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Wednesday, July 10, 2019

Astellas launches new therapeutic option for rheumatoid arthritis

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., ‘Astellas’ ) today announced the launch of the Smyraf® 50 mg and 100 mg Tablets (generic name: peficitinib hydrobromide), an oral Janus kinase (JAK) inhibitor, in Japan for the treatment of rheumatoid arthritis (including prevention of structural joint damage) in patients who have an inadequate response to conventional therapies.
Smyraf®, which was discovered by Astellas, suppresses activation and proliferation of inflammatory cells involved in synovial inflammation and joint destruction in rheumatoid arthritis patients by inhibiting various inflammatory cytokine signaling pathways.
The number of rheumatoid arthritis patients in Japan is estimated to be approximately 0.6 to 1.0 million*1. Currently, disease-modifying antirheumatic drugs (DMARDs)*2including Methotrexate (MTX) and biologics, are used to treat rheumatoid arthritis. By providing Smyraf® as a new therapeutic option, Astellas will contribute to treatment of rheumatoid arthritis patients with an inadequate response to conventional therapy such as DMARDs.
Astellas reflected the impact from this launch in its financial forecasts of the current fiscal year ending March 31, 2020.

Sanofi: FDA to review potential treatment for multiple myeloma

The U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for isatuximab for the treatment of patients with relapsed/refractory multiple myeloma (RRMM). The target action date for the FDA decision is April 30, 2020. Isatuximab is an investigational monoclonal antibody that targets a specific epitope on the CD38 receptor of a plasma cell.
The BLA is based on positive results from ICARIA-MM, an open-label pivotal Phase 3 clinical trial of isatuximab in patients with RRMM. ICARIA-MM is the first positive randomized Phase 3 trial to evaluate an antibody in combination with pomalidomide and dexamethasone. Results from this trial were presented at the 2019 American Society of Clinical Oncology Annual Meeting and the 2019 European Society of Hematology Annual Meeting.

Jazz Acquires Pre-clinical Pan-RAF Inhibitor Program from Redx Pharma

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company has signed a definitive agreement under which Jazz has acquired Redx Pharma’s (Redx) pan-RAF inhibitor program for the potential treatment of RAF and RAS mutant tumors.  Redx will perform certain pre-clinical activities for the program under a separate collaboration agreement with Jazz.  Jazz will be responsible for further development, regulatory activities and commercialization.
Under the terms of the agreement, Jazz will pay Redx an upfront payment of $3.5 million.  Redx is eligible to receive up to $203 million in development, regulatory and commercial milestone payments from Jazz, and incremental tiered royalties in mid-single digit percentage, based on any future net sales.
“We are excited to acquire Redx’s pan-RAF inhibitor program.  It has the potential to work in RAF driven tumors where current selective B-RAF inhibitors and their respective combinations are ineffective due to acquired resistance mechanisms.  In addition, there is the potential to address RAS driven tumors,” said Robert Iannone, M.D., M.S.C.E., executive vice president, research and development of Jazz Pharmaceuticals.  “We look forward to advancing the pan-RAF inhibitor program that is part of a novel class of next generation precision oncology drugs and is highly complementary to our growing R&D portfolio of early-stage, innovative, hematology/oncology therapies.”

