J&J dumps Phase 2-ready autoimmune asset, returns rights to French partner

J&J’s 5-year acquaintanceship with OSE Immunotherapeutics has come to an end as the pharma giant decided it doesn’t want the CD28 antagonist FR104 after all.

The deal termination means that Nantes, France-based OSE will once again hold worldwide rights to the asset — including any new data, IP and regulatory filings generated by J&J’s biotech unit Janssen — which is now ready for Phase II testing.

Janssen first laid its hands on the autoimmune asset in 2013, back when the drug was still being developed by Effimune, which later merged with OSE. Three years later, it exercised the option to take over global development and commercialization with an €10 million upfront and a promise of €145 million more, though the majority of that likely never materialized.

Saying everything they can to paint the news in a positive light, OSE said Janssen’s decision to return the program “is based on its own internal strategic review and prioritization of its portfolio.” A J&J spokesperson confirmed as much in response to my query.

“(W)e have all the necessary preclinical and clinical data required to conduct phase 2 trials,” said OSE CEO Alexis Peyroles in a statement. “OSE is currently evaluating the best options for continuing a sustainable development of FR104 including worldwide partnering opportunities.”

The T cell molecule CD28 is well-known in the CAR-T sphere as one of two commonly used costimulatory domains. OSE’s theory is that blocking it using a monoclonal antibody can offer immune control in a number of inflammatory and autoimmune diseases.

Aside from FR104, OSE is also developing a Phase III therapy for non-small cell lung cancer, as well as an SIRPα antagonist dubbed OSE-172, partnered with Boehringer Ingelheim and Servier in oncology and autoimmune indications, respectively.

https://endpts.com/jj-dumps-phii-ready-cd28-autoimmune-asset-returns-rights-to-french-partner/

FDA Approves Pfizer Lung Cancer Med

Pfizer Inc. PFE, -1.69% today announced that the U.S. Food and Drug Administration (FDA) has approved LORBRENA® [lor-BREN-ah] (lorlatinib), a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) for patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease; or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. This represents the third FDA approval Pfizer has received for an oncology treatment, including two lung cancer medicines, within two months.

“Over the years, Pfizer has transformed research, management and treatment for patients with ALK-positive non-small cell lung cancer. Building upon our extensive understanding of tumor complexity and treatment resistance, LORBRENA was discovered by Pfizer scientists and developed specifically to inhibit tumor mutations that may drive resistance to other ALK tyrosine kinase inhibitors,” said Andy Schmeltz, Global President, Pfizer Oncology. “We believe that LORBRENA will benefit patients with ALK-positive metastatic non-small cell lung cancer that have progressed on prior therapy and continue to deliver on our commitment to addressing unmet needs of cancer patients.”

Since Pfizer introduced XALKORI [®] (crizotinib) as the first TKI for the treatment of ALK-positive metastatic NSCLC in 2011, the availability of these medicines has created an opportunity to provide patients with treatment options other than chemotherapy. However, lung cancer remains the leading cause of cancer-related death around the world.

While many ALK-positive metastatic NSCLC patients respond to initial TKI therapy, they typically experience tumor progression. [1,2] Additionally, options for patients who progress after treatment with second-generation ALK TKIs, alectinib, brigatinib and ceritinib, are limited. [3] The approval of LORBRENA represents a new option for patients who have progressed on a second-generation ALK TKI, providing an opportunity to remain on oral therapy.

“The last decade has witnessed dramatic improvements in the treatment of metastatic ALK-positive non-small cell lung cancer due to earlier generation ALK biomarker-driven therapies. Yet almost all patients still relapse due to drug resistance, with a large proportion of patients developing new or worsening brain metastases,” said Alice T. Shaw, MD, PhD, Professor of Medicine at Harvard Medical School, and Director of the Center for Thoracic Cancers at Massachusetts General Hospital. “In a clinical study which included patients with or without brain metastases, LORBRENA demonstrated clinical activity in patients with metastatic ALK-positive non-small cell lung cancer who had failed other ALK biomarker-driven therapies.”

https://www.marketwatch.com/press-release/us-fda-approves-lorbrena-lorlatinib-for-previously-treated-alk-positive-metastatic-nsclc-2018-11-02

