Rockville’s MacroGenics Inc. is weeks away from a potential regulatory approval for its first product — and preparing to hit the ground running on a launch.
The clinical-stage biotech has teamed up with Milwaukee life sciences firm Eversana to commercialize its breast cancer therapy candidate in the U.S., if it receives approval from the Food and Drug Administration. That decision is expected to drop Dec. 18.
Under the deal, MacroGenics maintains full ownership of margetuximab. The five-year agreement gives Eversana a co-exclusive right to help take the product to market. That includes supporting sales and marketing, data and analytics, market access, channel management, medical affairs and patient access, among other services.
It also means MacroGenics will pay Eversana for its services prior to a possible FDA approval; if it then earns approval, the partners “will share costs equally” and Eversana “will earn future revenue share payments which shall be capped at 125% of Eversana’s cumulative service fees,” MacroGenics said in filings with the Securities and Exchange Commission. Once it hits that cap, MacroGenics will again compensate Eversana based on its services, it said.
Terms of the deal were not disclosed further.
“We are excited to partner with Eversana and leverage their integrated commercial services to efficiently launch margetuximab,” Dr. Scott Koenig, president and CEO of MacroGenics, said in a statement. “We have been working closely with Eversana to fully align our commercialization strategies to educate healthcare providers and ensure patient access to margetuximab, while maintaining MacroGenics’ cash runway to fund our broader portfolio.”
The deal comes about a year after MacroGenics (NASDAQ: MGNX) submitted to the FDA its Biologics License Application and, after working with the agency to answer questions, received in May a target action date for this month.
The candidate, called margetuximab, targets the HER2 gene that can fuel cancer cell growth. If approved, it could be used to treat patients with metastatic HER2-positive breast cancer along with chemotherapy. In clinical trials, the candidate was found to be safer and better tolerated than Genentech Inc.’s Herceptin, a standard treatment today, when both were given in combination with chemotherapy. And data later showed that patients on margetuximab and chemotherapy had a slightly longer overall survival rate.
“We believe that margetuximab, if approved, could become a valuable treatment option for patients living with this devastating disease,” Koenig said in a statement.
MacroGenics, which focuses on antibody-based cancer treatments, is also examining margetuximab in patients with gastric cancer. The company has long run clinical trials on several product candidates — since its founding in 2000 — but has not yet taken one to market. And margetuximab holds tremendous promise; the breast cancer drug market is estimated to grow by at least $30 billion by 2026.
The company’s revenue, predominantly from licensing deals, amounted to $52.2 million for the first three quarters of 2020, up from nearly $39 million for the same period of 2019, according to SEC filings. The business also suffered a net loss of $127.7 million for the first nine months of this year, an increase from a $121.4 million net loss in the first nine months of 2019. MacroGenics closed September with $280.7 million in cash, cash equivalents and marketable securities — after raking in $74 million in net proceeds from selling more than 2.55 million shares of stock.
The biotech’s stock was down about 2% early afternoon Thursday, trading at $21.83 per share.