$280,000 lab-grown burger could be a more palatable $10 in two years

Consumers concerned about climate change, animal welfare and their own health are fueling interest in so-called clean meat, with the number of associated business start-ups climbing from four at the end of 2016 to more than two dozen two years later, according to the Good Food Institute market researcher.
Plant-based meat alternatives are also booming. Shares in Beyond Meat have more than tripled in price since its initial public offering in May. Beyond Meat and Impossible Foods each sell 100% plant-based meat alternatives to retailers and fast food chains across the United States.
And cultured meat grown from animal cells could be next on the mainstream menu, with producers eyeing regulatory approval as they improve the technology and reduce costs.
It was Dutch start-up Mosa Meat’s co-founder Mark Post who created the first “cultured” beef hamburger in 2013 at a cost of 250,000 euros ($280,400), funded by Google co-founder Sergey Brin, but Mosa Meat and Spain’s Biotech Foods say that production costs have fallen dramatically since then.
“The burger was this expensive in 2013 because back then it was novel science and we were producing at very small scale. Once production is scaled up, we project the cost of producing a hamburger will be around 9 euros,” a Mosa Meat spokeswoman told Reuters, adding that it could ultimately become even cheaper than a conventional hamburger.
PRICE PARITY
Biotech Foods co-founder Mercedes Vila also highlighted the importance of moving from lab to factory.
“Our goal is to reach production scale and have regulatory approval by 2021,” Vila said.
She said the average cost of producing a kilogram of cultured meat is now about 100 euros, significantly below the $800 cited a year ago by Future Meat Technologies, an Israeli biotech company that has received funding from U.S. meat processor Tyson Foods.
Biotech Foods, Mosa Meat and Higher Steaks, a London-based competitor also contacted by Reuters, have yet to file applications for EU approval because they are still working to improve their growth serum.
To make cultured meat, stem cells from the muscle of an animal are placed in a culture medium that is then put in a bioreactor – similar to those used for fermentation of beer and yogurt – to support growth of new strands of muscle tissue.
Liz Specht, associate director at the Good Food Institute market research firm that focuses on meat alternatives, said in a white paper this year that it was likely that cell-based meat would achieve price parity with conventional meat once production is on an industrial scale.
Specht identified the cell culture medium as the most significant cost driver and said it was possible to produce it without animal-derived components and at much lower prices.
ENERGY EFFICIENCY
Proponents of this new technology say it’s the only environmentally sustainable way to satisfy meat demand that the United Nations’ Food and Agriculture Organization expects to double between 2000 and 2050.
But John Lynch, an environmental scientist at the University of Oxford, said it remains unclear whether scalable lab-grown meat production can really convert energy and nutrients into meat more efficiently than conventional meat production.
“Some studies have suggested that cultured meat may require less of a ‘feed’ source than conventional livestock production, but require more energy. If this is the case, then their impact on the climate will depend on where this energy comes from,” he said.
Interest in the category has ensured start-ups have had ample access to funding.
Biotech Foods’ Vila said the company had sufficient funds up to 2021, the year it hopes to generate its first revenue, thanks to a capital injection from an unidentified investor.
Mosa Meat has meat processors Bell Food Group and Merck KGaA’s venture capital arm M Ventures among its investors.
In May food and agriculture group Cargill announced it had invested in cultured meat company Aleph Farms.

GSK’s Dovato suppresses AIDS virus at same levels of 3-drug regimen

GlaxoSmithKline Plc two-drug HIV regimen Dovato was successful in suppressing the AIDS-causing virus in patients for six months at the same level of a previous three-drug treatment in a late-stage study, the drugmaker said on Wednesday.

The study evaluated the effectiveness of Dovato, a combination of dolutegravir and lamivudine, in adults with the HIV-1 virus who switched to the regimen from at least a triple combination containing Gilead Sciences Vemlidy, the British company’s HIV drugs division ViiV said.
The positive results further bolster GSK’s efforts to challenge U.S. drugmaker Gilead, which currently leads the HIV treatment market.
ViiV also said adults who used Dovato did not develop any resistance to the treatment.
Dovato already has the go ahead from U.S. and European authorities for use in some patients and GSK already has another double combination, Juluca, on the market for HIV. It also has a monthly-injectable, two-drug treatment in the works.
Pfizer Inc and Shionogi & Co Ltd also have small stakes in ViiV, which accounted for about 39% of GSK’s group operating profit last year, according to UBS analysts.
The HIV-1 category has the most widespread strains of the virus, which severely affects the body’s immune system.

Albireo expects late-stage data on odevixibat mid-2020

In an update for investors, Albireo Pharma (NASDAQ:ALBO) announces that enrollment in its Phase 3 clinical trial, PEDFIC 1, evaluating odevixibat in pediatric patients with progressive familial intrahepatic cholestasis (PFIC) is over 50% completed.
Topline results should be available by mid-2020.
An open-label extension study, PEDFIC 2, is ramping up.
Odevixibat selectively inhibits a protein called the ileal bile acid transporter (IBAT), which, as the name implies, plays a key role in transporting bile from the liver to the colon.
The company is developing another IBAT inhibitor, elobixibat, for the potential treatment of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH). A Phase 2 study is in process.

Oasmia cuts ties with former executive chairman over questionable transactions

Oasmia Pharmaceutical AB (NASDAQ:OASM) reports that it has terminated its “engagement and cooperation” with former executive chairman Julian Aleksov without further pay.
The company took action following a tax audit that revealed missing funds connected to suspicious transactions between Oasmia and companies controlled by Mr. Aleksov and his former father in-law.
The board has reported the matter to the Swedish Economic Crime Authority.
Shares are down 3% after hours.