A drug candidate Biohaven Pharmaceuticals acquired last fall from pharma giant AstraZeneca to treat a rare brain disease has been granted “orphan drug” status by federal regulators, making the New Haven company eligible for tax credits and other incentives.
Previously known as BHV-3241 and now called verdiperstat, the drug is a potential first-in-class myeloperoxidase (MPO) inhibitor that treats multiple system atrophy (MSA), a fast-progressing and fatal neurodegenerative disease that causes Parkinson’s-like symptoms.
“We believe verdiperstat has the potential to be the first effective treatment for people living with MSA,” said Irfan Qureshi, MD, Biohaven executive director and development lead for verdiperstat, in a statement.
The U.S. Food & Drug Administration awards the orphan drug designation to promising treatments for diseases affecting fewer than 200,000 people in the U.S.
In addition to tax incentives, the designation would give Biohaven seven years of market exclusivity for the indication if the drug is approved. The drug has also received orphan status from regulatory authorities in Europe.
Verdiperstat had already been through the first two phases of clinical trials when Biohaven obtained development and commercialization rights from AstraZeneca for an undisclosed sum of cash and stock last September.
Biohaven said it expects to start a global Phase 3 trial on the drug later this year.
Biohaven’s lead drug candidate is a cutting-edge treatment for migraine; the company expects to file for FDA approval of that drug by the end of the year.
***
Alexion Pharmaceuticals Inc. said last week it has created two new positions on its executive leadership team.
The New Haven-born company has elevated Ann-Marie Law to the new position of chief patient and employee experience officer, while Aradhana Sarin, MD, was promoted to the newly created role of chief strategy and business officer.
Both women joined the biotech in 2017.
Law had been serving as executive vice president, chief human resources officer. In her new role, she will continue to oversee human resources while ensuring the company “maintains its central focus on serving patients,” CEO Ludwig Hantson said in a statement.
Sarin previously served as senior vice president, business development and corporate strategy. In her new role, she will oversee Alexion’s corporate strategy, business development and business operations, including corporate planning, the company said.
The rare-disease drugmaker moved its corporate headquarters to Boston last summer but continues to house 450 research employees in the Elm City.
***
Shelton-based NanoViricides Inc., which is developing a cream to treat shingles, on Friday reported smaller fourth-quarter losses compared to a year ago.
For the period ended Dec. 31, 2018, the company reported a net loss of $2.23 million, or $.03 a share, compared to $2.79 million, or $.04 a share, for the same quarter in 2017.
The company attributed the decrease mostly to a reduction in operating expenses.
While R&D expenses increased by $18,185 year-over-year to $1.65 million during the quarter, the company trimmed its general and administrative costs by $42,779 to $711,360 due largely to the retirement of its longtime CEO Eugene Seymour last year, the company said in an SEC filing.
The company said it had approximately $4.07 million in assets on hand as of the end of the quarter, and roughly $1.16 million in cash liabilities.
It reported no revenues for the quarter, as is common with pre-clinical stage biotechs.
NanoViricides is developing drugs that use tiny particles called nanoviricides to attack and dismantle the viruses responsible for shingles and other diseases, such as herpes.
The biotech is hoping to advance the shingles drug into human trials this year.
Contact Natalie Missakian at news@newhavenbiz.com
