FDA accepts Bristol-Myers application for Opdivo + Yervoy for liver cancer

Under Priority Review status, the FDA accepts Bristol-Myers Squibb’s (NYSE:BMY) supplemental marketing application seeking approval to use Opdivo (nivolumab) + Yervoy (ipilimumab) to treat patients with advanced hepatocellular carcinoma (HCC) who have previously received Bayer’s Nexavar (sorafenib), a Breakthrough Therapy indication.

The agency’s action date is March 10, 2020.

https://seekingalpha.com/news/3517480-fda-accepts-bristol-myers-application-opdivo-yervoy-liver-cancer

Foamix Pharmaceuticals EPS beats by $0.05

Foamix Pharmaceuticals (NASDAQ:FOMX): Q3 GAAP EPS of -$0.41 beats by $0.05.

Cash and cash equivalents of $40.53M

Press Release

https://seekingalpha.com/news/3517435-foamix-pharmaceuticals-eps-beats-0_05

Almirall, S.A. reports 9M results

Almirall, S.A. (OTC:LBTSF): 9M net income of €97.3M

Revenue of €683.2M (+17.0% Y/Y)

Press Release

https://seekingalpha.com/news/3517429-almirall-s-reports-9m-results

FDA tags F2G’s olorofilm as Breakthrough Therapy for fungal infections

The US drugs regulator has tagged F2G’s olorofilm as a potential Breakthrough Therapy for life-threatening fungal infections, pledging to expedite development of the mid-stage candidate.

Based in the UK and Austria, F2G said the FDA granted the designation reserved for potentially game-changing medicines, for treatment of serious aspergillosis mould infections when standard therapies have failed.

The indication the biotech is targeting includes infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species, and makes this the first antifungal agent to be granted Breakthrough Therapy designation.

Breakthrough Therapy designation is an FDA process designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition.

The designation is granted based on preliminary clinical evidence indicating that the drug could be a substantial improvement over existing therapies on one or more clinically significant endpoints.

If data is supportive the FDA grants a faster Priority Review at the end of the process, allowing for a six-month review instead of the standard 10-month period.

Olorofim is currently being investigated in an open-label single-arm phase 2b study in patients with proven invasive fungal disease or probable invasive aspergillosis, whose disease resists standard therapies or when existing drugs cannot be tolerated.

So far olorofilm, which is being developed in both intravenous and oral formulations, has been well tolerated and data from this study were provided to the FDA as part of the company’s submission for Breakthrough Therapy status.

F2G said olorofilm, its lead product, belongs to a new class of antifungal agents it has discovered and developed called the orotomides.

Orotomides selectively target fungal dihydroorotate dehydrogenase (DHODH), a different mechanism from that of the currently marketed antifungal agents giving them fungicidal activity against a broad range of rare and resistant fungal mould infections

Ian Nicholson, CEO of F2G, said: “The granting of FDA Breakthrough Therapy designation is a truly transformational step for our company and will support our goal of rapidly developing this novel treatment for patients suffering from serious and life-threatening fungal infections.”

FDA tags F2G’s olorofilm as Breakthrough Therapy for fungal infections

Novartis buys Aspen’s Japanese generic unit for up to 400 million euros

Novartis is buying the Japanese generics unit of South Africa’s Aspen Pharmacare in a deal worth up to 400 million euros (344.5 million pounds) to expand in the world’s third-biggest drug market, the Swiss drugmaker said on Monday.

Novartis’s Sandoz generics business agreed to pay 300 million euros initially, plus a deferred amount not expected to exceed 100 million euros based on certain conditions being met, Novartis said. Completion of the transaction is expected in the first half of 2020.

Aspen Pharmacare has abandoned its dividend this year and is selling assets to pay down debt after levels moved close to breaching debt covenants.

Novartis’s Sandoz is adding Aspen’s Japan business in part to boost access to hospitals there. The South African’s portfolio consists of 20 off-patent medicines with annual sales of 130 million euros, including anaesthetics like Xylocaine as well as speciality brands such as the immune suppressing drug Imuran used by some multiple sclerosis patients.

“The acquisition of Aspen’s Japanese operations would significantly strengthen our position in this country, a stable but growing generics market,” Sandoz Chief Executive Richard Saynor said in a statement.

Sandoz is in the midst of a reorganisation within Novartis, as Chief Executive Vas Narasimhan sells U.S. generic pills and dermatology assets that had come under price pressure while simultaneously boosting the autonomy of the remaining businesses in a move he said will help them better compete.

https://www.marketscreener.com/ASPEN-PHARMACARE-HOLDINGS-1413350/news/Aspen-Pharmacare-Novartis-buys-Aspen-s-Japanese-generic-unit-for-up-to-400-million-euros-29559033/

First cannabis drugs approved for use on UK’s NHS

Two cannabis-based medicines – manufacturered by GW Pharmaceuticals (NASDAQ:GWPH) – have been recommended for use on the NHS for the first time.

Epidyolex has been approved for two rare types of epilepsy, Lennox-Gastaut and Dravet syndromes, while the spray Sativex has been recommended for muscle spasms in multiple sclerosis.

Campaigners welcomed the decision, but said thousands of other people with a range of conditions who could benefit from cannabis-based medicines were left in limbo.

https://seekingalpha.com/news/3517426-first-cannabis-drugs-approved-use-nhs

Roche sets sights on Novartis, Biogen as spinal muscular atrophy trial hits target

Roche’s bid to rival Biogen and Novartis in treating spinal muscular atrophy (SMA) got a lift on Monday when the Swiss drugmaker said its drug risdiplam improved motor function of patients in a key study.

Roche, which plans to seek approval for the investigational medicine this year, said its SUNFISH trial demonstrated statistically significant improvements in patients aged 2-25 years with Type 2 or 3 SMA, compared to a placebo.

The muscle-wasting disease, which hits 1 in every 10-11,000 newborns, has been a target of significant interest as drugmakers move into a rare disease area that commands ultra-high prices. Biogen’s Spinraza, approved in 2016, lists at $750,000 in year one and $375,000 thereafter, while Novartis’s Zolgensma is the costliest one-time treatment at $2.1 million.

Roche’s risdiplam, which would be the third treatment to market, is taken by mouth, as opposed to injected into the spine like Spinraza. Roche is also hoping data from its studies stacks up to that of Zolgensma, including in older SMA patients with forms of the disease that may emerge months after their birth but leave them with profound disabilities.

In its statement, Roche underscored the safety profile of Risdiplam just weeks after Novartis’s trial of Zolgensma in a similar population of SMA patients was halted by the U.S. Food and Drug Administration when primate study raised concerns of possible nerve damage or loss.

“No treatment related safety findings leading to study withdrawal have been seen in any risdiplam trial to date,” Roche said, adding it would release specific data from the SUNFISH trial at an upcoming medical conference.

Roche has partnered on risdiplam with PTC Therapeutics.

https://www.reuters.com/article/us-roche-risdiplam/roche-sets-sights-on-novartis-biogen-as-sma-trial-hits-target-idUSKBN1XL0MC