracy of Mr. Boyd’s articles.”)

→ Frequency Therapeutics — which is focused on creating a new class of drugs based on small molecule stimulation of dormant stem cells within the body to repair diseased or damaged tissue — closed $42 million in Series B round, bringing funds raised in total to $87 million. The capital will be used to finance the development of its experimental drug, FX-322, for hearing regeneration. Top-line results from an ongoing Phase 1/2 study are expected in the first half of 2019.

→ Bluebird bio $BLUE has joined forces with Inhibrx to co-develop CAR-T cell therapies using Inhibrx’s single domain antibody (sdAb) platform for multiple cancer targets. Inhibrx gets $7 million upfront, and is eligible to receive unspecified funds in milestones payments.

→ Pfizer $PFE has tied up with CytoReason — a machine learning company for drug discovery and development —for an undisclosed sum.CytoReason’s platform has the potential to offer valuable insights that may be applied to our research into the human immune system,” said Pfizer’s Michael Vincent, CSO for inflammation & immunology, in a statement.

→ Galapagos $GLPG is pairing up with privately held Fibrocor to focus on idiopathic pulmonary fibrosis and other indications. The two are working together on a small molecule inhibitor program for an undisclosed target, as part of the deal with undisclosed financial terms announced on Friday.


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VP Oncology Biology
Skyhawk Therapeutics Waltham, MA
Associate Director CMC
Elektroki Boston, MA
Director Process Development
Elektroki Boston, MA
Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT

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