The FDA approved Lybalvi from Alkermes Plc (ALKS) for the treatment of schizophrenia and bipolar I disorder on the June 1 PDUFA date, notes John McCamant, editor of The Medical Technology Stock Letter — and a participant in the MoneyShow July 13-15 Virtual Expo. Register here for free.
Lybalvi — known as (ALKS-3831) — is a once-daily, oral atypical antipsychotic, which combines Zyprexa (antipsychotic that is now generic) with samidorphan (new molecular entity; designed to help mitigate weight gain).
Lybalvi is indicated for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate.
ALKS is now guiding to a 4Q21 launch (likely October/November given need to scale up manufacturing). The label also includes the trial results where treatment with Lybalvi was associated with statistically significantly less weight gain than treatment with Zyprexa, and with a smaller proportion of patients who gained ≥10% body weight, and also includes a table on changes in weight.
ALKS continues their launch preparations, in particular they plan to add ~50 additional sales reps during the first year of launch based on payer access with a goal of eventually covering 80% of all branded prescribers (ALKS’ Aristada sales force currently covers ~60% of Lybalvi’s targeted provider universe).
With respect to Lybalvi pricing, management noted that they will disclose details closer to launch once negotiations with payers are finalized.
Investigators at ASCO presented updated data from two Phase I/II trials (ARTISTRY-1 and ARTISTRY-2) of ALKS‘s pipeline cancer drug Nemvaleukin (IL-2 fusion protein) both as monotherapy and in combination with MRK’s Keytruda in patients with advanced solid tumors.
In our view, the data was positive and ALKS reiterated plans to advance pivotal trials of the drug development candidate in mucosal melanoma, IV monotherapy, and platinum-resistant ovarian cancer, IV combo with Keytruda. ALKS also disclosed that it does not intend to pursue further development of the drug in RCC/kidney cancer given the competitive landscape.
In our view, ALKS received a solid label from the FDA for Lybalvi with weight loss being mentioned as an advantage and the inclusion of a weight table. Going forward we expect commercial execution on the Lybalvi launch to be a key investor focus.
We also look forward to additional updates for the immuno-oncology candidate Nemva in 2021 where a partnership has the potential to both validate the drug development candidate and serve as a significant stock catalyst.
