Just a few weeks after Otezla notched a Phase III win and hit all primary and secondary endpoints for a trial in genital psoriasis, Amgen’s blockbuster drug Otezla gets yet another OK from the FDA.

 

The biotech announced yesterday the FDA approved Otezla (apremilast) for an expanded indication: the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.

 

Otezla is now the first and only oral treatment approved in adult patients with plaque psoriasis across all severities, including mild, moderate and severe, Amgen said in a statement. The FDA approval is based on findings from the Phase III ADVANCE trial, where 21% of patients on the drug in the trial achieved the trial’s primary endpoint of Static Physician’s Global Assessment response after 16 weeks, compared to only 4% on placebo.

 

Adverse events observed in the trial were consistent with Otezla’s known safety profile, Amgen added.

 

This is Otezla’s third approval it’s received in the US — the others are for adult patients with active psoriatic arthritis and for adult patients with oral ulcers associated with Behçet’s disease. I-Mab CEO Joan Shen hits the exit

I-Mab is going through a shakeup with current CEO Joan Shen stepping down on Dec. 31 to “pursue other interests,” according to a statement. The company’s founder and chairman Jingwu Zang will become acting CEO as of Jan. 1.

 

The Chinese biotech announced further changes yesterday while implementing a new governance initiative designed to facilitate global pipeline development and accelerate its ongoing transformation towards an integrated global biopharma company. Andrew Zhu will be I-Mab’s new president and a member of the board of directors. Zhu will lead their R&D division, focusing on pipeline milestones and improving clinical development capabilities in China and in the US.

 

Zhu is a professor at Harvard Medical School and was the CSO at Jiahui Health.

 

Menarini Group signs in-licensing deal to commercialize Karyopharm’s MM drug

Karyopharm Therapeutics and Italian pharma Menarini Group said they’re going in on an exclusive licensing agreement for an oncology drug.

 

Menarini will commercialize Karyopharm’s oral Selective Inhibitor of Nuclear Export (SINE) compound Nexpovio in Europe and other global territories.

 

Nexpovio is designed to treat multiple myeloma, and under tight limitations, given conditional approval in the EU.

 

While Menarini receives exclusive rights to commercialize Nexpovio for the treatment of oncology indications in the EU and other European countries, Latin America and other key countries, Karyopharm will receive in exchange an upfront payment of $75 million by year’s end, and is eligible to receive up to an additional $202.5 million in future milestones, plus tiered double-digit royalties on net sales of the drug.

 

Nexpovio has received marketing authorization from the European Commission under the following conditions:

 

in combination with steroid dexamethasone for the treatment of multiple myeloma in adult patients who;

have received at least four prior therapies and whose disease is refractory to at least;

two proteasome inhibitors,

two immunomodulatory agents,

an anti-CD38 monoclonal antibody,

and who have demonstrated disease progression on the last therapy.

The EMA approved Nexpovio in combination with chemo drug Velcade and low-dose dexamethasone for treating multiple myeloma following at least one prior therapy. The MAA will be reviewed by the CHMP, which will issue an opinion to the European Commission regarding the potential approval for an expanded indication. This review is expected to be completed during the first half of next year, according to the two companies.

 

North Carolina-based Heat Biologics acquiring defense-focused biotech

Heat Biologics is buying up a company — Elusys Therapeutics.

 

The acquisition announced this morning is expected to close sometime in Q1 2022 — and the biotech has one product: obiltoxaximab, also known as Anthim for treating anthrax exposure.

 

While the numbers on this deal remain hidden, Heat’s acquisition of Elusys enhances Heat’s immunotherapy portfolio, the biotech said. Elusys had been awarded over $350 million in past R&D contracts with a host of government agencies, such as BARDA, NIAID and the DOD.

 

After the deal is finalized, Elusys will continue to operate as a wholly owned subsidiary of Heat, and Heat will acquire all outstanding shares of Elusys.

 

Heat CEO Jeff Wolf said in a statement that this acquisition is part of Heat’s vision to develop and commercialize biopharmaceuticals and vaccines for the “global biodefense market.”