Wednesday, October 10, 2018
Crispr Therapeutics initiated at Wells Fargo
Crispr Therapeutics initiated with an Outperform at Wells Fargo. Wells Fargo analyst Jim Birchenough started Crispr Therapeutics with an Outperform rating and $65 price target. The analyst cited the company’s “highly leverageable” gene editing platform, “substantially de-risked” lead program in ex-vivo gene editing for beta thalassemia and sickle cell disease, a broad pipeline of both ex vivo and in vivo gene-editing opportunities, and strong collaborations balancing wholly owned programs to optimize future value creation.
https://thefly.com/landingPageNews.php?id=2802107
AcelRx falls after FDA staff says Dsuvia ‘offers no apparent advantage’
Shares of AcelRx (ACRX) are plunging in pre-market trading after the FDA posted the briefing documents for a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee to discuss the new drug application for Dsuvia submitted by AcelRx Pharmaceuticals for the management of moderate-to-severe acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, in adult patients in a medically supervised setting. In the document, FDA staff wrote: “Overall, although efficacy was demonstrated, Dsuvia offers no apparent advantage to currently available therapies. There are two areas of safety concern with this product that require further evaluation: the safety of Dsuvia in patients requiring the maximum dosing proposed for labeling because of the accumulation of sufentanil and the risk of misplaced tablets due to the small tablet size, use of an applicator, and inadequate directions for use. These concerns outweigh the possible benefit at this time.” In pre-market trading, AcelRx shares have fallen $1.03, or 39%, to $1.62.
Tuesday, October 9, 2018
Lilly GIP/GLP-1 Receptor Agonist Cuts HbA1c, Body Weight in Type 2 Diabetes
Results from a phase 2b clinical trial of Eli Lilly and Company’s (NYSE: LLY) dual GIP and GLP-1 receptor agonist (GIP/GLP-1 RA, LY3298176) showed strong and clinically meaningful blood sugar reduction and weight loss in people with type 2 diabetes. The six-month data – showing average HbA1c reductions of up to 2.4 percentage points and an average weight reduction up to 11.3 kg (12.7 percent) – were presented today at the 54th Annual Meeting of the European Association for the Study of Diabetes in Berlin and simultaneously published in The Lancet.1
The weekly dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptor agonist integrates the action of both incretins into a single novel molecule, aiming to build upon the clinical benefits seen with a selective GLP-1 RA.
“These phase 2b clinical trial results for GIP/GLP-1 RA are unprecedented, and the impressive blood glucose and weight reductions seen may lead to a new treatment option for people with type 2 diabetes,” said Juan P. Frias, M.D., President and Principal Investigator, National Research Institute. “The next wave of innovation in the study of incretins for treating type 2 diabetes is fascinating. We’re taking the already proven benefits of GLP-1 receptor agonists and looking at a new molecule that integrates GIP action to see what additional benefits are possible.”
The analysis of participants while on treatment comparing GIP/GLP-1 RA to dulaglutide and placebo showed significant improvements across endpoints.1
- HbA1c reduction: All GIP/GLP-1 RA doses and dulaglutide showed significant blood sugar improvement (mean absolute reduction) from baseline [GIP/GLP-1 RA: -1.6 percent (5 mg), -2.0 percent (10 mg), and -2.4 percent (15 mg); dulaglutide -1.1 percent (1.5 mg)] compared to placebo (0.1 percent).
- HbA1c target: The higher doses of GIP/GLP-1 RA provided the most significant HbA1c reductions, with up to 30 percent of people who received the 10 mg and 15 mg doses achieving HbA1c levels of less than 5.7 percent, which is in the normal range for people without diabetes [18 percent (10 mg) and 30 percent (15 mg)]. Further, up to 90 percent of people reached the recommended HbA1c target of 7 percent or less [GIP/GLP-1 RA: 69.1 percent (5 mg), 90.0 percent (10 mg), and 77.4 percent (15 mg); dulaglutide 51.9 percent (1.5 mg)].
- Weight loss: Participants taking GIP/GLP-1 RA achieved significant weight loss [-4.8 kg (5 mg), -8.7 kg (10 mg) and -11.3 kg (15 mg)], as did those taking dulaglutide [-2.7 kg (1.5mg)], compared to placebo (-0.4 kg). More than a third of people lost 10 percent or more of their starting body weight with GIP/GLP-1 RA 10 mg (39.2 percent) and 15 mg (37.7 percent), and a quarter of people lost 15 percent or more with the 15 mg dose.
