Novartis has agreed to acquire biopharmaceutical maker Endocyte for $2.1 billion, entering into the world of prostate cancer treatment and potentially expanding its Novartis RLT platform with both a potential near-term product launch and early-stage clinical development programs.

The agreement provides Novartis with access to Endocyte’s drug conjugation technology for the development of targeted therapies that utilize imaging agents, including 177Lu-PSMA-617, a potential first-in-class investigational radioligand therapy (RLT) for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

“Today's announcement about the proposed acquisition of Endocyte builds on our growing capability in radiopharmaceuticals, which is expected to be an increasingly important treatment option for patients and a key growth driver for our business,” Liz Barrett, CEO of Novartis Oncology, said in a statement. “We are also excited about the opportunity to break into the prostate cancer arena with a near-term product that has the potential to make a meaningful impact for patients in great need of more options."

177Lu-PSMA-617 is designed to target the prostate-specific membrane antigen (PSMA), an entity present in the majority of patients with mCRPC, a disease limited in treatment options and involving significant unmet medical needs.

Findings in a Phase II study for the agent showed a median prostate specific antigen (PSA) progression-free survival (PFS) of 7.6 months in 50 patients with PSMA-positive mCRPC. Median overall survival was 13.5 months for the first cohort of 30 patients.

Following this and other promising Phase II results, the agent was submitted to, and is currently under investigation in, the Phase III global VISION clinical trial in men with mCRPC, for which the FDA has agreed to radiographic progression-free survival (rPFS) as an alternate primary endpoint to OS.

The acquisition of Endocyte would enable Novartis to leverage its research and development expertise for assessing the potential development of 177Lu-PSMA-617 for use in earlier lines of prostate cancer therapy, as well as additional investigational RLTs, such as 225Ac-PSMA-617, in preclinical studies for the treatment of mCRPC.

It also goes hand-in-hand with Novartis’ previous acquisition this year of Advanced Accelerator Applications (AAA), from which it gained the rights to Lutathera (lutetium Lu 177 dotatate / INN: lutetium (177Lu) oxodotreotide), the first-ever approved peptide receptor radionuclide therapy for the treatment of somatostatin-receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), an orphan disease.

"Novartis has a strong legacy of addressing unmet needs with transformative therapies and is building a leadership capability in new, technology-driven platforms that address some of the world's most complex health challenges, including cancer,” said Barrett.

If successful, the transaction will take the form of a merger between Endocyte and a new Novartis subsidiary, with holders of the Endocyte common stock receiving $24 in cash per share upon closing of the agreement.

The transaction is subject to customary closing conditions, including the approval of Endocyte’s stockholders and receipt of regulatory approvals.

Funding of the acquisition is expected to take place through available cash with Endocyte continuing to exist as a separate and independent company until closing.

VISION is a global, prospective, open-label, multicenter, randomized Phase III trial of 177Lu-PSMA-617 in combination with best supportive care versus best supportive care alone.

Enrollment for the trial is currently open to patients with mCRPC.

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