Drugs typically go through three phases of clinical testing to support an application for FDA approval. It’s easy to overlook Phase 4, which takes place after a drug reaches the market.
Post-marketing studies aim to identify side effects not observed in the first three phases of testing. They also evaluate how a therapy works over a longer period of time. This week, results of such a study led to the market withdrawal of weight-loss pill lorcaserin (Belviq). When the FDA approved the drug in 2012, the agency was concerned about heart risks. But the post-marketing study revealed a higher incidence of cancer—a concern initially found in preclinical testing. That cancer risk did not appear in the first three phases of clinical trials, but after it surfaced in Phase 4, the FDA concluded lorcaserin’s risks outweigh its benefits. The drug’s maker, Eisai, has agreed to pull its product.
There was other news of note in this Valentine’s week, including a gene-editing clinical trial that faces questions and a biotech’s big IPO splash. Let’s show some love with a look back at the rest of this week’s headlines.
DRUG DEVELOPMENTS
—The FDA asked Eisai to remove weight-loss drug lorcaserin from the market after a post-marketing study showed a higher incidence of cancer in the group given the pill compared to those who received a placebo.
—The FDA placed a clinical hold on a LogicBio Therapeutics application to start human tests of its gene-editing therapy for a rare liver disease. The biotech expects to receive the regulator’s formal questions about its submission within the next month.
—Wave Life Sciences is laying off approximately 22 percent of its staff in a corporate restructuring stemming from the Phase 1 failure of the company’s Duchenne muscular dystrophy drug candidate.
—Merck (NYSE: [[ticker:MRK]]) and Pfizer (NYSE: [[ticker:PFE]]) each ended alliances with clinical-stage biotechs following clinical trial failures.
DATA READOUTS
—Experimental Alzheimer’s disease drugs from Eli Lilly (NYSE: [[ticker:LLY]]) and Roche failed in a clinical trial testing them as a treatment for a rare, inherited form of the disease.
—Biohaven Pharmaceutical (NASDAQ: [[ticker:BHVN]]) reported that its drug troriluzole failed a Phase 3 study testing it as a treatment for generalized anxiety disorder. The drug is still being evaluated in clinical trials for obsessive compulsive disorder, Alzheimer’s disease, and spinocerebellar ataxia.
—Pembrolizumab (Keytruda), the flagship cancer immunotherapy of Merck (NYSE: [[ticker:MRK]]), met the main goal of a pivotal study testing it as a first-line treatment for metastatic triple-negative breast cancer. The company plans to share more data at upcoming medical meetings.
—Eli Lilly (NYSE: [[ticker:LLY]]) and partner Incyte (NASDAQ: [[ticker:INCY]]) announced preliminary results showing that their drug, baricitinib (Olumiant), succeeded in a Phase 3 study testing it in patients with moderate-to-severe atopic dermatitis. The drug is already approved for rheumatoid arthritis.
LET’S MAKE A DEAL
—Ligand Pharmaceuticals (NASDAQ: [[ticker:LGND]]) of San Diego agreed to pay Icagen $15 million up front to acquire its drug discovery assets and partnered programs in neurological diseases and cystic fibrosis. Ligand sees Icagen’s technology as complementary to its own suite of drug discovery offerings.
—Bayer is transferring “a large part” of a Berlin-based small molecule drug discovery site to pharmaceutical services provider Nuvisan, which will incorporate it into a new research unit. Financial terms were not disclosed. Bayer says it will still keep a significant presence in Berlin, where its pharmaceuticals division is headquartered.
—Medtronic (NYSE: [[ticker:MDT]]) spent an unspecified amount to acquire Digital Surgery, a privately held company that is applying artificial intelligence and data analytics to surgical training and practice. Digital Surgery will join Medtronic’s surgical robotics business unit but continue to operate from London.
—Intuitive Surgical (NASDAQ: [[ticker:ISRG]]) bolstered its robotic surgery capabilities through the acquisition of Orpheus Medical, a privately held company whose services include processing and archiving surgical video. No financial terms were disclosed.
COMPANIES CASHING IN
—Revolution Medicines (NASDAQ: [[ticker:RVMD]]) went public, raising $238 million. The Redwood City, CA, company plans to use most of the IPO cash to continue development of drugs that target RAS, a signaling pathway that has proven difficult for drug developers to address.
—Moderna (NASDAQ: [[ticker:MRNA]]) launched a $500 million stock offering, which the company says will finance development of therapies and vaccines in its messenger RNA pipeline.
—Rare disease drug developer Mereo BioPharma (NASDAQ: [[ticker:MREO]]) secured $5 million in equity financing from Novartis (NYSE: [[ticker:NVS]]) and reached a deal to raise up to $28 million from Aspire Capital Fund, which has agreed to purchase Mereo shares over a 30-month period. Mereo gained its stock listing a little more than a year ago through a reverse merger with cancer drug developer OncoMed Pharmaceuticals.
—ALX Oncology closed a $105 million Series C round to advance its lead cancer drug candidate, ALX 148, into mid-stage testing.
TRIALS AND TRIBULATIONS
—A federal judge dismissed charges that Theranos founder Elizabeth Holmes defrauded patients and doctors who uses the company’s blood testing services. But the judge let stand wire fraud charges alleging that she and an associate misrepresented the capabilities of the startup’s technology.
—Melinta Therapeutics received bankruptcy court approval for the sales process of the company. Parties wishing to make an offer for the Morristown, NJ-based antibiotics developer’s assets must submit bids by 4 p.m. on March 2.
PEOPLE ON THE MOVE
Pfizer veteran Robert Abraham was appointed chief scientific officer of Vividion Therapeutics… Christophe Arbet-Engels joined Millendo Therapeutics (NASDAQ: [[ticker:MLND]]) as chief medical officer… Avidity Biosciences appointed Joseph Barolodi chief operating officer… Encoded Therapetics named Salvador Rico chief medical officer and promoted Martin Moorhead to chief technology officer… Lyndra Therapeutics appointed Richard Stanton to serve as chief medical officer… Palleon Pharmaceuticals promoted Li Peng to chief scientific officer… and Cheryl Blanchard was named interim CEO of Anika Therapeutics (NASDAQ: [[ticker:ANIK]]).
Image: iStock/fotohunter
