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ALKS Pulls Off Sweet Surprise, APRI Thrashed, BMY Gets FDA Nod

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Today's Daily Dose brings you news about Alkermes' curious reversal of event; outcome of Apricus' end-of-review meeting with the FDA related to Vitaros; FDA approval of Bristol-Myers Squibb Co.'s Immuno-Oncology combination therapy, and Merck's KEYNOTE-189 study.

Read on…

Alkermes plc (ALKS), which suffered a setback related to its New Drug Application for ALKS 5461, proposed for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressant therapies, earlier in the month, has a reason to cheer now.

The FDA on March 30, 2018, had refused to even accept for review the NDA saying that there was insufficient evidence of overall effectiveness for the proposed indication, and that additional well-controlled clinical trials are needed prior to the resubmission of the NDA for ALKS 5461. In addition, the Company was also asked to conduct a bioavailability study to generate additional bridging data between ALKS 5461 and the reference listed drug, buprenorphine.

Now, the FDA has agreed to review the ALKS 5461 NDA, thanks to the productive interactions with the regulatory agency in which Alkermes clarified certain aspects of the NDA submission. The FDA's decision on ALKS 5461 is expected on January 31, 2019.

ALKS closed Monday's trading at $44.43, up 4.47%.

Shares of Apricus Biosciences Inc. (APRI) plunged more than 35% on Monday, following the outcome of its end-of-review meeting with the FDA related to its New Drug Application for Vitaros, a topical cream for the treatment of erectile dysfunction.

On February 16, 2018, the FDA turned down the Company's request to approve Vitaros, citing deficiencies related to Chemistry, Manufacturing and Control ("CMC") and certain safety concerns specific to the 2.5% concentration of DDAIP.HCl contained in the current formulation.

During the end-of-review meeting too, the FDA has insisted that the Company should develop a new Vitaros formulation that reduces the concentration of DDAIP.HCl from 2.5% to 0.5% in order to address the tumor promotion and partner transference safety concerns noted in the Complete response Letter.

The Company has also been asked to conduct two new phase III clinical efficacy trials with the reformulated product prior to resubmitting the NDA and that the trials should include an assessment of the potential risk of enhanced sexually transmitted infections with the new formulation.

APRI closed Monday's trading at $0.27, down 35.38%.

The FDA has approved Bristol-Myers Squibb Co.'s (BMY) Opdivo plus Yervoy as the first Immuno-Oncology combination therapy for previously untreated patients with intermediate- and poor-risk advanced renal cell carcinoma.

In a phase III trial, Opdivo + Yervoy reduced the risk of death by 37% compared to Pfizer's Sutent, the current standard of care. Also, Opdivo + Yervoy combo was associated with a 41.6% Objective Response Rate compared to 26.5% for Sutent.

BMY closed Monday's trading at $54.08, down 7.79%.

In Merck's (MRK) pivotal phase III trial, dubbed KEYNOTE-189, KEYTRUDA in combination with ALIMTA and cisplatin or carboplatin for the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC) reduced the risk of death by half compared with chemotherapy alone.

Leena Gandhi, director of thoracic medical oncology at NYU Langone's Perlmutter Cancer Center and lead author of The New England Journal of Medicine paper, said, "There is good scientific rationale for combining KEYTRUDA with Alimta and platinum chemotherapy, and these clinical data now suggest this combination as a new standard of care for the first-line treatment of these nonsquamous non-small cell lung cancer patients."

MRK closed Monday's trading at $58.65, up 2.59%.

Zimmer Biomet Holdings Inc. (ZBH) announced that it completed the first surgical case utilizing its Persona Trabecular Metal Tibia on March 20, 2018.

The Persona Trabecular Metal Tibia received FDA clearance in January 2018 and CE Mark approval in April 2018. The Persona Tibia is an integral component of the Company's portfolio of cementless total knee arthroplasty solutions.

The Company has planned a limited launch of the Persona Tibia in the first half of this year, followed by a full commercial launch in the second half of 2018.

ZBH closed Monday's trading at $107.24, up 1.58%.

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