Heron resubmits NDA for pain med HTX-011

Heron Therapeutics (NASDAQ:HRTX) has resubmitted its NDA to the FDA for HTX-011, an investigational agent for the management of postoperative pain. The Company anticipates a 6-month review by the FDA.

The NDA was resubmitted based on the outcome and final minutes of a Type A meeting with the FDA, which was conducted to obtain clarity on the Complete Response Letter (CRL) issued in April 2019.

The FDA had previously rejected HRTX’s application for HTX-011 in April 2019.

Previously: FDA rejects Heron’s application for pain med HTX-011; shares down 1% premarket (May 1)

https://seekingalpha.com/news/3502845-heron-resubmits-nda-pain-med-htxminus-011

Bayer and Arvinas launch new company together

Bayer (OTCPK:BAYZF) and Arvinas (NASDAQ:ARVN) say they have finalized the terms of their agreement to jointly launch a new company called Oerth Bio.

Oerth Bio will be supported by intellectual property and over $55M in committed funding from Bayer and technology and intellectual property from Arvinas.

Oerth Bio is said to leverage Arvinas’ expertise in targeted protein degradation and Bayer’s decades of experience in developing both human therapies and innovative, sustainable agricultural technologies.

Execs from the Oerth Bio team will be presenting an overview of the company at Bayer’s Future of Farming Dialogue meeting being held today in Monheim.

Bayer and Arvinas will equally share governance and equity ownership of the joint venture. Oerth Bio will build a team of leading scientists, enabling the company to run as an independent and sustainable organization.

Source: Press Release

https://seekingalpha.com/news/3502773-bayer-arvinas-launch-new-company-together

Brookdale +3.6% after overhauling HCP ties

Brookdale Senior Living (NYSE:BKD) rises 3.6% in premarket trading after announcing that it’s restructuring its relationship with HCP (NYSE:HCP) through transactions that include unwinding a CCRC joint venture and buying 18 triple-net leased communities from HCP.

Sees net cash proceeds of ~$208M after the acquisition of 18 communities.

The company is considering using a portion of net proceeds for opportunistic share repurchases and elective debt pay downs.

Brookdale says consolidated adjusted free cash flow will improve by ~$11M on an annual basis; net cash provided by operating activities is expected to be lower by $3M on an annual basis.

Brookdale will own 60% of its consolidated units.

The transactions reduces annual cash lease payments to HCP by ~$30M, or ~$34M after giving effect to the transitioned triple-net leased community.

Previously: HCP reduces its reliance on Brookdale Senior Living (Oct. 1)

https://seekingalpha.com/news/3502815-brookdale-plus-3_6-percent-overhauling-hcp-ties

Bausch Health files lawsuit against Sandoz for patent infringement

Bausch Health (NYSE:BHC) along with its subsidiary, Salix Pharmaceuticals has filed a lawsuit against Sandoz Inc., a Novartis (NYSE:NVS) division, alleging patent infringement of 14 patents by Sandoz’s filing of its ANDA for XIFAXAN (rifaximin) 550 mg tablets.

XIFAXAN is protected by 22 patents covering the composition of matter and use listed in the FDA Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book.

In September 2018, BHC resolved the outstanding patent dispute with Actavis Laboratories, regarding XIFAXAN 550 mg tablets.

BHC shares are down 1% premarket.

https://seekingalpha.com/news/3502817-bausch-health-files-lawsuit-sandoz-patent-infringement

Lannett inks deal for generic Advair Diskus

Lannett Company (NYSE:LCI) has entered into an exclusive U.S. distribution agreement for the therapeutically equivalent generic of ADVAIR DISKUS (Fluticasone Propionate – Salmeterol Xinafoate Powder Inhaler) of Respirent Pharmaceuticals.

Under the agreement, Lannett will make an upfront payment, as well as future milestone payments, and receive a portion of the net profits once it commences distribution.

The term of the agreement is 10 years. Other terms were not disclosed.

ADVAIR DISKUS is a registered trademark of GlaxoSmithKline. It had U.S. sales of $3.6B for the 12 months ending July, 2019, according to IQVIA.

https://seekingalpha.com/news/3502818-lannett-inks-deal-generic-advair-diskus

Mallinckrodt up 5% premarket on positive Acthar Gel data

Mallinckrodt (NYSE:MNK) is up 5% premarket on announcing positive top-line findings from its observational registry to assess treatment patterns and response to Acthar Gel (repository corticotropin injection) in reducing the clinical impact of disease exacerbations in patients with multiple sclerosis (MS) relapse.

Registry data showed that patients treated with Acthar Gel reported significant improvements in symptoms associated with MS exacerbations at two months from baseline, the primary measure of the study.

The response was sustained at six months. Improvement in physical symptoms in patients treated with Acthar Gel was also reported, based on Expanded Disability Status Scale scores.

https://seekingalpha.com/news/3502825-mallinckrodt-5-percent-premarket-positive-acthar-gel-data

Minerva plunges following delay in schizophrenia drug results

Minerva Neurosciences (NASDAQ:NERV) -27.8% pre-market after disclosing a delay in issuing top-line results for its roluperidone treatment for negative symptoms in schizophrenia.

NERV says a cyber attack on one of its external contractors caused a disruption to patient recruitment in the roluperidone study, and the company now expects to complete enrollment by year-end and release study results in H1 2020.

NERV also issued data for an exploratory trial of its seltorexant treatment of patients suffering from Major Depressive Disorder, intended to generate data to assist with the planning of Phase 3 studies and not powered to detect statistical significance.

https://seekingalpha.com/news/3502829-minerva-plunges-following-delay-schizophrenia-drug-results