The safety profile of GIP/GLP-1 RA was similar to the GLP-1 RA class. The most commonly reported side effects were gastrointestinal-related, and dose-dependent. These events included nausea [20 percent (5 mg), 22 percent (10 mg), 40 percent (15 mg)], diarrhea [24 percent (5 and 10 mg), 32 percent (15 mg)] and vomiting [8 percent (5 mg), 16 percent (10 mg), 26 percent (15 mg)], which were mild to moderate and generally temporary, most often occurring during the titration period. Dulaglutide 1.5 mg had a similar side effect profile to previous studies. No participants in any of the treatment groups experienced severe hypoglycemia.1 A further study examining an optimal titration schedule to help manage GI side effects was conducted and will be presented next year.
Humana 2019 Medicare Health Plans
- Enhanced or comparable plan value for 97 percent of Humana individual Medicare Advantage members
- More $0 premium plans and expanded Medicare Advantage HMO and PPO offerings
- Go365 wellness rewards and SilverSneakers fitness program available to most Humana Medicare Advantage members
Humana Inc. (NYSE: HUM) announced today that its Medicare plans for 2019 are designed to deliver affordable health benefits and wellness programs with added convenience and a focus on health and well-being for the whole person. Nearly all (97 percent) of Humana’s individual Medicare Advantage members will see enhanced or comparable value in their plan’s combination of monthly premiums and benefits in 2019, and 2.8 million members will see their monthly premiums decrease or stay the same.
Highlights of Humana’s 2019 Medicare plans include:
- Dental, hearing and vision coverage, fitness program memberships, home-delivered meals following an inpatient hospital stay, and an allowance for over-the-counter personal care items, at no additional cost, with most Humana Medicare Advantage plans;
- Home support and resources for caregivers, virtual doctor visits, telepsychiatry, personal emergency alert devices, rides to medical appointments, and acupuncture with select Humana Medicare Advantage plans;
- More $0 monthly premium Medicare Advantage HMO and PPO plans available across the country;
- And, more Special Needs Plans for dual-eligible (Medicare/Medicaid) members.
Many Humana Medicare Advantage plans include:
- Coverage for Medicare Parts A and B, with predictable copayments and no deductibles
- Part D prescription drug coverage (Medicare Advantage plans without Part D prescription coverage are also available)
- Benefits for services that Medicare doesn’t cover, including routine eye exams, preventive dental care and hearing coverage, including hearing aid coverage options for more than 2.6 million people
- Maximum out-of-pocket protection (on all Humana Medicare Advantage plans)
- Programs designed to improve health and manage chronic conditions
For 2019, Humana also has continued to expand its virtual visit telemedicine program, offering eligible members phone or Web access to board-certified physicians for non-emergency medical conditions. More than 1.8 million people will have virtual access to care providers through the program.
In addition, Humana is expanding transportation benefits. As a result, more than 1.2 million Humana Medicare Advantage members will have access to rides to doctor visits, participating gyms and fitness centers or other health-related appointments.
RWDC closes $13M Series A2 with Vickers, Harper funds to make plastic alternative
Singapore-headquartered biotech start-up RWDC Industries Pte Ltd announced today that it has successfully closed a US$13 million Series A2 round co-led by venture capital firms Vickers Venture Partners and WI Harper Group. Finance firm Ridgevale Enterprises Limited and individual investors also participated in the round.
Vickers Chairman and co-founding partner Dr. Finian Tan, along with WI Harper Chairman Mr. Peter Liu, have joined RWDC’s board of directors.
RWDC Executive Chairman Mr. Roland Wee said: “I am heartened by the trust that WI Harper, Vickers Venture Partners, Ridgevale Enterprises Limited and all our other investors have shown in us. We are a highly capable, passionate, and experienced team of scientists, engineers, financiers and marketers. This team is determined and confident in realising our vision of helping make this planet a greener place for future generations.”
Series A2 funds will primarily be used to expand RWDC’s PHA (polyhydroxyalkanoate) production capacity in Athens, Georgia (USA), to 2,000 tonnes per year, making it among the world’s largest PHA producers by early 2019.
RWDC develops innovative and cost-effective biopolymer material solutions. In particular, the company produces medium-chain-length polyhydroxyalkanoate (mcl-PHA). PHAs are naturally produced by bacterial fermentation of plant-based oils or sugar, and are widely recognized as the world’s only commercially viable biodegradable bioplastic due to its versatility1.
RWDC’s PHA is certified to be fully biodegradable in soil, water and marine conditions (i.e. all potential end-of-life scenarios) by certification agency TUV Austria (formerly Vincotte). It fully biodegrades within weeks with no toxic residue. RWDC’s customers will be able to label their products as 100% bio-based, non-toxic and truly biodegradable.
“Over the last few months, we have received strong support from our investors, as well as tremendous interest from potential customers, including major packaging manufacturers and F&B brand owners”, Mr. Wee said. “We are extremely excited and focused on the expansion of our PHA facility in the US, as this marks our first step towards producing PHA at commercially affordable prices for the global market. We have concrete plans to scale up very quickly from here.”
