March 19, 2019
Bioscience Notebook

Melinta moves headquarters to NJ; Biohaven spends $105M on FDA priority review voucher amid migraine drug race

PHOTO | File
PHOTO | File
Melinta Therapeutics Inc. is vacating its leased space in this building at 300 George Street in New Haven.
PHOTO | Contributed
Catalent's Zydis Fast-Dissolve technology platform.

New Haven-born Melinta Therapeutics Inc. has shifted the company headquarters to its Morristown, N.J. office as it moves to vacate its flagship New Haven location and another in Chapel Hill, N.C., according to its latest annual report filed with the SEC.

The closing of the 300 George St. office, which was not unexpected, comes after Melinta laid off all but three of its 25 New Haven-based employees last November in an effort to bolster its bottom line. The biotech cut roughly 20 percent of its workforce companywide and had 290 employees as of last month, according to the March 14 filing.

At the time of the layoffs, Melinta officials declined to comment on the future of the New Haven headquarters, saying no decision had been made on the 27,600-square-foot leased space, although employees were told the office was closing.

In the report, the company posted a net loss of $44 million, or $3.94 a share, for three months ended Dec. 31, 2018, compared to $20.9 million, or $7.40 a share, in the year-ago period.

For the year, Melinta reported a net loss of $157.2 million, or $17.12 a share, compared to $78.2 million, or $109.28 a share in 2017.

The company said its year-over-year net loss per share was impacted by changes in share count because of the company's merger with North Carolina-based Cempra Inc., financing related to its acquisition of New Jersey-based The Medicines Co.'s infectious disease unit, and a one-for-five reverse stock split which took effect Feb. 22.

The report included a dose of good news on the revenue side: net sales of Melinta's antibiotics rose to $14.6 million in the fourth quarter, a 32 percent increase over the third quarter.

The increase was driven by stronger sales of Vabomere and Orbactiv, two of three antibiotics Melinta acquired last year from The Medicines Co., the company said.

Melinta reported revenues of $96.4 million in 2018, its first year with a commercial product, including net product sales of $46.6 million. It expects net product sales of around $65 million for 2019.

"We are pleased with the decisive actions we took in 2018 to realign the business and help position Melinta for future growth and stockholder value creation," CEO John H. Johnson said in announcing the 2018 financial results.

Melinta announced last fall that it would pivot away from discovery research to focus on commercial activities, including the launch of its newly approved antibiotic Baxdela, which treats serious skin infections caused by MRSA (methicillin-resistant Staphylococcus aureus).

The move, which followed lower-than-expected sales in the third quarter, was part of a plan to save at least $50 million this year.

Johnson said the company has several opportunities to potentially expand product labels and increase its marketing territory in 2019.

The company plans to seek regulatory approval to market Baxdela for a second infectious disease, community acquired bacterial pneumonia (CABP), next year and last fall struck a deal with the Menarini Group to commercialize Vabomere, Orbactiv and Minocin in 68 countries outside the U.S. The company also received regulatory approval last fall to market Vabomere in Europe for five additional conditions, including hospital-acquired pneumonia. The drug previously had been approved only for complicated urinary tract infections.

Melinta said it ended the year with $81.1 million in cash and cash equivalents. It closed last month on a $75 million disbursement under a $135 million convertible loan facility from Vatera Healthcare Partners LLC.

Chief Financial Officer Peter Milligan said the funding "will provide valuable liquidity to support the company's operations as we continue to take steps to become cash-flow positive."

Founded in 2000 as Rib-X Pharmaceuticals and based on Nobel-prize winning Yale research, Melinta is one of New Haven's oldest biotech firms. The company also has an office in Lincolnshire, Ill.

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Biohaven Pharmaceutical Holding Co. Ltd., which is nearing the regulatory finish line for its migraine drug rimegepant, has purchased a U.S. Food and Drug Administration priority review voucher from U.K.-based GW Pharmaceuticals for $105 million.

The New Haven drug maker said Monday it plans to use the voucher when it seeks FDA approval for its Zydis ODT (orally-dissolving tablet) version of rimegepant in the second quarter of this year.

If accepted, the voucher would accelerate the regulatory review process for the drug to six months instead of the standard 10 — which could help Biohaven beat competitors to market with an oral version of the cutting-edge migraine treatment.

Rimegepant is part of a new class of drugs known as CGRP receptor antagonists, which work by blocking a brain chemical that transmits pain. It is billed as an alternative to widely used migraine drugs known as triptans.

Biohaven said it will pay for the voucher with upfront cash raised from the sale of preferred stock through a $200 million financing deal with Royalty Pharma, which invests in life science companies.

Under the deal, Royalty Pharma will provide $125 million at closing and allow Biohaven to draw up to an additional $75 million upon FDA acceptance of the rimegepant application.

Priority review vouchers are awarded through an FDA program to encourage the development of treatments for rare pediatric diseases, and the agency allows them to be sold or transferred.

GW Pharma obtained the voucher while developing its cannabis-based drug, Epidiolex, to treat seizures associated with rare types of childhood epilepsy. The sale is subject to customary closing conditions.

A speedy review could allow Biohaven to secure FDA approval for rimegepant by the end of this year, a timeframe similar to that of rival Allergan's oral CGRP receptor antagonist, ubrogepant, according to the trade publication EndPoints News.

Contact Natalie Missakian at news@newhavenbiz.com

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