FDA Commissioner: ‘very tight restrictions’ on Dsuvia distribution, use

FDA Commissioner Scott Gottlieb issued a statement on the agency’s approval of Dsuvia, stating in part: “In this particular case, Dsuvia is a sublingual (under the tongue) formulation of sufentanil that’s delivered through a disposable, pre-filled, single-dose applicator. The medicine is restricted to use in certified medically-supervised health care settings – such as hospitals, surgical centers and emergency departments – for administration by a health care professional. Dsuvia, which was previously approved by the European Medicines Agency in July under the brand name Dzuveo, has some unique features in that the drug is delivered in a stable form that makes it ideally suited for certain special circumstances where patients may not be able to swallow oral medication, and where access to intravenous pain relief is not possible. This includes potential uses on the battlefield. For this reason, the Department of Defense (DoD) worked closely with the sponsor on the development of this new medicine. This opioid formulation, along with Dsuvia’s unique delivery device, was a priority medical product for the Pentagon because it fills a specific and important, but limited, unmet medical need in treating our nation’s soldiers on the battlefield. The involvement and needs of the DoD in treating soldiers on the battlefield were discussed by the advisory committee. There are very tight restrictions being placed on the distribution and use of this product. We’ve learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis. We’ve applied those hard lessons as part of the steps we’re taking to address safety concerns for Dsuvia, including requiring a Risk Evaluation and Mitigation Strategy (REMS) to accompany this drug. The REMS reflects the potential risks associated with this product and will tightly control its distribution and use. Importantly, the distribution system will restrict Dsuvia’s use to certified medically-supervised health care settings, an important step to help prevent misuse and abuse of Dsuvia. The FDA will continue to carefully monitor the implementation of the REMS associated with Dsuvia and compliance with its requirements, and we’ll work to quickly make regulatory adjustments if problems arise. But underlying the debate surrounding this approval is a broader issue that must be addressed head on: why do we need an oral formulation of sufentanil – a more potent form of fentanyl that’s been approved for intravenous and epidural use in the U.S. since 1984 – on the market? […] Currently, in applying our statute and regulations, we generally consider each new drug approval – and each new opioid drug approval – largely on its own merits. As part of our review, we ask whether the individual drug meets the standard for safety and effectiveness, and whether additional controls are needed to ensure safe use of that specific drug. But opioids are a unique class of medicines… I recognize that the debate goes beyond the characteristics of this particular product or the actions that we’re taking to mitigate this drug’s risks and preserve its differentiated benefits. We won’t sidestep what I believe is the real underlying source of discontent among the critics of this approval – the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction…As a physician and regulator, I won’t bypass legitimate questions and concerns related to our role in addressing the opioid crisis.”

https://thefly.com/landingPageNews.php?id=2816879

AbbVie Q3 results do not convince Piper Jaffray to get off sidelines

Piper Jaffray analyst Christopher Raymond maintained a Neutral rating on AbbVie after the company’s Q3 earnings results, which Raymond noted were better than expected. However, the analyst was cautious given management’s indication of growing headwinds, which he believes “portend a meaningful downward revision to FY19 consensus.” Additionally, Raymond sees AbbVie “married to the prospects of Humira,” which he believes now faces international headwinds competing with four biosimilars.

https://thefly.com/landingPageNews.php?id=2816881

Trevena opioid painkiller fails to win FDA approval

Trevena (TRVN ) has received a CRL from the FDA in response to its marketing application seeking approval for pain med oliceridine, a not-unexpected action considering the close-but-negative vote from an advisory committee.

Shares, currently halted, will resume trading at 2:10 pm ET.

Previously: Trevena down 13% premarket after negative Ad Com vote (Oct. 12)

Update: Shares are down 33% on more than a 4x surge in volume in the last hour of the session.

Update: The CRL cited the need for additional data on a measure of heart function called QT prolongation, a larger safety database, more nonclinical data and validation reports.

https://seekingalpha.com/news/3404871-fda-rejects-trevenas-oliceridine

Sage’s postpartum depression treatment benefits outweigh risk: FDA panel

The benefits of Sage Therapeutics Inc’s experimental treatment for postpartum depression outweigh risks, an advisory panel to the U.S. Food and Drug Administration said on Friday.

The panel voted 17 to 1 in favor of the injectable treatment, Zulresso, that aims to treat major episodes of depression during pregnancy or within 4 weeks of delivery.

“I believe that (Zulresso) may be a game changer in the treatment of postpartum depression. This is what hope looks like,” said Felipe Jain, a panel member.

The decision comes two days after FDA staff reviewers raised safety concerns about the loss of consciousness, which was experienced by certain patients.

The FDA staffers also said Zulresso may not yet be suitable for use at home without supervision by a physician, and patients should be constantly monitored for signs of dizziness while under treatment.

Postpartum depression, a severe form of “baby blues”, is a common complication of childbirth that affects 1 in 9 women, according to the Centers for Disease Control and Prevention.

The FDA, expected to announce its final decision on the treatment by Dec. 19, is not mandated to follow the recommendation of the panel, but generally does.

https://www.reuters.com/article/us-sage-fda/sages-postpartum-depression-treatment-benefits-outweigh-risk-fda-panel-idUSKCN1N72EU

AcelRx has ‘very large market opportunity’ for Dsuvia, says Ladenburg

After the FDA approved AcelRx’s Dsuvia for the management of acute pain in certified medically supervised healthcare settings, Ladenburg analyst Michael Higgins said data shows there are more than 100M patients with pain in medical institutions annually and about 40M with moderate-to-severe acute pain that receive opioids in the Emergency Department, giving the drug a “very large market opportunity.” Adding that forecasting the rate of adoption of a novel drug to hospital formularies is difficult, Higgins left his prior revenue estimates unchanged following the approval news. He reiterates a Buy rating and $10 price target on AcelRx shares.

https://thefly.com/landingPageNews.php?id=281691