RWDC Chief Executive Officer Dr. Daniel Carraway said: “This facility will be a training ground for our staff, provide material for customer trials, and serve as a demonstration of our capabilities. At the same time, we have ambitious plans for the future. We look forward to providing the world with a truly biodegradable, 100% renewable, and highly versatile material.”
“PHA will be a major component in sustainable packaging materials of the future, and RWDC offers a comprehensive technical and material resource for brand owners and converters in the food service, food packaging, and consumer goods packaging industries.
Dr. Finian Tan said: “Every year, the world produces several hundred metric tonnes of plastic, mostly destined for single-use products that persist in the environment after disposal and creates a huge plastic pollution problem that the world is increasingly acutely aware of.”
“While it is unrealistic to curb the massive demand for plastic – especially in emerging markets where consumption is on a constant rise – we can still power innovators such as RWDC to develop a commercially attractive solution to a long-standing socio-ecological problem.”
Chairman of WI Harper Group, Mr. Peter Liu commented: “From microplastics in the arctic sea ice to once-pristine beaches in Thailandand Philippines being shut down, not only is plastic pollution at a negative tipping point but the world needs solutions and education on this topic. We are extremely excited to partner with RWDC and their dynamic management team. PHA produced at their pilot facility has already shown purity and yield above expectations.”
Mr. Liu further added, “Recycling is still the preferred choice among governments worldwide, as current biodegradable solutions may produce waste that has little value. There are many lobbyists for recycling in government, but not for biodegradability. We look forward to bringing positive change and social impact in sustainability for the future generations to come.”
In July, RWDC won the inaugural Liveability Challenge, presented by Temasek Foundation Ecosperity, securing S$980,000 in funding for its proposal to make fully biodegradable drinking straws made of PHA. The company is working towards developing drinking straw prototypes by the end of the year and will produce straws in commercial quantities by mid-2019.
RWDC’s PHA is suitable for a broad range of applications, including single-use food service articles (e.g. cutlery, drinking straws and cup lids), paper coatings (e.g. cups, bowls, plates and takeout containers), food and beverage packaging, consumer goods packaging, diapers, wipes and agricultural mulch films.
UK clinical trials fall as Brexit clouds drug approval process
The number of new clinical trials started in Britain last year was 25 percent lower than the average for 2009-16, as anxiety about Brexit’s impact on future medicines regulation made companies hesitate about running studies in the country.
A total of 597 trials were initiated in Britain in 2017, against an average of 806 over the previous eight years, according to a Fitch analysis on Tuesday.
Drugmakers’ confidence has been dented by fears research data collected in Britain might not be acceptable to the European Medicines Agency (EMA) after the UK leaves the European Union next March.
The pharmaceuticals industry has long warned that Brexit could have a serious impact on research and access to medicines, unless London and Brussels hammer out a deal for regulatory continuity and close liaison with the EMA.
If there is no deal, the UK’s Medicines and Healthcare products Regulatory Agency would have to operate as a stand-alone regulator and there is no clarity over how UK data would be treated by the EMA.
Historically, the UK’s National Health Service (NHS) has been an important centre for drug research, a backdrop that has encouraged pharmaceutical investment. Now industry leaders fear this could be at risk.
“We know from our members that Brexit-related uncertainty is a major concern when it comes to decisions about whether to set up trials in the NHS,” said Sheuli Porkess, deputy chief scientific officer at the Association of the British Pharmaceutical Industry.
“This is why it’s vital that we get a Brexit deal to keep the investment and skills in clinical trials here in the UK.”
Concerns over the issue were highlighted last week by news that U.S. biotech company Recardio had suspended trials of a new heart drug in Britain.
China approves 17 anti-cancer drugs for medical insurance coverage
China has approved 17 anti-cancer drugs for inclusion in its national health insurance system, the government said on Wednesday, part of its efforts to make cancer treatment more affordable as the number of cases increases.
China’s State Medical Insurance Administration has been in negotiations with domestic and overseas pharmaceutical companies to lower prices and put more cancer drugs on the list of medicines eligible for reimbursement.
The administration said in a notice that the negotiations were a major part of the government’s strategy to make cancer drugs more affordable to the general public. The 17 drugs, which include azacitidine, will remain eligible until Nov. 30, 2020.
China’s cancer rates have been soaring, driven by growing numbers of over-60s, heavy smoking among men and exposure to pollution. The National Cancer Center said last year there were 4.29 million new cases every year and 2.81 million deaths.
China has vowed to improve the five-year cancer survival rate by 15 percentage points by 2030. The rate stood at 30 percent in 2015, half the U.S. level.
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